Unassociated Document
Filed
Pursuant to Rule 424(b)(3)
Registration
No. 333-143755
Prospectus
Supplement No. 12
(to
Prospectus dated December 10, 2007)
CLEVELAND
BIOLABS, INC.
5,514,999
Shares
This
Prospectus Supplement No. 12 supplements and amends the prospectus dated
December 10, 2007 (the “Prospectus”) relating to the offer and sale of up to
5,514,999 shares of our common stock which may be offered from time to time by
the selling stockholders identified in the Prospectus for their own accounts.
This Prospectus Supplement is not complete without, and may not be delivered or
used except in connection with the original Prospectus.
This
Prospectus Supplement No. 12 includes the attached Form 8-K of Cleveland
BioLabs, Inc. (the “Company”) dated March 30, 2009, and the attached Form 10-K
of the Company dated March 30, 2009, as filed by us with the Securities and
Exchange Commission.
This
Prospectus Supplement No. 12 modifies and supersedes, in part, the information
in the Prospectus. Any information that is modified or superseded in the
Prospectus shall not be deemed to constitute a part of the Prospectus, except as
modified or superseded by this Prospectus Supplement No. 12. We may amend or
supplement the Prospectus from time to time by filing amendments or supplements
as required. You should read the entire Prospectus and any amendments or
supplements carefully before you make an investment decision.
Investing
in our common stock involves risk. See “Risk Factors” beginning on
page 8 of the Prospectus, and on page 20 of the attached Form
10-K.
Neither
the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if the Prospectus or
this Prospectus Supplement No. 12 is truthful or complete. Any
representation to the contrary is a criminal offense.
The date
of this Prospectus Supplement No. 12 is March 31, 2009.
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date of
Report: (Date of earliest event reported): March 27, 2009
CLEVELAND
BIOLABS, INC.
(Exact
name of registrant as specified in its charter)
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Delaware
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001-32954
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20-0077155
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(State
or other jurisdiction
of
incorporation or organization)
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(Commission
File Number)
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(I.R.S.
Employer
Identification
Number)
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73
High Street
Buffalo,
New York 14203
(Address
of principal executive offices)
Registrant’s
telephone number, including area code: (716) 849-6810
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
¨
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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x
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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¨
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
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¨
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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Item 1.01.
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Entry
into a Material Definitive
Agreement
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Securities Purchase
Agreement
On March
27, 2009, Cleveland BioLabs, Inc. (the “Company”) entered into a
Securities Purchase Agreement (the “Purchase Agreement”) with
various accredited investors (the “March 27 Purchasers”),
pursuant to which the Company agreed to sell to the March 27 Purchasers 78.90
shares of Series D Convertible Preferred Stock, with a par value of $0.005 per
share and a stated value of $10,000 per share (“Series D Preferred”), and
Common Stock Purchase Warrants (the “Warrants”) to purchase
563,576 shares of
the Company’s Common Stock, par value $0.005 per share (“Common Stock”). The sale of
the Series D Preferred and the Warrants to the March 27 Purchasers (the “March 27 Transaction”) was
consummated on March 27, 2009. The offering period for the Series D
Preferred and Warrants concluded on the same date.
As
described in the Form 8-K filed with the Securities and Exchange Commission (the
“Commission”) on March
23, 2009 (the “March 23
8-K”), the Company initially sold 170.18 shares of Series D Preferred and
Warrants to certain accredited investors (the “Original Purchasers”) on
February 13, 2009 (the “Original Transaction”), and
then sold an additional 293.76 shares of Series D Preferred and Warrants to
certain accredited investors (the “March 20 Purchasers,” and
collectively with the Original Purchasers and the March 27 Purchasers, the
“Purchasers”) on March
20, 2009 (the “March 20
Transaction,” and collectively with the Original Transaction and the
March 27 Transaction, the “Transactions”). At the time of
the Original Transaction, the Series D Preferred had a conversion price of
$1.85, and the Warrants had an exercise price of $2.60. However, as set forth in
the March 23 8-K, to accommodate a reduction in the conversion price of the
Series D Preferred and in the exercise price of the Warrants, the Company (i)
entered into an Amendment and Waiver Agreement with the Original Purchasers (the
“Amendment and Waiver
Agreement”), attached hereto as Exhibit 10.4, pursuant to which the
Original Purchasers agreed to amend the Purchase Agreement to, among other
things, waive certain rights that they would otherwise have as a result of the
March 20 Transaction, including the full anti-dilution protection of their
Warrants, such that the exercise price of their Warrants was reduced to $1.60
per share (rather than to $1.40), and the number of shares of Common Stock
underlying their Warrants was increased based on the adjusted conversion price
of the Series D Preferred ($1.40), and (ii) entered into an Amendment and
Reaffirmation Agreement with the March 20 Purchasers (the “Amendment and Reaffirmation
Agreement”), the form of which is attached hereto as Exhibit 10.5,
pursuant to which the March 20 Purchasers agreed to amend certain terms of the
Purchase Agreement that they had originally executed, including to change the
conversion price of the Series D Preferred to $1.40, and a change of the
exercise price of the Warrants to $1.60. In connection with the March 27
Transaction, the March 27 Purchasers also agreed to the terms of the Amendment
and Reaffirmation Agreement. As a result of these actions, as of the date of
this Form 8-K, all outstanding shares of Series D Preferred have a conversion
price of $1.40, subject to future adjustment for various events, and all
Warrants have an exercise price of $1.60, subject to future adjustment for
various events.
At the
conversion price of $1.40, each share of Series D Preferred is convertible into
approximately 7,143 shares of Common Stock, subject to future adjustment. In the
aggregate, the 542.84 shares of Series D
Preferred issued in the Transactions are convertible into 3,877,386 shares of
Common Stock as of the date hereof, and the Warrants issued in the Transactions
are exercisable for 4,265,122 shares of Common Stock, which includes
387,736 shares of
Common Stock underlying Warrants issued to Garden State Securities, Inc. (“GSS”) and its designees in
consideration for its services as exclusive placement agent. GSS also received
gross cash compensation equal to 10% of the aggregate offering amount in the
Transactions. In the aggregate, the Series D Preferred and Warrants issued in
the Transactions are convertible into, and exercisable for, as of the date
hereof, 8,142,508 shares of Common Stock.
The aggregate purchase price paid by
the March 27 Purchasers for the Series D Preferred and the Warrants was $789,000
(representing $10,000 for each share of Series D Preferred together with a
Warrant), and the Purchasers collectively paid an aggregate of approximately
$5,428,307 for the Series D Preferred and Warrants in the
Transactions. After related fees and expenses, the Company has
received in the Transactions net proceeds totaling approximately
$4,460,000. The Company intends to use the proceeds for working
capital purposes.
The form of the Purchase Agreement is
attached hereto as Exhibit 10.1 and the form of the Warrants is attached hereto
as Exhibit 4.1. A description of the material terms of the Transactions is set
forth below and is qualified in its entirety by reference to the documents
attached hereto as Exhibits 3.1, 4.1, 10.1, 10.2, 10.3, 10.4, and 10.5, which
are incorporated herein by reference.
Terms of the Series D
Preferred
To designate and establish the shares
of Series D Preferred, the Company’s Board of Directors (the “Board”) approved, and on
February 13, 2009, the Company filed with the Delaware Secretary of State, a
Certificate of Designation of Preferences, Rights and Limitations of Series D
Convertible Preferred Stock (the “Certificate of Designation”).
The terms of the Series D Preferred are described in more detail in the March 23
8-K and the Form 8-K filed with the Commission on February 17, 2009 (the “February 17 8-K,” and
collectively with the March 23 8-K, the “Prior 8-Ks”). The Certificate
of Designation is attached hereto as Exhibit 3.1.
Warrants
The Warrants have a seven-year term.
The initial exercise price of the Warrants in the Original Transaction was
$2.60, but, as described above, pursuant to the terms of the Amendment and
Waiver Agreement and the Amendment and Reaffirmation Agreement, the exercise
price of all of the Warrants is now $1.60. The form of Warrants is attached
hereto as Exhibit 4.1, and their terms are described in more detail in the Prior
8-Ks.
Registration Rights
Agreement
In connection with the Purchase
Agreement, the Company also entered into Registration Rights Agreements with the
Purchasers, dated as of February 13, 2009, March 20, 2009, and March 27, 2009,
respectively, the terms of which are described in more detail in the Prior 8-Ks.
The form of the Registration Rights Agreement is attached hereto as Exhibit
10.2.
Stockholder Approval and
Voting Agreements
Under The NASDAQ Marketplace Rules, the
Company may not issue more than an aggregate of 2,770,160 shares of Common Stock
(i.e., 19.99% of the issued and outstanding Common Stock on February 13, 2009)
upon the conversion of the Series D Preferred and the exercise of the Warrants
into Common Stock unless stockholder approval is obtained, and the Certificate
of Designation reflects this limitation. In addition, stockholder
approval is also required for an amendment to the Company’s charter to provide
for an increase in authorized shares of Common Stock from 40,000,000 to no less
than 60,000,000. Under the Amendment and Waiver Agreement and the
Amendment and Reaffirmation Agreement, the Company is required to seek these
approvals at a meeting of its stockholders held no later than June 26,
2009. The Board has resolved to seek these approvals and to recommend
approval of these proposals at the Company’s 2009 Annual Meeting of
Stockholders.
On February 13, 2009, the Company
entered into a Voting Agreement with Bernard L. Kasten, James J. Antal, Paul E.
DiCorleto, Michael Fonstein, Andrei Gudkov, Yakov Kogan, H. Daniel Perez, John
A. Marhofer, Jr. and The Cleveland Clinic Foundation, and subsequently, on March
20, 2009, the Company entered into a Voting Agreement with certain additional
stockholders. The parties to these Voting Agreements agreed to vote
in favor of the proposals described above. In the aggregate, the parties to the
Voting Agreements held approximately 33% of the Company’s outstanding voting
stock as of March 27, 2009.
The Company intends to file a proxy
statement and other relevant documents concerning the transaction described
above with the SEC. The proxy statement will be distributed to the
Company’s stockholders in connection with a meeting of
stockholders. Stockholders are urged to read the proxy statement, the
documents incorporated by reference in the proxy statement, the other documents
filed with the SEC and the other relevant materials when they become available
because they will contain important information about the
transaction. Investors will be able to obtain these documents free of
charge at the SEC’s website (http://www.sec.gov). The directors,
executive officers, and certain other members of management and employees of the
Company and its subsidiaries are participants in the solicitation of proxies in
favor of approval of the transaction and related matters from the stockholders
of the Company. Information about the directors and executive
officers of the Company is set forth in its proxy statement for the 2008 annual
meeting of stockholders filed with the SEC on April 1,
2008. Additional information regarding the interests of such
participants will be included in the transaction-related proxy statement and the
other relevant documents filed with the SEC when they become
available.
Impact of the Transactions
on Series B Preferred, Series B Warrants and Series C
Warrants
Immediately after the completion of the
Transactions, pursuant to weighted-average anti-dilution provisions, (a) the
conversion price of the Company’s Series B Preferred adjusted to $4.67 (from an original
conversion price of $7.00 prior to the Original Transaction), causing the
conversion rate of the Series B Preferred into Common Stock to become
approximately 1-to-1.49893; and (b) the aggregate number of shares of Common
Stock into which the 2,863,974 shares of outstanding Series B Preferred are
convertible increased to approximately 4,292,901. In addition,
pursuant to weighted-average anti-dilution provisions, (i) the exercise prices
of the Company’s Series B Warrants and Series C Warrants adjusted, to $6.79 and $7.20, respectively,
from the exercise prices of $10.36 and $11.00, respectively, that were in effect
prior to the Original Transaction, and (ii) the aggregate number of shares
issuable upon exercise of the Series B Warrants and the Series C Warrants
increased to approximately 3,609,261 and 408,032, respectively, from
2,365,528 and
267,074, respectively, prior to the Original Transaction.
Item 3.02.
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Unregistered
Sales of Equity
Securities
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The information contained in Item 1.01
is hereby incorporated by reference. The Series D Preferred and the Warrants
were sold in transactions exempt from registration under the Securities Act of
1933, in reliance on Section 4(2) thereof and Rule 506 of Regulation D
thereunder. Each Purchaser represented that it was an “accredited investor” as
defined in Regulation D.
Item
5.03
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Amendments
to Articles of Incorporation or Bylaws; Changes in Fiscal
Year
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The information contained in Item 1.01
is hereby incorporated by reference. The Certificate of Designation, which
authorizes a total of 1,300 shares of Series D Preferred, was filed with the
Delaware Secretary of State on February 13, 2009 and was effective upon
filing.
On March
30, 2009, the Company issued a press release announcing the March 27 Transaction
described in Item 1.01. A copy of the press release is attached as
Exhibit 99.1.
Item 9.01.
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Financial
Statements and Exhibits
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(d) Exhibits
Exhibit No.
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Exhibit
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3.1
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Certificate
of Designation of Preferences, Rights and Limitations of Series D
Convertible Preferred Stock, dated February 13, 2009.
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4.1
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Form
of Common Stock Purchase Warrant.
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10.1
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Form
of Securities Purchase Agreement.
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10.2
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Form
of Registration Rights Agreement.
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10.3
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Form
of Voting Agreement.
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10.4
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Amendment
and Waiver Agreement, dated March 20, 2009.
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10.5
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Form
of Amendment and Reaffirmation Agreement.
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99.1
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Press
Release, dated March 30,
2009.
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SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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CLEVELAND
BIOLABS, INC.
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Date: March 30,
2009
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By:
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/s/
Michael Fonstein
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Michael
Fonstein
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President
and Chief Executive
Officer
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EXHIBIT
INDEX
Exhibit No.
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Exhibit
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3.1
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Certificate
of Designation of Preferences, Rights and Limitations of Series D
Convertible Preferred Stock, dated February 13, 2009.
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4.1
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Form
of Common Stock Purchase Warrant.
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10.1
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Form
of Securities Purchase Agreement.
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10.2
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Form
of Registration Rights Agreement.
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10.3
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Form
of Voting Agreement.
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10.4
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Amendment
and Waiver Agreement, dated March 20, 2009.
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10.5
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Form
of Amendment and Reaffirmation Agreement.
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99.1
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Press
Release, dated March 30,
2009.
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CLEVELAND
BIOLABS, INC.
CERTIFICATE
OF DESIGNATION OF PREFERENCES,
RIGHTS
AND LIMITATIONS
OF
SERIES
D CONVERTIBLE PREFERRED STOCK
PURSUANT
TO SECTION 151 OF THE
DELAWARE
GENERAL CORPORATION LAW
The
undersigned, Michael Fonstein and Yakov Kogan, do hereby certify
that:
1.
They are the President and Secretary, respectively, of Cleveland BioLabs, Inc.,
a Delaware corporation (the “Corporation”).
2.
The Corporation is authorized to issue 10,000,000 shares of preferred stock,
3,750,000 of which have been previously designated as Series A Participating
Convertible Preferred Stock, and 4,579,010 of which have been previously
designated as Series B Convertible Preferred Stock (the “Series B
Preferred”).
3.
The following resolutions were duly adopted by the board of directors of the
Corporation (the “Board of
Directors”):
WHEREAS,
the certificate of incorporation of the Corporation provides for a class of its
authorized stock known as preferred stock, consisting of 10,000,000 shares,
$0.005 par value per share, issuable from time to time in one or more
series;
WHEREAS,
the Board of Directors is authorized to fix the dividend rights, dividend rate,
voting rights, conversion rights, rights and terms of redemption and liquidation
preferences of any wholly unissued series of preferred stock and the number of
shares constituting any series and the designation thereof, of any of them;
and
WHEREAS,
it is the desire of the Board of Directors, pursuant to its authority as
aforesaid, to fix the rights, preferences, restrictions and other matters
relating to a series of the preferred stock, which shall consist of up to 1,300
shares of the preferred stock which the Corporation has the authority to issue,
as follows.
NOW,
THEREFORE, BE IT RESOLVED, that the Board of Directors does hereby provide for
the issuance of a series of preferred stock for cash or exchange of other
securities, rights or property and does hereby fix and determine the rights,
preferences, restrictions and other matters relating to such series of preferred
stock as follows:
TERMS
OF PREFERRED STOCK
Section
1. Definitions. For the
purposes hereof, the following terms shall have the following
meanings:
“Adjustment Date”
shall have the meaning set forth in Section 6(b).
“Affiliate” means any
Person that, directly or indirectly through one or more intermediaries, controls
or is controlled by or is under common control with a Person, as such terms are
used in and construed under Rule 405 under the Securities Act.
“Aggregate Sinking Fund
Redemption Amount” shall have the meaning set forth in Section
8(b).
“Alternate
Consideration” shall have the meaning set forth in Section
7(e).
“Amendment” means an
amendment to the Corporation’s certificate of incorporation that increases the
number of authorized shares of Common Stock from 40,000,000 to no less than
60,000,000 shares.
“Authorized Share
Approval” means (a) the approval by the stockholders of the Corporation
of the Amendment and (b) the filing by the Corporation of the Amendment with the
Secretary of State of the State of Delaware and the acceptance of the Amendment
by the Secretary of State of the State of Delaware.
“Authorized Share Approval
Date” means the later of the date that the Corporation (a) receives the
approval by the stockholders of the Corporation of the Amendment or (b) files
the Amendment with the Secretary of State of the State of Delaware and receives
the acceptance of the Amendment by the Secretary of State of the State of
Delaware.
“Automatic Conversion
Date” shall have the meaning set forth in Section 8(a).
“Automatic Conversion
Notice” shall have the meaning set forth in Section 8(a).
“Automatic Conversion Notice
Date” shall have the meaning set forth in Section
8(a).
“Bankruptcy Event”
means any of the following events: (a) the Corporation or any Significant
Subsidiary (as such term is defined in Rule 1-02(w) of Regulation S-X) thereof
commences a case or other proceeding under any bankruptcy, reorganization,
arrangement, adjustment of debt, relief of debtors, dissolution, insolvency or
liquidation or similar law of any jurisdiction relating to the Corporation or
any Significant Subsidiary thereof; (b) there is commenced against the
Corporation or any Significant Subsidiary thereof any such case or proceeding
that is not dismissed within 60 days after commencement; (c) the Corporation or
any Significant Subsidiary thereof is adjudicated by a court of competent
jurisdiction insolvent or bankrupt or any order of relief or other order
approving any such case or proceeding is entered; (d) the Corporation or any
Significant Subsidiary thereof suffers any appointment of any custodian or the
like for it or any substantial part of its property that is not discharged or
stayed within 60 calendar days after such appointment; (e) the Corporation or
any Significant Subsidiary thereof makes a general assignment for the benefit of
creditors; (f) the Corporation or any Significant Subsidiary thereof calls a
meeting of its creditors with a view to arranging a composition, adjustment or
restructuring of its debts; or (g) the Corporation or any Significant Subsidiary
thereof, by any act or failure to act, expressly indicates its consent to,
approval of or acquiescence in any of the foregoing or takes any corporate or
other action for the purpose of effecting any of the foregoing.
“Base Conversion
Price” shall have the meaning set forth in Section 7(b).
“Board of Directors”
means the board of directors of the Corporation.
“Business Day” means
any day except Saturday, Sunday, any day which is a federal legal holiday in the
United States or any day on which banking institutions in the State of New York
are authorized or required by law or other governmental action to
close.
“Buy-In” shall have
the meaning set forth in Section 6(e)(iii).
“Capital Lease
Obligation” means, as to any Person, for any obligation that is required
to be classified and accounted for as a capital lease on a balance sheet of such
Person prepared in accordance with GAAP and the amount of such obligation shall
be the capitalized amount thereof, determined in accordance with
GAAP.
“Change of Control
Transaction” means the occurrence after the date hereof of any of (i) an
acquisition after the date hereof by an individual, legal entity or “group” (as
described in Rule 13d-5(b)(1) promulgated under the Exchange Act) of effective
control (whether through legal or beneficial ownership of capital stock of the
Corporation, by contract or otherwise) of in excess of 40% of the voting
securities of the Corporation (other than by means of conversion or exercise of
Preferred Stock and the Securities issued together with the Preferred Stock), or
(ii) the Corporation merges into or consolidates with any other Person, or any
Person merges into or consolidates with the Corporation and, after giving effect
to such transaction, the stockholders of the Corporation immediately prior to
such transaction own less than 60% of the aggregate voting power of the
Corporation or the successor entity of such transaction, or (iii) the
Corporation sells or transfers all or substantially all of its assets to another
Person and the stockholders of the Corporation immediately prior to such
transaction own less than 60% of the aggregate voting power of the acquiring
entity immediately after the transaction, or (iv) a replacement at one time or
within a one-year period of more than one-half of the members of the Board of
Directors which is not approved by a majority of those individuals who were
members of the Board of Directors on the Original Issue Date (or by those
individuals who are serving as members of the Board of Directors on any date
whose nomination to the Board of Directors was approved by a majority of the
members of the Board of Directors who are members on the Original Issue Date,
which individuals will be deemed, for purposes hereof, to have been members of
the Board of Directors on the Original Issue Date).
“Closing” means the
closing of the purchase and sale of the Securities pursuant to Section 2.1 of
any of the Purchase Agreements.
“Closing Date” means
the Trading Day on which all of the applicable Transaction Documents have been
executed and delivered by the applicable parties thereto and all conditions
precedent to (i) each original Holder’s obligations to pay the Subscription
Amount and (ii) the Corporation’s obligations to deliver the Securities have
been satisfied or waived.
“Closing Price” means
on any particular date (a) the last reported (closing) sale price per share
of Common Stock on such date on the Trading Market (as reported by Bloomberg
L.P. at 4:15 p.m. (New York City time)), or (b) if there is no sale on such
date, then the last reported (closing) sale price on the Trading Market on the
date nearest preceding such date (as reported by Bloomberg L.P. at 4:15 p.m.
(New York City time)), or (c) if the Common Stock is not then listed or
quoted on a Trading Market and if prices for the Common Stock are then reported
in the “pink sheets” published by Pink OTC Markets, Inc. (or a similar
organization or agency succeeding to its functions of reporting prices), the
most recent bid price per share of the Common Stock so reported as of 4:02p.m.
(New York City time) on such date, or (d) if the shares of Common Stock are
not then publicly traded, the fair market value as of such date of a share of
Common Stock as determined by an independent appraiser selected in good faith by
the Holders of a majority in interest of the Shares then outstanding and
reasonably acceptable to the Corporation, the fees and expenses of which shall
be paid by the Corporation.
“Commission” means the
United States Securities and Exchange Commission.
“Common Stock” means
the Corporation’s common stock, par value $0.005 per share, and stock of any
other class of securities into which such securities may hereafter be
reclassified or changed.
“Common Stock
Equivalents” means any securities of the Corporation or the Subsidiaries
which would entitle the holder thereof to acquire at any time Common Stock,
including, without limitation, any debt, preferred stock, rights, options,
warrants or other instrument that is at any time convertible into or exercisable
or exchangeable for, or otherwise entitles the holder thereof to receive, Common
Stock.
“Conversion Amount”
means the sum of the Stated Value at issue.
“Conversion Date”
shall have the meaning set forth in Section 6(a).
“Conversion Price”
shall have the meaning set forth in Section 6(b).
“Conversion Shares”
means, collectively, the shares of Common Stock issuable upon conversion of the
shares of Preferred Stock in accordance with the terms hereof.
“Conversion Shares
Registration Statement” means a registration statement that registers the
resale of all Conversion Shares of the Holders, who shall be named
as selling stockholders” therein, and meets the requirements of the
Registration Rights Agreement.
“Corporation Notice”
shall have the meaning set forth in Section 8(b).
“Corporation Notice
Date” shall have the meaning set forth in Section 8(b).
“Dilutive Issuance”
shall have the meaning set forth in Section 7(b).
“Dilutive Issuance
Notice” shall have the meaning set forth in Section 7(b).
“Effective Date” means
the date that the Conversion Shares Registration Statement) filed by the
Corporation pursuant to the Registration Rights Agreement is first declared
effective by the Commission.
“Equity Conditions”
means, during the period in question, (i) the Corporation shall have duly
honored all conversions scheduled to occur or occurring by virtue of one or more
Notices of Conversion of the applicable Holder on or prior to the dates so
requested or required, if any, (ii) the Corporation shall have paid all
liquidated damages and other amounts owing to the applicable Holder under this
Certificate of Designation in respect of the Preferred Stock, (iii)(a) there is
an effective Conversion Shares Registration Statement pursuant to which the
Holders are permitted to utilize the prospectus thereunder to resell all of the
shares of Common Stock issuable pursuant to the Transaction Documents (and the
Corporation believes, in good faith, that such effectiveness will continue
uninterrupted for the foreseeable future) or (b) all of the Conversion Shares
issuable upon conversion of the outstanding shares of Preferred Stock by any
Holder that is not an Affiliate of the Corporation may, immediately following
such issuance, be resold by such Holder pursuant to Rule 144 without volume or
manner-of-sale restrictions or current public information requirements (or the
Corporation is then current in its public filings) as determined by the
Corporation, upon advice of counsel to the Corporation as set forth in a written
opinion letter, if required by the Transfer Agent, to such effect, addressed and
acceptable to the Transfer Agent and the affected Holders, (iv) the Common Stock
is trading on a Trading Market and all of the shares issuable pursuant to the
Transaction Documents are listed for trading on such Trading Market (and the
Corporation believes, in good faith, that trading of the Common Stock on a
Trading Market will continue uninterrupted for the foreseeable future), (v)
there is a sufficient number of authorized, but unissued and otherwise
unreserved, shares of Common Stock for the issuance of all of the shares of
Common Stock then issuable pursuant to the Transaction Documents, (vi) there is
no existing Triggering Event and no existing event which, with the passage of
time or the giving of notice, would constitute a Triggering Event, (vii) the
issuance of the shares in question (or, in the case of a redemption, the shares
issuable upon conversion in full of the redemption amount) to the applicable
Holder would not violate the limitations set forth in Section 6(c) and Section
6(d) herein, (viii) there has been no public announcement of a pending or
proposed Fundamental Transaction or Change of Control Transaction that has not
been consummated or terminated, and (ix) the applicable Holder is not in
possession of any information provided by the Corporation that constitutes, or
could reasonably be deemed to constitute, material non-public
information.
“Escrow Agent” means
Signature Bank, a New York State chartered bank and having an office at 261
Madison Avenue, New York, New York 10016.
“Escrow Agreement”
means the escrow agreement entered into on December 15, 2008, by and among the
Corporation and the Escrow Agent, pursuant to which the original Holders shall
deposit Subscription Amounts with the Escrow Agent to be applied to the
transactions contemplated under the Purchase Agreements.
“Exchange Act” means
the Securities Exchange Act of 1934, as amended, and the rules and regulations
promulgated thereunder.
“Exempt Issuance”
means the issuance of (a) shares of Common Stock or options to employees,
officers, consultants or directors of the Corporation pursuant to any stock
incentive plan duly adopted for such purpose, by a majority of the non-employee
members of the Board of Directors or a majority of the members of a committee of
non-employee directors established for such purpose (provided, however, any such
issuance(s) to consultants shall not exceed an aggregate of 750,000 shares of
Common Stock or options (subject to forward and reverse stock splits, stock
dividends and the like that occur after the Original Issue Date) in any 12 month
period), (b) securities upon the exercise or exchange of or conversion of any
securities issued pursuant to the Purchase Agreements and/or other securities
exercisable or exchangeable for or convertible into shares of Common Stock
issued and outstanding on the date of the applicable Purchase Agreement,
provided that such securities have not been amended since the date of the
applicable Purchase Agreement to increase the number of such securities or to
decrease the exercise price or conversion price of any such securities other
than increases in the number of securities or decreases in exercise price or
conversion price resulting from anti-dilution or similar provisions contained in
the terms and conditions of such securities on the date of the applicable
Purchase Agreement, and (c) securities issued pursuant to acquisitions or
strategic transactions approved by a majority of the disinterested directors of
the Corporation, provided that any such issuance shall only be to a Person (or
to the equityholders of a Person) which is, itself or through its subsidiaries,
an operating company in a business synergistic with the business of the
Corporation or a seller of assets and shall provide to the Corporation
additional benefits in addition to the investment of funds, but shall not
include a transaction in which the Corporation is issuing securities primarily
for the purpose of raising capital or to an entity whose primary business is
investing in securities.
“FDA” means the U.S.
Food and Drug Administration.
“Fundamental
Transaction” shall have the meaning set forth in Section
7(e).
“GAAP” means United
States generally accepted accounting principles.
“Holder” shall have
the meaning given such term in Section 2.
“Indebtedness” means
(x) any liabilities for borrowed money in excess of $100,000 (other than trade
accounts payable and operating leases incurred in the ordinary course of
business), (y) all guaranties, endorsements and other contingent obligations in
respect of indebtedness of others, whether or not the same are or should be
reflected in the Corporation’s balance sheet (or the notes thereto), except
guaranties by endorsement of negotiable instruments for deposit or collection or
similar transactions in the ordinary course of business; and (z) the present
value of any lease payments in excess of $100,000 due under leases required to
be capitalized in accordance with GAAP.
“Initial Adjustment
Date” shall have the meaning set forth in Section 6(b).
“Junior Securities”
means the Common Stock and all other Common Stock Equivalents of the Corporation
other than the Series B Preferred and any other securities which are explicitly
senior or pari
passu to the
Preferred Stock in dividend rights or liquidation preference.
“Liens” means a lien,
charge, security interest, encumbrance, right of first refusal, preemptive right
or any other restriction that has the practical effect of creating any of the
foregoing.
“Liquidation” shall
have the meaning set forth in Section 5.
“Material Adverse
Effect” means (i) a material adverse effect on the legality, validity or
enforceability of any Transaction Document, (ii) a material adverse effect on
the results of operations, assets, business, prospects or condition (financial
or otherwise) of the Corporation, or (iii) a material adverse effect on the
Corporation’s ability to perform in any material respect on a timely basis its
obligations under any Transaction Document
“Maturity Conversion
Date” shall have the meaning set forth in Section 8(c).
“Maturity Conversion
Notice” shall have the meaning set forth in Section 8(c).
“Maturity Conversion Notice
Date” shall have the meaning set forth in Section 8(c).
“Maturity Redemption”
shall have the meaning set forth in Section 8(c).
“Maturity Redemption
Date” shall have the meaning set forth in Section 8(c).
“Maturity Redemption
Amount” means, with respect to each share of Preferred Stock held by any
Holder subject to a Maturity Redemption, the sum of (a) 100% of the aggregate
Stated Value thereof, and (b) all liquidated damages and other amounts then due
and payable in respect of such share of Preferred Stock under this Certificate
of Designation on such Maturity Redemption Date.
“Maturity Threshold
Period” shall have the meaning set forth in Section 8(c).
“New York Courts”
shall have the meaning set forth in Section 12(d).
“Notice of Conversion”
shall have the meaning set forth in Section 6(a).
“Original Issue Date”
means the date of the first issuance of any shares of the Preferred Stock
regardless of the number of transfers of any particular shares of Preferred
Stock and regardless of the number of certificates which may be issued to
evidence such Preferred Stock.
“Permitted
Indebtedness” means (a) the Indebtedness existing on the initial Original
Issue Date and set forth on Schedule 3.1(aa)
attached to each of the Purchase Agreements, (b) Indebtedness solely
among the Corporation and the Subsidiaries, (c) indebtedness to contract
research organizations, hospitals, or similar entities or organizations,
incurred in the ordinary course of business in connection with FDA
approval-related trials of the Corporation’s product candidates, (d)
Indebtedness under real property leases for the Corporation’s business operation
facilities, (e) Capital Lease Obligations, and (f) extensions, refinancing or
renewals of the items in clauses (a) through (e) above, provided that the
principal amount of such Indebtedness is not increased or the terms modified to
impose more burdensome terms upon the Corporation or any Subsidiary, as the case
may be.
“Permitted Lien” means
the individual and collective reference to the following: (a) Liens for taxes,
assessments and other governmental charges or levies not yet due or Liens for
taxes, assessments and other governmental charges or levies being contested in
good faith and by appropriate proceedings for which adequate reserves (in the
good faith judgment of the management of the Corporation) have been established
in accordance with GAAP; (b) Liens imposed by law which were incurred in the
ordinary course of the Corporation’s business, such as carriers’, warehousemen’s
and mechanics’ Liens, statutory landlords’ Liens, and other similar Liens
arising in the ordinary course of the Corporation’s business, and which (x) do
not individually or in the aggregate materially detract from the value of such
property or assets or materially impair the use thereof in the operation of the
business of the Corporation and its consolidated Subsidiaries or (y) which are
being contested in good faith by appropriate proceedings, which proceedings have
the effect of preventing for the foreseeable future the forfeiture or sale of
the property or asset subject to such Lien; and (c) Liens incurred in connection
with Permitted Indebtedness; (d) Liens arising in the ordinary course of
business in connection with worker’s compensation, unemployment compensation and
other types of social security claims, in each case, for which the Corporation
maintains adequate reserves in accordance with GAAP; and (e) easements, rights
of way, restrictions, minor defects or irregularities in title and other similar
Liens arising in the ordinary course of business and not materially detracting
from the value of the property subject thereto and not interfering in any
material respect with the ordinary conduct of the business of the
Corporation.
“Person” means an
individual or corporation, partnership, trust, incorporated or unincorporated
association, joint venture, limited liability company, joint stock company,
government (or an agency or subdivision thereof) or other entity of any
kind.
“Placement Agent”
means Garden State Securities, Inc.
“Preferred Stock”
shall have the meaning set forth in Section 2.
“Purchase Agreement”
means each of the securities purchase agreements entered into at any time on or
before March 15, 2009 or such other date as may be agreed upon, in writing, by
the Corporation and the Placement Agent, to which the Corporation and the
original Holders are parties, as amended, modified or supplemented from time to
time in accordance with its terms and relating to the sale of the Preferred
Stock and Warrants.
“Redeemable Shares”
shall have the meaning set forth in Section 8(b).
“Registration Rights
Agreement” means, collectively, each of the Registration Rights
Agreements, dated as of the date of each of the Purchase Agreements, among the
Corporation and the original Holders, in the form of Exhibit B attached to
each of the Purchase Agreements.
“Registration
Statement” means a registration statement meeting the requirements set
forth in the Registration Rights Agreement and covering the resale of the
Underlying Shares as provided for in the Registration Rights
Agreement.
“Rule 144” means Rule
144 promulgated by the Commission pursuant to the Securities Act, as such Rule
may be amended from time to time, or any similar rule or regulation hereafter
adopted by the Commission having substantially the same effect as such
Rule.
“Securities” means the
Preferred Stock, the Warrants, the Warrant Shares and the Underlying
Shares.
“Securities Act” means
the Securities Act of 1933, as amended, and the rules and regulations
promulgated thereunder.
“Series B Preferred”
means the Series B Convertible Preferred Stock, par value $0.005 per share, of
the Corporation.
“Share Delivery Date”
shall have the meaning set forth in Section 6(e).
“Sinking Fund” means
the cash proceeds deposited into the Escrow Account, as further defined in the
Purchase Agreements.
“Sinking Fund
Conversion” shall have the meaning set forth in Section
8(b).
“Sinking Fund Conversion
Date” shall have the meaning set forth in Section 8(b).
“Sinking Fund Conversion
Price” shall mean 100% of the Stated Value.
“Sinking Fund
Percentage” for any Holder with respect to any Sinking Fund Redemption or
Sinking Fund Conversion, means the quotient of the number of outstanding shares
of Preferred Stock held by such Holder on the Corporation Notice Date applicable
to such Sinking Fund Redemption or Sinking Fund Conversion, divided by the
aggregate number of outstanding shares of Preferred Stock held by all Holders on
the applicable Corporation Notice Date.
“Sinking Fund
Redemption” shall have the meaning set forth in Section
8(b).
“Sinking Fund Redemption
Amount” means, with respect to each share of Preferred Stock held by any
Holder subject to a Sinking Fund Redemption or Sinking Fund Conversion, the sum
of (a)(i) prior to or on the first anniversary of the Original Issue Date, 115%
of the aggregate Stated Value thereof and (ii) after the first anniversary of
the Original Issue Date, 120% of the aggregate Stated Value thereof, and (b) all
liquidated damages and other amounts due and payable in respect of such share of
Preferred Stock under this Certificate of Designation on the applicable
Corporation Notice Date.
“Sinking Fund Redemption
Date” shall have the meaning set forth in Section 8(b).
“Stated Value” shall
have the meaning set forth in Section 2.
“Stockholder Approval”
means such approval as may be required by the applicable rules and regulations
of the Nasdaq Stock Market (or any successor entity) from the stockholders of
the Corporation with respect to the transactions contemplated by the Transaction
Documents, including the issuance of all of the Underlying Shares in excess of
19.99% of the issued and outstanding Common Stock on the initial Closing
Date.
“Subscription Amount”
shall mean, as to each original Holder, the aggregate amount to be paid for the
Preferred Stock purchased pursuant to a Purchase Agreement as specified below
such Holder’s name on the signature page of such Purchase Agreement and next to
the heading “Subscription Amount,” in United States dollars and in immediately
available funds.
“Subsidiary” means any
direct or indirect subsidiary of the Corporation formed or acquired after the
Original Issue Date
“Threshold Period”
shall have the meaning set forth in Section 8(a).
“Trading Day” means a
day on which the principal Trading Market is open for business.
“Trading Market” means
any of the following markets or exchanges on which the Common Stock is listed or
quoted for trading on the date in question: NYSE Alternext US, the Nasdaq
Capital Market, the Nasdaq Global Market, the Nasdaq Global Select Market, the
New York Stock Exchange or the OTC Bulletin Board (or any successors to any of
the foregoing).
“Transaction
Documents” means this Certificate of Designation, the Purchase
Agreements, the Warrants, the Escrow Agreement, the Voting Agreement, all
exhibits and schedules thereto and hereto and any other documents or agreements
executed in connection with the transactions contemplated under each of the
Purchase Agreements.
“Transfer Agent” means
Continental Stock Transfer & Trust Company, the current transfer agent of
the Corporation, with a mailing address of 17 Battery Place, New York, New York
10004, and a facsimile number of (212) 509-5150, and any successor transfer
agent of the Corporation.
“Triggering Event”
shall have the meaning set forth in Section 9(a).
“Triggering Redemption
Amount” means, for each share of Preferred Stock, the sum of (i) the
greater of (A) 120% of the Stated Value and (B) the product of (a) the VWAP on
the Trading Day immediately preceding the date of the Triggering Event and (b)
the Stated Value divided by the then Conversion Price, and (ii) all liquidated
damages and other costs, expenses or amounts due in respect of such share of
Preferred Stock under this Certificate of Designation.
“Triggering Redemption
Payment Date” shall have the meaning set forth in Section
9(b).
“Underlying Shares”
means the shares of Common Stock issued and issuable upon conversion or
redemption of the Preferred Stock and upon exercise of the
Warrants.
“Variable Rate
Transaction” means a transaction in which the Corporation (i) issues or
sells any debt or equity securities that are convertible into, exchangeable or
exercisable for, or include the right to receive, additional shares of Common
Stock at a conversion price, exercise price or exchange rate or other price that
is based upon, and/or varies with, the trading prices of or quotations for the
shares of Common Stock at any time after the initial issuance of such debt or
equity securities or (ii) enters into any agreement, including, but not limited
to, an equity line of credit, whereby the Corporation may sell securities at a
future determined price.
“Voting Agreements”
means each of the written agreements, in the form of Exhibit E attached to
each of the Purchase Agreements, between the Corporation and each of (a) The
Cleveland Clinic Foundation, (b) Sunrise Equity Partners, LP, (c) Sunrise
Securities Corp. and (d) all of the executive officers and directors of the
Corporation, which shall be as set forth on Schedule 2.2(a)(vi)
attached to each of the Purchase Agreements, to vote all Common Stock over which
such Persons have voting control as of the record date for the meeting of
stockholders of the Corporation in favor of Stockholder Approval and Authorized
Share Approval; provided, however, the
Corporation shall not be required to obtain the Voting Agreements for the
initial Closing from Sunrise Equity Partners, LP, or Sunrise Securities Corp. if
the aggregate Subscription Amounts for the initial Closing are less than
$2,000,000.
“VWAP” means, for any
date, the price determined by the first of the following clauses that applies:
(a) if the Common Stock is then listed or quoted on a Trading Market, the daily
volume weighted average price of the Common Stock for such date (or the nearest
preceding date) on the Trading Market on which the Common Stock is then listed
or quoted as reported by Bloomberg L.P. (based on a Trading Day from 9:30 a.m.
(New York City time) to 4:02 p.m. (New York City time)); (b) if the
Common Stock is not then listed or quoted for trading on the OTC Bulletin Board
and if prices for the Common Stock are then reported in the “Pink Sheets”
published by Pink OTC Markets, Inc. (or a similar organization or agency
succeeding to its functions of reporting prices), the most recent bid price per
share of the Common Stock so reported; or (c) in all other cases, the fair
market value of a share of Common Stock as determined by an independent
appraiser selected in good faith by the Purchasers (as defined in each of the
Purchase Agreements) of a majority in interest of the Securities then
outstanding and reasonably acceptable to the Corporation, the fees and expenses
of which shall be paid by the Corporation.
“Warrants” means,
collectively, the Common Stock purchase warrants delivered to the original
Holders at the applicable Closing in accordance with Section 2.2(a) of each of
the Purchase Agreements, which Warrants shall be exercisable immediately and
have a term of exercise equal to seven years, in the form of Exhibit C attached to
each of the Purchase Agreements, with an initial Exercise Price (as defined
therein) equal to $2.60,
subject to adjustment therein.
“Warrant Shares” means
the shares of Common Stock issuable upon exercise of the Warrants.
Section
2. Designation, Amount and Par
Value. The series of preferred stock shall be designated as Series D
Convertible Preferred Stock (the “Preferred Stock”) and
the number of shares so designated shall be 1,300 (which series shall not be
subject to increase without the written consent of all of the holders of the
outstanding shares of the Preferred Stock (each, a “Holder” and
collectively, the “Holders”)). Each
share of Preferred Stock shall have a par value of $0.005 per share and a stated
value equal to $10,000 (the “Stated
Value”).
Section
3. Dividends and
Rights.
a) The
Preferred Stock shall participate in any dividends paid on the Common Stock on
an as-converted basis.
b) So
long as any Preferred Stock shall remain outstanding, neither the Corporation
nor any Subsidiary thereof shall redeem, purchase or otherwise acquire directly
or indirectly any Junior Securities except as expressly permitted by Section
9(a)(ix) nor shall any monies be set aside for or applied to the purchase or
redemption (through a sinking fund or otherwise) of any Junior Securities or
shares pari
passu with the
Preferred Stock.
c) The
Corporation acknowledges and agrees that the capital of the Corporation (as such
term is used in Section 154 of the Delaware General Corporation Law) in respect
of the Preferred Stock and any future issuances of the Corporation’s capital
stock shall be equal to the aggregate par value of such Preferred Stock or
capital stock, as the case may be, and that, on or after the date of any of the
Purchase Agreements, it shall not increase the capital of the Corporation with
respect to any shares of the Corporation’s capital stock issued and outstanding
on such date. The Corporation also acknowledges and agrees that it
shall not create any special reserves under Section 171 of the Delaware General
Corporation Law without the prior written consent of each
Holder.
Section
4. Voting Rights. Except
as otherwise provided herein or as otherwise required by law, the Preferred
Stock shall have no voting rights. However, as long as any shares of Preferred
Stock are outstanding, the Corporation shall not, without the affirmative vote
of the Holders of a majority of the then outstanding shares of the Preferred
Stock, (a) alter or change adversely the powers, preferences or rights given to
the Preferred Stock or alter or amend this Certificate of Designation, (b)
authorize or create any class of stock ranking as to dividends, redemption or
distribution of assets upon a Liquidation (as defined in Section 5) senior to,
or otherwise pari passu with, the
Preferred Stock, (c) amend its certificate of incorporation or other charter
documents in any manner that adversely affects any rights of the Holders, (d)
increase the number of authorized shares of Preferred Stock, or (e) enter into
any agreement with respect to any of the foregoing.
Section
5. Liquidation. Upon any
liquidation, dissolution or winding-up of the Corporation, whether voluntary or
involuntary (a “Liquidation”), the
Holders shall be entitled to receive out of the assets, whether capital or
surplus, of the Corporation an amount equal to the Stated Value, plus any other
fees or liquidated damages then due and owing thereon under this Certificate of
Designation, for each share of Preferred Stock (a) after any distribution or
payment required to be made to the holders of the Series B Preferred, until such
Series B Preferred is no longer outstanding, and (b) before any distribution or
payment shall be made to the holders of any Junior Securities, and if the assets
of the Corporation shall be insufficient to pay in full such amounts, after full
distribution or payment required to be made to the holders of the Series B
Preferred, then the entire assets to be distributed to the Holders shall be
ratably distributed among the Holders in accordance with the respective amounts
that would be payable on such shares if all amounts payable thereon were paid in
full. A Fundamental Transaction or Change of Control Transaction
shall not be deemed a Liquidation. The Corporation shall mail written notice of
any such Liquidation, not less than thirty (30) days prior to the payment date
stated therein, to each Holder.
Section
6. Conversion.
a) Conversions at Option of
Holder. Each share of Preferred Stock shall be convertible, at any time
and from time to time from and after the Original Issue Date at the option of
the Holder thereof, into that number of shares of Common Stock (subject to the
limitations set forth in Section 6(c) and Section 6(d)) determined by dividing
the Stated Value of such share of Preferred Stock by the Conversion Price.
Holders shall effect conversions by providing the Corporation with the form of
conversion notice attached hereto as Annex A (a “Notice of
Conversion”). Each Notice of Conversion shall specify the number of
shares of Preferred Stock to be converted, the number of shares of Preferred
Stock owned prior to the conversion at issue, the number of shares of Preferred
Stock owned subsequent to the conversion at issue and the date on which such
conversion is to be effected, which date may not be prior to the date the
applicable Holder delivers by facsimile such Notice of Conversion to the
Corporation (such date, the “Conversion Date”). If
no Conversion Date is specified in a Notice of Conversion, the Conversion Date
shall be the date that such Notice of Conversion to the Corporation is deemed
delivered hereunder. The calculations and entries set forth in the Notice of
Conversion shall control in the absence of manifest, mathematical or
other demonstrable error. To effect conversions of shares of
Preferred Stock, a Holder shall not be required to surrender the certificate(s)
representing the shares of Preferred Stock to the Corporation unless all of the
shares of Preferred Stock represented thereby are so converted, in which case
such Holder shall deliver the certificate representing such shares of Preferred
Stock promptly following the Conversion Date at issue. Shares of
Preferred Stock converted into Common Stock or redeemed in accordance with the
terms hereof shall be canceled and shall not be reissued.
b) Conversion
Price. The conversion price for the Preferred Stock shall
equal $1.85, subject to
adjustment herein (the “Conversion Price”);
provided, however, if the
Corporation does not (i) receive authorization from the FDA to initiate
“double-blind” clinical trials to evaluate the safety, pharmacokinetics and
pharmacodynamics of CBLB502 in healthy human volunteers by December 31, 2009 or
(ii) file its biologic license application for use of CBLB502 for the mitigation
of acute radiation syndrome in individuals exposed to whole body radiation by
December 31, 2010 (clause (i) and (ii), each a “Milestone”), then,
upon missing either Milestone, the Conversion Price shall be adjusted downward
to be equal to 80% of the Conversion Price on such date, subject to adjustment
herein (such adjustment, the “Milestone
Adjustment”); provided, further, however, if as of
such date of such Milestone, the Closing Price is greater than $3.69, subject to
adjustment herein, the Milestone Adjustment shall not apply. For clarity, if the
Corporation misses both of the Milestones set forth in clauses (i) and (ii)
above, there shall be two Milestone Adjustments such that, upon the Corporation
missing the Milestone set forth in clause (ii) above, the then Conversion Price
shall be adjusted to be equal to 80% of the immediately prior Conversion Price,
which may have been previously adjusted pursuant to the Milestone Adjustment
resulting from the Corporation missing the Milestone set forth in clause (i)
above. In addition to the Milestone Adjustment and any other adjustments set
forth herein, (a) on the six (6) month anniversary of the Original Issue Date
(the “Initial
Adjustment Date”), the Conversion Price shall be reduced to be equal to
95% of the then Conversion Price, and (b) on each three (3) month anniversary of
the Initial Adjustment Date (each, an “Adjustment Date”),
commencing on the first such date after the Initial Adjustment Date, the then
Conversion Price shall adjust downward by the dollar amount equal to the product
of (A) the initial Conversion Price (subject to adjustment for all adjustments
except for adjustments set forth in this sentence) and (B) 2.5%. For purposes of
clarification, the Corporation covenants and agrees that (i) it will honor all
conversions pursuant to the Notices of Conversion tendered on or before 11:59pm
(NY time) on the Initial Adjustment Date and on any Adjustment Date and (ii)
such conversions shall be honored by the Corporation at the Conversion Price in
effect immediately prior to the adjustment occurring on such Initial Adjustment
Date or such Adjustment Date, as applicable.
c) Beneficial Ownership
Limitation. The Corporation shall
not effect any conversion of the Preferred Stock, and a Holder shall not have
the right to convert any portion of the Preferred Stock, to the extent that,
after giving effect to the conversion set forth on the applicable Notice of
Conversion, such Holder (together with such Holder’s Affiliates, and any other
Persons acting as a group together with such Holder or any of such Holder’s
Affiliates) would beneficially own in excess of the Beneficial Ownership
Limitation (as defined below). For purposes of the foregoing sentence, the
number of shares of Common Stock beneficially owned by such Holder and its
Affiliates shall include the number of shares of Common Stock issuable upon
conversion of the Preferred Stock with respect to which such determination is
being made, but shall exclude the number of shares of Common Stock which are
issuable upon (A) conversion of the remaining, unconverted Stated Value of
Preferred Stock beneficially owned by such Holder or any of its Affiliates and
(B) exercise or conversion of the unexercised or unconverted portion of any
other securities of the Corporation subject to a limitation on
conversion or exercise analogous to the limitation contained herein (including
the Warrants) beneficially owned by such Holder or any of its Affiliates.
Except as set forth in the preceding sentence, for purposes of this Section
6(c), beneficial ownership shall be calculated in accordance with Section 13(d)
of the Exchange Act and the rules and regulations promulgated
thereunder. To the extent that the limitation contained in this
Section 6(c) applies, the determination of whether the Preferred Stock is
convertible (in relation to other securities owned by such Holder together with
any Affiliates) and of how many shares of Preferred Stock are convertible shall
be in the sole discretion of such Holder, and the submission of a Notice of
Conversion shall be deemed to be such Holder’s determination of whether the
shares of Preferred Stock may be converted (in relation to other securities
owned by such Holder together with any Affiliates) and how many shares of the
Preferred Stock are convertible, in each case subject to the Beneficial
Ownership Limitation. To ensure compliance with this restriction, each Holder
will be deemed to represent to the Corporation each time it delivers a Notice of
Conversion that such Notice of Conversion has not violated the restrictions set
forth in this paragraph and the Corporation shall have no obligation to verify
or confirm the accuracy of such determination. In addition, a
determination as to any group status as contemplated above shall be determined
in accordance with Section 13(d) of the Exchange Act and the rules and
regulations promulgated thereunder. For purposes of this Section
6(c), in determining the number of outstanding shares of Common Stock, a Holder
may rely on the number of outstanding shares of Common Stock as stated in the
most recent of the following: (A) the Corporation’s most recent periodic or
annual report filed with the Commission, as the case may be, (B) a more recent
public announcement by the Corporation or (C) a more recent written notice by
the Corporation or the Transfer Agent setting forth the number of shares of
Common Stock outstanding. Upon the written or oral request of a Holder,
the Corporation shall within two Trading Days confirm orally and in writing to
such Holder the number of shares of Common Stock then outstanding. In any
case, the number of outstanding shares of Common Stock shall be determined after
giving effect to the conversion or exercise of securities of the Corporation,
including the Preferred Stock, by such Holder or its Affiliates since the date
as of which such number of outstanding shares of Common Stock was reported. The
“Beneficial Ownership Limitation” shall be 9.99% of the number of shares of the
Common Stock outstanding immediately after giving effect to the issuance of
shares of Common Stock issuable upon conversion of Preferred Stock held by the
applicable Holder. A Holder, upon not less than 61 days’ prior notice
to the Corporation, may decrease the Beneficial Ownership Limitation provisions
of this Section 6(c) applicable to its Preferred Stock provided that the
provisions of this Section 6(c) shall continue to apply. Any such
decrease will not be effective until the 61st day
after such notice is delivered to the Corporation and shall only apply to such
Holder and no other Holder. The provisions of this
paragraph shall be construed and implemented in a manner otherwise than in
strict conformity with the terms of this Section 6(c) to correct this paragraph
(or any portion hereof) which may be defective or inconsistent with the intended
Beneficial Ownership Limitation herein contained or to make changes or
supplements necessary or desirable to properly give effect to such
limitation. The limitations contained in this paragraph shall apply to a
successor holder of Preferred Stock.
d) Issuance
Limitations. Notwithstanding anything herein to the contrary,
if the Corporation has not obtained Stockholder Approval, then the Corporation
may not issue, upon conversion of the Preferred Stock, a number of shares of
Common Stock which, when aggregated with any shares of Common Stock issued on or
after the Original Issue Date and prior to such Conversion Date (A) in
connection with any conversion of Preferred Stock issued pursuant to any of the
Purchase Agreements, (B) in connection with the exercise of any Warrants issued
pursuant to any of the Purchase Agreements and (C) in connection with the
exercise of any warrants issued to any registered broker-dealer as a fee in
connection with the issuance of the Securities pursuant to the Purchase
Agreements, would exceed 2,770,160 shares of Common Stock (subject to adjustment
for forward and reverse stock splits, recapitalizations and the like) (such
number of shares, the “Issuable
Maximum”). Each Holder shall be entitled to a portion of the
Issuable Maximum equal to the quotient obtained by dividing (x) the original
Stated Value of such Holder’s Preferred Stock by (y) the aggregate Stated Value
of all Preferred Stock issued on the Original Issue Dates to all
Holders. In addition, each Holder may allocate its pro-rata portion
of the Issuable Maximum among Preferred Stock and Warrants held by it in its
sole discretion. Such portion shall be adjusted upward ratably in the event a
Holder no longer holds any Preferred Stock or Warrants and the amount of shares
issued to such Holder pursuant to such Holder’s Preferred Stock and Warrants was
less than such Holder’s pro-rata share of the Issuable Maximum. In
the event that any Holder shall sell or otherwise transfer any of such Holder’s
Preferred Stock or Warrants, the transferee shall be allocated a pro rata
portion of such Holder’s portion of the Issuable Maximum. For avoidance of
doubt, unless and until any required Stockholder Approval is obtained and
effective, warrants issued to any registered broker-dealer as a fee in
connection with the Securities issued pursuant to the Purchase Agreements as
described in (C) above shall provide that such warrants shall not be allocated
any portion of the Issuable Maximum and shall be unexercisable unless and until
such Stockholder Approval is obtained and effective.
e) Mechanics of
Conversion
i. Delivery of Certificate Upon
Conversion. Not later than three Trading Days after each Conversion Date
(the “Share Delivery
Date”), the Corporation shall deliver, or cause to be delivered, to the
converting Holder a certificate or certificates which, on or after the Effective
Date, shall be free of restrictive legends and trading restrictions (other than
those which may then be required by the Purchase Agreements) representing the
number of Conversion Shares being acquired upon the conversion of shares of
Preferred Stock. On or after the Effective Date, the Corporation shall, upon
request of such Holder, use its reasonable best efforts to deliver any
certificate or certificates required to be delivered by the Corporation under
this Section 6 electronically through the Depository Trust Company or another
established clearing corporation performing similar functions. If, in the case
of any Notice of Conversion, such certificate or certificates are not delivered
to or as directed by the applicable Holder by the third Trading Day after the
Conversion Date, the applicable Holder shall be entitled to elect to rescind
such Conversion Notice by written notice to the Corporation at any time on or
before its receipt of such certificate or certificates, in which event the
Corporation shall promptly return to such Holder any original Preferred Stock
certificate delivered to the Corporation and such Holder shall promptly return
to the Corporation any Common Stock certificates issued to such Holder pursuant
to the rescinded Conversion Notice.
ii. Obligation Absolute; Partial
Liquidated Damages. The Corporation’s obligation to issue and
deliver the Conversion Shares upon conversion of Preferred Stock in accordance
with the terms hereof are absolute and unconditional, irrespective of any action
or inaction by a Holder to enforce the same, any waiver or consent with respect
to any provision hereof, the recovery of any judgment against any Person or any
action to enforce the same, or any setoff, counterclaim, recoupment, limitation
or termination, or any breach or alleged breach by such Holder or any other
Person of any obligation to the Corporation or any violation or alleged
violation of law by such Holder or any other Person, and irrespective of any
other circumstance which might otherwise limit such obligation of the
Corporation to such Holder in connection with the issuance of such Conversion
Shares; provided, however, that such
delivery shall not operate as a waiver by the Corporation of any such action
that the Corporation may have against such Holder. In the event a
Holder shall elect to convert any or all of the Stated Value of its Preferred
Stock, the Corporation may not refuse conversion based on any claim that such
Holder or any one associated or affiliated with such Holder has been engaged in
any violation of law, agreement or for any other reason, unless an injunction
from a court, on notice to Holder, restraining and/or enjoining conversion of
all or part of the Preferred Stock of such Holder shall have been sought and
obtained, and the Corporation posts a surety bond for the benefit of such Holder
in the amount of 110% of the Stated Value of Preferred Stock which is subject to
the injunction, which bond shall remain in effect until the completion of
arbitration/litigation of the underlying dispute and the proceeds of which shall
be payable to such Holder to the extent it obtains judgment. In the
absence of such injunction, the Corporation shall issue Conversion Shares and,
if applicable, cash, upon a properly noticed conversion. If the Corporation
fails to deliver to a Holder such certificate or certificates pursuant to
Section 6(e)(i) on the second Trading Day after the Share Delivery Date
applicable to such conversion, the Corporation shall pay to such Holder, in
cash, as liquidated damages and not as a penalty, for each $5,000 of Stated
Value of Preferred Stock being converted, $50 per Trading Day (increasing to
$100 per Trading Day on the third Trading Day and increasing to $200 per Trading
Day on the sixth Trading Day after such damages begin to accrue) for each
Trading Day after such second Trading Day after the Share Delivery Date until
such certificates are delivered. Nothing herein shall limit a Holder’s right to
pursue actual damages or declare a Triggering Event pursuant to Section 9 for
the Corporation’s failure to deliver Conversion Shares within the period
specified herein and such Holder shall have the right to pursue all remedies
available to it hereunder, at law or in equity including, without limitation, a
decree of specific performance and/or injunctive relief. The exercise
of any such rights shall not prohibit a Holder from seeking to enforce damages
pursuant to any other Section hereof or under applicable law.
iii. Compensation for Buy-In on
Failure to Timely Deliver Certificates Upon Conversion. If the
Corporation fails to deliver to a Holder the applicable certificate or
certificates by the Share Delivery Date pursuant to Section 6(e)(i), and, if
after such Share Delivery Date such Holder is required by its brokerage firm to
purchase (in an open market transaction or otherwise), or the Holder’s brokerage
firm purchases, shares of Common Stock to deliver in satisfaction of a sale by
such Holder of the Conversion Shares which such Holder was entitled to receive
upon the conversion relating to such Share Delivery Date (a “Buy-In”), then the
Corporation shall (A) pay in cash to such Holder (in addition to any other
remedies available to or elected by such Holder) the amount by which (x) such
Holder’s total purchase price (including any brokerage commissions) for the
shares of Common Stock so purchased exceeds (y) the product of (1) the aggregate
number of shares of Common Stock that such Holder was entitled to receive from
the conversion at issue multiplied by (2) the actual sale price at which the
sell order giving rise to such purchase obligation was executed (including any
brokerage commissions) and (B) at the option of such Holder, either reissue (if
surrendered) the shares of Preferred Stock equal to the number of shares of
Preferred Stock submitted for conversion (in which case, the Conversion Notice
shall be deemed rescinded) or deliver to such Holder the number of shares of
Common Stock that would have been issued if the Corporation had timely complied
with its delivery requirements under Section 6(e)(i). For example, if a Holder
purchases shares of Common Stock having a total purchase price of $11,000 to
cover a Buy-In with respect to an attempted conversion of shares of Preferred
Stock with respect to which the actual sale price (including any brokerage
commissions) giving rise to such purchase obligation was a total of $10,000
under clause (A) of the immediately preceding sentence, the Corporation shall be
required to pay such Holder $1,000. The Holder shall provide the Corporation
written notice indicating the amounts payable to such Holder in respect of the
Buy-In and, upon request of the Corporation, written evidence of the Buy-In and
the amount of such loss. Nothing herein shall limit a Holder’s right to pursue
any other remedies available to it hereunder, at law or in equity including,
without limitation, a decree of specific performance and/or injunctive relief
with respect to the Corporation’s failure to timely deliver certificates
representing shares of Common Stock upon conversion of the shares of Preferred
Stock as required pursuant to the terms hereof.
iv. Reservation of Shares
Issuable Upon Conversion. The Corporation covenants that it will at all
times, following the Authorized Share Approval Date, reserve and keep available
out of its authorized and unissued shares of Common Stock for the sole purpose
of issuance upon conversion of the Preferred Stock, as herein provided, free
from preemptive rights or any other actual contingent purchase rights of Persons
other than the Holders of the Preferred Stock, not less than such aggregate
number of shares of the Common Stock as shall (subject to the terms and
conditions in the Purchase Agreements) be issuable (taking into account the
adjustments of Section 7) upon the conversion of all then outstanding shares of
Preferred Stock. The Corporation covenants that all shares of Common
Stock that shall be so issuable shall, upon issue, be duly authorized, validly
issued, fully paid and nonassessable and, if the Conversion Shares Registration
Statement is then effective under the Securities Act, shall be registered for
public resale in accordance with such Conversion Shares Registration Statement
(subject to such Holder’s compliance with its obligations under the Registration
Rights Agreement).
v. Fractional Shares. No
fractional shares or scrip representing fractional shares shall be issued upon
the conversion of the Preferred Stock. As to any fraction of a
share which a Holder would otherwise be entitled to purchase upon such
conversion, the Corporation shall at its election, either pay a cash adjustment
in respect of such final fraction in an amount equal to such fraction multiplied
by the Conversion Price or round up to the next whole share.
vi. Transfer
Taxes. The issuance of certificates for shares of the Common
Stock on conversion of this Preferred Stock shall be made without charge to any
Holder for any documentary stamp or similar taxes that may be payable in respect
of the issue or delivery of such certificates; provided that the Corporation
shall not be required to pay any tax that may be payable in respect of any
transfer involved in the issuance and delivery of any such certificate upon
conversion in a name other than that of the Holders of such shares of Preferred
Stock and the Corporation shall not be required to issue or deliver such
certificates unless or until the Person or Persons requesting the issuance
thereof shall have paid to the Corporation the amount of such tax or shall have
established to the satisfaction of the Corporation that such tax has been
paid.
Section
7. Certain
Adjustments.
a) Stock Dividends and Stock
Splits. If the Corporation, at any time while this Preferred
Stock is outstanding: (A) pays a stock dividend or otherwise makes a
distribution or distributions payable in shares of Common Stock on shares of
Common Stock or any other Common Stock Equivalents (which, for avoidance of
doubt, shall not include any shares of Common Stock issued by the Corporation
upon conversion of this Preferred Stock, or upon conversion of or payment of a
dividend on the Series B Preferred pursuant to the terms of the Series B
Preferred as in effect on the Original Issue Date); (B) subdivides outstanding
shares of Common Stock into a larger number of shares; (C) combines (including
by way of a reverse stock split) outstanding shares of Common Stock into a
smaller number of shares; or (D) issues, in the event of a reclassification of
shares of the Common Stock, any shares of capital stock of the Corporation, then
the Conversion Price shall be multiplied by a fraction of which the numerator
shall be the number of shares of Common Stock (excluding any treasury shares of
the Corporation) outstanding immediately before such event and of which the
denominator shall be the number of shares of Common Stock outstanding
immediately after such event. Any adjustment made pursuant to this
Section 7(a) shall become effective immediately after the record date for the
determination of stockholders entitled to receive such dividend or distribution
and shall become effective immediately after the effective date in the case of a
subdivision, combination or re-classification.
b) Subsequent Equity
Sales. If, at any time while this Preferred Stock is
outstanding, the Corporation or any Subsidiary sells or grants any option to
purchase or sells or grants any right to reprice its securities, or otherwise
disposes of or issues any Common Stock or Common Stock Equivalents
entitling any Person to acquire shares of Common Stock at an effective price per
share that is lower than the Conversion Price then in effect (such
lower price, the “Base
Conversion Price” and such issuances collectively, a “Dilutive Issuance”)
(if the holder of the Common Stock or Common Stock Equivalents so issued shall
at any time, whether by operation of purchase price adjustments, reset
provisions, floating conversion, exercise or exchange prices or otherwise, or
due to warrants, options or rights per share which are issued in connection with
such issuance, be entitled to receive shares of Common Stock at an effective
price per share that is lower than the Conversion Price then in effect, such
issuance shall be deemed to have occurred for less than the Conversion Price on
such date of the Dilutive Issuance), then the Conversion Price shall be reduced
to equal the Base Conversion Price. Notwithstanding the foregoing, no
adjustment will be made under this Section 7(b) in respect of an Exempt
Issuance. If the Corporation enters into a Variable Rate Transaction,
despite the prohibition set forth in the Purchase Agreements, the Corporation
shall be deemed to have issued Common Stock or Common Stock Equivalents at the
lowest possible conversion price at which such securities may be converted or
exercised. The Corporation shall notify the Holders in writing, no
later than the Trading Day following the issuance of any Common Stock or Common
Stock Equivalents subject to this Section 7(b), indicating therein the
applicable issuance price, or applicable reset price, exchange price, conversion
price and other pricing terms (such notice, the “Dilutive Issuance
Notice”). For purposes of clarification, whether or not the
Corporation provides a Dilutive Issuance Notice pursuant to this Section 7(b),
upon the occurrence of any Dilutive Issuance, the Holders are entitled to
receive a number of Conversion Shares based upon the Base Conversion Price on or
after the date of such Dilutive Issuance, regardless of whether a Holder
accurately refers to the Base Conversion Price in the Notice of
Conversion.
c) Subsequent Rights
Offerings. If the Corporation, at any time while this
Preferred Stock is outstanding, shall issue rights, options or warrants to all
holders of Common Stock (and not to Holders) entitling them to subscribe for or
purchase shares of Common Stock at a price per share that is lower than the VWAP
on the record date referenced below, then the Conversion Price shall be
multiplied by a fraction of which the denominator shall be the number of shares
of the Common Stock outstanding on the date of issuance of such rights, options
or warrants plus the number of additional shares of Common Stock offered for
subscription or purchase, and of which the numerator shall be the number of
shares of the Common Stock outstanding on the date of issuance of such rights or
warrants plus the number of shares which the aggregate offering price of the
total number of shares so offered (assuming delivery to the Corporation in full
of all consideration payable upon exercise of such rights, options or warrants)
would purchase at such VWAP. Such adjustment shall be made whenever
such rights or warrants are issued, and shall become effective immediately after
the record date for the determination of stockholders entitled to receive such
rights, options or warrants.
d) Pro Rata
Distributions. If the Corporation, at any time while this Preferred Stock
is outstanding, distributes to all holders of Common Stock (and not to Holders)
evidences of its indebtedness or assets (including cash and cash dividends) or
rights or warrants to subscribe for or purchase any security (other than Common
Stock, which shall be subject to Section 7(b)), then in each such case the
Conversion Price shall be adjusted by multiplying such Conversion Price in
effect immediately prior to the record date fixed for determination of
stockholders entitled to receive such distribution by a fraction of which the
denominator shall be the VWAP determined as of the record date mentioned above,
and of which the numerator shall be such VWAP on such record date less the then
fair market value at such record date of the portion of such assets, evidence of
indebtedness or rights or warrants so distributed applicable to one outstanding
share of the Common Stock as determined by the Board of Directors of the
Corporation in good faith. In either case the adjustments shall be
described in a statement delivered to the Holders describing the portion of
assets or evidences of indebtedness so distributed or such subscription rights
applicable to one share of Common Stock. Such adjustment shall be
made whenever any such distribution is made and shall become effective
immediately after the record date mentioned above.
e) Fundamental
Transaction. If, at any time while this Preferred Stock is outstanding,
(A) the Corporation effects any merger or consolidation of the Corporation with
or into another Person, (B) the Corporation effects any sale of all or
substantially all of its assets in one transaction or a series of related
transactions, (C) any tender offer or exchange offer (whether by the Corporation
or another Person) is completed pursuant to which holders of Common Stock are
permitted to tender or exchange their shares for other securities, cash or
property, or (D) the Corporation effects any reclassification of the Common
Stock or any compulsory share exchange pursuant to which the Common Stock is
effectively converted into or exchanged for other securities, cash or property
(in any such case, a “Fundamental
Transaction”), then, upon any subsequent conversion of this Preferred
Stock, the Holders shall have the right to receive, for each Conversion Share
that would have been issuable upon such conversion immediately prior to the
occurrence of such Fundamental Transaction, the same kind and amount of
securities, cash or property as it would have been entitled to receive upon the
occurrence of such Fundamental Transaction if it had been, immediately prior to
such Fundamental Transaction, the holder of one share of Common Stock (the
“Alternate
Consideration”). For purposes of any such conversion, the
determination of the Conversion Price shall be appropriately adjusted to apply
to such Alternate Consideration based on the amount of Alternate Consideration
issuable in respect of one share of Common Stock in such Fundamental
Transaction, and the Corporation shall apportion the Conversion Price among the
Alternate Consideration in a reasonable manner reflecting the relative value of
any different components of the Alternate Consideration. If holders
of Common Stock are given any choice as to the securities, cash or property to
be received in a Fundamental Transaction, then the Holders shall be given the
same choice as to the Alternate Consideration it receives upon any conversion of
this Preferred Stock following such Fundamental Transaction. To the
extent necessary to effectuate the foregoing provisions, any successor to the
Corporation or surviving entity in such Fundamental Transaction shall file a new
Certificate of Designation with the same terms and conditions and issue to the
Holders new preferred stock, in exchange for the Preferred Stock, consistent
with the foregoing provisions and evidencing the Holders’ right to convert such
preferred stock into Alternate Consideration. The terms of any agreement
pursuant to which a Fundamental Transaction is effected shall include terms
requiring any such successor or surviving entity to comply with the provisions
of this Section 7(e) and ensuring that this Preferred Stock (or any such
replacement security) will be similarly adjusted upon any subsequent transaction
analogous to a Fundamental Transaction.
f) Calculations. All
calculations under this Section 7 shall be made to the nearest cent or the
nearest 1/100th of a share, as the case may be. For purposes of this
Section 7, the number of shares of Common Stock deemed to be issued and
outstanding as of a given date shall be the sum of the number of shares of
Common Stock (excluding any treasury shares of the Corporation) issued and
outstanding.
g) Notice to the
Holders.
i. Adjustment to Conversion
Price. Whenever the Conversion Price is adjusted pursuant to
any provision of this Section 7, the Corporation shall promptly deliver to each
Holder a notice setting forth the Conversion Price after such adjustment and
setting forth a brief statement of the facts requiring such
adjustment.
ii. Notice to Allow Conversion
by Holder. If (A) the Corporation shall declare a dividend (or
any other distribution in whatever form) on the Common Stock, (B) the
Corporation shall declare a special nonrecurring cash dividend on or a
redemption of the Common Stock, (C) the Corporation shall authorize the granting
to all holders of the Common Stock of rights or warrants to subscribe for or
purchase any shares of capital stock of any class or of any rights, (D) the
approval of any stockholders of the Corporation shall be required in connection
with any reclassification of the Common Stock, any consolidation or merger to
which the Corporation is a party, any sale or transfer of all or substantially
all of the assets of the Corporation, or any compulsory share exchange whereby
the Common Stock is converted into other securities, cash or property or (E) the
Corporation shall authorize the voluntary or involuntary dissolution,
liquidation or winding up of the affairs of the Corporation, then, in each case,
the Corporation shall cause to be filed at each office or agency maintained for
the purpose of conversion of this Preferred Stock, and shall cause to be
delivered to each Holder at its last address as it shall appear upon the stock
books of the Corporation, at least 20 calendar days prior to the applicable
record or effective date hereinafter specified, a notice stating (x) the date on
which a record is to be taken for the purpose of such dividend, distribution,
redemption, rights or warrants, or if a record is not to be taken, the date as
of which the holders of the Common Stock of record to be entitled to such
dividend, distributions, redemption, rights or warrants are to be determined,
(y) the date on which such reclassification, consolidation, merger, sale,
transfer or share exchange is expected to become effective or close, and the
date as of which it is expected that holders of the Common Stock of record shall
be entitled to exchange their shares of the Common Stock for securities, cash or
other property deliverable upon such reclassification, consolidation, merger,
sale, transfer or share exchange, provided that the failure to deliver such
notice or any defect therein or in the delivery thereof shall not affect the
validity of the corporate action required to be specified in such notice or (z)
the date on which such dissolution, liquidation or winding up is expected to
commence. The Holder shall remain entitled to convert the Conversion
Amount of this Preferred Stock (or any part hereof) during the 20-day period
commencing on the date of such notice through the effective date of the event
triggering such notice except as otherwise set forth herein.
|
Section
8.
|
Automatic Conversion,
Optional Conversion and Redemption, Maturity
Conversion/Redemption.
|
a) Automatic
Conversion. Notwithstanding anything herein to the contrary,
if after the Effective Date, the Closing Price for each of any 20 consecutive
Trading Day period, which 20 consecutive Trading Day period shall have commenced
only after the Effective Date (“Threshold Period”),
exceeds 300% of the then effective Conversion Price, the Corporation shall,
within one (1) Trading Day after the end of any such Threshold Period, deliver a
written notice to all Holders (a “Automatic Conversion
Notice” and the date such notice is delivered to all Holders, the “Automatic Conversion Notice
Date”) to cause each Holder to convert all of such Holder’s Preferred
Stock (as specified in such Automatic Conversion Notice) plus all liquidated
damages and other amounts then due and payable under this Certificate of
Designation in respect of such Preferred Stock pursuant to Section 6, it being
agreed that the “Conversion Date” for purposes of Section 6 shall be deemed to
occur on the fifth Trading Day following the Automatic Conversion Notice Date
(such fifth Trading Day, the “Automatic Conversion
Date”). The Corporation may not deliver an Automatic
Conversion Notice, and any Automatic Conversion Notice delivered by the
Corporation shall not be effective, unless all of the Equity Conditions have
been met on each Trading Day during the applicable Threshold Period through and
including the later of the Automatic Conversion Date and the Trading Day that
the Conversion Shares issuable pursuant to such conversion are actually
delivered to the Holders pursuant to the Automatic Conversion
Notice. Any Automatic Conversion Notices shall be applied
ratably to all of the Holders based on each Holder’s initial purchases of
Preferred Stock hereunder; provided that any voluntary conversions by a Holder
shall be applied against such Holder’s pro rata allocation,
thereby decreasing the aggregate amount automatically converted hereunder if
less than all shares of the Preferred Stock are automatically
converted. For purposes of clarification, an Automatic Conversion
shall be subject to all of the provisions of Section 6, including, without
limitation, the provisions requiring payment of liquidated damages and
limitations on conversions; provided, however, no Holder
shall be required to deliver a Notice of Conversion to effect an Automatic
Conversion, and the failure of a Holder to deliver a notice to the Corporation
on the Automatic Conversion Date specifying such Holder’s Beneficial Ownership
Limitation shall be deemed to be a representation by such Holder
(upon which the Corporation may rely without investigation) that all of the
shares of Preferred Stock held by such Holder may be converted on the Automatic
Conversion Date without exceeding such Holder’s Beneficial Ownership Limitation
..
b) Redemption and Conversion of
the Sinking Fund. Subject to the provisions of this Section 8
and Section 11, at any time after the later of the Effective Date and the
6-month anniversary of the initial contribution by the Corporation to the
Sinking Fund, but no more than once in any 6 month period thereafter, the
Corporation shall deliver a notice to the Holders (a “Corporation Notice”
and the date such notice is deemed delivered hereunder, the “Corporation Notice
Date”) which Corporation Notice shall specify the aggregate amount of the
funds in the Sinking Fund as of the Corporation Notice Date (such aggregate
amount, the “Aggregate
Sinking Fund Redemption Amount”), and each Holder shall have the option
to either (i) have the Corporation redeem some or all of such number of the
outstanding shares of Preferred Stock held by such Holder equal to the quotient
of (A) the product of (I) the Aggregate Sinking Fund Redemption Amount,
multiplied by (II) such Holder’s Sinking Fund Percentage, divided by (B) the
Sinking Fund Redemption Amount with respect to each share of Preferred Stock
held by such Holder (such number of the outstanding shares of Preferred Stock
held by such Holder, the “Redeemable Shares”),
for cash in an amount per share equal to the Sinking Fund Redemption Amount, on
the 20th Trading Day following the Corporation Notice Date (such date, the
“Sinking Fund
Redemption Date” and such redemption, the “Sinking Fund
Redemption”) and/or (ii) convert some or all of the Redeemable Shares
pursuant to Section 6, by delivery of a Notice of Conversion in accordance
therewith (provided, however, that each Redeemable Share so converted shall
convert at a rate equal to the quotient of the Sinking Fund Redemption Amount,
divided by the Conversion Price in effect on the Sinking Fund
Redemption Date) on the 20th Trading
Day following the Corporation Notice Date (such date, the “Sinking Fund Conversion
Date,” and such conversion, the “Sinking Fund
Conversion”). Each Holder’s Sinking Fund Redemption Amount is
payable, in full, on the Sinking Fund Redemption Date. If any portion
of the Redeemable Shares have not been redeemed, as required hereby, on the
Sinking Fund Redemption Date or any portion of the shares of Common Stock
issuable upon conversion of any of the Redeemable Shares that have been
converted have not been issued by the Corporation by the Sinking Fund Conversion
Date, interest shall accrue thereon until such Redeemable Shares have been
redeemed and/or converted in full, as required hereby, at a rate equal to the
lesser of 18% per annum or the maximum rate permitted by applicable law. At any
time after all of the Redeemable Shares of each of the Holders have been
redeemed and/or converted in full, as required hereby, any funds remaining in
the Sinking Fund as of the Corporation Notice Date that remain in the Sinking
Fund may be removed by the Corporation from the Sinking Fund and deposited into
the general funds of the Corporation. Any Notice of Conversion
submitted by any Holder after any Corporation Notice Date and prior to the
Sinking Redemption Date shall be deemed to be an election for conversion of such
Holder’s Redeemable Shares on the Sinking Fund Redemption Date, except to the
extent otherwise indicated thereon or to the extent that the aggregate number of
shares of Preferred Stock so elected for conversion exceeds the total number of
such Holder’s Redeemable Shares. A Holder shall be deemed to have
elected a Sinking Fund Redemption with respect to any of such Holder’s
Redeemable Shares which such Holder has not elected to convert by delivery of a
Notice of Conversion after the applicable Corporation Notice Date and prior to
the applicable Sinking Fund Redemption Date, and any such Redeemable Shares
shall be redeemed on the Sinking Fund Redemption Date in accordance
herewith. The Corporation covenants and agrees that it will honor all
Notices of Conversion tendered from the time of delivery of the Corporation
Notice through the date that the Redeemable Shares are redeemed on the Sinking
Fund Redemption Date and/or converted on the Sinking Fund Conversion Date, as
applicable and required hereby. For purposes of clarification, a Sinking Fund
Conversion shall be subject to all of the provisions of Section 6, including,
without limitation, the provisions requiring payment of liquidated damages and
limitations on conversions, except as otherwise expressly provide
hereby.
c) Maturity Conversion and
Maturity Redemption. Subject to Section 11, at any time after
the three-year anniversary of the Original Issue Date, the Corporation shall
either (i) deliver a written notice to all Holders (a “Maturity Conversion
Notice” and the date such notice is delivered to all Holders, the “Maturity Conversion Notice
Date”) to cause each Holder to convert all of such Holder’s Preferred
Stock (as specified in such Maturity Conversion Notice) plus all liquidated
damages and other amounts then due and payable under this Certificate of
Designation in respect of such Preferred Stock pursuant to Section 6 (such
conversion, the “Maturity
Conversion”), it being agreed that the “Conversion Date” for purposes of
Section 6 shall be the fifth Trading Day following the Maturity Conversion
Notice Date (such fifth Trading Day, the “Maturity Conversion
Date”) or (ii) redeem all of the then outstanding Preferred Stock, for an
amount in cash, for each outstanding share of Preferred Stock, equal to the
Maturity Redemption Amount (such redemption, the “Maturity
Redemption”), and the effective date of such Maturity Redemption shall be
deemed to occur on the fifth Trading Day following the Maturity Conversion
Notice Date (such fifth Trading Day, the “Maturity Redemption
Date”). The Corporation may not exercise a Maturity Redemption
or deliver a Maturity Conversion Notice, as applicable, and notice of a Maturity
Redemption or the Maturity Automatic Conversion Notice, as applicable, delivered
by the Corporation shall not be effective, unless all of the Equity Conditions
have been met on each Trading Day during the twenty (20) consecutive Trading Day
period immediately prior to the Maturity Redemption Date or the Maturity
Conversion Notice Date, as applicable, (such period, the “Maturity Threshold
Period”), and, in the case of a Maturity Conversion, on the Maturity
Conversion Date and each Trading Day thereafter through the later of the
Maturity Conversion Date and the Trading Day that the Conversion Shares issuable
pursuant to such conversion are actually delivered to the Holders pursuant to
the Maturity Conversion Notice. For purposes of clarification,
a Maturity Conversion shall be subject to all of the provisions of Section 6,
including, without limitation, the provisions requiring payment of liquidated
damages and limitations on conversions; provided, however, that no
Holder shall be required to deliver a Notice of Conversion to effect a Maturity
Conversion, and the failure of a Holder to deliver a notice to the Corporation
on the Maturity Conversion Date specifying such Holder’s Beneficial Ownership
Limitation shall be deemed to be a representation by such Holder
(upon which the Corporation may rely without investigation) that all of the
shares of Preferred Stock held by such Holder may be converted on the Maturity
Conversion Date without exceeding such Holder’s Beneficial Ownership Limitation.
The Corporation covenants and agrees that it will honor all Conversion Notices
tendered up until the Maturity Redemption Amount is paid in full. The payment of
cash pursuant to a Maturity Redemption shall be made on the Maturity Redemption
Date. If any portion of the cash payment for a Maturity Redemption
has not been paid by the Corporation on the Maturity Redemption Date, interest
shall accrue thereon until such amount is paid in full at a rate equal to the
lesser of 18% per annum and the maximum rate permitted by applicable
law.
d) Notwithstanding
anything to the contrary herein, if the Corporation is prohibited from issuing
any shares of Common Stock to any Holder pursuant to an Automatic Conversion on
an Automatic Conversion Date or a Maturity Conversion on a Maturity Conversion
Date, as the case may be, solely as a result of the limitations on conversion
set forth in Section 6(c) herein, then, on the 90th
calendar day following the Automatic Conversion Date or the Maturity Conversion
Date, as applicable, the conversion limitations set forth in Section 6(c) shall
no longer apply to such Automatic Conversion or Maturity Conversion, as
applicable, and all of the shares of Common Stock not issued to the applicable
Holder pursuant to the Automatic Conversion on the Automatic Conversion or
pursuant to the Maturity Conversion on the Maturity Conversion Date, as
applicable, shall be issued by the Corporation to such Holder on such 90th
calendar day thereafter.
Section
9. Redemption Upon Triggering
Events.
a) “Triggering Event”
means any one or more of the following events (whatever the reason and whether
it shall be voluntary or involuntary or effected by operation of law or pursuant
to any judgment, decree or order of any court, or any order, rule or regulation
of any administrative or governmental body):
i. the
failure of the initial Conversion Shares Registration Statement to be declared
effective by the Commission on or prior to the Effectiveness Date (as defined in
the Registration Rights Agreement);
ii. if,
during the Effectiveness Period (as defined in the Registration Rights
Agreement), the effectiveness of the Conversion Shares Registration Statement
lapses for more than an aggregate of 60 calendar days (which need not be
consecutive calendar days) during any 12 month period, or the Holders shall not
otherwise be permitted to resell Registrable Securities under the Conversion
Shares Registration Statement for more than an aggregate of 60 calendar days
(which need not be consecutive calendar days) during any 12 month
period;
iii. the
Corporation shall fail to deliver certificates representing Conversion Shares
issuable upon a conversion hereunder that comply with the provisions hereof
prior to the fifth Trading Day after such shares are required to be delivered
hereunder, or the Corporation shall provide written notice to any Holder,
including by way of public announcement, at any time, of its intention not to
comply with requests for conversion of any shares of Preferred Stock in
accordance with the terms hereof;
iv. one
of the Events (as defined in the Registration Rights Agreement) described in
subsections (i), (ii) or (iii) of Section 2(b) of the Registration Rights
Agreement shall not have been cured to the reasonable satisfaction of the
Holders prior to the expiration of 30 calendar days from the Event Date (as
defined in the Registration Rights Agreement) relating thereto (other than an
Event resulting from a failure of the initial Conversion Shares Registration
Statement to be declared timely effective by the Commission on or prior to
Effectiveness Date (as defined in the Registration Rights Agreement), which
shall be covered by Section 9(a)(i));
v. the
Corporation shall fail for any reason to pay in full the amount of cash due
pursuant to a Buy-In within five calendar days after notice therefor is
delivered hereunder or shall fail to pay all amounts owed on account of any
Event (as defined in the Registration Rights Agreement) within five days of the
date due and payable;
vi. after
the Authorized Share Approval Date, the Corporation shall fail to have available
a sufficient number of authorized and unreserved shares of Common Stock to issue
to any Holder upon a conversion hereunder;
vii. unless
specifically addressed elsewhere in this Certificate of Designation as a
Triggering Event, the Corporation shall fail to observe or perform any other
covenant, agreement or warranty contained in, or otherwise commit any breach of
the Transaction Documents, and such failure or breach shall have a Material
Adverse Effect and shall not, if subject to the possibility of a cure by the
Corporation, have been cured within 30 calendar days after the date on which
written notice of such failure or breach shall have been delivered;
viii. any
breach of the Voting Agreements that results in the Corporation not obtaining
Stockholder Approval and Authorized Share Approval;
ix.
the Corporation shall redeem more than a de minimis number
of Junior Securities other than as to repurchases of Common Stock or
Common Stock Equivalents from departing officers and directors, provided that,
while any of the Preferred Stock remains outstanding, such repurchases do not
exceed an aggregate of $100,000 from all officers and directors;
x.
the Corporation shall be party to a Change of Control
Transaction;
xi. there
shall have occurred a Bankruptcy Event;
xii. the
Common Stock shall fail to be listed or quoted for trading on a Trading Market
for more than five Trading Days, which need not be consecutive Trading
Days;
xiii. any
monetary judgment, writ or similar final process shall be entered or filed
against the Corporation, any subsidiary or any of their respective property or
other assets for greater than $100,000, and such judgment, writ or similar final
process shall remain unpaid, unbonded or unstayed for a period of 45 calendar
days; or
xiv.
the Corporation shall fail to file the Amendment after receipt of the approval
by the stockholders of the Corporation of the Amendment as required by Section
4.11(c) of each of the Purchase Agreements.
b) Upon
the occurrence of a Triggering Event, to the extent required under the Series B
Preferred Certificate of Designation, the Corporation agrees to use commercially
reasonable best efforts to obtain waivers from the holders of Series B Preferred
to permit the payment of all Triggering Redemption Amounts in connection
therewith. So long as the Series B Preferred remains outstanding, the
Corporation shall not be permitted to pay any Triggering Redemption Amounts in
cash unless and until it receives waivers from the holders of the Series B
Preferred as required under the Series B Preferred Certificate of
Designation. Subject to the preceding two sentences, upon the
occurrence of a Triggering Event, each Holder shall (in addition to all other
rights it may have hereunder or under applicable law) have the right,
exercisable at the sole option of such Holder, to require the Corporation to,
(A) with respect to the Triggering Events set forth in Sections 9(a)(iii), (v),
(vii), (ix), (x) (as to Changes of Control approved by the Board of Directors of
the Corporation), (xi) (as to voluntary filings only) and (xiv), redeem all of
the Preferred Stock then held by such Holder for a redemption price, in cash,
equal to the Triggering Redemption Amount or (B) at the option of each Holder
and with respect to the Triggering Events set forth in Sections 9(a)(i), (ii),
(iv), (vi), (viii), (x) (as to Changes of Control not approved by the Board of
Directors of the Corporation), (xi) (as to involuntary filings only), (xii) and
(xiii), either (a) redeem all of the Preferred Stock then held by such Holder
for a redemption price, in shares of Common Stock, equal to a number of shares
of Common Stock equal to the Triggering Redemption Amount divided by the lesser
of (i) the then Conversion Price and (ii) 75% of the average of the 10 VWAPs
immediately prior to the date of election hereunder (so long as the price at
which such shares shall be valued in sub-clause (ii) is greater than the greater
of (x) the conversion price then in effect for the Series B Preferred, (y) the
exercise price then in effect of the Corporation’s Series B Warrants and (z) the
exercise price then in effect of the Corporation’s Series C Warrants, or (b) the
then Conversion Price shall be reduced by the dollar amount equal to the product
of (A) the initial Conversion Price (subject to adjustment for all adjustments
except for adjustments set forth in the penultimate sentence of Section 6(b))
and (B) 5.0%. Subject to the first two sentences of this Section, the
Triggering Redemption Amount, in cash or in shares, shall be due and payable or
issuable, as the case may be, within five Trading Days of the date on which the
notice for the payment therefor is provided by a Holder (the “Triggering Redemption
Payment Date”). If the Corporation fails to pay in full the
Triggering Redemption Amount hereunder on the date such amount is due in
accordance with this Section (whether in cash or shares of Common Stock), the
Corporation will pay interest thereon at a rate equal to the lesser of 15% per
annum and the maximum rate permitted by applicable law, accruing daily from such
date until the Triggering Redemption Amount, plus all such interest thereon, is
paid in full. For purposes of this Section, a share of Preferred
Stock is outstanding until such date as the applicable Holder shall have
received Conversion Shares upon a conversion (or attempted conversion) thereof
that meets the requirements hereof or has been paid the Triggering Redemption
Amount in cash.
Section
10. Negative
Covenants. So long as any shares of Preferred Stock are
outstanding (or such other period as specified below), unless the holders of at
least 67% in Stated Value of the then outstanding shares of Preferred Stock
shall have otherwise given prior written consent, the Corporation shall not, and
shall not permit any of its Subsidiaries to, directly or
indirectly:
a) other
than Permitted Indebtedness, enter into, create, incur, assume, guarantee or
suffer to exist any indebtedness for borrowed money of any kind, including but
not limited to, a guarantee, on or with respect to any of its property or assets
now owned or hereafter acquired or any interest therein or any income or profits
therefrom;
b) other
than Permitted Liens, enter into, create, incur, assume or suffer to exist any
Liens of any kind, on or with respect to any of its property or assets now owned
or hereafter acquired or any interest therein or any income or profits
therefrom;
c) amend
its certificate of incorporation, bylaws or other charter documents so as to
materially and adversely affect any rights of any Holder;
d) repay,
repurchase or offer to repay, repurchase or otherwise acquire more than a de minimis number
of shares of its Common Stock, Common Stock Equivalents or Junior Securities,
except for (i) the Conversion Shares to the extent permitted or required under
the Transaction Documents or as otherwise permitted by the Transaction Documents
and (ii) the Series B Preferred in accordance with the terms and conditions
thereof as in effect on the Original Issue Date;
e) enter
into any agreement or understanding with respect to any of the foregoing;
or
f) pay
cash dividends or distributions on Junior Securities of the
Corporation.
Section
11. Rank.
The Preferred Stock shall rank, with
respect to distributions and payments upon the liquidation, dissolution and
winding up of the Corporation, junior to the Series B
Preferred and senior to
all shares of Common Stock and other capital stock of the Corporation (other
than the Series B Preferred). Without limiting the foregoing, as long
as any share of Series B Preferred is outstanding, (a) the Corporation shall
not, and shall not be obligated to, make any distributions on the Preferred
Stock, unless either (i) each holder of the outstanding Series B Preferred has
been paid in full all dividends and other distributions to which such holder is
then entitled or (ii) the Corporation shall have received the consent to make
payment of distributions from at least the Required Holders (as defined in the
Certificate of Designations for the Series B Preferred), and (b) the Corporation
shall not redeem any of the Preferred Stock. In no event shall the
Corporation pay, or be obligated to pay, any cash distributions on the Preferred
Stock, or redeem, or be obligated to redeem, any of the Preferred Stock, except
in each case out of funds legally available therefor.
Section
12. Miscellaneous.
a) Notices. Any
and all notices or other communications or deliveries to be provided by the
Holders hereunder including, without limitation, any Notice of Conversion, shall
be in writing and delivered personally, by facsimile, or sent by a nationally
recognized overnight courier service, addressed to the Corporation, at the
address set forth above, facsimile number (716) 849-6820, Attention:
Michael Fonstein and John A. Marhofer, Jr. or such other facsimile number or
address as the Corporation may specify for such purposes by notice to the
Holders delivered in accordance with this Section 12. Any and all
notices or other communications or deliveries to be provided by the Corporation
hereunder shall be in writing and delivered personally, by facsimile, or sent by
a nationally recognized overnight courier service addressed to each Holder at
the facsimile number or address of such Holder appearing on the books of the
Corporation, or if no such facsimile number or address appears on the books of
the Corporation, at the principal place of business of such
Holder. Any notice or other communication or deliveries hereunder
shall be deemed given and effective on the earliest of (i) the date of
transmission, if such notice or communication is delivered via facsimile at the
facsimile number set forth on the signature pages attached hereto prior to 5:30
p.m. (New York City time) on a Trading Day, (ii) the next Trading Day after the
date of transmission, if such notice or communication is delivered via facsimile
at the facsimile number set forth on the signature pages attached hereto on a
day that is not a Trading Day or later than 5:30 p.m. (New York City time) on
any Trading Day, (iii) the second Trading Day following the date of mailing, if
sent by U.S. nationally recognized overnight courier service, or (iv) upon
actual receipt by the party to whom such notice is required to be
given.
b) Absolute Obligation.
Except as expressly provided herein, no provision of this Certificate of
Designation shall alter or impair the obligation of the Corporation, which is
absolute and unconditional, to pay liquidated damages, accrued dividends and
accrued interest, as applicable, on the shares of Preferred Stock at the time,
place, and rate, and in the coin or currency, herein prescribed.
c) Lost or Mutilated Preferred
Stock Certificate. If any certificate or instrument evidencing
any Preferred Stock is mutilated, lost, stolen or destroyed, the Corporation
shall issue or cause to be issued in exchange and substitution for and upon
cancellation thereof (in the case of mutilation), or in lieu of and substitution
therefor, a new certificate or instrument, but only upon receipt of evidence
reasonably satisfactory to the Corporation of such loss, theft or
destruction. The applicant for a new certificate or instrument under
such circumstances shall also execute a customary affidavit and pay any
reasonable third-party costs (including customary indemnity, and bond, if
required by the Transfer Agent) associated with the issuance of such replacement
Preferred Stock certificate(s).
d) Governing
Law. All questions concerning the construction, validity,
enforcement and interpretation of this Certificate of Designation shall be
governed by and construed and enforced in accordance with the internal laws of
the State of Delaware, without regard to the principles of conflict of laws
thereof. Each party agrees that all legal proceedings concerning the
interpretation, enforcement and defense of the transactions contemplated by any
of the Transaction Documents (whether brought against a party hereto or its
respective Affiliates, directors, officers, stockholders, employees or agents)
shall be commenced in the state and federal courts sitting in the City of New
York, Borough of Manhattan (the “New York
Courts”). Each party hereto hereby irrevocably submits to the
exclusive jurisdiction of the New York Courts for the adjudication of any
dispute hereunder or in connection herewith or with any transaction contemplated
hereby or discussed herein (including with respect to the enforcement of any of
the Transaction Documents), and hereby irrevocably waives, and agrees not to
assert in any suit, action or proceeding, any claim that it is not personally
subject to the jurisdiction of such New York Courts, or such New York Courts are
improper or inconvenient venue for such proceeding. Each party hereby
irrevocably waives personal service of process and consents to process being
served in any such suit, action or proceeding by mailing a copy thereof via
registered or certified mail or overnight delivery (with evidence of delivery)
to such party at the address in effect for notices to it under this Certificate
of Designation and agrees that such service shall constitute good and sufficient
service of process and notice thereof. Nothing contained herein shall
be deemed to limit in any way any right to serve process in any other manner
permitted by applicable law. Each party hereto hereby irrevocably waives, to the
fullest extent permitted by applicable law, any and all right to trial by jury
in any legal proceeding arising out of or relating to this Certificate of
Designation or the transactions contemplated hereby. If any party shall commence
an action or proceeding to enforce any provisions of this Certificate of
Designation, then the prevailing party in such action or proceeding shall be
reimbursed by the other party for its attorneys’ fees and other costs and
expenses incurred in the investigation, preparation and prosecution of such
action or proceeding.
e) Waiver. Any
waiver by the Corporation or a Holder of a breach of any provision of this
Certificate of Designation shall not operate as or be construed to be a waiver
of any other breach of such provision or of any breach of any other provision of
this Certificate of Designation or a waiver by any other Holders. The
failure of the Corporation or a Holder to insist upon strict adherence to any
term of this Certificate of Designation on one or more occasions shall not be
considered a waiver or deprive that party (or any other Holder) of the right
thereafter to insist upon strict adherence to that term or any other term of
this Certificate of Designation on any other occasion. Any waiver by
the Corporation or a Holder must be in writing.
f) Severability. If
any provision of this Certificate of Designation is invalid, illegal or
unenforceable, the balance of this Certificate of Designation shall remain in
effect, and if any provision is inapplicable to any Person or circumstance, it
shall nevertheless remain applicable to all other Persons and
circumstances. If it shall be found that any interest or other amount
deemed interest due hereunder violates the applicable law governing usury, the
applicable rate of interest due hereunder shall automatically be lowered to
equal the maximum rate of interest permitted under applicable law.
g) Next Business
Day. Whenever any payment or other obligation hereunder shall
be due on a day other than a Business Day, such payment shall be made on the
next succeeding Business Day.
h) Headings. The
headings contained herein are for convenience only, do not constitute a part of
this Certificate of Designation and shall not be deemed to limit or affect any
of the provisions hereof.
i)
Status of Converted or
Redeemed Preferred Stock. Shares of Preferred Stock may only
be issued pursuant to each of the Purchase Agreements. If any shares
of Preferred Stock shall be converted, redeemed or reacquired by the
Corporation, such shares shall resume the status of authorized but unissued
shares of preferred stock and shall no longer be designated as Series D
Convertible Preferred Stock.
*********************
RESOLVED,
FURTHER, that the Chairman, the president or any
vice-president, and the secretary or any assistant secretary,
of the Corporation be and they hereby are authorized and directed to prepare and
file this Certificate of Designation of Preferences, Rights and Limitations in
accordance with the foregoing resolution and the provisions of Delaware
law.
IN
WITNESS WHEREOF, the undersigned have executed this Certificate this 13th day of
February 2009.
/s/ Michael Fonstein
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|
/s/ Yakov Kogan
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|
|
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Name: Michael
Fonstein
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Name: Yakov
Kogan
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Title: President
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Title: Secretary
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ANNEX
A
NOTICE OF
CONVERSION
(TO BE
EXECUTED BY THE REGISTERED HOLDER IN ORDER TO CONVERT SHARES OF PREFERRED
STOCK)
The
undersigned hereby elects to convert the number of shares of Series D
Convertible Preferred Stock indicated below into shares of common stock, par
value $0.005 per share (the “Common Stock”), of
Cleveland BioLabs, Inc., a Delaware corporation (the “Corporation”),
according to the conditions hereof, as of the date written below. If shares of
Common Stock are to be issued in the name of a Person other than the
undersigned, the undersigned will pay all transfer taxes payable with respect
thereto and is delivering herewith such certificates and opinions as may be
required by the Corporation in accordance with the applicable Purchase
Agreement. No fee will be charged to the Holders for any conversion, except for
any such transfer taxes.
Conversion
calculations:
Date
to Effect Conversion:
_____________________________________________
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Number
of shares of Preferred Stock owned prior to Conversion:
_______________
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Number
of shares of Preferred Stock to be Converted:
________________________
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Aggregate
Stated Value of shares of Preferred Stock to be Converted:
____________________
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Number
of shares of Common Stock to be Issued:
___________________________
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Applicable
Conversion Price:____________________________________________
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Number
of shares of Preferred Stock subsequent to Conversion:
________________
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Address
for Delivery: ______________________
or
DWAC
Instructions:
Broker
no: _________
Account
no: ___________
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[HOLDER]
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By:
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Name:
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Title:
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WARRANT
NO. D-_
NEITHER
THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE
BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES
COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER
THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY,
MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION
STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO AN AVAILABLE EXEMPTION FROM,
OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE
SECURITIES ACT AND IN ACCORDANCE WITH APPLICABLE STATE SECURITIES LAWS AS
EVIDENCED BY A LEGAL OPINION OF COUNSEL TO THE TRANSFEROR TO SUCH EFFECT, THE
FORM AND SUBSTANCE OF WHICH SHALL BE REASONABLY ACCEPTABLE TO THE
COMPANY. THIS SECURITY AND THE SECURITIES ISSUABLE UPON EXERCISE OF
THIS SECURITY MAY BE PLEDGED IN CONNECTION WITH A BONA FIDE MARGIN ACCOUNT OR
OTHER LOAN SECURED BY SUCH SECURITIES.
COMMON
STOCK PURCHASE WARRANT
CLEVELAND
BIOLABS, INC.
Warrant
Shares: ________
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Initial
Exercise Date: __________, 2009
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THIS
COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies
that, for value received, _________ ( “Holder”) is entitled,
upon the terms and subject to the limitations on exercise and the conditions
hereinafter set forth, at any time on or after the date hereof (the “Initial Exercise
Date”) and on or prior to the close of business on the seven year
anniversary of the Initial Exercise Date (the “Termination Date”)
but not thereafter, to subscribe for and purchase from Cleveland BioLabs, Inc.,
a Delaware corporation (the “Company”), up to
______ shares (the “Warrant Shares”) of
Common Stock. The purchase price of one share of Common Stock under
this Warrant shall be equal to the Exercise Price, as defined in Section
2(b).
Section 1. Definitions. Capitalized
terms used and not otherwise defined herein shall have the meanings set forth in
that certain Securities Purchase Agreement (the “Purchase Agreement”),
dated ________, 2009, among the Company and the purchasers signatory
thereto.
Section 2.
Exercise.
a)
Exercise
of Warrant. Exercise of the purchase rights represented by
this Warrant may be made, in whole or in part, at any time or times on or after
the Initial Exercise Date and on or before the Termination Date by delivery to
the Company (or such other office or agency of the Company as it may designate
by notice in writing to the registered Holder at the address of Holder appearing
on the books of the Company) of a duly executed facsimile copy of the Notice of
Exercise Form annexed hereto; and, within three (3) Trading Days of the date
said Notice of Exercise is delivered to the Company, the Company shall have
received payment of the aggregate Exercise Price of the shares
thereby purchased by wire transfer or cashier’s check drawn on a United States
bank. Notwithstanding anything herein to the contrary (but subject to
Sections 4(a) and 4(b), Holder shall not be required to physically surrender
this Warrant to the Company until Holder has purchased all of the Warrant Shares
available hereunder and the Warrant has been exercised in full, in which case,
Holder shall surrender this Warrant to the Company for cancellation within three
(3) Trading Days of the date the final Notice of Exercise is delivered to the
Company. Partial exercises of this Warrant resulting in purchases of
a portion of the total number of Warrant Shares available hereunder shall have
the effect of lowering the outstanding number of Warrant Shares purchasable
hereunder in an amount equal to the applicable number of Warrant Shares
purchased. Holder and the Company shall maintain records showing the
number of Warrant Shares purchased and the date of such
purchases. The Company shall deliver any objection to any Notice of
Exercise Form within two (2) Business Days of receipt of such
notice. In the event of any dispute or discrepancy, the records of
the Company shall be controlling and determinative in the absence of manifest
error. Holder and any assignee,
by acceptance of this Warrant, acknowledge and agree that, by reason of the
provisions of this paragraph, following the purchase of a portion of the Warrant
Shares hereunder, the number of Warrant Shares available for purchase hereunder
at any given time may be less than the amount stated on the face
hereof.
b)
Exercise
Price. The exercise price per share of the Common Stock under
this Warrant shall be $2.60,
subject to adjustment hereunder (the “Exercise
Price”).
c)
Cashless
Exercise. If at any time after the earlier of (i) the one year
anniversary of the date of the Purchase Agreement and (ii) the completion of the
then-applicable holding period required by Rule 144, or any successor provision
then in effect, there is no effective Registration Statement registering, or no
current prospectus available for, the resale of the Warrant Shares by Holder,
then this Warrant may also be exercised at such time by means of a “cashless
exercise” in which Holder shall be entitled to receive a certificate for the
number of Warrant Shares equal to the quotient obtained by dividing [(A-B) (X)]
by (A), where:
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(A)
=
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the
VWAP on the Trading Day immediately preceding the date on which Holder
elects to exercise this Warrant by means of a “cashless exercise,” as set
forth in the applicable Notice of
Exercise;
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(B)
=
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the
Exercise Price of this Warrant, as adjusted hereunder;
and
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(X)
=
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the
number of Warrant Shares that would be issuable upon exercise of this
Warrant in accordance with the terms of this Warrant if such exercise were
by means of a cash exercise rather than a cashless
exercise.
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d)
Exercise
Limitations.
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i.
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Holder’s
Restrictions. The Company shall not effect any exercise
of this Warrant, and a Holder shall not have the right to exercise any
portion of this Warrant, pursuant to Section 2 or otherwise, to the extent
that after giving effect to such issuance after exercise as set forth on
the applicable Notice of Exercise, Holder (together with Holder’s
Affiliates, and any other Persons acting as a group together with Holder
or any of Holder’s Affiliates), would beneficially own in excess of the
Beneficial Ownership Limitation (as defined below). For
purposes of the foregoing sentence, the number of shares of Common Stock
beneficially owned by Holder and its Affiliates shall include the number
of shares of Common Stock issuable upon exercise of this Warrant with
respect to which such determination is being made, but shall exclude the
number of shares of Common Stock which would be issuable upon (A) exercise
of the remaining, nonexercised portion of this Warrant beneficially owned
by Holder or any of its Affiliates and (B) exercise or conversion of the
unexercised or nonconverted portion of any other securities of the Company
(including, without limitation, any other Common Stock
Equivalents) subject to a limitation on conversion or exercise analogous
to the limitation contained herein beneficially owned by Holder or any of
its Affiliates. Except as set forth in the preceding sentence, for
purposes of this Section 2(d)(i), beneficial ownership shall be calculated
in accordance with Section 13(d) of the Exchange Act and the rules and
regulations promulgated thereunder, it being acknowledged by Holder that
the Company is not representing to Holder that such calculation is in
compliance with Section 13(d) of the Exchange Act and Holder is solely
responsible for any schedules required to be filed in accordance
therewith. To the extent that the limitation contained in
this Section 2(d)(i) applies, the determination of whether this Warrant is
exercisable (in relation to other securities owned by Holder together with
any Affiliates) and of which portion of this Warrant is exercisable shall
be in the sole discretion of Holder, and the submission of a Notice of
Exercise shall be deemed to be Holder’s determination of whether this
Warrant is exercisable (in relation to other securities owned by Holder
together with any Affiliates) and of which portion of this Warrant is
exercisable, in each case subject to the Beneficial Ownership Limitation,
and the Company shall have no obligation to verify or confirm the accuracy
of such determination. In addition, a determination as to
any group status as contemplated above shall be determined in accordance
with Section 13(d) of the Exchange Act and the rules and regulations
promulgated thereunder. For purposes of this Section 2(d)(i),
in determining the number of outstanding shares of Common Stock, a Holder
may rely on the number of outstanding shares of Common Stock as reflected
in (A) the Company’s most recent periodic or annual report filed with the
Commission, as the case may be, (B) a more recent public announcement by
the Company or (C) a more recent written notice by the Company or the
Transfer Agent setting forth the number of shares of Common Stock
outstanding. Upon the written or oral request of a Holder, the
Company shall within two Trading Days confirm orally and in writing to
Holder the number of shares of Common Stock then outstanding. In any
case, the number of outstanding shares of Common Stock shall be determined
after giving effect to the conversion or exercise of securities of the
Company, including this Warrant, by Holder or its Affiliates since the
date as of which such number of outstanding shares of Common Stock was
reported. The “Beneficial Ownership
Limitation” shall be 9.99% of the number of shares of the Common
Stock outstanding immediately after giving effect to the issuance of
shares of Common Stock issuable upon exercise of this
Warrant. Holder, upon not less than 61 days’ prior notice to
the Company, may decrease the Beneficial Ownership Limitation provisions
of this Section 2(d)(i), provided that the provisions of this Section
2(d)(i) shall continue to apply. Any such decrease will not be
effective until the 61st day after such notice is delivered to the
Company. The provisions of this paragraph shall be construed
and implemented in a manner otherwise than in strict conformity with the
terms of this Section 2(d)(i) to correct this paragraph (or any portion
hereof) which may be defective or inconsistent with the intended
Beneficial Ownership Limitation herein contained or to make changes or
supplements necessary or desirable to properly give effect to such
limitation. The limitations contained in this paragraph shall apply to a
successor holder of this Warrant.
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ii.
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Issuance
Restrictions. If the Company has not obtained
Stockholder Approval, then the Company may not issue upon exercise of this
Warrant a number of shares of Common Stock, which, when aggregated with
any shares of Common Stock issued (A) pursuant to the conversion of any
Preferred Stock issued pursuant to any of the Purchase Agreements, (B)
upon prior exercise of this or any other Warrant issued pursuant to any of
the Purchase Agreements and (C) pursuant to any warrants issued to any
registered broker-dealer as a fee in connection with the issuance of
Securities pursuant to the Purchase Agreements, would exceed
2,770,160 shares of Common Stock, subject to adjustment for
reverse and forward stock splits, stock dividends, stock combinations and
other similar transactions of the Common Stock that occur after the date
of the Purchase Agreement (such number of shares, the “Issuable
Maximum”). Holder and the holders of the other Warrants
issued pursuant to the Purchase Agreement shall be entitled to a portion
of the Issuable Maximum equal to the quotient obtained by dividing (x)
Holder’s original Subscription Amount by (y) the aggregate original
Subscription Amount of all holders pursuant to the Purchase Agreements. In
addition, Holder may allocate its pro-rata portion of the Issuable Maximum
among Warrants held by it in its sole discretion. Such portion shall be
adjusted upward ratably in the event a Purchaser no longer holds any
Warrants and the amount of shares issued to such Purchaser pursuant to its
Warrants was less than such Purchaser’s pro-rata share of the Issuable
Maximum. In the event that any Holder shall sell or otherwise
transfer any of such Holder’s Warrants, the transferee shall be allocated
a pro rata portion of such Holder’s portion of the Issuable Maximum. For
avoidance of doubt, unless and until any required Stockholder Approval is
obtained and effective, warrants issued to any registered broker-dealer as
a fee in connection with the Securities issued pursuant to the Purchase
Agreements as described in clause (C) above shall provide that such
warrants shall not be allocated any portion of the Issuable Maximum and
shall be unexercisable unless and until such Stockholder Approval is
obtained and effective.
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e)
Mechanics of
Exercise.
i. Delivery of Certificates
Upon Exercise. Certificates for shares purchased hereunder
shall be transmitted by the Transfer Agent to Holder by crediting the account of
Holder’s prime broker with the Depository Trust Company through its Deposit
Withdrawal Agent Commission (“DWAC”) system if the
Company is then a participant in such system and either (A) there is an
effective Registration Statement permitting the resale of the Warrant Shares by
Holder or (B) the shares are eligible for resale by Holder without volume or
manner-of-sale limitations pursuant to Rule 144, and otherwise by physical
delivery to the address specified by Holder in the Notice of Exercise by the
date that is three (3) Trading Days after the latest of (A) the delivery to the
Company of the Notice of Exercise Form, (B) surrender of this Warrant (if
required), and (C) payment of the aggregate Exercise Price as set forth above
(such date, the “Warrant Share Delivery
Date”). This Warrant shall be deemed to have been exercised on
the first date on which all of the foregoing have been delivered to the
Company. The Warrant Shares shall be deemed to have been issued, and
Holder or any other person so designated to be named therein shall be deemed to
have become a holder of record of such shares for all purposes, as of the date
the Warrant has been exercised, with payment to the Company of the Exercise
Price (or by cashless exercise, if permitted) and all taxes required to be paid
by Holder, if any, pursuant to Section 2(e)(vi) prior to the issuance of such
shares, having been paid. If the Company fails for any reason to deliver to
Holder certificates evidencing the Warrant Shares subject to a Notice of
Exercise by the Warrant Share Delivery Date, the Company shall pay to Holder, in
cash, as liquidated damages and not as a penalty, for each $1,000 of Warrant
Shares subject to such exercise (based on the VWAP of the Common Stock on the
date of the applicable Notice of Exercise), $10 per Trading Day (increasing to
$20 per Trading Day on the fifth Trading Day after such liquidated damages begin
to accrue) for each Trading Day after such second Trading Day following the
Warrant Share Delivery Date until such certificates are delivered or Holder
rescinds such exercise.
ii. Delivery of New Warrants
Upon Exercise. If this Warrant shall have been exercised in
part, the Company shall, at the request of a Holder and upon surrender of this
Warrant certificate, at the time of delivery of the certificate or certificates
representing Warrant Shares, deliver to Holder a new Warrant evidencing the
rights of Holder to purchase the unpurchased Warrant Shares called for by this
Warrant, which new Warrant shall in all other respects be identical with this
Warrant.
iii. Rescission
Rights. If the Company fails to cause the Transfer Agent to
transmit to Holder a certificate or the certificates representing the Warrant
Shares pursuant to Section 2(e)(i) by the Warrant Share Delivery Date, then,
Holder will have the right to rescind such exercise.
iv. Compensation for Buy-In on
Failure to Timely Deliver Certificates Upon Exercise. In
addition to any other rights available to Holder, if the Company fails to cause
the Transfer Agent to transmit to Holder a certificate or the certificates
representing the Warrant Shares pursuant to an exercise on or before the Warrant
Share Delivery Date, and if after such date Holder is required by its broker to
purchase (in an open market transaction or otherwise) or Holder’s brokerage firm
otherwise purchases, shares of Common Stock to deliver in satisfaction of a sale
by Holder of the Warrant Shares which Holder anticipated receiving upon such
exercise (a “Buy-In”), then the
Company shall (A) pay in cash to Holder the amount by which (x) Holder’s total
purchase price (including brokerage commissions, if any) for the shares of
Common Stock so purchased exceeds (y) the amount obtained by multiplying (1) the
number of Warrant Shares that the Company was required to deliver to Holder in
connection with the exercise at issue times (2) the price at which the sell
order giving rise to such purchase obligation was executed, and (B) at the
option of Holder, either reinstate the portion of the Warrant and equivalent
number of Warrant Shares for which such exercise was not honored (in which case
such exercise shall be deemed rescinded) or deliver to Holder the number of
shares of Common Stock that would have been issued had the Company timely
complied with its exercise and delivery obligations hereunder. For
example, if Holder purchases Common Stock having a total purchase price of
$11,000 to cover a Buy-In with respect to an attempted exercise of shares of
Common Stock with an aggregate sale price giving rise to such purchase
obligation of $10,000, under clause (A) of the immediately preceding sentence
the Company shall be required to pay Holder $1,000. Holder shall provide the
Company written notice indicating the amounts payable to Holder in respect of
the Buy-In and, upon request of the Company, written evidence of the Buy-In and
the amount of such loss. Nothing herein shall limit a Holder’s right
to pursue any other remedies available to it hereunder, at law or in equity
including, without limitation, a decree of specific performance and/or
injunctive relief with respect to the Company’s failure to timely deliver
certificates representing shares of Common Stock upon exercise of the Warrant as
required pursuant to the terms hereof.
v.
No Fractional Shares or
Scrip. No fractional shares or scrip representing fractional
shares shall be issued upon the exercise of this Warrant. As to any
fraction of a share which Holder would otherwise be entitled to purchase upon
such exercise, the Company shall, at its election, either pay a cash adjustment
in respect of such final fraction in an amount equal to such fraction multiplied
by the Exercise Price or round up to the next whole share.
vi. Charges, Taxes and
Expenses. Issuance of certificates for Warrant Shares shall be
made without charge to Holder for any issue or transfer tax or other incidental
expense in respect of the issuance of such certificate, all of which taxes and
expenses shall be paid by the Company, and such certificates shall be issued in
the name of Holder or in such name or names as may be directed by Holder; provided, however, that in the
event certificates for Warrant Shares are to be issued in a name other than the
name of Holder, this Warrant when surrendered for exercise shall be accompanied
by the Assignment Form attached hereto duly executed by Holder and the Company
may require, as a condition thereto, the payment of a sum sufficient to
reimburse it for any transfer tax incidental thereto.
vii. Closing of
Books. The Company will not close its stockholder books or
records in any manner which prevents the timely exercise of this Warrant,
pursuant to the terms hereof.
Section 3. Certain
Adjustments.
a) Stock Dividends and
Splits. If the Company, at any time while this Warrant is outstanding:
(i) pays a stock dividend or otherwise make a distribution or distributions on
shares of its Common Stock or any other equity or equity equivalent securities
payable in shares of Common Stock (which, for avoidance of doubt, shall not
include any shares of Common Stock issued by the Company upon exercise of this
Warrant or upon conversion of, or as payment of a dividend on, the Preferred
Stock or the Series B Preferred in accordance with the terms thereof as in
effect as of the date of the Purchase Agreement), (ii) subdivides outstanding
shares of Common Stock into a larger number of shares, (iii) combines (including
by way of reverse stock split) outstanding shares of Common Stock into a smaller
number of shares or (iv) issues by reclassification of shares of the Common
Stock any shares of capital stock of the Company, then in each case the Exercise
Price shall be multiplied by a fraction of which the numerator shall be the
number of shares of Common Stock (excluding treasury shares, if any) outstanding
immediately before such event and of which the denominator shall be the number
of shares of Common Stock outstanding immediately after such event, and the
number of shares issuable upon exercise of this Warrant shall be proportionately
adjusted such that the aggregate Exercise Price of this Warrant shall remain
unchanged. Any adjustment made pursuant to this Section 3(a) shall
become effective immediately after the record date for the determination of
stockholders entitled to receive such dividend or distribution and shall become
effective immediately after the effective date in the case of a subdivision,
combination or re-classification.
b)
Subsequent
Equity Sales. If the Company or any Subsidiary thereof, as applicable, at
any time while this Warrant is outstanding, shall sell or grant any option to
purchase, or sell or grant any right to reprice, or otherwise dispose of or
issue any Common Stock or Common Stock Equivalents entitling any Person to
acquire shares of Common Stock, at an effective price per share less than the
Exercise Price then in effect (such lower price, the “Base Share Price” and
such issuances collectively, a “Dilutive Issuance”)
(if the holder of the Common Stock or Common Stock Equivalents so issued shall
at any time, whether by operation of purchase price adjustments, reset
provisions, floating conversion, exercise or exchange prices or otherwise, or
due to warrants, options or rights per share which are issued in connection with
such issuance, be entitled to receive shares of Common Stock at an effective
price per share that is less than the Exercise Price then in effect, such
issuance shall be deemed to have occurred for less than the Exercise Price on
such date of the Dilutive Issuance), then, the Exercise Price shall be reduced
and only reduced to equal the Base Share Price. Such adjustment shall
be made whenever such Common Stock or Common Stock Equivalents are
issued. Notwithstanding the foregoing, no adjustments shall be made,
paid or issued under this Section 3(b) in respect of an Exempt
Issuance. The Company shall notify Holder, in writing, no later than
the Trading Day following the issuance of any Common Stock or Common Stock
Equivalents subject to this Section 3(b), indicating therein the applicable
issuance price, or applicable reset price, exchange price, conversion price and
other pricing terms (such notice, the “Dilutive Issuance
Notice”). For purposes of clarification, whether or not the
Company provides a Dilutive Issuance Notice pursuant to this Section 3(b), upon
the occurrence of any Dilutive Issuance, after the date of such Dilutive
Issuance Holder is entitled to receive a number of Warrant Shares based upon the
Base Share Price on or after the date of such Dilutive Issuance, regardless of
whether Holder accurately refers to the Base Share Price in the Notice of
Exercise.
c)
Subsequent Rights
Offerings. If the Company, at any time while the Warrant is
outstanding, shall issue rights, options or warrants to all holders of Common
Stock (and not to Holder) entitling them to subscribe for or purchase shares of
Common Stock at a price per share less than the VWAP on the record date
mentioned below, then, the Exercise Price shall be multiplied by a fraction, of
which the denominator shall be the number of shares of the Common Stock
outstanding on the date of issuance of such rights or warrants plus the number
of additional shares of Common Stock offered for subscription or purchase, and
of which the numerator shall be the number of shares of the Common Stock
outstanding on the date of issuance of such rights or warrants plus the number
of shares which the aggregate offering price of the total number of shares so
offered (assuming receipt by the Company in full of all consideration payable
upon exercise of such rights, options or warrants) would purchase at such
VWAP. Such adjustment shall be made whenever such rights or warrants
are issued, and shall become effective immediately after the record date for the
determination of stockholders entitled to receive such rights, options or
warrants.
d)
Pro Rata
Distributions. If the Company, at any time while this Warrant
is outstanding, shall distribute to all holders of Common Stock (and not to
Holder) evidences of its indebtedness or assets (including cash and cash
dividends) or rights or warrants to subscribe for or purchase any security other
than the Common Stock (which shall be subject to Section 3(b)), then in each
such case the Exercise Price shall be adjusted by multiplying the Exercise Price
in effect immediately prior to the record date fixed for determination of
stockholders entitled to receive such distribution by a fraction of which the
denominator shall be the VWAP determined as of the record date mentioned above,
and of which the numerator shall be such VWAP on such record date less the then
per share fair market value at such record date of the portion of such assets or
evidence of indebtedness so distributed applicable to one outstanding share of
the Common Stock as determined by the Board of Directors in good
faith. In either case the adjustments shall be described in a
statement provided to Holder of the portion of assets or evidences of
indebtedness so distributed or such subscription rights applicable to one share
of Common Stock. Such adjustment shall be made whenever any such
distribution is made and shall become effective immediately after the record
date mentioned above.
e)
Fundamental
Transaction. If, at any time while this Warrant is outstanding, (i) the
Company effects any merger or consolidation of the Company with or into another
Person, (ii) the Company effects any sale of all or substantially all of its
assets in one or a series of related transactions, (iii) any tender offer or
exchange offer (whether by the Company or another Person) is completed pursuant
to which holders of Common Stock are permitted to tender or exchange their
shares for other securities, cash or property or (iv) the Company effects any
reclassification of the Common Stock or any compulsory share exchange pursuant
to which the Common Stock is effectively converted into or exchanged for other
securities, cash or property (each a “Fundamental
Transaction”), then, upon any subsequent exercise of this Warrant, Holder
shall have the right to receive, for each Warrant Share that would have been
issuable upon such exercise immediately prior to the occurrence of such
Fundamental Transaction, the number of shares of Common Stock of the successor
or acquiring corporation or of the Company, if it is the surviving corporation,
and any additional consideration (the “Alternate
Consideration”) receivable as a result of such merger, consolidation or
disposition of assets by a holder of the number of shares of Common Stock for
which this Warrant is exercisable immediately prior to such event. For purposes
of any such exercise, the determination of the Exercise Price shall be
appropriately adjusted to apply to such Alternate Consideration based on the
amount of Alternate Consideration issuable in respect of one share of Common
Stock in such Fundamental Transaction, and the Company shall apportion the
Exercise Price among the Alternate Consideration in a reasonable manner
reflecting the relative value of any different components of the Alternate
Consideration. If holders of Common Stock are given any choice as to
the securities, cash or property to be received in a Fundamental Transaction,
then Holder shall be given the same choice as to the Alternate Consideration it
receives upon any exercise of this Warrant following such Fundamental
Transaction. To the extent necessary to effectuate the foregoing
provisions, any successor to the Company or surviving entity in such Fundamental
Transaction shall issue to Holder a new warrant, in exchange for the Warrant,
consistent with the foregoing provisions and evidencing Holder’s right to
exercise such warrant into Alternate Consideration. The terms of any agreement
pursuant to which a Fundamental Transaction is effected shall include terms
requiring any such successor or surviving entity to comply with the provisions
of this Section 3(e) and ensuring that this Warrant (or any such replacement
security) will be similarly adjusted upon any subsequent transaction analogous
to a Fundamental Transaction. Notwithstanding anything to the contrary, in the
event of a Fundamental Transaction that is (1) an all cash transaction, (2) a
“Rule 13e-3 transaction” as defined in Rule 13e-3 under the Exchange Act, or (3)
a Fundamental Transaction involving a person or entity not traded on a national
securities exchange, including, but not limited to, the Nasdaq Global Select
Market, the Nasdaq Global Market, or the Nasdaq Capital Market, the Company or
any successor entity shall pay at Holder’s option, exercisable at any time
concurrently with or within 30 days after the consummation of the Fundamental
Transaction, in exchange for this Warrant, an amount of cash equal to the value
of this Warrant as determined in accordance with the Black Scholes Option
Pricing Model obtained from the “OV” function on Bloomberg L.P. using (A) a
price per share of Common Stock equal to the VWAP of the Common Stock for the
Trading Day immediately preceding the date of consummation of the
applicable Fundamental Transaction, (B) the risk-free interest rate
corresponding to the U.S. Treasury rate for a period equal to the remaining term
of this Warrant as of the date of consummation of the applicable Fundamental
Transaction, (C) an expected volatility equal to the 100 day volatility obtained
from the “HVT” function on Bloomberg L.P. determined as of the Trading Day
immediately following the public announcement of the applicable Fundamental
Transaction and (D) a remaining option time equal to the time between the date
of the public announcement of such transaction and the Termination Date. Upon
such payment, in full, this Warrant shall be canceled and shall be of no further
force or effect.
f)
Calculations. All
calculations under this Section 3 shall be made to the nearest cent or the
nearest 1/100th of a share, as the case may be. For purposes of this Section 3,
the number of shares of Common Stock deemed to be issued and outstanding as of a
given date shall be the sum of the number of shares of Common Stock (excluding
treasury shares, if any) issued and outstanding.
g)
Notice to
Holder.
i. Adjustment to Exercise
Price. Whenever the Exercise Price is adjusted pursuant to any provision
of this Section 3, the Company shall promptly mail to Holder a notice setting
forth the Exercise Price after such adjustment and setting forth a brief
statement of the facts requiring such adjustment. If the Company enters into a
Variable Rate Transaction, despite the prohibition thereon in the Purchase
Agreements, the Company shall be deemed to have issued Common Stock or Common
Stock Equivalents at the lowest possible conversion or exercise price at which
such securities may be converted or exercised.
ii. Notice to Allow Exercise by
Holder. If (A) the Company shall declare a dividend (or any other
distribution in whatever form) on the Common Stock, (B) the Company shall
declare a special nonrecurring cash dividend on or a redemption of the Common
Stock, (C) the Company shall authorize the granting to all holders of the Common
Stock rights or warrants to subscribe for or purchase any shares of capital
stock of any class or of any rights, (D) the approval of any stockholders of the
Company shall be required in connection with any reclassification of the Common
Stock, any consolidation or merger to which the Company is a party, any sale or
transfer of all or substantially all of the assets of the Company, or any
compulsory share exchange whereby the Common Stock is converted into other
securities, cash or property, or (E) the Company shall authorize the voluntary
or involuntary dissolution, liquidation or winding up of the affairs of the
Company, then, in each case, the Company shall cause to be mailed to Holder at
its last address as it shall appear upon the Warrant Register of the Company, at
least 20 calendar days prior to the applicable record or effective date
hereinafter specified, a notice stating (x) the date on which a record is to be
taken for the purpose of such dividend, distribution, redemption, rights or
warrants, or if a record is not to be taken, the date as of which the holders of
the Common Stock of record to be entitled to such dividend, distributions,
redemption, rights or warrants are to be determined (y) the date on which such
reclassification, consolidation, merger, sale, transfer or share exchange is
expected to become effective or close, and the date as of which it is expected
that holders of the Common Stock of record shall be entitled to exchange their
shares of the Common Stock for securities, cash or other property deliverable
upon such reclassification, consolidation, merger, sale, transfer or share
exchange; provided that the failure to mail such notice or any defect therein or
in the mailing thereof shall not affect the validity of the corporate action
required to be specified in such notice or (z) the date on which such
dissolution, liquidation or winding up is expected to
commence. Holder shall remain entitled to exercise this Warrant
during the period commencing on the date of such notice to the effective date of
the event triggering such notice except as otherwise set forth
herein.
Section 4. Transfer and Exchange of
Warrant.
a)
Transferability. Subject
to compliance with any applicable securities laws and the conditions set forth
in Section 4(d) hereof and to the provisions of Section 4.1 of the Purchase
Agreement, this Warrant and all rights hereunder (including, without limitation,
any registration rights) are transferable, in whole or in part, upon surrender
of this Warrant at the principal office of the Company or its designated agent,
together with a written assignment of this Warrant substantially in the form
attached hereto duly executed by Holder or its agent or attorney and funds
sufficient to pay any transfer taxes payable upon the making of such
transfer. Upon such surrender and, if required, such payment, the
Company shall execute and deliver a new Warrant or Warrants in the name of the
assignee or assignees, as applicable, and in the denomination or denominations
specified in such instrument of assignment, and shall issue to the assignor a
new Warrant evidencing the portion of this Warrant not so assigned, and this
Warrant shall promptly be cancelled. The Warrant, if properly
assigned in accordance herewith, may be exercised by a new holder for the
purchase of Warrant Shares without having a new Warrant issued.
b)
New
Warrants. This Warrant may be divided or combined with other Warrants
upon presentation hereof at the aforesaid office of the Company, together with a
written notice specifying the names and denominations in which new Warrants are
to be issued, signed by Holder or its agent or attorney. Subject to
compliance with Section 4(a), as to any transfer which may be involved in such
division or combination, the Company shall execute and deliver a new Warrant or
Warrants in exchange for the Warrant or Warrants to be divided or combined in
accordance with such notice. All Warrants issued on transfers or exchanges shall
be dated the original Issue Date and shall be identical with this Warrant except
as to the number of Warrant Shares issuable pursuant thereto.
c)
Warrant Register. The
Company shall register this Warrant, upon records to be maintained by the
Company for that purpose (the “Warrant Register”),
in the name of the record Holder hereof from time to time. The
Company may deem and treat the registered Holder of this Warrant as the absolute
owner hereof for the purpose of any exercise hereof or any distribution to
Holder, and for all other purposes, absent actual notice to the
contrary.
d)
Transfer
Restrictions. If, at the time of the surrender of this Warrant in connection with
any transfer of this Warrant, the transfer of this Warrant shall not be
either (i) registered pursuant to an effective
registration statement under the Securities
Act and under applicable state securities
or blue sky laws or (ii) eligible for
resale without volume or manner-of-sale restrictions or current public information requirements pursuant to Rule 144, the Company may require, as a condition of allowing
such transfer, that Holder or transferee of this Warrant, as the case may
be, comply with the provisions of Section
5.7 of the Purchase Agreement.
e)
Representation by
Holder. Holder, by the acceptance hereof, represents and warrants that it
is acquiring this Warrant and, upon any exercise hereof, will acquire the
Warrant Shares issuable upon such exercise, for its own account and not with a
view to or for distributing or reselling such Warrant Shares or any part thereof
in violation of the Securities Act or any applicable state securities law,
except pursuant to sales registered or exempted under the Securities
Act.
Section 5. Miscellaneous.
a)
No
Rights as Stockholder Until Exercise. This Warrant does not
entitle Holder to any voting rights, dividends or other rights as a stockholder
of the Company prior to the exercise hereof as set forth in Section
2(e)(i).
b)
Loss, Theft, Destruction or
Mutilation of Warrant. The Company covenants that upon receipt by the
Company of evidence reasonably satisfactory to it of the loss, theft,
destruction or mutilation of this Warrant or any stock certificate relating to
the Warrant Shares, and in case of loss, theft or destruction, of indemnity or
security reasonably satisfactory to it (which, in the case of the Warrant, shall
not include the posting of any bond, unless required by the Transfer Agent), and
upon surrender and cancellation of such Warrant or stock certificate, if
mutilated, the Company will make and deliver a new Warrant or stock certificate
of like tenor and dated as of such cancellation, in lieu of such Warrant or
stock certificate.
c)
Saturdays, Sundays,
Holidays, etc. If the last or appointed day for the taking of
any action or the expiration of any right required or granted herein shall not
be a Business Day, then, such action may be taken or such right may be exercised
on the next succeeding Business Day.
d)
Authorized
Shares.
The
Company covenants that, during the period commencing on the Authorized Share
Approval Date and ending on the date on which the Warrant is no longer
outstanding, it will reserve from its authorized and unissued Common Stock a
sufficient number of shares to provide for the issuance of the Warrant Shares
upon the exercise of any purchase rights under this Warrant. The
Company further covenants that its issuance of this Warrant shall constitute
full authority to its officers who are charged with the duty of executing stock
certificates to execute and issue the necessary certificates for the Warrant
Shares upon the exercise of the purchase rights under this
Warrant. The Company will take all such reasonable action as may be
necessary to assure that such Warrant Shares may be issued as provided herein
without violation of any applicable law or regulation, or of any requirements of
the Trading Market upon which the Common Stock may be listed. The
Company covenants that all Warrant Shares which may be issued upon the exercise
of the purchase rights represented by this Warrant will, upon exercise of the
purchase rights represented by this Warrant and payment for such Warrant Shares
in accordance herewith, be duly authorized, validly issued, fully paid and
nonassessable and free from all taxes, liens and charges created by the Company
in respect of the issue thereof (other than taxes in respect of any transfer
occurring contemporaneously with such issue).
Except
and to the extent as waived or consented to by Holder, the Company shall not by
any action, including, without limitation, amending its certificate of
incorporation or through any reorganization, transfer of assets, consolidation,
merger, dissolution, issue or sale of securities or any other voluntary action,
avoid or seek to avoid the observance or performance of any of the terms of this
Warrant, but will at all times in good faith assist in the carrying out of all
such terms and in the taking of all such actions as may be reasonably necessary
or appropriate to protect the rights of Holder as set forth in this Warrant
against impairment. Without limiting the generality of the foregoing,
the Company will (i) not increase the par value of any Warrant Shares above the
amount payable therefor upon such exercise immediately prior to such increase in
par value, (ii) take all such action as may be reasonably necessary or
appropriate in order that the Company may validly and legally issue fully paid
and nonassessable Warrant Shares upon the exercise of this Warrant and (iii) use
commercially reasonable efforts to obtain all such authorizations, exemptions or
consents from any public regulatory body having jurisdiction thereof as may be
reasonably necessary to enable the Company to perform its obligations under this
Warrant.
Before
taking any action which would result in an adjustment in the number of Warrant
Shares for which this Warrant is exercisable or in the Exercise Price, the
Company shall obtain all such authorizations or exemptions thereof, or consents
thereto, as may be reasonably necessary from any public regulatory body or
bodies having jurisdiction thereof.
e) Jurisdiction. All
questions concerning the construction, validity, enforcement and interpretation
of this Warrant shall be determined in accordance with the provisions of the
Purchase Agreement.
f) Restrictions. Holder
acknowledges that the Warrant Shares acquired upon the exercise of this Warrant,
if not registered, will have restrictions upon resale imposed by state and
federal securities laws.
g)
Nonwaiver and
Expenses. No course of dealing or any delay or failure to
exercise any right hereunder on the part of Holder shall operate as a waiver of
such right or otherwise prejudice Holder’s rights, powers or remedies,
notwithstanding the fact that all rights hereunder terminate on the Termination
Date. If the Company willfully and knowingly fails to comply with any
provision of this Warrant, which results in any material damages to Holder, the
Company shall pay to Holder such amounts as shall be sufficient to cover any
costs and expenses including, but not limited to, reasonable attorneys’ fees,
including those of appellate proceedings, incurred by Holder in collecting any
amounts due pursuant hereto or in otherwise enforcing any of its rights, powers
or remedies hereunder.
h)
Notices. Any
notice, request or other document required or permitted to be given or delivered
to Holder by the Company shall be delivered in accordance with the notice
provisions of the Purchase Agreement.
i)
Limitation of
Liability. No provision hereof, in the absence of any
affirmative action by Holder to exercise this Warrant to purchase Warrant
Shares, and no enumeration herein of the rights or privileges of Holder, shall
give rise to any liability of Holder for the purchase price of any Common Stock
or as a stockholder of the Company, whether such liability is asserted by the
Company or by creditors of the Company.
j)
Remedies. Holder,
in addition to being entitled to exercise all rights granted by law, including
recovery of damages, will be entitled to specific performance of its rights
under this Warrant. The Company agrees that monetary damages would
not be adequate compensation for any loss incurred by reason of a breach by it
of the provisions of this Warrant and hereby agrees to waive and not to assert
the defense in any action for specific performance that a remedy at law would be
adequate.
k) Successors and
Assigns. Subject to applicable securities laws, this Warrant
and the rights and obligations evidenced hereby shall inure to the benefit of,
and be binding upon, the successors and permitted assigns of the Company and the
successors and permitted assigns of Holder. The provisions of this
Warrant are intended to be for the benefit of any Holder from time to time of
this Warrant and shall be enforceable by such Holder or holder of Warrant
Shares.
l)
Amendment. This
Warrant may be modified or amended, or the provisions hereof waived with the
written consent of the Company and Holders holding Warrants at least equal to
67% of the Warrant Shares issuable upon exercise of all then outstanding
Warrants.
m)
Severability. Wherever
possible, each provision of this Warrant shall be interpreted in such manner as
to be effective and valid under applicable law, but if any provision of this
Warrant shall be prohibited by or invalid under applicable law, such provision
shall be ineffective to the extent of such prohibition or invalidity, without
invalidating the remainder of such provisions or the remaining provisions of
this Warrant.
n)
Headings. The
headings used in this Warrant are for the convenience of reference only and
shall not, for any purpose, be deemed a part of this Warrant.
********************
(Signature
Pages Follow)
IN
WITNESS WHEREOF, the Company has caused this Warrant to be executed by its
officer thereunto duly authorized as of the date first above
indicated.
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CLEVELAND
BIOLABS, INC.
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By:
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/s/
Michael Fonstein
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Name:
Michael Fonstein
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Title:
President and Chief Executive
Officer
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NOTICE
OF EXERCISE
TO: CLEVELAND
BIOLABS, INC.
(1)
The undersigned hereby elects to purchase ________ Warrant Shares of the
Company pursuant to the terms of the attached Warrant (only if exercised in
full), and tenders herewith payment of the exercise price in full, together with
all applicable transfer taxes, if any.
(2)
Payment shall take the form of (check applicable box):
¨ in
lawful money of the United States; or
¨ [if
permitted] the cancellation of such number of Warrant Shares as is necessary, in
accordance with the formula set forth in subsection 2(c), to exercise this
Warrant with respect to the maximum number of Warrant Shares purchasable
pursuant to the cashless exercise procedure set forth in subsection
2(c).
(3)
Please issue a certificate or certificates representing said Warrant Shares in
the name of the undersigned or in such other name as is specified
below:
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_______________________________
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The
Warrant Shares shall be delivered to the following DWAC Account Number or by
physical delivery of a certificate to:
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_______________________________
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_______________________________
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_______________________________
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(4) Accredited
Investor. The undersigned is an “accredited investor” as
defined in Regulation D promulgated under the Securities Act of 1933, as
amended.
[SIGNATURE
OF HOLDER]
Name of Investing Entity:
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Signature of Authorized Signatory of Investing Entity:
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Name of Authorized Signatory:
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Title of Authorized Signatory:
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ASSIGNMENT
FORM
(To
assign the foregoing warrant, execute
this form
and supply required information.
Do not
use this form to exercise the warrant.)
FOR VALUE
RECEIVED, [____] all of or [_______] shares of the foregoing Warrant and all
rights evidenced thereby are hereby assigned to
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Dated:
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,
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Holder’s
Signature:
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Holder’s
Address:
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NOTE: The
signature to this Assignment Form must correspond with the name as it appears on
the face of the Warrant, without alteration or enlargement or any change
whatsoever, and must be guaranteed by a bank or trust
company. Officers of corporations and those acting in a fiduciary or
other representative capacity should file proper evidence of authority to assign
the foregoing Warrant.
SECURITIES
PURCHASE AGREEMENT
This
Securities Purchase Agreement (this “Agreement”) is dated
as of _________, 2009, between Cleveland BioLabs, Inc., a Delaware corporation
(the “Company”), and each
purchaser identified on the signature pages hereto (each, including its
successors and assigns, a “Purchaser” and
collectively, the “Purchasers”).
WHEREAS,
subject to the terms and conditions set forth in this Agreement and pursuant to
Section 4(2) of the Securities Act of 1933, as amended (the “Securities Act”), and
Rule 506 promulgated thereunder, the Company desires to issue and sell to each
Purchaser, and each Purchaser, severally and not jointly, desires to purchase
from the Company, securities of the Company as more fully described in this
Agreement.
NOW,
THEREFORE, IN CONSIDERATION of the mutual covenants contained in this Agreement,
and for other good and valuable consideration the receipt and adequacy of which
are hereby acknowledged, the Company and each Purchaser agree as
follows:
ARTICLE
I.
DEFINITIONS
1.1 Definitions. In
addition to the terms defined elsewhere in this Agreement: (a) capitalized terms
that are not otherwise defined herein have the meanings given to such terms in
the Certificate of Designation (as defined herein), and (b) the following terms
have the meanings set forth in this Section 1.1:
“Acquiring Person”
shall have the meaning ascribed to such term in Section 4.7.
“Action” shall have
the meaning ascribed to such term in Section 3.1(j).
“Affiliate” means any
Person that, directly or indirectly through one or more intermediaries, controls
or is controlled by or is under common control with a Person, as such terms are
used in and construed under Rule 405 under the Securities Act.
“Amendment” means an
amendment to the Company’s certificate of incorporation that increases the
number of authorized shares of Common Stock from 40,000,000 to no less than
60,000,000 shares.
“Authorized Share
Approval” means (a) the approval by the stockholders of the Company of
the Amendment and (b) the filing by the Company of the Amendment with the
Secretary of State of the State of Delaware and the acceptance of the Amendment
by the Secretary of State of the State of Delaware.
“Authorized Share Approval
Date” means the later of the date that the Company (a) receives the
approval by the stockholders of the Company of the Amendment or (b) files the
Amendment with the Secretary of State of the State of Delaware and receives the
acceptance of the Amendment by the Secretary of State of the State of
Delaware.
“Board of Directors”
means the board of directors of the Company.
“Business Day” means
any day except Saturday, Sunday, any day which is a federal legal holiday in the
United States or any day on which banking institutions in the State of New York
are authorized or required by law or other governmental action to
close.
“Certificate of
Designation” means the Certificate of Designation to be filed prior to
the Closing by the Company with the Secretary of State of Delaware, in the form
of Exhibit A
attached hereto.
“Closing” means the
closing of the purchase and sale of the Securities pursuant to Section
2.1.
“Closing Date” means
the Trading Day on which all of the applicable Transaction Documents have been
executed and delivered by the applicable parties thereto, and all conditions
precedent to (i) the Purchasers’ obligations to pay the Subscription Amount and
(ii) the Company’s obligations to deliver the Securities have been satisfied or
waived.
“Closing Price” means
on any particular date (a) the last reported (closing) sale price per share
of Common Stock on such date on the Trading Market (as reported by Bloomberg
L.P. at 4:15 p.m. (New York City time)), or (b) if there is no sale on such
date, then the last reported (closing) sale price on the Trading Market on the
date nearest preceding such date (as reported by Bloomberg L.P. at 4:15 p.m.
(New York City time)), or (c) if the Common Stock is not then listed or
quoted on a Trading Market and if prices for the Common Stock are then reported
in the “pink sheets” published by Pink OTC Markets, Inc. (or a similar
organization or agency succeeding to its functions of reporting prices), the
most recent bid price per share of the Common Stock so reported as of 4:02p.m.
(New York City time) on such date, or (d) if the shares of Common Stock are
not then publicly traded, the fair market value as of such date of a share of
Common Stock as determined by an independent appraiser selected in good faith by
the Purchasers of a majority in interest of the Shares then outstanding and
reasonably acceptable to the Company, the fees and expenses of which shall be
paid by the Company.
“Closing Statement”
means the Closing Statement in the form of Annex A attached
hereto.
“Commission” means the
United States Securities and Exchange Commission.
“Common Stock” means
the common stock of the Company, par value $0.005 per share, and any other class
of securities into which such securities may hereafter be reclassified or
changed.
“Common Stock
Equivalents” means any securities of the Company or the Subsidiaries
which would entitle the holder thereof to acquire at any time Common Stock,
including, without limitation, any debt, preferred stock, rights, options,
warrants or other instrument that is at any time convertible into or exercisable
or exchangeable for, or otherwise entitles the holder thereof to receive, Common
Stock.
“Company Counsel”
means Katten Muchin Rosenman LLP, with offices located at 525 West Monroe
Street, Suite 1900, Chicago, Illinois 60661.
“Conversion Price”
shall have the meaning ascribed to such term in the Certificate of
Designation.
“Disclosure Schedules”
shall have the meaning ascribed to such term in Section 3.1.
“Discussion Time”
shall have the meaning ascribed to such term in Section 3.2(g).
“Effective Date” means
the date that the initial Registration Statement (including the Conversion
Shares Registration Statement as defined in the Certificate of Designation)
filed by the Company pursuant to the Registration Rights Agreement is first
declared effective by the Commission.
“Escrow Agent” means
Signature Bank, a New York State chartered bank and having an office at 261
Madison Avenue, New York, New York 10016.
“Escrow Agreement”
means the escrow agreement entered into on December 15, 2008, by and among the
Company and the Escrow Agent pursuant to which the Purchasers shall deposit
Subscription Amounts with the Escrow Agent to be applied to the transactions
contemplated hereunder.
“Evaluation Date”
shall have the meaning ascribed to such term in Section 3.1(r).
“Exchange Act” means
the Securities Exchange Act of 1934, as amended, and the rules and regulations
promulgated thereunder.
“Exempt Issuance”
means the issuance of (a) shares of Common Stock or options to employees,
consultants, officers or directors of the Company pursuant to any stock
incentive plan duly adopted for such purpose, by a majority of the non-employee
members of the Board of Directors or a majority of the members of a committee of
non-employee directors established for such purpose (provided, however, any such
issuance(s) to consultants shall not exceed an aggregate of 750,000 shares of
Common Stock or options (subject to forward and reverse stock splits, stock
dividends and the like that occur after the Original Issue Date) in any 12 month
period), (b) securities upon the exercise or exchange of or conversion of any
securities issued pursuant to the Purchase Agreements and/or other securities
exercisable or exchangeable for or convertible into shares of Common Stock
issued and outstanding on the date of this Agreement, provided that such
securities have not been amended since the date of this Agreement to increase
the number of such securities or to decrease the exercise price or conversion
price of any such securities other than increases in the number of securities or
decreases in exercise price or conversion price resulting from anti-dilution or
similar provisions contained in the terms and conditions of such securities on
the date hereof, (c) securities issued pursuant to acquisitions or strategic
transactions approved by a majority of the disinterested directors of the
Company, provided that any such issuance shall only be to a Person (or to the
equityholders of a Person) which is, itself or through its subsidiaries, an
operating company in a business synergistic with the business of the Company or
a seller of assets and shall provide to the Company additional benefits in
addition to the investment of funds, but shall not include a transaction in
which the Company is issuing securities primarily for the purpose of raising
capital or to an entity whose primary business is investing in securities, and
(d) up to an amount of Preferred Stock and Warrants equal to the difference
between $13,000,000 and the aggregate Subscription Amounts under the Purchase
Agreements, on the same terms and conditions and prices as hereunder,
with investors executing definitive agreements for the purchase of such
securities and such transactions having closed on or before March 15, 2009 or
such other date as may be agreed upon, in writing, by the Company and the
Placement Agent (provided, however, clause (d) of this definition of “Exempt
Issuance” shall not apply to Section 3(b) of the Warrant or Section 7(b) of the
Certificate of Designation).
“FDA” means the U.S.
Food and Drug Administration.
“FDCA” shall have the
meaning ascribed to such term in Section 3.1(kk).
“FWS” means Feldman
Weinstein & Smith LLP with offices located at 420 Lexington Avenue, Suite
2620, New York, New York 10170-0002.
“GAAP” means United
States generally accepted accounting principles.
“Indebtedness” means
(x) any liabilities for borrowed money in excess of $100,000 (other than trade
accounts payable and operating leases incurred in the ordinary course of
business), (y) all guaranties, endorsements and other contingent obligations in
respect of indebtedness of others, whether or not the same are or should be
reflected in the Company’s balance sheet (or the notes thereto), except
guaranties by endorsement of negotiable instruments for deposit or collection or
similar transactions in the ordinary course of business; and (z) the present
value of any lease payments in excess of $100,000 due under leases required to
be capitalized in accordance with GAAP.
“Intellectual Property
Rights” shall have the meaning ascribed to such term in Section
3.1(o).
“Knowledge of the
Company” means the actual knowledge that was, or would reasonably be
expected to be, obtained after due inquiry of all the officers and directors of
the Company.
“Legend Removal Date”
shall have the meaning ascribed to such term in Section 4.1(c).
“Liens” means a lien,
charge, security interest, encumbrance, right of first refusal, preemptive right
or any other restriction that has the practical effect of creating any of the
foregoing.
“Material Adverse
Effect” shall have the meaning assigned to such term in Section
3.1(b).
“Material Permits”
shall have the meaning ascribed to such term in Section 3.1(m).
“Maximum Rate” shall
have the meaning ascribed to such term in Section 5.17.
“Participation
Maximum” shall have the meaning ascribed to such term in Section
4.12(a).
“Person” means an
individual or corporation, partnership, trust, incorporated or unincorporated
association, joint venture, limited liability company, joint stock company,
government (or an agency or subdivision thereof) or other entity of any
kind.
“Pharmaceutical
Product” shall have the meaning ascribed to such term in Section
3.1(kk).
“Placement Agent”
means Garden State Securities, Inc.
“Preferred Stock”
means up to 1,300 shares of the Company’s Series D Convertible Preferred Stock
issued hereunder having the rights, preferences and privileges set forth in the
Certificate of Designation, in the form of Exhibit A hereto,
including an initial Conversion Price equal to $1.85, subject to adjustment
therein.
“Pre-Notice” shall
have the meaning ascribed to such term in Section 4.12(b).
“Proceeding” means an
action, claim, suit, investigation or proceeding (including, without limitation,
an informal investigation or partial proceeding, such as a deposition), whether
commenced or threatened.
“Public Information
Failure” shall have the meaning ascribed to such term in Section
4.3(b).
“Public Information Failure
Payments” shall have the meaning ascribed to such term in Section
4.3(b).
“Purchase Agreements”
means this Agreement together with the other Purchase Agreements, substantially
identical to this Agreement, by and between the Company and each purchaser
identified on the signature pages thereto and entered into at any time on or
before March 15, 2009 or such other date as may be agreed upon, in writing, by
the Company and the Placement Agent.
“Purchaser Party”
shall have the meaning ascribed to such term in Section 4.10.
“Registration Rights
Agreement” means the Registration Rights Agreements, dated the date
hereof, among the Company and the Purchasers, in the form of Exhibit B attached
hereto.
“Registration
Statement” means a registration statement meeting the requirements set
forth in the Registration Rights Agreement and covering the resale of the
Underlying Shares as provided for in the Registration Rights
Agreement.
“Required Approvals”
shall have the meaning ascribed to such term in Section 3.1(e).
“Required Minimum”
means, as of any date, the maximum aggregate number of shares of Common Stock
then issued or issuable, other than in connection with an unmatured Dilutive
Issuance, in the future pursuant to the Transaction Documents, including any
Underlying Shares issuable upon exercise in full of all outstanding Warrants or
conversion in full of all outstanding shares of Preferred Stock, ignoring any
conversion or exercise limits set forth therein, and assuming that any
previously unconverted shares of Preferred Stock are held until the third
anniversary of the Closing Date.
“Rule 144” means Rule
144 promulgated by the Commission pursuant to the Securities Act, as such Rule
may be amended from time to time, or any similar rule or regulation hereafter
adopted by the Commission having substantially the same effect as such
Rule.
“SEC Reports” shall
have the meaning ascribed to such term in Section 3.1(h).
“Securities” means the
Preferred Stock, the Warrants, the Warrant Shares and the Underlying
Shares.
“Securities Act” means
the Securities Act of 1933, as amended, and the rules and regulations
promulgated thereunder.
“Series B Preferred”
means the Series B Convertible Preferred Stock, par value $0.005 per share, of
the Company.
“Stockholder Approval”
means such approval as may be required by the applicable rules and regulations
of the Nasdaq Stock Market (or any successor entity) from the stockholders of
the Company with respect to the transactions contemplated by the Transaction
Documents, including the issuance of all of the Underlying Shares in excess of
19.99% of the issued and outstanding Common Stock on the Closing
Date.
“Short Sales” means
all “short sales” as defined in Rule 200 of Regulation SHO under the Exchange
Act (but shall not be deemed to include the location and/or reservation of
borrowable shares of Common Stock).
“Stated Value” means
$10,000 per share of Preferred Stock.
“Subscription Amount”
shall mean, as to each Purchaser, the aggregate amount to be paid for the
Preferred Stock purchased hereunder as specified below such Purchaser’s name on
the signature page of this Agreement and next to the heading “Subscription
Amount,” in United States dollars and in immediately available
funds.
“Subsequent Financing”
shall have the meaning ascribed to such term in Section 4.12(a).
“Subsequent Financing
Notice” shall have the meaning ascribed to such term in Section
4.12(b).
“Subsidiary” means any
direct or indirect subsidiary of the Company formed or acquired after the date
hereof.
“Trading Day” means a
day on which the principal Trading Market is open for trading.
“Trading Market” means
any of the following markets or exchanges on which the Common Stock is listed or
quoted for trading on the date in question: NYSE Alternext US, the Nasdaq
Capital Market, the Nasdaq Global Market, the Nasdaq Global Select Market, the
New York Stock Exchange or the OTC Bulletin Board (or any successors to any of
the foregoing).
“Transaction
Documents” means this Agreement, the Certificate of Designation, the
Warrants, the Registration Rights Agreement, the Escrow Agreement, the Voting
Agreement, all exhibits and schedules thereto and hereto and any other documents
or agreements executed in connection with the transactions contemplated
hereunder.
“Transfer Agent” means
Continental Stock Transfer & Trust Company, the current transfer agent of
the Company, with a mailing address of 17 Battery Place, New York, New York
10004, and a facsimile number of (212) 509-5150, and any successor transfer
agent of the Company.
“Underlying Shares”
means the shares of Common Stock issued and issuable upon conversion or
redemption of the Preferred Stock and upon exercise of the
Warrants.
“Variable Rate
Transaction” shall have the meaning ascribed to such term in Section
4.13(b).
“Voting Agreements” means each of the
written agreements, in the form of Exhibit E attached
hereto, between the Company and each of (a) The Cleveland Clinic Foundation, (b)
Sunrise Equity Partners, LP, (c) Sunrise Securities Corp. and (d) all of the
executive officers and directors of the Company, which shall be as set forth on
Schedule
2.2(a)(vi) attached hereto, to
vote all Common Stock over which such Persons have voting control as of the
record date for the meeting of stockholders of the Company in favor of
Stockholder Approval and Authorized Share Approval; provided, however, the Company
shall not be required to obtain the Voting Agreements for the initial Closing
from Sunrise Equity Partners, LP, or Sunrise Securities Corp. if the
aggregate Subscription Amounts for the initial Closing are less than
$2,000,000.
“VWAP” means, for any
date, the price determined by the first of the following clauses that applies:
(a) if the Common Stock is then listed or quoted on a Trading Market, the daily
volume weighted average price of the Common Stock for such date (or the nearest
preceding date) on the Trading Market on which the Common Stock is then listed
or quoted as reported by Bloomberg L.P. (based on a Trading Day from 9:30 a.m.
(New York City time) to 4:02 p.m. (New York City time)); (b) if the Common
Stock is not then listed or quoted for trading on the OTC Bulletin Board and if
prices for the Common Stock are then reported in the “Pink Sheets” published by
Pink OTC Markets, Inc. (or a similar organization or agency succeeding to its
functions of reporting prices), the most recent bid price per share of the
Common Stock so reported; or (c) in all other cases, the fair market value
of a share of Common Stock as determined by an independent appraiser selected in
good faith by the Purchasers of a majority in interest of the Securities then
outstanding and reasonably acceptable to the Company, the fees and expenses of
which shall be paid by the Company.
“Warrants” means,
collectively, the Common Stock purchase warrants delivered to the Purchasers at
the applicable Closing in accordance with Section 2.2(a) hereof, which Warrants
shall be exercisable immediately and have a term of exercise equal to seven
years, in the form of Exhibit C attached
hereto, with an initial Exercise Price (as defined therein) equal to $2.60, subject to adjustment
therein.
“Warrant Shares” means
the shares of Common Stock issuable upon exercise of the
Warrants.
ARTICLE
II.
PURCHASE
AND SALE
2.1 Closing. On
the Closing Date, upon the terms and subject to the conditions set forth herein,
substantially concurrent with the execution and delivery of this Agreement by
the parties hereto, the Company agrees to sell, and the Purchasers, severally
and not jointly, agree to purchase, up to an aggregate of $13,000,000 of Stated
Value of shares of Preferred Stock with an aggregate Stated Value for each
Purchaser equal to such Purchaser’s Subscription Amount as set forth on the
signature page hereto executed by such Purchaser, and Warrants as determined
pursuant to Section 2.2(a). The aggregate number of shares of
Preferred Stock purchased and sold under the Purchase Agreements shall not
exceed 1,300. Each Purchaser shall deliver to the Company via wire
transfer of immediately available funds equal to its Subscription Amount and the
Company shall deliver to each Purchaser its respective shares of Preferred Stock
and Warrants as determined pursuant to Section 2.2(a), and the Company and each
Purchaser shall deliver the other items set forth in Section 2.2 deliverable at
the Closing. Upon satisfaction of the covenants and conditions set
forth in Sections 2.2 and 2.3, the Closing shall occur at the offices of FWS or
such other location as the parties shall mutually agree and the Placement Agent
shall deliver to the Escrow Agent the Form of Escrow Release Notice (as defined
in the Escrow Agreement), duly executed.
(a) On
or prior to the Closing Date, the Company shall deliver or cause to be delivered
to each Purchaser the following:
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(i)
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this Agreement duly executed by the
Company;
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(ii) a
legal opinion of Company Counsel, substantially in the form of Exhibit D attached
hereto;
(iii) evidence
of the filing and acceptance of the Certificate of Designation from the
Secretary of State of Delaware;
(iv) a
certificate evidencing a number of shares of Preferred Stock equal to such
Purchaser’s Subscription Amount divided by the Stated Value (the “Shares”), registered
in the name of such Purchaser;
(v) a
Warrant registered in the name of such Purchaser to purchase up to a number of
shares of Common Stock equal to such Purchaser’s Shares multiplied by the Stated
Value and divided by $1.85, with an exercise price
equal to $2.60, subject
to adjustment therein;
(vi) the
Voting Agreements; and
(vii) the
Registration Rights Agreement, duly executed by the Company.
(b) On
or prior to the Closing Date, each Purchaser shall deliver or cause to be
delivered to the Company the following:
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(i)
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this
Agreement, duly executed by such
Purchaser;
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(ii) such
Purchaser’s Subscription Amount by wire transfer to the Escrow Agent;
and
(iii) the
Registration Rights Agreement, duly executed by such Purchaser.
(c) On
or prior to the Closing Date, unless deferred by the Placement Agent until
another Closing Date, the Company shall deliver or cause to be delivered to the
Placement Agent, the Warrant(s) registered in the name of the Placement Agent or
its assigns or designees, to purchase up to a number of shares of Common Stock
equal to 10% of the aggregate Subscription Amounts, with an exercise price equal
to $2.60, subject to
adjustment therein.
(a) The
obligations of the Company hereunder in connection with the Closing are subject
to the following conditions being met:
(i) the
accuracy in all material respects on the Closing Date of the representations and
warranties of the Purchasers contained herein (unless as of a specific date
therein);
(ii) all
obligations, covenants and agreements of each Purchaser required to be performed
at or prior to the Closing Date shall have been performed; and
(iii) the
delivery by each Purchaser of the items set forth in Section 2.2(b) of this
Agreement.
(b) The
respective obligations of the Purchasers hereunder in connection with the
Closing are subject to the following conditions being met:
(i) the
accuracy in all material respects on the Closing Date of the representations and
warranties of the Company contained herein (unless as of a specific date
therein);
(ii) all
obligations, covenants and agreements of the Company required to be performed at
or prior to the Closing Date shall have been performed;
(iii) the
delivery by the Company of the items set forth in Section 2.2(a) of this
Agreement;
(iv) there
shall have been no Material Adverse Effect with respect to the Company since the
date hereof; and
(v) from
the date hereof to the Closing Date, trading in the Common Stock shall not have
been suspended by the Commission or the Company’s principal Trading Market
(except for any suspension of trading of limited duration agreed to by the
Company, which suspension shall be terminated prior to the Closing), and, at any
time prior to the Closing Date, trading in securities generally as reported by
Bloomberg L.P. shall not have been suspended or limited, or minimum prices shall
not have been established on securities whose trades are reported by such
service, or on any Trading Market, nor shall a banking moratorium have been
declared either by the United States or New York State authorities nor shall
there have occurred any material outbreak or escalation of hostilities or other
national or international calamity of such magnitude in its effect on, or any
material adverse change in, any financial market which, in each case, has not
ended or terminated and in the reasonable judgment of each Purchaser, makes it
impracticable or inadvisable to purchase the Securities at the
Closing.
ARTICLE
III.
REPRESENTATIONS
AND WARRANTIES
3.1 Representations and
Warranties of the Company. Except as set forth in the
Disclosure Schedules, which Disclosure Schedules shall be deemed a part hereof
and shall qualify any representation or otherwise made herein to the extent of
the disclosure contained in the corresponding section of the Disclosure
Schedules, the Company hereby makes the following representations and warranties
to each Purchaser.
(a) Subsidiaries. The
Company does not have, nor has it ever had, any direct or indirect
subsidiaries.
(b) Organization and
Qualification. The Company is an entity duly incorporated,
validly existing and in good standing under the laws of the jurisdiction of its
incorporation, with the requisite power and authority to own and use its
properties and assets and to carry on its business as currently
conducted. The Company is not in material violation or default of any
of the provisions of its certificate of incorporation, bylaws or other
organizational or charter documents. The Company is duly qualified to
conduct business and is in good standing as a foreign corporation in each
jurisdiction in which the nature of the business conducted or property owned by
it makes such qualification necessary, except where the failure to be so
qualified or in good standing, as the case may be, could not have or reasonably
be expected to result in: (i) a material adverse effect on the legality,
validity or enforceability of any Transaction Document, (ii) a material adverse
effect on the results of operations, assets, business, prospects or condition
(financial or otherwise) of the Company, or (iii) a material adverse effect on
the Company’s ability to perform in any material respect on a timely basis its
obligations under any Transaction Document (any of (i), (ii) or (iii), a “Material Adverse
Effect”) and no Proceeding has been instituted in any such jurisdiction
revoking, limiting or curtailing or seeking to revoke, limit or curtail such
power and authority or qualification.
(c) Authorization;
Enforcement. The Company has the requisite corporate power and
authority to enter into and to consummate the transactions contemplated by each
of the Transaction Documents and otherwise to carry out its obligations
hereunder and thereunder. The execution and delivery of each of the
Transaction Documents by the Company and the consummation by it of the
transactions thereby have been duly authorized by all necessary action on the
part of the Company and no further such action is required of the Board of
Directors or the Company’s stockholders in connection therewith other than in
connection with the Required Approvals. Each Transaction Document to
which it is a party has been (or upon delivery will have been) duly executed by
the Company and, when executed and delivered in accordance with the terms hereof
and thereof, will constitute the valid and binding obligation of the Company
enforceable against the Company in accordance with its terms, except (i) as
limited by applicable bankruptcy, insolvency, reorganization, moratorium and
other laws of general application affecting enforcement of creditors’ rights
generally, (ii) as limited by general principles of equity and (iii) insofar as
indemnification and contribution provisions may be limited by applicable law and
public policy.
(d) No
Conflicts. The execution, delivery and performance of the
Transaction Documents by the Company, the issuance and sale of the Securities by
the Company and the consummation by the Company of the other transactions
contemplated hereby and thereby do not and will not: (i) conflict with or
violate any provision of the Company’s certificate of incorporation, bylaws or
other organizational or charter documents, or (ii) conflict with, or violate or
constitute a default (or an event that with notice or lapse of time or both
would become a default) under, or give to others any rights of termination,
amendment, acceleration or cancellation (with or without notice, lapse of time
or both) of, any agreement, credit facility, debt or other instrument
(evidencing a Company debt or otherwise) or other understanding to which the
Company is a party or by which any property or asset of the Company is bound or
affected, or result in the creation of any Lien upon any of the properties or
assets of the Company, or (iii) subject to the Required Approvals, conflict with
or result in a violation of any law, rule, regulation, order, judgment,
injunction, decree or other restriction of any court or governmental authority
to which the Company is subject (including federal and state securities laws and
regulations), or by which any property or asset of the Company is bound or
affected; except in the case of each of clauses (ii) and (iii), such as would
not have or reasonably be expected to result in a Material Adverse
Effect.
(e) Filings, Consents and
Approvals. The Company is not required to obtain any consent,
waiver, authorization or order of, give any notice to, or make any filing or
registration with, any court or other federal, state, local or other
governmental authority or other Person in connection with the execution,
delivery and performance by the Company of the Transaction Documents, other than
(i) filings required pursuant to Section 4.6 of this Agreement, (ii) the filing
with the Commission of the Registration Rights Agreement, (iii) the notice
and/or application(s) to each applicable Trading Market for the issuance and
sale of the Securities and the listing of the Underlying Shares for trading
thereon in the time and manner required thereby, (iv) the filing of Form D with
the Commission and such filings as are required to be made under applicable
state securities laws and (v) Stockholder Approval, Authorized Share Approval
and filings and notices in connection therewith (collectively, the “Required
Approvals”).
(f) Issuance of the
Securities. The Securities are duly authorized and, when
issued and paid for in accordance with the applicable Transaction Documents,
will be duly and validly issued, fully paid and nonassessable, free and clear of
all Liens imposed by the Company other than restrictions on transfer provided
for in the Transaction Documents. The Underlying Shares, when issued
in accordance with the terms of the Transaction Documents, will be validly
issued, fully paid and nonassessable, free and clear of all Liens imposed by the
Company other than restrictions on transfer provided for in the Transaction
Documents. Subject to the Authorized Share Approval, the Company will
reserve from its duly authorized capital stock a number of shares of Common
Stock for issuance of the Underlying Shares at least equal to the Required
Minimum on the date hereof.
(g) Capitalization. The
capitalization of the Company is as set forth on Schedule 3.1(g),
which Schedule
3.1(g) shall also include the number of shares of Common Stock, to the
Knowledge of the Company, owned beneficially, and of record, by Affiliates of
the Company as of the date hereof. The Company has not issued any capital stock
since its most recently filed periodic report under the Exchange Act, other than
pursuant to the exercise of employee stock options under the Company’s stock
incentive plans, the issuance of shares of Common Stock to employees and other
eligible recipients pursuant to the Company’s stock incentive plans and pursuant
to the conversion and/or exercise of Common Stock Equivalents outstanding as of
the date of the most recently filed periodic report under the Exchange
Act. No Person has any right of first refusal, preemptive right,
right of participation, or any similar right to participate in the transactions
contemplated by the Transaction Documents. Except as a result of the
purchase and sale of the Securities or as set forth on Schedule 3.1(g),
there are no outstanding options, warrants, scrip rights to subscribe to, calls
or commitments of any character whatsoever relating to, or securities, rights or
obligations convertible into or exercisable or exchangeable for, or giving any
Person any right to subscribe for or acquire, any shares of Common Stock, or
contracts, commitments, understandings or arrangements by which the Company is
or may become bound to issue additional shares of Common Stock or Common Stock
Equivalents. Except as set forth on Schedule 3.1(g), the
issuance and sale of the Securities will not obligate the Company to issue
shares of Common Stock or other securities to any Person (other than the
Purchasers) and will not result in a right of any holder of Company securities
to adjust the exercise, conversion, exchange or reset price under any of such
securities. All of the outstanding shares of capital stock of the Company are
validly issued, fully paid and nonassessable, have been issued in compliance
with all applicable federal and state securities laws (including registration
requirements (or exemptions therefrom)), and none of such outstanding shares was
issued in violation of any preemptive rights or similar rights to subscribe for
or purchase securities. Except as set forth on Schedule 3.1(g), no
further approval or authorization of any stockholder, the Board of Directors or
others is required for the issuance and sale of the
Securities. Except as set forth on Schedule 3.1(g),
there are no stockholders agreements, voting agreements or other similar
agreements in effect with respect to the Company’s capital stock to which the
Company is a party or, to the Knowledge of the Company, between or among any of
the Company’s stockholders.
(h) SEC Reports; Financial
Statements. The Company has filed all reports, schedules,
forms, statements and other documents required to be filed by the Company under
the Securities Act and the Exchange Act, including pursuant to Section 13(a) or
15(d) thereof, for the two years preceding the date hereof (or such shorter
period as the Company was required by law or regulation to file such material)
(the foregoing materials, including the exhibits thereto and documents
incorporated by reference therein, being collectively referred to herein as the
“SEC Reports”)
on a timely basis or has received a valid extension of such time of filing and
has filed any such SEC Reports prior to the expiration of any such
extension. As of their respective dates, the SEC Reports complied in
all material respects with the requirements of the Securities Act and the
Exchange Act, as applicable, and none of the SEC Reports, when filed (or, if
amended thereafter, as so amended), contained any untrue statement of a material
fact or omitted to state a material fact required to be stated therein or
necessary in order to make the statements therein, in the light of the
circumstances under which they were made, not misleading. The Company
has never been an issuer subject to Rule 144(i) under the Securities Act. The
financial statements of the Company included in the SEC Reports complied in all
material respects with applicable accounting requirements and the rules and
regulations of the Commission with respect thereto as in effect at the time of
filing. Such financial statements have been prepared in accordance
with GAAP applied on a consistent basis during the periods involved, except as
may be otherwise specified in such financial statements or the notes thereto and
except that unaudited financial statements may not contain all footnotes
required by GAAP, and fairly present in all material respects the financial
position of the Company as of and for the dates thereof and the results of
operations and cash flows for the periods then ended, subject, in the case of
unaudited statements, to normal, immaterial, year-end audit
adjustments.
(i) Material Changes;
Undisclosed Events, Liabilities or Developments. Since the date of the
latest audited financial statements included within the SEC Reports, except as
specifically disclosed in a subsequent SEC Report filed prior to the date
hereof, (i) there has been no event, occurrence or development that has had or
that could reasonably be expected to result in a Material Adverse Effect, (ii)
the Company has not incurred any liabilities (contingent or otherwise) other
than (A) trade payables and accrued expenses incurred in the ordinary course of
business consistent with past practice and (B) liabilities not required to be
reflected in the Company’s financial statements pursuant to GAAP or disclosed in
filings made with the Commission, (iii) the Company has not altered its method
of accounting, (iv) the Company has not declared or made any dividend or
distribution of cash or other property to its stockholders or purchased,
redeemed or made any agreements to purchase or redeem any shares of its capital
stock and (v) the Company has not issued any equity securities to any officer,
director or Affiliate, except pursuant to existing Company stock incentive
plans. The Company does not have pending before the Commission any
request for confidential treatment of information. Except for the
issuance of the Securities contemplated by this Agreement or as set forth on
Schedule
3.1(i), no event, liability or development has occurred or exists with
respect to the Company or its respective business, properties, operations or
financial condition, that would be required to be disclosed by the Company under
applicable securities laws at the time this representation is made or deemed
made that has not been publicly disclosed at least 1 Trading Day prior to the
date that this representation is made.
(j) Litigation. There
is no action, suit, inquiry, notice of violation, proceeding or investigation
pending or, to the Knowledge of the Company, threatened against or, to the
actual knowledge of the Company, affecting the Company or any of its properties
before or by any court, arbitrator, governmental or administrative agency or
regulatory authority (federal, state, county, local or foreign) (collectively,
an “Action”)
which (i) adversely affects or challenges the legality, validity or
enforceability of any of the Transaction Documents or the Securities or (ii)
could, if there were an unfavorable decision, reasonably be expected to have or
reasonably be expected to result in a Material Adverse
Effect. Neither the Company nor, to the Knowledge of the Company, any
director or officer thereof in their capacity as such, is or has been the
subject of any Action involving a claim of violation of or liability under
federal or state securities laws or a claim of breach of fiduciary
duty. There has not been, and to the Knowledge of the Company, there
is not pending or contemplated, any investigation by the Commission involving
the Company or any current or former director or officer of the Company in their
capacity as such. The Commission has not issued any stop order or
other order suspending the effectiveness of any registration statement filed by
the Company under the Exchange Act or the Securities Act.
(k) Labor
Relations. No material labor dispute exists or, to the
Knowledge of the Company, is imminent with respect to any of the employees of
the Company, which could reasonably be expected to result in a Material Adverse
Effect. None of the Company’s employees is a member of a union that
relates to such employee’s relationship with the Company, and the Company is not
a party to a collective bargaining agreement and the Company believes its
relationship with its employees is good. No executive officer, to the Knowledge
of the Company, is, or is now expected to be, in violation of any material term
of any employment contract, confidentiality, disclosure or proprietary
information agreement or non-competition agreement, or any other contract or
agreement or any restrictive covenant in favor of any third party, and to the
Knowledge of the Company, the continued employment of each such executive
officer does not subject the Company to any liability with respect to any of the
foregoing matters, except in each case as would not reasonably be expected to
have a Material Adverse Effect. The Company is in compliance with all
U.S. federal, state, local and foreign laws and regulations relating to
employment and employment practices, terms and conditions of employment and
wages and hours, except where the failure to be in compliance would not,
individually or in the aggregate, reasonably be expected to have a Material
Adverse Effect.
(l) Compliance. The
Company (i) is not in default under or in violation of (and no event has
occurred that has not been waived that, with notice or lapse of time or both,
would result in a default by the Company), nor has the Company received notice
of a claim that it is in default under or that it is in violation of, any
indenture, loan or credit agreement or any other agreement or instrument to
which it is a party or by which it or any of its properties is bound (whether or
not such default or violation has been waived), (ii) is not in violation of any
order of any court, arbitrator or governmental body, or (iii) has not been in
violation of any statute, rule or regulation of any governmental authority,
including without limitation all foreign, federal, state and local laws
applicable to its business and all such laws that affect the environment, except
in each case as would not reasonably be expected to result in a Material Adverse
Effect.
(m) Regulatory
Permits. The Company possesses all certificates,
authorizations and permits issued by the appropriate federal, state, local or
foreign regulatory authorities necessary to conduct their respective businesses
as described in the SEC Reports, except where the failure to possess such
permits would not reasonably be expected to result in a Material Adverse Effect
(“Material
Permits”), and the Company has not received any notice of proceedings
relating to the revocation or modification of any Material Permit, except where
such revocation or modification would not reasonably be expected to have a
Material Adverse Effect.
(n) Title to
Assets. The Company has good and marketable title in fee
simple to all real property owned by them and good and marketable title in all
personal property owned by them that is material to the business of the Company,
in each case free and clear of all Liens, except for Permitted Liens, and such
Liens as do not materially affect the value of such property and do not
materially interfere with the use made and proposed to be made of such property
by the Company. Any real property and facilities held under lease by
the Company are held by it under valid, subsisting and enforceable leases with
which the Company is in compliance.
(o) Patents and
Trademarks. The Company has, or has rights to use, all
patents, patent applications, trademarks, trademark applications, service marks,
trade names, trade secrets, inventions, copyrights, licenses and other
intellectual property rights and similar rights as described in the SEC Reports
necessary or material for use in connection with their respective businesses and
which the failure to so have would reasonably be expected to have a Material
Adverse Effect (collectively, the “Intellectual Property
Rights”). The Company has not received a notice (written or
otherwise) that any of such Intellectual Property Rights used by the Company
violates or infringes upon the rights of any Person. To the Knowledge of the
Company, all such Intellectual Property Rights are enforceable and there is no
existing infringement by another Person of any of the Intellectual Property
Rights. The Company has taken reasonable security measures to protect
the secrecy, confidentiality and value of all of their intellectual properties,
except where failure to do so could not, individually or in the aggregate,
reasonably be expected to have a Material Adverse Effect.
(p) Insurance. The
Company is insured by insurers of recognized financial responsibility against
such losses and risks and in such amounts as the Company believes to be prudent
and customary in the businesses in which the Company is engaged, including, but
not limited to, directors and officers insurance coverage at least equal to
$5,000,000 per occurrence. The Company has no reason to believe that it will not
be able to renew its existing insurance coverage as and when such coverage
expires or to obtain similar coverage from similar insurers as may be reasonably
necessary to continue its business.
(q) Transactions With Affiliates
and Employees. Except as set forth in the SEC Reports, none of
the officers or directors of the Company and, to the Knowledge of the Company,
none of the employees of the Company is presently a party to any transaction
with the Company (other than for services as employees, officers and directors),
including any contract, agreement or other arrangement providing for the
furnishing of services to or by, providing for rental of real or personal
property to or from, or otherwise requiring payments to or from any such
officer, director or employee or, to the Knowledge of the Company, any entity in
which any such officer, director, or any employee has a substantial interest or
is an officer, director, trustee or partner, in each case in excess of $120,000
other than for (i) payment of salary, director compensation, or consulting fees
for services rendered, (ii) reimbursement for expenses incurred for or on behalf
of the Company (including for the costs of director expenses incurred in
connection with attendance at meetings of the Board of Directors, or committees
thereof) and (iii) other employee benefits, including stock option agreements
under any stock incentive plan of the Company.
(r) Sarbanes-Oxley; Internal
Accounting Controls. The Company is in material compliance
with all provisions of the Sarbanes-Oxley Act of 2002 which are applicable to it
as of the Closing Date. The Company maintains a system of internal
accounting controls sufficient to provide reasonable assurance that (i)
transactions are executed in accordance with management’s general or specific
authorizations, (ii) transactions are recorded as necessary to permit
preparation of financial statements in conformity with GAAP and to maintain
asset accountability, (iii) access to assets is permitted only in accordance
with management’s general or specific authorization, and (iv) the recorded
accountability for assets is compared with the existing assets at reasonable
intervals and appropriate action is taken with respect to any differences. The
Company has established disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) for the Company and designed such
disclosure controls and procedures to provide reasonable assurance that
information required to be disclosed by the Company in the reports it files or
submits under the Exchange Act is recorded, processed, summarized and reported,
within the time periods specified in the Commission’s rules and
forms. The Company’s certifying officers have evaluated the
effectiveness of the Company’s disclosure controls and procedures as of the end
of the period covered by the Company’s most recently filed periodic report under
the Exchange Act (such date, the “Evaluation
Date”). The Company presented in its most recently filed
periodic report under the Exchange Act the conclusions of the certifying
officers about the effectiveness of the disclosure controls and procedures based
on their evaluations as of the Evaluation Date. Since the Evaluation
Date, there have been no changes in the Company’s internal control over
financial reporting (as such term is defined in the Exchange Act) that has
materially affected, or is reasonably likely to materially affect, the Company’s
internal control over financial reporting.
(s) Certain
Fees. Except as set forth on Schedule 3.1(s), no
brokerage or finder’s fees or commissions are or will be payable by the Company
to any broker, financial advisor or consultant, finder, placement agent,
investment banker, bank or other Person with respect to the transactions
contemplated by the Transaction Documents. The Purchasers shall have
no obligation with respect to any fees or with respect to any claims made by or
on behalf of other Persons for fees of a type contemplated in this Section that
may be due in connection with the transactions contemplated by the Transaction
Documents.
(t) Private Placement.
Assuming the accuracy of the Purchasers’ representations and warranties set
forth in Section 3.2, no registration under the Securities Act is required for
the offer and sale of the Securities by the Company to the Purchasers as
contemplated hereby. Except as set forth on Schedule 3.1(t), the
issuance and sale of the Securities hereunder does not contravene the rules and
regulations of the Trading Market.
(u) Investment Company.
The Company is not, and is not an Affiliate of, and immediately after receipt of
payment for the Securities, will not be or be an Affiliate of, an “investment
company” within the meaning of the Investment Company Act of 1940, as
amended. The Company shall conduct its business in a manner so that
it will not become an “investment company” subject to registration under the
Investment Company Act of 1940, as amended.
(v) Registration
Rights. Other than (i) each of the Purchasers, (ii) any
purchasers under the other Purchaser Agreements or (iii) as set forth on Schedule 3.1(v), no
Person has any right to cause the Company to effect the registration under the
Securities Act of any securities of the Company.
(w) Listing and Maintenance
Requirements. The Common Stock is registered pursuant to
Section 12(b) of the Exchange Act, and the Company has taken no action designed
to, or which, to the Knowledge of the Company, is likely to have the effect of,
terminating the registration of the Common Stock under the Exchange Act nor has
the Company received any notification that the Commission is contemplating
terminating such registration. Except as set forth on Schedule 3.1(w), the
Company has not, in the 12 months preceding the date hereof, received notice
from any Trading Market on which the Common Stock is or has been listed or
quoted to the effect that the Company is not in compliance with the listing or
maintenance requirements of such Trading Market. The Company is, and has no
reason to believe that it will not in the foreseeable future continue to be, in
compliance with all such listing and maintenance requirements.
(x) Application of Takeover
Protections. The Company and the Board of Directors have taken
all necessary action, if any, in order to render inapplicable any control share
acquisition, business combination, poison pill (including any distribution under
a rights agreement) or other similar anti-takeover provision under the Company’s
certificate of incorporation (or similar charter documents) or the laws of its
state of incorporation that is or could become applicable to the Purchasers as a
result of the Purchasers and the Company fulfilling their obligations or
exercising their rights under the Transaction Documents, including without
limitation as a result of the Company’s issuance of the Securities and the
Purchasers’ ownership of the Securities.
(y) Disclosure. Except
with respect to the material terms and conditions of the transactions
contemplated by the Transaction Documents, the Company confirms that neither it
nor any other Person acting on its behalf has provided any of the Purchasers or
their agents or counsel with any information that it believes constitutes, or
could reasonably be deemed to constitute, material, non-public
information. The Company understands and confirms that the Purchasers
will rely on the foregoing representation in effecting transactions in
securities of the Company. All of the disclosure furnished by or on
behalf of the Company to the Purchasers regarding the Company, its business and
the transactions contemplated hereby, including (i) this Agreement, (ii) the
Disclosure Schedules to this Agreement, (iii) the other Transaction Documents
and (iv) the SEC Reports filed since December 31, 2007 (which shall be deemed so
furnished by virtue of their having been made available on the Commission’s
Edgar system), is true and correct and does not contain any untrue statement of
a material fact or omit to state any material fact necessary in order to make
the statements made therein, in light of the circumstances under which they were
made, not misleading. The press releases disseminated by the
Company during the twelve months preceding the date of this Agreement, together
with the SEC Reports filed by the Company during such period, taken as a whole,
do not contain any untrue statement of a material fact or omit to state a
material fact required to be stated therein or necessary in order to make the
statements therein, in light of the circumstances under which they were made and
when made, not misleading. The Company acknowledges and agrees that
no Purchaser makes or has made any representations or warranties with respect to
the transactions contemplated hereby other than those specifically set forth in
Section 3.2 hereof.
(z) No Integrated
Offering. Assuming the accuracy of the Purchasers’ representations and
warranties set forth in Section 3.2, neither the Company, nor any of its
Affiliates acting on behalf of the Company, nor any Person acting on its or
their behalf has, directly or indirectly, except in connection with any other
Purchase Agreements, made any offers or sales of any security or solicited any
offers to buy any security, under circumstances that would cause this offering
of the Securities to be integrated with prior offerings by the Company for
purposes of (i) the Securities Act which would require the registration of any
of the Securities under the Securities Act, or (ii) any applicable stockholder
approval (including the Stockholder Approval and the Authorized Share Approval)
provisions of any Trading Market on which any of the securities of the Company
are listed or designated.
(aa) Solvency. Except
as set forth on Schedule 3.1(aa),
based on the consolidated financial condition of the Company as of the Closing
Date, after giving effect to the receipt by the Company of the proceeds from the
sale of the Securities hereunder: (i) the fair saleable value of the Company’s
assets exceeds the amount that will be required to be paid on or in respect of
the Company’s existing debts and other liabilities (including known contingent
liabilities) as they mature, (ii) the Company’s assets do not constitute
unreasonably small capital to carry on its business as now conducted and as
proposed to be conducted including its capital needs taking into account the
particular capital requirements of the business conducted by the Company, and
projected capital requirements and capital availability thereof, and (iii) the
current cash flow of the Company, together with the proceeds the Company would
receive, were it to liquidate all of its assets, after taking into account all
anticipated uses of the cash, would be sufficient to pay all amounts on or in
respect of its liabilities when such amounts are required to be
paid. The Company does not intend to incur debts beyond its ability
to pay such debts as they mature (taking into account the timing and amounts of
cash to be payable on or in respect of its debt). The Company has no
knowledge of any facts or circumstances which lead it to believe that it will
file for reorganization or liquidation under the bankruptcy or reorganization
laws of any jurisdiction within one year from the Closing Date. Schedule 3.1(aa) sets
forth as of the date hereof all outstanding secured and unsecured Indebtedness
of the Company, or for which the Company has commitments. The Company is not in
default with respect to any Indebtedness.
(bb) Tax
Status. Except for matters that would not, individually or in
the aggregate, have or reasonably be expected to result in a Material Adverse
Effect, the Company has filed all necessary federal, state and foreign income
and franchise tax returns and has paid or accrued all taxes shown as due
thereon, and, to the Knowledge of the Company, has no knowledge of a tax
deficiency which has been asserted or threatened against the
Company.
(cc) No General
Solicitation. Neither the Company nor any person acting on
behalf of the Company has offered or sold any of the Securities by any form of
general solicitation or general advertising. The Company has sold or
agreed to sell the Securities for sale only to the Purchasers and certain other
“accredited investors” within the meaning of Rule 501 under the Securities
Act.
(dd) Foreign Corrupt
Practices. Neither the Company, nor, to the Knowledge of the
Company, any agent or other person acting on behalf of the Company, has: (i)
directly or indirectly, used any funds for unlawful contributions, gifts,
entertainment or other unlawful expenses related to foreign or domestic
political activity, (ii) made any unlawful payment to foreign or domestic
government officials or employees or to any foreign or domestic political
parties or campaigns from corporate funds, (iii) failed to disclose fully any
contribution made by the Company (or made by any person acting on its behalf of
which the Company is aware) which is in violation of law or (iv)
violated in any material respect any provision of the Foreign Corrupt Practices
Act of 1977, as amended.
(ee) Accountants. The
Company’s accounting firm is set forth on Schedule 3.1(ee) of
the Disclosure Schedules. To the Knowledge of the Company, such
accounting firm: (i) is a registered public accounting firm as required by the
Exchange Act and (ii) shall express its opinion with respect to the financial
statements to be included in the Company’s annual report on Form 10-K for the
year ended December 31, 2008.
(ff) Seniority. As
of the Closing Date, except as set forth on Schedule
3.1(ff), as of
the Closing Date, no Indebtedness or other claim against the Company is senior
to the Preferred Stock in right of payment, whether with respect to interest or
upon liquidation or dissolution, or otherwise, other than indebtedness secured
by purchase money security interests (which is senior only as to underlying
assets covered thereby) and capital lease obligations (which is senior only as
to the property covered thereby).
(gg) No Disagreements with
Accountants and Lawyers. There are no material disagreements
presently existing, or reasonably anticipated by the Company to arise, between
the Company and the accountants employed by the Company with respect to the
Company’s financial statements and notes thereto, or other disclosures contained
in the SEC Reports and the Company is current with respect to any fees owed to
its accountants which could affect the Company’s ability to perform any of its
obligations under any of the Transaction Documents. No lawyer who
formerly represented or presently represents the Company has reported, or is
currently obligated to report, evidence of a material violation of the
Securities Act, the Exchange Act or any federal or state securities laws, breach
of fiduciary duty or similar violation by the Company or any of its officers,
directors, employees or agents to the Board of Directors or any committee
thereof, pursuant to Section 307 of the Sarbanes-Oxley Act of 2002, as amended,
and the rules and regulations thereunder.
(hh) Acknowledgment Regarding
Purchasers’ Purchase of Securities. The Company acknowledges
and agrees that each of the Purchasers is acting solely in the capacity of an
arm’s length purchaser with respect to the Transaction Documents and the
transactions contemplated thereby. The Company further acknowledges
that no Purchaser is acting as a financial advisor or fiduciary of the Company
(or in any similar capacity) with respect to the Transaction Documents and the
transactions contemplated thereby and any advice given by any Purchaser or any
of their respective representatives or agents in connection with the Transaction
Documents and the transactions contemplated thereby is merely incidental to the
Purchasers’ purchase of the Securities. The Company further
represents to each Purchaser that the Company’s decision to enter into this
Agreement and the other Transaction Documents has been based solely on the
independent evaluation of the transactions contemplated hereby by the Company
and its advisors and representatives.
(ii) Acknowledgment Regarding
Purchasers’ Trading Activity. Notwithstanding anything in this
Agreement or elsewhere herein to the contrary (except for Sections 3.2(g) and
4.15 hereof), it is understood and acknowledged by the Company that: (i) none of
the Purchasers has been asked to agree by the Company, nor has any Purchaser
agreed, to desist from purchasing or selling, long and/or short, securities of
the Company, or “derivative” securities based on securities issued by the
Company or to hold the Securities for any specified term, in accordance with
applicable law, (ii) past or future open market or other transactions by any
Purchaser, specifically including, without limitation, Short Sales or
“derivative” transactions, before or after the closing of this or future private
placement transactions, may negatively impact the market price of the Company’s
publicly-traded securities, (iii) any Purchaser, and counter-parties in
“derivative” transactions to which any such Purchaser is a party, directly or
indirectly, may presently have a “short” position in the Common Stock and (iv)
each Purchaser shall not be deemed to have any affiliation with or control over
any arm’s length counter-party in any “derivative” transaction, so long as such
Purchaser has no arrangement or understanding with such counterparty providing
such Purchaser with affiliation or control. The Company further
understands and acknowledges that (y) one or more Purchasers may engage in
hedging activities at various times during the period that the Securities are
outstanding, including, without limitation, during the periods that the value of
the Underlying Shares deliverable with respect to Securities are being
determined, and (z) such hedging activities (if any) could reduce the value of
the existing stockholders’ equity interests in the Company at and after the time
that the hedging activities are being conducted. The Company acknowledges
that, subject to Sections 3.2(g) and 4.15 hereof, such aforementioned hedging
activities do not constitute a breach of any of the Transaction
Documents.
(jj) Regulation M
Compliance. The Company has not, and to the Knowledge of the
Company, no one acting on its behalf has, during the two years preceding the
date hereof, (i) taken, directly or indirectly, any action designed to cause or
to result in the stabilization or manipulation of the price of any security of
the Company to facilitate the sale or resale of any of the Securities, (ii)
sold, bid for, purchased, or paid any compensation for soliciting purchases of,
any of the Securities, or (iii) paid or agreed to pay to any Person any
compensation for soliciting another to purchase any other securities of the
Company, other than, in the case of clauses (ii) and (iii), compensation paid to
the Company’s placement agents in connection with the placements of the
Securities.
(kk) FDA. As to
each product subject to the jurisdiction of the FDA under the Federal Food, Drug
and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is
manufactured, packaged, labeled, tested, distributed, sold, and/or marketed, as
applicable, by the Company (each such product, a “Pharmaceutical
Product”), such Pharmaceutical Product is being manufactured, packaged,
labeled, tested, distributed, sold and/or marketed by the Company in compliance
with all applicable requirements under FDCA and similar laws, rules and
regulations relating to registration, investigational use, premarket clearance,
licensure, or application approval, good manufacturing practices, good
laboratory practices, good clinical practices, product listing, quotas,
labeling, advertising, record keeping and filing of reports, except where the
failure to be in compliance would not have a Material Adverse
Effect. There is no pending, completed or, to the Knowledge of the
Company, threatened action (including any lawsuit, arbitration, or legal or
administrative or regulatory proceeding, charge, complaint, or investigation)
against the Company, and the Company has not received any notice, warning letter
or other communication from the FDA or any other governmental entity, which (i)
contests the premarket clearance, licensure, registration, or approval of, the
uses of, the distribution of, the manufacturing or packaging of, the testing of,
the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii)
withdraws its approval of, requests the recall, suspension, or seizure of, or
withdraws or orders the withdrawal of advertising or sales promotional materials
relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any
clinical investigation by the Company, (iv) enjoins production at any facility
of the Company, (v) enters or proposes to enter into a consent decree of
permanent injunction with the Company, or (vi) otherwise alleges any violation
of any laws, rules or regulations by the Company, and which in each such case,
either individually or in the aggregate, would have a Material Adverse
Effect. The properties, business and operations of the Company have
been and are being conducted in all material respects in accordance with all
applicable laws, rules and regulations of the FDA. The Company has not
been informed by the FDA that the FDA will prohibit the marketing, sale, license
or use in the United States of any product proposed to be developed, produced or
marketed by the Company nor has the FDA expressed any concern as to approving or
clearing for marketing any product being developed or proposed to be developed
by the Company.
(ll) Stock Incentive
Plans. To the Knowledge of the Company, each stock option granted by the
Company under the Company’s stock incentive plans was granted (i) in accordance
with the terms of the applicable stock incentive plan and (ii) with an exercise
price at least equal to the fair market value of the Common Stock on the date
such stock option would be considered granted under GAAP and applicable law. To
the Knowledge of the Company, no stock incentive granted under the Company’s
stock incentive plan has been backdated. The Company has not
knowingly granted, and there is no and has been no Company policy or practice to
knowingly grant, stock incentives prior to, or otherwise knowingly coordinate
the grant of stock incentives with, the release or other public announcement of
material information regarding the Company or its financial results or
prospects.
3.2 Representations and
Warranties of the Purchasers. Each Purchaser, for itself and
for no other Purchaser, hereby represents and warrants as of the date hereof and
as of the Closing Date to the Company as follows (unless as of a specific date
therein):
(a) Organization;
Authority. Such Purchaser is either an individual or an entity
duly organized, validly existing and in good standing under the laws of the
jurisdiction of its organization with full right, corporate or partnership power
and authority to enter into and to consummate the transactions contemplated by
the Transaction Documents and otherwise to carry out its obligations hereunder
and thereunder. The execution and delivery of the Transaction Documents and
performance by such Purchaser of the transactions contemplated by the
Transaction Documents have been duly authorized by all necessary corporate,
partnership, limited liability company or similar action, as applicable, on the
part of such Purchaser. Each Transaction Document to which it is a
party has been duly executed by such Purchaser, and when delivered by such
Purchaser in accordance with the terms hereof, will constitute the valid and
legally binding obligation of such Purchaser, enforceable against it in
accordance with its terms, except (i) as limited by applicable bankruptcy,
insolvency, reorganization, moratorium and other laws of general application
affecting enforcement of creditors’ rights generally, (ii) as limited by laws
relating to general principles of equity and (iii) insofar as indemnification
and contribution provisions may be limited by applicable law and public
policy.
(b) No Conflicts. The
execution, delivery and performance of the Transaction Documents to which it is
a party by such Purchaser and the consummation by such Purchaser of the
transactions contemplated thereby do not and will not: (i) conflict with or
violate, if such Purchaser is an entity, any provision of the Purchaser’s
certificate or articles of incorporation, bylaws or other organizational or
charter documents, (ii) violate, or constitute a default (or an event which with
notice or lapse of time or both would become a default) under, or give to others
any rights of termination, amendment, acceleration or cancellation (with or
without notice, lapse of time or both) of, any agreement, credit facility, debt
or other instrument to which such Purchaser is a party or (iii) result in a
violation of any law, rule, regulation, order, judgment, injunction, decree or
other restriction of any court or governmental authority to which such Purchaser
is subject (including federal and state securities laws and regulations), or by
which any property or asset of such Purchaser is bound or affected; except in
the case of clauses (ii) and (iii) above, for such conflicts, defaults, rights
or violations which would not, individually or in the aggregate, reasonably be
expected to have a material adverse effect on the transactions contemplated
hereby or in the other Transaction Documents or the authority or ability of
such Purchaser to perform its obligations under the Transaction
Documents.
(c) Own
Account. Such Purchaser understands that the Securities are
“restricted securities” and have not been registered under the Securities Act or
any applicable state securities law and is acquiring the Securities as principal
for its own account and not with a view to or for distributing or reselling such
Securities or any part thereof in violation of the Securities Act or any
applicable state securities law, has no present intention of distributing any of
such Securities in violation of the Securities Act or any applicable state
securities law and has no direct or indirect arrangement or understandings with
any other persons to distribute or regarding the distribution of such Securities
(this representation and warranty not limiting such Purchaser’s right to sell
the Securities pursuant to the Registration Statement or otherwise in compliance
with applicable federal and state securities laws) in violation of the
Securities Act or any applicable state securities law. Such Purchaser
is acquiring the Securities hereunder in the ordinary course of its
business.
(d) Purchaser
Status. At the time such Purchaser was offered the Securities,
it was, as of the date hereof it is, as of the Closing Date it will be,and on
each date on which it exercises any Warrants or converts any shares of Preferred
Stock, it will be an “accredited investor” as defined in Rule 501(a)(1), (a)(2),
(a)(3), (a)(7) or (a)(8) under the Securities Act. Such Purchaser is
not required to be registered as a broker-dealer under Section 15 of the
Exchange Act.
(e) Experience of Such
Purchaser. Such Purchaser, either alone or together with its
representatives, has such knowledge, sophistication and experience in business
and financial matters so as to be capable of evaluating the merits and risks of
the prospective investment in the Securities, and has so evaluated the merits
and risks of such investment. Such Purchaser is able to bear the
economic risk of an investment in the Securities and, at the present time, is
able to afford a complete loss of such investment. Such Purchaser and its
advisors, if any, have been furnished with all materials relating to the
business, finances and operations of the Company and materials relating to the
offer and sale of the Securities that have been requested by such
Purchaser. Such Purchaser and its advisors, if any, have been
afforded the opportunity to ask questions of the Company.
(f) General
Solicitation. Such Purchaser is not purchasing the Securities
as a result of any advertisement, article, notice or other communication
regarding the Securities published in any newspaper, magazine or similar media
or broadcast over television or radio or presented at any seminar or any other
general solicitation or general advertisement.
(g) Short Sales and
Confidentiality Prior To The Date Hereof. Other than
consummating the transactions contemplated hereunder, such Purchaser has not
directly or indirectly, nor has any Person acting on behalf of or pursuant to
any understanding with such Purchaser, executed any purchases or sales,
including Short Sales, of the securities of the Company during the period
commencing from the time that such Purchaser first received a summary of terms
(written or oral) from the Company or any other Person representing the Company
setting forth the material terms of the transactions contemplated hereunder
until the date hereof (the “Discussion
Time”). Notwithstanding the foregoing, in the case of a
Purchaser that is a multi-managed investment vehicle whereby separate portfolio
managers manage separate portions of such Purchaser’s assets and the portfolio
managers have no direct knowledge of the investment decisions made by the
portfolio managers managing other portions of such Purchaser’s assets, the
representation set forth above shall only apply with respect to the portion of
assets managed by the portfolio manager that made the investment decision to
purchase the Securities covered by this Agreement. Other than to
other Persons party to this Agreement, such Purchaser has maintained the
confidentiality of all disclosures made to it in connection with this
transaction (including the existence and terms of this transaction).
Notwithstanding the foregoing, for avoidance of doubt, nothing contained herein
shall constitute a representation or warranty, or preclude any actions, with
respect to the identification of the availability of, or securing of, available
shares to borrow in order to effect Short Sales or similar transactions in the
future.
(h) Disclosure. Such
Purchaser acknowledges and agrees that the Company is not making any and has not
made any representation or warranty with respect to the transactions
contemplated hereby other than those set forth in Section 3.1
hereof.
ARTICLE
IV.
OTHER
AGREEMENTS OF THE PARTIES
4.1 Transfer
Restrictions.
(a) The
Securities may only be disposed of in compliance with state and federal
securities laws. In connection with any transfer of Securities other
than pursuant to an effective registration statement or Rule 144, to the Company
or to an Affiliate of a Purchaser or in connection with a pledge as contemplated
in Section 4.1(b), the Company may require the transferor thereof to provide to
the Company an opinion of counsel selected by the transferor and reasonably
acceptable to the Company, the form and substance of which opinion shall be
reasonably satisfactory to the Company, to the effect that such transfer does
not require registration of such transferred Securities under the Securities
Act. As a condition of transfer, any such transferee shall agree in
writing to be bound by the terms of this Agreement and the Registration Rights
Agreement and shall have the rights and obligations of a Purchaser under this
Agreement and the Registration Rights Agreement.
(b) The
Purchasers agree to the imprinting, so long as is required by this Section 4.1,
of a legend on any of the Securities in substantially the following form (and
the placement of a stop transfer order against transfer of the Securities
consistent therewith):
[NEITHER]
THIS SECURITY [NOR THE SECURITIES INTO WHICH THIS SECURITY IS [EXERCISABLE]
[CONVERTIBLE]] HAS [NOT] BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE
COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN
EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE
“SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT
TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO
AN AVAILABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE
REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN ACCORDANCE WITH
APPLICABLE STATE SECURITIES LAWS AS EVIDENCED BY A LEGAL OPINION OF COUNSEL TO
THE TRANSFEROR TO SUCH EFFECT, THE FORM AND SUBSTANCE OF WHICH SHALL BE
REASONABLY ACCEPTABLE TO THE COMPANY. THIS SECURITY [AND THE SECURITIES ISSUABLE
UPON [EXERCISE] [CONVERSION] OF THIS SECURITY] MAY BE PLEDGED IN CONNECTION WITH
A BONA FIDE MARGIN ACCOUNT WITH A REGISTERED BROKER-DEALER OR OTHER LOAN WITH A
FINANCIAL INSTITUTION THAT IS AN “ACCREDITED INVESTOR” AS DEFINED IN RULE 501(a)
UNDER THE SECURITIES ACT OR OTHER LOAN SECURED BY SUCH SECURITIES.
The
Company acknowledges and agrees that a Purchaser may from time to time pledge
pursuant to a bona fide margin agreement with a registered broker-dealer or
grant a security interest in some or all of the Securities to a financial
institution that is an “accredited investor” as defined in Rule 501(a) under the
Securities Act and who agrees to be bound by the provisions of this Agreement
and the Registration Rights Agreement and, if required under the terms of such
arrangement, such Purchaser may transfer pledged or secured Securities to the
pledgees or secured parties. Such a pledge or transfer would not be
subject to approval of the Company and no legal opinion of legal counsel of the
pledgee, secured party or pledgor shall be required in connection
therewith. Further, no notice shall be required of such
pledge. At the appropriate Purchaser’s expense, the Company will
execute and deliver such reasonable documentation as a pledgee or secured party
of Securities may reasonably request in connection with a pledge or transfer of
the Securities, including, if the Securities are subject to registration
pursuant to the Registration Rights Agreement, the preparation and filing of any
required prospectus supplement under Rule 424(b)(3) under the Securities Act or
other applicable provision of the Securities Act to appropriately amend the list
of Selling Stockholders (as defined in the Registration Rights Agreement)
thereunder.
(c) Certificates
evidencing the Underlying Shares shall not contain any legend (including the
legend set forth in Section 4.1(b) hereof): (i) while a registration statement
(including the Registration Statement) covering the resale of such Underlying
Shares is effective under the Securities Act, (ii) following any sale of such
Underlying Shares pursuant to Rule 144, as certified to the Company in customary
certificates with respect thereto, executed by the seller of such Underlying
Shares and (to the extent applicable) the seller’s broker with respect thereto,
or (iii) if such Underlying Shares are held by a Person that is not an
Affiliate, as certified in writing by such Person to the Company, and are
eligible for sale under Rule 144, without the requirement for the Company to be
in compliance with the current public information required under Rule 144 as to
such Underlying Shares and without volume or manner-of-sale restrictions or (iv)
if such legend is expressly permitted to be removed under applicable
requirements of the Securities Act (including judicial interpretations and
pronouncements issued by the staff of the Commission). The Company shall cause
its counsel to issue a legal opinion to the Transfer Agent promptly after the
Effective Date if required by the Transfer Agent to effect the removal of the
legend hereunder. If all or any shares of Preferred Stock are converted or any
portion of a Warrant is exercised at a time when there is an effective
registration statement to cover the resale of the Underlying Shares, or if such
Underlying Shares may be sold under Rule 144, without the requirement for the
Company to be in compliance with the current public information required under
Rule 144 as to such Underlying Shares and without volume or manner-of-sale
restrictions or if such legend is expressly permitted to be removed under
applicable requirements of the Securities Act (including judicial
interpretations and pronouncements issued by the staff of the Commission) then
such Underlying Shares shall be issued free of all legends. The
Company agrees that following the Effective Date or at such time as such legend
is no longer required under this Section 4.1(c), it will, no later than three
Trading Days following the delivery by a Purchaser to the Company or the
Transfer Agent of a certificate representing Underlying Shares, as applicable,
issued with a restrictive legend (such third Trading Day, the “Legend Removal
Date”), deliver or cause to be delivered to such Purchaser a certificate
representing such shares that is free from all restrictive and other
legends. The Company may not make any notation on its records or give
instructions to the Transfer Agent that enlarge the restrictions on transfer set
forth in this Section 4. Certificates for Underlying Shares subject
to legend removal hereunder shall be transmitted by the Transfer Agent to the
Purchaser by crediting the account of the Purchaser’s prime broker with the
Depository Trust Company System as directed by such Purchaser.
(d) In
addition to such Purchaser’s other available remedies, the Company shall pay to
a Purchaser, in cash, as partial liquidated damages and not as a penalty, for
each $1,000 of Underlying Shares (based on the VWAP of the Common Stock on the
date such Securities are submitted to the Transfer Agent) delivered for removal
of the restrictive legend and subject to Section 4.1(c), $10 per Trading Day
(increasing to $20 per Trading Day five (5) Trading Days after such damages have
begun to accrue) for each Trading Day after the second Trading Day after the
Legend Removal Date until such certificate is delivered without a
legend. Nothing herein shall limit such Purchaser’s right to pursue
actual damages for the Company’s failure to deliver certificates representing
any Securities as required by the Transaction Documents, and such Purchaser
shall have the right to pursue all remedies available to it at law or in equity
including, without limitation, a decree of specific performance and/or
injunctive relief.
(e) Each
Purchaser, severally and not jointly with the other Purchasers,
agrees with the Company that such Purchaser will sell any Securities
pursuant to either the registration requirements of the Securities Act,
including any applicable prospectus delivery requirements, or an exemption
therefrom, and that if Securities are sold pursuant to a Registration Statement,
they will be sold in compliance with the plan of distribution set forth therein,
and acknowledges that the removal of the restrictive legend from certificates
representing Securities as set forth in this Section 4.1 is predicated upon the
Company’s reliance upon this understanding.
4.2 Acknowledgment of
Dilution. The Company acknowledges that the issuance of the
Securities may result in dilution of the outstanding shares of Common Stock,
which dilution may be substantial under certain market
conditions. The Company further acknowledges that its obligations
under the Transaction Documents, including, without limitation, its obligation
to issue the Underlying Shares pursuant to the Transaction Documents, are
unconditional and absolute and not subject to any right of set off,
counterclaim, delay or reduction, regardless of the effect of any such dilution
or any claim the Company may have against any Purchaser and regardless of the
dilutive effect that such issuance may have on the ownership of the other
stockholders of the Company.
4.3 Furnishing of Information;
Public Information.
(a) Until
the time that no Purchaser owns Preferred Stock and Warrants, the Company
covenants to maintain the registration of the Common Stock under Section 12(b)
or 12(g) of the Exchange Act and to timely file (or obtain extensions in respect
thereof and file within the applicable grace period) all reports required to be
filed by the Company after the date hereof pursuant to the Exchange Act other
than filings, the failure of which would not impact the eligibility of the
Company with respect to the use of Form S-3 or Rule
144. As long as any Purchaser owns Securities, if the
Company is not required to file reports pursuant to the Exchange Act, it will
prepare and furnish to the Purchasers and make publicly available in accordance
with Rule 144(c) such information as is required for the Purchasers to sell the
Securities under Rule 144. The Company further covenants that it will
take such further action as any holder of Securities may reasonably request, to
the extent required from time to time to enable such Person to sell such
Securities without registration under the Securities Act within the requirements
of the exemption provided by Rule 144.
(b) At
any time during the period commencing from the six (6) month anniversary of the
date hereof and ending at such time that all of the Securities may be sold
without the requirement for the Company to be in compliance with Rule 144(c)(1)
and otherwise without restriction or limitation pursuant to Rule 144, assuming
the Warrants are exercised by way of a cashless exercise and none of the
Securities are (or were at any time) held by an Affiliate of the Company, if the
Company shall fail for any reason to satisfy the current public information
requirement under Rule 144(c) (a “Public Information
Failure”) then, in addition to such Purchaser’s other available remedies,
the Company shall pay to a Purchaser, in cash, as partial liquidated damages and
not as a penalty, by reason of any such delay in or reduction of its ability to
sell the Securities, an amount in cash equal to one and one half percent (1.5%)
of the aggregate Subscription Amount of such Purchaser’s Securities on the day
of a Public Information Failure and on every thirtieth (30th) day
(pro rated for periods totaling less than thirty days) thereafter until the
earlier of (a) the date such Public Information Failure is cured and (b) such
time that such public information is no longer required for the Purchasers
to transfer the Underlying Shares pursuant to Rule 144. The payments to
which a Purchaser shall be entitled pursuant to this Section 4.3(b) are referred
to herein as “Public
Information Failure Payments.” Public Information Failure Payments shall be paid
on the earlier of (i) the last day of the calendar month during which such
Public Information Failure Payments are incurred
and (ii) the third (3rd)
Business Day after the event or failure giving rise to the Public Information
Failure Payments is
cured. In the event the Company fails to make Public Information
Failure Payments in
a timely manner, such Public Information Failure Payments shall bear
interest at the rate of 1.5% per month (prorated for partial months) until paid
in full. Nothing herein shall limit such Purchaser’s right to pursue actual
damages for the Public Information Failure, and such Purchaser shall have the
right to pursue all remedies available to it at law or in equity including,
without limitation, a decree of specific performance and/or injunctive
relief.
4.4 Integration. The
Company shall not sell, offer for sale or solicit offers to buy or otherwise
negotiate in respect of any security (as defined in Section 2 of the Securities
Act) that would be integrated with the offer or sale of the Securities to the
Purchasers in a manner that would require the registration under the Securities
Act of the sale of the Securities to the Purchasers or, except in connection
with any other Purchase Agreements, that would be integrated with the offer or
sale of the Securities for purposes of the rules and regulations, including, but
not limited to, the stockholder approval requirements, of any Trading
Market.
4.5 Conversion and Exercise
Procedures. Each of the form of Notice of Exercise included in
the Warrants and the form of Notice of Conversion included in the Certificate of
Designation set forth the totality of the information required to be provided by
the Purchasers in order to exercise the Warrants or convert the Preferred
Stock. No additional legal opinion, other information or instructions
shall be required of the Purchasers to exercise their Warrants or convert their
Preferred Stock. The Company shall honor exercises of the Warrants
and conversions of the Preferred Stock and shall deliver Underlying Shares in
accordance with the terms, conditions and time periods set forth in the
Transaction Documents.
4.6 Securities Laws Disclosure;
Publicity. The Company shall (a) by 8:30 a.m. (New
York City time) on the Trading Day immediately following the date hereof, issue
a press release disclosing the material terms of each of the Transaction
Documents contemplated hereby, which shall be in compliance with Rule 135(c) and
(b) by 8:30 a.m. (New York City time) on the second Trading Day immediately
following the date hereof, issue a Current Report on Form 8-K, disclosing the
material terms of the transactions contemplated hereby, and, upon the final
closing of the offering of the Preferred Stock and the Warrants, including the
Transaction Documents as exhibits thereto. The Company and each
Purchaser shall consult with each other in issuing any other press releases with
respect to the transactions contemplated hereby, and neither the Company nor any
Purchaser shall issue any such press release nor otherwise make any such public
statement without the prior consent of the Company, with respect to any press
release of any Purchaser, or without the prior consent of each Purchaser, with
respect to any press release of the Company, which consent shall not
unreasonably be withheld or delayed, except if such disclosure is required by
law, in which case the disclosing party shall promptly provide the other party
with prior notice of such public statement or
communication. Notwithstanding the foregoing, the Company shall not
publicly disclose the name of any Purchaser, or include the name of any
Purchaser in any filing with the Commission or any regulatory agency or Trading
Market, without the prior written consent of such Purchaser, except: (a) as
required by federal securities law in connection with (i) any registration
statement contemplated by the Registration Rights Agreement and (ii) the filing
of final Transaction Documents (including signature pages thereto) with the
Commission and (b) to the extent such disclosure is required by law or Trading
Market regulations, in which case the Company shall provide the Purchasers with
prior notice of such disclosure permitted under this clause (b).
4.7 Stockholder Rights
Plan. No claim will be made or enforced by the Company or,
with the consent of the Company, any other Person, that any Purchaser is an
“Acquiring Person” under any control share acquisition, business combination,
poison pill (including any distribution under a rights agreement) or similar
anti-takeover plan or arrangement in effect or hereafter adopted by the Company,
or that any Purchaser could be deemed to trigger the provisions of any such plan
or arrangement, by virtue of receiving Securities under the Transaction
Documents or under any other agreement between the Company and the
Purchasers.
4.8 Non-Public
Information. Except with respect to the material terms and
conditions of the transactions contemplated by the Transaction Documents, the
Company covenants and agrees that neither it, nor any other Person acting on its
behalf, will provide any Purchaser or its agents or counsel with any information
that the Company believes constitutes material non-public information, unless
prior thereto such Purchaser shall have executed a written agreement regarding
the confidentiality and use of such information. The Company
understands and confirms that each Purchaser shall be relying on the foregoing
covenant in effecting transactions in securities of the Company.
4.9 Use of
Proceeds. Except as set forth on Schedule 4.9 attached
hereto, the Company shall use the net proceeds from the sale of the Securities
hereunder for working capital purposes and shall not use such proceeds for: (a)
the satisfaction of any portion of the Company’s debt (other than payment of
trade payables in the ordinary course of the Company’s business and prior
practices), (b) the redemption of any Common Stock or Common Stock Equivalents
or (c) the settlement of any outstanding litigation.
4.10 Indemnification of
Purchasers. Subject to the provisions of this Section
4.10, the Company will indemnify and hold each Purchaser and its directors,
officers, stockholders, members, partners, employees and agents (and any other
Persons with a functionally equivalent role of a Person holding such titles
notwithstanding a lack of such title or any other title), each Person who
controls such Purchaser (within the meaning of Section 15 of the Securities Act
and Section 20 of the Exchange Act), and the directors, officers, stockholders,
agents, members, partners or employees (and any other Persons with a
functionally equivalent role of a Person holding such titles notwithstanding a
lack of such title or any other title) of such controlling persons (each, a
“Purchaser
Party”) harmless from any and all losses, liabilities, obligations,
claims, contingencies, damages, costs and expenses, including all judgments,
amounts paid in settlements, court costs and reasonable attorneys’ fees and
costs of investigation that any such Purchaser Party may suffer or incur as a
result of or relating to (a) any breach of any of the representations,
warranties, covenants or agreements made by the Company in this Agreement or in
the other Transaction Documents or (b) any action instituted against a Purchaser
in any capacity, or any of them or their respective Affiliates, by any
stockholder of the Company who is not an Affiliate of such Purchaser, with
respect to any of the transactions contemplated by the Transaction Documents
(unless such action is based upon a breach of such Purchaser’s representations,
warranties or covenants under the Transaction Documents or any agreements or
understandings such Purchaser may have with any such stockholder or any
violations by the Purchaser of state or federal securities laws or any conduct
by such Purchaser which constitutes fraud, gross negligence, willful misconduct
or malfeasance). If any action shall be brought against any Purchaser
Party in respect of which indemnity may be sought pursuant to this Agreement,
such Purchaser Party shall promptly notify the Company in writing, and the
Company shall have the right to assume the defense thereof with counsel of its
own choosing reasonably acceptable to the Purchaser Party. Any
Purchaser Party shall have the right to employ separate counsel in any such
action and participate in the defense thereof, but the fees and expenses of such
counsel shall be at the expense of such Purchaser Party except to the extent
that (i) the employment thereof has been specifically authorized by the Company
in writing, (ii) the Company has failed after a reasonable period of time to
assume such defense and to employ counsel or (iii) in such action there is, in
the reasonable opinion of such separate counsel, a material conflict on any
material issue between the position of the Company and the position of such
Purchaser Party, in which case the Company shall be responsible for the
reasonable fees and expenses of no more than one such separate
counsel. The Company will not be liable to any Purchaser Party under
this Agreement (y) for any settlement by a Purchaser Party effected without the
Company’s prior written consent, which shall not be unreasonably withheld or
delayed; or (z) to the extent, but only to the extent that a loss, claim, damage
or liability is attributable to any Purchaser Party’s breach of any of the
representations, warranties, covenants or agreements made by such Purchaser
Party in this Agreement or in the other Transaction Documents or any violations
by the Purchaser of state or federal securities laws or any conduct by such
Purchaser which constitutes fraud, gross negligence, willful misconduct or
malfeasance.
4.11
Reservation and Listing of
Securities.
(a) The
Company shall, while the Preferred Stock and Warrants are outstanding, maintain
a reserve from its duly authorized shares of Common Stock for issuance pursuant
to the Transaction Documents in such amount as may be required to fulfill its
obligations in full on such date under the Transaction
Documents.
(b) If,
on any date following the Authorized Share Approval Date, the number of
authorized but unissued (and otherwise unreserved) shares of Common Stock is
less than 130% of the result of (i) the Required Minimum on such date,
minus (ii) the number of shares of Common Stock previously issued pursuant to
the Transaction Documents, then the Board of Directors shall use commercially
reasonable efforts to amend the Company’s certificate of incorporation to
increase the number of authorized but unissued shares of Common Stock to at
least the Required Minimum at such time (minus the number of shares of Common
Stock previously issued pursuant to the Transaction Documents), as soon as
possible and in any event not later than the 75th day
after such date; provided that the Company will not be required at any time to
authorize a number of shares of Common Stock greater than the maximum remaining
number of shares of Common Stock that could possibly be issued after such time
pursuant to the Transaction Documents.
(c) The
Company shall, if applicable: (i) in the time and manner required by the
principal Trading Market, prepare and file with such Trading Market an
additional shares listing application covering a number of shares of Common
Stock at least equal to the Required Minimum on the date of such application,
(ii) take all steps necessary to cause such shares of Common Stock to be
approved for listing or quotation on such Trading Market as soon as possible
thereafter, (iii) provide to the Purchasers evidence of such listing or
quotation and (iv) maintain the listing or quotation of such Common Stock on any
date at least equal to the Required Minimum on such date on such Trading Market
or another Trading Market. In addition, no later than the 90th
calendar day following the date of termination or expiration of the offering of
the securities pursuant to the Purchase Agreements, the Company shall hold a
special meeting of its stockholders (which period may be reasonably extended in
the case of Commission review of the Company’s proxy statement) for the purpose
of obtaining Stockholder Approval and Authorized Share Approval, with the
recommendation of the Board of Directors that such proposals be approved, and
the Company shall solicit proxies from its stockholders in connection therewith
in the same manner as all other management proposals in such proxy statement and
all management-appointed proxyholders shall vote their proxies in favor of such
proposals. If the Company does not obtain Stockholder Approval and Authorized
Share Approval at the first meeting, the Company shall call a meeting every 60
days thereafter to seek Stockholder Approval and Authorized Share Approval, as
applicable, until the earlier of the date that both of the Stockholder Approval
and the Authorized Share Approval are obtained or the Preferred Stock is no
longer outstanding. The Company agrees, as required by subclause (b) of the
definition of Authorized Share Approval, to file the Amendment with the
Secretary of State of Delaware on the Business Day immediately following
(provided the Secretary of State of Delaware is accepting filings on such day)
the receipt of Authorized Share Approval as required by subclause (a) of the
definition of Authorized Share Approval.
4.12
Participation in
Future Financing.
(a) From
the date on which no shares of the Series B Preferred are outstanding until the
date that the Preferred Stock is no longer outstanding, upon any issuance by the
Company or any of its Subsidiaries of Common Stock or Common Stock Equivalents
for cash consideration (or a combination of units thereof) (a “Subsequent
Financing”), each Purchaser shall have the right to participate in such
Subsequent Financing up to an amount of the Subsequent Financing equal to such
percentage of the Subsequent Financing that enables such Purchaser to maintain
the same percentage of ownership of the Common Stock, assuming full conversion
of the Preferred Stock (without giving effect to any limitations on conversion
set forth in the Certificate of Designation), as such Purchaser held immediately
following the Closing Date (the “Participation
Maximum”) on the same terms, conditions and price provided for in the
Subsequent Financing.
(b) At
least five (5) Trading Days prior to the closing of the Subsequent Financing,
the Company shall deliver to each Purchaser a written notice of its intention to
effect a Subsequent Financing (“Pre-Notice”), which
Pre-Notice shall ask such Purchaser if it wants to review the details of such
financing (such additional notice, a “Subsequent Financing
Notice”). Upon the request of a Purchaser, and only upon a
request by such Purchaser, for a Subsequent Financing Notice, the Company shall
promptly, but no later than one (1) Trading Day after such request, deliver a
Subsequent Financing Notice to such Purchaser. The Subsequent
Financing Notice shall describe in reasonable detail the proposed terms of such
Subsequent Financing, the amount of proceeds intended to be raised thereunder
and the Person or Persons through or with whom such Subsequent Financing is
proposed to be effected and shall include a term sheet or similar document
relating thereto as an attachment. Each Purchaser hereby agrees to keep
confidential the information included in any Subsequent Financing Notice
provided to such Purchaser.
(c) Any
Purchaser desiring to participate in such Subsequent Financing must provide
written notice to the Company by not later than 5:30 p.m. (New York City time)
on the fifth (5th)
Trading Day after all of the Purchasers have received the Pre-Notice that the
Purchaser is willing to participate in the Subsequent Financing, the amount of
the Purchaser’s participation, and representing and warranting that the
Purchaser has such funds ready, willing, and available for investment on the
terms set forth in the Subsequent Financing Notice. If the Company
receives no such notice from a Purchaser as of such fifth (5th)
Trading Day, such Purchaser shall be deemed to have notified the Company that it
does not elect to participate.
(d) If
by 5:30 p.m. (New York City time) on the fifth (5th) Trading
Day after all of the Purchasers have received the Pre-Notice, notifications by
the Purchasers of their willingness to participate in the Subsequent Financing
(or to cause their designees to participate) is, in the aggregate, less than the
total amount of the Subsequent Financing, then the Company may effect the
remaining portion of such Subsequent Financing on the terms and with the Persons
set forth in the Subsequent Financing Notice.
(e) The
Company must provide the Purchasers with a second Subsequent Financing Notice,
and the Purchasers will again have the right of participation set forth above in
this Section 4.12, if the Subsequent Financing subject to the initial Subsequent
Financing Notice is not consummated for any reason substantially on the terms
set forth in such Subsequent Financing Notice within 30 Trading Days after the
date of the initial Subsequent Financing Notice.
(f) Notwithstanding
the foregoing, this Section 4.12 shall not apply in respect of (i) an Exempt
Issuance, or (ii) an underwritten public offering of Common Stock.
4.13
Subsequent Equity
Sales.
(a) From
the date hereof until 60 days after the earlier of (i) the Effective Date and
(ii) the date that the Securities are eligible for resale without volume or
manner-of-sale restrictions or current public information requirements pursuant
to Rule 144 (assuming the Warrants are exercised by way of cashless exercise and
none of the Securities are (or were at any time) held by an Affiliate of the
Company), neither the Company nor any Subsidiary shall issue shares of Common
Stock or Common Stock Equivalents; provided, however, that the 60
day period set forth in this Section 4.13 shall be extended for the number of
Trading Days during such period in which (i) trading in the Common Stock is
suspended by any Trading Market, or (ii) following the Effective Date, the
Registration Statement is not effective or the prospectus included in the
Registration Statement may not be used by the Purchasers for the resale of the
Underlying Shares.
(b) From
the date hereof until such time as no Purchaser holds any of the Preferred Stock
and Warrants, the Company shall be prohibited from effecting or entering into an
agreement to effect any Subsequent Financing involving a Variable Rate
Transaction. “Variable
Rate Transaction” means a transaction in which the Company (i) issues or
sells any debt or equity securities that are convertible into, exchangeable or
exercisable for, or include the right to receive, additional shares of Common
Stock at a conversion price, exercise price or exchange rate or other price that
is based upon, and/or varies with, the trading prices of, or quotations for, the
shares of Common Stock at any time after the initial issuance of such debt or
equity securities or (ii) enters into any agreement, including, but not limited
to, an equity line of credit, whereby the Company may sell securities at a
future determined price. Any Purchaser shall be entitled to obtain
injunctive relief against the Company to preclude any such issuance, which
remedy shall be in addition to any right to collect damages.
(c) Unless
Stockholder Approval has been obtained and deemed effective, neither the Company
nor any Subsidiary shall make any issuance whatsoever of Common Stock or Common
Stock Equivalents which would cause any adjustment of the Conversion Price to
the extent the holders of Preferred Stock would not be permitted, pursuant to
Section 6(d) of the Certificate of Designation, to convert their respective
outstanding shares of Preferred Stock and exercise their respective Warrants in
full, ignoring for such purposes the other conversion or exercise limitations
therein. Any Purchaser shall be entitled to obtain injunctive relief
against the Company to preclude any such issuance, which remedy shall be in
addition to any right to collect damages.
(d) Notwithstanding
the foregoing, this Section 4.13 shall not apply in respect of an Exempt
Issuance, except that no Variable Rate Transaction shall be an Exempt
Issuance.
4.14 Equal Treatment of
Purchasers. No consideration (including any modification of
any Transaction Document) shall be offered or paid to any Person to amend or
consent to a waiver or modification of any provision of any of the Transaction
Documents unless the same consideration is also offered to all of the parties to
the Transaction Documents. For clarification purposes, this provision
constitutes a separate right granted to each Purchaser by the Company and
negotiated separately by each Purchaser, and is intended for the Company to
treat the Purchasers as a class and shall not in any way be construed as the
Purchasers acting in concert or as a group with respect to the purchase,
disposition or voting of Securities or otherwise.
4.15 Short Sales and
Confidentiality After The Date Hereof. Each Purchaser, severally and not
jointly with the other Purchasers, covenants that neither it, nor any Affiliate
acting on its behalf or pursuant to any understanding with it, will engage in
any transactions in securities of the Company, including any purchases or sales,
including any Short Sales or any other transactions (including any derivative
transactions) with respect to any securities of the Company, during the period
commencing with the Discussion Time and ending at such time as the transactions
contemplated by this Agreement are first publicly announced as described in
Section 4.6. Each Purchaser, severally and not jointly with the other
Purchasers, covenants that until such time as the transactions contemplated by
this Agreement are publicly disclosed by the Company as described in Section
4.6, such Purchaser will maintain the confidentiality of the existence and terms
of this transaction and the information included in the Transaction Documents
and the Disclosure Schedules. Each Purchaser severally and not
jointly with any other Purchaser, acknowledges the positions of the Commission
as set forth in Item 65, Section A, of the Manual of Publicly Available
Telephone Interpretations, dated July 1997, compiled by the Office of Chief
Counsel, Division of Corporation Finance. Notwithstanding the foregoing, no
Purchaser makes any representation, warranty or covenant hereby that it will not
engage in Short Sales in the securities of the Company after the time that the
transactions contemplated by this Agreement are first publicly announced as
described in Section 4.6. Notwithstanding the foregoing, in the case of a
Purchaser that is a multi-managed investment vehicle whereby separate portfolio
managers manage separate portions of such Purchaser’s assets and the portfolio
managers have no direct knowledge of the investment decisions made by the
portfolio managers managing other portions of such Purchaser’s assets, the
covenant set forth above shall only apply with respect to the portion of assets
managed by the portfolio manager that made the investment decision to purchase
the Securities covered by this Agreement.
4.16 Form D; Blue Sky
Filings. The Company agrees to timely file a Form D with
respect to the Securities as required under Regulation D and to provide a copy
thereof, promptly upon request of any Purchaser. The Company shall take such
action as the Company shall reasonably determine is necessary in order to obtain
an exemption for, or to qualify the Securities for, sale to the Purchasers at
the Closing under applicable securities or “Blue Sky” laws of the states of the
United States, and shall provide evidence of such actions promptly upon request
of any Purchaser.
4.17 Capital
Changes. Until the one year anniversary of the Effective Date,
the Company shall not undertake a reverse stock split or reclassification of the
Common Stock without the prior written consent of the Purchasers holding a
majority in interest of the shares of Preferred Stock; provided, however, this Section
4.17 shall not apply solely in connection with any reverse stock split conducted
to maintain compliance with listing standards of the Trading
Market.
4.18 Most Favored Nation
Provision. From the first date hereafter on which no shares of Series B
Preferred are outstanding until the earlier of (a) the date when such Purchaser
no longer holds any Preferred Stock and (b) the three year anniversary of the
date hereof, if the Company effects a Subsequent Financing, each Purchaser may
elect, in its sole discretion, to exchange all or some of the Preferred Stock
(but not the Warrants) then held by such Purchaser for such preferred stock or
debt issued in a Subsequent Financing on the basis of a $0.90 in stated value or
principal amount, as applicable, of such preferred stock or debt for each $1.00
of outstanding Stated Value of the Preferred Stock, along with any liquidated
damages and other amounts then due and owing thereon. By way of example, if the
Company undertakes a Subsequent Financing of convertible debentures and
warrants, each Purchaser shall have the right to participate in such Subsequent
Financing and use the exchange of its Preferred Stock (but not the Warrants) as
consideration for purchase of the debentures (but not the warrants), on a $1.00
for $0.90 basis, as described above, in lieu of cash
consideration. The Company shall provide prior written notice of any
such Subsequent Financing in the manner set forth in Section
4.12. Notwithstanding the foregoing, this Section 4.18 shall not
apply in respect of an Exempt Issuance.
4.19 Sinking Fund. If the
Company (a) receives any cash funds from fees, royalties or revenues as a result
of the license of any of the Intellectual Property, after the Company fulfills
all of the obligations to the Cleveland Clinic Foundation as set forth on Schedule 4.19
attached hereto (such net proceeds the “IP Proceeds”), (b)
pursuant to awards made after the date hereof, receives cash funds
from development grants from any government agency for the development of (i)
anti-cancer applications for any of the Company’s curaxin compounds or (ii)
anti-cancer or biodefense applications for the Company’s CBLB502 compound (the
“Governmental
Grant Proceeds”), or (c) shall determine, in its sole
discretion, to allocate cash proceeds to the Escrow Account (as defined below)
(the “Company
Allocation”), then the Company shall deposit, into a segregated escrow
account to be in the name of “Cleveland BioLabs, Inc., Sinking Fund Account” and
managed by Key Bank, with an address of 50 Fountain Plaza, 17th Floor,
Buffalo, New York 14202 (such account, the “Escrow Account” and
such escrow agent, “Key Bank”), (i) 40%
of the IP Proceeds, (ii) 20% of the Governmental Grant Proceeds and (iii) the
Company Allocation (collectively, (i), (ii) and (iii), the “Sinking Fund”). The
Company shall use the Sinking Fund solely for the purpose of a Sinking Fund
Redemption or Sinking Fund Conversion (as defined in the Certificate of
Designation).
ARTICLE
V.
MISCELLANEOUS
5.1 Termination.
This Agreement may be terminated by any Purchaser, as to such Purchaser’s
obligations hereunder only and without any effect whatsoever on the obligations
between the Company and the other Purchasers, by written notice to the other
parties, if the initial Closing has not been consummated on or before February
27, 2009; provided, however, that such
termination will not affect the right of any party to sue for any breach by the
other party (or parties).
5.2 Fees and
Expenses. At the Closing, the Company has agreed to reimburse
the Placement Agent the non-accountable sum of $50,000 for its legal fees and
expenses, $10,000 of which has been paid prior to the Closing. The
Company shall deliver to each Purchaser, prior to the Closing, a completed and
executed copy of the Closing Statement, attached hereto as Annex
A. Except as expressly set forth in the Transaction Documents
to the contrary, each party shall pay the fees and expenses of its advisers,
counsel, accountants and other experts, if any, and all other expenses incurred
by such party incident to the negotiation, preparation, execution, delivery and
performance of this Agreement. The Company shall pay all Transfer
Agent fees, stamp taxes and other taxes and duties levied in connection with the
delivery of any Securities to the Purchasers (other than taxes on income,
profits or revenues of any Purchaser).
5.3 Entire
Agreement. The Transaction Documents, together with the
exhibits and schedules thereto, contain the entire understanding of the parties
with respect to the subject matter hereof and supersede all prior agreements and
understandings, oral or written, with respect to such matters, which the parties
acknowledge have been merged into such documents, exhibits and
schedules.
5.4 Notices. Any
and all notices or other communications or deliveries required or permitted to
be provided hereunder shall be in writing and shall be deemed given and
effective on the earliest of: (a) the date of transmission, if such notice or
communication is delivered via facsimile at the facsimile number set forth on
the signature pages attached hereto prior to 5:30 p.m. (New York City time) on a
Trading Day, (b) the next Trading Day after the date of transmission, if such
notice or communication is delivered via facsimile at the facsimile number set
forth on the signature pages attached hereto on a day that is not a Trading Day
or later than 5:30 p.m. (New York City time) on any Trading Day, (c) the second
(2nd) Trading
Day following the date of mailing, if sent by U.S. nationally recognized
overnight courier service or (d) upon actual receipt by the party to whom such
notice is required to be given. The address for such notices and
communications shall be as set forth on the signature pages attached
hereto.
5.5 Amendments;
Waivers. Prior to Closing, no provision of this Agreement may
be waived, modified, supplemented or amended except in a written instrument
signed, in the case of an amendment, by the Company and the Purchasers obligated
to purchase at least 67% of the Preferred Stock or, in the case of a waiver, by
the party against whom enforcement of any such waived provision is sought. After
the Closing, no provision of this Agreement may be waived, modified,
supplemented or amended except in a written instrument signed, in the case of an
amendment, by the Company and the Purchasers holding at least 67% of the
outstanding Preferred Stock or, in the case of a waiver, by the party against
whom enforcement of any such waived provision is sought. No waiver of
any default with respect to any provision, condition or requirement of this
Agreement shall be deemed to be a continuing waiver in the future or a waiver of
any subsequent default or a waiver of any other provision, condition or
requirement hereof, nor shall any delay or omission of any party to exercise any
right hereunder in any manner impair the exercise of any such
right.
5.6 Headings. The
headings herein are for convenience only, do not constitute a part of this
Agreement and shall not be deemed to limit or affect any of the provisions
hereof.
5.7 Successors and
Assigns. This Agreement shall be binding upon and inure to the
benefit of the parties and their successors and permitted
assigns. The Company may not assign this Agreement or any rights or
obligations hereunder without the prior written consent of each Purchaser (other
than by merger). Prior to the Closing Date, no Purchaser may assign
any or all of its rights under this Agreement to any Person without the prior
written consent of the Company. After the Closing Date, any Purchaser may assign
any or all of its rights under this Agreement to any Person to whom such
Purchaser assigns or transfers any Securities (subject to Section 4.1), provided
that such transferee agrees in writing to be bound, with respect to the
transferred Securities, by the provisions of the Transaction Documents that
apply to the “Purchasers” and otherwise complies with Section 4.1
hereof.
5.8 No Third-Party
Beneficiaries. This Agreement is intended for the benefit of
the parties hereto and their respective successors and permitted assigns and is
not for the benefit of, nor may any provision hereof be enforced by, any other
Person, except as otherwise set forth in Section 4.10.
5.9 Governing
Law. All questions concerning the construction, validity,
enforcement and interpretation of the Transaction Documents shall be governed by
and construed and enforced in accordance with the internal laws of the State of
New York, without regard to the principles of conflicts of law
thereof. Each party agrees that all legal proceedings concerning the
interpretations, enforcement and defense of the transactions contemplated by
this Agreement and any other Transaction Documents (whether brought against a
party hereto or its respective affiliates, directors, officers, stockholders,
employees or agents) shall be commenced exclusively in the state and federal
courts sitting in the City of New York, Borough of Manhattan. Each
party hereby irrevocably submits to the exclusive jurisdiction of the state and
federal courts sitting in the City of New York for the adjudication of any
dispute hereunder or in connection herewith or with any transaction contemplated
hereby or discussed herein (including with respect to the enforcement of any of
the Transaction Documents), and hereby irrevocably waives, and agrees not to
assert in any suit, action or proceeding, any claim that it is not personally
subject to the jurisdiction of any such court, that such suit, action or
proceeding is improper or is an inconvenient venue for such
proceeding. Each party hereby irrevocably waives personal service of
process and consents to process being served in any such suit, action or
proceeding by mailing a copy thereof via registered or certified mail or
overnight delivery (with evidence of delivery) to such party at the address in
effect for notices to it under this Agreement and agrees that such service shall
constitute good and sufficient service of process and notice
thereof. Nothing contained herein shall be deemed to limit in any way
any right to serve process in any other manner permitted by law. If
any party shall commence an action or proceeding to enforce any provisions of
the Transaction Documents, then the prevailing party in such action or
proceeding shall be reimbursed by the other party for its reasonable attorneys’
fees and other costs and expenses incurred with the investigation, preparation
and prosecution of such action or proceeding.
5.10 Survival. The
representations and warranties contained herein shall survive the Closing and
the delivery of the Securities for the applicable statute of
limitations.
5.11 Execution. This
Agreement may be executed in two or more counterparts, all of which when taken
together shall be considered one and the same agreement and shall become
effective when counterparts have been signed by each party and delivered to the
other party, it being understood that both parties need not sign the same
counterpart. In the event that any signature is delivered by
facsimile transmission or by e-mail delivery of a “.pdf” format data file, such
signature shall create a valid and binding obligation of the party executing (or
on whose behalf such signature is executed) with the same force and effect as if
such facsimile or “.pdf” signature page were an original thereof.
5.12 Severability. If
any term, provision, covenant or restriction of this Agreement is held by a
court of competent jurisdiction to be invalid, illegal, void or unenforceable,
the remainder of the terms, provisions, covenants and restrictions set forth
herein shall remain in full force and effect and shall in no way be affected,
impaired or invalidated, and the parties hereto shall use their commercially
reasonable efforts to find and employ an alternative means to achieve the same
or substantially the same result as that contemplated by such term, provision,
covenant or restriction. It is hereby stipulated and declared to be the
intention of the parties that they would have executed the remaining terms,
provisions, covenants and restrictions without including any of such that may be
hereafter declared invalid, illegal, void or unenforceable.
5.13 Rescission and Withdrawal
Right. Notwithstanding anything to the contrary contained in
(and without limiting any similar provisions of) any of the other Transaction
Documents, whenever any Purchaser exercises a right, election, demand or option
under a Transaction Document and the Company does not timely perform its related
obligations within the periods therein provided, then such Purchaser may rescind
or withdraw, in its sole discretion from time to time upon written notice to the
Company, any relevant notice, demand or election in whole or in part without
prejudice to its future actions and rights; provided, however, that in the
case of a rescission of a conversion of the Preferred Stock or exercise of a
Warrant, the Purchaser shall be required to return any shares of Common Stock
subject to any such rescinded conversion or exercise notice.
5.14 Replacement of
Securities. If any certificate or instrument evidencing any
Securities is mutilated, lost, stolen or destroyed, the Company shall issue or
cause to be issued in exchange and substitution for and upon cancellation
thereof (in the case of mutilation), or in lieu of and substitution therefor, a
new certificate or instrument, but only upon receipt of evidence reasonably
satisfactory to the Company of such loss, theft or destruction. The
applicant for a new certificate or instrument under such circumstances shall
also execute a customary affidavit and pay any reasonable third-party costs
(including customary indemnity, and bond, if required by the Transfer Agent)
associated with the issuance of such replacement Securities.
5.15 Remedies. In
addition to being entitled to exercise all rights provided herein or granted by
law, including recovery of damages, each of the Purchasers and the Company will
be entitled to specific performance under the Transaction
Documents. The parties agree that monetary damages may not be
adequate compensation for any loss incurred by reason of any breach of
obligations contained in the Transaction Documents and hereby agree to waive and
not to assert in any action for specific performance of any such obligation the
defense that a remedy at law would be adequate.
5.16 Payment Set Aside. To
the extent that the Company makes a payment or payments to any Purchaser
pursuant to any Transaction Document or a Purchaser enforces or exercises its
rights thereunder, and such payment or payments or the proceeds of such
enforcement or exercise or any part thereof are subsequently invalidated,
declared to be fraudulent or preferential, set aside, recovered from, disgorged
by or are required to be refunded, repaid or otherwise restored to the Company,
a trustee, receiver or any other person under any law (including, without
limitation, any bankruptcy law, state or federal law, common law or equitable
cause of action), then to the extent of any such restoration the obligation or
part thereof originally intended to be satisfied shall be revived and continued
in full force and effect as if such payment had not been made or such
enforcement or setoff had not occurred.
5.17 Usury. To
the extent it may lawfully do so, the Company hereby agrees not to insist upon
or plead or in any manner whatsoever claim, and will resist any and all efforts
to be compelled to take the benefit or advantage of, usury laws wherever
enacted, now or at any time hereafter in force, in connection with any claim,
action or proceeding that may be brought by any Purchaser in order to enforce
any right or remedy under any Transaction Document. Notwithstanding
any provision to the contrary contained in any Transaction Document, it is
expressly agreed and provided that the total liability of the Company under the
Transaction Documents for payments in the nature of interest shall not exceed
the maximum lawful rate authorized under applicable law (the “Maximum Rate”), and,
without limiting the foregoing, in no event shall any rate of interest or
default interest, or both of them, when aggregated with any other sums in the
nature of interest that the Company may be obligated to pay under the
Transaction Documents exceed such Maximum Rate. It is agreed that if
the maximum contract rate of interest allowed by law and applicable to the
Transaction Documents is increased or decreased by statute or any official
governmental action subsequent to the date hereof, the new maximum contract rate
of interest allowed by law will be the Maximum Rate applicable to the
Transaction Documents from the effective date thereof forward, unless such
application is precluded by applicable law. If under any
circumstances whatsoever, interest in excess of the Maximum Rate is paid by the
Company to any Purchaser with respect to indebtedness evidenced by the
Transaction Documents, such excess shall be applied by such Purchaser to the
unpaid principal balance of any such indebtedness or be refunded to the Company,
the manner of handling such excess to be at such Purchaser’s election (unless
prohibited by law).
5.18 Independent Nature of
Purchasers’ Obligations and Rights. The obligations of each
Purchaser under any Transaction Document are several and not joint with the
obligations of any other Purchaser, and no Purchaser shall be responsible in any
way for the performance or non-performance of the obligations of any other
Purchaser under any Transaction Document. Nothing contained herein or
in any other Transaction Document, and no action taken by any Purchaser pursuant
thereto, shall be deemed to constitute the Purchasers as a partnership, an
association, a joint venture or any other kind of entity, or create a
presumption that the Purchasers are in any way acting in concert or as a group
with respect to such obligations or the transactions contemplated by the
Transaction Documents. Each Purchaser shall be entitled to
independently protect and enforce its rights, including, without limitation, the
rights arising out of this Agreement or out of the other Transaction Documents,
and it shall not be necessary for any other Purchaser to be joined as an
additional party in any proceeding for such purpose. Each Purchaser
has been represented by its own separate legal counsel in their review and
negotiation of the Transaction Documents. For reasons of
administrative convenience only, Purchasers and their respective counsel have
chosen to communicate with the Company through FWS. FWS does not
represent all of the Purchasers but only the Placement Agent. The
Company has elected to provide all Purchasers with the same terms and
Transaction Documents for the convenience of the Company and not because it was
required or requested to do so by the Purchasers.
5.19 Liquidated
Damages. The Company’s obligations to pay any partial
liquidated damages or other amounts owing under the Transaction Documents is a
continuing obligation of the Company and shall not terminate until all unpaid
partial liquidated damages and other amounts have been paid notwithstanding the
fact that the instrument or security pursuant to which such partial liquidated
damages or other amounts are due and payable shall have been
canceled.
5.20 Saturdays, Sundays,
Holidays, etc. If the last or appointed day for the taking of any
action or the expiration of any right required or granted herein shall not be a
Business Day, then such action may be taken or such right may be exercised on
the next succeeding Business Day.
5.21 Construction. The
parties agree that each of them and/or their respective counsel has reviewed and
had an opportunity to revise the Transaction Documents and, therefore, the
normal rule of construction to the effect that any ambiguities are to be
resolved against the drafting party shall not be employed in the interpretation
of the Transaction Documents or any amendments hereto. In addition, each and
every reference to share prices in any Transaction Document shall be subject to
adjustment for reverse and forward stock splits, stock dividends, stock
combinations and other similar transactions of the Common Stock that occur after
the date of this Agreement.
5.22 WAIVER OF
JURY TRIAL. IN ANY ACTION, SUIT, OR
PROCEEDING IN ANY JURISDICTION BROUGHT BY ANY PARTY AGAINST ANY OTHER PARTY, THE
PARTIES EACH KNOWINGLY AND INTENTIONALLY, TO THE GREATEST EXTENT PERMITTED BY
APPLICABLE LAW, HEREBY ABSOLUTELY, UNCONDITIONALLY, IRREVOCABLY AND EXPRESSLY
WAIVES FOREVER TRIAL BY JURY.
(Signature
Pages Follow)
IN
WITNESS WHEREOF, the parties hereto have caused this Securities Purchase
Agreement to be duly executed by their respective authorized signatories as of
the date first indicated above.
CLEVELAND
BIOLABS, INC.
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Address for Notice:
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73
High Street
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Buffalo,
NY 14203
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By:
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/s/
Michael Fonstein
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Fax:
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Name:
Michael Fonstein
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Title:
President and Chief Executive Officer
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With
a copy to (which shall not constitute notice):
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Katten
Muchin Rosenman LLP
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525
West Monroe Street, Suite 1900
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Chicago,
IL 60661
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Attention:
Ram Padmanabhan
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[REMAINDER
OF PAGE INTENTIONALLY LEFT BLANK
SIGNATURE
PAGE FOR PURCHASER FOLLOWS]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Jan Arnett
Signature of Authorized Signatory of
Purchaser: /s/ Jan Arnett
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $50,000
Shares of
Preferred Stock: 5
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Berdon Ventures LLC
Signature of Authorized Signatory of
Purchaser: /s/ Frederick Berdon
Name of
Authorized Signatory: Frederick Berdon
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $300,000
Shares of
Preferred Stock: 30
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Guy Michael Dart
Signature of Authorized Signatory of
Purchaser: /s/ Guy Michael Dart
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $50,000
Shares of
Preferred Stock: 5
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Michael N. Emmerman
Signature of Authorized Signatory of
Purchaser: /s/ Michael N. Emmerman
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $180,000
Shares of
Preferred Stock: 18
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Jonathan Kamen
Signature of Authorized Signatory of
Purchaser: /s/ Jonathan Kamen
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $100,000
Shares of
Preferred Stock: 10
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Lindsay E. Dart Separate Property Trust
Signature of Authorized Signatory of
Purchaser: /s/ Lindsay Dart Lincoln
Name of
Authorized Signatory: Lindsay Dart Lincoln
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $50,000
Shares of
Preferred Stock: 5
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Richard and Arline McGowan, JTWROS
Signature of Authorized Signatory of
Purchaser: /s/ Richard S. McGowan /s/
Arline McGowan
Name of
Authorized Signatory: Richard S. McGowan / Arline
McGowan
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $370,000
Shares of
Preferred Stock: 37
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Martin H. Meyerson
Signature of Authorized Signatory of
Purchaser: /s/ Martin H. Meyerson
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $50,000
Shares of
Preferred Stock: 5
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: William F. Quirk, Jr.
Signature of Authorized Signatory of
Purchaser: /s/ William F. Quirk, Jr.
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $100,000
Shares of
Preferred Stock: 10
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Stuart Schapiro Keough
Signature of Authorized Signatory of
Purchaser: /s/ Stuart Schapiro
Name of
Authorized Signatory: Stuart Schapiro
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $50,000
Shares of
Preferred Stock: 5
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Lorin Wels
Signature of Authorized Signatory of
Purchaser: /s/ Lorin Wels
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $101,750
Shares of
Preferred Stock: 10.18
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Iroquois Master Fund Ltd.
Signature of Authorized Signatory of
Purchaser: /s/ Joshua Silverman
Name of
Authorized Signatory: Joshua Silverman
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $100,000
Shares of
Preferred Stock: 10
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Greenwich Growth Fund Limited
Signature of Authorized Signatory of
Purchaser: /s/ J.P. Furey
Name of
Authorized Signatory: J.P. Furey
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $100,000
Shares of
Preferred Stock: 10
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Cranshire Capital LP
Signature of Authorized Signatory of
Purchaser: /s/ Keith Goodman
Name of
Authorized Signatory: Keith Goodman
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $100,000
Shares of
Preferred Stock: 10
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Marschall–Cook–Critchley Family Ventures,
F.L.P.
Signature of Authorized Signatory of
Purchaser: /s/ Harry Critchley
Name of
Authorized Signatory: Harry Critchley
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $25,000
Shares of
Preferred Stock: 2.5
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: George L. Black Jr. Trust
Signature of Authorized Signatory of
Purchaser: /s/ George L. Black, Jr.
Name of
Authorized Signatory: George L. Black, Jr.
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $20,000
Shares of
Preferred Stock: 2
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Brad DeHaan
Signature of Authorized Signatory of
Purchaser: /s/ Brad DeHaan
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $9,250
Shares of
Preferred Stock: 0.93
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Frank C. Heyman
Signature of Authorized Signatory of
Purchaser: /s/ Frank C. Heyman
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $25,900
Shares of
Preferred Stock: 2.59
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Michael Silver and Lori Silver JT TEN
Signature of Authorized Signatory of
Purchaser: /s/ Michael Silver /s/ Lori
Silver
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $20,000
Shares of
Preferred Stock: 2
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Steven E. Slawson
Signature of Authorized Signatory of
Purchaser: /s/ Steven E. Slawson
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $50,000
Shares of
Preferred Stock: 5
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Old Kings Capital LP
Signature of Authorized Signatory of
Purchaser: /s/ Peter J. Gavey
Name of
Authorized Signatory: Peter J. Gavey
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $39,629
Shares of
Preferred Stock: 3.96
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Zanett Opportunity Fund Ltd.
Signature of Authorized Signatory of
Purchaser: /s/ Gianfranco Cicogna
Name of
Authorized Signatory: Gianfranco Cicogna
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $100,000
Shares of
Preferred Stock: 10
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Robert Brous
Signature of Authorized Signatory of
Purchaser: /s/ Robert Brous
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $40,000
Shares of
Preferred Stock: 4
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: CRCK, LLC
Signature of Authorized Signatory of
Purchaser: /s/ Maria Lamari Burden
Name of
Authorized Signatory: Maria Lamari Burden
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $1,000,000
Shares of
Preferred Stock: 100
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Entrust NE FBO Walter Schenker A/C 1374
Signature of Authorized Signatory of
Purchaser: /s/ Jennifer N. Bzik
Name of
Authorized Signatory: Jennifer N. Bzik
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $50,000
Shares of
Preferred Stock: 5
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: James W. Harpel
Signature of Authorized Signatory of
Purchaser: /s/ James W. Harpel
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $300,000
Shares of
Preferred Stock: 30
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Susan Schenker
Signature of Authorized Signatory of
Purchaser: /s/ Susan Schenker
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $50,000
Shares of
Preferred Stock: 5
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Walter Schenker
Signature of Authorized Signatory of
Purchaser: /s/ Walter Schenker
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $50,000
Shares of
Preferred Stock: 5
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Jed F. Fisher
Signature of Authorized Signatory of
Purchaser: /s/ Jed F. Fisher
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $12,500.10
Shares of
Preferred Stock: 1.25
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: William F. Quirk Jr.
Signature of Authorized Signatory of
Purchaser: /s/ William F. Quirk Jr.
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $100,000
Shares of
Preferred Stock: 10
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Ronald Lukas
Signature of Authorized Signatory of
Purchaser: /s/ Ronald Lukas
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $83,000
Shares of
Preferred Stock: 8.3
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: J.S.A. Investments, LLC
Signature of Authorized Signatory of
Purchaser: /s/ Joelle A. Meyerson
Name of
Authorized Signatory: Joelle A. Meyerson
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $50,000
Shares of
Preferred Stock: 5
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: TCMP3 Partners
Signature of Authorized Signatory of
Purchaser: /s/ Walter Schenker
Name of
Authorized Signatory: Walter Schenker
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $150,000
Shares of
Preferred Stock: 15
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Frank Decarolis IRA FCC as Custodian
Signature of Authorized Signatory of
Purchaser: /s/ First Clearing LLC
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $20,000
Shares of
Preferred Stock: 2
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Robert H. Cohen
Signature of Authorized Signatory of
Purchaser: /s/ Robert H. Cohen
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $500,000
Shares of
Preferred Stock: 50
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: John G. Manos Living Trust U/A/D – 7/21/04
Signature of Authorized Signatory of
Purchaser: /s/ John Manos /s/ Dorothy
Mason
Name of
Authorized Signatory: John Manos / Dorothy Mason
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $35,000
Shares of
Preferred Stock: 3.5
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Guy Michael Dart
Signature of Authorized Signatory of
Purchaser: /s/ Guy Michael Dart
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $25,000
Shares of
Preferred Stock: 2.5
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Vertical Partners LP
Signature of Authorized Signatory of
Purchaser: /s/ Peter J. Gavey
Name of
Authorized Signatory: Peter J. Gavey
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $107,278
Shares of
Preferred Stock: 10.73
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Jan Arnett
Signature of Authorized Signatory of
Purchaser: /s/ Jan Arnett
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $25,000
Shares of
Preferred Stock: 2.5
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Martin H. Meyerson
Signature of Authorized Signatory of
Purchaser: /s/ Martin H. Meyerson
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $50,000
Shares of
Preferred Stock: 5
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Philip Patt and Maxine Patt JTWROS
Signature of Authorized Signatory of
Purchaser: /s/ Philip Patt /s/ Maxine
Patt
Name of
Authorized Signatory: Philip Patt and Maxine Patt
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $50,000
Shares of
Preferred Stock: 5.00
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Lindsay Dart Lincoln TTEE, Lindsay E. Dart Separate
Property Trust
Signature of Authorized Signatory of
Purchaser: /s/ Lindsay Dart Lincoln
Name of
Authorized Signatory: Lindsay Dart Lincoln
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $25,000
Shares of
Preferred Stock: 2.50
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Cranshire Capital LP
Signature of Authorized Signatory of
Purchaser: /s/ Mitchell Kopin
Name of
Authorized Signatory: Mitchell Kopin
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $100,000
Shares of
Preferred Stock: 10.00
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Philip Patt and Maxine Patt JTWROS
Signature of Authorized Signatory of
Purchaser: /s/ Philip Patt /s/ Maxine
Patt
Name of
Authorized Signatory: Philip Patt and Maxine Patt
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $50,000
Shares of
Preferred Stock: 5.00
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Thomas R. Ulie
Signature of Authorized Signatory of
Purchaser: /s/ Thomas R. Ulie
Name of
Authorized Signatory: Thomas R. Ulie
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $150,000
Shares of
Preferred Stock: 15.00
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: William F. Quirk Jr.
Signature of Authorized Signatory of
Purchaser: /s/ William F. Quirk Jr.
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $100,000
Shares of
Preferred Stock: 10
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Miriam Koryn
Signature of Authorized Signatory of
Purchaser: /s/ Miriam Koryn
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $50,000
Shares of
Preferred Stock: 5
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: Michael B. Pisani
Signature of Authorized Signatory of
Purchaser: /s/ Michael B. Pisani
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $14,000
Shares of
Preferred Stock: 1.4
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
[PURCHASER
SIGNATURE PAGES TO CBLI SECURITIES PURCHASE AGREEMENT]
IN
WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement
to be duly executed by their respective authorized signatories as of the date
first indicated above.
Name of
Purchaser: James W. Harpel
Signature of Authorized Signatory of
Purchaser: /s/ James W. Harpel
Name of
Authorized Signatory:
Title of
Authorized Signatory: _____________________________________
Email
Address of Authorized Signatory:
___________________________________________
Facsimile
Number of Authorized Signatory:
_________________________________________
Address
for Notice of Purchaser:
Address
for Delivery of Securities for Purchaser (if not same as address for
notice):
Subscription
Amount: $250,000
Shares of
Preferred Stock: 25
Warrant
Shares:
EIN
Number:
[PERSONAL
INFORMATION OMITTED]
Annex
A
CLOSING
STATEMENT
Pursuant
to the attached Securities Purchase Agreement, dated as of the date hereto, the
purchasers shall purchase up to $13,000,000 of Preferred Stock and Warrants from
Cleveland BioLabs, Inc., a Delaware corporation (the “Company”). All
funds will be wired into an account maintained by the Escrow
Agent. All funds will be disbursed in accordance with this Closing
Statement.
Disbursement Date:
__________,
2009
|
|
|
|
I. PURCHASE
PRICE
|
|
|
|
|
|
Gross
Proceeds to be Received
|
$
|
|
|
II.
DISBURSEMENTS
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
Total
Amount Disbursed:
|
$
|
|
|
WIRE INSTRUCTIONS:
|
|
|
|
To:
_____________________________________
|
|
To:
_____________________________________
|
|
REGISTRATION
RIGHTS AGREEMENT
This Registration Rights Agreement
(this “Agreement”) is made
and entered into as of ________, 2009, between Cleveland BioLabs, Inc., a
Delaware corporation (the “Company”), and each
of the several purchasers signatory hereto (each such purchaser, a “Purchaser” and,
collectively, the “Purchasers”).
This Agreement is made pursuant to the
Securities Purchase Agreement, dated as of the date hereof, between the Company
and each Purchaser (the “Purchase
Agreement”).
The Company and each Purchaser hereby
agrees as follows:
Capitalized terms used and not
otherwise defined herein that are defined in the Purchase Agreement shall have
the meanings given such terms in the Purchase Agreement. As used in this
Agreement, the following terms shall have the following meanings:
“Advice” shall have
the meaning set forth in Section 6(d).
“Effectiveness Date”
means, with respect to the Initial Registration Statement required to be filed
hereunder, the 90th
calendar day following the earlier of the (a) actual Stockholder Approval Date
and (b) Required Stockholder Approval Date (or, in the event of a “full review”
by the Commission, the 180th
calendar day following the earlier of the (a) actual Stockholder Approval Date
and (b) Required Stockholder Approval Date) and with respect to any additional
Registration Statements which may be required pursuant to Section 3(c), the
60th
calendar day following the date on which an additional Registration Statement is
required to be filed hereunder; provided, however, that in the
event the Company is notified by the Commission that one or more of the above
Registration Statements will not be reviewed or is no longer subject to further
review and comments, the Effectiveness Date as to such Registration Statement
shall be the fifth Trading Day following the date on which the Company is so
notified if such date precedes the dates otherwise required above.
“Effectiveness Period”
shall have the meaning set forth in Section 2(a).
“Event” shall have the
meaning set forth in Section 2(b).
“Event Date” shall
have the meaning set forth in Section 2(b).
“Filing Date” means,
with respect to the Initial Registration Statement required hereunder, the
30th
calendar day following the earlier of the (a) actual Stockholder Approval Date
and (b) Required Stockholder Approval Date and, with respect to any additional
Registration Statements which may be required pursuant to Section 3(c), the
earliest practical date on which the Company is permitted by SEC Guidance to
file such additional Registration Statement related to the Registrable
Securities.
“Holder” or “Holders” means the
holder or holders, as the case may be, from time to time of Registrable
Securities.
“Indemnified Party”
shall have the meaning set forth in Section 5(c).
“Indemnifying Party”
shall have the meaning set forth in Section 5(c).
“Initial Registration
Statement” means the initial Registration Statement filed pursuant to
this Agreement.
“Initial Shares” means
a number of Registrable Securities equal to the lesser of (i) the total number
of Registrable Securities and (ii) one-third of the number of issued and
outstanding shares of Common Stock that are held by non-Affiliates of the
Company on the day immediately prior to the filing date of the Initial
Registration Statement.
“Losses” shall have
the meaning set forth in Section 5(a).
“Plan of Distribution”
shall have the meaning set forth in Section 2(a).
“Prospectus” means the
prospectus included in a Registration Statement (including, without limitation,
a prospectus that includes any information previously omitted from a prospectus
filed as part of an effective registration statement in reliance upon Rule 430A
promulgated by the Commission pursuant to the Securities Act), as amended or
supplemented by any prospectus supplement, with respect to the terms of the
offering of any portion of the Registrable Securities covered by a Registration
Statement, and all other amendments and supplements to the Prospectus, including
post-effective amendments, and all material incorporated by reference or deemed
to be incorporated by reference in such Prospectus.
“Registrable
Securities” means, as of any date of determination, (a) all of the shares
of Common Stock then issuable upon conversion in full of the Preferred Stock
(assuming on such date the shares of Preferred Stock are converted in full
without regard to any conversion limitations therein), (b) all Warrant Shares
then issuable upon exercise of the Warrants (assuming on such date the Warrants
are exercised in full without regard to any exercise limitations therein), (c)
any additional shares of Common Stock issuable in connection with any
anti-dilution provisions in the Preferred Stock or the Warrants (in each case,
without giving effect to any limitations on conversion set forth in the
Certificate of Designation or limitations on exercise set forth in the Warrants)
and (d) any securities issued or then issuable upon any stock split, dividend or
other distribution, recapitalization or similar event with respect to
the foregoing; provided, however, that any
such Registrable Securities shall cease to be Registrable Securities (and the
Company shall not be required to maintain the effectiveness of any, or file
another, Registration Statement hereunder with respect thereto) for so long as
(a) a Registration Statement with respect to the sale of such Registrable
Securities is declared effective by the Commission under the Securities Act and
such Registrable Securities have been disposed of by the Holder in accordance
with such Registration Statement, (b) such Registrable Securities have been
previously sold in accordance with Rule 144, or (c) such securities become
eligible for resale without volume or manner-of-sale restrictions and without
current public information pursuant to Rule 144 as set forth in a written
opinion letter to such effect, addressed, delivered and acceptable to the
Transfer Agent and the affected Holders (assuming that such securities and any
securities issuable upon exercise, conversion or exchange of which, or as a
dividend upon which, such securities were issued or are issuable, were at no
time held by any Affiliate of the Company, and all Warrants are exercised by
“cashless exercise” as provided in Section 2(c) of each of the Warrants), as
reasonably determined by the Company, upon the advice of counsel to the
Company.
“Registration
Statement” means any registration statement required to be filed
hereunder pursuant to Section 2(a) and any additional registration statements
contemplated by Section 3(c), including (in each case) the Prospectus,
amendments and supplements to any such registration statement or Prospectus,
including pre- and post-effective amendments, all exhibits thereto, and all
material incorporated by reference or deemed to be incorporated by reference in
any such registration statement.
“Required Stockholder
Approval Date” means the 90th
calendar day following the date of termination or expiration of the offering of
the Securities pursuant to the Purchase Agreements.
“Rule 144” means Rule
144 promulgated by the Commission pursuant to the Securities Act, as such Rule
may be amended from time to time, or any similar rule or regulation hereafter
adopted by the Commission having substantially the same effect as such
Rule.
“Rule 415” means Rule
415 promulgated by the Commission pursuant to the Securities Act, as such Rule
may be amended or interpreted from time to time, or any similar rule or
regulation hereafter adopted by the Commission having substantially the same
purpose and effect as such Rule.
“Rule 424” means Rule
424 promulgated by the Commission pursuant to the Securities Act, as such Rule
may be amended or interpreted from time to time, or any similar rule or
regulation hereafter adopted by the Commission having substantially the same
purpose and effect as such Rule.
“Selling Stockholder
Questionnaire” shall have the meaning set forth in Section
3(a).
“SEC Guidance” means
(i) any publicly-available written or oral guidance of the Commission staff, or
any comments, requirements or requests of the Commission staff and (ii) the
Securities Act.
“Stockholder Approval
Date” means the date that the Company receives the Stockholder
Approval.
(a) On
or prior to each Filing Date, the Company shall prepare and file with the
Commission a Registration Statement covering the resale of all or such maximum
portion of the Registrable Securities as permitted by SEC Guidance (provided
that, the Company shall use diligent efforts to advocate with the Commission for
the registration of all of the Registrable Securities in accordance with the SEC
Guidance, including without limitation, the Manual of Publicly Available
Telephone Interpretations D.29) that are not then registered on an effective
Registration Statement for an offering to be made on a continuous basis pursuant
to Rule 415. Each Registration Statement filed hereunder shall be on
Form S-3 (except if the Company is not then eligible to register for resale the
Registrable Securities on Form S-3, in which case such registration shall be on
another appropriate form in accordance herewith) and shall contain (unless
otherwise directed by at least an 85% majority in interest of the Holders)
substantially the “Plan of Distribution”
attached hereto as Annex
A. Subject to the terms of this Agreement, the Company shall
use its reasonable best efforts to cause a Registration Statement filed
hereunder to be declared effective under the Securities Act as promptly as
reasonably possible after the filing thereof, but in any event prior to the
applicable Effectiveness Date, and shall use its reasonable best efforts to keep
such Registration Statement continuously effective under the Securities Act
until all Registrable Securities covered by such Registration Statement (i) have
been sold thereunder or pursuant to Rule 144, or (ii) (A) may be sold without
volume or manner-of-sale restrictions pursuant to Rule 144 and (B) (I) may be
sold without the requirement for the Company to be in compliance with the
current public information requirement under Rule 144 or (II) the Company is in
compliance with the current public information requirement under Rule 144, as
determined by the counsel to the Company pursuant to a written opinion letter to
such effect, addressed and acceptable to the Transfer Agent and the affected
Holders (the “Effectiveness
Period”). The Company shall telephonically request
effectiveness of a Registration Statement as of 5:00 p.m. New York City time on
a Trading Day. The Company shall immediately notify the Holders
via facsimile or by e-mail of the effectiveness of a Registration Statement on
the same Trading Day that the Company telephonically confirms effectiveness with
the Commission, which shall be the date requested for effectiveness of such
Registration Statement. The Company shall, by 9:30 a.m. New York City
time on the Trading Day after the effective date of such Registration Statement,
file a final Prospectus with the Commission as required by Rule
424. Failure to so notify the Holder within one (1) Trading Day of
such notification of effectiveness or failure to file a final Prospectus as
foresaid shall be deemed an Event under Section 2(b). Notwithstanding any other provision of this Agreement
and subject to the payment of liquidated
damages pursuant to Section 2(b), if any
SEC Guidance sets forth a limitation
on the number of Registrable Securities
permitted to be registered on a particular Registration Statement
(and notwithstanding that the Company used diligent efforts to
advocate with the Commission for the registration of all or a greater portion of Registrable
Securities), unless otherwise directed in writing by a Holder as to its
Registrable Securities, the number of Registrable Securities to be registered on
such Registration Statement will first be reduced by Registrable Securities
represented by Warrant Shares (applied, in the case that some Warrant Shares may
be registered, to the Holders on a pro rata basis based on the total number of
unregistered Warrant Shares held by such Holders), and second by Registrable
Securities represented by Conversion Shares
(applied, in the case that some
Conversion Shares may be registered, to the Holders on a pro rata
basis based on the total number of unregistered Conversion Shares
held by such Holders); provided, however, that, prior to any reduction in the number of
Registrable Securities included in a Registration Statement as set forth in this
sentence, all shares of Common Stock set forth on Schedule 6(b) hereto shall
be reduced first. In the event of a cutback
hereunder, the Company shall give the Holder at least 5 Trading Days prior
written notice along with the calculations as to such Holder’s
allotment.
(b) If:
(i) the Initial Registration Statement is not filed on or prior to its Filing
Date (if the Company files the Initial Registration Statement without affording
the Holders the opportunity to review and comment on the same as required by
Section 3(a) herein, the Company shall be deemed to have not satisfied this
clause (i)), or (ii) the Company fails to file with the Commission a request for
acceleration of a Registration Statement in accordance with Rule 461 promulgated
by the Commission pursuant to the Securities Act, within five Trading Days of
the date that the Company is notified (orally or in writing, whichever is
earlier) by the Commission that such Registration Statement will not be
“reviewed” or will not be subject to further review, or (iii) prior to the
effective date of a Registration Statement, the Company fails to file a
pre-effective amendment and otherwise respond in writing to comments made by the
Commission in respect of such Registration Statement within 20 Business Days
after the receipt of comments by or notice from the Commission that such
amendment is required in order for such Registration Statement to be declared
effective, or (iv) as to, in the aggregate among all Holders on a pro-rata basis
based on their purchase of the Securities pursuant to the Purchase Agreement, a
Registration Statement registering for resale all of the Initial Shares is not
declared effective by the Commission by the Effectiveness Date of the Initial
Registration Statement, or (v) after the effective date of a Registration
Statement, such Registration Statement ceases for any reason to remain
continuously effective as to all Registrable Securities included in such
Registration Statement, or the Holders are otherwise not permitted to utilize
the Prospectus therein to resell such Registrable Securities, for more than 15
consecutive calendar days or more than an aggregate of 30 calendar days (which
need not be consecutive calendar days) during any 12-month period, or (vi) the
Company shall fail for any reason to satisfy the current public information
requirement under Rule 144 as to the applicable Registrable Securities (any such
failure or breach being referred to as an “Event”, and for
purposes of clauses (i), (iv) and (vi), the date on which such Event occurs, and
for purpose of clause (ii) the date on which such five Trading Day period is
exceeded, and for purpose of clause (iii) the date which such 20 Business Day
period is exceeded, and for purpose of clause (v) the date on which such 15 or
30 calendar day period, as applicable, is exceeded being referred to as “Event Date”), then,
in addition to any other rights the Holders may have hereunder or under
applicable law, on each such Event Date and on each monthly anniversary of each
such Event Date (if the applicable Event shall not have been cured by such date)
until the applicable Event is cured, the Company shall pay to each Holder an
amount in cash, as partial liquidated damages and not as a penalty, equal to
1.0% of the aggregate purchase price paid by such Holder pursuant to the
Purchase Agreement for any unregistered Registrable Securities then held by such
Holder. The parties agree that (1) the Company shall not be liable
for liquidated damages under this Agreement with respect to any unexercised
Warrants or Warrant Shares and (2) the maximum aggregate liquidated damages
payable to a Holder under this Agreement shall be 15% of the aggregate
Subscription Amount paid by such Holder pursuant to the Purchase
Agreement. If the Company fails to pay any partial liquidated damages
pursuant to this Section in full within seven days after the date payable, the
Company will pay interest thereon at a rate of 18% per annum (or such lesser
maximum amount that is permitted to be paid by applicable law) to the Holder,
accruing daily from the date such partial liquidated damages are due until such
amounts, plus all such interest thereon, are paid in full. The partial
liquidated damages pursuant to the terms hereof shall apply on a daily pro rata
basis for any portion of a month prior to the cure of an Event.
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3.
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Registration
Procedures.
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In
connection with the Company’s registration obligations hereunder, the Company
shall:
(a) Not
less than five (5) Trading Days prior to the filing of each Registration
Statement and not less than one (1) Business Day prior to the filing of any
related Prospectus or any amendment or supplement thereto (including any
document that would be incorporated or deemed to be incorporated therein by
reference), the Company shall (i) furnish to each Holder copies of all such
documents proposed to be filed, which documents (other than those incorporated
or deemed to be incorporated by reference) will be subject to the review of such
Holders, and (ii) cause its officers and directors, counsel and independent
registered public accountants to respond to such inquiries as shall be
necessary, in the reasonable opinion of respective counsel to each Holder, to
conduct a reasonable investigation within the meaning of the Securities Act. The
Company shall not file a Registration Statement or any such Prospectus or any
amendments or supplements thereto to which the Holders of a majority of the
Registrable Securities shall reasonably object in good faith, provided that, the
Company is notified of such objection in writing no later than five (5) Trading
Days after the Holders have been so furnished copies of a Registration Statement
or one (1) Business Day after the Holders have been so furnished copies of any
related Prospectus or amendments or supplements thereto. Each Holder agrees to
furnish to the Company a completed questionnaire in the form attached to this
Agreement as Annex
B (a “Selling
Stockholder Questionnaire”) not later than the earlier of two (2)
Business Days prior to the Filing Date and the end of the third (3rd) Business
Day following the date on which such Holder receives draft materials in
accordance with this Section.
(b) (i)
Prepare and file with the Commission such amendments, including post-effective
amendments, to a Registration Statement and the Prospectus used in connection
therewith as may be necessary to keep a Registration Statement continuously
effective as to the applicable Registrable Securities for the Effectiveness
Period and prepare and file with the Commission such additional Registration
Statements in order to register for resale under the Securities Act all of the
Registrable Securities, (ii) cause the related Prospectus to be amended or
supplemented by any required Prospectus supplement (subject to the terms of this
Agreement), and, as so supplemented or amended, to be filed pursuant to Rule
424, (iii) respond as promptly as reasonably possible to any comments received
from the Commission with respect to a Registration Statement or any amendment
thereto and provide as promptly as reasonably possible to the Holders true and
complete copies of all correspondence from and to the Commission relating to a
Registration Statement (provided that, the Company may excise any information
contained therein which would constitute material non-public information as to
any Holder which has not executed a confidentiality agreement with respect
thereto with the Company), and (iv) comply in all material respects with the
applicable provisions of the Securities Act and the Exchange Act with respect to
the disposition of all Registrable Securities covered by a Registration
Statement during the applicable period in accordance (subject to the terms of
this Agreement) with the intended methods of disposition by the Holders thereof
set forth in such Registration Statement as so amended or in such Prospectus as
so supplemented.
(c) If
during the Effectiveness Period, the number of Registrable Securities at any
time exceeds 100% of the number of shares of Common Stock then registered in a
Registration Statement, then the Company shall file as soon as reasonably
practicable, but in any case prior to the applicable Filing Date, an additional
Registration Statement covering the resale by the Holders of not less than the
number of such Registrable Securities, subject to any SEC Guidance
setting forth a limitation on the number of
Registrable Securities permitted
to be registered on such additional Registration Statement.
(d) Notify
the Holders of Registrable Securities to be sold (which notice shall, pursuant
to clauses (iii) through (vi) hereof, be accompanied by an instruction to
suspend the use of the Prospectus until the requisite changes have been made) as
promptly as reasonably possible (and, in the case of (i)(A) below, not less than
one (1) Trading Day prior to such filing) and (if requested by any such Person)
confirm such notice in writing no later than one (1) Trading Day following the
day (i)(A) when a Prospectus or any Prospectus supplement or post-effective
amendment to a Registration Statement is proposed to be filed, (B) when the
Commission notifies the Company whether there will be a “review” of such
Registration Statement and whenever the Commission comments in writing on such
Registration Statement, and (C) with respect to a Registration Statement or any
post-effective amendment, when the same has become effective, (ii) of any
request by the Commission or any other federal or state governmental authority
for amendments or supplements to a Registration Statement or Prospectus or for
additional information, (iii) of the issuance by the Commission or any other
federal or state governmental authority of any stop order suspending the
effectiveness of a Registration Statement covering any or all of the Registrable
Securities or the initiation of any Proceedings for that purpose; (iv) of the
receipt by the Company of any notification with respect to the suspension of the
qualification or exemption from qualification of any of the Registrable
Securities for sale in any jurisdiction, or the initiation or threatening of any
Proceeding for such purpose, (v) of the occurrence of any event or passage of
time that makes the financial statements included in a Registration Statement
ineligible for inclusion therein or any statement made in a Registration
Statement or Prospectus or any document incorporated or deemed to be
incorporated therein by reference untrue in any material respect or that
requires any revisions to a Registration Statement, Prospectus or other
documents so that, in the case of a Registration Statement or the Prospectus, as
the case may be, it will not contain any untrue statement of a material fact or
omit to state any material fact required to be stated therein or necessary to
make the statements therein, in light of the circumstances under which they were
made, not misleading and (vi) of the occurrence or existence of any pending
corporate development with respect to the Company that the Company believes may
be material and that, in the determination of the Company, makes it not in the
best interest of the Company to allow continued availability of a Registration
Statement or Prospectus, provided that, any and all of such information shall
remain confidential to each Holder until such information otherwise becomes
public, unless disclosure by a Holder is required by law; provided, further, that
notwithstanding each Holder’s agreement to keep such information confidential,
each such Holder makes no acknowledgement that any such information is material,
non-public information.
(e) Use
its reasonable best efforts to avoid the issuance of, or, if issued, obtain the
withdrawal of (i) any order stopping or suspending the effectiveness of a
Registration Statement, or (ii) any suspension of the qualification (or
exemption from qualification) of any of the Registrable Securities for sale in
any jurisdiction, at the earliest practicable moment.
(f) Furnish
to each Holder, without charge, at least one conformed copy of each such
Registration Statement and each amendment thereto, including financial
statements and schedules, all documents incorporated or deemed to be
incorporated therein by reference to the extent requested by such Person, and
all exhibits to the extent requested by such Person (including those previously
furnished or incorporated by reference) promptly after the filing of such
documents with the Commission; provided, that any such item which is available
on the EDGAR system (or successor thereto) need not be furnished in
physical form.
(g) Subject
to the terms of this Agreement, the Company hereby consents to the use of such
Prospectus and each amendment or supplement thereto by each of the selling
Holders in connection with the offering and sale of the Registrable Securities
covered by such Prospectus and any amendment or supplement thereto, except after
the giving of any notice pursuant to Section 3(d).
(h)
The Company shall cooperate with any broker-dealer through which a Holder
proposes to resell its Registrable Securities in effecting a filing with the
FINRA Corporate Financing Department pursuant to NASD Rule 2710, as requested by
any such Holder, and the Company shall pay the filing fee required by such
filing within two (2) Business Days of request therefor.
(i) Prior
to any resale of Registrable Securities by a Holder, use its commercially
reasonable efforts to register or qualify or cooperate with the selling Holders
in connection with the registration or qualification (or exemption from the
Registration or qualification) of such Registrable Securities for the resale by
the Holder under the securities or Blue Sky laws of such jurisdictions within
the United States as any Holder reasonably requests in writing, to keep each
registration or qualification (or exemption therefrom) effective during the
Effectiveness Period and to do any and all other acts or things reasonably
necessary to enable the disposition in such jurisdictions of the Registrable
Securities covered by each Registration Statement; provided, that, the Company
shall not be required to qualify generally to do business in any jurisdiction
where it is not then so qualified, subject the Company to any material tax in
any such jurisdiction where it is not then so subject or file a general consent
to service of process in any such jurisdiction.
(j) If
requested by a Holder, cooperate with such Holder to facilitate the timely
preparation and delivery of certificates representing Registrable Securities to
be delivered to a transferee pursuant to a Registration Statement, which
certificates shall be free, to the extent permitted by the Purchase Agreement,
of all restrictive legends, and to enable such Registrable Securities to be in
such denominations and registered in such names as any such Holder may
request.
(k) Upon
the occurrence of any event contemplated by Section 3(d), as promptly as
reasonably possible under the circumstances taking into account the Company’s
good faith assessment of any adverse consequences to the Company and its
stockholders of the premature disclosure of such event, prepare a supplement or
amendment, including a post-effective amendment, to a Registration Statement or
a supplement to the related Prospectus or any document incorporated or deemed to
be incorporated therein by reference, and file any other required document so
that, as thereafter delivered, neither a Registration Statement nor such
Prospectus will contain an untrue statement of a material fact or omit to state
a material fact required to be stated therein or necessary to make the
statements therein, in light of the circumstances under which they were made,
not misleading. If the Company notifies the
Holders in accordance with clauses (iii) through (vi) of Section 3(d) above to
suspend the use of any Prospectus until the requisite changes to such Prospectus
have been made, then the Holders shall suspend use of such
Prospectus. The Company will use its reasonable best efforts to
ensure that the use of the Prospectus may be resumed as promptly as is
practicable. The Company shall be entitled to exercise its right
under this Section 3(k) to suspend the availability of a Registration Statement
and Prospectus, subject to the payment of partial liquidated damages otherwise
required pursuant to Section 2(b), for a period not to exceed 60 calendar days
(which need not be consecutive days) in any 12 month period.
(l) Comply
with all applicable rules and regulations of the Commission.
(m) The
Company may require each selling Holder to furnish to the Company a certified
statement as to the number of shares of Common Stock beneficially owned by such
Holder and, if required by the Commission, the natural persons thereof that have
voting and dispositive control over the shares. During any periods that the
Company is unable to meet its obligations hereunder or provide any other
information requested by the Commission with respect to the registration of the
Registrable Securities solely because any Holder fails to furnish such
information within three Trading Days of the Company’s request, any liquidated
damages that are accruing at such time as to such Holder only shall be tolled
and any Event that may otherwise occur solely because of such delay shall be
suspended as to such Holder only, until such information is delivered to the
Company.
4. Registration
Expenses. All fees and expenses incident to the performance of or
compliance with, this Agreement by the Company shall be borne by the Company
whether or not any Registrable Securities are sold pursuant to a Registration
Statement. The fees and expenses referred to in the foregoing sentence shall
include, without limitation, (i) all registration and filing fees (including,
without limitation, fees and expenses of the Company’s counsel and independent
registered public accountants) (A) with respect to filings made with the
Commission, (B) with respect to filings required to be made with any Trading
Market on which the Common Stock is then listed for trading, (C) in compliance
with applicable state securities or Blue Sky laws reasonably agreed to by the
Company in writing (including, without limitation, fees and disbursements of
counsel for the Company in connection with Blue Sky qualifications or exemptions
of the Registrable Securities) and (D) if not previously paid by the Company in
connection with an Issuer Filing, with respect to any filing that may be
required to be made by any broker through which a Holder intends to make sales
of Registrable Securities with the FINRA pursuant to NASD Rule 2710, so long as
the broker is receiving no more than a customary brokerage commission in
connection with such sale, (ii) printing expenses (including, without
limitation, expenses of printing certificates for Registrable Securities), (iii)
messenger, telephone and delivery expenses, (iv) fees and disbursements of
counsel for the Company, (v) Securities Act liability insurance, if the Company
so desires such insurance, and (vi) fees and expenses of all other Persons
retained by the Company in connection with the consummation of the transactions
contemplated by this Agreement. In addition, the Company shall be
responsible for all of its internal expenses incurred in connection with the
consummation of the transactions contemplated by this Agreement (including,
without limitation, all salaries and expenses of its officers and employees
performing legal or accounting duties), the expense of any annual audit and the
fees and expenses incurred in connection with the listing of the Registrable
Securities on any securities exchange as required hereunder. In no
event shall the Company be responsible for any broker or similar commissions of
any Holder or, except to the extent provided for in the Transaction Documents,
any legal fees or other costs of the Holders.
5. Indemnification.
(a) Indemnification by the
Company. The Company shall, notwithstanding any termination of this
Agreement, indemnify and hold harmless each Holder, the officers, directors,
members, partners, agents, brokers (including brokers who offer and sell
Registrable Securities as principal as a result of a pledge or any failure to
perform under a margin call of Common Stock), investment advisors and employees
(and any other Persons with a functionally equivalent role of a Person holding
such titles, notwithstanding a lack of such title or any other title) of each of
them, each Person who controls any such Holder (within the meaning of Section 15
of the Securities Act or Section 20 of the Exchange Act) and the officers,
directors, members, stockholders, partners, agents and employees (and any other
Persons with a functionally equivalent role of a Person holding such titles,
notwithstanding a lack of such title or any other title) of each such
controlling Person, to the fullest extent permitted by applicable law, from and
against any and all losses, claims, damages, liabilities, costs (including,
without limitation, reasonable attorneys’ fees) and expenses (collectively,
“Losses”), as
incurred, arising out of or relating to (1) any untrue or alleged untrue
statement of a material fact contained in a Registration Statement, any
Prospectus or any form of prospectus included in a Registration Statement, or in
any amendment or supplement thereto or in any preliminary prospectus included in
a Registration Statement, or arising out of or relating to any omission or
alleged omission of a material fact required to be stated therein or necessary
to make the statements therein (in the case of any Prospectus, form of
prospectus, preliminary prospectus or amendment or supplement thereto, in light
of the circumstances under which they were made) not misleading or (2) any
violation or alleged violation by the Company of the Securities Act, the
Exchange Act or any state securities law, or any rule or regulation thereunder,
in connection with the performance of its obligations under this Agreement,
except to the extent, but only to the extent, that (i) such untrue statements or
omissions are based solely upon information regarding such Holder furnished in
writing to the Company by such Holder expressly for use therein, or to the
extent that such information relates to such Holder or such Holder’s proposed
method of distribution of Registrable Securities and was reviewed and expressly
approved in writing by such Holder expressly for use in a Registration
Statement, such Prospectus, form of prospectus or preliminary prospectus or in
any amendment or supplement thereto (it being understood that the Holder has
approved Annex A hereto for this purpose) or (ii) in the case of an occurrence
of an event of the type specified in Section 3(d)(iii)-(vi), the use by such
Holder of an outdated, defective or otherwise unavailable Prospectus after the
Company has notified such Holder in writing that the Prospectus is outdated,
defective or otherwise unavailable for use by such Holder and prior to the
receipt by such Holder of the Advice contemplated in Section
6(d). The Company shall notify the Holders promptly of the
institution, threat or assertion of any Proceeding arising from or in connection
with the transactions contemplated by this Agreement of which the Company is
aware.
(b) Indemnification by
Holders. Each Holder shall, severally and not jointly, indemnify and hold
harmless the Company, its directors, officers, agents and employees, each Person
who controls the Company (within the meaning of Section 15 of the Securities Act
and Section 20 of the Exchange Act), and the directors, officers, agents or
employees of such controlling Persons, to the fullest extent permitted by
applicable law, from and against all Losses, as incurred, to the extent arising
out of or based solely upon: (x) such Holder’s failure to comply with the
prospectus delivery requirements of the Securities Act or (y) any untrue or
alleged untrue statement of a material fact contained in any Registration
Statement, any Prospectus, any form of prospectus included in a Registration
Statement or in any amendment or supplement thereto or in any preliminary
prospectus included in a Registration Statement, or arising out of or relating
to any omission or alleged omission of a material fact required to be stated
therein or necessary to make the statements therein not misleading (i) to the
extent, but only to the extent, that such untrue statement or omission is
contained in any information so furnished in writing by such Holder to the
Company specifically for inclusion in such Registration Statement or such
Prospectus, form of prospectus or preliminary prospectus or (ii) to the extent
that such information relates to such Holder’s proposed method of distribution
of Registrable Securities and was reviewed and expressly approved in writing by
such Holder expressly for use in a Registration Statement (it being understood
that the Holder has approved Annex A hereto for this purpose), such Prospectus,
form of prospectus or preliminary prospectus or in any amendment or supplement
thereto or (ii) in the case of an occurrence of an event of the type specified
in Section 3(d)(iii)-(vi), the use by such Holder of an outdated, defective or
otherwise unavailable Prospectus after the Company has notified such Holder in
writing that the Prospectus is outdated, defective or otherwise unavailable for
use by such Holder and prior to the receipt by such Holder of the Advice
contemplated in Section 6(d). In no event shall the liability of any selling
Holder under this Section 5(b) be greater in amount than the dollar amount of
the net proceeds received by such Holder upon the sale of the Registrable
Securities giving rise to such indemnification obligation.
(c) Conduct of Indemnification
Proceedings. If any Proceeding shall be brought or asserted against any
Person entitled to indemnity hereunder (an “Indemnified Party”),
such Indemnified Party shall promptly notify the Person from whom indemnity is
sought (the “Indemnifying Party”)
in writing, and the Indemnifying Party shall have the right to assume the
defense thereof, including the employment of counsel reasonably satisfactory to
the Indemnified Party and the payment of all fees and expenses incurred in
connection with defense thereof; provided, that, the failure of any Indemnified
Party to give such notice shall not relieve the Indemnifying Party of its
obligations or liabilities pursuant to this Agreement, except (and only) to the
extent that it shall be finally determined by a court of competent jurisdiction
(which determination is not subject to appeal or further review) that such
failure shall have prejudiced the Indemnifying Party.
An Indemnified Party shall have the
right to employ separate counsel in any such Proceeding and to participate in
the defense thereof, but the fees and expenses of such counsel shall be at the
expense of such Indemnified Party or Parties unless: (1) the
Indemnifying Party has agreed in writing to pay such fees and expenses, (2) the
Indemnifying Party shall have failed promptly to assume the defense of such
Proceeding and to employ counsel reasonably satisfactory to such Indemnified
Party in any such Proceeding, or (3) the named parties to any such Proceeding
(including any impleaded parties) include both such Indemnified Party and the
Indemnifying Party, and counsel to the Indemnified Party shall reasonably
believe that a material conflict of interest is likely to exist if the same
counsel were to represent such Indemnified Party and the Indemnifying Party (in
which case, if such Indemnified Party notifies the Indemnifying Party in writing
that it elects to employ separate counsel at the expense of the Indemnifying
Party, the Indemnifying Party shall not have the right to assume the defense
thereof and the reasonable fees and expenses of no more than one separate
counsel shall be at the expense of the Indemnifying Party). The
Indemnifying Party shall not be liable for any settlement of any such Proceeding
effected without its written consent, which consent shall not be unreasonably
withheld or delayed. No Indemnifying Party shall, without the prior
written consent of the Indemnified Party, effect any settlement of any pending
Proceeding in respect of which any Indemnified Party is a party, unless such
settlement includes an unconditional release of such Indemnified Party from all
liability on claims that are the subject matter of such
Proceeding.
Subject to the terms of this Agreement,
all reasonable fees and expenses of the Indemnified Party (including reasonable
fees and expenses to the extent incurred in connection with investigating or
preparing to defend such Proceeding in a manner not inconsistent with this
Section) shall be paid to the Indemnified Party, as incurred, within ten Trading
Days of written notice thereof to the Indemnifying Party; provided, that, the
Indemnified Party shall promptly reimburse the Indemnifying Party for that
portion of such fees and expenses applicable to such actions for which such
Indemnified Party is judicially determined not to be entitled to indemnification
hereunder.
(d) Contribution. If the
indemnification under Section 5(a) or 5(b) is unavailable to an Indemnified
Party or insufficient to hold an Indemnified Party harmless for any Losses, then
each Indemnifying Party shall contribute to the amount paid or payable by such
Indemnified Party, in such proportion as is appropriate to reflect the relative
fault of the Indemnifying Party and Indemnified Party in connection with the
actions, statements or omissions that resulted in such Losses as well as any
other relevant equitable considerations. The relative fault of such Indemnifying
Party and Indemnified Party shall be determined by reference to, among other
things, whether any action in question, including any untrue or alleged untrue
statement of a material fact or omission or alleged omission of a material fact,
has been taken or made by, or relates to information supplied by, such
Indemnifying Party or Indemnified Party, and the parties’ relative intent,
knowledge, access to information and opportunity to correct or prevent such
action, statement or omission. The amount paid or payable by a party
as a result of any Losses shall be deemed to include, subject to the limitations
set forth in this Agreement, any reasonable attorneys’ or other fees or expenses
incurred by such party in connection with any Proceeding to the extent such
party would have been indemnified for such fees or expenses if the
indemnification provided for in this Section was available to such party in
accordance with its terms.
The parties hereto agree that it would
not be just and equitable if contribution pursuant to this Section 5(d) were
determined by pro rata allocation or by any other method of allocation that does
not take into account the equitable considerations referred to in the
immediately preceding paragraph. Notwithstanding the provisions of
this Section 5(d), no Holder shall be required to contribute pursuant to this
Section 5(d), in the aggregate, any amount in excess of the amount by which the
net proceeds actually received by such Holder from the sale of the Registrable
Securities subject to the Proceeding exceeds the amount of any damages that such
Holder has otherwise been required to pay by reason of such untrue or alleged
untrue statement or omission or alleged omission.
The
indemnity and contribution agreements contained in this Section are in addition
to any liability that the Indemnifying Parties may have to the Indemnified
Parties.
6. Miscellaneous.
(a) Remedies. In
the event of a breach by the Company or by a Holder of any of their respective
obligations under this Agreement, each Holder or the Company, as the case may
be, in addition to being entitled to exercise all rights granted by law and
under this Agreement, including recovery of damages, shall be entitled to
specific performance of its rights under this Agreement. Each of the
Company and each Holder agrees that monetary damages would not provide adequate
compensation for any losses incurred by reason of a breach by it of any of the
provisions of this Agreement and hereby further agrees that, in the event of any
action for specific performance in respect of such breach, it shall not assert
or shall waive the defense that a remedy at law would be adequate.
(b) No Piggyback on
Registrations; Prohibition on Filing Other Registration Statements.
Except as set forth on Schedule 6(b)
attached hereto and in connection with transactions contemplated by clause (d)
under Exempt Issuance, neither the Company nor any of its security holders
(other than the Holders in such capacity pursuant hereto) may include securities
of the Company in any Registration Statements other than the Registrable
Securities. The Company shall not file any other registration
statements until the earlier of such time that all Registrable Securities are
(i) registered pursuant to a Registration Statement that is declared effective
by the Commission or (ii) eligible for resale
without volume or manner-of-sale restrictions or current public information
requirements pursuant to Rule 144; provided, however, that this
Section 6(b) shall not prohibit the Company from filing (x) amendments to
registration statements filed prior to the date of this Agreement, (y)
registration statements pursuant to registration rights obligations in effect as
of this Agreement and described on Schedule 6(i) hereto,
and (z) registration statements on Form S-4 or Form S-8 (each as promulgated
under the Securities Act) or their then equivalents relating to equity
securities to be issued solely in connection with any acquisition of any entity
or business or equity securities issuable in connection with the Company’s stock
option or other employee benefit plans.
(c) Compliance. Each
Holder covenants and agrees that it will comply with the prospectus delivery
requirements of the Securities Act as applicable to it in connection with sales
of Registrable Securities pursuant to a Registration Statement.
(d) Discontinued
Disposition. By its acquisition of Registrable Securities,
each Holder agrees that, upon receipt of a notice from the Company of the
occurrence of any event of the kind described in Section 3(d)(iii) through (vi),
such Holder will forthwith discontinue disposition of such Registrable
Securities under a Registration Statement until it is advised in writing (the
“Advice”) by
the Company that the use of the applicable Prospectus (as it may have been
supplemented or amended) may be resumed. The Company will use its
best efforts to ensure that the use of the Prospectus may be resumed as promptly
as is practicable. The Company agrees and acknowledges that any
periods during which the Holder is required to discontinue the disposition of
the Registrable Securities hereunder shall be subject to the provisions of
Section 2(b).
(e) Piggy-Back
Registrations. Except as set forth on Schedule 6(e)
attached hereto, if, at any time during the Effectiveness Period, there is not
an effective Registration Statement covering all of the Registrable Securities
and the Company shall determine to prepare and file with the Commission a
registration statement relating to an offering for its own account or the
account of others under the Securities Act of any of its equity securities,
other than on Form S-4 or Form S-8 (each as promulgated under the Securities
Act) or their then equivalents relating to equity securities to be issued solely
in connection with any acquisition of any entity or business or equity
securities issuable in connection with the Company’s stock option or other
employee benefit plans, then the Company shall deliver to each Holder a written
notice of such determination and, if within fifteen days after the date of the
delivery of such notice, any such Holder shall so request in writing, the
Company shall include in such registration statement all or any part of such
Registrable Securities such Holder requests to be registered; provided, however, that the
Company shall not be required to register any Registrable Securities pursuant to
this Section 6(e) that are eligible for resale pursuant to Rule 144 promulgated
by the Commission pursuant to the Securities Act or that are the subject of a
then effective Registration Statement.
(f) Amendments and
Waivers. The provisions of this Agreement, including the provisions of
this sentence, may not be amended, modified or supplemented, and waivers or
consents to departures from the provisions hereof may not be given, unless the
same shall be in writing and signed by the Company and the Holders of 67% or
more of the then outstanding Registrable Securities (including, for this purpose
any Registrable Securities issuable upon exercise or conversion of any
Security). If a Registration Statement does not register all of the
Registrable Securities pursuant to a waiver or amendment done in compliance with
the previous sentence, then the number of Registrable Securities to be
registered for each Holder shall be reduced pro rata among all Holders and each
Holder shall have the right to designate which of its Registrable Securities
shall be omitted from such Registration Statement. Notwithstanding the
foregoing, a waiver or consent to depart from the provisions hereof with respect
to a matter that relates exclusively to the rights of a Holder or some Holders
and that does not directly or indirectly affect the rights of other Holders may
be given by such Holder or Holders of all of the Registrable Securities to which
such waiver or consent relates; provided, however, that the
provisions of this sentence may not be amended, modified, or supplemented except
in accordance with the provisions of the first sentence of this
Section 6(f).
(g) Notices. Any and all
notices or other communications or deliveries required or permitted to be
provided hereunder shall be delivered as set forth in the Purchase
Agreement.
(h) Successors and
Assigns. This Agreement shall inure to the benefit of and be binding upon
the successors and permitted assigns of each of the parties and shall inure to
the benefit of each Holder. The Company may not assign (except by merger) its
rights or obligations hereunder without the prior written consent of the Holders
of at least 67% of the then outstanding Registrable Securities. Each Holder may
assign their respective rights hereunder in the manner and to the Persons as
permitted under Section 5.7 of the Purchase Agreement.
(i) No Inconsistent
Agreements. Neither the Company nor any of its Subsidiaries has entered,
as of the date hereof, nor shall the Company or any of its Subsidiaries, on or
after the date of this Agreement, enter into any agreement with respect to its
securities, that would have the effect of impairing the rights granted to the
Holders in this Agreement or otherwise materially conflicts with the
provisions hereof. Except as set forth on Schedule 6(i),
neither the Company nor any of its Subsidiaries has previously entered into any
agreement granting any registration rights with respect to any of its securities
to any Person that have not been satisfied in full.
(j) Execution and
Counterparts. This Agreement may be executed in two or more counterparts,
all of which when taken together shall be considered one and the same agreement
and shall become effective when counterparts have been signed by each party and
delivered to the other party, it being understood that both parties need not
sign the same counterpart. In the event that any signature is
delivered by facsimile transmission or by e-mail delivery of a “.pdf” format
data file, such signature shall create a valid and binding obligation of the
party executing (or on whose behalf such signature is executed) with the same
force and effect as if such facsimile or “.pdf” signature page were an original
thereof.
(k) Governing
Law. All questions concerning the construction, validity,
enforcement and interpretation of this Agreement shall be determined in
accordance with the provisions of the Purchase Agreement.
(l)
Cumulative Remedies.
The remedies provided herein are cumulative and not exclusive of any other
remedies provided by law.
(m) Severability. If any
term, provision, covenant or restriction of this Agreement is held by a court of
competent jurisdiction to be invalid, illegal, void or unenforceable, the
remainder of the terms, provisions, covenants and restrictions set forth herein
shall remain in full force and effect and shall in no way be affected, impaired
or invalidated, and the parties hereto shall use their commercially reasonable
efforts to find and employ an alternative means to achieve the same or
substantially the same result as that contemplated by such term, provision,
covenant or restriction. It is hereby stipulated and declared to be the
intention of the parties that they would have executed the remaining terms,
provisions, covenants and restrictions without including any of such that may be
hereafter declared invalid, illegal, void or unenforceable.
(n) Headings. The
headings in this Agreement are for convenience only, do not constitute a part of
the Agreement and shall not be deemed to limit or affect any of the provisions
hereof.
(o) Independent Nature of
Holders’ Obligations and Rights. The obligations of each Holder hereunder
are several and not joint with the obligations of any other Holder hereunder,
and no Holder shall be responsible in any way for the performance of the
obligations of any other Holder hereunder. Nothing contained herein or in any
other agreement or document delivered at any closing, and no action taken by any
Holder pursuant hereto or thereto, shall be deemed to constitute the Holders as
a partnership, an association, a joint venture or any other kind of entity, or
create a presumption that the Holders are in any way acting in concert with
respect to such obligations or the transactions contemplated by this Agreement.
Each Holder shall be entitled to protect and enforce its rights, including
without limitation the rights arising out of this Agreement, and it shall not be
necessary for any other Holder to be joined as an additional party in any
proceeding for such purpose.
********************
(Signature
Pages Follow)
IN WITNESS WHEREOF, the parties have
executed this Registration Rights Agreement as of the date first written
above.
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CLEVELAND BIOLABS,
INC. |
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By:
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/s/
Michael Fonstein
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Name: Michael
Fonstein
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Title: President
and Chief Executive
Officer
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[SIGNATURE
PAGE OF HOLDERS FOLLOWS]
[SIGNATURE
PAGE OF HOLDERS TO CBLI RRA]
Name of
Holder: __________________________
Signature of Authorized Signatory of
Holder: __________________________
Name of
Authorized Signatory: _________________________
Title of
Authorized Signatory: __________________________
[SIGNATURE
PAGES OF HOLDERS OMITTED]
Annex A
Plan of
Distribution
Each
Selling Stockholder (the “Selling
Stockholders”) of the common stock and any of their pledgees, assignees
and successors-in-interest may, from time to time, sell any or all of their
shares of common stock covered hereby on the [principal Trading Market] or any
other stock exchange, market or trading facility on which the shares are traded
or in private transactions. These sales may be at fixed or negotiated
prices. A Selling Stockholder may use any one or more of the
following methods when selling shares:
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·
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ordinary
brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
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·
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block
trades in which the broker-dealer will attempt to sell the shares as agent
but may position and resell a portion of the block as principal to
facilitate the transaction;
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purchases
by a broker-dealer as principal and resale by the broker-dealer for its
account;
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an
exchange distribution in accordance with the rules of the applicable
exchange;
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privately
negotiated transactions;
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settlement
of short sales entered into after the effective date of the registration
statement of which this prospectus is a
part;
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in
transaction through broker-dealers that agree with the Selling
Stockholders to sell a specified number of such shares at a stipulated
price per share;
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through
the writing or settlement of options or other hedging transactions,
whether through an options exchange or
otherwise;
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a
combination of any such methods of sale;
or
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·
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any
other method permitted pursuant to applicable
law.
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The
Selling Stockholders may also sell shares under Rule 144 under the Securities
Act of 1933, as amended (the “Securities Act”), if
available, rather than under this prospectus.
Broker-dealers
engaged by the Selling Stockholders may arrange for other brokers-dealers to
participate in sales. Broker-dealers may receive commissions or
discounts from the Selling Stockholders (or, if any broker-dealer acts as agent
for the purchaser of shares, from the purchaser) in amounts to be negotiated,
but, except as set forth in a supplement to this Prospectus, in the case of an
agency transaction, not in excess of a customary brokerage commission in
compliance with FINRA NASD Rule 2440; and in the case of a principal
transaction, a markup or markdown in compliance with NASD
IM-2440.
In
connection with the sale of the common stock or interests therein, the Selling
Stockholders may enter into hedging transactions with broker-dealers or other
financial institutions, which may in turn engage in short sales of the common
stock in the course of hedging the positions they assume. The Selling
Stockholders may also sell shares of the common stock short after the effective
date of the registration statement of which this prospectus is a part and
deliver these securities to close out their short positions, or loan or pledge
the common stock to broker-dealers that in turn may sell these
securities. The Selling Stockholders may also enter into option or
other transactions with broker-dealers or other financial institutions or create
one or more derivative securities which require the delivery to such
broker-dealer or other financial institution of shares offered by this
prospectus, which shares such broker-dealer or other financial institution may
resell pursuant to this prospectus (as supplemented or amended to reflect such
transaction).
The
Selling Stockholders and any broker-dealers or agents that are involved in
selling the shares may be deemed to be “underwriters” within the meaning of the
Securities Act in connection with such sales. In such event, any
commissions received by such broker-dealers or agents and any profit on the
resale of the shares purchased by them may be deemed to be underwriting
commissions or discounts under the Securities Act. Each Selling
Stockholder has informed the Company that it does not have any written or oral
agreement or understanding, directly or indirectly, with any person to
distribute the Common Stock. In no event shall any broker-dealer receive fees,
commissions and markups which, in the aggregate, would exceed eight percent
(8%).
The
Company is required to pay certain fees and expenses incurred by the Company
incident to the registration of the shares. The Company has agreed to
indemnify the Selling Stockholders against certain losses, claims, damages and
liabilities, including liabilities under the Securities Act.
Because
Selling Stockholders may be deemed to be “underwriters” within the meaning of
the Securities Act, they will be subject to the prospectus delivery requirements
of the Securities Act including Rule 172 thereunder. The Selling
Stockholders have advised us that there is no underwriter or coordinating broker
acting in connection with the proposed sale of the resale shares by the Selling
Stockholders.
We agreed
to keep this prospectus effective until the earlier of (i) the date on which the
shares may be resold by the Selling Stockholders without registration and
without regard to any volume or manner-of-sale limitations by reason of Rule
144, without the requirement for the Company to be in compliance with the
current public information under Rule 144 under the Securities Act or any other
rule of similar effect or (ii) all of the shares have been sold pursuant to this
or another prospectus or Rule 144 under the Securities Act or any other rule of
similar effect. The resale shares will be sold only through
registered or licensed brokers or dealers if required under applicable state
securities laws. In addition, in certain states, the resale shares of Common
Stock covered hereby may not be sold unless they have been registered or
qualified for sale in the applicable state or an exemption from the registration
or qualification requirement is available and is complied with.
Under
applicable rules and regulations under the Exchange Act, any person engaged in
the distribution of the resale shares may not simultaneously engage in market
making activities with respect to the common stock for the applicable restricted
period, as defined in Regulation M, prior to the commencement of the
distribution. In addition, the Selling Stockholders will be subject
to applicable provisions of the Exchange Act and the rules and regulations
thereunder, including Regulation M, which may limit the timing of purchases and
sales of shares of the common stock by the Selling Stockholders or any other
person. We will make copies of this prospectus available to the
Selling Stockholders and have informed them of the need to deliver a copy of
this prospectus to each purchaser at or prior to the time of the sale (including
by compliance with Rule 172 under the Securities Act).
Annex
B
CLEVELAND
BIOLABS, INC.
Selling
Stockholder Notice and Questionnaire
The
undersigned beneficial owner of common stock (the “Registrable
Securities”) of Cleveland BioLabs, Inc., a Delaware corporation (the
“Company”),
understands that the Company has filed or intends to file with the Securities
and Exchange Commission (the “Commission”) a
registration statement (the “Registration
Statement”) for the registration and resale under Rule 415 of the
Securities Act of 1933, as amended (the “Securities Act”), of
the Registrable Securities, in accordance with the terms of the Registration
Rights Agreement (the “Registration Rights
Agreement”) to which this document is annexed. A copy of the
Registration Rights Agreement is available from the Company upon request at the
address set forth below. All capitalized terms not otherwise defined
herein shall have the meanings ascribed thereto in the Registration Rights
Agreement.
Certain
legal consequences arise from being named as a selling stockholder in the
Registration Statement and the related prospectus. Accordingly,
holders and beneficial owners of Registrable Securities are advised to consult
their own securities law counsel regarding the consequences of being named or
not being named as a selling stockholder in the Registration Statement and the
related prospectus.
NOTICE
The
undersigned beneficial owner (the “Selling Stockholder”)
of Registrable Securities hereby elects to include the Registrable Securities
owned by it in the Registration Statement.
The
undersigned hereby provides the following information to the Company and
represents and warrants that such information is accurate:
QUESTIONNAIRE
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(a)
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Full
Legal Name of Selling Stockholder
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b)
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Full
Legal Name of Registered Holder (if not the same as (a) above) through
which Registrable Securities are held:
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(c)
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Full
Legal Names of any Control Persons, including any Natural Control Person
(which means a natural person who directly or indirectly alone or with
others has power to vote or dispose of the securities covered by this
Questionnaire):
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2. Address
for Notices to Selling Stockholder:
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(a)
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Are
you a broker-dealer?
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Yes ¨ No ¨
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(b)
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If
“yes” to Section 3(a), did you receive your Registrable Securities as
compensation for investment banking services to the
Company?
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Yes ¨ No ¨
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Note:
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If
“no” to Section 3(b), the Commission’s staff has indicated that you should
be identified as an underwriter in the Registration
Statement.
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(c)
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Are
you an affiliate of a
broker-dealer?
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Yes ¨ No ¨
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(d)
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If
you are an affiliate of a broker-dealer, do you certify that you purchased
the Registrable Securities in the ordinary course of business, and at the
time of the purchase of the Registrable Securities to be resold, you had
no agreements or understandings, directly or indirectly, with any person
to distribute the Registrable
Securities?
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Yes ¨ No ¨
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Note:
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If
“no” to Section 3(d), the Commission’s staff has indicated that you should
be identified as an underwriter in the Registration
Statement.
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4. Beneficial
Ownership of Securities of the Company Owned by the Selling
Stockholder.
Except
as set forth below in this Item 4, the undersigned is not the beneficial or
registered owner of any securities of the Company other than the securities
issuable pursuant to the Purchase Agreement.
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(a)
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Type
and Amount of other securities beneficially owned by the Selling
Stockholder:
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5. Relationships
with the Company:
Except
as set forth below, neither the undersigned nor any of its affiliates, officers,
directors or principal equity holders (owners of 5% of more of the equity
securities of the undersigned) has held any position or office or has had any
other material relationship with the Company (or its predecessors or affiliates)
during the past three years.
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State
any exceptions here:
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The
undersigned agrees to promptly notify the Company of any inaccuracies or changes
in the information provided herein that may occur subsequent to the date hereof
at any time prior to the effectiveness of the Registration Statement and
thereafter at any times while the Registration Statement remains
effective.
By
signing below, the undersigned consents to the disclosure of the information
contained herein in its answers to Items 1 through 5 and the inclusion of such
information in the Registration Statement and the related prospectus and any amendments or supplements
thereto. The undersigned understands that such information
will be relied upon by the Company in connection with the preparation or
amendment of the Registration Statement and the related prospectus and any
amendments or supplements thereto.
IN
WITNESS WHEREOF the undersigned, by authority duly given, has caused this Notice
and Questionnaire to be executed and delivered either in person or by its duly
authorized agent.
Date:
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Beneficial
Owner:____________________________________
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By:
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Name:
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Title:
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PLEASE
FAX A COPY (OR EMAIL A .PDF COPY) OF THE COMPLETED AND EXECUTED NOTICE AND
QUESTIONNAIRE, AND RETURN THE ORIGINAL BY OVERNIGHT MAIL, TO:
VOTING
AGREEMENT
This
Voting Agreement, dated as of ________, 2009 (this “Agreement”), is by and among
Cleveland BioLabs, Inc., a Delaware corporation (the “Company”), and the holders of
securities of the Company listed on the signature pages hereto under the heading
“Holder” (each a “Holder” and collectively, the
“Holders”).
WHEREAS, the Company and
certain investors (each, an “Investor”, and collectively,
the “Investors”) have
entered into a Securities Purchase Agreement, dated as of ________, 2009 (the
“Securities Purchase
Agreement”), pursuant to which, among other things, and subject to the
terms and conditions thereof, the Company has agreed to issue and sell to the
Investors and the Investors have agreed to purchase, (i) Series D Convertible
Preferred Stock, par value $0.005 per share (“Series D Preferred”), which
will, among other things, be convertible into shares of the Company’s common
stock, par value $0.005 per share (the “Common Stock”) in accordance
with the terms of the Certificate of Designation for the Series D Preferred, and
(ii) Common Stock Purchase Warrants (“Warrants”), which will be
exercisable to purchase shares of Common Stock; and
WHEREAS, as of the date
hereof, the Holders own the shares of Common Stock
and shares of Series B Convertible Preferred Stock, par value $0.005 per share
(“Series B Preferred”),
set forth on Appendix
A; and
WHEREAS, as a condition to the
willingness of the Investors to enter into the Securities Purchase Agreement and
to consummate the transactions contemplated thereby (collectively, the “Transaction”), the Investors
have requested that the Company be a party to this Agreement in order to enforce
the terms hereof and have required that each Holder agree, and in order to
induce the Investors to enter into the Securities Purchase Agreement, each
Holder has agreed, to enter into this Agreement with respect to all of the
Common Stock and Series B Preferred now owned or which may hereafter be acquired
by the Holder that is eligible to be voted, and any other securities of the
Company (the “Other
Securities”), if any, which such Holder is currently entitled to vote, or
after the date hereof becomes entitled to vote, at any meeting of stockholders
of the Company. The Other Securities are, collectively with the Common Stock and
Series B Preferred that is eligible to be voted, referred to herein as the
“Voting
Securities”.
NOW, THEREFORE, in
consideration of the foregoing and the mutual covenants and agreements contained
herein, and intending to be legally bound hereby, the parties hereto hereby
agree as follows:
ARTICLE
I
VOTING AGREEMENT OF THE
HOLDERS
SECTION
1.01. Voting
Agreement. Subject to the last sentence of this
Section 1.01, each Holder hereby agrees that at any meeting of the
stockholders of the Company, however called, each of the Holders shall vote the
Voting Securities over which each Holder has voting power as of the record date
for such meeting: (a) in favor of Stockholder Approval and Authorized
Share Approval (as defined in the Securities Purchase Agreement), as described
in Section 4.11(c) of the Securities Purchase Agreement, and in favor of
any proposal or matter that would reasonably be expected to facilitate
Stockholder Approval and Authorized Share Approval or the transactions
contemplated by the Securities Purchase Agreement; and (b) against any proposal
or any other corporate action or agreement that would result in a breach of any
covenant, representation or warranty or any other obligation or agreement of the
Company under the Securities Purchase Agreement or which could result in any of
the conditions to the Company’s obligations under the Securities Purchase
Agreement not being fulfilled. Each Holder acknowledges receipt and
review of a copy of the Transaction Documents (as defined in the Securities
Purchase Agreement). The obligations of the Holders under this Section 1.01
shall terminate immediately following the occurrence of the Stockholder Approval
and Authorized Share Approval. Nothing herein shall require or be deemed to
require any Holder who holds options, warrants or other securities convertible
into, or exercisable or exchangeable for, Voting Securities to convert, exercise
or exchange such options, warrants or other securities.
ARTICLE
II
REPRESENTATIONS AND
WARRANTIES OF THE HOLDERS
Each
Holder hereby represents and warrants, severally but not jointly, to each of the
Investors as follows:
SECTION
2.01. Authority Relative to This
Agreement. Each Holder has all necessary power and authority
to execute and deliver this Agreement, to perform his or its obligations
hereunder and to consummate the transactions contemplated hereby. This Agreement
has been duly executed and delivered by such Holder and constitutes a legal,
valid and binding obligation of such Holder, enforceable against such Holder in
accordance with its terms, except (a) as such enforceability may be limited by
applicable bankruptcy, insolvency, reorganization, fraudulent conveyance,
moratorium or similar laws now or hereafter in effect relating to, or affecting
generally, the enforcement of creditors’ and other obligees’ rights, (b) to the
extent the remedy of specific performance or other forms of equitable relief may
be subject to certain equitable defenses and principles and to the discretion of
the court before which the proceeding may be brought, and (c) to the extent
rights to indemnity and contribution hereunder may be limited by applicable law
and public policy.
SECTION
2.02. No
Conflict. (a) The execution and delivery of this
Agreement by such Holder does not, and the performance of this Agreement by such
Holder shall not, (i) conflict with or violate any federal, state or local law,
statute, ordinance, rule, regulation, order, judgment or decree applicable to
any Holder or by which the Voting Securities owned by such Holder are bound or
affected or (ii) result in any breach of or constitute a default (or an event
that with notice or lapse of time or both would become a default) under, or give
to others any rights of termination, amendment, acceleration or cancellation of,
or result in the creation of a lien or encumbrance on the Voting Securities
owned by such Holder, pursuant to any note, bond, mortgage, indenture, contract,
agreement, lease, license, permit, franchise or other instrument or obligation
to which such Holder is a party or by which such Holder or the Voting Securities
owned by such Holder are bound.
(b) The execution and delivery of this
Agreement by such Holder does not, and the performance of this Agreement by such
Holder will not, require any consent, approval, authorization or permit of, or
filing with or notification to, any governmental entity or other third party by
such Holder.
SECTION
2.03. Title to the
Stock. As of the date hereof, each Holder is the record and
beneficial owner of the number of shares of Common Stock and Series B Preferred
set forth opposite its name on Appendix A attached
hereto. Such Common Stock and Series B Preferred are owned free and clear of all
security interests, liens, claims, pledges, options, rights of first refusal,
agreements, limitations on such Holder’s voting rights, charges and other
encumbrances of any nature whatsoever. No Holder has previously
appointed or granted any proxy, which appointment or grant is still effective,
with respect to the Common Stock or Series B Preferred owned by such
Holder.
ARTICLE
III
COVENANTS
SECTION
3.01. Grant of
Proxy. Each Holder hereby revokes any and all previous proxies
granted with respect to its Common Stock or Series B Preferred. By
entering into this Agreement, each Holder hereby grants a proxy appointing the
Company, with full power of substitution, as such Holder’s attorney-in-fact and
proxy, for and in such Holder’s name, to be counted as present and to vote
(including by written consent, if applicable) or otherwise to act on behalf of
the Holder with respect to its Voting Securities solely with respect to the
matters set forth in, and in the manner contemplated by Section 1.01, as such
proxy or its substitutes shall, in the Company’s sole and absolute discretion,
deem proper with respect to such Voting Securities. The proxy granted
by each Holder pursuant to this Section 3.01 is subject to the penultimate
sentence of this Section 3.01, irrevocable and is coupled with an interest, in
accordance with Section 212(e) of the Delaware General Corporation Law and is
granted in order to secure such Holder’s performance under this Agreement and
also in consideration of the Company entering into this Agreement and the
Securities Purchase Agreement. If any Holder fails for any reason to
be counted as present or to vote (including by written consent, if applicable)
such Holder’s Voting Securities in accordance with the requirements of Section
1.01 above, then the Company shall have the right to cause to be present or vote
such Holder’s Voting Securities in accordance with the provisions of Section
1.01. The proxy granted by each Holder shall be automatically revoked
upon termination of this Agreement in accordance with its terms. Each
Holder agrees, from the date hereof, not to attempt to revoke, frustrate the
exercise of, or challenge the validity of, the irrevocable proxy granted
pursuant to this Section 3.01.
SECTION
3.02. No
Disposition or Encumbrance of Stock. Each Holder hereby
covenants and agrees that, until the Stockholder Approval and Authorized Share
Approval have been obtained, such Holder shall not offer or agree to sell,
transfer, tender, assign, hypothecate or otherwise dispose of, grant a proxy or
power of attorney with respect to (except in a manner that is consistent with
Section 1.01 or Section 3.01), or create or permit to exist any security
interest, lien, claim, pledge, option, right of first refusal, agreement,
limitation on such Holder’s voting rights, charge or other encumbrance of any
nature whatsoever (“Encumbrance”) with respect to
the Voting Securities, or directly or indirectly initiate, solicit or encourage
any person to take actions which could reasonably be expected to lead to the
occurrence of any of the foregoing; provided, however, that any
such Holder may assign, sell or transfer any Voting Securities provided that any
such recipient of the Voting Securities has delivered to the Company and each
Investor a written agreement, in a form reasonably satisfactory to the
Investors, that the recipient shall be bound by, and the Voting Securities so
transferred, assigned or sold shall remain subject to, this
Agreement.
SECTION
3.03. Company
Cooperation. The Company hereby covenants and agrees that it
will not, and each Holder irrevocably and unconditionally acknowledges and
agrees that the Company will not (and waives any rights against the Company in
relation thereto), recognize any Encumbrance or agreement on any of the Voting
Securities subject to this Agreement unless the provisions of Section 3.02 have
been complied with.
ARTICLE
IV
MISCELLANEOUS
SECTION
4.01. Further
Assurances. Each Holder shall execute and deliver such further
documents and instruments and take all further action as may be reasonably
necessary in order to consummate the transactions contemplated
hereby.
SECTION
4.02. Specific
Performance. The parties hereto agree that irreparable damage
would occur in the event any provision of this Agreement was not performed in
accordance with the terms hereof and that the Company or any Investor (without
being joined by any other Investor) shall be entitled to specific performance of
the terms hereof (without the necessity of posting bond or other security, or
proving actual damages), in addition to any other remedy at law or in
equity. Any Investor shall be entitled to its reasonable attorneys’
fees in any action brought to enforce this Agreement in which it is the
prevailing party.
SECTION
4.03. Entire
Agreement. This Agreement constitutes the entire agreement
among the Company and the Holders with respect to the subject matter hereof and
supersedes all prior agreements and understandings, both written and oral, among
the Company and the Holders with respect to the subject matter
hereof.
SECTION
4.04. Amendment. This
Agreement may not be amended except by an instrument in writing signed by the
parties hereto and with the consent of the Investors.
SECTION
4.05. Severability. If
any term or other provision of this Agreement is invalid, illegal or incapable
of being enforced by any rule of law, or public policy, all other conditions and
provisions of this Agreement shall nevertheless remain in full force and effect
so long as the economic or legal substance of this Agreement is not affected in
any manner materially adverse to any party. Upon such determination
that any term or other provision is invalid, illegal or incapable of being
enforced, the parties hereto shall negotiate in good faith to modify this
Agreement so as to effect the original intent of the parties as closely as
possible in a mutually acceptable manner in order that the terms of this
Agreement remain as originally contemplated to the fullest extent
possible.
SECTION
4.06. Governing
Law. This Agreement shall be construed and enforced in
accordance with, and all questions concerning the construction, validity,
interpretation and performance of this Agreement shall be governed by, the
internal laws of the State of Delaware, without giving effect to provisions
thereof regarding conflict of laws. IN ANY ACTION, SUIT, OR PROCEEDING IN
ANY JURISDICTION BROUGHT BY ANY PARTY AGAINST ANY OTHER PARTY, THE PARTIES EACH
KNOWINGLY AND INTENTIONALLY, TO THE GREATEST EXTENT PERMITTED BY APPLICABLE LAW,
HEREBY ABSOLUTELY, UNCONDITIONALLY, IRREVOCABLY AND EXPRESSLY WAIVES FOREVER
TRIAL BY JURY.
SECTION
4.07. Third-Party
Beneficiaries. The Investors shall be intended third party
beneficiaries of this Agreement to the same extent as if they were parties
hereto, and shall be entitled to enforce the provisions hereof.
SECTION
4.08. Termination. This
Agreement shall terminate immediately following the occurrence of the
Stockholder Approval and Authorized Share Approval or upon the mutual consent of
the Company, each Holder and the Investors.
[Signature
Pages Follow]
IN
WITNESS WHEREOF, each Holder and the Company has duly executed this
Agreement.
|
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THE
COMPANY:
|
|
|
|
|
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CLEVELAND
BIOLABS, INC.
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|
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|
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By:
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/s/
Michael Fonstein
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|
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Name:
|
Michael
Fonstein
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|
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Title:
|
President
and Chief Executive Officer
|
Dated:
_________, 2009
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|
|
Address:
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73
High Street
Buffalo,
New York
14203
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|
|
HOLDER:
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|
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|
|
|
|
|
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Dated: __________,
2009
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|
Address:
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[SIGNATURE
PAGES OF HOLDERS OMITTED]
APPENDIX
A
Holder
|
|
Outstanding Common
Stock Owned
|
|
|
Outstanding Series B
Preferred Owned
|
|
|
Common Stock
Beneficially Owned
|
|
Bernard
L. Kasten
|
|
|
0 |
|
|
|
0 |
|
|
|
85,0001 |
|
James
J. Antal
|
|
|
0 |
|
|
|
0 |
|
|
|
85,0002 |
|
Paul
E. DiCorleto
|
|
|
0 |
|
|
|
0 |
|
|
|
70,0003 |
|
Michael
Fonstein
|
|
|
1,311,200 |
|
|
|
0 |
|
|
|
1,485,9504 |
|
Andrei
Gudkov
|
|
|
1,549,600 |
|
|
|
0 |
|
|
|
1,724,3505 |
|
Yakov
Kogan
|
|
|
715,200 |
|
|
|
0 |
|
|
|
889,9506 |
|
H.
Daniel Perez
|
|
|
0 |
|
|
|
0 |
|
|
|
85,0007 |
|
John
A. Marhofer, Jr.
|
|
|
0 |
|
|
|
0 |
|
|
|
159,6848 |
|
The
Cleveland Clinic Foundation
|
|
|
1,341,000 |
|
|
|
0 |
|
|
|
1,341,000 |
|
1 Includes
stock options to purchase 85,000 shares of Common Stock, which are currently
exercisable.
2 Includes
stock options to purchase 85,000 shares of Common Stock, which are currently
exercisable.
3 Includes
stock options to purchase 70,000 shares of Common Stock, which are currently
exercisable.
4 Includes
1,311,200 shares of Common Stock, and stock options to purchase 174,750 shares
of Common Stock, which are currently exercisable.
5 Includes
1,549,600 shares of Common Stock, and stock options to purchase 174,750 shares
of Common Stock, which are currently exercisable.
6 Includes
715,200 shares of Common Stock, and stock options to purchase 174,750 shares of
Common Stock, which are currently exercisable.
7 Includes
stock options to purchase 85,000 shares of Common Stock, which are currently
exercisable.
8 Includes
stock options to purchase 154,684 shares of Common Stock, which are currently
exercisable, and stock options to purchase 5,000 shares of Common Stock, which
will become exercisable on March 1, 2009.
Holder
|
|
Outstanding Common
Stock Owned
|
|
|
Common Stock
Beneficially Owned
|
|
Chembridge
Corporation
|
|
|
340,864 |
|
|
|
605,4881 |
|
Elena
Feinstein
|
|
|
238,200 |
|
|
|
238,200 |
|
George
Stark
|
|
|
236,757 |
|
|
|
236,757 |
|
Alexander
Shakhov
|
|
|
36,060 |
|
|
|
36,060 |
|
Vadim
Krivokrysenko
|
|
|
50,660 |
|
|
|
50,660 |
|
Dmitriy
A. Bosykh
|
|
|
1,250 |
|
|
|
1,250 |
|
Katerina
Gurova
|
|
|
60,000 |
|
|
|
60,000 |
|
Mikhail
Chernov
|
|
|
37,260 |
|
|
|
37,260 |
|
1 Includes
264,624 shares of Common Stock underlying a warrant, which is currently
exercisable.
AMENDMENT AND WAIVER
AGREEMENT
THIS AMENDMENT AND WAIVER
AGREEMENT (this
“Agreement”),
dated as of March 20, 2009, is entered into by and among Cleveland BioLabs,
Inc., a Delaware corporation (the “Company”) and each of
the purchasers (each, including its successors and assigns, a “Purchaser” and
collectively, the “Purchasers”) to the
Securities Purchase Agreement, dated as of February 13, 2009 (the “Purchase Agreement”).
Any defined terms used herein
and otherwise undefined shall have the same meaning ascribed to such terms in
the Purchase Agreement.
WHEREAS, the Company expects
to sell additional shares of Series D Convertible Preferred Stock (the “Series D Preferred”)
and Warrants to additional purchasers on the same terms and conditions as set
forth in the Purchase Agreement except that (1) the Conversion Price of the
Series D Preferred shall be reduced from $1.85 to $1.40, subject to further
adjustment therein and (2) the Exercise Price of the Warrants shall be reduced
from $2.60 to $1.60, subject to further adjustment therein (the “Additional Series D
Transaction”).
WHEREAS, to effect the
foregoing price reductions, immediately prior to the consummation of the
Additional Series D Transaction, the Company will issue to the Placement Agent a
common stock purchase warrant to purchase ten (10) shares of Common Stock at an
exercise price of $1.40 per share, subject to adjustment therein, on the date
hereof, which warrant shall be otherwise identical to the Warrants (such
issuance, the “Warrant
Issuance”).
WHEREAS, the Warrant Issuance
constitutes a Dilutive Issuance under Section 7(b) of the Certificate of
Designation.
WHEREAS, in connection with
the foregoing Dilutive Issuance, the Company has requested that the Purchasers
agree to certain amendments and waivers under the Transaction Documents, and the
Purchasers have agreed to such request, subject to the terms and conditions of
this Agreement.
NOW THEREFORE, for good and
valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, each Purchaser hereby agrees as follows:
1. Adjustment to Conversion
Price of Series D Preferred. Pursuant to Section 7(b) of the
Certificate of Designation, effective upon the Warrant Issuance, the Conversion
Price of the Series D Preferred shall be adjusted to be equal to $1.40 per
share, subject to further adjustment therein (the “Adjusted Conversion
Price”). This Agreement shall constitute notice thereof under
Section 7(g)(i) of the Certificate of Designation. Each Purchaser
acknowledges and agrees that that the Adjusted Conversion Price shall apply in
the Additional Series D Transaction and any subsequent issuances of the Series D
Preferred on the same terms and conditions as set forth in the Additional Series
D Transaction.
2.
Partial
Waiver of Anti-Dilution of Warrants and Adjustment to Exercise Price of
Warrants. Each
Purchaser hereby agrees to a waiver of the adjustment of the Exercise Price
pursuant to Section 3(b) of the Warrants as a result of the Warrant Issuance,
the Additional Series D Transaction and any subsequent issuances of the Warrants
on the same terms and conditions as set forth in the Additional Series D
Transaction; provided, however, effective upon the Warrant Issuance,
the Exercise Price of the Warrants shall be reduced to be equal to $1.60 per
share, subject to further adjustment therein, and the number of Warrant Shares
issuable under each Warrant shall be adjusted to be equal to the quotient of (x)
a Purchaser’s Shares multiplied by the Stated Value, divided by (y) the Adjusted
Conversion Price. This Agreement shall constitute notice
of such adjustment under Section 3(g)(i) of the
Warrants.
3.
Extension of Offering
Period. The termination of the offering shall be extended from
March 15, 2009 until March 27, 2009, and, as such, each reference to “March 15,
2009” in the Transaction Documents shall be replaced with a reference to “March
27, 2009.”
4. Amendment to Deadline for
Stockholder Meeting. Each Purchaser hereby agrees that the
deadline for the Company to hold a meeting of its stockholders for the purpose
of obtaining Stockholder Approval and Authorized Share Approval pursuant to
Section 4.11(c) of the Purchase Agreement shall be June 26, 2009 (which period
may be reasonably extended in the case of Commission review of the Company’s
proxy statement).
5. Voting
Agreements. The definition of “Voting Agreements” in Section 1
of the Purchase Agreement shall be amended such that the Company shall not be
required to obtain Voting Agreements from Sunrise Equity Partners, LP or Sunrise
Securities Corp. so long as the Company obtains Voting Agreements from
stockholders holding at least 1,000,000 shares of Common Stock. As such, the
definition of “Voting Agreement” in Section 1.1 shall be amended and restated as
follows:
““Voting Agreements”
means each of the written agreements, in the form of Exhibit E attached
hereto, between the Company and each of (a) The Cleveland Clinic Foundation, (b)
Sunrise Equity Partners, LP, (c) Sunrise Securities Corp. and (d) all of the
executive officers and directors of the Company, which shall be as set forth on
Schedule
2.2(a)(vi) attached hereto, to vote all Common Stock over which such
Persons have voting control as of the record date for the meeting of
stockholders of the Company in favor of Stockholder Approval and Authorized
Share Approval; provided, however, the Company
shall not be required to obtain the Voting Agreements for the initial Closing
from Sunrise Equity Partners, LP, or Sunrise Securities Corp. if the aggregate
Subscription Amounts for the initial Closing are less than $2,000,000; and,
provided, further, the Company
shall not be required to obtain Voting Agreements from Sunrise Equity Partners,
LP and Sunrise Securities Corp. (regardless of the Subscription Amounts) if the
Company obtains Voting Agreements executed by stockholders of the
Company (in addition to those listed above under subsections (a) and (d))
holding no less than 1,000,000 shares of Common Stock, in the
aggregate.”
6. Other
Waivers
(a) Waiver of Participation in
Future Financing. The Purchasers hereby waive the terms of Section 4.12
of the Purchase Agreement, solely in connection with the Additional Series D
Transaction and the Warrant Issuance.
(b) Waiver of Subsequent Equity
Sales. The Purchasers hereby waive the terms of Section 4.13(a) of the
Purchase Agreement, solely in connection with the Additional Series D
Transaction and the Warrant Issuance.
(c) Waiver of Most Favored
Nation Provision. The Purchasers hereby waive the terms of Section 4.18
of the Purchase Agreement, solely in connection with the Additional Series D
Transaction and the Warrant Issuance.
7. Representations and
Warranties of the Company. The Company hereby makes the representations
and warranties set forth below to the Purchasers that as of the date of its
execution of this Agreement:
(a) The
Company has the requisite corporate power and authority to enter into and to
consummate the transactions contemplated by this Agreement and otherwise to
carry out its obligations hereunder. The execution and delivery of
this Agreement by the Company and the consummation by it of the transactions
contemplated hereby have been duly authorized by all necessary action on the
part of the Company and no further action is required by the Company, its board
of directors or its stockholders in connection therewith other than in
connection with the Required Approvals. This Agreement has been duly
executed by the Company and, when delivered in accordance with the terms hereof
will constitute the valid and binding obligation of the Company enforceable
against the Company in accordance with its terms except (i) as limited by
applicable bankruptcy, insolvency, reorganization, moratorium and other laws of
general application affecting enforcement of creditors’ rights generally, (ii)
as limited by general principles of equity and (iii) insofar as indemnification
and contribution provisions may be limited by applicable law and public
policy.
(b) The
execution, delivery and performance of this Agreement by the Company and the
consummation by the Company of the transactions contemplated hereby do not and
will not: (i) conflict with or violate any provision of the Company’s
certificate of incorporation, bylaws or other organizational or charter
documents, or (ii) conflict with, or constitute a default (or an event that with
notice or lapse of time or both would become a default) under, result in the
creation of any Lien upon any of the properties or assets of the Company, or
give to others any rights of termination, amendment, acceleration or
cancellation (with or without notice, lapse of time or both) of, any material
agreement, credit facility, debt or other material instrument (evidencing
Company debt or otherwise) or other material understanding to which the Company
is a party or by which any property or asset of the Company is bound or
affected, or (iii) subject to the Required Approvals, conflict with or result in
a violation of any law, rule, regulation, order, judgment, injunction, decree or
other restriction of any court or governmental authority to which the Company is
subject (including federal and state securities laws and regulations), or by
which any property or asset of the Company is bound or affected; except in the
case of each of clauses (ii) and (iii), such as would not have or reasonably be
expected to result in a Material Adverse Effect.
8. Representations and
Warranties of the Purchasers. Each Purchaser, for itself and
for no other Purchaser, hereby represents and warrants as of the date of such
Purchaser’s execution of this Agreement:
(a) Such
Purchaser is either an individual or an entity duly organized, validly existing
and in good standing under the laws of the jurisdiction of its organization with
full right, corporate or partnership power and authority to enter into and to
consummate the transactions contemplated by this Agreement and otherwise to
carry out its obligations hereunder. The execution and delivery of
this Agreement and performance by such Purchaser of the transactions
contemplated by this Agreement have been duly authorized by all necessary
corporate, partnership, limited liability company or similar action, as
applicable, on the part of such Purchaser. This Agreement has been
duly executed by such Purchaser, and when delivered by such Purchaser in
accordance with the terms hereof, will constitute the valid and legally binding
obligation of such Purchaser, enforceable against it in accordance with its
terms, except (i) as limited by applicable bankruptcy, insolvency,
reorganization, moratorium and other laws of general application affecting
enforcement of creditors’ rights generally, (ii) as limited by laws relating to
general principles of equity and (iii) insofar as indemnification and
contribution provisions may be limited by applicable law and public
policy.
(b) The
execution, delivery and performance of this Agreement by such Purchaser and the
consummation by such Purchaser of the transactions contemplated thereby do not
and will not: (i) conflict with or violate, if such Purchaser is an entity, any
provision of the Purchaser’s certificate or articles of incorporation, bylaws or
other organizational or charter documents, (ii) violate, or constitute a default
(or an event which with notice or lapse of time or both would become a default)
under, or give to others any rights of termination, amendment, acceleration or
cancellation (with or without notice, lapse of time or both) of, any agreement,
credit facility, debt or other instrument to which such Purchaser is a party or
(iii) result in a violation of any law, rule, regulation, order, judgment,
injunction, decree or other restriction of any court or governmental authority
to which such Purchaser is subject (including federal and state securities laws
and regulations), or by which any property or asset of such Purchaser is bound
or affected; except in the case of clauses (ii) and (iii) above, for such
conflicts, defaults, rights or violations which would not, individually or in
the aggregate, reasonably be expected to have a material adverse effect on the
transactions contemplated hereby or the authority or ability of such Purchaser
to perform its obligations under this Agreement.
9. Miscellaneous.
(a) Effect on Transaction
Documents. Except as specifically modified herein, all of the terms,
provisions and conditions of the Transaction Documents shall remain in full
force and effect and the rights and obligations of the parties with respect
thereto shall, except as specifically provided herein, be unaffected by this
Agreement and shall continue as provided in such documents and shall not be in
any way changed, modified or superseded by the terms set forth
herein.
(b) Notices. Any
and all notices or other communications or deliveries required or permitted to
be provided hereunder shall be delivered as set forth in the Purchase
Agreement.
(c) Construction. All
questions concerning the construction, validity, enforcement and interpretation
of this Agreement shall be determined in accordance with the provisions of
the Purchase Agreement.
(d) Successors and
Assigns. This Agreement shall be binding upon and inure to the
benefit of the parties hereto and their respective successors and permitted
assigns. This Agreement shall be for the sole benefit of the parties
to this Agreement and their respective successors and permitted assigns and is
not intended, nor shall be construed, to give any person or entity, other than
the parties hereto and their respective successors and permitted assigns, any
legal or equitable right, remedy or claim hereunder.
(e) Execution. This
Agreement may be executed in counterparts, all of which when taken together
shall be considered one and the same agreement and shall become effective when
counterparts have been signed by each party and delivered to the other party, it
being understood that both parties need not sign the same
counterpart. In the event that any signature is delivered by
facsimile transmission or by e-mail delivery of a “.pdf” format data file, such
signature shall create a valid and binding obligation of the party executing (or
on whose behalf such signature is executed) with the same force and effect as if
such facsimile or “.pdf” signature page were an original thereof.
(f) Entire
Agreement. This Agreement constitutes the entire agreement
among the parties with respect to the matters covered hereby and supersedes all
previous written, oral or implied understandings among them with respect to such
matters.
(g) Severability. If
any term, provision, covenant or restriction of this Agreement is held by a
court of competent jurisdiction to be invalid, illegal, void or unenforceable,
the remainder of the terms, provisions, covenants and restrictions set forth
herein shall remain in full force and effect and shall in no way be affected,
impaired or invalidated, and the parties hereto shall use their commercially
reasonable efforts to find and employ an alternative means to achieve the same
or substantially the same result as that contemplated by such term, provision,
covenant or restriction. It is hereby stipulated and declared to be
the intention of the parties that they would have executed the remaining terms,
provisions, covenants and restrictions without including any of such that may be
hereafter declared invalid, illegal, void or unenforceable.
(h) Waiver. No
provision of this Agreement may be waived or amended except in accordance with
the terms of the Purchase Agreement.
(i) Independent Nature of
Purchasers’ Obligations and Rights. The obligations of each
Purchaser hereunder are several and not joint with the obligations of any other
Purchasers hereunder, and no Purchaser shall be responsible in any way for the
performance of the obligations of any other Purchaser hereunder. Nothing
contained herein or in any other agreement or document delivered at any closing,
and no action taken by any Purchaser pursuant hereto, shall be deemed to
constitute the Purchasers as a partnership, an association, a joint venture or
any other kind of entity, or create a presumption that the Purchasers are in any
way acting in concert with respect to such obligations or the transactions
contemplated by this Agreement. Each Purchaser shall be entitled to protect and
enforce its rights, including without limitation the rights arising out of this
Agreement, and it shall not be necessary for any other Purchaser to be joined as
an additional party in any proceeding for such purpose.
SIGNATURE
PAGES TO FOLLOW
IN WITNESS WHEREOF, the
undersigned has caused this Amendment and Waiver Agreement to be duly executed
as of the date first written above.
CLEVELAND
BIOLABS, INC.
|
|
By:
|
/s/ Michael Fonstein
|
Name:
|
Michael
Fonstein
|
Title:
|
President
and Chief Executive Officer
|
|
|
[AMENDMENT
AND WAIVER AGREEMENT FOR PURCHASERS]
Acknowledgement
and Confirmation
The
undersigned investor hereby acknowledges receipt of this Amendment and Waiver
Agreement and confirms its agreement to the terms thereof.
Signature: _________________________
Name of
Investor(s): _________________________
Title (if
investor is not an individual):_________________________
Dated:
March ___, 2009
[SIGNATURE
PAGES OF PURCHASERS OMITTED]
AMENDMENT
AND REAFFIRMATION AGREEMENT
THIS AMENDMENT AND REAFFIRMATION
AGREEMENT (this
“Agreement”),
dated as of March __, 2009, has been prepared to provide additional information
to prospective investors in the private placement of the securities of Cleveland
BioLabs, Inc., a Delaware corporation (the “Company”) and
supplements information contained in the Securities Purchase Agreement by and
among each prospective investor (each, a “Purchaser” and
collectively, the “Purchasers”) and the
Company (the “Purchase
Agreement”) and each of the Transaction Documents
thereto. Each Purchaser is requested to agree and acknowledge this
Agreement by executing the attached signature page and failure to agree to this
Agreement will result in the Company returning the funds of any such Purchaser.
Capitalized terms not defined
herein shall have the same meaning as set forth in the Purchase
Agreement.
The
following terms of the Transaction Documents have been amended as
follows:
1. Conversion Price of the
Series D Preferred. The Conversion Price of the Series D Convertible
Preferred Stock (the “Series D Preferred”)
shall be equal to $1.40, subject to further adjustment as set forth in the
Certificate of Designation.
2. Exercise Price of the
Warrants. The Exercise Price of the Warrants shall be equal to $1.60,
subject to further adjustment therein.
3. Extension of Offering
Period. The termination of the offering shall be extended from March 15,
2009 until March 27, 2009, and, as such, each reference to “March 15, 2009” in
the Transaction Documents shall be replaced with a reference to “March 27,
2009.”
4. Amendment to Deadline for
Stockholder Meeting. Each Purchaser hereby agrees that the
deadline for the Company to hold a meeting of its stockholders for the purpose
of obtaining Stockholder Approval and Authorized Share Approval pursuant to
Section 4.11(c) of the Purchase Agreement shall be June 26, 2009 (which period
may be reasonably extended in the case of Commission review of the Company’s
proxy statement).
5. Voting
Agreements. The definition of “Voting Agreements” in Section 1
of the Purchase Agreement shall be amended such that the Company shall not be
required to obtain Voting Agreements from Sunrise Equity Partners, LP or Sunrise
Securities Corp. so long as the Company obtains Voting Agreements from
stockholders holding at least 1,000,000 shares of Common Stock. As such, the
definition of “Voting Agreement” in Section 1.1 shall be amended and restated as
follows:
““Voting Agreements”
means each of the written agreements, in the form of Exhibit E attached
hereto, between the Company and each of (a) The Cleveland Clinic Foundation, (b)
Sunrise Equity Partners, LP, (c) Sunrise Securities Corp. and (d) all of the
executive officers and directors of the Company, which shall be as set forth on
Schedule
2.2(a)(vi) attached hereto, to vote all Common Stock over which such
Persons have voting control as of the record date for the meeting of
stockholders of the Company in favor of Stockholder Approval and Authorized
Share Approval; provided, however, the Company
shall not be required to obtain the Voting Agreements for the initial Closing
from Sunrise Equity Partners, LP, or Sunrise Securities Corp. if the aggregate
Subscription Amounts for the initial Closing are less than $2,000,000; and,
provided, further, the Company
shall not be required to obtain Voting Agreements from Sunrise Equity Partners,
LP and Sunrise Securities Corp. (regardless of the Subscription Amounts) if the
Company obtains Voting Agreements executed by stockholders of the
Company (in addition to those listed above under subsections (a) and (d))
holding no less than 1,000,000 shares of Common Stock, in the
aggregate.”
6. Representations and
Warranties of the Company. The Company hereby makes the representations
and warranties set forth below to the Purchasers that as of the date of its
execution of this Agreement:
(a) The
Company has the requisite corporate power and authority to enter into and to
consummate the transactions contemplated by this Agreement and otherwise to
carry out its obligations hereunder. The execution and delivery of
this Agreement by the Company and the consummation by it of the transactions
contemplated hereby have been duly authorized by all necessary action on the
part of the Company and no further action is required by the Company, its board
of directors or its stockholders in connection therewith other than in
connection with the Required Approvals. This Agreement has been duly
executed by the Company and, when delivered in accordance with the terms hereof
will constitute the valid and binding obligation of the Company enforceable
against the Company in accordance with its terms except (i) as limited by
applicable bankruptcy, insolvency, reorganization, moratorium and other laws of
general application affecting enforcement of creditors’ rights generally, (ii)
as limited by general principles of equity and (iii) insofar as indemnification
and contribution provisions may be limited by applicable law and public
policy.
(b) The
execution, delivery and performance of this Agreement by the Company and the
consummation by the Company of the transactions contemplated hereby do not and
will not: (i) conflict with or violate any provision of the Company’s
certificate of incorporation, bylaws or other organizational or charter
documents, or (ii) conflict with, or constitute a default (or an event that with
notice or lapse of time or both would become a default) under, result in the
creation of any Lien upon any of the properties or assets of the Company, or
give to others any rights of termination, amendment, acceleration or
cancellation (with or without notice, lapse of time or both) of, any material
agreement, credit facility, debt or other material instrument (evidencing
Company debt or otherwise) or other material understanding to which the Company
is a party or by which any property or asset of the Company is bound or
affected, or (iii) subject to the Required Approvals, conflict with or result in
a violation of any law, rule, regulation, order, judgment, injunction, decree or
other restriction of any court or governmental authority to which the Company is
subject (including federal and state securities laws and regulations), or by
which any property or asset of the Company is bound or affected; except in the
case of each of clauses (ii) and (iii), such as would not have or reasonably be
expected to result in a Material Adverse Effect.
7. Miscellaneous.
(a) Effect on Transaction
Documents. Except as specifically modified herein, all of the terms,
provisions and conditions of the Transaction Documents shall remain in full
force and effect and the rights and obligations of the parties with respect
thereto shall, except as specifically provided herein, be unaffected by this
Agreement and shall continue as provided in such documents and shall not be in
any way changed, modified or superseded by the terms set forth
herein.
(b) Notices. Any and all
notices or other communications or deliveries required or permitted to be
provided hereunder shall be delivered as set forth in the Purchase
Agreement.
(c) Construction. All
questions concerning the construction, validity, enforcement and interpretation
of this Agreement shall be determined in accordance with the provisions of
the Purchase Agreement.
(d) Successors and
Assigns. This Agreement shall be binding upon and inure to the benefit of
the parties hereto and their respective successors and permitted
assigns. This Agreement shall be for the sole benefit of the parties
to this Agreement and their respective successors and permitted assigns and is
not intended, nor shall be construed, to give any person or entity, other than
the parties hereto and their respective successors and permitted assigns, any
legal or equitable right, remedy or claim hereunder.
(e) Execution. This
Agreement may be executed in counterparts, all of which when taken together
shall be considered one and the same agreement and shall become effective when
counterparts have been signed by each party and delivered to the other party, it
being understood that both parties need not sign the same
counterpart. In the event that any signature is delivered by
facsimile transmission or by e-mail delivery of a “.pdf” format data file, such
signature shall create a valid and binding obligation of the party executing (or
on whose behalf such signature is executed) with the same force and effect as if
such facsimile or “.pdf” signature page were an original thereof.
(f) Entire Agreement.
This Agreement constitutes the entire agreement among the parties with respect
to the matters covered hereby and supersedes all previous written, oral or
implied understandings among them with respect to such matters.
(g) Severability. If any
term, provision, covenant or restriction of this Agreement is held by a court of
competent jurisdiction to be invalid, illegal, void or unenforceable, the
remainder of the terms, provisions, covenants and restrictions set forth herein
shall remain in full force and effect and shall in no way be affected, impaired
or invalidated, and the parties hereto shall use their commercially reasonable
efforts to find and employ an alternative means to achieve the same or
substantially the same result as that contemplated by such term, provision,
covenant or restriction. It is hereby stipulated and declared to be
the intention of the parties that they would have executed the remaining terms,
provisions, covenants and restrictions without including any of such that may be
hereafter declared invalid, illegal, void or unenforceable.
(h) Waiver. No provision
of this Agreement may be waived or amended except in accordance with the terms
of the Purchase Agreement.
(i) Independent Nature of
Purchasers’ Obligations and Rights. The obligations of each
Purchaser hereunder are several and not joint with the obligations of any other
Purchasers hereunder, and no Purchaser shall be responsible in any way for the
performance of the obligations of any other Purchaser
hereunder. Nothing contained herein or in any other agreement or
document delivered at any closing, and no action taken by any Purchaser pursuant
hereto, shall be deemed to constitute the Purchasers as a partnership, an
association, a joint venture or any other kind of entity, or create a
presumption that the Purchasers are in any way acting in concert with respect to
such obligations or the transactions contemplated by this
Agreement. Each Purchaser shall be entitled to protect and enforce
its rights, including without limitation the rights arising out of this
Agreement, and it shall not be necessary for any other Purchaser to be joined as
an additional party in any proceeding for such purpose.
SIGNATURE
PAGES TO FOLLOW
IN WITNESS WHEREOF, the
undersigned has caused this Amendment and Reaffirmation Agreement to be duly
executed as of the date first written above.
CLEVELAND
BIOLABS, INC.
|
|
|
By:
|
/s/
Michael Fonstein
|
Name:
|
Michael
Fonstein
|
Title:
|
President
and Chief Executive
Officer
|
[AMENDMENT
AND REAFFIRMATION AGREEMENT FOR PURCHASERS]
Acknowledgement
and Confirmation
The
undersigned investor hereby acknowledges receipt of this Amendment and
Reaffirmation Agreement and confirms its subscription to purchase Securities in
the offering pursuant to the terms of the Purchase Agreement.
Signature: ______________________________
Name of
Investor(s): ______________________________
Title (if
investor is not an
individual): ______________________________
Dated:
March ___, 2009
[SIGNATURE
PAGES OF PURCHASERS OMITTED]
FOR IMMEDIATE
RELEASE
CLEVELAND
BIOLABS CONCLUDES PRIVATE PLACEMENT
OF
SERIES D PREFERRED STOCK AND COMMON
STOCK
WARRANTS
Buffalo, NY – March 30, 2009. Cleveland BioLabs,
Inc. (NASDAQ: CBLI)
(the “Company”) announced today that it concluded its offering of series D
convertible preferred stock (“Series D Preferred”), and warrants to purchase
common stock, raising in a final closing on March 27, 2009, approximately
$800,000 in capital through a private placement of 78.9 shares of Series D
Preferred and warrants to purchase 563,576 shares of the Company’s common
stock. This issuance of Series D Preferred and warrants is in
addition to the previous issuances of Series D Preferred and warrants to
purchase common stock consummated on February 13, 2009, and March 20, 2009,
announced by the Company on February 17, 2009, and March 23, 2009,
respectively.
The
aggregate purchase price paid by the purchasers in the recently consummated
transaction was $789,000 bringing the total amount raised at all three closings
to approximately $5,428,000. After related fees and expenses, the Company
received approximately $4,460,000 in the aggregate. The Company
intends to use the proceeds of the private placement for working capital
purposes.
Michael
Fonstein, Ph.D., President and Chief Executive Officer of Cleveland BioLabs,
commented, “The Company has prepared itself to weather the economic downturn
currently experienced in the capital markets by adding to our coffers and
streamlining our development programs. With capital resources
anticipated to be sufficient to see Protectan CBLB502 through to submission for
FDA approval and potential commercialization for defense applications, and a
rich pipeline of additional compounds at or nearing critical valuation
inflection points, we believe the Company is positioned to achieve success in
these challenging times and continue to deliver value to all of our
stakeholders.”
Garden
State Securities, Inc. (the “Agent”) served as exclusive placement agent in the
transaction. For its services, the Agent received gross cash
compensation in the amount of approximately $543,000 and warrants (in gross
amount) to purchase 387,736 shares of common stock.
Each
share of Series D Preferred is convertible into approximately 7,143 shares of
common stock at the conversion price of $1.40, and each warrant is exercisable
for one share of common stock at the exercise price of $1.60. In the
aggregate, all of the Series D Preferred issued are convertible into 3,877,386
shares of common stock and all of the warrants issued (including those issued to
the Agent) are exercisable for 4,265,122 shares of common
stock.
At its
annual meeting of stockholders, the Company intends to seek approval of various
matters relating to the transaction. Directors, executive officers
and certain large stockholders of the Company who together hold approximately
33% of the total voting power of the outstanding capital stock of the Company
eligible to vote as of the date of the issuance have agreed to vote in favor of
these approvals. The Company has scheduled the annual meeting for
June 25, 2009 in Buffalo, New York, for stockholders of record on April 27,
2009.
The
Company intends to file a Current Report or Form 8-K with the Securities and
Exchange Commission today, which will include a more detailed description of the
transaction.
About
Cleveland BioLabs, Inc.
Cleveland
BioLabs, Inc. is a drug discovery and development company leveraging its
proprietary discoveries around programmed cell death to develop treatments for
cancer and protection of normal tissues from exposure to radiation and other
stresses. The Company has strategic partnerships with the Cleveland
Clinic, Roswell Park Cancer Institute, ChemBridge Corporation and the Armed
Forces Radiobiology Research Institute. To learn more about Cleveland
BioLabs, Inc., please visit the company's website at http://www.cbiolabs.com.
Cautionary
Note Regarding Forward-Looking Statements
Certain
statements included in this press release are “forward-looking statements”
intended to qualify for the safe harbors from liability established by the
Private Securities Litigation Reform Act of 1995. The transaction
described above does not assure that the Company’s business or financial results
will be successful or that the Company will not need to raise additional
capital. The Company may not be able to raise needed additional
capital on the same terms as those in the transactions described above or on any
other terms. Factors that may affect the business or financial
results or condition of the Company include the availability of capital, the
progress and outcome of clinical trials and obtaining necessary regulatory
approvals and are described more extensively in the Company’s filings with the
SEC. Stockholders and other readers are urged to consider these risks
carefully in evaluating the forward-looking statements made herein and are
cautioned not to place undue reliance on such forward-looking
statements. The forward-looking statements made herein are only made
as of the date of this press release and, except as expressly required by the
federal securities laws, the Company disclaims any obligation to publicly update
such forward-looking statements to reflect subsequent events, circumstances or
development.
Additional
Information
The Company intends to file a proxy
statement and other relevant documents concerning the transaction described
above with the SEC. The proxy statement will be distributed to the
Company’s stockholders in connection with a meeting of
stockholders. Stockholders are urged to read the proxy statement, the
documents incorporated by reference in the proxy statement, the other documents
filed with the SEC and the other relevant materials when they become available
because they will contain important information about the
transaction. Investors will be able to obtain these documents free of
charge at the SEC’s website (http://www.sec.gov). The directors,
executive officers, and certain other members of management and employees of the
Company and its subsidiaries are participants in the solicitation of proxies in
favor of approval of the transaction and related matters from the stockholders
of the Company. Information about the directors and executive
officers of the Company is set forth in its proxy statement for the 2008 annual
meeting of stockholders filed with the SEC on April 1,
2008. Additional information regarding the interests of such
participants will be included in the transaction-related proxy statement and the
other relevant documents filed with the SEC when they become
available.
The
preferred stock and warrants described in this press release will not be
registered under the Securities Act of 1933, as amended, or applicable state
securities laws and, unless so registered, may not be offered or sold in the
United States except pursuant to an exemption from the registration requirements
of the Securities Act and applicable state securities laws. This
press release does not constitute an offer to sell or the solicitation of an
offer to buy securities, nor shall it constitute an offer, solicitation or sale
in any jurisdiction in which such offer, solicitation or sale is
unlawful.
Contact:
Rachel
Levine, Director Corporate Development & Communications
Cleveland
BioLabs, Inc.
T: (646)
284-9439
E:
rlevine@cbiolabs.com
United States Securities and Exchange
Commission
WASHINGTON,
D.C. 20549
FORM
10-K
(Mark One)
x Annual Report Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
For
the fiscal year ended December 31, 2008
or
¨ Transition Report
pursuant to Section 13 or 15(d) of the Securities Exchange Act of
1934
For
the transition period from ___________to ___________
Commission
file number 001-32954
CLEVELAND
BIOLABS, INC.
(Exact
name of registrant as specified in its charter)
DELAWARE
|
|
20-0077155
|
(State
or other jurisdiction of incorporation
or
organization)
|
|
(I.R.S.
Employer Identification No.)
|
73
High Street, Buffalo, NY 14203
|
|
(716)
849-6810
|
(Address
of principal executive offices)
|
|
Telephone
No.
|
Securities
Registered Pursuant to Section 12(b) of the Act:
Title
of each class
|
|
Name
of each exchange which registered
|
Common
Stock, par value $0.005 per share
|
|
NASDAQ
Capital Market
|
Securities
Registered Pursuant to Section 12(g) of the Act:
None
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act. Yes ¨ No x
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Act. Yes ¨ No x
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days. Yes x No ¨
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K is not contained herein, and will not be contained, to the best
of registrant’s knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K. x
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
definition of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large
accelerated filer o
|
Accelerated
filer o
|
Non-accelerated
filer o
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Act). Yes ¨ No x
The
aggregate market value of the voting and non-voting common equity held by
non-affiliates, computed by reference to the price at which the common equity
was last sold or the average bid and asked price of such common equity, as of
the last business day of the registrant’s most recently completed second fiscal
quarter was $37,767,484. There were 14,014,137 shares of common stock
outstanding as of March 16, 2009.
DOCUMENTS
INCORPORATED BY REFERENCE
The
definitive proxy statement relating to the registrant’s Annual Meeting of
Stockholders, to be held on June 25, 2009, is incorporated by reference in Part
III to the extent described therein.
CLEVELAND
BIOLABS, INC.
FORM
10-K
03/30/09
Cleveland
BioLabs, Inc.
Form
10-K
For
the Fiscal Year Ended December 31, 2008
INDEX
|
|
Page
|
|
PART I
|
|
Item 1
|
Description of
Business
|
1
|
Item 1A
|
Risk
Factors
|
20
|
Item 1B
|
Unresolved Staff
Comments
|
29
|
Item 2
|
Description of
Property
|
29
|
Item 3
|
Legal
Proceedings
|
29
|
Item 4
|
Submission of
Matters to a Vote of Security Holders
|
29
|
|
Executive
Officers of the Registrant
|
|
|
PART II
|
|
Item 5
|
Market for
Registrant’s Common Equity, Related Stockholder Matters and
Issuer
|
|
|
Purchases of
Equity Securities
|
31
|
Item 6
|
Selected
Financial Data
|
32
|
Item 7
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
33
|
Item 7A
|
Quantitative and
Qualitative Disclosures About Market Risk
|
44
|
Item 8
|
Financial
Statements and Supplementary Data
|
45
|
Item 9
|
Changes in and
Disagreements with Accountants on Accounting and Financial
Disclosures
|
72
|
Item 9A
|
Controls and
Procedures
|
72
|
Item 9B
|
Other
Information
|
72
|
|
PART III
|
|
Item 10
|
Directors,
Executive Officers and Corporate Governance
|
73
|
Item 11
|
Executive
Compensation
|
73
|
Item 12
|
Security
Ownership of Certain Beneficial Owners and Management and
Related
|
|
|
Stockholder
Matters
|
73
|
Item 13
|
Certain
Relationships and Related Transactions, and Director Independence
|
73
|
Item 14
|
Principal
Accountant Fees and Services
|
73
|
|
PART IV
|
|
Item 15
|
Exhibits and
Financial Statement Schedules
|
73
|
SIGNATURES
|
|
77
|
FORWARD-LOOKING
STATEMENTS
This Annual Report on Form 10-K
contains forward-looking statements that involve risks and uncertainties.
Forward-looking statements give our current expectations of forecasts of future
events. All statements other than statements of current or historical fact
contained in this annual report, including statements regarding our future
financial position, business strategy, new products, budgets, liquidity, cash
flows, projected costs, regulatory approvals or the impact of any laws or
regulations applicable to us, and plans and objectives of management for future
operations, are forward-looking statements. The words “anticipate,” “believe,”
“continue,” “should,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,”
“will,” and similar expressions, as they relate to us, are intended to identify
forward-looking statements.
We
have based these forward-looking statements on our current expectations about
future events. While we believe these expectations are reasonable, such
forward-looking statements are inherently subject to risks and uncertainties,
many of which are beyond our control. The actual future results for Cleveland
BioLabs, Inc. may differ materially from those discussed here for various
reasons. When you consider these forward-looking statements, you should keep in
mind these risk factors and other cautionary statements in this annual report
including in Item 7 “Management’s Discussion and Analysis of Financial Condition
and Results of Operations” and in Item 1A “Risk Factors.
Given
these risks and uncertainties, you are cautioned not to place undue reliance on
such forward-looking statements. The forward-looking statements included in this
report are made only as of the date hereof. We do not undertake and specifically
decline any obligation to update any such statements or to publicly announce the
results of any revisions to any of such statements to reflect future events or
developments. When used in the report, unless otherwise indicated, “CBLI,” the
“Company,” “we,” “our” and “us” refers to Cleveland BioLabs, Inc.
PART
I
Item 1. Description of
Business
GENERAL OVERVIEW
We
were incorporated in Delaware and commenced business operations in
June 2003 as a development-stage, biotechnology company, with a very specific
and targeted focus on radiation drug discovery. We have devoted substantially
all of our resources to the identification, development and commercialization of
new types of drugs for protection of normal tissues from exposure to radiation
and other stresses, such as toxic chemicals and cancer treatments. Our pipeline
includes products from two primary families of compounds: protectans and
curaxins. We are developing protectans as drug candidates that protect healthy
tissues from acute stresses such as radiation, chemotherapy and ischemia
(pathologies that develop as a result of blocking blood flow to a part of the
body). Curaxins are being developed as anticancer agents that could act as
mono-therapy drugs or in combination with other existing anticancer
therapies.
On July 20, 2006, we sold 1,700,000
shares of common stock, par value $0.005 per share, in our initial public
offering at a per share price of $6.00. After our initial public offering, our
common stock was listed on the NASDAQ Capital Market under the symbol “CBLI” and
on the Boston Stock Exchange under the symbol “CFB.” Our trading symbol on the
Boston Stock Exchange was later changed to “CBLI.” On August 28, 2007, trading
of our common stock transferred from the NASDAQ Capital Market to the NASDAQ
Global Market. In September 2007, we ceased our listing on the Boston Stock
Exchange. On November 28, 2008, trading of our common stock
transferred from the NASDAQ Global Market back to the NASDAQ Capital
Market.
TECHNOLOGY
Our development efforts are based on
discoveries made in connection with the investigation of the cell-level process
known as apoptosis. Apoptosis is a highly specific and tightly regulated form of
cell death that can occur in response to external events such as exposure to
radiation, toxic chemicals or internal stresses. Apoptosis is a major
determinant of tissue damage caused by a variety of medical conditions including
cerebral stroke, heart attack and acute renal failure. Conversely, apoptosis is
also an important protective mechanism that allows the body to shed itself of
defective cells, which otherwise can cause cancerous growth.
Research has demonstrated that apoptosis
is sometimes suppressed naturally. For example, most cancer cells develop
resistance to apoptotic death caused by drugs or natural defenses of the human
body. Our research is geared towards identifying the means by which apoptosis
can be affected and manipulated depending on the need.
If the need is to protect healthy
tissues against an external event such as exposure to radiation, we focus our
research efforts on attempting to temporarily and reversibly suppress apoptosis
in those healthy tissues, thereby imitating the apoptotic-resistant tendencies
displayed by cancer cells. A drug with this effect would also be useful in
ameliorating the toxicities of anticancer drugs and radiation that cause
collateral damage to healthy tissues during cancer treatment. Because the severe
toxicities of anticancer drugs and radiation often limit their dosage in cancer
patients, an apoptosis suppressant drug may enable a more aggressive treatment
regimen using anticancer drugs and radiation and thereby increase their
effectiveness. At the
present time, the primary focus of our research is on the protection
of healthy tissues against external exposures resulting from military or defense
activities.
On the other hand, if the need is to
destroy cancerous cells, we focus our research efforts on restoring apoptotic
mechanisms that are suppressed in tumors, so that those cancerous cells will
once again become vulnerable to apoptotic death. In this regard, we believe that
our drug candidates could have significant potential for improving, and becoming
vital to, the treatment of cancer patients. At the present time, our research
efforts in this area are limited as we dedicate the majority of our resources to
military and defense applications.
Through our research and development, or
R&D, and our strategic partnerships, we have established a technological
foundation for the development of new pharmaceuticals and their rapid
preclinical evaluation.
We have acquired rights to develop and
commercialize the following prospective drugs:
|
·
|
Protectans - modified factors of
microbes and tumors that protect cells from apoptosis, and which therefore
have a broad spectrum of potential applications. The potential
applications include both non-medical applications such as protection from
exposure to radiation, whether as a result of military or terrorist action
or as a result of a nuclear accident, as well as medical applications such
as reducing cancer treatment
toxicities.
|
|
·
|
Curaxins - small
molecules designed to kill tumor cells by simultaneously targeting two
regulators of apoptosis. Initial test results indicate that curaxins can
be effective against a number of malignancies, including
hormone-refractory prostate cancer, renal cell carcinoma, or RCC (a highly
fatal form of kidney cancer) and soft-tissue
sarcoma.
|
In the area of radiation protection, we
have achieved high levels of protection in animal models. With respect to cancer
treatment, the biology of cancer is such that there is no single drug that can
be successfully used to treat 100% or even 50% of all cancer patients. This
means that there likely will be a need for additional anticancer drugs for each
type of cancer.
These drug candidates demonstrate the
value of our scientific foundation. Based on the expedited approval process
currently available for non-medical applications such as protection from
exposure to radiation, our most advanced drug candidate, Protectan CBLB502, may
be approved for such applications within 24 months. Another drug candidate,
Curaxin CBLC102, demonstrated efficacy and safety in a Phase IIa clinical
trial concluded in late 2008.
INDUSTRY
CBLI is a biotechnology, or biotech,
company focused on developing cancer treatment, tissue protection and biodefense
drugs. Historically, biotech was defined by newly discovered “genetic
engineering” technology, which was first developed in universities and new
startup biotech companies in the mid-1970s. Later, other technologies (based on
a constant flow of discoveries in the field of biology) started playing a
leading role in biotech development. Medicine, and specifically drug
development, is a lucrative field for use of these technologies. Large
pharmaceutical, or Pharma, companies joined the biotech arena through licensing,
sponsored research, and corporate agreement relationships. Today biotech is a
$296 billion industry (based on total market capitalization) and includes large
companies such as Amgen, Inc. and Genentech, Inc.
The traditional biotech business model
is a derivative of the long drug development process. Typical biotech companies
go through the following stages:
|
·
|
During the first stage, biotech
companies fund their development through equity or debt financings while
conducting R&D, which culminates in phased drug
trials.
|
|
·
|
During the second stage, when
their lead drug candidates enter the drug trials, biotech companies may
start licensing their drug candidates to Pharma companies in order to (1)
generate revenue, (2) gain access to additional expertise, and (3)
establish relations with Pharma companies in the market who can eventually
take a leading role in distributing successful
drugs.
|
|
·
|
At the most advanced stage,
biotech companies generate revenues by selling drugs or other biotech
products to consumers or through alliances of
equals.
|
The Project BioShield Act, which was
signed into law in July 2004, allocated $5.6 billion over ten years to fund the
research, development and procurement of drugs, biological products or devices
to treat or prevent injury from exposure to biological, chemical, radiological
or nuclear agents as a result of a military, terrorist or nuclear attack. The
legislation provides for a more expedited approval process by allowing for
approval based on Phase I safety studies in humans and efficacy studies in two
animal species (rodents and non-human primates) instead of Phase II and III
human clinical trials (see Government
Regulation). With the
Project BioShield Act, biotech companies now have greater access to grants and
contracts with the U.S. government. Several biotech companies
have secured grants and contracts from the U.S. government to develop drugs and
vaccines as medical countermeasures against potential terrorist attacks. For
biotech companies focused on these types of drugs and vaccines, this type of
funding, together with the modified Food and Drug Administration, or FDA,
approval process, are major departures from the traditional biotech business
model. The principal provisions of this law are to:
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Facilitate R&D efforts of
biomedical countermeasures by the
NIH;
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Provide for the procurement of
needed countermeasures through a special reserve fund of $5.6 billion over
ten years; and
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Authorize, under limited
circumstances, the emergency use of medical products that have not been
approved by the FDA.
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STRATEGIES AND
OBJECTIVES
Our primary objective is to become a
leading developer of drugs for the protection of human tissues against radiation
and other stresses and for cancer treatment. Key elements of our strategy
include:
Aggressively working
towards the commercialization of Protectan CBLB502. Our most advanced drug candidate,
Protectan CBLB502, offers the potential to protect normal tissues against
exposure to radiation. Because of the potential military and defense
implications of such a drug, the normally lengthy FDA approval process for these
non-medical applications is substantially abbreviated resulting in a large cost
savings to us. We expect to complete development of Protectan CBLB502 for these
non-medical applications by the end of 2010.
Leveraging our
relationship with leading research and clinical development
institutions. The Cleveland
Clinic Foundation, one of the top research medical facilities in the world, is
one of our co-founders. In addition to providing us with drug leads and
technologies, the Cleveland Clinic will share valuable expertise with us as
clinical trials are performed on our drug candidates. In January 2007, we
entered into a strategic research partnership with Roswell Park Cancer
Institute, or RPCI, in Buffalo, New York. This partnership will enhance the
speed and efficiency of our clinical research and provide us with access to the
state-of-the-art clinical development facilities of a globally recognized cancer
research center.
Utilizing
governmental initiatives to target our markets. Our focus on drug candidates such as
Protectan CBLB502, which has applications that have been deemed useful for
military and defense purposes, provides us with a built-in market for our drug
candidates. This enables us to invest less in costly retail and marketing
resources. In an effort to improve our responsiveness to military and defense
needs, we have established a collaborative relationship with the Armed Forces
Radiobiology Research Institute.
Utilizing other
strategic relationships. We
have collaborative relationships with other leading organizations that enhance
our drug development and marketing efforts. For example, one of our founders,
with whom we maintain a strategic partnership, is ChemBridge Corporation. Known
for its medicinal chemistry expertise and synthetic capabilities, ChemBridge
provides valuable resources to our drug development
research.
PRODUCTS IN
DEVELOPMENT
Protectans
We are exploring a new natural source of
factors that suppress the programmed cell death (apoptosis) response in human
cells, which can be rapidly developed into therapeutic products. These
inhibitors are anti-apoptotic factors developed by microorganisms of human
microflora throughout millions of years of co-evolution with mammalian
host. We are using the same strategy that was applied for the
discovery of antibiotics, one of the biggest medical achievements of the
20
th century. We have
established a technological pipeline for screening of such factors, named
protectans, and their rapid preclinical evaluation. Such inhibitors can be used
as protection from cancer treatment side effects and antidotes against injuries
induced by radiation and other stresses associated with severe pathologies
(i.e., heart attack or stroke).
Fourteen families of patents have been
filed over the past five years around various aspects and qualities of the
protectan family of compounds. The first patent covering the method of
protecting a mammal from radiation using flagellin or its derivatives, including
Protectan CBLB502, was recently granted by the Eurasian Patent Organization
(nine countries) and two other countries.
We spent approximately $8,995,500 and
$11,828,423 on R&D for
protectans for all applications in the fiscal years ended December 31,
2008 and December 31, 2007, respectively. From our inception to December 31,
2008, we spent approximately $26,508,500 on R&D for protectans.
Protectan CBLB502
Protectan CBLB502 is our leading
radioprotectant molecule in the protectans series. Protectan CBLB502 represents
a rationally-designed derivative of the microbial protein, flagellin. Flagellin
is secreted by Salmonella
typhimurium and many other
Gram-negative bacteria, and in nature, arranges itself in a hollow cylinder to
form the filament in bacterial flagellum and acts as a natural activator of
NF-kB (nuclear factor-kappa B), a protein complex widely used by cells as a
regulator of genes that control cell proliferation and cell survival. Thus,
Protectan CBLB502 reduces injury from acute stresses by mobilizing several
natural cell protective mechanisms, including inhibition of apoptosis, reduction
of oxidative damage and induction of factors (cytokines) that induce protection
and regeneration of stem cells in bone marrow and the
intestines.
Protectan CBLB502 is a single agent
anti-radiation therapy with significant survival benefits at a single dose.
Animal studies indicate that Protectan CBLB502 protects mice without increasing
the risk of radiation-induced cancer development. The remarkably strong
radioprotective abilities of Protectan CBLB502 are the result of a combination
of several mechanisms of action. Potential applications for Protectan CBLB502
include reduction of radiation therapy or chemotherapy toxicities in cancer
patients, protection from Acute Radiation Syndrome (ARS) in defense scenarios,
and protection from acute organ failure. Protectan CBLB502 is administered
through intramuscular injection.
We spent approximately $8,021,040 and
$10,701,175 on R&D for Protectan CBLB502 in the fiscal years ended December
31, 2008 and December 31, 2007, respectively. From our inception to December 31,
2008, we spent approximately $23,378,126 on R&D for Protectan
CBLB502.
We intend to enter into negotiations for
contracts to purchase Protectan CBLB502 with various U.S. and international government agencies
in the third quarter of 2009. If the U.S. government makes significant future
contract awards for the supply of its emergency stockpile to our competitors,
our business will be harmed and it is unlikely that we will be able to
ultimately commercialize our competitive product.
Non-medical
Applications
Our scientists have demonstrated that
injecting Protectan CBLB502 into mice, rats and non-human primates protects them
from lethal doses of total body gamma radiation. An important advantage of
Protectan CBLB502, above any other radioprotectant known to us, is the ability
to effectively protect not only the hematopoietic system, but also the
gastrointestinal, or GI, tract, which is among the most sensitive areas of the
human body to radiation. High levels of radiation, among other effects, induce
moderate to severe bone marrow damage. The immune and blood stem cells are also
depleted and death is caused by anemia, infection, bleeding and poor wound
healing. GI damage often occurs at higher doses of radiation, and may result in
death through sepsis as a result of perforation of the GI tract. Protectan
CBLB502’s ability to effectively protect the hematopoietic system and GI tract
may make Protectan CBLB502 uniquely useful as a radioprotective antidote.
Protectan CBLB502 was shown to be safe at its therapeutic doses in rodents and
non-human primates. In addition, Protectan CBLB502 has proved to be a stable
compound for storage purposes. It can be stored at temperatures close to
freezing, room temperature or extreme heat. Manufacturing of Protectan CBLB502
is cost efficient, due to its high yield bacterial producing strain and simple
purification process.
We have successfully established cGMP
quality manufacturing for Protectan CBLB502 and are nearing completion of the
first of two Phase I human safety studies for Protectan CBLB502 in ARS.
Protectan CBLB502 is being developed under the FDA's animal efficacy rule to
treat radiation injury following exposure to radiation from nuclear or
radiological weapons, or from nuclear accident. This approval pathway requires
demonstration of efficacy in two animal species and safety and drug metabolism
testing in a representative sample of healthy human volunteers. Protectan
CBLB502 has demonstrated activity as a radioprotectant in several animal
species, including non-human primates. Phase I is the only stage of human
testing required for approval in this indication.
The FDA gave us permission to start
safety testing on humans on August 7, 2008. The first healthy volunteer in the
dose escalation safety study was dosed on October 14, 2008. The initial safety
study will involve single injections of Protectan CBLB502 in ascending dose
groups of six healthy volunteers each. Participants in the study are being
assessed for adverse side effects over two-week time period and blood samples
are being obtained to assess the effects of Protectan CBLB502 on various
biomarkers. The study is currently projected to be completed in spring 2009. The
second safety study in a larger number of healthy volunteers is planned to start
in the third quarter of 2009.
We are working towards filing a BLA for
FDA approval of Protectan CBLB502 for non-medical applications by the end of
2010.
The Defense Threat Reduction Agency of
the U.S. Department of Defense, or DoD, awarded us a $1.3 million grant in March
2007, to fund “development leading to the acquisition” of Protectan CBLB502 as a
radiation countermeasure, in collaboration with the Armed Forces Radiobiology
Research Institute, which has also received significant independent funding for
work on Protectan CBLB502.
In March 2008, the U.S. Department of
Defense, or DoD, awarded us a contract valued at up to $8.9 million through the
Chemical Biological Medical Systems Joint Project Management Office Broad Agency
Announcement, or BAA, for selected tasks in the advanced development of
Protectan CBLB502 as a Medical Radiation Countermeasure to treat radiation
injury following exposure to radiation from nuclear or radiological
weapons.
On September 12, 2008, we were awarded a
$774,183 grant from the National Institute of Allergy and Infectious Diseases
(NIAID) of the National Institutes of Health (NIH), to further study certain
mitigating properties of Protectan CBLB502 in the context of hematopoietic
damage from radiation exposure. The grant program, Medical Countermeasures to
Enhance Platelet Regeneration and Increase Survival Following Radiation
Exposure, is funded through the Project BioShield Act of 2004 and administered
by the Department of Health and Human Services.
On September 16, 2008, the Biomedical
Advanced Research and Development Authority (BARDA) of the Department of Health
and Human Services (HHS) awarded us a contract under the Broad Agency
Announcement titled, "Therapies for Hematopoietic Syndrome, Bone Marrow Stromal
Cell Loss, and Vascular Injury Resulting from Acute Exposure to Ionizing
Radiation," for selected tasks in the advanced development of Protectan CBLB502.
The total contract value including all milestone-based options is $13.3 million
over a three-year period, with the first year's award of $3.4 million. BARDA
seeks to acquire developed medical countermeasures that will be clinically
useful in a civilian medical emergency situation that results from or involves
exposure of a large population to the effects of a nuclear detonation, a
radiologic dispersive device (such as a dirty bomb), or exposure to radioactive
material with or without combined injury or trauma.
Protectan CBLB502's unprecedented
efficacy, unique ability to address both hematopoietic and GI damage, broad time
window of use, and mitigation effects that do not require additional supportive
care and set it apart from any other existing or therapies.
We spent approximately $7,264,813 and
$9,885,776 on R&D for the non-medical applications of Protectan CBLB502 in
the fiscal years ended December 31, 2008 and December 31, 2007, respectively.
From our inception to December 31, 2008, we spent approximately $21,601,196 on
R&D for the non-medical applications of Protectan
CBLB502.
Protectan CBLB502 is a candidate for
procurement by the DoD, HHS/BARDA and other countries facing even more imminent
threats. The HHS opportunity is particularly positive for us as the agency’s
mandate is to protect the U.S. civilian population in the event of a
radiological emergency, including stockpiling radiation countermeasures for mass
distribution. Our contract awards from the DoD and from BARDA emphasize the
government’s focus on acquiring adequate protection against nuclear and
radiation threats for military and civilian populations. Upon FDA approval, our
Protectan CBLB502 will be well positioned to fulfill both of these needs, with
its demonstrated unprecedented efficacy and survival benefits, unique ability to
address both hematopoietic and GI damage, broad window of efficacy relative to
radiation exposure, and suitability for both military and civilian delivery
scenarios. We believe that Protectan CBLB502 is the only radiation
countermeasure with these capabilities in advanced development that can be self
or buddy-administered, without the need of additional supportive care in a
battlefield or civilian community setting.
Regulatory Status
Extraordinary radioprotective
properties, an excellent toxicity profile, outstanding stability and cost
efficient production of Protectan CBLB502 make it a primary candidate for
entering formal preclinical and clinical studies. Initially, Protectan CBLB502
will be developed for non-medical purposes — as a radioprotectant antidote for
the protection of people from severe doses of ionizing radiation. Our drug
development strategy complies with the recently adopted FDA rules for
investigational drugs that address situations such as radiation injury, where it
would be unethical to conduct efficacy studies in humans. While Phase II and
Phase III human clinical trials are normally required for the approval of
marketing an investigational drug, under the FDA rules, Protectan CBLB502 would
be considered for approval for this indication based on Phase I safety studies
in humans and efficacy studies in two animal species (rodents and non-human
primates). Based upon this expedited approval process, Protectan CBLB502 could
be approved for non-medical applications within 24 months. Because Phase II and
Phase III testing involves applying a drug candidate to a large numbers of
participants who suffer from the targeted disease and condition and can last for
a total of anywhere from three to six or additional years, bypassing these
phases represents a significant time and cost savings in receiving FDA
approval.
As part of this expedited approval
process, the FDA has indicated that it intends to engage in a highly interactive
review of Investigational New Drug, or IND, applications and New Drug
Applications, or NDAs, and to provide for accelerated review or approval of
certain medical products for counterterrorism applications, including granting
eligible applications “Fast Track” approval status. The Fast Track designation
ordinarily allows a product to be considered for accelerated approval through
the use of surrogate endpoints to demonstrate effectiveness. As a result of
these provisions, the FDA has broader authority to consider evidence of partial
tumor shrinkage or other surrogate endpoints of clinical benefit in deciding on
approval. This new policy is intended to facilitate the study of cancer
therapies and shorten the total time required for marketing approvals. In cases
where priority review is given to Fast Track applications, the applicant is
permitted to submit applications on a rolling basis.
As part of the process to receive final
FDA approval for Protectan CBLB502 for non-medical applications, we have
completed Good Manufacturing Practices compliant (cGMP) manufacturing of
Protectan CBLB502. The yields from the process and the purity of the final
product exceeded our expectations. We were able to develop a complicated,
high-yield manufacturing process for CBLB502 was and were able to prototype the
process and resolve multiple challenges during the industrial development. We
currently have drug substance corresponding to several hundred thousand
projected human doses, or potentially many more, depending on the final
therapeutic dose to be used, which will be determined through our Phase I safety
trial. The process we developed gives us the ability to manufacture up to five
million estimated doses within a year without any additional scale-up; and if
necessary, scale-up could be implemented relatively easily.
Prior to our receiving final FDA
approval for Protectan CBLB502 for non-medical applications, we will need to
complete several interim steps, including:
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Performing a Phase I
dose-escalation human study on a small number of volunteers. We expect to
complete this study in March 2009 at an approximate cost of
$1,500,000.
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Conducting pivotal animal efficacy
studies with the cGMP manufactured drug candidate. We expect to complete
these studies in mid 2010. At the present time, the costs of these studies
cannot be approximated with any level of
certainty.
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Performing a human safety study in
a larger number of volunteers using the dose of Protectan CBLB502
previously shown to be safe in humans and efficacious in animals. We
estimate completion of this study in late 2010 at an approximate cost of
$5,300,000 based on 500 subjects tested in four
locations.
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Filing a BLA which we expect to
complete in late 2010. At the present time, the costs of the filing cannot
be approximated with any level of
certainty.
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The Project BioShield Act of 2004, which
further expedites the approval of drug candidates for certain uses, is intended
to bolster our nation’s ability to provide protections and countermeasures
against biological, chemical, radiological or nuclear agents that may be used in
a military, terrorist or nuclear attack. This law also allows for the use of
expedited peer review when assessing the merit of grants and contracts of up to
$1,500,000 for countermeasure research. We have been awarded a $1,500,000
research grant pursuant to this law.
The DoD also awarded a $1 million grant
to our founding partner, the Cleveland Clinic, to conduct pre-clinical studies
on Protectan CBLB502 for use in tourniquet and other ligation-reperfusion
battlefield injuries where blood flow is stopped and then restored after a
prolonged period of time.
Medical Applications
While our current focus remains on its
military and other non-medical applications, Protectan CBLB502 has been observed
to dramatically increase the efficacy of radiotherapy of experimental tumors in
mice. Protectan CBLB502 appears to increase the tolerance of mice to radiation
while having no effect on the radiosensitivity of tumors, thus opening the
possibility of combining radiotherapy with Protectan CBLB502 treatment to
improve the overall anticancer efficacy of radiotherapy. Our animal efficacy
studies have demonstrated that up to 100% of mice treated with Protectan CBLB502
prior to being exposed to radiation survived without any associated signs of
toxicity. This compares to a 100% mortality rate in the animal group that
received a placebo drug.
Specifically, Protectan CBLB502 has
demonstrated the ability to reduce the toxicities of a chemotherapeutic drug,
cisplatin (Platinol), broadly used for the treatment of ovarian, endometrial,
head and neck, lung, stomach and other types of cancer in animal models.
Cisplatin treatment was used in the study as an example of
chemotherapy-associated toxicity. Cisplatin injected at toxic doses is known to
induce myelosuppression (suppression of bone marrow) and nephrotoxicity (kidney
damage).
The prospect of increasing patients'
tolerance to chemotherapeutic drugs and optimizing treatment regimens would be a
significant paradigm shift in cancer treatment. It is estimated that
approximately 40% of the roughly $50 billion annually spent on cancer treatment
represents supportive care addressing toxicities of various treatments,
including chemotherapy.
Consistent with this strategy, we plan
to initiate a Phase I/II study for Protectan CBLB502 in head and neck cancer
patients in mid-2009. The endpoint of the study will be
the reduction of toxicities of radiation and chemotherapy, such as mucositis (a
painful inflammation and ulceration of oral mucosa causing difficulties with
speaking and eating). Mucositis weakens the patient by not allowing for the oral
intake of nutrients and fluids and forces the temporary suspension of
radiotherapy and chemotherapy until the tissues of the mouth and throat have
healed. Due to the ability of head and neck cancer cells to regrow during
periods of interrupted treatment, any interruption in radiotherapy should be
avoided. Since the main cause of treatment interruptions in radiotherapy or
combinations of chemotherapy and radiotherapy treatment regimens of head and
neck cancer is acute mucositis, the ability to prevent mucositis, and therefore,
interruptions in treatment, could potentially result in better outcomes for
patients with cancers of the head and neck.
In other studies, we have demonstrated
the potential of Protectan CBLB502 to be applicable to ischemic conditions. Our
researchers, in collaboration with investigators from Cleveland Clinic, have
demonstrated that a single injection of Protectan CBLB502 effectively prevents
acute renal failure and subsequent death in a mouse model of
ischemia-reperfusion renal injury.
Moreover, studies funded by a grant from
the DoD and conducted at the Cleveland Clinic, have demonstrated Protectan
CBLB502’s ability to accelerate limb recovery in an animal model of
tourniquet-mediated injury simulating the situation occurring in human. It has
been demonstrated that injection of Protectan CBLB502 within 30 minutes of
tourniquet removal leads to a marked reduction in the severity of injury,
including reductions in tissue edema, pro-inflammatory cytokine production and
leukocyte infiltration leading to accelerated recovery of limb
function.
In contrast to the non-medical
applications of CBLB502, the use of Protectan CBLB502 to ameliorate the side
effects of radiation treatment and anticancer drugs will be subject to the full
FDA approval process.
In order for us to receive final FDA
approval for Protectan CBLB502 for medical applications, we will need to
complete various tasks, including:
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Submitting an amendment to our
CBLB502 IND application and receiving allowance from the FDA. We cannot
estimate with any certainty when the FDA may allow the application. We
expect to submit the amendment upon the receipt of dedicated federal
funding. We estimate that the approximate cost of filing will be less than
$100,000.
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Performing a Phase I/II human
efficacy study on a small number of cancer patients. We expect to complete
this study two years from the receipt of allowance from the FDA of the IND
amendment at an approximate cost of
$1,500,000.
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Performing an additional Phase II
efficacy study on a larger number of cancer patients. At the present time,
the costs and the scope of this study cannot be approximated with any
level of certainty.
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Performing a Phase III human
clinical study on a large number of cancer patients and filing a BLA with
the FDA. At the present time, the costs and the scope of these steps
cannot be approximated with any level of
certainty.
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We spent approximately $756,227 and
$815,399 on R&D for the medical applications of Protectan CBLB502 in the
fiscal years ended December 31, 2008 and December 31, 2007, respectively. From
our inception to December 31, 2008, we spent approximately $1,776,929 on R&D
for the medical applications of Protectan CBLB502.
Protectan CBLB612
While the bulk of our R&D has
focused on Protection CBLB502, we have conducted some preliminary research into
a compound derived from the same family and which we refer to as Protectan
CBLB612. Protectan CBLB612
is a modified lipopeptide mycoplasma that acts as a powerful stimulator and
mobilizer of hematopoietic (bone marrow/blood production) stem cells, or HSC, to
peripheral blood. Potential applications for Protectan CBLB612 include
accelerated hematopoietic recovery during chemotherapy and during donor
preparation for bone marrow transplantation.
Our research indicates that Protectan
CBLB612 is not only a potent stimulator of bone marrow stem cells, but also
causes their mobilization and proliferation throughout the blood. A single
administration of Protectan CBLB612 resulted in a three-fold increase in the
number of progenitor stem cells in mouse bone marrow within 24 hours after
administration. Furthermore, the number of these stem cells in peripheral blood
was increased ten-fold within four days of administration.
Protectan CBLB612 was also found to be
highly efficacious in stimulating proliferation and mobilization of
hematopoietic stem cells into peripheral blood in a primate model (Rhesus
macaques). A single injection of Protectan CBLB612 in Rhesus macaques
resulted in a 20-fold increase of hematopoietic progenitor cells in
blood. At the peak of the effect (48-72 hours post-injection) the
proportion of free-floating CD34+ cells in the total white blood cell count
reached 30% (compared with 1.5% in normal blood). CD34 is a molecule
present on certain cells within the human body. Cells expressing
CD34, otherwise known as CD34+ cells, are normally found in the umbilical cord
and bone marrow as hematopoietic cells.
This discovery opens a new and
innovative way for us to address a broad spectrum of human diseases, some of
which currently lack effective treatment. Direct comparisons of Protectan
CBLB612 and the market leading drug used for stimulation of blood regeneration,
G-CSF (Neupogen®, Amgen, Inc., Thousand Oaks, California), demonstrated a
stronger efficacy of Protectan CBLB612 as a propagator and mobilizer of HSC in
peripheral blood.
Protectan CBLB612's strength as a stem
cell stimulator was further demonstrated by the outcome of its combined use with
G-CSF and Mozibil (AMD3100) (a recently FDA approved stem cell mobilizer from
Genzyme Corporation (Cambridge, Massachusetts)), where the addition of Protectan
CBLB612 resulted in eight to ten times higher yields of HSC in peripheral blood
in comparison with the standard protocol.
In addition to efficacy in stimulation
and mobilization of stem cells, Protectan CBLB612 was found to be highly
effective in an animal bone marrow stem cell transplantation model. Blood from
healthy mice treated by Protectan CBLB612 was transplanted into mice that
received a lethal dose of radiation that killed hematopoietic (bone marrow/blood
production) stem cells. A small amount of blood from the Protectan
CBLB612 treated mice successfully rescued the mice with radiation-induced bone
marrow stem cell deficiency. 100% of the deficient mice transplanted
with blood from CBLB612 treated mice survived past the 60-day mark, while 85% of
the untreated deficient mice died within the first three weeks of the
experiment. The 60-day mark is considered to be the critical point in
defining the presence of long-term, adult bone marrow stem cells, which are
capable of completely restoring lost or injured bone marrow
function. The rescuing effect of the peripheral blood of the treated
mice was equivalent to that of conventional bone marrow
transplantation.
Adult hematological bone marrow stem
cell transplantation is currently used for hematological disorders (malignant
and non-malignant), as well as some non-hematological diseases, such as breast
cancer, testicular cancer, neuroblastoma, ovarian cancer, Severe Combined Immune
Deficiency (SCID), Wiskott-Aldrich syndrome, and Chediak-Higashi
syndrome.
With efficacy and non-GLP safety already
studied in mice and monkeys, Protectan CBLB612 entered formal pre-clinical
safety and manufacturing development in February 2008. Further development of
CBLB612 will continue upon achieving sufficient funding for completing
pre-clinical development and a Phase I study. Development of Protectan CBLB612
has been supported by a grant from the Defense Advanced Research Projects Agency
of the Department of Defense.
In order for us to receive final FDA
approval for Protectan CBLB612, we need to complete several interim steps,
including:
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Conducting pivotal animal safety
studies with GMP-manufactured
CBLB612.
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Submitting an IND application and
receiving approval from the
FDA;
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Performing a Phase I
dose-escalation human study;
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Performing a Phase II and Phase
III human efficacy study using the dose of CBLB612 selected from the
previous studies previously shown to be safe in humans and efficacious in
animals; and
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Filing a New Drug
Application.
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At this time, none of the above costs
are reasonably estimitable.
We spent approximately $974,459 and
$1,127,248 on R&D for Protectan CBLB612 in the fiscal years ended December
31, 2008 and December 31, 2007, respectively. From our inception to December 31,
2008, we spent approximately $3,130,374 on R&D for Protectan CBLB612.
Further development and extensive testing will be required to determine its
technical feasibility and commercial viability.
Curaxins
Curaxins are small molecules that
destroy tumor cells by simultaneously targeting two regulators of apoptosis. Our
initial test results indicate that curaxins can be effective against a number of
malignancies, including renal cell carcinoma, or RCC, soft-tissue sarcoma, and
hormone-refractory prostate cancer.
The original focus of our drug
development program was to develop drugs to treat one of the most
treatment-resistant types of cancer, RCC. Unlike many cancer types that
frequently mutate or delete p53, one of the major tumor suppressor genes, RCC
belongs to a rare category of cancers that typically maintain a wild type form
of this protein. Nevertheless, RCC cells are resistant to apoptosis, suggesting
that in spite of its normal structure, p53 is functionally disabled. The work of
our founders has shown that p53 function is indeed inhibited in RCC by an
unknown dominant factor. We have established a drug discovery program to
identify small molecules that selectively destroy tumor cells by restoring the
normal function to functionally impaired p53 in RCC. This program yielded a
series of chemicals with the desirable properties named curaxins (CBLC100
series). We have isolated three chemical classes of curaxins. One of them
includes relatives of 9-aminoacridine, the compound that is the core structure
of many existing drugs. Pre-existing information about this compound has allowed
us to bypass the preclinical development and Phase I studies and bring one of
our drug candidates into Phase IIa clinical trials, saving years of R&D
efforts and improving the probability of success.
One of the most important outcomes of
this drug discovery program was the identification of the mechanism by which
curaxins deactivate NF-kB. This mechanism of action makes curaxins potent
inhibitors of the production and the activity of NF-kB not only in its
stimulated form, but also in its basal form. The level of active NF-kB is
usually also increased in cancer cells. Moreover, due to curaxin-dependent
functional conversion of NF-kB-DNA complexes, the cells with the highest basal
or induced NF-kB activity are supposed to be the most significantly affected by
curaxins. Clearly, this paradoxical activity makes deactivation of NF-kB by
curaxins more advantageous compared to conventional strategies targeting NF-kB
activators.
The discovery of the mechanism of action
of curaxins allowed us to predict and later experimentally verify that curaxins
could be used for treatment of multiple forms of cancers, including
hormone-refractory prostate cancer, hepatocellular carcinoma, multiple myeloma,
acute lymphocytic leukemia, acute myeloid leukemia, soft-tissue sarcomas and
several others.
A significant milestone in the curaxin
program was a recently achieved breakthrough in deciphering the finer details of
the mechanism of action of these compounds. Successful identification
of the exact cellular moiety that binds to curaxins has provided a mechanistic
explanation for the unprecedented ability of these compounds to simultaneously
target several signal transduction pathways.
This new mechanistic knowledge enabled
us to discover additional advantages of curaxins and to rationally design
treatment regimens and drug combinations, which have since been validated in
experimental models. In addition, this understanding further
strengthens our intellectual property position for this exciting class of
principally new anticancer drugs.
We spent approximately $3,233,872 and
$4,708,773 on R&D for curaxins overall in the fiscal years ended December
31, 2008 and December 31, 2007, respectively. From our inception to December 31,
2008, we spent approximately $11,641,592 on R&D for
curaxins.
Curaxin CBLC102
One of the curaxins from the
9-aminoacridine group is a long-known, anti-infective compound known as
quinacrine, which we refer to as Curaxin CBLC102. It has been used for over 40
years to treat malaria, osteoarthritis and autoimmune disorders. However, we
have discovered new mechanisms of action for quinacrine in the area of
apoptosis. Through assay testing performed at Dr. Andrei Gudkov’s laboratories
at the Cleveland Clinic beginning in 2002, which included testing in a variety
of human tumor-derived cell lines representing cancers of different tissue
origin (including RCC, sarcomas, prostate, breast and colon carcinomas), we have
observed that Curaxin CBLC102 behaves as a potent NF-kB suppressor and activator
of p53 in these types of cancer cells. It has favorable pharmacological and
toxicological profiles and demonstrates the anticancer effect in transplants of
human cancer cells into primates.
We have applied for a patent covering
the use of Curaxin CBLC102 as an anticancer agent.
We have an agreement with Regis
Technologies, Inc., a GMP manufacturer, to produce sufficient quantities of
Curaxin CBLC102 according to the process previously used for the production of
this drug when it was in common use.
We launched a Phase II study with
CBLC102 in January 2007 to provide proof of safety and of anti-neoplastic
activity in cancer patients and establish a foundation for clinical trials of
our new proprietary curaxin molecules, which have been designed and optimized
for maximum anticancer effects, as well as for additional treatment regimens
based on ongoing research into the precise molecular mechanisms of action of
curaxins.
Thirty-one patients were enrolled in a
Phase II study of CBLC102 as a monotherapy in late stage, hormone-refractory
taxane-resistant prostate cancer. All patients had previously
received hormonal treatment for advanced prostate cancer and 28 of the 31 had
also previously received chemotherapy. One patient had a partial
response, while 50% of the patients exhibited a decrease or stabilization in PSA
velocity, a measure of the speed of prostate cancer
progression. CBLC102 was well tolerated and there were no serious
adverse events attributed to the drug. The trial demonstrated
indications of activity and a remarkable safety profile in one of the most
difficult groups of cancer patients.
The indications of activity and
remarkable safety demonstrated in the CBLC102 Phase II trial, in conjunction
with new mechanistic discoveries, point to additional potential treatment
paradigms including combination therapies with existing drugs or prospective use
as a cancer prevention agent. Additional potential uses for CBLC102
will be explored in conjunction with our strategic partners at Roswell Park
Cancer Institute.
We anticipate that additional clinical
efficacy studies will be required before we are able to apply for FDA approval.
Because of the uncertainties of the scope of the remaining clinical studies, we
cannot currently estimate when any development efforts may be completed or the
cost of completion. Nor can we estimate when we may realize any cash flow from
the development of Curaxin CBLC102.
We spent approximately $1,741,194 and
$2,712,521 on R&D for Curaxin CBLC102 in the fiscal years ended December 31,
2008 and December 31, 2007, respectively. From our inception to December 31,
2008, we spent approximately $6,466,483 on R&D for Curaxin
CBLC102.
Other Curaxins
As mentioned above, screening of the
chemical library for compounds capable of restoring normal function to wild type
p53 in the context of RCC yielded three chemical classes of compounds.
Generation of focused chemical libraries around the hits from one of these
classes and their structure-activity optimization brought about a new generation
of curaxins. As the part of this program performed in the partnership with
ChemBridge Corporation, more than 800 proprietary compounds were screened for
p53 activation, efficacy in animal tumor models, selective toxicity and
metabolic stability in the presence of rat and human microsomes. The most active
compounds were efficacious in preventing tumor growth in models for colon
carcinoma, melanoma, ovarian cancer, RCC, and breast cancer.
As a result of this comprehensive
hit-to-lead optimization program, we have developed CBLC137, which is a drug
candidate with proprietary composition of matter intellectual property
protection belonging to our next generation of highly improved curaxins. CBLC137
has demonstrated reliable anti-tumor effects in animal models of colon, breast,
renal and prostate cancers. CBLC137 has favorable pharmacological
characteristics, is suitable for oral administration and demonstrates a complete
lack of genotoxicity. It shares all of the positive aspects of
CBLC102, but significantly exceeds the former compound’s activity and efficacy
in preclinical tumor models. CBLC137 is currently undergoing
manufacturing and preclinical toxicology studies in preparation for clinic
trials in 2010.
We spent approximately $1,492,678 and
$1,996,252 on R&D for other curaxins in the fiscal years ended December 31,
2008 and December 31, 2007, respectively. From our inception to December 31,
2008, we spent approximately $5,175,110 on R&D for other
curaxins.
CBLC137 is at a very early stage of its
development and, as a result, it is premature to estimate when any development
may be completed, the cost of development or when any cash flow could be
realized from development.
COLLABORATIVE RESEARCH
AGREEMENTS
Cleveland Clinic Foundation
We have a unique opportunity to
accelerate our development by utilizing intellectual property, drug leads, new
research technologies, technical know-how and original scientific concepts
derived from 25 years of research achievements relevant to cancer by Dr. Andrei
Gudkov and his research team while at the Cleveland Clinic. Pursuant to an
agreement we entered into with the Cleveland Clinic effective as of July 1,
2004, we were granted an exclusive license to the Cleveland Clinic’s research
base underlying our therapeutic platform (the CBLC100, CBLB500 and CBLB600
series). In consideration for obtaining this exclusive license, we agreed
to:
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Issue to the Cleveland Clinic
1,341,000 shares of common
stock;
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Make certain milestone payments
(ranging from $50,000 to $4,000,000, depending on the type of drug and the
stage of such drug’s
development);
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Make royalty payments (calculated
as a percentage of the net sales of the drugs ranging from 1-2%);
and
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Make sublicense royalty payments
(calculated as a percentage of the royalties received from the sublicenses
ranging from 5-35%).
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The schedule of milestone payments is as
follows:
File IND
application for Protectan CBLB502 (completed February
2008)
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$ |
50,000 |
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Complete
Phase I studies for Protectan CBLB502
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$ |
100,000 |
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File
NDA application for Protectan CBLB502
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$ |
350,000 |
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Receive
regulatory approval to sell Protectan CBLB502
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$ |
1,000,000 |
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File IND
application for Curaxin CBLC102 (completed May 2006)
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$ |
50,000 |
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Commence
Phase II clinical trials for Curaxin CBLC102 (completed January
2007)
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$ |
250,000 |
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Commence
Phase III clinical trials for Curaxin CBLC102
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$ |
700,000 |
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File
NDA application for Curaxin CBLC102
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$ |
1,500,000 |
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Receive
regulatory approval to sell Curaxin CBLC102
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$ |
4,000,000 |
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Under this license agreement, we may
exclusively license additional technologies discovered by Dr. Gudkov in this
field by providing the Cleveland Clinic with notice within 60 days after
receiving an invention disclosure report from the Cleveland Clinic relating to
any such additional technologies. We believe that this relationship will prove
valuable, not only for the purposes of developing the discoveries of Dr. Gudkov
and his colleagues, but also as a source of additional new technologies. We also
expect that the Cleveland Clinic will play a critical role in validating
therapeutic concepts and in conducting trials. The Cleveland Clinic may
terminate the license upon a material breach by us, as specified in the
agreement. However, we may avoid such termination if we cure the breach within
90 days of receipt of a termination notice.
In August 2004, we entered into a
cooperative research and development agreement, or CRADA, with (i) the Uniformed
Services University of the Health Sciences, which includes the Armed Forces
Radiobiology Research Institute, or AFRRI, (ii) the Henry M. Jackson Foundation
for the Advancement of Military Medicine, Inc., and (iii) the Cleveland Clinic,
to evaluate one of our radioprotective drug candidates and its effects on
intracellular and extracellular signaling pathways. As a collaborator under this
agreement, we are able to use the laboratories of the Armed Forces Radiobiology
Research Institute to evaluate Protectan CBLB502 and its effects on
intracellular and extracellular signaling pathways in order to improve
countermeasures to lethal doses of radiation. Under the terms of the agreement,
all parties are financially responsible for their own expenses related to the
agreement. The agreement has a five-year term, but may be unilaterally
terminated by any party upon 30 days prior written notice with or without
cause.
In February 2008, the terms of the
agreement were extended by an additional two years expiring August 15, 2010 and
an additional scope of the research to be performed under the CRADA has been
added. As the part of the extended research plan AFRRI will perform additional
experiments in non-human primates to evaluate radioprotection efficacy of
Protectan CBLB502 and perform analysis of hematopoietic stem cell mobilization
by Protectan CBLB612.
Roswell Park Cancer
Institute
In January 2007, we entered into a
strategic research partnership with Roswell Park Cancer Institute, or RPCI, to
develop our anticancer and radioprotectant drug candidates.
RPCI, founded in 1898, is a
world-renowned cancer research hospital and the nation's first cancer research,
treatment and education center. RPCI is a member of the prestigious National
Comprehensive Cancer Network, an alliance of the nation's leading cancer
centers, and is one of only ten free-standing cancer centers in the
nation.
RPCI and various agencies of the state
of New York will provide us with up to $5 million
of grant and other funding. We established a major research/clinical facility at
the RPCI campus in Buffalo, New York, which has become the foundation for
several of our advanced research and clinical trials.
Our partnership with RPCI will enhance
the speed and efficiency of our clinical research, and will provide us with
access to state-of-the-art clinical development facilities in partnership with a
globally recognized cancer research center. We believe that our proprietary
technology, combined with the assistance of RPCI, and our continuing strong
relationship with the Cleveland Clinic, will position us to become a leading
oncology company. A key element of our long-term business strategy is to partner
with world-class institutions to aid us in accelerating our drug development
timeline. We believe that our firm alliances with both RPCI and the Cleveland
Clinic provide us with a significant competitive advantage.
ChemBridge
Corporation
Another vital component of our drug
development capabilities is our strategic partnership with ChemBridge
Corporation, an established leader in combinatorial chemistry and in the
manufacture of diverse chemical libraries.
On April 27, 2004, we entered into a
library access agreement with ChemBridge that, in exchange for shares of our
common stock and warrants, provides us with continual access to a chemical
library of 214,000 compounds. Under the library access agreement, we have also
agreed to collaborate with ChemBridge in the future on two optimization
projects, wherein ChemBridge will have the responsibility of providing the
chemistry compounds for the project and we will have the responsibility of
providing the pharmacological/biological compounds. Upon providing ChemBridge
with our data after at least two positive repeat screening assays, which have
been confirmed in at least one additional functional assay, ChemBridge will have
the option to select such compound as one of the two optimization projects.
ChemBridge will retain a 50% ownership interest in two lead compounds selected
by ChemBridge and all derivative compounds thereof. The parties will jointly
manage the development and commercialization of any compounds arising from an
optimization project. The library access agreement does not have a specified
term or any termination provisions.
We have a strong working relationship
with ChemBridge. As is December 31, 2008 we have fully completed one
joint hit-to-lead optimization program with ChemBridge. As a
result of this program, we have
developed CBLC137, which is a drug candidate belonging to our next generation of
highly improved curaxins with proprietary, composition of matter, intellectual property
protection. CBLC137 has demonstrated reliable anti-tumor effects in
animal models of colon, breast, renal and prostate cancers. CBLC137
has favorable pharmacological characteristics, is suitable for oral
administration and demonstrates a complete lack of genotoxicity. It
shares all of the positive aspects of CBLC102, but significantly exceeds that
compound’s activity and efficacy in preclinical tumor
models.
PATENTS
As a result of the license agreement
with the Cleveland Clinic, we have filed, on the Cleveland Clinic’s behalf,
thirteen patent applications covering new classes of anticancer and
radiation-protecting compounds, their utility and mode of
action.
Our intellectual property platform is
based primarily on these thirteen patent applications exclusively licensed to us
by the Cleveland Clinic and five patent applications, which we have filed and
own exclusively.
The aforementioned thirteen patent
applications licensed from the Cleveland Clinic are as
follows:
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Methods of Inhibiting Apoptosis
Using Latent TFGß;
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Methods of Identifying Modulators
of Apoptosis From Parasites and Uses
Thereof;
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Methods of Inhibiting Apoptosis
Using Inducers of NF-kB;
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Methods of Protecting Against
Radiation Using Inducers of
NF-kB;
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Methods of Protecting Against
Radiation Using Flagellin;
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Small Molecules Inhibitors of MRP1
and Other Multidrug
Transporters;
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Flagellin Related Polypeptides and
Uses Thereof;
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Modulation of Apoptosis Using
Aminoacridines;
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Modulation of Immune
Responses;
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Methods of Protecting Against
Apoptosis Using
Lipopeptides;
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Modulation of Cell
Growth;
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Mitochondrial Cytochrome B;
and
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Methods of Reducing the Effects of
Reperfusion.
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The aforementioned five patent
applications, which we filed, are as follows:
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Modulation of Androgen Receptor
for Treatment of Prostate
Cancer;
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Method of Increasing Hematopoietic
Stem Cells;
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Method for Reducing the Effects of
Chemotherapy Using Flagellin Related
Polypeptides;
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Modulation of Heat Shock Response;
and
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Carbozole Compounds and
Therapeutic Uses of the
Compounds.
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In 2008, four patent applications were
introduced and filed for approval with the U.S. Patent Office. One of the patent
applications is licensed from the Cleveland Clinic and three are licensed to
us.
We review our patent applications on a
continuing basis. In 2008, two patent applications were abandoned. The first was
an application licensed from the Cleveland Clinic titled ‘Activation of p53
and Inhibition of NF-kB for Cancer Treatment’. This patent application was abandoned
due to developing another Curaxin for the same application. The second patent
application was licensed to us and titled ‘Quinacrine
Isomers”. The
patent application was abandoned due to the discovery of improved
technology.
MANUFACTURING
We do not intend to establish or operate
facilities to manufacture our drug candidates, and therefore will be dependent
upon third parties to do so. As we develop new products or increase sales of any
existing product, we must establish and maintain relationships with
manufacturers to produce and package sufficient supplies of our finished
pharmaceutical products. We have established a relationship with SynCo Bio
Partners B.V. or SynCo, a leading biopharmaceutical manufacturer, to produce
Protectan CBLB502 under cGMP specifications, and have completed an agreement to
produce sufficient amounts for clinical trials and a commercial launch.
As discussed above, the
yields from the established manufacturing process at SynCo have been very high
and the current process is expected to handle up to several million estimated
human doses per year without need for any additional scale up.. For CBLC102, we have contracted with
Regis Technologies, Inc. to manufacture sufficient amounts for clinical
trials.
Reliance on third party manufacturing
presents several risks, however, including the
following:
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Delays in the delivery of
quantities needed for multiple clinical trials or failure to manufacture
such quantities to our specifications, either of which could cause delays
in clinical trials, regulatory submissions or commercialization of our
drug candidates;
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Inability to fulfill our needs in
the event market demand for our drug candidates suddenly increases, which
may require us to seek new manufacturing arrangements, which, in turn,
could be expensive and time consuming;
and
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Ongoing inspections by the FDA or
other regulators and other regulatory authorities for compliance with
rules, regulations and standards, the failure to comply with which may
subject us to, among other things, product seizures, recalls, fines,
injunctions, suspensions or revocations of marketing licenses, operating
restrictions and criminal
prosecution.
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GOVERNMENT
REGULATION
The R&D, manufacturing and marketing
of drug candidates are subject to regulation, primarily by the FDA in the
U.S. and by comparable authorities in other
countries. These national agencies and other federal, state, local and foreign
entities regulate, among other things, R&D activities (including testing in
primates and in humans) and the testing, manufacturing, handling, labeling,
storage, record keeping, approval, advertising and promotion of the products
that we are developing. Noncompliance with applicable requirements can result in
various adverse consequences, including approval delays or refusals to approve
drug licenses or other applications, suspension or termination of clinical
investigations, revocation of approvals previously granted, fines, criminal
prosecution, recalls or seizures of products, injunctions against shipping
drugs, and total or partial suspension of production and/or refusal to allow a
company to enter into governmental supply contracts.
The process of obtaining FDA approval
for a new drug may take many years and generally involves the expenditure of
substantial resources. The steps required before a new drug can be produced and
marketed for human use include clinical trials and the approval of an NDA and
typically proceed as follows:
Preclinical Testing
In the preclinical phase of development,
the promising compound is subjected to extensive laboratory and animal testing
to determine if the compound is biologically active and
safe.
Investigational New
Drug (IND)
Before human tests can start, the drug
sponsor must file an IND application with the FDA, showing how
the drug is made and the results of animal testing. IND status allows initiation of clinical
investigation within 30 days of filing if the FDA does not respond with
questions during the 30-day period.
Human Clinical
Testing
The human clinical testing program
usually involves three phases that generally are conducted sequentially, but
which, particularly in the case of anti-cancer and other life-saving drugs, may
overlap or be combined. Clinical trials are conducted in accordance with
protocols that detail the objectives of the study, the parameters to be used to
monitor safety and the efficacy criteria to be evaluated. Each protocol is
submitted to the FDA as part of the IND filing. Each clinical study is
conducted under the direction of an independent Institutional Review Board, or
IRB, for each institution at which the study will be conducted. The IRB will
consider, among other things, all existing pharmacology and toxicology
information on the product, ethical factors, the risk to human subjects and the
potential benefits of therapy relative to risk.
In Phase I clinical trials, studies
usually are conducted on healthy volunteers or, in the case of certain terminal
illnesses such as advanced prostate cancer, patients with the disease who have
failed to respond to other treatment, to determine the maximum tolerated dose,
side effects and pharmacokinetics of a product. Phase II studies are conducted
on a small number of patients having a specific disease to determine initial
efficacy in humans for that specific disease, the most effective doses and
schedules of administration, and possible adverse effects and safety risks.
Phase II/III differs from Phase II in that the trials involved may include more
patients and, at the sole discretion of the FDA, be considered the “pivotal”
trials, or trials that will form the basis for FDA approval. Phase III normally
involves the pivotal trials of a drug, consisting of wide-scale studies on
patients with the same disease, in order to evaluate the overall benefits and
risks of the drug for the treated disease compared with other available
therapies. The FDA continually reviews the clinical trial plans and results, and
may suggest design changes or may discontinue the trials at any time if
significant safety or other issues arise.
As described above, for several of the
product opportunities we are pursuing, we may apply for approval based upon a
rule adopted by the FDA in 2002, titled “Approval of New Drugs When Human
Efficacy Studies Are Not Ethical or Feasible” (Part 314, Subpart I), which is
also referred to as the two animal rule. Pursuant to this new rule, in
situations where it would be unethical to conduct traditional Phase II and Phase
III efficacy studies in humans, as is the case with countermeasures to a number
of weapons of mass destruction, the FDA will review new drugs for approval on
the basis of safety in humans and efficacy in relevant animal
models.
New Drug Application
(NDA)
Upon successful completion of Phase III
clinical trials, the drug sponsor files an NDA with the FDA for approval,
containing all information that has been gathered. The NDA must include the
chemical composition of the drug, scientific rationale, purpose, animal and
laboratory studies, results of human tests, formation and production details,
and proposed labeling.
Post-Approval
Regulation
Following any initial regulatory
approval of any drugs we may develop, we will also be subject to continuing
regulatory review, including the review of adverse experiences and clinical
results that are reported after our drug candidates are made commercially
available. This will include results from any post-marketing tests or vigilance
required as a condition of approval. The manufacturer and manufacturing
facilities we use to make any of our drug candidates will also be subject to
periodic review and inspection by the FDA. The discovery of any previously
unknown problems with the drug, manufacturer or facility may result in
restrictions on the drug, manufacturer or facility, including withdrawal of the
drug from the market. We do not have, and currently do not intend to develop,
the ability to manufacture material for our clinical trials or on a commercial
scale. Reliance on third-party manufacturers entails risks to which we would not
be subject if we manufactured drugs ourselves, including reliance on the
third-party manufacturer for regulatory compliance. Our drug promotion and
advertising is also subject to regulatory requirements and continuing FDA
review.
The testing and approval process is
likely to require substantial time and effort, and there can be no assurance
that any FDA approval will be granted on a timely basis, if at all. The approval
process is affected by a number of factors, primarily the side effects of the
drug (safety) and its therapeutic benefits (efficacy). Additional preclinical or
clinical trials may be required during the FDA review period and may delay
marketing approval. The FDA may also deny an NDA if applicable regulatory
criteria are not met.
The FDA reviews the results of the
clinical trials and may order the temporary or permanent discontinuation of
clinical trials at any time if it believes the drug candidate exposes clinical
subjects to an unacceptable health risk.
Sales outside the U.S. of products that we develop will also
be subject to regulatory requirements governing human clinical trials and
marketing for drugs and biological products and devices. The requirements vary
widely from country to country, but typically the registration and approval
process takes several years and requires significant resources. In most cases,
even if the FDA has not approved a product for sale in the U.S., the product may be exported to any
country if it complies with the laws of that country and has valid marketing
authorization by the appropriate authority. There are specific FDA regulations
that govern this process.
We also are subject to the following
risks and obligations relating to government regulation, among
others:
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The FDA or foreign regulators may
interpret data from pre-clinical testing and clinical trials differently
than we interpret them;
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If regulatory approval of a
product is granted, the approval may be limited to specific indications or
limited with respect to its distribution. In addition, many foreign
countries control pricing and coverage under their respective national
social security systems;
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The FDA or foreign regulators may
not approve our manufacturing processes or manufacturing
facilities;
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The FDA or foreign regulators may
change their approval policies or adopt new
regulations;
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Even if regulatory approval for
any product is obtained, the marketing license will be subject to
continual review, and newly discovered or developed safety or
effectiveness data may result in suspension or revocation of the marketing
license;
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If regulatory approval of the
product candidate is granted, the marketing of that product would be
subject to adverse event reporting requirements and a general prohibition
against promoting products for unapproved or “off-label”
uses;
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In some foreign countries, we may
be subject to official release requirements that require each batch of the
product we produce to be officially released by regulatory authorities
prior to its distribution by us;
and
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We will be
subject to continual regulatory review and periodic inspection and
approval of manufacturing modifications, including compliance with current
GMP regulations.
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EMPLOYEES
As of March 16, 2009, we had 33
employees, 31 of whom were full-time employees.
ENVIRONMENT
We have made, and will continue to make,
expenditures for environmental compliance and protection. Expenditures for
compliance with environmental laws and regulations have not had, and are not
expected to have, a material effect on our capital expenditures, results of
operations, or competitive position.
COMPETITION
Non-Medical
Applications
In the area of radiation-protective
antidotes, various companies, such as RxBio, Inc., Exponential Biotherapies
Inc., Osiris Therapeutics, Inc., ImmuneRegen BioSciences, Inc., Onconova
Therapeutics, Inc and Humanetics Corporation are developing biopharmaceutical
products that potentially directly compete with our non-medical application drug
candidates even though their approaches to such treatment are
different.
We believe that due to the global
political environment, the level of development advancement is the critical
factor in the marketing of an effective medical radiation countermeasure for
federal agencies, such as DoD and HHS. New developments in this area
are expected to continue at a rapid pace in both industry and
academia.
Anticancer
Applications
The arsenal of medical
radiation-protectors is limited to ETHYOL™ (amifostine), sold by MedImmune, and
recently acquired by AstraZeneca International. This radiation-protector is
limited because of the serious side effects of the drug. Other
radiation-protectors may enter the market.
Biomedical research for anticancer
therapies is a large industry, with many companies, universities, research
institutions and foreign government-sponsored companies competing for market
share. The top ten public U.S.-based companies involved in cancer therapy have a
combined market capitalization exceeding $1 trillion. In addition, there are
several hundred biotech companies who have as their mission anticancer drug
development. These companies account for the approximately 150 anticancer
compounds currently in drug trials. However, despite the numerous companies in
this field, there is still a clear, unmet need in the anticancer drug
development market.
Each of the approximately 200 types of
cancer recognized by the National Cancer Institute, or NCI, has dozens of
subtypes, both etiological and on a treatment basis. Due to this market
segmentation, the paradigm of a one-size-fits-all, super-blockbuster approach to
drug treatments does not work well in cancer therapy. Currently, even the most
advanced therapeutics on the market do not provide substantial health
benefits.
This suggests that innovative anticancer
therapies are driven by the modest success of current therapeutics, the need for
an improved understanding of the underlying science, and a shift in the
treatment paradigm towards more personalized medicine. Our technology addresses
this need for an improved understanding of the underlying science and implements
a fundamental shift in the approach to developing anticancer
therapies.
Stem Cell
Mobilization
G-CSF (Neupogen® and Neulast@, Amgen,
Inc., Thousand
Oaks, California) is the current standard against which
all other mobilization agents for stem cells are measured. This is because it
has been shown to both mobilize more CD34+ stem cells and have less toxicity
than any other single agent against which it has been tested to date. In a few
cases, the use of G-SCF has caused deaths attributed to thrombosis (acute
myocardial infarction and stroke) in sibling donors. Other side effects include
pain, nausea, vomiting, diarrhea, insomnia, chills, fevers, and night
sweats.
Mozibil (Genzyme Corporation (Cambridge,
Massachusetts)is a newly FDA approved drug designed to help increase the number
of stem cells collected in a patient’s blood before being transplanted back into
the body after chemotherapy.
Sargramostim (Bayer HealthCare
Pharmaceuticals Inc., Wayne, New Jersey) as a single agent is used less often
today for mobilization than G-CSF, because it mobilizes somewhat less well than
G-CSF and because of a relatively higher incidence of both mild and severe side
effects. Erythropoietin (Amgen, Inc.), now commonly used among cancer patients
undergoing chemotherapy to maintain hemoglobin in the near normal range, also
has some ability to mobilize CD34+ cells.
Other Sources of
Competition
In addition to the direct competition
outlined above, there is potential for adverse market effects from other outside
developments. For example, producing a new drug with fewer side effects reduces
the need for anti-side effects therapies. Because of this, we must monitor a
broad area of anticancer R&D and be ready to fine-tune our development as
needed.
The biotechnology and biopharmaceutical
industries are characterized by rapid technological developments and intense
competition. This competition comes both from biotech firms and from major
pharmaceutical and chemical companies. Many of these companies have
substantially greater financial, marketing and human resources than we do
(including, in some cases, substantially greater experience in clinical testing,
manufacturing and marketing of pharmaceutical products). Our drug candidates’
competitive position among other biotech and biopharmaceutical companies may be
based on, among other things, patent position, product efficacy, safety,
reliability, availability, patient convenience, delivery devices, and price, as
well as the development and marketing of new competitive
products.
We also experience competition in the
development of our drug candidates from universities and other research
institutions and compete with others in acquiring technology from such
universities and institutions. In addition, certain of our drug candidates may
be subject to competition from products developed using other technologies, some
of which have completed numerous clinical trials. As a result, our actual or
proposed drug candidates could become obsolete before we recoup any portion of
our related R&D and commercialization expenses. However, we believe our
competitive position is enhanced by our commitment to research leading to the
discovery and development of new products and manufacturing
methods.
Some of our competitors are actively
engaged in R&D in areas where we also are developing drug candidates. The
competitive marketplace for our drug candidates is significantly dependent upon
the timing of entry into the market. Early entrants may have important
advantages in gaining product acceptance and market share contributing to the
product’s eventual success and profitability. Accordingly, in some cases, the
relative speed with which we can develop products, complete the testing, receive
approval, and supply commercial quantities of the product to the market is vital
towards establishing a strong competitive position.
Our ability to sell to the government
also can be influenced by indirect competition from other providers of products
and services. For instance, a major breakthrough in an unrelated area of
biodefense could cause a major reallocation of government funds from radiation
protection. Likewise, an outbreak or threatened outbreak of some other form of
disease or condition may also cause a reallocation of funds away from the
condition that Protectan CBLB502 is intended to address.
Item 1A. Risk
Factors
Risks Relating to our
Operations
We have a history of operating losses.
We expect to continue to incur losses and may not continue as a going
concern.
We have a history of losses and can
provide no assurance as to future operating results. As a result of losses that
will continue throughout our development stage, we may exhaust our financial
resources and be unable to complete the development of our drug
candidates.
We expect losses to continue for the
next few years as we spend substantial additional sums on the continued R&D
of proprietary drugs and technologies, and there is no certainty that we will
ever become profitable as a result of these expenditures.
Our ability to become profitable depends
primarily on the following factors:
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our ability to obtain approval
for, and if approved, to successfully commercialize, Protectan
CBLB502;
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our ability to bring to market
other proprietary drugs that are progressing through our development
process;
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our R&D efforts, including the
timing and cost of clinical trials;
and
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our ability to enter into
favorable alliances with third-parties who can provide substantial
capabilities in clinical development, manufacturing, regulatory affairs, sales,
marketing and distribution.
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Even if we successfully develop and
market our drug candidates, we may not generate sufficient or sustainable
revenue to achieve or sustain profitability.
We will likely require substantial
additional financing in order to meet our business
objectives.
Upon expiration of current capital
reserves or sooner if we experience unanticipated cash requirements, we may be
required to issue additional equity or debt securities or enter into other
financial arrangements, including relationships with corporate and other
partners, in order to raise substantial additional capital during the period of
product development and FDA testing. Depending upon market conditions and
subject to limitations imposed by the terms of our outstanding securities and
contractual obligations; we may not be successful in raising sufficient
additional capital for our long-term requirements. If we fail to raise
sufficient additional financing, we will not be able to develop our product
candidates, and may be required to reduce staff, reduce or eliminate R&D,
slow the development of our product candidates, outsource or eliminate several
business functions or shut down operations. Even if we are successful in raising
such additional financing, we may not be able to successfully complete planned
clinical trials, development, and marketing of all, or of any, of our product
candidates. In such event, our business, prospects, financial condition and
results of operations could be materially adversely
affected.
If we lose our funding from R&D
contracts and grants, we may not be able to fund future R&D and implement
technological improvements, which would materially harm our financial conditions
and operating results.
We receive over 90% of our revenues from
grant and contract development work in connection with grants from the
Department of Defense, NIH, NASA and the Defense Advanced Research Projects
Agency, or DARPA.
These revenues have funded some of our
personnel and other R&D costs and expenses. However, if these awards are not
funded in their entirety or if new grants and contracts are not awarded in the
future, our ability to fund future R&D and implement technological
improvements would be diminished, which would negatively impact our ability to
compete in our industry.
We can provide no assurance of the
successful and timely development of new products.
Our products are in their developmental
stage. Further development and extensive testing will be required to determine
their technical feasibility and commercial viability. Our success will depend on
our ability to achieve scientific and technological advances and to translate
such advances into reliable, commercially competitive products on a timely
basis. Products that we may develop are not likely to be commercially available
for a few years. The proposed development schedules for our products may be
affected by a variety of factors, including technological difficulties,
proprietary technology of others, and changes in government regulation, many of
which will not be within our control. Any delay in the development, introduction
or marketing of our products could result either in such products being marketed
at a time when their cost and performance characteristics would not be
competitive in the marketplace or in the shortening of their commercial lives.
In light of the long-term nature of our projects and the unproven technology
involved, we may not be able to complete successfully the development or
marketing of any products.
We may fail to successfully develop and
commercialize our products because they:
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are found to be unsafe or
ineffective in clinical
trials;
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do not receive necessary approval
from the FDA or foreign regulatory
agencies;
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fail to conform to a changing
standard of care for the diseases they seek to treat;
or
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are less effective or more
expensive than current or alternative treatment
methods.
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Product development failure can occur at
any stage of clinical trials and as a result of many factors and there can be no
assurance that we or our collaborators will reach our anticipated clinical
targets. Even if we or our collaborators complete our clinical trials, we do not
know what the long-term effects of exposure to our product candidates will be.
Furthermore, our products may be used in combination with other treatments and
there can be no assurance that such use will not lead to unique safety issues.
Failure to complete clinical trials or to prove that our product candidates are
safe and effective would have a material adverse effect on our ability to
generate revenue and could require us to reduce the scope of or discontinue our
operations.
Many of our projects
are in the early stages of drug development which carry their own set of
risks.
Projects that appear promising in the
early phases of development may fail to reach the market for several reasons
including:
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pre-clinical or clinical study
results that may show the product to be less effective than desired (e.g.,
the study failed to meet its primary objectives) or to have harmful or
problematic side effects;
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failure to receive the necessary
regulatory approvals or a delay in receiving such approvals. Among other
things, such delays may be caused by slow enrollment in clinical studies,
length of time to achieve study endpoints, additional time requirements
for data analysis or a NDA/BLA, preparation, discussions with
the FDA, an FDA request for additional pre-clinical or clinical data or
unexpected safety or manufacturing
issues;
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manufacturing costs, pricing or
reimbursement issues, or other factors that make the product not
economical; and
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the proprietary rights of others
and their competing products and technologies that may prevent the product
from being commercialized.
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Our R&D expenses are subject to
uncertainty.
We are highly dependent on the success
of our R&D efforts and, ultimately, upon regulatory approval and market
acceptance of our products under development. Our ability to complete our
research and development on schedule is, however, subject to a number of risks
and uncertainties. Because we expect to expend substantial resources on R&D,
our success depends in large part on the results as well as the costs of our
R&D. R&D expenditures are uncertain and subject to much fluctuation.
Factors affecting our R&D expenses include, but are not limited
to:
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the number and outcome of clinical
studies we are planning to conduct; for example, our R&D expenses may
increase based on the number of late-stage clinical studies that we may be
required to conduct;
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the number of products entering
into development from late-stage research; for example, there is no
guarantee that internal research efforts will succeed in generating
sufficient data for us to make a positive development decision or that an
external candidate will be available on terms acceptable to us, and some
promising candidates may not yield sufficiently positive pre-clinical
results to meet our stringent development
criteria;
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in-licensing activities, including
the timing and amount of related development funding or milestone
payments; for example, we may enter into agreements requiring us to pay a
significant up-front fee for the purchase of in-process R&D that we
may record as R&D expense;
or
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future levels of revenue; R&D
expenses as a percentage of future potential revenues can fluctuate with
the changes in future levels of revenue and lower revenues can lead to
less spending on R&D
efforts.
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U.S. government agencies
have special contracting requirements, which create additional
risks.
We have entered into contracts with
various U.S. government agencies. For the near
future, substantially all of our revenue may be derived from government
contracts and grants. In contracting with government agencies, we will be
subject to various federal contract requirements. Future sales to U.S. government agencies will depend, in
part, on our ability to meet these requirements, certain of which we may not be
able to satisfy.
U.S. government contracts typically contain
unfavorable termination provisions and are subject to audit and modification by
the government at its sole discretion, which subjects us to additional risks.
These risks include the ability of the U.S. government to
unilaterally:
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suspend or prevent us for a set
period of time from receiving new contracts or extending existing
contracts based on violations or suspected violations of laws or
regulations;
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terminate our existing
contracts;
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reduce the scope and value of our
existing contracts;
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audit and object to our
contract-related costs and fees, including allocated indirect
costs;
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control and potentially prohibit
the export of our products;
and
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change certain terms and
conditions in our contracts.
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As a U.S. government contractor, we may become
subject to periodic audits and reviews. Based on the results of these audits,
the U.S. government may adjust our
contract-related costs and fees, including allocated indirect costs. As part of
any such audit or review, the U.S. government may review the adequacy of,
and our compliance with, our internal control systems and policies, including
those relating to our purchasing, property, compensation and/or management
information systems. In addition, if an audit or review uncovers any improper or
illegal activity, we may be subject to civil and criminal penalties and
administrative sanctions, including termination of our contracts, forfeiture of
profits, suspension of payments, fines and suspension or prohibition from doing
business with the U.S. government. We could also suffer
serious harm to our reputation if allegations of impropriety were made against
us. In addition, under U.S. government purchasing regulations, some
of our costs, including most financing costs, amortization of intangible assets,
portions of our R&D costs and some marketing expenses, may not be
reimbursable or allowed under our contracts. Further, as a U.S. government contractor, we may become
subject to an increased risk of investigations, criminal prosecution, civil
fraud, whistleblower lawsuits and other legal actions and liabilities to which
purely private sector companies are not.
We are subject to numerous risks
inherent in conducting clinical trials any of which could delay or prevent us
from developing or commercializing our products.
Before obtaining required regulatory
approvals for the commercial sale of any of our product candidates, we must
demonstrate through pre-clinical testing and clinical trials that our product
candidates are safe and effective for use in humans. We must outsource our
clinical trials and negotiate with third parties to conduct such trials. We are
not certain that we will successfully or promptly finalize agreements for the
conduct of all our clinical trials. Delay in finalizing such agreements would
delay the commencement of the Phase I/II trials of Protectan CBLB502 for medical
applications and Phase II/III clinical trials of Curaxin CBLC102 in multiple
cancers.
Agreements with clinical investigators
and medical institutions for clinical testing and with other third parties for
data management services place substantial responsibilities on these parties,
which could result in delays in, or termination of, our clinical trials if these
parties fail to perform as expected. For example, if any of our clinical trial
sites fail to comply with FDA-approved good clinical practices, we may be unable
to use the data gathered at those sites. If these clinical investigators,
medical institutions or other third parties do not carry out their contractual
duties or obligations or fail to meet expected deadlines, or if the quality or
accuracy of the clinical data they obtain is compromised due to their failure to
adhere to our clinical protocols or for other reasons, our clinical trials may
be extended, delayed or terminated, and we may be unable to obtain regulatory
approval for or successfully commercialize Protectan CBLB502, Curaxin CBLC102 or
other product candidates.
We or regulators may suspend or
terminate our clinical trials for a number of reasons. We may voluntarily
suspend or terminate our clinical trials if at any time we believe that they
present an unacceptable risk to the patients enrolled in our clinical trials. In
addition, regulatory agencies may order the temporary or permanent
discontinuation of our clinical trials at any time if they believe that the
clinical trials are not being conducted in accordance with applicable regulatory
requirements or that they present an unacceptable safety risk to the patients
enrolled in our clinical trials.
Our clinical trial operations will be
subject to regulatory inspections at any time. If regulatory inspectors conclude
that we or our clinical trial sites are not in compliance with applicable
regulatory requirements for conducting clinical trials, we may receive reports
of observations or warning letters detailing deficiencies, and we will be
required to implement corrective actions. If regulatory agencies deem our
responses to be inadequate, or are dissatisfied with the corrective actions that
we or our clinical trial sites have implemented, our clinical trials may be
temporarily or permanently discontinued, we may be fined, we or our
investigators may be precluded from conducting any ongoing or any future
clinical trials, the government may refuse to approve our marketing applications
or allow us to manufacture or market our products or we may be criminally
prosecuted.
We cannot assure that our products will
obtain regulatory approval or that the results of clinical studies will be
favorable.
The testing, marketing and manufacturing
of any product for use in the United States will require approval from the FDA. We
cannot predict with any certainty the amount of time necessary to obtain such
FDA approval and whether any such approval will ultimately be granted.
Preclinical and clinical trials may reveal that one or more products are
ineffective or unsafe, in which event further development of such products could
be seriously delayed or terminated. Moreover, obtaining approval for certain
products may require testing on human subjects of substances whose effects on
humans are not fully understood or documented. Delays in obtaining FDA or any
other necessary regulatory approvals of any proposed product and failure to
receive such approvals would have an adverse effect on the product’s potential
commercial success and on our business, prospects, financial condition and
results of operations. In addition, it is possible that a product may be found
to be ineffective or unsafe due to conditions or facts that arise after
development has been completed and regulatory approvals have been obtained. In
this event, we may be required to withdraw such product from the market. To the
extent that our success will depend on any regulatory approvals from government
authorities outside of the United States that perform roles similar to that of
the FDA, uncertainties similar to those stated above will also
exist.
Our collaborative relationships with
third parties could cause us to expend significant resources and incur
substantial business risk with no assurance of financial
return.
We anticipate substantial reliance upon
strategic collaborations for marketing and the commercialization of our drug
candidates and we may rely even more on strategic collaborations for R&D of
our other drug candidates. Our business depends on our ability to sell drugs to
both government agencies and to the general pharmaceutical market. Offering our
drug candidates for non-medical applications to government agencies does not
require us to develop new sales, marketing or distribution capabilities beyond
those already existing in the company. Selling anticancer drugs, however, does
require such development. We plan to sell anticancer drugs through strategic
partnerships with pharmaceutical companies. If we are unable to establish or
manage such strategic collaborations on terms favorable to us in the future, our
revenue and drug development may be limited. To date, we have not entered into
any strategic collaborations with third parties capable of providing these
services. In addition, we have not yet marketed or sold any of our drug
candidates or entered into successful collaborations for these services in order
to ultimately commercialize our drug candidates.
Manufacturers producing our drug
candidates must follow cGMP regulations enforced by the FDA and foreign
equivalents. If a manufacturer of our drug candidates does not conform to the
cGMP regulations and cannot be brought up to such a standard, we will be
required to find alternative manufacturers that do conform. This may be a long
and difficult process, and may delay our ability to receive FDA or foreign
regulatory approval of our drug candidates and cause us to fall behind on our
business objectives.
Establishing strategic collaborations is
difficult and time-consuming. Our discussion with potential collaborators may
not lead to the establishment of collaborations on favorable terms, if at all.
Potential collaborators may reject collaborations based upon their assessment of
our financial, regulatory or intellectual property position. Even if we
successfully establish new collaborations, these relationships may never result
in the successful development or commercialization of our drug candidates or the
generation of sales revenue. In addition to the extent that we enter into collaborative
arrangements, our drug revenues are likely to be lower than if we directly
marketed and sold any drugs that we may develop.
We rely upon licensed patents to protect
our technology. We may be unable to obtain or protect such intellectual property
rights, and we may be liable for infringing upon the intellectual property
rights of others.
Our ability to compete effectively will
depend on our ability to maintain the proprietary nature of our technologies and
the proprietary technology of others with which we have entered into licensing
agreements. We have exclusively licensed thirteen patent applications from the
Cleveland Clinic and have filed five patent applications on our own. There can
be no assurance that any of these patent applications will ultimately result in
the issuance of a patent with respect to the technology owned by us or licensed
to us. The patent position of pharmaceutical or biotechnology companies,
including ours, is generally uncertain and involves complex legal and factual
considerations. The standards that the United States Patent and Trademark Office
use to grant patents are not always applied predictably or uniformly and can
change. There is also no uniform, worldwide policy regarding the subject matter
and scope of claims granted or allowable in pharmaceutical or biotechnology
patents. Accordingly, we do not know the degree of future protection for our
proprietary rights or the breadth of claims that will be allowed in any patents
issued to us or to others. Further, we rely on a combination of trade secrets,
know-how, technology and nondisclosure, and other contractual agreements and
technical measures to protect our rights in the technology. If any trade secret,
know-how or other technology not protected by a patent were to be disclosed to
or independently developed by a competitor, our business and financial condition
could be materially adversely affected.
We do not believe that any of the
products we are currently developing infringe upon the rights of any third
parties nor are they infringed upon by third parties; however, there can be no
assurance that our technology will not be found in the future to infringe upon
the rights of others or be infringed upon by others. In such a case, others may
assert infringement claims against us, and should we be found to infringe upon
their patents, or otherwise impermissibly utilize their intellectual property,
we might be forced to pay damages, potentially including treble damages, if we
are found to have willfully infringed on such parties’ patent rights. In
addition to any damages we might have to pay, we may be required to obtain
licenses from the holders of this intellectual property, enter into royalty
agreements, or redesign our products so as not to utilize this intellectual
property, each of which may prove to be uneconomical or otherwise impossible.
Conversely, we may not always be able to successfully pursue our claims against
others that infringe upon our technology and the technology exclusively licensed
from the Cleveland Clinic. Thus, the proprietary nature of our technology or
technology licensed by us may not provide adequate protection against
competitors.
Moreover, the cost to us of any
litigation or other proceeding relating to our patents and other intellectual
property rights, even if resolved in our favor, could be substantial, and the
litigation would divert our management’s efforts. Uncertainties resulting from
the initiation and continuation of any litigation could limit our ability to
continue our operations.
If we fail to comply
with our obligations under our license agreement with the Cleveland Clinic and other
parties,
we could lose our ability to
develop
our drug candidates.
The manufacture and sale of any products
developed by us may involve the use of processes, products or information, the
rights to certain of which are owned by others. Although we have obtained
licenses with regard to the use of the Cleveland Clinic’s patent applications as
described above and certain processes, products and information of others, we
cannot assure you that such licenses will not be terminated or expire during
critical periods, that we will be able to obtain licenses for other rights that
may be important to us, or, if obtained, that such licenses will be obtained on
commercially reasonable terms. If we are unable to maintain and/or obtain
licenses, we may have to develop alternatives to avoid infringing upon the
patents of others, potentially causing increased costs and delays in product
development and introduction or preclude the development, manufacture, or sale
of planned products. Additionally, we cannot assure that the patents underlying
any licenses will be valid and enforceable. To the extent any products developed
by us are based on licensed technology, royalty payments on the licenses will
reduce our gross profit from such product sales and may render the sales of such
products uneconomical.
Our current exclusive license with the
Cleveland Clinic imposes various development, royalty, diligence, record
keeping, insurance and other obligations on us. If we breach any of these
obligations and do not cure such breaches within the 90 day period provided, the
licensor may have the right to terminate the license, which could result in us
being unable to develop, manufacture and sell products that are covered by the
licensed technology or enable a competitor to gain access to the licensed
technology. In addition, while we cannot currently determine the dollar amount
of the royalty obligations we will be required to pay on sales of future
products, if any, the amounts may be significant. The dollar amount of our
future royalty obligations will depend on the technology and intellectual
property we use in products that we successfully develop and commercialize, if
any.
We may incur substantial liabilities
from any product liability claims if our insurance coverage for those claims
is inadequate.
We face an inherent risk of product
liability exposure related to the testing of our product candidates in human
clinical trials, and will face an even greater risk if the product candidates
are sold commercially. An individual may bring a liability claim against us if
one of the product candidates causes, or merely appears to have caused, an
injury. If we cannot successfully defend ourselves against the product liability
claim, we will incur substantial liabilities. Regardless of merit or eventual
outcome, liability claims may result in:
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decreased demand for our product
candidates;
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injury to our
reputation;
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withdrawal of clinical trial
participants;
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costs of related
litigation;
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diversion of our management’s time
and attention;
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substantial monetary awards to
patients or other claimants;
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the inability to commercialize
product candidates; and
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increased difficulty in raising
required additional funds in the private and public capital
markets.
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We currently have product liability
insurance and intend to expand such coverage from coverage for clinical trials
to include the sale of commercial products if marketing approval is obtained for
any of our product candidates. However, insurance coverage is increasingly
expensive. We may not be able to maintain insurance coverage that will be
adequate to satisfy any liability that may arise.
Our laboratories use certain chemical
and biological agents and compounds that may be deemed hazardous and we are
therefore subject to various safety and environmental laws and regulations.
Compliance with these laws and regulations may result in significant costs,
which could materially reduce our ability to become
profitable.
We use hazardous materials, including
chemicals and biological agents and compounds that could be dangerous to human
health and safety or the environment. As appropriate, we safely store these
materials and wastes resulting from their use at our laboratory facility pending
their ultimate use or disposal. We contract with a third party to properly
dispose of these materials and wastes. We are subject to a variety of federal,
state and local laws and regulations governing the use, generation, manufacture,
storage, handling and disposal of these materials and wastes. We may incur
significant costs complying with environmental laws and regulations adopted in
the future.
Risks Relating to our Industry and Other
External Factors
Adverse conditions in the capital and
credit markets may significantly affect our ability to obtain financing. If we
are unable to obtain financing in the amounts and on terms and dates acceptable
to us, we may not be able to expand or continue our operations and development,
and thus may be forced to curtail or cease operations or discontinue our
business.
We cannot assure that we will be able to
obtain financing when it is needed. Over the past year, the capital and credit
markets have reached unprecedented levels of volatility and disruption, and if
such adverse conditions continue, our ability to obtain financing may be
significantly diminished. Our internal sources of liquidity may prove to be
insufficient, and in such case, we may not be able to successfully obtain
financing on favorable terms, or at all. If we are unable to obtain financing in
the amounts and on terms and dates acceptable to us, we may not be able to
continue our operations and development, and thus may be forced to curtail or
cease operations or discontinue our business.
The successful development of
biopharmaceuticals is highly uncertain.
Successful development of
biopharmaceuticals is highly uncertain and is dependent on numerous factors,
many of which are beyond our control. Products that appear promising in the
early phases of development may fail to reach the market for several reasons
including:
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pre-clinical study results that
may show the product to be less effective than desired (e.g., the study
failed to meet its primary objectives) or to have harmful or problematic
side effects;
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failure to receive the necessary
regulatory approvals or a delay in receiving such approvals. Among other
things, such delays may be caused by slow enrollment in clinical studies,
length of time to achieve study endpoints, additional time requirements
for data analysis or a BLA, preparation, discussions with the FDA, an FDA
request for additional pre-clinical or clinical data or unexpected safety
or manufacturing issues;
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manufacturing costs, pricing or
reimbursement issues, or other factors that make the product not
economical; and
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the proprietary rights of others
and their competing products and technologies that may prevent the product
from being commercialized.
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Success in pre-clinical and early
clinical studies does not ensure that large-scale clinical studies will be
successful. Clinical results are frequently susceptible to varying
interpretations that may delay, limit or prevent regulatory approvals. The
length of time necessary to complete clinical studies and to submit an
application for marketing approval for a final decision by a regulatory
authority varies significantly from one product to the next, and may be
difficult to predict.
Political or social factors may delay or
impair our ability to market our products.
Products developed to treat diseases
caused by or to combat the threat of bio-terrorism will be subject to changing
political and social environments. The political and social responses to
bio-terrorism have been highly charged and unpredictable. Political or social
pressures may delay or cause resistance to bringing our products to market or
limit pricing of our products, which would harm our business. Changes to
favorable laws, such as the Project BioShield Act, could have a material adverse
effect on our ability to generate revenue and could require us to reduce the
scope of or discontinue our operations.
We hope to continue receiving funding
from the Department of Defense, BARDA and other government agencies for the
development of our bio-defense product candidates. Changes in government budgets
and agendas, however, may result in future funding being decreased and
de-prioritized, and government contracts contain provisions that permit
cancellation in the event that funds are unavailable to the government agency.
Furthermore, we cannot be certain of the timing of any future funding, and
substantial delays or cancellations of funding could result from protests or
challenges from third parties. If the U.S. government fails to continue to
adequately fund R&D programs, we may be unable to generate sufficient
revenues to continue operations. Similarly, if we develop a product candidate
that is approved by the FDA, but the U.S. government does not place sufficient
orders for this product, our future business may be harmed.
Risks Relating to our
Securities
The price of our common stock may be
volatile, which may in turn
expose us to securities litigation.
Our common stock is listed on the NASDAQ
Capital Market. The listing of our common stock on the NASDAQ Capital Market
does not assure that a meaningful, consistent and liquid trading market will
exist, and in recent years, the market has experienced extreme price and volume
fluctuations that have particularly affected the market prices of many smaller
companies like us. Our common stock is thus subject to this volatility.
Factors that could cause
fluctuations include, but are not limited to, the following:
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price and volume fluctuations in
the overall stock market from time to
time;
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fluctuations in stock market
prices and trading volumes of similar
companies;
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actual or anticipated changes in
our earnings or fluctuations in our operating results or in the
expectations of securities
analysts;
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general economic conditions and
trends;
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major catastrophic
events;
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sales of large blocks of our
stock;
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departures of key
personnel;
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changes in the regulatory status
of our product candidates, including results of our clinical
trials;
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events affecting the Cleveland
Clinic, Roswell Park Cancer Institute or any other
collaborators;
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announcements of new products or
technologies, commercial relationships or other events by us or our
competitors;
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regulatory developments in the
United States and other
countries;
|
|
·
|
failure of our common stock to be
listed or quoted on the NASDAQ Capital Market, other national market
system or any national stock
exchange;
|
|
·
|
changes in accounting principles;
and
|
|
·
|
discussion of us or our stock
price by the financial and scientific press and in online investor
communities.
|
In the past, following periods of
volatility in the market price of a company’s securities, securities class
action litigation has occasionally been brought against that company. Due to the
potential volatility of our stock price, we may therefore be the target of
securities litigation in the future. Regardless of its outcome, securities
litigation could result in substantial costs and divert management’s attention
and resources from our business.
Sales of additional equity securities
may adversely affect the market price of our common stock.
We expect to continue to incur product
development and selling, general and administrative costs, and in order to
satisfy our funding requirements, we may need to sell additional equity
securities. The sale or the proposed sale of substantial amounts of our common
stock in the public markets may adversely affect the market price of our common
stock and our stock price may decline substantially. Any new securities issued
may have greater rights, preferences or privileges than our existing common
stock.
Additional authorized shares of common
stock available for issuance may adversely affect the
market.
We are currently authorized to issue
40,000,000 shares of our common stock and 10,000,000 of our preferred stock As
of December 31, 2008, we had 13,775,805 shares of our common stock and 3,160,974
shares of our preferred stock issued and outstanding, excluding shares issuable
upon the exercise of our outstanding warrants and options. As of March 16, 2009,
we had 14,014,137 shares of our common stock and 3,024,144 shares of our preferred stock issued and
outstanding and 4,797,396 warrants and 1,938,742 options outstanding. To the
extent the shares of common stock are issued or options and warrants are
exercised, holders of our common stock will experience dilution. In addition, in
the event of any future financing of equity securities or securities convertible
into or exchangeable for, common stock, holders of our common stock may
experience dilution.
Item 1B. Unresolved Staff
Comments
None
Item 2. Description of
Property
Our corporate headquarters is located at
73 High Street, Buffalo, New York 14203. We have approximately 28,000 square
feet of laboratory and office space under a five year lease through June of
2012. This space serves as the corporate headquarters and primary research
facilities. In addition, we have leased approximately 2,500 square feet of
office space located at 9450 W. Bryn Mawr Rd., Rosemont, Illinois, 60018 through July 2011. We do not own any
real property.
Item 3. Legal
Proceedings
As of March 16, 2009, we were not a
party to any litigation or other legal proceeding.
Item 4. Submission of Matters to a Vote
of Security Holders
Not applicable.
Executive Officers of the Registrant as
of March 16, 2009
Name
|
|
Age
|
|
Position
|
|
|
|
|
|
Michael
Fonstein. Ph.D.
|
|
49
|
|
President
and Chief Executive Officer
|
Andrei
Gudkov, Ph.D., D.Sci.
|
|
52
|
|
Chief
Scientific Officer
|
Yakov
Kogan, Ph.D.
|
|
35
|
|
Chief
Operating Officer
|
John
A. Marhofer, Jr., CMA, CFM
|
|
46
|
|
Chief
Financial Officer
|
The Board of Directors appoints all
executive officers annually and such officers serve at the discretion of the
Board of Directors. There is no family relationship between or among any of the
executive officers or directors.
Michael Fonstein,
Ph.D. Dr. Fonstein has served as our Chief
Executive Officer, President, and as one of our directors since our inception in
June 2003. He served as Director of the DNA Sequencing Center at the University of Chicago from its creation in 1994 to 1998, when
he left to found Integrated Genomics, Inc. located in Chicago, Illinois. He served as CEO and President of
Integrated Genomics from 1997 to 2003. Dr. Fonstein has won several business
awards, including the Incubator of the Year Award from the Association of
University Related Research Parks. He was also the winner of a coveted KPMG
Illinois High Tech Award.
Andrei Gudkov,
Ph.D., D. Sci. Dr. Gudkov
has served as one of our directors and as our Chief Scientific Officer since our
inception in June 2003. Prior to 1990, he worked at The National Cancer Research
Center in Moscow, where he led a broad research program
focused on virology and cancer drug resistance. In 1990, he reestablished his
lab at the University of Illinois at Chicago where he became a tenured faculty
member in the Department of Molecular Genetics. His lab concentrated on the
development of new functional gene discovery methodologies and the
identification of new candidate cancer treatment targets. In 1999, he defined
p53 as a major determinant of cancer treatment side effects and suggested this
protein as a target for therapeutic suppression. In 2001, Dr. Gudkov moved his
laboratory to the Lerner Research Institute at the Cleveland Clinic where he
became Chairman of the Department of Molecular Biology and Professor of
Biochemistry at Case Western Reserve University. In May 2007, Dr. Gudkov became Senior
Vice President of Research Programming and Development for Roswell Park Cancer
Institute. He continues in his capacity as a consultant with
CBLI.
Yakov Kogan,
Ph.D. Dr. Kogan has served as one of our
directors since our inception in June 2003, as Secretary since March 2006, and
as Chief Operating Officer since February 2008. Dr. Kogan also served as our
Executive Vice President of Business Development from our inception until
February 2008. From 2002 to 2003, as Director for Business Development at
Integrated Genomics, he was responsible for commercial sales and expansion of
the company’s capital base. Prior to his tenure in business development, Dr.
Kogan worked as a Group Leader/Senior Scientist at Integrated Genomics and
ThermoGen, Inc. and as Research Associate at the University of Chicago. Dr. Kogan holds a Ph.D. degree in
Molecular Biology from All-Union Research Institute of Genetics and Selection of
Industrial Microorganisms (VNIIGenetika) (Moscow, Russia), as well as an MBA degree from the
University of Chicago Graduate School Of
Business.
John (Jack) A.
Marhofer, Jr., CMA, CFM Mr.
Marhofer joined us as Controller and General Manager in February 2005 and was
subsequently appointed to be our Chief Financial Officer in August 2005. He was
Corporate Controller of Litehouse Products, Inc. from June 2001 to February
2005. Mr. Marhofer earned his Bachelor of Science in Accounting and Marketing
from Miami University in Ohio in 1984, and his Masters in Business
Administration in Finance from Akron University in Ohio in 1997, where he was named to the
National Honor Society of the Financial Management
Association.
PART II
Item 5: Market for Registrant’s Common
Equity, Related Stockholder Matters and Issuer Purchases of Equity
Securities
Stock Exchange
Listing
Our common stock trades on the NASDAQ
Capital Market under the symbol “CBLI.” We have not paid dividends on our common
stock. We currently intend to retain all future income for use in the operation
of our business and for future stock repurchases and, therefore, we have no
plans to pay cash dividends on our common stock at this
time.
Common Stockholders
As of December 31, 2008, there were
approximately 40 stockholders of record of our Common Stock. Because many of our
shares are held by brokers and other institutions on behalf of stockholders, we
are unable to estimate the total number of beneficial stockholders represented
by these record holders.
We made no repurchases of our securities
during the year ended December 31, 2008.
Stock Prices
The following table sets forth the range
of high and low sale prices on The NASDAQ Stock Market and/or NASDAQ Capital
Market, as applicable, for each quarter during 2008 and 2007. On March 16, 2009,
the last reported sale price of our common stock was $1.40 per
share.
2008
|
|
High
|
|
|
Low
|
|
First
Quarter
|
|
$ |
8.79 |
|
|
$ |
2.03 |
|
Second
Quarter
|
|
$ |
6.40 |
|
|
$ |
3.82 |
|
Third
Quarter
|
|
$ |
5.65 |
|
|
$ |
3.70 |
|
Fourth
Quarter
|
|
$ |
4.59 |
|
|
$ |
1.51 |
|
2007
|
|
High
|
|
|
Low
|
|
First
Quarter
|
|
$ |
13.99 |
|
|
$ |
4.49 |
|
Second
Quarter
|
|
$ |
11.98 |
|
|
$ |
8.00 |
|
Third
Quarter
|
|
$ |
13.89 |
|
|
$ |
9.10 |
|
Fourth
Quarter
|
|
$ |
13.07 |
|
|
$ |
6.64 |
|
Item 6: Selected Financial
Data
The following selected financial data
has been derived from our audited financial statements. The information below is
not necessarily indicative of the results of future operations and should be
read in conjunction with Item 7, “Management’s Discussion and Analysis of
Financial Condition and Results of Operations,” and Item 1A, “Risk Factors,” of
this Form 10-K, and the financial statements and related notes thereto included
in Item 8 of this Form 10-K, in order to fully understand factors that may
affect the comparability of the information presented below
SELECTED
FINANCIAL DATA
|
|
(in
thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
Total
Operating Revenue
|
|
$ |
4,706 |
|
|
$ |
2,019 |
|
|
$ |
1,708 |
|
|
$ |
1,139 |
|
|
$ |
636 |
|
Government
contract or grant
|
|
|
4,586 |
|
|
|
1,729 |
|
|
|
1,503 |
|
|
|
1,000 |
|
|
|
531 |
|
Commercial
|
|
|
120 |
|
|
|
290 |
|
|
|
205 |
|
|
|
139 |
|
|
|
105 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(14,026 |
)
(1) |
|
$ |
(26,997 |
)
(1) |
|
$ |
(7,223 |
)
(1) |
|
$ |
(2,678 |
)
(1) |
|
$ |
(2,523 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per share, basic and diluted
|
|
$ |
(1.13 |
) |
|
$ |
(2.34 |
) |
|
$ |
(0.84 |
) |
|
$ |
(0.43 |
) |
|
$ |
(0.55 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$ |
4,706 |
|
|
$ |
17,422 |
|
|
$ |
6,417 |
|
|
$ |
4,253 |
|
|
$ |
382 |
|
Long-term
debt
|
|
|
- |
|
|
|
- |
|
|
|
50 |
|
|
|
303 |
|
|
|
334 |
|
Stockholder's
equity (deficit)
|
|
|
538 |
|
|
|
14,194 |
|
|
|
5,593 |
|
|
|
3,557 |
|
|
|
(374 |
) |
We have not paid any dividends on common
stock.
All per share amounts reflect the
596-to-1 stock split that was effected in 2004.
|
(1)
|
Net loss in 2008, 2007, 2006 and
2005 included employee stock-based compensation costs of $1.5 million,
$7.8 million, $0.5 million and $0.3 million, net of tax, respectively, due
to our adoption of Statement of Financial Accounting Standards No.
123(R),“Share-Based
Payment,” on a
modified prospective basis on January 1, 2005. No employee stock-based
compensation expense was recognized in reported amounts in any period
prior to January 1,
2005.
|
Item 7. Management’s Discussion and
Analysis of Financial Condition and Results of Operations
This management’s discussion and
analysis of financial condition and results of operations and other portions of
this filing contain forward-looking information that involves risks and
uncertainties. Our actual results could differ materially from those anticipated
by the forward-looking information. Factors that may cause such differences
include, but are not limited to, availability and cost of financial resources,
results of our R&D efforts and clinical trials, product demand, market
acceptance and other factors discussed in this annual report and the Company’s
other SEC filings under the heading “Risk Factors.” This management’s discussion
and analysis of financial condition and results of operations should be read in
conjunction with our financial statements and the related notes included
elsewhere in this filing.
Overview
We incorporated in Delaware and commenced business operations in
June 2003. We secured a $6,000,000 investment via a private placement of Series
A Preferred Stock in March 2005. On July 20, 2006, we sold 1,700,000 shares of common
stock in our initial public offering at $6.00 per share. The net proceeds from
this offering were approximately $8,300,000. Beginning July 21, 2006, our common
stock was listed on the NASDAQ Capital Market and on the Boston Stock Exchange
under the symbols “CBLI” and “CFB” respectively. On August 28, 2007, trading of
our stock moved from the NASDAQ Capital Market to the NASDAQ Global Market. In
September 2007, we ceased our listing on the Boston Stock Exchange. On November
28, 2008, trading of our common stock transferred from the NASDAQ Global Market
to the NASDAQ Capital Market.
On September 21, 2006, the SEC declared
effective a registration statement of the Company registering up to 4,453,601
shares of common stock for resale from time to time by the selling stockholders
named in the prospectus contained in the registration statement. We will not
receive any proceeds from the sale of the underlying shares of common stock,
although to the extent the selling stockholders exercise warrants for the
underlying shares of common stock, we will receive the exercise price of those
warrants. The registration statement was filed to satisfy registration rights
that we had previously granted in connection with our Series A Preferred
transaction.
On March 16, 2007, we consummated a
transaction with various accredited investors pursuant to which we agreed to
sell to the investors, in a private placement, an aggregate of approximately
4,288,712 shares of Series B Convertible Preferred Stock, par value $0.005 per
share, and Series B Warrants to purchase approximately 2,144,356 shares of our
common stock pursuant to a Securities Purchase Agreement of the same date. The
aggregate purchase price paid by the investors for the Series B Preferred and
Series B Warrants was approximately $30,000,000. After related fees and expenses, we received
net proceeds of approximately $29,000,000. We intend to use the proceeds for
general corporate and working capital purposes.
The Series B Preferred have an initial
conversion price of $7.00 per share, and in the event of a conversion at such
conversion price, one share of Series B Preferred would convert into one share
of common stock. Based on the closing price of our stock on March 16, 2007 of
$10.19, the Series B Preferred sold to investors and issued to certain of the
Agents had a market value of $46,660,112. The Series B Warrants have an exercise
price of $10.36 per share, the closing bid price on the day prior to the private
placement. To the extent, however, that the conversion price of the Series B
Preferred or the exercise price of the Series B Warrants is reduced as a result
of certain anti-dilution protections, the number of shares of common stock into
which the Series B Preferred are convertible and for which the Series B Warrants
are exercisable may increase.
We also issued to the placement agents
in the private placement, as compensation for their services, Series B
Preferred, Series B Warrants, and Series C Warrants. The agents collectively
received Series B Preferred that are convertible into an aggregate of 290,298
shares of common stock, Series B Warrants that are exercisable for an aggregate
of 221,172 shares of our common stock, and Series C Warrants that are
exercisable for 267,074 shares of our common stock. The Series C Warrants have
an exercise price of $11.00 per share, and are also subject to antidilution
protections that could increase the number of shares of common stock for which
they are exercisable.
In total, the securities issued in the
private placement were convertible into, or exercisable for, up to approximately
7,211,612 shares of common stock (subject to adjustments for stock splits,
anti-dilution, etc.). As of March 16, 2009 the securities issued in the
transaction, in the aggregate, were convertible into or exercisable for
approximately 6,249,469 shares of common stock that remain outstanding
(subject to adjustments for stock splits, anti-dilution,
etc.).
Proceeds from these transactions,
together with grants we have received, have supported our R&D activities
through December 31, 2008. We are actively seeking new grants and co-development
contacts with premier pharmaceutical partners to support further development of
other promising leads resulting from our R&D program.
On December 11, 2007, the SEC declared
effective a registration statement of the Company registering up to 5,514,999
shares of common stock for resale from time to time by the selling stockholders
named in the prospectus contained in the registration statement. This number
represents 5,514,999 shares of common stock issuable upon the conversion or
exercise of the securities issued the Company’s March 2007 private placement at
the current conversion and exercise prices. Of these 5,514,999 shares of common
stock, 3,717,515 shares are issuable upon conversion of Series B Preferred and
1,797,484 shares are issuable upon exercise of the Series B Warrants. We will
not receive any proceeds from the sale of the underlying shares of common stock,
although to the extent the selling stockholders exercise warrants for the
underlying shares of common stock, we will receive the exercise price of those
warrants. The registration statement was filed to satisfy registration rights
that we had previously granted. Subsequent to the effectiveness of
the registration statement, 1,418,036 Series B Preferred were converted and
$321,293 in dividends earned have been accrued as of December 31,
2008.
Critical Accounting
Policies
Our management’s discussion and analysis
of our financial condition and results of operations is based upon our financial
statements, which have been prepared in accordance with generally accepted
accounting principles in the U.S., or GAAP. The preparation of these
financial statements requires us to make estimates and judgments that affect the
reported amounts of our assets, liabilities, revenues, expenses and other
reported disclosures. We base our estimates on historical experience and on
various other assumptions that we believe are reasonable under the
circumstances.
Note 2 to our financial statements
include disclosure of our significant accounting policies. While all decisions
regarding accounting policies are important, we believe that our policies
regarding revenue recognition, R&D expenses, intellectual property related
costs, stock-based compensation expense and income taxes could be considered
critical.
Revenue Recognition
We recognize revenue in accordance with
Staff Accounting Bulletin No. 104, “Revenue Recognition”, and Statement of
Financial Accounting Standards No. 116, or SFAS 116. Our revenue sources consist
of government contracts, government grants and a commercial development
contract.
Government contract and grant revenue is
recognized using two different methods depending on the type of contract or
grant. Cost reimbursement contracts and grants require us to submit proof of
costs incurred that are invoiced by us to the government agency, which then pays
the invoice. In this case, revenue is recognized during the period that the
costs were incurred.
Fixed-cost grants require no proof of
costs and are paid as a request for payment is submitted for expenses. The grant
revenue under these fixed cost grants is recognized using a
percentage-of-completion method, which uses assumptions and estimates. These
assumptions and estimates are developed in coordination with the principal
investigator performing the work under the government fixed-cost grants to
determine key milestones, expenses incurred, and deliverables to perform a
percentage-of-completion analysis to ensure that revenue is appropriately
recognized. Critical estimates involved in this process include total costs
incurred and anticipated to be incurred during the remaining life of the
grant.
We recognize revenue related to the
funds received in 2007 from the State of New York under the sponsored research agreement
with the Roswell Park Cancer Institute in accordance with SFAS 116. The
principles of SFAS 116 result in the recognition of revenue as allowable costs
are incurred. We recognize revenue on research laboratory services and the
purchase and subsequent use of related equipment. The amount paid as a payment
toward future use related to the equipment is recognized as a prepaid asset and
will be recognized as revenue as the equipment is amortized over its useful life
and the prepaid asset is recognized as expense.
Government contract revenue is
recognized as allowable research and development expenses are incurred during
the period and according to the terms of the contract. Commercial development
revenues are recognized when the service or development is
delivered.
Research and Development
Expenses
R&D costs are expensed as incurred.
These expenses consist primarily of our proprietary R&D efforts, including
salaries and related expenses for personnel, costs of materials used in our
R&D, costs of facilities and costs incurred in connection with our
third-party collaboration efforts. Pre-approved milestone payments made by us to
third parties under contracted R&D arrangements are expensed when the
specific milestone has been achieved. As of December 31, 2008, $50,000 has been
paid to CCF for milestone payments relating to the filing of an IND with the FDA
for Curaxin CBLC102, $250,000 has been paid to CCF as a result of commencing
Phase II clinical trials for Curaxin CBLC102 and $50,000 has been paid to CCF
relating to the filing of an IND with the FDA for Protectan CBLB502. Once a drug
receives regulatory approval, we will record any subsequent milestone payments
in identifiable intangible assets, less accumulated amortization, and amortize
them evenly over the remaining agreement term or the expected drug life cycle,
whichever is shorter.
Intellectual Property Related
Costs
We capitalize costs associated with the
preparation, filing and maintenance of our intellectual property rights.
Capitalized intellectual property is reviewed annually for impairment. If a
patent application is approved, costs paid by us associated with the
preparation, filing and maintenance of the patent will be amortized on a
straight line basis over the shorter of 20 years or the anticipated useful life
of the patent. If the patent application is not approved, costs paid by us
associated with the preparation, filing and maintenance of the patent will be
expensed as part of general and administrative expenses at that
time.
Through December 31, 2007, we had
capitalized $459,102 in expenditures associated with the preparation, filing and
maintenance of certain of our patents. For the year ending December 31, 2008, we
capitalized an additional $333,995. In addition, the company
abandoned two patent applications and expensed $60,046 to selling, general and
administrative expenses. This resulted in a balance of $733,051 in
expenditures associated with the filing and maintenance of certain patents as a
December 31, 2008 capitalized balance for intellectual
property.
Stock-based
Compensation
The Financial Accounting Standards Board
(FASB) issued SFAS No. 123(R) requiring all share-based payments to employees,
including grants of employee stock options, be recognized in the statement of
operations based at their fair values. Accordingly, effective January 1, 2005,
we value employee stock based compensation under the provisions of SFAS 123(R)
and related interpretations.
The fair value of each stock option
granted is estimated on the grant date using the Black-Scholes option valuation
model or the Monte Carlo Simulation depending on the terms and conditions
present within the specific option being valued. The Black-Scholes option valuation model
was developed for use in estimating the fair value of traded options that have
no vesting restrictions and are fully transferable. In addition, the
Black-Scholes valuations model requires the input of highly subjective
assumptions including the expected stock price volatility. Because our employee
stock options have characteristics significantly different from those of traded
options, and because changes in subjective input assumptions can materially
affect the fair value estimate, in management’s opinion, the existing models do
not necessarily provide a reliable single measure of the fair value of our
options. For those stock options where market conditions are present within the
stock options, we utilize Monte Carlo simulation to value the stock options.
There was one issuance in the fiscal year ended December 31, 2007, for a total
of 90,000 options to an outside consultant where Monte Carlo simulation was used to value the
issuance.
On March 1, 2006, we granted 116,750
options pursuant to stock award agreements to certain employees and key
consultants. On July 20, 2006, we granted a total of 45,000 fully-vested, stock
options to our new independent board members (Messrs. Antal, Kasten, and Perez)
pursuant to stock award agreements.
In the fiscal year ended December 31,
2007, we granted 520,000 options pursuant to stock award agreements to certain
employees and key consultants. On June 12, 2007 we granted 140,000 fully- vested
stock options to the independent board members (Messrs. Antal, DiCorleto,
Kasten, and Perez) pursuant to stock award agreements.
In the fiscal year ended December 31,
2008, we granted 857,721 options pursuant to stock award agreements to certain
employees and key consultants. On April 29, 2008 we granted
140,000 fully-vested stock options to the independent board members (Messrs.
Antal, DiCorleto, Kasten, and Perez) pursuant to stock award
agreements. In addition, during the fiscal year ended December 31,
2008, we issued 130,000 restricted shares to certain key employees and key
consultants and granted an additional 15,000 restricted shares to a key employee
that vest over a three year period.
We recognized a total of $828,377,
$3,401,499, and $506,078 in expense for options for the years ended December 31,
2008, 2007 and 2006 respectively. For the year ended December 31, 2008, we
recognized a total of $626,500 in expense for shares issued and a total of
$72,722 in expense related to the amortization of restricted
shares. For the year ended December 31, 2007 and 2006, the Company
recognized a total of $1,700,450 and $0, respectively, in expense for shares
issued to various consultants.
The weighted average, estimated grant
date fair values of stock options granted during the years ended December 31,
2008, 2007 and 2006 were $3.16, $6.08 and $3.14,
respectively.
Income Taxes
The Company accounts for income taxes in
accordance with Statement of Financial Accounting Standards No. 109 “Accounting
for Income Taxes,” which requires an asset and liability approach to financial
accounting and reporting for income taxes. Deferred tax assets and
liabilities are recognized for the estimated future tax consequences
attributable to operating loss and tax credit carryforwards, and temporary
differences between the financial statement carrying amounts of existing assets
and liabilities and their respective tax bases. Deferred tax assets
and liabilities are measured using enacted tax rates expected to apply to
taxable income in the years in which those operating loss carryforwards and
temporary differences are expected to be recovered or settled. The
effect on deferred income tax assets and liabilities of a change in tax rates is
recognized in income in the period that includes the enactment
date. A valuation allowance is established, if necessary, to reduce
the deferred tax asset to the amount that will, more likely than not, be
realized. The Company accounts for interest and penalties related to
uncertain tax positions as part of its provision for income
taxes.
Impact of Recently Issued Accounting
Pronouncements
In June 2008, the Financial Accounting
Standards Board ("FASB") issued EITF Issue No. 07-5 ("EITF 07-5"), Determining
whether an Instrument (or Embedded Feature) is indexed to an Entity's Own Stock.
EITF No. 07-5 is effective for financial statements issued for fiscal years
beginning after December 15, 2008, and interim periods within those fiscal
years. Early application is not permitted. Paragraph 11(a) of SFAS No. 133 -
specifies that a contract that would otherwise meet the definition of a
derivative but is both (a) indexed to the Company's own stock and (b) classified
in stockholders' equity in the statement of financial position would not be
considered a derivative financial instrument. EITF 07-5 provides a new two-step
model to be applied in determining whether a financial instrument or an embedded
feature is indexed to an issuer's own stock and thus able to qualify for the
SFAS No. 133 paragraph 11(a) scope exception. The adoption of EITF 07-5 is not
anticipated to materially impact our financial statements.
In June 2008, the FASB issued EITF 08-4,
"Transition Guidance for Conforming Changes to Issue No. 98-5." The objective of
EITF 08-4 is to provide transition guidance for conforming changes made to EITF
No. 98-5, "Accounting for Convertible Securities with Beneficial Conversion
Features or Contingently Adjustable Conversion Ratios," that result from EITF
No. 00-27 "Application of Issue No. 98-5 to Certain Convertible Instruments,"
and SFAS 150, "Accounting for Certain Financial Instruments with Characteristics
of both Liabilities and Equity." This Issue is effective for financial
statements issued for fiscal years ending after December 15, 2008. Early
application is permitted. We are currently evaluating the impact of adoption of
EITF 08-4.
In May 2008, the FASB issued SFAS No.
162,
Hierarchy of Generally Accepted Accounting Principles (“SFAS No. 162”). SFAS No. 162
identifies the sources of accounting principles and the framework for selecting
the principles used in the preparation of financial statements. The
implementation of this standard did not have an impact on our financial
statements.
In April 2008, the FASB issued FASB
Staff Position No. FAS 142-3, “Determination of the Useful Life of
Intangible Assets” (“FSP FAS 142-3”). FSP FAS 142-3 amends the
factors that should be considered in developing renewal or extension assumptions
used to determine the useful life of a recognized intangible asset under FASB
Statement No. 142, “Goodwill and Other Intangible Assets”. The FSP is intended
to improve the consistency between the useful life of a recognized intangible
asset under Statement 142 and the period of expected cash flows used to measure
the fair value of the asset under SFAS 141(R) and other U.S. generally accepted
accounting principles. The new standard is effective for financial
statements issued for fiscal years and interim periods beginning after December
15, 2008. We are currently evaluating the impact, if any of FSP FAS
142-3 upon adoption on our financial statements.
In March 2008, the FASB issued SFAS No.
161. “Disclosures about Derivative Instruments and Hedging
Activities,” (SFAS No. 161). SFAS No. 161 amends and expands the
disclosure requirements of SFAS No. 133, “Accounting for Derivative Instruments
and Hedging Activities.” SFAS No. 161 requires qualitative
disclosures about objectives and strategies for using derivatives, quantitative
disclosures about fair value amounts of gains and losses on derivative
instruments and disclosures about credit-risk-related contingent features in
derivative agreements. SFAS No. 161 is intended to improve financial
reporting about derivative instruments and hedging activities by requiring
enhanced disclosures to enable investors to better understand their effects on
an entity's financial position, financial performance, and cash flows. This
statement is effective for financial statements issued for fiscal years
beginning after November 15, 2008. The adoption of SFAS No.161 will
not affect our financial condition and results of operations, but may require
additional disclosures if we enter into derivative and hedging
activities.
In December 2007, the FASB issued
Statement No. 160, Noncontrolling Interests in Consolidated Financial Statements
— An Amendment of ARB No. 51, or SFAS 160. SFAS 160 establishes new accounting
and reporting standards for the noncontrolling interest in a subsidiary and for
the deconsolidation of a subsidiary. Specifically, SFAS 160 requires the
recognition of a noncontrolling interest (minority interest) as equity in the
consolidated financial statements and separate from the parent's equity. The
amount of net income attributable to the noncontrolling interest will be
included in consolidated net income on the face of the income statement. In
addition, SFAS 160 requires that a parent recognize a gain or loss in net income
when a subsidiary is deconsolidated. Such gain or loss will be measured using
the fair value of the noncontrolling equity investment on the deconsolidation
date. SFAS 160 also includes expanded disclosure requirements regarding the
interests of the parent and its noncontrolling interest. SFAS 160 is effective
for fiscal years, and interim periods within those fiscal years, beginning on or
after December 15, 2008. We do not expect a material impact from the adoption of
SFAS 160.
In December 2007, the FASB issued
Statement No. 141 (revised 2007), Business
Combinations ("SFAS
141(R)"), which replaces SFAS 141. SFAS 141(R) requires an acquiring entity to
recognize all the assets acquired and liabilities assumed in a transaction at
the acquisition-date fair value with limited exceptions. In addition, SFAS
141(R) will require acquisition costs to be expensed as incurred, acquired
contingent liabilities will be recorded at fair value at the acquisition date
and subsequently measured at either the higher of such amount or the amount
determined under existing guidance for non-acquired contingencies, in-process
research and development will be recorded at fair value as an indefinite-lived
intangible asset at the acquisition date, restructuring costs associated with a
business combination will be generally expensed subsequent to the acquisition
date and changes in deferred tax asset valuation allowances and income tax
uncertainties after the acquisition date generally will affect income tax
expense. SFAS 141(R) also includes a substantial number of new disclosure
requirements. SFAS 141(R) is effective prospectively to business combinations
for which the acquisition date is on or after the beginning of the first annual
reporting period beginning on or after December 15, 2008. We anticipate that the
prospective application of the provisions of SFAS 141(R) could have a material
impact on the fair values assigned to assets and liabilities of any future
acquisitions.
In October 2008, the FASB issued FAS
157-3, Determining the Fair
Value of a Financial Asset When the Market for That Asset Is Not Active
(FAS 157-3). FAS 157-3
clarifies the application of FASB Statement No. 157, Fair Value
Measurements, in a market
that is not active and provides an example to illustrate key considerations in
determining the fair value of a financial asset when the market for that
financial asset is not active. The FSP is effective upon issuance, including for
prior periods for which financial statements have not been issued. Revisions
resulting from a change in the valuation technique or its application should be
accounted for as a change in accounting estimate following the guidance in FASB
Statement No. 154, Accounting Changes
and Error Corrections.
However, the disclosure provisions in Statement 154 for a change in accounting
estimate are not required for revisions resulting from a change in valuation
technique or its application. We believe the impact of this pronouncement on our
financial statements to be immaterial.
In September 2006, the Financial
Accounting Standards Board (“FASB”) issued Statement of Financial Accounting
Standard (“SFAS”) No. 157, “Fair Value Measurements.” SFAS No. 157 provides
enhanced guidance for using fair value to measure assets and liabilities and
expands disclosure with respect to fair value measurement. This statement was
originally effective for fiscal years beginning after November 15, 2007. In
February 2008, the FASB issued Staff Position FSP 157-2 which allows companies
to elect a one year deferral of adoption of SFAS No. 157 for non-financial
assets and non-financial liabilities that are recognized or disclosed at fair
values in the financial statements on a non-recurring basis. The Company has
adopted SFAS No. 157 as of January 1, 2008. There has been no material impact to
our financial statements due to the adoptions of SFAS No.
157.
Results of
Operations
Our operating results for the past three
fiscal years have been nominal. The following table sets forth our statement of
operations data for the years ended December 31, 2008, 2007 and 2006 and should
be read in conjunction with our financial statements and the related notes
appearing elsewhere in this annual report on Form 10-K.
|
Year
Ended
|
|
Year
Ended
|
|
Year
Ended
|
|
|
December
31,
|
|
December
31,
|
|
December
31,
|
|
|
2008
|
|
2007
|
|
2006
|
|
|
|
|
|
|
|
|
Revenues
|
|
$ |
4,705,597 |
|
|
$ |
2,018,558 |
|
|
$ |
1,708,214 |
|
Operating
expenses
|
|
|
19,050,965 |
|
|
|
27,960,590 |
|
|
|
9,126,315 |
|
Other
expense (income)
|
|
|
(59,597 |
) |
|
|
2,058,236 |
|
|
|
- |
|
Net
interest expense (income)
|
|
|
(259,844 |
) |
|
|
(1,003,766 |
) |
|
|
(195,457 |
) |
Net
income (loss)
|
|
$ |
(14,025,927 |
) |
|
$ |
(26,996,502 |
) |
|
$ |
(7,222,644 |
) |
|
Year Ended December
31, 2008 Compared to Year Ended December 31, 2007
Revenue
Revenue increased from $2,018,558 for
the year ended December 31, 2007 to $4,705,597 for the year ended December 31,
2008, representing an increase of $2,687,039 or 133.1%, resulting primarily from
an increase in revenue from the DoD contract, the BARDA contract and the NIAID
grant.
See the table below for further details
regarding the sources of our grant and government contract
revenue:
|
|
|
|
|
Period
of
|
|
Revenue
|
|
|
Revenue
|
|
Agency
|
Program
|
|
Amount
|
|
Performance
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DoD
|
DTRA
Contract
|
|
$ |
1,263,836 |
|
03/2007-02/2009
|
|
$ |
613,901 |
|
|
$ |
466,322 |
|
NIH
|
Phase
II NIH SBIR program
|
|
$ |
750,000 |
|
07/2006-06/2008
|
|
$ |
77,971 |
|
|
$ |
459,621 |
|
NASA
|
Phase
I NASA STTR program
|
|
$ |
100,000 |
|
01/2006-01/2007
|
|
$ |
- |
|
|
$ |
33,197 |
|
NY
State/RPCI
|
Sponsored
Research Agreement
|
|
$ |
3,000,000 |
|
03/2007-02/2012
|
|
$ |
305,298 |
|
|
$ |
329,390 |
|
NIH
|
NCI
Contract
|
|
$ |
750,000 |
|
09/2006-08/2008
|
|
$ |
219,618 |
|
|
$ |
440,028 |
|
DoD
|
DOD
Contract
|
|
$ |
8,900,000 |
|
05/2008
- 09/2009
|
|
$ |
2,938,357 |
|
|
$ |
- |
|
HHS
|
BARDA
Contract
|
|
$ |
13,300,000 |
|
09/2008-09/2011
|
|
$ |
219,412 |
|
|
$ |
- |
|
NIH
|
NIAID
Grant
|
|
$ |
774,183 |
|
09/2008-02/2010
|
|
$ |
211,040 |
|
|
$ |
- |
|
|
|
|
|
|
|
Totals
|
|
$ |
4,585,597 |
|
|
$ |
1,728,558 |
|
We anticipate our revenue over the next
year to be derived mainly from government grants and contracts. We have been
awarded 17 government contracts and grants totaling over $30 million in funding
for R&D. We plan to submit proposals for
additional government contracts and grants over the next two years totaling over
$30 million in funding. Many of the proposals will be submitted to government
agencies that have awarded contracts and grants to us in the recent past, but
there is no guarantee that any will be awarded to us.
If these awards are not funded in their
entirety or if new grants and contracts are not awarded in the future, our
ability to fund future R&D and implement technological improvements would be
diminished, which would negatively impact our ability to compete in our
industry.
Operating Expenses
Operating expenses have historically
consisted of costs relating to R&D and general and administrative expenses.
R&D expenses have consisted mainly of supporting our R&D teams, process
development, sponsored research at the Roswell Park Cancer Institute and the
Cleveland Clinic, clinical trials and consulting fees. We plan to incur only
those R&D costs that are properly funded, either through a government
contract or grant or other capital sources such as direct investment. General
and administrative expenses include all corporate and administrative functions
that serve to support our current and future operations while also providing an
infrastructure to support future growth. Major items in this category include
management and staff salaries, rent/leases, professional services and
travel-related expenses. Some of these costs will be funded through government
contracts and grants that provide indirect cost reimbursement for certain
indirect costs such as fringe benefits, overhead and general and administrative
expenses.
Operating expenses decreased from
$27,960,590 for the year ended December 31, 2007 to $19,050,965 for the year
ended December 31, 2008. This represents a decrease of $8,909,625 or 31.9%. We
recognized a total of $1,527,598 of non-cash compensation for stock based
compensation for the year December 31, 2008 compared to $7,789,305 for the year
ended December 31, 2007. If these non-cash stock based compensation expenses
were excluded, operating expenses would have decreased from $20,171,285 for the
year ended December 31, 2007 to $17,523,367 for the year ended December 31,
2008. This represents a decrease in operating expenses of $2,647,918 or
15.1%.
This decrease resulted primarily from a
decrease in R&D expenses from $17,429,652 for the year ended December 31,
2007 to $13,160,812 for the year ended December 31, 2008, a decrease of
$4,268,840 or 24.5%. The reduced R&D expenses were incurred primarily as a
result of decreasing the number of R&D subcontracts and other costs until
sufficient funding is obtained. We recognized a total of $1,836,787
of non-cash compensation for R&D stock based compensation for the year ended
December 31, 2007 compared to $632,252 for the year ended December 31, 2008.
Without the non-cash stock based compensation, the R&D expenses decreased
from $15,592,865 for the year ended December 31, 2007 to $12,528,560 for the
year ended December 31, 2008; a decrease of $3,064,305 or
19.7%.
The following table summarizes research
and development expenses for the years ended December 31, 2008, 2007 and 2006
and since inception:
|
|
Year Ended
|
|
|
Year Ended
|
|
|
Year Ended
|
|
|
Total
|
|
|
|
December
31,
|
|
|
December
31,
|
|
|
December
31,
|
|
|
Since
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
Inception
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
$ |
13,160,812 |
|
|
$ |
17,429,652 |
|
|
$ |
6,989,804 |
|
|
$ |
43,256,722 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
|
|
$ |
931,441 |
|
|
$ |
892,456 |
|
|
$ |
378,113 |
|
|
$ |
5,106,630 |
|
Protectan
CBLB502 - non-medical applications
|
|
$ |
7,264,813 |
|
|
$ |
9,885,776 |
|
|
$ |
3,574,593 |
|
|
$ |
21,601,196 |
|
Protectan
CBLB502 - medical applications
|
|
$ |
756,227 |
|
|
$ |
815,399 |
|
|
$ |
144,369 |
|
|
$ |
1,776,929 |
|
Protectan
CBLB612
|
|
$ |
974,459 |
|
|
$ |
1,127,248 |
|
|
$ |
466,715 |
|
|
$ |
3,130,374 |
|
Curaxin
CBLC102
|
|
$ |
1,741,194 |
|
|
$ |
2,712,521 |
|
|
$ |
1,372,998 |
|
|
$ |
6,466,483 |
|
Other
Curaxins
|
|
$ |
1,492,678 |
|
|
$ |
1,996,252 |
|
|
$ |
1,053,016 |
|
|
$ |
5,175,110 |
|
In addition, selling, general and
administrative expenses decreased from $10,530,938 for the year ended December
31, 2007 to $5,890,153, for the year ended December 31, 2008. This represents a
decrease of $4,640,785 or 44.1%. These lower selling, general and administrative
expenses were incurred as a result of a substantial reduction in the non-cash
stock based compensation for the selling, general and administrative area of the
Company. We recognized a total of $5,952,517 of non-cash stock-based
compensation for general and administrative compensation for the year ended
December 31, 2007 compared to $895,346 for the year ended December 31, 2008.
Without the non-cash stock based compensation, the general and administrative
expenses increased from $4,578,421 for the year ended December 31, 2007 to
$4,994,807 for the year ended December 31, 2008; an increase of $416,386 or
9.1%.
Until we introduce a product to the
market, expenses in the categories mentioned above will be the largest component
of our income statement.
Year Ended December 31, 2007 Compared to
Year Ended December 31, 2006
Revenue
Revenue increased from $1,708,214 for
the year ended December 31, 2006 to $2,018,558 for the year ended December 31,
2007, representing an increase of $310,344 or 18.2%, resulting primarily from an
increase in revenue from various grants including the sponsored research
agreement with RPCI, the DTRA contract, and the NCI contract. As the term of the
BioShield grant ended, the proceeds from the BioShield grant were $0 for the
year ended December 31, 2007 as compared to $1,100,293 for the year ended
December 31, 2006.
Operating Expenses
Operating expenses increased from
$9,126,315 for the year ended December 31, 2006 to $27,960,590 for the year
ended December 31, 2007. This represents an increase of $18,834,275 or 206.4%.
We recognized a total of $7,789,305 of non-cash compensation for stock based
compensation for the year December 31, 2007 compared to $506,078 for the year
ended December 31, 2006. If these non-cash stock based compensation expenses
were excluded, operating expenses would have increased from $8,620,237 for the
year ended December 31, 2006 to $20,171,285 for the year ended December 31,
2007. This represents an increase in operating expenses of $11,551,048 or
134.0%.
This increase resulted primarily from an
increase in R&D expenses from $6,989,804 for the year ended December 31,
2006 to $17,429,652 for the year ended December 31, 2007, an increase of
$10,439,848 or 149.4%. The higher R&D expenses were incurred as a result of
increasing the number of research and development personnel, commencing clinical
trials for CBLC102 and completing the cGMP manufacturing of CBLB502. We
recognized a total of $250,682 of non-cash compensation for R&D stock based
compensation for the year ended December 31, 2006 compared to $1,836,787 for the
year ended December 31, 2007. Without the non-cash stock based compensation, the
R&D expenses increased from $6,739,122 for the year ended December 31, 2006
to $15,592,865 for the year ended December 31, 2007; an increase of $8,853,743
or 131.4%.
In addition, general and administrative
expenses increased from $2,136,511 for the year ended December 31, 2006 to
$10,530,938, for the year ended December 31, 2007. This represents an increase
of $8,394,427 or 392.9%. These higher general and administrative expenses were
incurred as a result of creating and improving the infrastructure of the company
and the costs associated with being a publicly traded company. We recognized a
total of $255,396 of non-cash stock-based compensation for general and
administrative compensation for the year ended December 31, 2006 compared to
$5,952,517 for the year ended December 31, 2007. Without the non-cash stock
based compensation, the general and administrative expenses increased from
$1,881,115 for the year ended December 31, 2006 to $4,578,421 for the year ended
December 31, 2007; an increase of $2,697,306 or 143.4%.
Liquidity and Capital
Resources
We have incurred annual operating losses
since our inception, and, as of December 31, 2008 we had an accumulated deficit
of $56,246,173. Our principal sources of liquidity have been cash
provided by sales of our securities, and government grants, contracts and
agreements. Our principal uses of cash have been R&D and working capital. We
expect our future sources of liquidity to be primarily government contracts and
grants, equity financing, licensing fees and milestone payments in the event we
enter into licensing agreements with third parties, and research collaboration
fees in the event we enter into research collaborations with third
parties.
Net cash used in operating activities
totaled $12,121,102 for the year ended December 31, 2008, compared to
$16,607,922 used in operating activities for the same period in 2007. This
decrease in cash used in operating activities resulted from a reduction in our
net loss due to increase contract and grant revenues. Net cash used
in operating activities totaled $6,653,602 for the same period in
2006.
Net cash used in investing activities
was $558,407 for the year ended December 31, 2008 and $442,523 used for the same
period in 2007. The increase in cash used for investing activities resulted
primarily from an increase in the investment in intellectual property and the
reduction in proceeds from the maturity of short term investment as compared to
2007. Net cash used in investing activities was $14,281 for the same period in
2006.
Net cash used in financing activities
totaled $1,232,831 for the year ended December 31, 2008, compared to $28,200,591
provided by financing activities for the same period in 2007. The decrease in
cash provided by financing activities was attributed to the dividends paid on
the Series B Preferred in 2008 as compared to the proceeds from the issuance of
Series B Preferred in connection with our private placement offering in 2007.
Net cash provided by financing activities totaled $8,523,414 for the same period
in 2006. The funds provided for the year ended December 31, 2006 were
attributable primarily to the net proceeds from our initial public offering in
July 2006.
Under our exclusive license agreement
with the Cleveland Clinic, we may be responsible for making milestone payments
to the Cleveland Clinic in amounts ranging from $50,000 to $4,000,000. The
milestones and corresponding payments for Protectan CBLB502 and Curaxin CBLC102
are set forth below:
File IND application for Protectan
CBLB502 (completed February 2008)
|
|
$ |
50,000 |
|
Complete Phase I studies for
Protectan CBLB502
|
|
$ |
100,000 |
|
File NDA application for Protectan
CBLB502
|
|
$ |
350,000 |
|
Receive regulatory approval to
sell Protectan CBLB502
|
|
$ |
1,000,000 |
|
File IND application for Curaxin CBLC102
(completed May 2006)
|
|
$ |
50,000 |
|
Commence Phase II clinical trials
for Curaxin CBLC102 (completed January 2007)
|
|
$ |
250,000 |
|
Commence Phase III clinical trials
for Curaxin CBLC102
|
|
$ |
700,000 |
|
File NDA application for Curaxin
CBLC102
|
|
$ |
1,500,000 |
|
Receive regulatory approval to
sell Curaxin CBLC102
|
|
$ |
4,000,000 |
|
As of December 31, 2008, we had accrued
and paid $50,000 for the milestone payment relating to the filing of the IND
application for Curaxin CBLC102, $50,000 for the milestone related to the filing
of the IND application for Protectan CBLB502 and $250,000 for the milestone
payment relating to starting a Phase II hormone-refractory prostate cancer
clinical trial for Curaxin CBLC102.
Our agreement with CCF also provides for
payment by us to the CCF of royalty payments calculated as a percentage of the
net sales of the drug candidates ranging from 1-2%, and sublicense royalty
payments calculated as a percentage of the royalties received from the
sublicenses ranging from 5-35%. However, any royalty payments and sublicense
royalty payments assume that we will be able to commercialize our drug
candidates, which are subject to numerous risks and uncertainties, including
those associated with the regulatory approval process, our R&D process and
other factors. Accrued milestone payments, royalty payments and sublicense
royalty payments are payable upon achievement of the
milestone.
To more effectively match short-term
investment maturities with cash flow requirements, we have obtained a working
capital line of credit, which is fully secured by our short-term investments.
This line of credit has an interest rate of prime, a borrowing limit of
$1,000,000 and expires on September 25, 2009. At December 31, 2008, there were
no outstanding borrowings under this credit facility.
We believe that existing cash resources
will be sufficient to finance our currently planned operations for the near-term
(approximately 12-24 months), such amounts will not be sufficient to meet our
longer-term cash requirements, including our cash requirements for the
commercialization of certain of our drug candidates currently in development. We
may be required to issue equity or debt securities or enter into other financial
arrangements, including relationships with corporate and other partners, in
order to raise additional capital. Depending upon market conditions, we may not
be successful in raising sufficient additional capital for our long-term
requirements. In such event, our business, prospects, financial condition and
results of operations could be materially adversely
affected.
The following factors, among others,
could cause actual results to differ from those indicated in the above
forward-looking statements: the results of our R&D efforts, the timing and
success of preclinical testing, the timing and success of any clinical trials we
may commence in the future, the timing of and responses to regulatory
submissions, the amount of cash generated by our operations, the amount of
competition we face, and how successful we are in obtaining any required
licenses and entering into collaboration arrangements.
Subsequent Event
On
February 13, 2009, March 20, 2009, and March 27, 2009, the Company entered into
Securities Purchase Agreements (the “Purchase Agreement”) with various
accredited investors (the “Purchasers”), pursuant to which the Company agreed to
sell to the Purchasers an aggregate of 542.84 shares (the “Shares”) of Series D
Convertible Preferred Stock, with a par value of $0.005 per share and a stated
value of $10,000 per share (“Series D Preferred”), and Common Stock Purchase
Warrants (the “Warrants”) to purchase an aggregate of 3,877,386 shares of the
Company’s Common Stock, par value $0.005 per share (“Common
Stock”). The Warrants have a seven-year term and an exercise price of
$1.60. Each share of Series D Preferred is convertible into approximately 7,143
shares of Common Stock, subject to the adjustment as described
below.
The
aggregate purchase price paid by the Purchasers for the Shares and the Warrants
was approximately $5,428,307 (representing $10,000 for each Share together with
a Warrant). After related fees and expenses, the Company received net
proceeds of approximately $4,460,000. The Company intends to use the
proceeds for working capital purposes.
In
consideration for its services as exclusive placement agent, Garden State
Securities, Inc. (“GSS”), received cash compensation and Warrants to purchase an
aggregate of approximately 387,736 shares of Common Stock. In the
aggregate, Series D Preferred and Warrants issued in the transaction (including
those issued to GSS) are convertible into, and exercisable for, approximately
8,142,508 shares of Common Stock. Each share of Series D Preferred is
convertible into a number of shares of Common Stock equal to (1) the stated
value of the share ($10,000), divided by (2) $1.40, subject to adjustment as
discussed below (the “Conversion Price”).
The
Series D Preferred ranks junior to the Company’s Series B Convertible Preferred
Stock (“Series B Preferred”) and senior to all shares of Common Stock and other
capital stock of the Company.
If the
Company does not meet certain milestones, the Conversion Price will, unless the
closing price of the Common Stock is greater than $3.69 on the date the
Milestone is missed, be reduced to 80% of the Conversion Price in effect on that
date (the “Milestone Adjustment”). In addition to the Milestone
Adjustment, (a) on August 13, 2009 (the “Initial Adjustment Date”), the
Conversion Price shall be reduced to 95% of the then Conversion Price, and (b)
on each three month anniversary of the Initial Adjustment Date (each, an
“Adjustment Date”), the then Conversion Price shall be reduced by $0.05 (subject
to adjustment) until maturity. The Conversion Price is also subject
to proportional adjustment in the event of any stock split, stock dividend,
reclassification or similar event with respect to the Common Stock and to
anti-dilution adjustment in the event of any Dilutive Issuance (as defined in
the Certificate of Designation).
If the
closing price for each of any 20 consecutive trading days after the effective
date of the initial registration statement filed pursuant to the Registration
Rights Agreement (as defined below) (the “Effective Date”) exceeds 300% of the
then effective Conversion Price and various other equity conditions are
satisfied, the Series D Preferred will automatically convert into shares of
Common Stock.
At any
time after February 13, 2012, the Company may, if various equity conditions are
satisfied, elect either to redeem any outstanding Series D Preferred in cash or
to convert any outstanding Series D Preferred into shares of Common Stock at the
conversion rate then in effect.
If the
Company receives any cash funds after February 13, 2009 from fees, royalties or
revenues as a result of the license of any of its intellectual property (such
net proceeds the “IP Proceeds”), cash funds from development grants from any
government agency for the development of anti-cancer applications of any of the
Company’s curaxin compounds or anti-cancer or biodefense applications for the
Company’s CBLB502 compound (the “Governmental Grant Proceeds”) or allocates cash
proceeds to its Escrow Account (as defined in the Purchase Agreement) (the
“Company Allocation”), then the Company must deposit 40% of the IP Proceeds, 20%
of the Governmental Grant Proceeds and the Company Allocation into an escrow
account (the “Sinking Fund”). At any time after the later of the
Effective Date and the 6-month anniversary of the initial contribution by the
Company to the Sinking Fund, but no more than once in every six-month period,
the Company will be required to use the funds then in the Sinking Fund to redeem
outstanding shares of Series D Preferred, from the holders on a pro rata basis,
at a premium of 15% to the stated value through February 13, 2010, and 20%
thereafter.
Immediately
after the completion of the transactions contemplated by the Purchase Agreement,
the conversion price of the Company’s Series B Preferred was adjusted, pursuant
to weighted-average anti-dilution provisions, to $4.67, causing the conversion
rate of Series B Preferred into Common Stock to change to approximately
1-to-1.49893. In addition, the exercise prices of the Company’s
Series B Warrants and Series C Warrants were adjusted, pursuant to
weighted-average anti-dilution provisions, to $6.79 and $7.20, respectively,
from the original exercise prices of $10.36 and $11.00. In addition to the
adjustment to the exercise prices of the Series B Warrants and the Series C
Warrants, the aggregate number of shares issuable upon exercise of the Series B
Warrants and the Series C Warrants increased to 3,609,261 and 408,032,
respectively, from 2,365,528 and 267,074. Certain
other warrants issued prior to the Company’s initial public offering were also
adjusted pursuant to anti-dilution provisions contained in those warrants such
that their per share exercise price reduced from $2.00 to $1.48 and the
aggregate number of shares of Common Stock issuable increased from approximately
281,042 to approximately 379,787.
Impact of Inflation
We believe that our results of
operations are not dependent upon moderate changes in inflation
rates.
Impact of Exchange Rate
Fluctuations
We believe that our results of
operations are somewhat dependent upon changes in foreign currency exchange
rates. We have entered into agreements with foreign third parties to produce one
of our drug compounds and are required to make payments in the foreign currency.
As a result, our financial results could be affected by changes in foreign
currency exchange rates. As of December 31, 2008, we are obligated to make
payments under these agreements of 916,354 Euros and 39,100 Great British
Pounds. We have established means to purchase forward contracts to hedge against
this risk.
Off-Balance Sheet
Arrangements
We have not entered into any off-balance
sheet arrangements.
Item 7A: Quantitative and Qualitative Disclosures
About Market Risk
We are exposed to certain market risks,
including changes to interest rates, foreign currency exchange rates and equity
investment prices. To reduce the volatility related to these exposures, we may
enter into various derivative hedging transactions pursuant to our investment
and risk management policies. There are inherent risks that may only be
partially offset by our hedging programs should there be unfavorable movements
in interest rates, foreign currency exchange rates, or equity investment
prices.
Interest Rate Risk.
Our interest income is
sensitive to changes in the general level of domestic interest rates,
particularly since our investments are in short-term held to
maturity. Due to our intention to hold our investments to maturity,
we have concluded that there is no material interest rate risk
exposure.
Our revolving credit facility also would
have been affected by fluctuations in interest rates as it is based on prime
minus 1% or the Federal Funds Effective Rate in effect plus 0.50%. As of
December 31, 2008, we had not drawn on this facility.
Foreign Currency
Risk. As of December 31,
2008, we have agreements with third parties that require payment in the foreign
currency. As a result, our financial results could be affected by changes in
foreign currency exchange rates. Currently, the Company's exposure primarily
exists with the Euro and the British Pound. As a consequence,
movements in exchange rates could cause our foreign currency denominated
expenses to fluctuate as a percentage of net revenue, affecting our
profitability and cash flows. At this time, our exposure to foreign currency
fluctuations is not material.
In addition, the indirect effect of
fluctuations in interest rates and foreign currency exchange rates could have a
material adverse effect on our business financial condition and results of
operations. For example, currency exchange rate fluctuations could affect
international demand for our products in the future. Furthermore, interest rate
and currency exchange rate fluctuations may broadly influence the United States and foreign economies resulting in a
material adverse effect on our business, financial condition and results of
operations. As a result, we cannot give any assurance as to the effect that
future changes in foreign currency rates will have on our consolidated financial
position, results of operations or cash flows.
Item 8: Financial Statements and
Supplementary Data
REPORT OF INDEPENDENT REGISTERED PUBLIC
ACCOUNTING FIRM
Board of Directors and Stockholders
of
Cleveland BioLabs,
Inc.
We have audited the accompanying balance
sheets of CLEVELAND BIOLABS, INC. as of December 31, 2008 and 2007, and the related statements of
operations, stockholders' equity and comprehensive income, and cash flows for
each of the years in the three-year period ended December 31, 2008. Cleveland BioLabs, Inc.'s management
is responsible for these financial statements. Our responsibility is to express
an opinion on these financial statements based on our
audits.
We conducted our audits in accordance
with the standards of the Public Company Accounting Oversight Board
(United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. The Company is not required to
have, nor were we engaged to perform, an audit of its internal control over
financial reporting. Our audit included consideration of internal control over
financial reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company's internal control over financial
reporting. Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements, assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, the financial statements
referred to above present fairly, in all material respects, the financial
position of Cleveland BioLabs Inc. as of December 31, 2008 and 2007, and the results of its operations and
its cash flows for each of the years in the three-year period ended December 31,
2008 in conformity with accounting
principles generally accepted in the United States of
America.
MEADEN & MOORE,
LTD.
Certified Public
Accountants
Cleveland, Ohio
March 27, 2009
CLEVELAND
BIOLABS, INC.
|
|
|
|
BALANCE
SHEETS
|
|
|
|
December
31, 2008 and December 31, 2007
|
|
|
|
|
|
|
|
|
|
|
December
31
|
|
|
December
31
|
|
|
|
2008
|
|
|
2007
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS
|
|
|
|
|
|
|
Cash
and equivalents
|
|
$ |
299,849 |
|
|
$ |
14,212,189 |
|
Short-term
investments
|
|
|
1,000,000 |
|
|
|
1,000,000 |
|
Accounts
receivable:
|
|
|
|
|
|
|
|
|
Trade
|
|
|
1,043,821 |
|
|
|
163,402 |
|
Interest
|
|
|
9,488 |
|
|
|
50,042 |
|
Other
prepaid expenses
|
|
|
510,707 |
|
|
|
325,626 |
|
Total
current assets
|
|
|
2,863,865 |
|
|
|
15,751,259 |
|
|
|
|
|
|
|
|
|
|
EQUIPMENT
|
|
|
|
|
|
|
|
|
Computer
equipment
|
|
|
309,323 |
|
|
|
258,089 |
|
Lab
equipment
|
|
|
1,102,465 |
|
|
|
966,517 |
|
Furniture
|
|
|
312,134 |
|
|
|
274,903 |
|
|
|
|
1,723,922 |
|
|
|
1,499,509 |
|
Less
accumulated depreciation
|
|
|
637,840 |
|
|
|
313,489 |
|
|
|
|
1,086,082 |
|
|
|
1,186,020 |
|
|
|
|
|
|
|
|
|
|
OTHER
ASSETS
|
|
|
|
|
|
|
|
|
Intellectual
property
|
|
|
733,051 |
|
|
|
459,102 |
|
Deposits
|
|
|
23,482 |
|
|
|
25,445 |
|
|
|
|
756,533 |
|
|
|
484,547 |
|
|
|
|
|
|
|
|
|
|
TOTAL
ASSETS
|
|
$ |
4,706,480 |
|
|
$ |
17,421,826 |
|
CLEVELAND
BIOLABS, INC.
|
|
|
|
BALANCE
SHEETS
|
|
|
|
December
31, 2008 and December 31, 2007
|
|
|
|
|
|
|
|
|
|
|
December
31
|
|
|
December
31
|
|
|
|
2008
|
|
|
2007
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
1,101,961 |
|
|
$ |
710,729 |
|
Deferred
revenue
|
|
|
2,365,312 |
|
|
|
1,670,610 |
|
Dividends
payable
|
|
|
321,293 |
|
|
|
396,469 |
|
Accrued
expenses
|
|
|
379,653 |
|
|
|
449,774 |
|
Total
current liabilities
|
|
|
4,168,219 |
|
|
|
3,227,582 |
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY
|
|
|
|
|
|
|
|
|
Series
B convertible preferred stock, $.005 par value
|
|
|
|
|
|
|
|
|
Authorized
- 10,000,000 shares at December 31, 2008
|
|
|
|
|
|
|
|
|
and
December 31, 2007
|
|
|
|
|
|
|
|
|
Issued
and outstanding 3,160,974 and 3,870,267
|
|
|
|
|
|
|
|
|
shares
at December 31, 2008 and December 31, 2007, respectively
|
|
|
15,805 |
|
|
|
19,351 |
|
Additional
paid-in capital
|
|
|
19,918,696 |
|
|
|
24,383,695 |
|
Common
stock, $.005 par value
|
|
|
|
|
|
|
|
|
Authorized
- 40,000,000 shares at December 31, 2008
|
|
|
|
|
|
|
|
|
and
December 31, 2007
|
|
|
|
|
|
|
|
|
Issued
and outstanding 13,775,805 and 12,899,241
|
|
|
|
|
|
|
|
|
shares
at December 31, 2008 and December 31, 2007, respectively
|
|
|
68,879 |
|
|
|
64,496 |
|
Additional
paid-in capital
|
|
|
36,781,054 |
|
|
|
30,764,914 |
|
Accumulated
deficit
|
|
|
(56,246,173 |
) |
|
|
(41,038,212 |
) |
Total
stockholders' equity
|
|
|
538,261 |
|
|
|
14,194,244 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
$ |
4,706,480 |
|
|
$ |
17,421,826 |
|
CLEVELAND
BIOLABS, INC.
|
|
|
|
STATEMENTS
OF OPERATIONS
|
|
|
|
Years
Ended December 31, 2008, 2007, and 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31
|
|
|
December
31
|
|
|
December
31
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
REVENUES
|
|
|
|
|
|
|
|
|
|
Contract
and Grant
|
|
$ |
4,585,597 |
|
|
$ |
1,728,558 |
|
|
$ |
1,503,214 |
|
Service
|
|
|
120,000 |
|
|
|
290,000 |
|
|
|
205,000 |
|
|
|
|
4,705,597 |
|
|
|
2,018,558 |
|
|
|
1,708,214 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
13,160,812 |
|
|
|
17,429,652 |
|
|
|
6,989,804 |
|
Selling,
general and administrative
|
|
|
5,890,153 |
|
|
|
10,530,938 |
|
|
|
2,136,511 |
|
Total
operating expenses
|
|
|
19,050,965 |
|
|
|
27,960,590 |
|
|
|
9,126,315 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS
FROM OPERATIONS
|
|
|
(14,345,368 |
) |
|
|
(25,942,032 |
) |
|
|
(7,418,101 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER
INCOME
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
259,844 |
|
|
|
1,004,853 |
|
|
|
206,655 |
|
Buffalo
relocation reimbursement
|
|
|
220,000 |
|
|
|
- |
|
|
|
- |
|
Sublease
revenue
|
|
|
12,475 |
|
|
|
4,427 |
|
|
|
- |
|
Gain
on disposal of fixed assets
|
|
|
1,394 |
|
|
|
- |
|
|
|
- |
|
Gain
on investment
|
|
|
3,292 |
|
|
|
- |
|
|
|
- |
|
Total
other income
|
|
|
497,005 |
|
|
|
1,009,280 |
|
|
|
206,655 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER
EXPENSE
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
|
- |
|
|
|
1,087 |
|
|
|
11,198 |
|
Corporate
relocation
|
|
|
177,564 |
|
|
|
1,741,609 |
|
|
|
- |
|
Loss
on disposal of fixed assets
|
|
|
- |
|
|
|
15,575 |
|
|
|
- |
|
Loss
on investment
|
|
|
- |
|
|
|
305,479 |
|
|
|
- |
|
|
|
|
177,564 |
|
|
|
2,063,750 |
|
|
|
11,198 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
LOSS
|
|
|
(14,025,927 |
) |
|
|
(26,996,502 |
) |
|
|
(7,222,644 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
DIVIDENDS
ON CONVERTIBLE PREFERRED STOCK
|
|
|
(1,182,033 |
) |
|
|
(1,265,800 |
) |
|
|
(214,928 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
LOSS AVAILABLE TO COMMON STOCKHOLDERS
|
|
$ |
(15,207,960 |
) |
|
$ |
(28,262,302 |
) |
|
$ |
(7,437,572 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
LOSS AVAILABLE TO COMMON STOCKHOLDERS
|
|
|
|
|
|
|
|
|
|
|
|
|
PER
SHARE OF COMMON STOCK - BASIC AND
|
|
|
|
|
|
|
|
|
|
|
|
|
DILUTED
|
|
$ |
(1.13 |
) |
|
$ |
(2.34 |
) |
|
$ |
(0.84 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED
AVERAGE NUMBER OF SHARES USED
|
|
|
|
|
|
|
|
|
|
|
|
|
IN
CALCULATING NET LOSS PER SHARE, BASIC AND
|
|
|
|
|
|
|
|
|
|
|
|
|
DILUTED
|
|
|
13,492,391 |
|
|
|
12,090,430 |
|
|
|
8,906,266 |
|
CLEVELAND BIOLABS,
INC.
STATEMENTS OF STOCKHOLDERS' EQUITY AND
COMPREHENSIVE LOSS
Period From January 1, 2006 to December
31, 2008
|
|
Common
Stock
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
|
|
|
|
|
|
|
|
|
|
Paid-in
|
|
|
Penalty
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Shares
|
|
Balance at January 1,
2006
|
|
|
6,396,801 |
|
|
|
31,984 |
|
|
|
3,338,020 |
|
|
|
81,125 |
|
Issuance of shares - previously
accrued penalty shares
|
|
|
54,060 |
|
|
|
270 |
|
|
|
80,855 |
|
|
|
(81,125
|
) |
Issuance of shares - stock
dividend
|
|
|
184,183 |
|
|
|
922 |
|
|
|
367,445 |
|
|
|
- |
|
Issuance of penalty
shares
|
|
|
15,295 |
|
|
|
76 |
|
|
|
(76
|
) |
|
|
- |
|
Issuance of shares - initial
public offering
|
|
|
1,700,000 |
|
|
|
8,500 |
|
|
|
10,191,500 |
|
|
|
- |
|
Fees associated with initital
public offering
|
|
|
- |
|
|
|
- |
|
|
|
(1,890,444
|
) |
|
|
- |
|
Conversion of preferred stock to
common stock
|
|
|
3,351,219 |
|
|
|
16,756 |
|
|
|
5,291,385 |
|
|
|
- |
|
Conversion of notes payable to
common stock
|
|
|
124,206 |
|
|
|
621 |
|
|
|
312,382 |
|
|
|
- |
|
Issuance of
options
|
|
|
- |
|
|
|
- |
|
|
|
506,078 |
|
|
|
- |
|
Exercise of
options
|
|
|
625 |
|
|
|
3 |
|
|
|
2,810 |
|
|
|
- |
|
Issuance of
warrants
|
|
|
- |
|
|
|
- |
|
|
|
114,032 |
|
|
|
- |
|
Proceeds from sales of
warrants
|
|
|
- |
|
|
|
- |
|
|
|
110 |
|
|
|
- |
|
Net loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Other comprehensive
income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains (losses)
on short term investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in
unrealized holding gains (losses)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
arising during
period
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Less
reclassification adjustment for (gains) losses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
included in net
loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Comprehensive
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2006
|
|
|
11,826,389 |
|
|
$ |
59,132 |
|
|
$ |
18,314,097 |
|
|
$ |
- |
|
Issuance of
options
|
|
|
- |
|
|
|
- |
|
|
|
3,401,499 |
|
|
|
- |
|
Options to be issued in
2008
|
|
|
- |
|
|
|
- |
|
|
|
2,687,355 |
|
|
|
- |
|
Issuance of shares - Series B
financing
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Fees associated with Series B
Preferred offering
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Issuance of restricted
shares
|
|
|
190,000 |
|
|
|
950 |
|
|
|
1,699,500 |
|
|
|
- |
|
Exercise of
options
|
|
|
126,046 |
|
|
|
630 |
|
|
|
110,650 |
|
|
|
- |
|
Exercise of
warrants
|
|
|
48,063 |
|
|
|
240 |
|
|
|
90,275 |
|
|
|
- |
|
Conversion of Series B Preferred
Shares to Common
|
|
|
708,743 |
|
|
|
3,544 |
|
|
|
4,461,537 |
|
|
|
- |
|
Dividends on Series B Preferred
shares
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Net Loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Other comprehensive
income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains (losses)
on short term investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in unrealized holding gains (losses)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
arising during period
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Less reclassification adjustment for (gains) losses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
included in net loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2007
|
|
|
12,899,241 |
|
|
$ |
64,496 |
|
|
$ |
30,764,914 |
|
|
$ |
- |
|
Issuance of
options
|
|
|
- |
|
|
|
- |
|
|
|
2,287,803 |
|
|
|
- |
|
Partial recapture of expense for
options expensed in 2007
|
|
|
- |
|
|
|
- |
|
|
|
(1,459,425
|
) |
|
|
- |
|
but issued in
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of restricted
shares
|
|
|
130,000 |
|
|
|
650 |
|
|
|
625,850 |
|
|
|
- |
|
Restricted stock
awards
|
|
|
- |
|
|
|
- |
|
|
|
72,722 |
|
|
|
- |
|
Exercise of
options
|
|
|
37,271 |
|
|
|
186 |
|
|
|
24,191 |
|
|
|
- |
|
Conversion of Series B Preferred
Shares to Common
|
|
|
709,293 |
|
|
|
3,547 |
|
|
|
4,464,999 |
|
|
|
- |
|
Dividends on Series B Preferred
shares
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Net Loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Other comprehensive
income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains (losses)
on short term investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in unrealized holding gains (losses)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
arising during period
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Less reclassification adjustment for (gains) losses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
included in net loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2008
|
|
|
13,775,805 |
|
|
$ |
68,879 |
|
|
$ |
36,781,054 |
|
|
$ |
- |
|
CLEVELAND BIOLABS,
INC.
STATEMENTS OF STOCKHOLDERS' EQUITY AND
COMPREHENSIVE LOSS
Period From January 1, 2006 to December
31, 2008
|
|
Preferred
Stock
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
|
|
|
|
|
|
|
|
|
|
Paid-in
|
|
|
Penalty
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Shares
|
|
Balance at January 1,
2006
|
|
|
3,051,219 |
|
|
|
15,256 |
|
|
|
4,932,885 |
|
|
|
360,000 |
|
Issuance of shares - previously
accrued penalty shares
|
|
|
240,000 |
|
|
|
1,200 |
|
|
|
358,800 |
|
|
|
(360,000
|
) |
Issuance of shares - stock
dividend
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Issuance of penalty
shares
|
|
|
60,000 |
|
|
|
300 |
|
|
|
(300
|
) |
|
|
- |
|
Issuance of shares - initial
public offering
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Fees associated with initital
public offering
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Conversion of preferred stock to
common stock
|
|
|
(3,351,219
|
) |
|
|
(16,756
|
) |
|
|
(5,291,385
|
) |
|
|
- |
|
Conversion of notes payable to
common stock
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Issuance of
options
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Exercise of
options
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Issuance of
warrants
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Proceeds from sales of
warrants
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Net loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Other comprehensive
income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains (losses)
on short term investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in unrealized holding gains (losses)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
arising during period
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Less reclassification adjustment for (gains) losses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
included in net loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2006
|
|
|
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
Issuance of
options
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Options to be issued in
2008
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Issuance of shares - Series B
financing
|
|
|
4,579,010 |
|
|
|
22,895 |
|
|
|
32,030,175 |
|
|
|
- |
|
Fees associated with Series B
Preferred offering
|
|
|
- |
|
|
|
- |
|
|
|
(3,184,943
|
) |
|
|
- |
|
Issuance of restricted
shares
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Exercise of
options
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Exercise of
warrants
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Conversion of Series B Preferred
Shares to Common
|
|
|
(708,743
|
) |
|
|
(3,544
|
) |
|
|
(4,461,537
|
) |
|
|
- |
|
Dividends on Series B Preferred
shares
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Net Loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Other comprehensive
income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains (losses)
on short term investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in unrealized holding gains (losses)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
arising during period
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Less reclassification adjustment for (gains) losses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
included in net loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2007
|
|
|
3,870,267 |
|
|
$ |
19,351 |
|
|
$ |
24,383,695 |
|
|
$ |
- |
|
Issuance of
options
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Partial recapture of expense for
options expensed in 2007
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
but issued in
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of restricted
shares
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Restricted stock
awards
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Exercise of
options
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Conversion of Series B Preferred
Shares to Common
|
|
|
(709,293
|
) |
|
|
(3,547
|
) |
|
|
(4,464,999
|
) |
|
|
- |
|
Dividends on Series B Preferred
shares
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Net Loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Other comprehensive
income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains (losses)
on short term investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in unrealized holding gains (losses)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
arising during period
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Less reclassification adjustment for (gains) losses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
included in net loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2008
|
|
|
3,160,974 |
|
|
$ |
15,805 |
|
|
$ |
19,918,696 |
|
|
$ |
- |
|
STATEMENTS
OF STOCKHOLDERS' EQUITY AND COMPREHENSIVE LOSS
Period
From January 1, 2006 to December 31, 2008
|
|
Other
|
|
|
|
|
|
|
|
|
Comprehensive
|
|
|
|
Comprehensive
|
|
|
Accumulated
|
|
|
|
|
|
Income
|
|
|
|
Income/(Loss)
|
|
|
Deficit
|
|
|
Total
|
|
|
(Loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at January 1, 2006
|
|
|
(17,810 |
) |
|
|
(5,184,856 |
) |
|
|
3,556,604 |
|
|
|
|
Issuance
of shares - previously accrued penalty shares
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
Issuance
of shares - stock dividend
|
|
|
- |
|
|
|
(368,410 |
) |
|
|
(43 |
) |
|
|
|
Issuance
of penalty shares
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
Issuance
of shares - initial public offering
|
|
|
- |
|
|
|
- |
|
|
|
10,200,000 |
|
|
|
|
Fees
associated with initital public offering
|
|
|
- |
|
|
|
- |
|
|
|
(1,890,444 |
) |
|
|
|
Conversion
of preferred stock to common stock
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
Conversion
of notes payable to common stock
|
|
|
- |
|
|
|
- |
|
|
|
313,003 |
|
|
|
|
Issuance
of options
|
|
|
- |
|
|
|
- |
|
|
|
506,078 |
|
|
|
|
Exercise
of options
|
|
|
- |
|
|
|
- |
|
|
|
2,813 |
|
|
|
|
Issuance
of warrants
|
|
|
- |
|
|
|
- |
|
|
|
114,032 |
|
|
|
|
Proceeds
from sales of warrants
|
|
|
- |
|
|
|
- |
|
|
|
110 |
|
|
|
|
Net
loss
|
|
|
- |
|
|
|
(7,222,644 |
) |
|
|
(7,222,644 |
) |
|
|
(7,222,644 |
) |
Other
comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains (losses) on short term investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes
in unrealized holding gains (losses)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
arising
during period
|
|
|
6,678 |
|
|
|
- |
|
|
|
6,678 |
|
|
$ |
6,678 |
|
Less
reclassification adjustment for (gains) losses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
included
in net loss
|
|
|
6,967 |
|
|
|
- |
|
|
|
6,967 |
|
|
$ |
6,967 |
|
Comprehensive
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(7,208,999 |
) |
Balance
at December 31, 2006
|
|
$ |
(4,165 |
) |
|
$ |
(12,775,910 |
) |
|
$ |
5,593,154 |
|
|
|
|
|
Issuance
of options
|
|
|
- |
|
|
|
- |
|
|
|
3,401,499 |
|
|
|
|
|
Options
to be issued in 2008
|
|
|
- |
|
|
|
- |
|
|
|
2,687,355 |
|
|
|
|
|
Issuance
of shares - Series B financing
|
|
|
- |
|
|
|
- |
|
|
|
32,053,070 |
|
|
|
|
|
Fees
associated with Series B Preferred offering
|
|
|
- |
|
|
|
- |
|
|
|
(3,184,943 |
) |
|
|
|
|
Issuance
of restricted shares
|
|
|
- |
|
|
|
- |
|
|
|
1,700,450 |
|
|
|
|
|
Exercise
of options
|
|
|
- |
|
|
|
- |
|
|
|
111,280 |
|
|
|
|
|
Exercise
of warrants
|
|
|
- |
|
|
|
- |
|
|
|
90,515 |
|
|
|
|
|
Conversion
of Series B Preferred Shares to Common
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
Dividends
on Series B Preferred shares
|
|
|
- |
|
|
|
(1,265,800 |
) |
|
|
(1,265,800 |
) |
|
|
|
|
Net
Loss
|
|
|
- |
|
|
|
(26,996,502 |
) |
|
|
(26,996,502 |
) |
|
|
(26,996,502 |
) |
Other
comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized
gains (losses) on short term investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes
in unrealized holding gains (losses)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
arising
during period
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
$ |
- |
|
Less
reclassification adjustment for (gains) losses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
included
in net loss
|
|
|
4,165 |
|
|
|
- |
|
|
|
4,165 |
|
|
$ |
4,165 |
|
Comprehensive
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(26,992,337 |
) |
Balance
at December 31, 2007
|
|
$ |
- |
|
|
$ |
(41,038,212 |
) |
|
$ |
14,194,244 |
|
|
|
|
|
Issuance
of options
|
|
|
- |
|
|
|
- |
|
|
|
2,287,803 |
|
|
|
|
|
Partial
recapture of expense for options expensed in 2007
|
|
|
- |
|
|
|
- |
|
|
|
(1,459,425 |
) |
|
|
|
|
but
issued in 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of restricted shares
|
|
|
- |
|
|
|
- |
|
|
|
626,500 |
|
|
|
|
|
Restricted
stock awards
|
|
|
- |
|
|
|
- |
|
|
|
72,722 |
|
|
|
|
|
Exercise
of options
|
|
|
- |
|
|
|
- |
|
|
|
24,378 |
|
|
|
|
|
Conversion
of Series B Preferred Shares to Common
|
|
|
- |
|
|
|
- |
|
|
|
(0 |
) |
|
|
|
|
Dividends
on Series B Preferred shares
|
|
|
- |
|
|
|
(1,182,033 |
) |
|
|
(1,182,033 |
) |
|
|
|
|
Net
Loss
|
|
|
- |
|
|
|
(14,025,927 |
) |
|
|
(14,025,927 |
) |
|
|
(14,025,927 |
) |
Other
comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized
gains (losses) on short term investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes
in unrealized holding gains (losses)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
arising
during period
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
$ |
- |
|
Less
reclassification adjustment for (gains) losses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
included
in net loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
$ |
- |
|
Comprehensive
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(14,025,927 |
) |
Balance
at December 31, 2008
|
|
$ |
- |
|
|
$ |
(56,246,172 |
) |
|
$ |
538,261 |
|
|
|
|
|
|
|
|
|
STATEMENTS
OF CASH FLOWS
|
|
|
|
For
the Years Ended December 31, 2008, 2007 and 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
CASH
FLOWS FROM OPERATING ACTIVITIES
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(14,025,927 |
) |
|
$ |
(26,996,502 |
) |
|
$ |
(7,222,644 |
) |
Adjustments
to reconcile net loss to net cash
|
|
|
|
|
|
|
|
|
|
|
|
|
used
by operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
324,351 |
|
|
|
188,395 |
|
|
|
94,931 |
|
Noncash
interest expense
|
|
|
- |
|
|
|
- |
|
|
|
9,929 |
|
Noncash
salaries and consulting expense
|
|
|
1,527,600 |
|
|
|
7,789,305 |
|
|
|
620,119 |
|
Deferred
compensation
|
|
|
- |
|
|
|
- |
|
|
|
5,886 |
|
Loss
on disposal of fixed assets
|
|
|
- |
|
|
|
15,575 |
|
|
|
- |
|
Loss
on investments
|
|
|
- |
|
|
|
305,479 |
|
|
|
- |
|
Loss
on abandoned patents
|
|
|
60,045 |
|
|
|
- |
|
|
|
- |
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
receivable - trade
|
|
|
(880,419 |
) |
|
|
(3,652 |
) |
|
|
(159,750 |
) |
Accounts
receivable - interest
|
|
|
40,553 |
|
|
|
(12,870 |
) |
|
|
(5,616 |
) |
Prepaid
expenses
|
|
|
(185,081 |
) |
|
|
109,049 |
|
|
|
(422,427 |
) |
Deposits
|
|
|
1,963 |
|
|
|
(10,390 |
) |
|
|
(3,750 |
) |
Accounts
payable
|
|
|
391,232 |
|
|
|
65,923 |
|
|
|
380,023 |
|
Deferred
revenue
|
|
|
694,702 |
|
|
|
1,670,610 |
|
|
|
(100,293 |
) |
Accrued
expenses
|
|
|
(70,121 |
) |
|
|
321,206 |
|
|
|
99,990 |
|
Milestone
payments
|
|
|
- |
|
|
|
(50,000 |
) |
|
|
50,000 |
|
Total
adjustments
|
|
|
1,904,825 |
|
|
|
10,388,630 |
|
|
|
569,042 |
|
Net
cash (used by) provided by operating
|
|
|
|
|
|
|
|
|
|
|
|
|
activities
|
|
|
(12,121,102 |
) |
|
|
(16,607,872 |
) |
|
|
(6,653,602 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM INVESTING ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase
of short-term investments
|
|
|
(2,000,000 |
) |
|
|
(1,000,000 |
) |
|
|
(4,800,000 |
) |
Sale
of short-term investments
|
|
|
2,000,000 |
|
|
|
2,000,000 |
|
|
|
5,200,000 |
|
Issuance
of notes receivable
|
|
|
- |
|
|
|
(250,000 |
) |
|
|
(50,000 |
) |
Purchase
of equipment
|
|
|
(224,413 |
) |
|
|
(987,649 |
) |
|
|
(187,660 |
) |
Sale
of equipment
|
|
|
- |
|
|
|
1,250 |
|
|
|
- |
|
Costs
of patents pending
|
|
|
(333,994 |
) |
|
|
(206,124 |
) |
|
|
(176,621 |
) |
Net
cash (used in) provided by investing activities
|
|
|
(558,407 |
) |
|
|
(442,523 |
) |
|
|
(14,281 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of preferred stock
|
|
|
- |
|
|
|
30,020,984 |
|
|
|
- |
|
Financing
costs
|
|
|
- |
|
|
|
(1,152,857 |
) |
|
|
(1,679,456 |
) |
Dividends
|
|
|
(1,257,209 |
) |
|
|
(869,331 |
) |
|
|
(43 |
) |
Issuance
of common stock
|
|
|
- |
|
|
|
- |
|
|
|
10,200,000 |
|
Exercise
of stock options
|
|
|
24,378 |
|
|
|
111,280 |
|
|
|
2,813 |
|
Exercise
of warrants
|
|
|
- |
|
|
|
90,515 |
|
|
|
- |
|
Issuance
of warrants
|
|
|
- |
|
|
|
- |
|
|
|
100 |
|
Net
cash (used in) provided by financing activities
|
|
|
(1,232,831 |
) |
|
|
28,200,591 |
|
|
|
8,523,414 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INCREASE
(DECREASE) IN CASH AND EQUIVALENTS
|
|
|
(13,912,340 |
) |
|
|
11,150,196 |
|
|
|
1,855,531 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH
AND EQUIVALENTS AT BEGINNING OF
|
|
|
14,212,189 |
|
|
|
3,061,993 |
|
|
|
1,206,462 |
|
PERIOD
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH
AND EQUIVALENTS AT END OF PERIOD
|
|
$ |
299,849 |
|
|
$ |
14,212,189 |
|
|
$ |
3,061,993 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosures of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
paid during the period for interest
|
|
$ |
- |
|
|
$ |
1,087 |
|
|
$ |
1,269 |
|
Cash
paid during the year for income taxes
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
schedule of noncash financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of stock options to employees, consultants, and
|
|
$ |
2,287,803 |
|
|
$ |
3,401,499 |
|
|
$ |
506,078 |
|
independent
board members
|
|
|
|
|
|
|
|
|
|
|
|
|
Expense
recapture for expense for options expensed in 2007 but issued in
2008
|
|
$ |
(1,459,425 |
) |
|
$ |
- |
|
|
$ |
- |
|
Stock
options due to employees and a consultant
|
|
$ |
- |
|
|
$ |
2,687,355 |
|
|
$ |
- |
|
Issuance
of shares to consultants and employees
|
|
$ |
626,500 |
|
|
$ |
1,700,450 |
|
|
$ |
368,367 |
|
Amortization
of restricted shares to be issued to employees and
consultants
|
|
$ |
72,722 |
|
|
$ |
- |
|
|
$ |
- |
|
Issuance
of non-cash financing fees
|
|
$ |
- |
|
|
$ |
2,032,086 |
|
|
$ |
- |
|
Conversion
of preferred stock to common stock
|
|
$ |
4,468,546 |
|
|
$ |
4,465,081 |
|
|
$ |
5,308,141 |
|
Accrual
of preferred stock dividends
|
|
$ |
321,293 |
|
|
$ |
396,469 |
|
|
$ |
- |
|
Issuance
of warrants to consultant
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
114,042 |
|
Conversion
of notes payable and accrued interest to common stock
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
313,003 |
|
CLEVELAND BIOLABS,
INC.
NOTES TO FINANCIAL
STATEMENTS
Note 1.
Organization
Cleveland BioLabs, Inc. (“CBLI” or the
“Company”) is engaged in the discovery, development and commercialization of
products for cancer treatment and protection of normal tissues from radiation
and other stresses. The Company was incorporated under the laws of the State of
Delaware on June 5, 2003 and is headquartered in
Buffalo, New York.
The Company’s financial statements have
been prepared on the accrual basis of accounting in accordance with accounting
principles generally accepted in the United States of America and on a going concern basis
which contemplates the realization of assets and the liquidation of liabilities
in the ordinary course of business. The Company has incurred substantial losses
from operations and it has a working capital deficit which raises a question
about its ability to continue as a going concern. The Company sustained a net
loss of $14,025,927 for the fiscal year ended December 31, 2008 and it had
a working capital deficit of $1,304,354 at December 31, 2008.
The
Company plans to secure additional financing to sustain operations by issuing
additional preferred shares and exploring individual investment or licensing
arrangements. Subsequent to year-end, the Company has raised
approximately $4,300,000 from the issuance of additional preferred shares (see
Note 8 for details). The
Company also plans to submit proposals for government
contracts and grants over the next two years totaling over $30 million. Many of the proposals will be
submitted to government agencies that have awarded contracts and grants
to the Company in the recent
past. Finally,
the Company
plans to incur costs only on R&D projects that are properly funded, either
through a government contract or grant or other capital sources such as direct
investment.
.
Note 2. Summary of
Significant Accounting Policies
A.
|
Cash and Equivalents - The Company
considers highly liquid investments with a maturity date of three months
or less to be cash equivalents. In addition, the Company maintains cash
and equivalents at financial institutions, which may exceed federally
insured amounts at times and which may, at times, significantly exceed
balance sheet amounts due to outstanding
checks.
|
B.
|
Marketable Securities and Short
Term Investments - The Company considers investments with a maturity date
of more than three months to be short-term investments and has classified
these securities as available-for-sale. Such investments are carried at
fair value, with unrealized gains and losses included as accumulated other
comprehensive income (loss) in stockholders' equity. The cost of
available-for-sale securities sold is determined based on the specific
identification method.
|
C.
|
Accounts Receivable - The Company
extends unsecured credit to customers under normal trade agreements, which
generally require payment within 30 days. Management estimates an
allowance for doubtful accounts which is based upon management's review of
delinquent accounts and an assessment of the Company's historical evidence
of collections. There is no allowance for doubtful accounts as of December
31, 2008 and December 31,
2007.
|
D.
|
Equipment - Equipment is stated at
cost and depreciated over the estimated useful lives of the assets
(generally five years) using the straight-line method. Leasehold
improvements are depreciated on the straight-line method over the shorter
of the lease term or the estimated useful lives of the assets.
Expenditures for maintenance and repairs are charged to expense as
incurred. Major expenditures for renewals and betterments are capitalized
and depreciated. Depreciation expense was $324,351, $188,395, and $94,931
for the years ended December 31, 2008, 2007 and 2006,
respectively
|
E.
|
Impairment of Long-Lived Assets -
In accordance with Statements of Financial Accounting Standards, or SFAS,
No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets,
long-lived assets to be held and used, including equipment and intangible
assets subject to depreciation and amortization, are reviewed for
impairment at least annually and whenever events or changes in
circumstances indicate that the carrying amounts of the assets or related
asset group may not be recoverable. Determination of recoverability is
based on an estimate of discounted future cash flows resulting from the
use of the asset and its eventual disposition. In the event that such cash
flows are not expected to be sufficient to recover the carrying amount of
the asset or asset group, the carrying amount of the asset is written down
to its estimated net realizable
value.
|
F.
|
Intellectual Property - The
Company capitalizes the costs associated with the preparation, filing, and
maintenance of patent applications relating to intellectual property. If
the patent applications are approved, costs paid by the Company associated
with the preparation, filing, and maintenance of the patents will be
amortized on a straight-line basis over the shorter of 20 years or the
anticipated useful life of the patent. If the patent application is not
approved, the costs associated the patent application will be expensed as
part of selling, general and administrative expenses at that time.
Capitalized intellectual property is reviewed annually for
impairment.
|
A portion of this intellectual property
is owned by the Cleveland Clinic Foundation, or CCF, and granted to the Company
through an exclusive licensing agreement. As part of the licensing agreement,
CBLI agrees to bear the costs associated with the preparation, filing and
maintenance of patent applications relating to this intellectual property. Gross
capitalized patents pending costs were $629,363 and $407,425 for thirteen patent
applications as of December 31, 2008 and December 31, 2007, respectively. All of
the CCF patent applications are still pending approval. During 2008, the Company
abandoned one patent application due to developing another drug for the same
application and expensed $44,790 in selling, general and administrative
expenses.
The Company also has submitted five
patent applications as a result of intellectual property exclusively developed
and owned by the Company. Gross capitalized patents pending costs were $103,688
and $51,677 for five patent applications as of December 31, 2008 and December
31, 2007, respectively. The patent applications are still pending approval.
During 2008, the Company abandoned one patent application due to discovering
that the patent would provide no future economic benefit and expensed $15,256 in
selling, general and administrative expenses.
G.
|
Line of Credit - The Company has a
working capital line of credit that is fully secured by short-term
investments. This fully-secured, working capital line of credit carries an
interest rate of prime minus 1%, a borrowing limit of $1,000,000, and
expires on September 25, 2009. At December 31, 2008 and 2007, there were
no outstanding borrowings under this credit
facility.
|
H.
|
Fair Value of Financial
Instruments - Financial instruments, including cash and equivalents,
accounts receivable, notes receivable, accounts payable and accrued
liabilities, are carried at net realizable
value.
|
In September 2006, The Financial
Accounting Standards Board (“FASB”) issued Statement of Financial Accounting
Standards (“SFAS”) No. 157, “Fair Value Measurements.” SFAS No. 157
provides enhanced guidance for using fair value to measure assets and
liabilities and expands disclosure with respect to fair value
measurements. This statement was originally effective for fiscal
years beginning after November 15, 2007. In February 2008, the FASB issued
FSP157-2 which allows companies to elect a one-year deferral of adoption of SFAS
No. 157 for non-recurring assets and non-financial liabilities that are
recognized or disclosed at fair value in the financial statements on a
non-recurring basis. The Company has adopted SFAS No. 157 as of January 1,
2008.
SFAS No. 157 establishes a valuation
hierarchy for disclosure of the inputs to valuation used to measure fair
value. This hierarchy prioritizes the inputs into three broad levels
as follows: Level 1 inputs are quoted prices (unadjusted) in active markets for
identical assets or liabilities; Level 2 inputs are quoted prices for similar
assets and liabilities in active markets or inputs that are observable for the
asset or liability, either directly or indirectly; and Level 3 inputs are
unobservable inputs in which little or no market data exists, therefore
requiring a company to develop its own assumptions. The Company does
not have any significant assets or liabilities measured at fair value using
Level 1 or Level 3 inputs as of December 31, 2008.
I.
|
Use of Estimates - The preparation
of financial statements in conformity with accounting principles generally
accepted in the U.S. requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the
reporting period. The Company bases its estimates on historical experience
and on various other assumptions that the Company believes to be
reasonable under these circumstances. Actual results could differ from
those estimates.
|
J.
|
Revenue Recognition - The Company
recognizes revenue in accordance with Staff Accounting Bulletin No. 104,
“Revenue Recognition”, or SAB 104, and Statement of Financial Accounting
Standards No. 116, or SFAS 116. Revenue sources consist
of government grants, government contracts and commercial development
contracts.
|
Revenues from government grants and
contracts are for research and development purposes and are recognized in
accordance with the terms of the award and the government agency per SAB 104.
Grant revenue is recognized in one of two different ways depending on the grant.
Cost reimbursement grants require us to submit proof of costs incurred that are
invoiced by us to the government agency, which then pays the invoice. In this
case, grant revenue is recognized during the period that the costs were incurred
according to the terms of the government grant. Fixed cost grants require no
proof of costs at the time of invoicing, but proof is required for audit
purposes and grant revenue is recognized during the period that the costs were
incurred according to the terms of the government grant. The grant revenue under
these fixed costs grants is recognized using a percentage-of-completion method,
which uses assumptions and estimates. These assumptions and estimates are
developed in coordination with the principal investigator performing the work
under the government fixed-cost grants to determine key milestones, expenses
incurred, and deliverables to perform a percentage-of-completion analysis to
ensure that revenue is appropriately recognized. Critical estimates involved in
this process include total costs incurred and anticipated to be incurred during
the remaining life of the grant.
Government contract revenue is
recognized as allowable research and development expenses are incurred during
the period and according to the terms of the government contract. The Company
has recognized grant revenue from the following agencies: the Department of
Defense (DoD), the Defense Threat Reduction Agency (DTRA), the Defense Advanced
Research Projects Agency (DARPA), National Aeronautics and Space Administration
(NASA), the National Institutes of Health (NIH) and the Department of Health and
Human Services (HHS).
The Company recognizes revenue related
to the funds received from the State of New York under the sponsored research agreement
with the Roswell Park Cancer Institute (RPCI) in accordance with SFAS
116. The principles of SFAS 116 result in the recognition of revenue
as allowable costs are incurred. The Company recognizes revenue on research
laboratory services and the subsequent use of related equipment. The amount paid
as a payment toward future services related to the equipment is recognized as a
prepaid asset and will be recognized as revenue as the services are performed
and the prepaid asset is recognized as expense.
Commercial development revenues are
recognized when the service or development is delivered.
|
K.
|
Deferred Revenue – Deferred
revenue results when payment is received in advance of revenue being
earned. The Company makes a determination as to whether the revenue has
been earned by applying a percentage-of-completion analysis to compute the
need to recognize deferred revenue. The percentage of completion method is
based upon (1) the total income projected for the project at the time of
completion and (2) the expenses incurred to date. The
percentage-of-completion can be measured using the proportion of costs
incurred versus the total estimated cost to complete the
contract.
|
The Company received $2,000,000 in funds
from the State of New
York through the Roswell
Park Cancer Institute (“RPCI”) during the second quarter of 2007. The
Company received an additional $1,000,000 in funds from the State of
New York through the RPCI during the second
quarter of 2008. The Company is recognizing this revenue over the
terms and conditions of the sponsored research agreement. The Company recognizes
revenue on research laboratory services and the purchase and subsequent use of
related equipment. The amount paid as a payment toward future services related
to the equipment is recognized as a prepaid asset and will be recognized as
revenue as the services are performed.
The following table summarizes the
deferred revenue activity for the years ended December 31, 2008 and December 31,
2007, respectively:
|
|
Activity
|
|
|
|
|
|
Beginning Balance, December
31, 2007
|
|
$ |
1,670,610 |
|
Funds Recived From State of
NY
|
|
$ |
1,000,000 |
|
Funds Recognized as
Revenue
|
|
$ |
(305,298 |
) |
Ending Balance, December 31,
2008
|
|
$ |
2,365,312 |
|
|
|
|
|
|
|
|
Activity
|
|
|
|
|
|
|
Beginning Balance, December
31, 2006
|
|
$ |
- |
|
Funds Recived From State of
NY
|
|
$ |
2,000,000 |
|
Funds Recognized as
Revenue
|
|
$ |
(329,390 |
) |
Ending Balance, December 31,
2007
|
|
$ |
1,670,610 |
|
..
L.
|
Research and Development -
Research and development expenses consist primarily of costs associated
with salaries and related expenses for personnel, costs of materials used
in research and development, costs of facilities and costs incurred in
connection with third-party collaboration efforts. Expenditures relating
to research and development are expensed as
incurred.
|
M.
|
2006 Equity Incentive Plan - On
May 26, 2006, the Company's Board of Directors adopted the 2006 Equity
Incentive Plan (“Plan”) to attract and retain persons eligible to
participate in the Plan, motivate participants to achieve long-term
Company goals, and further align participants' interests with those of the
Company's other stockholders. The Plan expires on May 26, 2016 and the
aggregate number of shares of stock which may be delivered under the Plan
shall not exceed 2,000,000 shares. On February 14, 2007, these 2,000,000
shares were registered with the SEC by filing a Form S-8 registration
statement. On April 29, 2008, the stockholders of the Company approved an
amendment and restatement of the Plan (the “Amended Plan”). The Amended
Plan increases the number of shares available for issuance by an
additional 2,000,000 shares, clarifies other aspects of the 2006 Plan, and
contains updates that reflect changes and developments in federal tax
laws. As of December 31, 2008 there were 1,702,721 stock
options and 235,000 shares granted under the Amended Plan and 18,053
forfeited leaving 2,080,332 shares of stock to be awarded under the
Amended Plan.
|
N.
|
Executive Compensation Plan - On
May 11, 2007, the Compensation Committee (the “Compensation Committee”) of
the Board of Directors approved an executive compensation program designed
to reward each of the Company’s Chief Executive Officer, Chief Operating
Officer, Chief Financial Officer and Chief Scientific Officer (the
“Executive Officers”) for the achievement of certain pre-determined
milestones. The purpose of the program is to link each Executive Officer’s
compensation to the achievement of key Company milestones that the
Compensation Committee believes have a strong potential to create
long-term stockholder value.
|
Under the terms of this program, after
each fiscal year beginning with the fiscal year ended December 31, 2007, each
component of our Executive Officers’ compensation packages - base salary, cash
bonus and stock option awards - will be measured against the Company’s
achievement of (1) stock performance milestones, (2) scientific milestones, (3)
business milestones and (4) financial milestones, each of which will be weighted
equally. The milestones will be set at the beginning of each fiscal year. Each
set of milestones has a minimum threshold performance level, a target level and
a high performance level. For base salary, increases will range between 2% for
threshold performance to 6% for high performance. For cash bonuses, increases
will range between 15% for threshold performance and 60% for high performance.
For stock option awards, awards will range between 50,000 stock options for
threshold performance and 300,000 for high performance.
For the year ended December 31, 2008 the
Compensation Committee awarded no cash bonuses or stock option awards under the
Executive Compensation Plan. For 2007, the Compensation Committee
awarded $185,288 in cash bonuses and expensed $2,687,355 in non-cash,
stock-based compensation for the stock options to be awarded by the Compensation
Committee and issued in the subsequent year. In 2008, $1,459,425 of this
non-cash, stock-based compensation was recaptured as discussed in note O
below.
O.
|
Stock-Based Compensation - The
FASB issued SFAS No. 123(R) (revised December 2004), Share Based Payment,
which is a revision of SFAS No. 123 Accounting for Stock-Based
Compensation. SFAS 123(R) requires all share-based payments to employees,
including grants of employee stock options, to be recognized in the
statement of operations based on their fair values. The Company values
employee stock-based compensation under the provisions of SFAS 123(R) and
related interpretations.
|
The fair value of each stock option
granted is estimated on the grant date. The Black Scholes model is used for
standard stock options, but if market conditions are present within the stock
options, the Company utilizes Monte Carlo simulation to value the stock options.
The assumptions used to calculate the fair value of options granted are
evaluated and revised, as necessary, to reflect the Company's experience. The
Company uses a risk-free rate published by the St. Louis Federal Reserve at the
time of the option grant, assumes a forfeiture rate of zero, assumes an expected
dividend yield rate of zero based on the Company's intent not to issue a
dividend in the foreseeable future, uses an expected life based on the safe
harbor method, and computes an expected volatility based on similar high-growth,
publicly-traded, biotechnology companies. In 2008, the Company began to include
the use of its own stock in the volatility calculation and is layering in the
volatility of the stock of the Company with that of comparable companies since
there is not an adequate trading history to rely solely on the Company’s
volatility. The Company recognizes the fair value of stock-based compensation in
net income on a straight-line basis over the requisite service
period.
The assumptions used to value these
option and warrant grants using the Black-Scholes option valuation model are as
follows:
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
Risk-free
interest rate
|
|
|
2.43-3.58
|
% |
|
|
3.38-5.11
|
% |
|
|
4.66-5.04
|
% |
Expected
dividend yield
|
|
|
0
|
% |
|
|
0
|
% |
|
|
0
|
% |
Expected
life
|
|
5-6
years
|
|
|
2.74-6
years
|
|
|
5
years
|
|
Expected
volatility
|
|
|
64.25-82.47
|
% |
|
|
71.86-76.29
|
% |
|
|
71.43-75.11
|
% |
During the year ended December 31, 2008,
the Company granted 997,721 stock options pursuant to stock award agreements.
The Company recognized a total of $2,287,803 in expense related to stock options
granted for the year ended December 31, 2008. The Company also
recaptured $1,459,425 of previously recognized expense relating to the stock
options awarded under the 2007 Executive Compensation Plan. These
options were originally expensed based on the December 31, 2007 variables, but
were not issued until February 4, 2008. The change in dates resulted
in a difference in valuation assumptions used in the Black-Scholes model causing
a reduction in the grant date fair value. This reduction in the grant
date fair value from $5.34 to $2.58 per share resulted in the recapture of
$1,459,425 in expense and a net expense for options granted for the year ended
December 31, 2008 of $828,377.
The Company issued 997,721, 660,000 and
161,750 stock options during the years ended December 31, 2008, 2007, and 2006,
respectively, pursuant to various stock award agreements. The Company recognized
a total of $828,377, $3,401,499, and $506,078 in expense related to options for
the years ended December 31, 2008, 2007, and 2006, respectively. The weighted
average, estimated grant date fair values of stock options granted was $3.16,
$6.08, and $3.14 during the years ended December 31, 2008, 2007, and 2006,
respectively.
The following tables summarize the stock
option activity for the years ended December 31, 2008 and December 31, 2007,
respectively.
|
|
|
|
|
Weighted
|
|
|
Weighted
|
|
|
|
|
|
|
Average
|
|
|
Average
|
|
|
|
|
|
|
Exercise
|
|
|
Remaining
|
|
|
|
|
|
|
Price
per
|
|
|
Contractual
|
|
|
|
Shares
|
|
|
Share
|
|
|
Term
(in Years)
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding,
December 31, 2007
|
|
|
1,011,740 |
|
|
$ |
7.29 |
|
|
|
|
|
Granted
|
|
|
997,721 |
|
|
$ |
3.16 |
|
|
|
|
|
Exercised
|
|
|
42,534 |
|
|
$ |
1.04 |
|
|
|
|
|
Forfeited,
Canceled
|
|
|
18,053 |
|
|
$ |
9.00 |
|
|
|
|
|
Outstanding,
December 31, 2008
|
|
|
1,948,874 |
|
|
$ |
6.17 |
|
|
|
8.53 |
|
Exercisable,
December 31, 2008
|
|
|
1,597,837 |
|
|
$ |
5.52 |
|
|
|
8.50 |
|
|
|
|
|
|
Weighted
|
|
|
Weighted
|
|
|
|
|
|
|
Average
|
|
|
Average
|
|
|
|
|
|
|
Exercise
|
|
|
Remaining
|
|
|
|
|
|
|
Price
per
|
|
|
Contractual
|
|
|
|
Shares
|
|
|
Share
|
|
|
Term
(in Years)
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding,
December 31, 2006
|
|
|
483,490 |
|
|
$ |
2.17 |
|
|
|
|
|
Granted
|
|
|
660,000 |
|
|
$ |
9.85 |
|
|
|
|
|
Exercised
|
|
|
131,750 |
|
|
$ |
1.34 |
|
|
|
|
|
Forfeited,
Canceled
|
|
|
0 |
|
|
|
n/a |
|
|
|
|
|
Outstanding,
December 31, 2007
|
|
|
1,011,740 |
|
|
$ |
7.29 |
|
|
|
8.80 |
|
Exercisable,
December 31, 2007
|
|
|
646,930 |
|
|
$ |
6.89 |
|
|
|
8.75 |
|
The table summarizing the stock option
activity for the year ended December 31, 2008 indicates 42,534 shares exercised.
This figure includes 5,263 shares used to compensate the Company for a cashless
stock option exercise and therefore, were surrendered instead of
issued.
For the year ended December 31, 2008,
the Company recognized a total of $626,500 in expense for shares issued under
the Amended Plan and a total of $72,722 in expense related to the amortization
of restricted shares. For the year ended December 31, 2007 the
Company recognized a total of $1,700,450 in expense for shares issued under the
Plan to various consultants. During the year ended December 31, 2006, there was
no compensation expense related to share issuance because there were no shares
issued for compensation.
P.
|
Net Loss Per Share - Basic and
diluted net loss per share has been computed using the weighted-average
number of shares of common stock outstanding during the
period.
|
The following table presents the
calculation of basic and diluted net loss per share for the years ended December
31, 2008, 2007 and 2006:
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
Net loss available to common
stockholders
|
|
$ |
(15,207,960 |
) |
|
$ |
(28,262,302 |
) |
|
$ |
(7,437,572 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted
|
|
$ |
(1.13 |
) |
|
$ |
(2.34 |
) |
|
$ |
(0.84 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares used in
computing net loss per share, basic and diluted
|
|
|
13,492,391 |
|
|
|
12,090,430 |
|
|
|
8,906,266 |
|
The Company has excluded all outstanding
warrants and options from the calculation of diluted net loss per share because
all such securities are antidilutive for all applicable periods
presented.
The total number of shares excluded from
the calculations of diluted net loss per share, prior to application of the
treasury stock method for warrants, was 3,453,268, 3,453,268, and 814,424
for the years ended December 31, 2008, 2007 and 2006, respectively. Such
securities, had they been dilutive, would have been included in the computation
of diluted earnings per share.
The total number of shares excluded from
the calculations of diluted net loss per share, prior to the application of the
treasury stock method for options, was 1,948,874, 1,011,740, and 483,490
for the years ended December 31, 2008, 2007 and 2006, respectively. Such
securities, had they been dilutive, would have been included in the computation
of diluted earnings per share.
Q.
|
Concentrations of Risk - Grant
revenue accounted for 97.4%, 85.6% and 88.0% for the year ended December
31 2008, 2007 and 2006, respectively. Although the Company anticipates
ongoing federal government contract and grant revenue, there is no
guarantee that this revenue stream will continue in the
future.
|
Financial instruments that potentially
subject us to a significant concentration of credit risk consist primarily of
cash and cash equivalents and securities available-for-sale. The Company
maintains deposits in federally insured institutions in excess of federally
insured limits. The Company does not believe it is exposed to significant credit
risk due to the financial position of the depository institutions in which those
deposits are held. Additionally, the Company has established guidelines
regarding diversification of its investment portfolio and maturities of
investments, which are designed to meet safety and
liquidity.
R.
|
Foreign Currency Exchange Rate
Risk - The Company has entered into a manufacturing agreement to produce
one of its drug compounds and into an agreement for assay development and
validation with foreign third parties and is required to make payments in
the foreign currency. As a result, the Company's financial results could
be affected by changes in foreign currency exchange rates. Currently, the
Company's exposure primarily exists with the Euro and the British Pound,
or GBP. As of December 31, 2008, the Company is obligated to make payments
under the agreements of 916,354 Euros and 39,100 GBP. As of December 31,
2008, the Company has not purchased any forward contracts for Euros or GBP
and, therefore, at December 31, 2008, had foreign currency commitments of
$1,275,473 for Euros and $46,635 for GBP given prevailing currency
exchange spot rates..
|
S.
|
Comprehensive Income/(Loss) - The
Company applies Statement of Financial Accounting Standards (SFAS) No.
130, “Reporting Comprehensive Income.” SFAS No. 130 requires disclosure of
all components of comprehensive income on an annual and interim basis.
Comprehensive income is defined as the change in equity of a business
enterprise during a period from transactions and other events and
circumstances from non-owner
sources.
|
T.
|
Segment Reporting – As of December
31, 2008, the Company has determined that it operates in only one
segment. Accordingly, no segment disclosures have been included
in the notes to the consolidated financial
statements.
|
U.
|
Recently Issued Accounting
Pronouncements – In June 2008, the Financial Accounting Standards Board
("FASB") issued EITF Issue No. 07-5 ("EITF 07-5"), Determining whether an
Instrument (or Embedded Feature) is indexed to an Entity's Own Stock. EITF
No. 07-5 is effective for financial statements issued for fiscal years
beginning after December 15, 2008, and interim periods within those fiscal
years. Early application is not permitted. Paragraph 11(a) of SFAS No. 133
- specifies that a contract that would otherwise meet the definition of a
derivative but is both (a) indexed to the Company's own stock and (b)
classified in stockholders' equity in the statement of financial position
would not be considered a derivative financial instrument. EITF 07-5
provides a new two-step model to be applied in determining whether a
financial instrument or an embedded feature is indexed to an issuer's own
stock and thus able to qualify for the SFAS No. 133 paragraph 11(a) scope
exception. The adoption of EITF 07-5 is not anticipated to materially
impact the Company's financial
statements.
|
In June 2008, the FASB issued EITF 08-4,
"Transition Guidance for Conforming Changes to Issue No. 98-5." The objective of
EITF 08-4 is to provide transition guidance for conforming changes made to EITF
No. 98-5, "Accounting for Convertible Securities with Beneficial Conversion
Features or Contingently Adjustable Conversion Ratios," that result from EITF
No. 00-27 "Application of Issue No. 98-5 to Certain Convertible Instruments,"
and SFAS 150, "Accounting for Certain Financial Instruments with Characteristics
of both Liabilities and Equity." This Issue is effective for financial
statements issued for fiscal years ending after December 15, 2008. Early
application is permitted. Management is currently evaluating the impact of
adoption of EITF 08-4.
In May 2008, the FASB issued SFAS No.
162, “The Hierarchy of Generally Accepted Accounting Principles” (“SFAS 162”).
SFAS No. 162 identifies the sources of accounting principles and the framework
for selecting the principles to be used in the preparation of financial
statements of nongovernmental entities that are presented in conformity with
GAAP. Effective December 31, 2008, the Company adheres to SFAS No. 162, which
did not have any impact on the Company’s financial
statements.
In March 2008, the FASB
issued SFAS No. 161, "Disclosures about
Derivative Instruments and Hedging Activities, an amendment of FASB Statement
No. 133," which requires
additional disclosures about the objectives of using derivative instruments, the
method by which the derivative instruments and related hedged items are
accounted for under FASB Statement No.133 and its related interpretations, and
the effect of derivative instruments and related hedged items on financial
position, financial performance and cash flows. SFAS No. 161 also requires
disclosure of the fair values of derivative instruments and their gains and
losses in a tabular format. SFAS No. 161 will be effective for the Company on
January 1, 2009. The Company does not expect that the adoption of SFAS No. 161
will have a material impact on its consolidated financial statement
disclosures.
In
December 2007, the FASB
issued SFAS No. 141 (revised 2007), or SFAS No. 141R, "Business
Combinations" and SFAS No.
160, "Noncontrolling
Interests in Consolidated Financial Statements, an amendment of Accounting
Research Bulletin No. 51."
SFAS 141R will change how business acquisitions are accounted for and will
impact financial statements both on the acquisition date and in subsequent
periods. SFAS No. 160 will change the accounting and reporting for minority
interests, which will be recharacterized as noncontrolling interests and
classified as a component of equity. SFAS No. 141R and SFAS No. 160 are
effective for the Company on January 1, 2009. Early adoption is not permitted.
The Company does not expect that the adoption of SFAS No. 141R and SFAS No. 160
will have will have a material impact on its consolidated financial statements.
In
December 2007, the FASB
ratified the consensuses reached in Emerging Issue Task Force, or EITF, Issue
No. 07-1, "Collaborative
Arrangements". EITF Issue
No. 07-1 defines collaborative arrangements and establishes reporting
requirements for transactions between participants in a collaborative
arrangement and between participants in the arrangements and third parties.
Under EITF Issue No. 07-1, payments between participants pursuant to a
collaborative arrangement that are within the scope of other authoritative
accounting literature on income statement classification should be accounted for
using the relevant provisions of that literature. If the payments are not within
the scope of other authoritative accounting literature, the income statement
classification for the payments should be based on an analogy to authoritative
accounting literature or if there is no appropriate analogy, a reasonable,
rational, and consistently applied accounting policy election. EITF Issue No.
07-1 also provides disclosure requirements and is effective for the Company on
January 1, 2009. The effect of applying EITF Issue No. 07-1 will be reported as
a change in accounting principle through retrospective applications to all prior
periods presented for all collaborative arrangements existing as of the
effective date, unless it is impracticable. The Company does not expect the
adoption of EITF Issue No. 07-1 will have a material impact on its financial
statements.
Note 3. Significant Alliances and
Related Parties
The Cleveland Clinic Foundation
Effective July 2004, the Company entered
into a strategic alliance with CCF. Under the agreement, the Company received an
exclusive license to use CCF licensed patents and CCF technology for the benefit
of the Company for research and drug development. The Company has primary
responsibility to fund all newly developed patents; however, CCF retains patent
ownership on those contained in the agreement. The Company also has the
responsibility to secure applicable regulatory approvals. In partial
consideration of this agreement, in December 2004, the Company issued 1,341,000
shares of its common stock to CCF and recognized $2,250,000 as non-cash research
and development expense in exchange for the stock. The calculation of this
expense was based in part on an estimate of the Company’s value based on
discussions in 2004 with potential investors, in which the Company was estimated
to have a value of approximately $12,500,000. This valuation was reflected in an
agreement between the Company and an investment bank dated September 30, 2004.
This agreement set forth the terms on which the investment bank was to raise
equity capital for the Company. In light of the preliminary and subjective
nature of that estimate, the Company discounted that estimate to arrive at a
valuation of $10,000,000.
CCF will receive milestone payments for
each product developed with CCF technology as development passes through major
developmental stages. In addition, the Company will pay CCF royalties and
sublicense royalties as a percentage of net sales of all commercial products
developed with CCF technology. Milestone payments amounted to $50,000, $300,000,
and $0 for the years ended December 31, 2008, 2007, and 2006,
respectively.
The Company also incurred $518,904,
$927,347, and $1,142,290 in subcontract expense to CCF related to research
grants and other agreements for the years ended December 31, 2008, 2007 and
2006, respectively. The balance remaining in accrued payables is $15,209,
$70,539 and $7,309 at December 31, 2008, 2007 and 2006, respectively. Finally,
the Company recognized a balance of $0, $10,227 and $0 in accounts receivable at
December 31, 2008, 2007 and 2006, respectively.
Roswell Park Cancer
Institute
In January 2007, the Company entered
into a sponsored research agreement with RPCI to develop the Company’s cancer
and radioprotectant drug candidates. The Company received $2,000,000 in funds
from RPCI during the second quarter of 2007 and received an additional
$1,000,000 in the second quarter of 2008. This money was funded by the State of
New York as part of an incentive package for the
Company to relocate and establish a major research/clinical facility in
Buffalo, New York. The Company has an open-ended license
to any intellectual property resulting from any basic research conducted within,
or in collaboration with RPCI.
The Company also incurred $1,120,571
$414,389, and $0 in subcontract expense to RPCI related to research grants and
agreements for the years ended December 31, 2008, 2007 and 2006, respectively.
The balance remaining in accrued payables is $174,693 and $16,190 at December
31, 2008 and 2007, respectively
ChemBridge
Corporation
In April 2004, ChemBridge Corporation
acquired 357,600 shares of the Company’s common stock valued at $6,081 (subject
to antidilution provisions for future equity issues) and holds warrants to
purchase an additional 264,624 shares of the Company’s common stock for $1.13
per share. The warrants expire in April 2010. Under the agreement, ChemBridge
has agreed to provide chemical technology and expertise for the benefit of the
Company for research and drug development.
In April 2004, the Company entered into
a chemical libraries license agreement with ChemBridge. Under the terms of the
agreement, the Company has a non-exclusive worldwide license to use certain
chemical compound libraries for drug research conducted on its own or in
collaboration with others. In return, ChemBridge will receive royalty payments
on any revenue received by the Company for all contracts, excluding CCF, in
which the libraries are used. No revenues or royalties are due or have been paid
through the year ended December 31, 2008.
The Company has also agreed to
collaborate with ChemBridge on two optimization projects, wherein ChemBridge
will have the responsibility of providing the chemistry compounds of the project
and the Company will have the responsibility of providing the biological
expertise. ChemBridge will retain a 50% ownership interest in two selected
“confirmed hits” that make up the optimization projects. The parties will
jointly manage the development and commercialization of any compounds arising
from an optimization project. No “confirmed hits” have been selected during the
year ended December 31, 2008.
In addition, the Company paid ChemBridge
$916, $41,780, and $29,910 for the purchase of chemical compounds in the normal
course of business in 2008, 2007 and 2006, respectively.
Cooperative Research and Development
Agreement
In August 2004, the Company entered into
a five-year cooperative research and development agreement (CRADA) with the
Uniformed Service University of the Health Sciences, which includes the Armed
Forces Radiobiology Research Institute, the Henry M. Jackson Foundation for the
Advancement of Military Medicine, Inc., and CCF, to evaluate the Company’s
radioprotective drug candidates and their effects on intracellular and
extracellular signaling pathways. Under the terms of the agreement, all parties
are financially responsible for their own expenses related to the agreement. The
agreement may be unilaterally terminated by any party upon 30 days prior written
notice.
In August 2007, the Company entered into
an additional one-year CRADA with the Uniformed Service University of the Health Sciences to evaluate the
Company’s radioprotective drug candidate Protectan CBLB502 in non-human
primates. Under the terms of the agreement, the Company paid $628,465 to Henry
M. Jackson Foundation for the Advancement of Military Medicine, Inc to purchase,
house and irradiate animals and perform blood and cytokine analysis. The
agreement may be unilaterally terminated by any party upon 30 days prior written
notice.
Sunrise Securities
Corp.
The Company engaged Sunrise Securities
Corporation, or SSC, to act as the investment banker for the private placement
that took place in March 2005, as a lead underwriter for the initial public
offering in 2006, and as placement agent for its private placement of Series B
Convertible Preferred Stock, or Series B Preferred. SSC and its related parties
are owners of both common stock and warrants of the Company as a result of the
private placement and the initial public offering. The Company paid SSC $75,000
as an initial retainer for underwriting work associated with the initial public
offering and SSC received $945,000 in underwriting commissions from the initial
public offering. In addition, the Company paid SSC $95,000 related to legal fees
incurred in the March 2007 Series B Preferred offering.
Consultants
In addition, a Company stockholder, who
serves as the Company’s Chief Scientific Officer, received payments for
consulting services performed on certain grant awards and internal research and
development. Total cash consultant expense made to this person amounted to
$114,215, $120,580, and $104,168 for the years ended December 31, 2008, 2007 and
2006, respectively. The Company recaptured $378,810 in non-cash, stock-based
compensation expense in 2008 previously expensed as discussed in Note 2O to this
consultant. In 2007, the Company incurred $198,375 in non-cash,
stock-based compensation expense to this consultant, accrued an additional
$732,915 in non-cash, stock-based compensation and an additional $19,215 in
subcontractor expense related to the 2007 Executive Compensation
Plan.
A Company stockholder, who serves as the
Company’s Vice President of Research - Radioprotectant Group, received payment
for consulting services performed related to the Company’s research efforts.
Total consultant expense made to this person amounted to $78,380, $95,520, and
$84,330 for the years ended December 31, 2008, 2007, and 2006,
respectfully.
Note 4. Equity
Transactions
On February 1, 2006, the Company paid a
common stock dividend of 91,776 shares to holders of the Series A preferred
stock to satisfy the dividend requirement of the preferred stock
issuance.
On March 1, 2006, the Company issued
116,750 stock options to various employees and consultants of the Company under
non-qualified stock option agreements. These options allow for the purchase of
116,750 shares of common stock at a price of $4.50. These options have a
three-year vesting schedule and expire on February 29, 2016.
On June 21, 2006, after the expiration
of the 115-day extension and an additional 30-day period, the Company incurred
one additional penalty period in which 60,000 shares of Series A preferred stock
were earned at $120,000 and 15,295 shares of common stock were earned at
$30,590. The Company has not incurred any further obligation to issue penalty
shares since these issuances.
On July 20, 2006, the Company sold
1,700,000 shares of common stock in its initial public offering at $6.00 per
share. The net proceeds to the Company from this offering were approximately
$8,300,000. Beginning July 21, 2006, the Company’s shares were quoted on the
NASDAQ Capital Market and listed on the Boston Stock Exchange under the symbols
“CBLI” and “CFB” respectively. On August 28, 2007, trading of the Company’s
common stock moved from the NASDAQ Capital Market to the NASDAQ Global Market.
In September 2007, we ceased our listing on the Boston Stock Exchange. In
connection with its initial public offering, the Company sold warrants to
purchase 170,000 shares of common stock to the underwriters and their designees
at a cost of $100.00. The warrants have an exercise price of $8.70 per
share.
On July 20, 2006, the effective date of
the Company’s initial public offering, the Company issued 92,407 shares of
common stock as accumulated dividends to the Series A preferred stockholders. On
the same date, all of the Company’s Series A Preferred shares automatically
converted on a one-for-one basis into 3,351,219 shares of common stock and notes
of the Company in the principal amount of $283,500 plus accrued interest of
$29,503 automatically converted into 124,206 shares of common stock. In
connection with their appointment to the Board, the Company issued to each of
the Company’s three new independent directors, options to purchase 15,000 shares
of common stock with an exercise price of $6.00 per share.
On September 21, 2006, the SEC declared
effective a registration statement of the Company registering up to 4,453,601
shares of common stock for resale from time to time by the selling stockholders
named in the prospectus contained in the registration statement. The Company
will not receive any proceeds from the sale of the underlying shares of common
stock, although to the extent the selling stockholders exercise warrants for the
underlying shares of common stock, the Company will receive the exercise price
of those warrants. The registration statement was filed to satisfy registration
rights that the Company had previously granted.
On November 16, 2006 the Company issued
50,000 warrants to an outside consultant. These warrants are immediately
exercisable into common shares of the Company and have an exercise price of
$6.00 per share and an expiration date of November 16, 2011.
On February 14, 2007, the Company issued
99,500 stock options to various employees and consultants of the Company under
non-qualified stock option agreements. These options allow for the purchase of
99,500 shares of common stock at a price of $9.14. These options have various
vesting schedules from immediate vesting to three years and expire on February
14, 2017.
On February 26, 2007, the Company issued
55,000 warrants at an exercise price of $9.19 per share, to a placement agent as
incentive for work on the private placement offering.
On March 16, 2007, the Company entered
into a Securities Purchase Agreement with various accredited investors (the
Buyers), pursuant to which the Company agreed to sell to the Buyers Series B
Convertible Preferred Stock (Series B Preferred) convertible into an aggregate
of 4,288,712 shares of common stock and Series B Warrants that are exercisable
for an aggregate of 2,144,356 shares of common stock. The Series B Preferred
have an initial conversion price of $7.00 per share, pay an annual dividend of
$.35 per share, and in the event of a conversion at such conversion price, one
share of Series B Preferred would convert into one share of common stock. The
Series B Warrants have an exercise price of $10.36 per share, the closing bid
price on the day prior to the private placement. To the extent, however, that
the conversion price of the Series B Preferred or the exercise price of the
Series B Warrants is reduced as a result of certain anti-dilution protections,
the number of shares of common stock into which the Series B Preferred are
convertible and for which the Series B Warrants are exercisable may
increase.
The Company also issued to the placement
agents in the private placement (the Agents), as compensation for their
services, Series B Preferred, Series B Warrants, and Series C Warrants. The
Agents collectively received Series B Preferred that are convertible into an
aggregate of 290,298 shares of common stock, Series B Warrants that are
exercisable for an aggregate of 221,172 shares of the Company’s common stock,
and Series C Warrants that are exercisable for 267,074 shares of the Company’s
common stock. The Series C Warrants have an exercise price of $11.00 per share,
and are also subject to anti-dilution protections that could increase the number
of shares of common stock for which they are exercisable.
In total, the securities issued in the
private placement will be convertible into, or exercisable for, up to
approximately 7,211,612 shares of common stock, which amount is subject to
adjustment in the event of certain corporate events such as stock splits or
issuances of securities at a price below the conversion price of the Series B
Preferred or exercise price of the warrants, as the case may be. On
September 13, 2007, the Company paid $807,913 to the Series B Preferred
stockholders for the semiannual dividend.
On March 19, 2007, the Company issued
20,000 stock options to members of the Scientific Advisory Board of the Company
under non-qualified stock option agreements. These options are immediately
exercisable and allow for the purchase of 20,000 shares of common stock at a
price of $8.82. These options expire on March 18, 2017.
On April 6, 2007, the Company issued
152,500 stock options to officers and consultants under non-qualified stock
option agreements. These options are immediately exercisable and allow for the
purchase of 152,500 shares of common stock at a price of $8.36. These
options expire on April 5, 2017. The Company also issued 115,000
shares of common stock to consultants under the Plan.
On June 12, 2007, the Company issued
140,000 stock options to four independent members of the Board of Directors of
the Company under non-qualified stock option agreements. These
options are immediately exercisable and allow for the purchase of 140,000 shares
of common stock at a price of $9.40. These options expire on June 11,
2017.
On June 15, 2007, the Company issued
110,000 stock options to various key employees and consultants under
non-qualified stock option agreements. These options have various
vesting schedules including immediate vesting, up to three year vesting, and
vesting upon the company stock price obtaining certain levels. These
options allow for the purchase of 110,000 shares of common stock at a price
ranging from $9.93 to $17.00. These options expire on June 14, 2017.
The Company also issued 30,000 shares of common stock to the same consultants
under the Plan.
On June 21, 2007, the Company issued
3,000 stock options to a consultant under a non-qualified stock option
agreement. These options vest over a six month period and allow for
the purchase of 3,000 shares of common stock at a price of
$10.84. These options expire on June 20, 2017.
On June 27, 2007, the Company issued
30,000 shares of common stock to various outside consultants under the
Plan.
On July 18, 2007, the Company issued
15,000 shares of common stock to an outside consultant under the
Plan. On that date, the Company also issued 18,000 stock options to
another consultant under a non-qualified stock option
agreement. These options are immediately exercisable and allow for
the purchase of 18,000 shares of common stock at a price of
$10.61. These options expire on December 31,
2012.
On December 4, 2007, the Company issued
117,000 stock options to various key employees and consultants under
non-qualified stock option agreements. These options have up to three
year vesting. These options allow for the purchase of 117,000 shares
of common stock at an exercise price of $10.00 per share. These
options expire on or before December 3, 2017.
On December 11, 2007, the SEC declared
effective a registration statement of the Company registering up to 5,514,999
shares of common stock for resale from time to time by the selling stockholders
named in the prospectus contained in the registration statement. This number
represents 5,514,999 shares of common stock issuable upon the conversion or
exercise of the securities issued in the Company’s March 2007 private placement
at the current conversion and exercise prices. Of these 5,514,999 shares of
common stock, 3,717,515 shares are issuable upon conversion of Series B
Preferred and 1,797,484 shares are issuable upon exercise of the Series B
Warrants. The Company will not receive any proceeds from the sale of the
underlying shares of common stock, although to the extent the selling
stockholders exercise warrants for the underlying shares of common stock, the
Company will receive the exercise price of those warrants. The registration
statement was filed to satisfy registration rights that the Company had
previously granted. Subsequent to the effectiveness of the
registration statement, 708,743 Series B Preferred were converted and $61,418 in
dividends earned were paid as of December 31, 2007. At December 31, 2007,
$396,469 in dividends were accrued on the outstanding Series B
Preferred.
On January 1, 2008, the Company issued
100,000 options to a new employee and 60,000 options to a key consultant of the
Company under the Plan. The options vest over a period from one to
three years and allow for the purchase of 160,000 shares of common stock at a
price of $8.00 per share. These options expire on December 31,
2017.
On January 4, 2008, the Company issued
20,000 restricted shares of common stock to a new employee. These
shares vest over a three-year period with 25% vested on issuance and 25% vesting
on the anniversary date of the agreement for each of the next three
years.
On February 4, 2008, the Company issued
options to purchase 503,250 shares of common stock under non-qualified stock
option agreements to the executive management team under the 2007 Executive
Compensation Plan. These options were originally expensed in 2007 at
the December 31, 2007 closing price of $8.80. These options vest
immediately, contain an exercise price of $4.00 per share, and expire on
February 4, 2018. The Company also issued options to purchase
34,398 shares of common stock to various employees under non-qualified stock
option agreements under an employee bonus program. These options vest
immediately, contain an exercise price of $4.00 per share, and expire on
February 3, 2018. Finally, the Company issued stock options to
various key employees under non-qualified stock option
agreements. These options have up to three years
vesting. These options allow for the purchase of 21,300 shares of
common stock at an exercise price of $4.00 per share and expire on February 3,
2018.
On March 12, 2008, the Company issued
1,000 stock options to a consultant under a non-qualified stock option
agreement. These options vest immediately and allow for the purchase
of 1,000 shares of common stock at an exercise price of $4.81 per
share. These options expire on March 11, 2018.
On March 14, 2008, the Company issued
100,000 unrestricted shares of common stock to a key consultant under the
Plan.
On April 8, 2008, the Company issued
40,000 stock options to three consultants under non-qualified stock option
agreements. These options vest immediately and allow for the purchase
of 40,000 shares of common stock at an exercise price of $4.18 per
share. These options expire on April 7, 2018. On April 8,
2008, the Company also issued 25,000 restricted shares of common
stock. These shares vest over a three-month period with 40% vested on
issuance and 60% vesting three months from the date of the
agreement.
On April 29, 2008, the Company issued
140,000 stock options to four independent members of the Board of Directors of
the Company under non-qualified stock option agreements. These
options vest immediately and allow for the purchase of 140,000 shares of common
stock at an exercise price of $5.33 per share. These options expire
on April 28, 2018.
On May 7, 2008, the Company issued
14,976 stock options to various employees under non-qualified stock option
agreements under an employee bonus program. These options vest immediately and
allow for the purchase of 14,976 shares of common stock at an exercise price of
$5.28 per share. These options expire on May 6,
2018.
On July 15, 2008, the Company issued
28,456 stock options to various employees under non-qualified stock option
agreements under an employee bonus program. These options vest immediately and
allow for the purchase of 28,456 shares of common stock at an exercise price of
$3.98 per share. These options expire on July 14,
2018.
On September 22 2008, the Company issued
35,000 stock options to a new employee under non-qualified stock option
agreements. These options vest over a three-year period and allow for
the purchase of 35,000 shares of common stock at an exercise price of $4.69 per
share. These options expire on September 21,
2018.
On November 14, 2008, the Company issued
19,341 stock options to various employees under non-qualified stock option
agreements under an employee bonus program. These options vest immediately and
allow for the purchase of 19,341 shares of common stock at an exercise price of
$3.10 per share. These options expire on November 13,
2018.
For the year ending December 31, 2008,
Series B Preferred Shares were converted into 709,293 shares of common stock. At
December 31, 2008, there were 3,160,974 outstanding Series B Preferred for which
$321,293 in dividends had been accrued.
Note 5. Income Taxes
The provisions for income taxes charged
to continuing operations is $0 for the years ended December 31, 2008, 2007, and
2006, respectively.
Deferred tax assets (liabilities) are
comprised of the following at December 31:
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
Deferred tax
assets:
|
|
|
|
|
|
|
|
|
|
Operating loss
carryforwards
|
|
$ |
18,383,000 |
|
|
$ |
13,289,000 |
|
|
$ |
4,586,000 |
|
Tax credit
carryforwards
|
|
|
1,772,000 |
|
|
|
737,000 |
|
|
|
- |
|
Deferred
compensation
|
|
|
3,102,000 |
|
|
|
2,765,000 |
|
|
|
345,000 |
|
Other
|
|
|
4,000 |
|
|
|
- |
|
|
|
2,000 |
|
Total deferred income tax
assets
|
|
|
23,261,000 |
|
|
|
16,791,000 |
|
|
|
4,933,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred tax
liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
Equipment
|
|
|
(83,000
|
) |
|
|
(61,000
|
) |
|
|
(35,000
|
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net deferred income tax
asset
|
|
|
23,178,000 |
|
|
|
16,730,000 |
|
|
|
4,898,000 |
|
Valuation
allowance
|
|
|
(23,178,000
|
) |
|
|
(16,730,000
|
) |
|
|
(4,898,000
|
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
The provision for income taxes differs
from the amount of income tax determined by applying the applicable U.S. statutory federal income tax rate to
the pretax loss from continuing operations as a result of the following
differences:
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
Tax at the U.S. statutory
rate
|
|
$ |
(4,769,000 |
) |
|
$ |
(9,474,000 |
) |
|
$ |
(2,456,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock option
exercises
|
|
|
(20,000 |
) |
|
|
(363,000 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Valuation
allowance
|
|
|
4,879,000 |
|
|
|
9,831,000 |
|
|
|
2,456,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
|
|
|
(90,000 |
) |
|
|
6,000 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
At December 31, 2008, the Company has
federal net operating loss carryforwards of approximately $46,658,000, which
begin to expire if not utilized by 2023, and approximately $1,509,000 of tax
credit carryforwards that begin to expire if not utilized by
2024. The utilization of approximately $329,000 of the net operating
loss carryforwards and approximately $203,000 of the tax credit carryforwards is
limited through 2011 as a result of ownership changes. The Company also has
state net operating loss carryforwards of approximately $35,486,000, which begin
to expire if not utilized by 2027, and state tax credit carryforwards of
approximately $517,000, which begin to expire if not utilized by
2010. The utilization of these federal and state net operating loss
and tax credit carryforwards is limited as a result of ownership
changes.
The Company files a United States federal tax return, along with various
state and local income tax returns. The federal, state and local tax returns for
the years ended December 31, 2007, 2006 and 2005 are still open for
examination.
Effective January 1, 2007, the Company
adopted Financial Accounting Standards Board FIN 48, “Accounting for Uncertainty
in Income Taxes”, which prescribes a minimum recognition threshold and
measurement methodology that a tax position taken or expected to be taken in a
tax return is required to meet before being recognized in the financial
statements. There was no impact to the financial statements upon the adoption of
FIN 48.
The following presents a rollforward of
the unrecognized tax benefits under FIN 48, and the associated interest and
penalties:
|
|
Unrecognized
|
|
|
Interest
|
|
|
|
Tax
Benefits
|
|
|
and
Penalties
|
|
Balance at January 1, 2007
(adoption)
|
|
$ |
- |
|
|
$ |
- |
|
Prior year tax
positions
|
|
|
- |
|
|
|
- |
|
Current year tax
positions
|
|
|
- |
|
|
|
- |
|
Deferred tax
positions
|
|
|
230,000 |
|
|
|
- |
|
Settlements with tax
authorities
|
|
|
- |
|
|
|
- |
|
Expiration of the statute of
limitations
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2007
|
|
|
230,000 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Prior year tax
positions
|
|
|
- |
|
|
|
- |
|
Current year tax
positions
|
|
|
- |
|
|
|
- |
|
Deferred tax
positions
|
|
|
24,000 |
|
|
|
- |
|
Settlements with tax
authorities
|
|
|
- |
|
|
|
- |
|
Expiration of the statute of
limitations
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2008
|
|
$ |
254,000 |
|
|
$ |
- |
|
The Company’s 2007 and 2008 New York state tax returns include approximately
$724,000 of refundable state incentive tax credits, which are based upon
research and development activities, real estate tax payments, hiring employees
and equipment purchases. At December 31, 2008, none of these refunds
have been received from the NY tax authorities, and accordingly, no benefit has
been recorded in the accompanying financial statements.
Note 6. Other Balance Sheet
Details
Available-For-Sale Cash Equivalents and
Marketable Securities
Available-for-sale Marketable Securities
consist of the following:
|
|
|
|
|
|
|
|
Gross
|
|
|
Gross
|
|
|
|
|
|
|
|
|
|
Accrued
|
|
|
Unrealized
|
|
|
Unrealized
|
|
|
Fair
|
|
|
|
Cost
|
|
|
Interest
|
|
|
Gains
|
|
|
Losses
|
|
|
Value
|
|
December 31, 2008 - Current
Marketable Securities
|
|
$ |
1,000,000 |
|
|
$ |
9,488 |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
1,009,488 |
|
The Company considers investments with a
maturity date of more than three months from the date of purchase to be
short-term investments and has classified these securities as
available-for-sale. Such investments are carried at fair value, with unrealized
gains and losses included as accumulated other comprehensive income (loss) in
stockholders’ equity. The cost of available-for-sale securities sold is
determined based on the specific identification method. As a result of changes
in market interest rates on investment, the Company recognized unrealized
gains/(losses) of $0 $4,165, and $13,645 for the years ending December 31, 2008,
2007, and 2006, respectively.
Equipment
Equipment consists of the
following:
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
Laboratory
Equipment
|
|
$ |
309,323 |
|
|
$ |
966,517 |
|
Computer
Equipment
|
|
|
1,102,465 |
|
|
|
258,089 |
|
Furniture
|
|
|
312,134 |
|
|
|
274,903 |
|
|
|
|
1,723,922 |
|
|
|
1,499,509 |
|
Less accumulated
depreciation
|
|
|
(637,840 |
) |
|
|
(313,489 |
) |
|
|
$ |
1,086,082 |
|
|
$ |
1,186,020 |
|
Note 7. Commitments and
Contingencies
The Company has entered into various
agreements with third parties and certain related parties in connection with the
research and development activities of its existing product candidates as well
as discovery efforts on potential new product candidates. These agreements
include costs for research and development and license agreements that represent
the Company's fixed obligations payable to sponsor research and minimum royalty
payments for licensed patents. These amounts do not include any additional
amounts that the Company may be required to pay under its license agreements
upon the achievement of scientific, regulatory and commercial milestones that
may become payable depending on the progress of scientific development and
regulatory approvals, including milestones such as the submission of an
investigational new drug application to the FDA and the first commercial sale of
the Company's products in various countries. These agreements include costs
related to manufacturing, clinical trials and preclinical studies performed by
third parties.
The Company is also party to three
agreements that require it to make milestone payments, royalties on net sales of
the Company's products and payments on sublicense income received by the
Company. As of December 31, 2008, $350,000 in milestone payments have been made
under one of these agreements.
From time to time, the Company may have
certain contingent liabilities that arise in the ordinary course of business.
The Company accrues for liabilities when it is probable that future expenditures
will be made and such expenditures can be reasonably estimated. For all periods
presented, the Company is not a party to any pending material litigation or
other material legal proceedings. From time to time in the ordinary course of
business, the Company may be subject to claims brought against it. It is not
possible to state the ultimate liability, if any, in these
matters
The Company currently has operating
lease commitments in place for facilities in Buffalo, New York and Chicago, Illinois as well as office equipment. The
Company recognizes rent expense on a straight-line basis over the term of the
related operating leases. The operating lease expense recognized were $332,584,
$218,635 and $160,742 for the years ended December 31, 2008, 2007 and 2006,
respectively.
Annual future minimum lease payments
under present lease commitments are as follows.
|
|
Operating
|
|
|
|
Leases
|
|
|
|
|
|
2009
|
|
$ |
355,900 |
|
2010
|
|
|
343,656 |
|
2011
|
|
|
311,803 |
|
2012
|
|
|
144,375 |
|
2013
|
|
|
- |
|
|
|
|
|
|
|
|
$ |
1,155,734 |
|
The Company has entered into stock
option agreements with key employees, board members and consultants with
exercise prices ranging from $0.66 to $17.00. These awards were approved by the
Company’s Board of Directors. The options expire ten years from the date of
grant except 18,000 options that expire on December 31, 2012, subject to the
terms applicable in the agreement.
The following tables summarize the stock
option activity for the year ended December 31, 2008 and
2007:
|
|
Number
of
|
|
|
Weighted
Average
|
|
|
|
Options
|
|
|
Exercise Price
|
|
|
|
|
|
|
|
|
Outstanding
at December 31, 2006
|
|
|
483,490 |
|
|
$ |
2.17 |
|
Granted
|
|
|
660,000 |
|
|
$ |
9.85 |
|
Exercised
|
|
|
131,750 |
|
|
$ |
1.34 |
|
Forfeited
|
|
|
0 |
|
|
|
n/a |
|
Outstanding
at December 31, 2007
|
|
|
1,011,740 |
|
|
$ |
7.29 |
|
Granted
|
|
|
997,721 |
|
|
$ |
3.16 |
|
Exercised
|
|
|
42,534 |
|
|
$ |
1.04 |
|
Forfeited
|
|
|
18,053 |
|
|
$ |
9.00 |
|
Outstanding
at December 31, 2008
|
|
|
1,948,874 |
|
|
$ |
6.17 |
|
The number of options and weighted
average exercise price of options fully vested and exercisable for the years
ending December 31, 2008, 2007 and 2006 were 1,597,837, 646,930, and 243,183
options at $5.52, $6.89, and $2.27 respectively. A table showing the number of
options outstanding and exercisable (fully vested) at December 31, 2008 appears
below:
The Company has entered into warrant
agreements with strategic partners, consultants and investors with exercise
prices ranging from $1.13 to $11.00. These awards were approved by the Company’s
Board of Directors. The warrants expire between five and six years from the date
of grant, subject to the terms applicable in the agreement. A list of the total
warrants awarded and exercised appears below:
|
|
Number
of
|
|
|
Weighted
Average
|
|
|
|
Warrants
|
|
|
Exercise
Price
|
|
|
|
|
|
|
|
|
Outstanding
at December 31, 2006
|
|
|
814,424 |
|
|
$ |
3.36 |
|
Granted
|
|
|
2,687,602 |
|
|
$ |
10.40 |
|
Exercised
|
|
|
48,758 |
|
|
$ |
2.00 |
|
Outstanding
at December 31, 2007
|
|
|
3,453,268 |
|
|
$ |
8.86 |
|
Granted
|
|
|
- |
|
|
|
N/A |
|
Exercised
|
|
|
- |
|
|
|
N/A |
|
Outstanding
at December 31, 2007
|
|
|
3,453,268 |
|
|
$ |
8.86 |
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
|
Number
of
|
|
|
Years
to
|
|
|
Number
of
|
|
Exercise
Price
|
|
|
Options
|
|
|
Expiration
|
|
|
Options
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
0.66 |
|
|
|
112,500 |
|
|
|
6.50 |
|
|
|
112,500 |
|
$ |
0.67 |
|
|
|
45,981 |
|
|
|
6.50 |
|
|
|
45,981 |
|
$ |
3.10 |
|
|
|
19,341 |
|
|
|
9.87 |
|
|
|
19,341 |
|
$ |
3.98 |
|
|
|
28,456 |
|
|
|
9.54 |
|
|
|
28,456 |
|
$ |
4.00 |
|
|
|
557,902 |
|
|
|
9.09 |
|
|
|
541,927 |
|
$ |
4.18 |
|
|
|
40,000 |
|
|
|
9.27 |
|
|
|
40,000 |
|
$ |
4.50 |
|
|
|
111,500 |
|
|
|
7.17 |
|
|
|
81,688 |
|
$ |
4.69 |
|
|
|
35,000 |
|
|
|
9.73 |
|
|
|
8,750 |
|
$ |
4.81 |
|
|
|
1,000 |
|
|
|
9.20 |
|
|
|
1,000 |
|
$ |
5.28 |
|
|
|
14,694 |
|
|
|
9.35 |
|
|
|
14,694 |
|
$ |
5.33 |
|
|
|
140,000 |
|
|
|
9.33 |
|
|
|
140,000 |
|
$ |
6.00 |
|
|
|
45,000 |
|
|
|
7.56 |
|
|
|
45,000 |
|
$ |
8.00 |
|
|
|
160,000 |
|
|
|
9.01 |
|
|
|
55,000 |
|
$ |
8.36 |
|
|
|
152,500 |
|
|
|
8.27 |
|
|
|
152,500 |
|
$ |
8.82 |
|
|
|
20,000 |
|
|
|
8.22 |
|
|
|
20,000 |
|
$ |
9.14 |
|
|
|
77,000 |
|
|
|
8.12 |
|
|
|
39,000 |
|
$ |
9.40 |
|
|
|
140,000 |
|
|
|
8.45 |
|
|
|
140,000 |
|
$ |
9.93 |
|
|
|
30,000 |
|
|
|
8.46 |
|
|
|
20,000 |
|
$ |
10.00 |
|
|
|
117,000 |
|
|
|
8.93 |
|
|
|
71,000 |
|
$ |
10.61 |
|
|
|
18,000 |
|
|
|
4.00 |
|
|
|
18,000 |
|
$ |
10.84 |
|
|
|
3,000 |
|
|
|
8.48 |
|
|
|
3,000 |
|
$ |
11.00 |
|
|
|
25,000 |
|
|
|
8.46 |
|
|
|
- |
|
$ |
14.00 |
|
|
|
25,000 |
|
|
|
8.46 |
|
|
|
- |
|
$ |
17.00 |
|
|
|
30,000 |
|
|
|
8.46 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
1,948,874 |
|
|
|
8.53 |
|
|
|
1,597,837 |
|
The Company has entered into employment
agreements with three key executives who, if terminated by the Company without
cause as described in these agreements, would be entitled to severance
pay.
The Company was awarded a $440,000 grant
from the New York Empire State Certified Development Corporation and received
$220,000 in the year ended December 31, 2008. The award provides minimum
employee levels required to receive the remainder of the award and contains
provisions of recapture of monies paid if required employment levels are not
maintained.
Note 8. Subsequent
Events
On
February 13, 2009, March 20, 2009, and March 27, 2009, the Company entered into
Securities Purchase Agreements (the “Purchase Agreement”) with various
accredited investors (the “Purchasers”), pursuant to which the Company agreed to
sell to the Purchasers an aggregate of 542.84 shares (the “Shares”) of Series D
Convertible Preferred Stock, with a par value of $0.005 per share and a stated
value of $10,000 per share (“Series D Preferred”), and Common Stock Purchase
Warrants (the “Warrants”) to purchase an aggregate of 3,877,386 shares of the
Company’s Common Stock, par value $0.005 per share (“Common
Stock”). The Warrants have a seven-year term and an exercise price of
$1.60. Each share of Series D Preferred is convertible into approximately 7,143
shares of Common Stock, subject to the adjustment as described
below.
The
aggregate purchase price paid by the Purchasers for the Shares and the Warrants
was approximately $5,428,307 (representing $10,000 for each Share together with
a Warrant). After related fees and expenses, the Company received net
proceeds of approximately $4,460,000. The Company intends to use the
proceeds for working capital purposes.
In
consideration for its services as exclusive placement agent, Garden State
Securities, Inc. (“GSS”), received cash compensation and Warrants to purchase an
aggregate of approximately 387,736 shares of Common Stock. In the
aggregate, Series D Preferred and Warrants issued in the transaction (including
those issued to GSS) are convertible into, and exercisable for, approximately
8,142,508 shares of Common Stock. Each share of Series D Preferred is
convertible into a number of shares of Common Stock equal to (1) the stated
value of the share ($10,000), divided by (2) $1.40, subject to adjustment as
discussed below (the “Conversion Price”).
The
Series D Preferred ranks junior to the Company’s Series B Convertible Preferred
Stock (“Series B Preferred”) and senior to all shares of Common Stock and other
capital stock of the Company.
If the
Company does not meet certain milestones, the Conversion Price will, unless the
closing price of the Common Stock is greater than $3.69 on the date the
Milestone is missed, be reduced to 80% of the Conversion Price in effect on that
date (the “Milestone Adjustment”). In addition to the Milestone
Adjustment, (a) on August 13, 2009 (the “Initial Adjustment Date”), the
Conversion Price shall be reduced to 95% of the then Conversion Price, and (b)
on each three month anniversary of the Initial Adjustment Date (each, an
“Adjustment Date”), the then Conversion Price shall be reduced by $0.05 (subject
to adjustment) until maturity. The Conversion Price is also subject
to proportional adjustment in the event of any stock split, stock dividend,
reclassification or similar event with respect to the Common Stock and to
anti-dilution adjustment in the event of any Dilutive Issuance (as defined in
the Certificate of Designation).
If the
closing price for each of any 20 consecutive trading days after the effective
date of the initial registration statement filed pursuant to the Registration
Rights Agreement (as defined below) (the “Effective Date”) exceeds 300% of the
then effective Conversion Price and various other equity conditions are
satisfied, the Series D Preferred will automatically convert into shares of
Common Stock.
At any
time after February 13, 2012, the Company may, if various equity conditions are
satisfied, elect either to redeem any outstanding Series D Preferred in cash or
to convert any outstanding Series D Preferred into shares of Common Stock at the
conversion rate then in effect.
If the
Company receives any cash funds after February 13, 2009 from fees, royalties or
revenues as a result of the license of any of its intellectual property (such
net proceeds the “IP Proceeds”), cash funds from development grants from any
government agency for the development of anti-cancer applications of any of the
Company’s curaxin compounds or anti-cancer or biodefense applications for the
Company’s CBLB502 compound (the “Governmental Grant Proceeds”) or allocates cash
proceeds to its Escrow Account (as defined in the Purchase Agreement) (the
“Company Allocation”), then the Company must deposit 40% of the IP Proceeds, 20%
of the Governmental Grant Proceeds and the Company Allocation into an escrow
account (the “Sinking Fund”). At any time after the later of the
Effective Date and the six-month anniversary of the initial contribution by the
Company to the Sinking Fund, but no more than once in every 6-month period, the
Company will be required to use the funds then in the Sinking Fund to redeem
outstanding shares of Series D Preferred, from the holders on a pro rata basis,
at a premium of 15% to the stated value through February 13, 2010, and 20%
thereafter.
Immediately
after the completion of the transactions contemplated by the Purchase Agreement,
the conversion price of the Company’s Series B Preferred was adjusted, pursuant
to weighted-average anti-dilution provisions, to $4.67, causing the conversion
rate of Series B Preferred into Common Stock to change to approximately
1-to-1.49893. In addition, the exercise prices of the Company’s
Series B Warrants and Series C Warrants were adjusted, pursuant to
weighted-average anti-dilution provisions, to $6.79 and $7.20, respectively,
from the original exercise prices of $10.36 and $11.00. In addition to the
adjustment to the exercise prices of the Series B Warrants and the Series C
Warrants, the aggregate number of shares issuable upon exercise of the Series B
Warrants and the Series C Warrants increased to 3,609,261 and 408,032,
respectively, from 2,365,528 and 267,074.
Certain other warrants issued prior to the Company’s initial public offering
were also adjusted pursuant to anti-dilution provisions contained in those
warrants such that their per share exercise price reduced from $2.00 to $1.48
and the aggregate number of shares of Common Stock issuable increased from
approximately 281,042 to approximately 379,787.
Item 9: Changes in and Disagreements
with Accountants on Accounting and Financial Disclosure
None
Item 9A: Controls and
Procedures
Effectiveness of
Disclosure
Our management, with the participation
of our Chief Executive
Officer and Chief Financial Officer, evaluated the effectiveness of our
disclosure controls and procedures as of December 31, 2008 as defined in Rules 13a-15(e) and
15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act. Our management
recognizes that any controls and procedures, no matter how well designed and
operated, can provide only reasonable assurance of achieving their objectives
and management necessarily applies its judgment in evaluating the cost-benefit
relationship of possible controls and procedures. Based on the evaluation of our
disclosure controls and procedures as of December 31, 2008, our Chief Executive
Officer and Chief Financial Officer concluded that, as of such date, our
disclosure controls and procedures were effective to assure that information
required to be declared by us in reports that we file or submit under the
Exchange Act is (1) recorded, processed, summarized, and reported within the
periods specified in the SEC’s rules and forms and (2) accumulated and
communicated to our management, including our Chief Executive Officer and Chief
Financial Officer, as
appropriate, to allow timely decisions regarding required
disclosure.
Changes in Internal Control over
Financial Reporting
Our management is responsible for
establishing and maintaining adequate internal control over financial reporting,
as such term is defined in Exchange Act Rules 13a-15(f). Under the
supervision and with the participation of management, including our principal
executive officer and principal financial officer, we conducted an evaluation of
the effectiveness of our internal control over financial reporting based on the
framework in Internal Control –
Integrated Framework issued
by the Committee of Sponsoring Organizations of the Treadway
Commission. Based on our evaluation under the framework in
Internal Control –
Integrated Framework, our
management concluded that our internal control over financial reporting was
effective as of December 31, 2008.
This annual report does not include an
attestation report of the Company’s registered public accounting firm regarding
internal control over financial reporting. Management’s report was
not subject to attestation by the Company’s registered public accounting firm
pursuant to temporary rules of the Securities and Exchange Commission that
permit the Company to provide only management’s report in this annual report on
Form 10-K.
There was no change in our internal control over
financial reporting during
our fourth fiscal quarter
ended December
31, 2008 that has
materially affected, or is reasonably likely to materially affect, our internal
control over financial reporting.
Item 9B: Other Information
Not applicable.
PART III
Pursuant to General Instruction G(3) of
Form 10-K, Items 10 through 14, inclusive, have not been restated or answered in
this annual report on Form 10-K because the Company intends to file within 120
days after the close of its fiscal year with the Securities and Exchange
Commission a definitive proxy statement pursuant to Regulation 14A under the
Securities Exchange Act of 1934, which proxy statement involves the election of
directors. The information required in these Items 10 through 14, inclusive, is
incorporated by reference to that proxy statement.
PART IV
Item 15. Exhibits and Financial
Statement Schedules
(a) The following financial statements
and supplementary data are filed as a part of this annual report on Form
10-K.
Report of Independent Registered Public
Accounting Firm
Balance Sheets at December 31, 2008 and
2007
Statements of Operations for years ended
December 31, 2008, 2007, and 2006
Statements of Stockholders’ Equity for
period from January 1, 2006 to December 31, 2008
Statements of Cash Flows for years ended
December 31, 2008, 2007, and 2006
Notes to Financial
Statements
(b) The following exhibits are
incorporated herein by reference or attached hereto.
Exhibit
No.
|
|
Description
|
3.1
|
|
Certificate of Incorporation filed
with the Secretary of State of Delaware on June 5,
2003***
|
|
|
3.2
|
|
Certificate of Amendment of
Certificate of Incorporation filed with the Secretary of State of Delaware
on February 25, 2005***
|
|
|
3.3
|
|
Certificate of Designation of
Series A Participating Convertible Preferred Stock filed with the
Secretary of State of Delaware on March 8,
2005***
|
|
|
|
3.4
|
|
Second Certificate of Amendment of
Certificate of Incorporation filed with Secretary of State of Delaware on
June 30, 2006***
|
|
|
3.5
|
|
Certificate of Designations,
Preferences and Rights of Series B Convertible Preferred Stock, dated
March 16, 2007******
|
|
|
3.6
|
|
Certificate of Designation of
Preferences, Rights and Limitations of Series D Convertible Preferred
Stock, dated February 13, 2009.†
|
|
|
|
3.7
|
|
Second Amended and Restated
By-Laws*******
|
|
|
4.1
|
|
Form of Specimen Common Stock
Certificate*
|
|
|
4.2
|
|
Form of Warrants issues to
designees of Sunrise Securities Corp., dated March
2005*
|
4.3
|
|
Form of Warrants issued to
underwriters***
|
|
|
4.4
|
|
Warrant to Purchase Common Stock
issued to ChemBridge Corporation, dated April 27,
2004*
|
|
|
4.5
|
|
Form of Series B Warrant
******
|
|
|
|
4.6
|
|
Form of Series C Warrant
******
|
|
|
|
4.7
|
|
Form of Common Stock Purchase
Warrant.†
|
|
|
|
10.1
|
|
Restricted Stock Agreement between
Cleveland BioLabs, Inc. and Michael Fonstein, dated as of July 5,
2003*
|
|
|
10.2
|
|
Restricted Stock Agreement between
Cleveland BioLabs, Inc. and Yakov Kogan, dated as of July 5,
2003*
|
|
|
10.3
|
|
Restricted Stock Agreement between
Cleveland BioLabs, Inc. and Andrei Gudkov, dated as of July 5,
2003*
|
|
|
10.4
|
|
Library Access Agreement by and
between ChemBridge Corporation and Cleveland BioLabs, Inc., effective as
of April 27, 2004*
|
|
|
10.5
|
|
Restricted Stock and Investor
Rights Agreement between Cleveland BioLabs, Inc. and ChemBridge
Corporation, dated as of April 27, 2004*
|
|
|
10.6
|
|
Common Stockholders Agreement by
and among Cleveland BioLabs, Inc. and the stockholders named therein,
dated as of July 1, 2004*
|
|
|
10.7
|
|
Exclusive License Agreement by and
between The Cleveland Clinic Foundation and Cleveland BioLabs, Inc.,
effective as of July 1, 2004*
|
|
|
10.8
|
|
Employment Agreement by and
between Cleveland BioLabs, Inc. and Dr. Michael Fonstein, dated August 1,
2004*
|
|
|
10.9
|
|
Employment Agreement by and
between Cleveland BioLabs, Inc. and Dr. Yakov Kogan, dated August 1,
2004*
|
|
|
10.10
|
|
Consulting Agreement between
Cleveland BioLabs, Inc. and Dr. Andrei Gudkov, dated August 1,
2004*
|
|
|
10.11
|
|
Cooperative Research and
Development Agreement by and between the Uniformed Services University of
the Health Sciences, the Henry M. Jackson Foundation for the Advancement
of Military Medicine, Inc., the Cleveland Clinic Foundation, and Cleveland
BioLabs, Inc., dated as of August 1,
2004**
|
10.12
|
|
Employment Agreement by and
between Cleveland BioLabs, Inc. and Dr. Farrel Fort, dated June 1,
2005*
|
|
|
10.13
|
|
Amendment to Employment Agreement
by and between Cleveland BioLabs, Inc. and Dr. Farrel Fort, dated September 30,
2005*
|
|
|
10.14
|
|
Amendment to Consulting Agreement
between Cleveland BioLabs, Inc. and Dr. Andrei Gudkov, dated as of January 23,
2006*
|
|
|
10.15
|
|
Amendment to Restricted Stock
Agreement between Cleveland BioLabs, Inc. and Michael Fonstein, dated as of January 23,
2006*
|
|
|
10.16
|
|
Amendment to Restricted Stock
Agreement between Cleveland BioLabs, Inc. and Yakov Kogan, dated as of January 23,
2006*
|
|
|
10.17
|
|
Amendment to Restricted Stock
Agreement between Cleveland BioLabs, Inc. and Andrei Gudkov, dated as of January 23,
2006*
|
|
|
10.18
|
|
Amendment to Common Stockholders
Agreement by and among Cleveland BioLabs, Inc. and the parties thereto,
dated as of January 26, 2006*
|
|
|
10.19
|
|
Cleveland BioLabs, Inc. 2006
Equity Incentive Plan***
|
|
|
10.20
|
|
Process Development and
Manufacturing Agreement between Cleveland BioLabs, Inc. and SynCo Bio
Partners B.V., effective as of August 31,
2006****
|
|
|
10.21
|
|
Sponsored Research Agreement
between Cleveland BioLabs, Inc. and Roswell Park Cancer Institute
Corporation, effective as of January 12,
2007*****
|
|
|
10.22
|
|
Securities Purchase Agreement,
dated March 16, 2007******
|
|
|
|
10.23
|
|
Registration Rights Agreement,
dated March 16, 2007******
|
|
|
|
10.24
|
|
Amendment to Employment Agreement
by and between Cleveland BioLabs, Inc. and Dr. Michael Fonstein, dated as of December 31,
2008.
|
|
|
|
10.25
|
|
Amendment to Employment Agreement
by and between Cleveland BioLabs, Inc. and Dr. Yakov Kogan, dated as of December 31,
2008.
|
|
|
|
10.26
|
|
Form of Securities Purchase
Agreement. †
|
|
|
|
10.27
|
|
Form of Registration Rights
Agreement.†
|
10.28
|
|
Form of Voting
Agreement.†
|
|
|
|
10.29
|
|
Amendment and Waiver Agreement,
dated March 20, 2009.†
|
|
|
|
10.30
|
|
Form of Amendment and
Reaffirmation Agreement.†
|
|
|
|
23.1
|
|
Consent of Meaden & Moore,
Ltd.
|
|
|
31.1
|
|
Rule 13a-14(a)/15d-14(a)
Certification of Michael
Fonstein
|
|
|
31.2
|
|
Rule 13a-14(a)/15d-14(a)
Certification of John A. Marhofer, Jr.
|
|
|
32.1
|
|
Section 1350
Certification.
|
*
|
Incorporated by reference to
Amendment No. 1 to Registration Statement on Form SB-2 as filed on April
25, 2006 (File No. 333-131918).
|
|
|
**
|
Incorporated by reference to
Amendment No. 2 to Registration Statement on Form SB-2 as filed on May 31,
2006 (File No. 333-131918).
|
|
|
***
|
Incorporated by reference to
Amendment No. 3 to Registration Statement on Form SB-2 as filed on July
10, 2006 (File No. 333-131918).
|
|
|
****
|
Incorporated by reference to Form
8-K as filed on October 25, 2006.
|
|
|
*****
|
Incorporated by reference to Form
8-K as filed on January 12, 2007.
|
|
|
******
|
Incorporated by reference to Form
8-K as filed on March 19, 2007.
|
|
|
*******
|
Incorporated by reference to Form
8-K as filed on December 5, 2007.
|
|
|
†
|
Incorporated by reference to Form
8-K as filed on March 30,
2009.
|
(c) Not applicable.
SIGNATURES
Pursuant
to the requirements of Section 13
or 15(d) of the Securities Exchange Act of 1934, the Registrant has caused this
report to be signed on its behalf by the undersigned thereunto duly
authorized.
|
CLEVELAND BIOLABS,
INC. |
|
|
|
|
|
|
By:
|
/s/ MICHAEL
FONSTEIN |
|
|
|
Michael
Fonstein |
|
|
|
Chief
Executive Officer |
|
|
|
(Principal
Executive Officer) |
|
|
CLEVELAND BIOLABS,
INC. |
|
|
|
|
|
|
By:
|
/s/ JOHN
A. MARHOFER, JR. |
|
|
|
John
A. Marhofer, Jr. |
|
|
|
Chief
Financial Officer |
|
|
|
(Principal Financial and
Accounting Officer) |
|
Pursuant to the requirements of the
Securities Exchange Act of 1934, this report has been signed by the following
persons in the capacities and on the dates indicated.
|
|
|
|
Date
|
|
|
|
|
|
/ S
/ Michael Fonstein
|
|
Chief Executive Officer,
President, and Director (Principal Executive
Officer)
|
|
|
|
|
|
|
|
|
|
|
|
|
/ S
/ John A. Marhofer, Jr.
|
|
Chief Financial Officer (Principal
Financial and Accounting Officer)
|
|
|
|
|
|
|
|
|
|
|
|
|
/ S
/ James Antal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/
S / Paul DiCorleto
|
|
Director
|
|
March 30,
2009
|
Paul
DiCorleto
|
|
|
|
|
|
|
|
|
|
/
S / Andrei Gudkov
|
|
Chief Scientific Officer, and
Director
|
|
March 30,
2009
|
Andrei
Gudkov
|
|
|
|
|
|
|
|
|
|
/
S / Bernard L. Kasten
|
|
Director
|
|
March 30,
2009
|
Bernard L.
Kasten
|
|
|
|
|
|
|
|
|
|
/
S / Yakov Kogan
|
|
Chief Operating Officer,
Secretary, and Director
|
|
March 30,
2009
|
Yakov Kogan
|
|
|
|
|
|
|
|
|
|
/
S / H. Daniel Perez
|
|
Director
|
|
March 30,
2009
|
H. Daniel
Perez
|
|
|
|
|
EXHIBIT INDEX
Exhibit
No.
|
|
Description
|
3.1
|
|
Certificate of Incorporation filed
with the Secretary of State of Delaware on June 5,
2003***
|
|
|
3.2
|
|
Certificate of Amendment of
Certificate of Incorporation filed with the Secretary of State of Delaware
on February 25, 2005***
|
|
|
3.3
|
|
Certificate of Designation of
Series A Participating Convertible Preferred Stock filed with the
Secretary of State of Delaware on March 8,
2005***
|
|
|
|
3.4
|
|
Second Certificate of Amendment of
Certificate of Incorporation filed with Secretary of State of Delaware on
June 30, 2006***
|
|
|
3.5
|
|
Certificate of Designations,
Preferences and Rights of Series B Convertible Preferred Stock, dated
March 16, 2007******
|
|
|
3.6
|
|
Certificate of Designation of
Preferences, Rights and Limitations of Series D Convertible Preferred
Stock Preferred Stock, dated February 13, 2009.†
|
|
|
|
3.7
|
|
Second Amended and Restated
By-Laws*******
|
|
|
4.1
|
|
Form of Specimen Common Stock
Certificate*
|
|
|
4.2
|
|
Form of Warrants issues to
designees of Sunrise Securities Corp., dated March
2005*
|
|
|
4.3
|
|
Form of Warrants issued to
underwriters***
|
|
|
4.4
|
|
Warrant to Purchase Common Stock
issued to ChemBridge Corporation, dated April 27,
2004*
|
|
|
4.5
|
|
Form of Series B Warrant
******
|
|
|
|
4.6
|
|
Form of Series C Warrant
******
|
|
|
|
4.7
|
|
Form of Common Stock Purchase
Warrant.†
|
|
|
|
10.1
|
|
Restricted Stock Agreement between
Cleveland BioLabs, Inc. and Michael Fonstein, dated as of July 5,
2003*
|
|
|
10.2
|
|
Restricted Stock Agreement between
Cleveland BioLabs, Inc. and Yakov Kogan, dated as of July 5,
2003*
|
10.3
|
|
Restricted Stock Agreement between
Cleveland BioLabs, Inc. and Andrei Gudkov, dated as of July 5,
2003*
|
|
|
10.4
|
|
Library Access Agreement by and
between ChemBridge Corporation and Cleveland BioLabs, Inc., effective as
of April 27, 2004*
|
|
|
10.5
|
|
Restricted Stock and Investor
Rights Agreement between Cleveland BioLabs, Inc. and ChemBridge
Corporation, dated as of April 27, 2004*
|
|
|
10.6
|
|
Common Stockholders Agreement by
and among Cleveland BioLabs, Inc. and the stockholders named therein,
dated as of July 1, 2004*
|
|
|
10.7
|
|
Exclusive License Agreement by and
between The Cleveland Clinic Foundation and Cleveland BioLabs, Inc.,
effective as of July 1, 2004*
|
|
|
10.8
|
|
Employment Agreement by and
between Cleveland BioLabs, Inc. and Dr. Michael Fonstein, dated August 1,
2004*
|
|
|
10.9
|
|
Employment Agreement by and
between Cleveland BioLabs, Inc. and Dr. Yakov Kogan, dated August 1,
2004*
|
|
|
10.10
|
|
Consulting Agreement between
Cleveland BioLabs, Inc. and Dr. Andrei Gudkov, dated August 1,
2004*
|
|
|
10.11
|
|
Cooperative Research and
Development Agreement by and between the Uniformed Services University of
the Health Sciences, the Henry M. Jackson Foundation for the Advancement
of Military Medicine, Inc., the Cleveland Clinic Foundation, and Cleveland
BioLabs, Inc., dated as of August 1, 2004**
|
|
|
10.12
|
|
Employment Agreement by and
between Cleveland BioLabs, Inc. and Dr. Farrel Fort, dated June 1,
2005*
|
|
|
10.13
|
|
Amendment to Employment Agreement
by and between Cleveland BioLabs, Inc. and Dr. Farrel Fort, dated September 30,
2005*
|
|
|
10.14
|
|
Amendment to Consulting Agreement
between Cleveland BioLabs, Inc. and Dr. Andrei Gudkov, dated as of January 23,
2006*
|
|
|
10.15
|
|
Amendment to Restricted Stock
Agreement between Cleveland BioLabs, Inc. and Michael Fonstein, dated as of January 23,
2006*
|
|
|
10.16
|
|
Amendment to Restricted Stock
Agreement between Cleveland BioLabs, Inc. and Yakov Kogan, dated as of January 23,
2006*
|
10.17
|
|
Amendment to Restricted Stock
Agreement between Cleveland BioLabs, Inc. and Andrei Gudkov, dated as of January 23,
2006*
|
|
|
10.18
|
|
Amendment to Common Stockholders
Agreement by and among Cleveland BioLabs, Inc. and the parties thereto,
dated as of January 26, 2006*
|
|
|
10.19
|
|
Cleveland BioLabs, Inc. 2006
Equity Incentive Plan***
|
|
|
10.20
|
|
Process Development and
Manufacturing Agreement between Cleveland BioLabs, Inc. and SynCo Bio
Partners B.V., effective as of August 31,
2006****
|
|
|
10.21
|
|
Sponsored Research Agreement
between Cleveland BioLabs, Inc. and Roswell Park Cancer Institute
Corporation, effective as of January 12,
2007*****
|
|
|
10.22
|
|
Securities Purchase Agreement,
dated March 16, 2007******
|
|
|
|
10.23
|
|
Registration Rights Agreement,
dated March 16, 2007******
|
|
|
|
10.24
|
|
Amendment to Employment Agreement
by and between Cleveland BioLabs, Inc. and Dr. Michael Fonstein, dated as of December 31,
2008.
|
|
|
|
10.25
|
|
Amendment to Employment Agreement
by and between Cleveland BioLabs, Inc. and Dr. Yakov Kogan, dated as of December 31,
2008.
|
|
|
|
10.26
|
|
Form of Securities Purchase
Agreement.†
|
|
|
|
10.27
|
|
Form of Registration Rights
Agreement.†
|
|
|
|
10.28
|
|
Form of Voting
Agreement.†
|
|
|
|
10.29
|
|
Amendment and Waiver Agreement,
dated March 20, 2009.†
|
|
|
|
10.30
|
|
Form of Amendment and
Reaffirmation Agreement.†
|
|
|
|
23.1
|
|
Consent of Meaden & Moore,
Ltd.
|
|
|
31.1
|
|
Rule 13a-14(a)/15d-14(a)
Certification of Michael
Fonstein
|
|
|
31.2
|
|
Rule 13a-14(a)/15d-14(a)
Certification of John A. Marhofer, Jr.
|
|
|
32.1
|
|
Section 1350
Certification.
|
*
|
Incorporated by reference to
Amendment No. 1 to Registration Statement on Form SB-2 as filed on April
25, 2006 (File No. 333-131918).
|
|
|
**
|
Incorporated by reference to
Amendment No. 2 to Registration Statement on Form SB-2 as filed on May 31,
2006 (File No. 333-131918).
|
|
|
***
|
Incorporated by reference to
Amendment No. 3 to Registration Statement on Form SB-2 as filed on July
10, 2006 (File No. 333-131918).
|
|
|
****
|
Incorporated by reference to Form
8-K as filed on October 25, 2006.
|
|
|
*****
|
Incorporated by reference to Form
8-K as filed on January 12, 2007.
|
|
|
******
|
Incorporated by reference to Form
8-K as filed on March 19, 2007.
|
|
|
*******
|
Incorporated by reference to Form
8-K as filed on December 5, 2007.
|
|
|
†
|
Incorporated by reference to Form
8-K as filed on March 30,
2009.
|
Cleveland
BioLabs, Inc.
73
High Street
Buffalo,
New York 14203
December
31, 2008
Michael
Fonstein
c/o
Cleveland BioLabs, Inc.
73 High
Street
Buffalo,
New York 14203
Re: Amendment
to Employment Agreement dated August 1, 2004
Dear
Michael
Pursuant
to Section 14.11 of the Employment Agreement dated August 1, 2004, (the
“Agreement”) by and between you (“Executive”) and Cleveland BioLabs, Inc. (the
“Company”), the Agreement shall be amended and modified to incorporate the
following as Section 14.12:
“Section
14.12 Section 409
A.
(a) This
Agreement is intended to comply with Section 409A of the Internal Revenue Code
of 1986, as amended ("Section 409A") and shall, to the extent practicable, be
construed in accordance therewith. Accordingly, notwithstanding anything in this
Agreement to the contrary, if the Company determines that Executive is a
"specified employee" (as defined in Code Section 409A(a)(2)(B)(i)) at the time
of his or her Separation from Service (as defined under Section 409A) and any
amount payable to Executive under this Agreement is a deferral of compensation
subject to the additional tax described in Code Section 409A(a)(1)(B) and would
be considered a payment upon Executive’s Separation from Service, then
notwithstanding anything in this Agreement to the contrary, such amount shall
not be paid before the date that is the earlier of (i) six (6) months and one
(1) day after Executive’s Separation from Service or (ii) Executive’s death (the
"Delay Period"). Upon the expiration of the Delay Period, the initial payment
following the Delay Period shall include a lump sum payment equal to those
payments that otherwise would have been paid if the delay had not applied, and
any remaining payments due shall be payable in accordance with their original
payment schedule.
(b) If
either party to this Agreement reasonably determines that any amount payable
pursuant to this Agreement would result in adverse tax consequences under
Section 409A (including, but not limited to, the additional tax described in
Code Section 409A(a)(1)(B)), then such party shall deliver written notice of
such determination to the other party, and the parties hereby agree to work in
good faith to amend this Agreement so it (i) is exempt from, or compliant with,
the requirements of Section 409A and (ii) preserves as nearly as possible the
original intent and economic effect of the affected provisions.”
Please
indicate your agreement to the foregoing amendment and modification by
countersigning below where indicated.
CLEVELAND
BIOLABS, INC.
/s/ John A. Marhofer,
Jr.
By: John
A. Marhofer, Jr.
Title:
Chief Financial Officer
Acknowledged
and agreed to as of
December
31, 2008
/s/ Michael
Fonstein
Michael
Fonstein
Cleveland
BioLabs, Inc.
73
High Street
Buffalo,
New York 14203
December
31, 2008
Yakov
Kogan
c/o
Cleveland BioLabs, Inc.
73 High
Street
Buffalo,
New York 14203
Re: Amendment
to Employment Agreement dated August 1, 2004
Dear
Yakov:
Pursuant
to Section 14.11 of the Employment Agreement dated August 1, 2004, (the
“Employment Agreement”) by and between you (“Executive”) and Cleveland BioLabs,
Inc. (the “Company”) and in order to maintain compliance with Section 409A of
the Internal Revenue Code of 1986, as amended, the Employment Agreement shall be
amended and modified to incorporate the following as Section 14.12:
“Section
14.12 Section 409
A.
(a) This
Agreement is intended to comply with Section 409A of the Internal Revenue Code
of 1986, as amended ("Section 409A") and shall, to the extent practicable, be
construed in accordance therewith. Accordingly, notwithstanding anything in this
Agreement to the contrary, if the Company determines that Executive is a
"specified employee" (as defined in Code Section 409A(a)(2)(B)(i)) at the time
of his or her Separation from Service (as defined under Section 409A) and any
amount payable to Executive under this Agreement is a deferral of compensation
subject to the additional tax described in Code Section 409A(a)(1)(B) and would
be considered a payment upon Executive’s Separation from Service, then
notwithstanding anything in this Agreement to the contrary, such amount shall
not be paid before the date that is the earlier of (i) six (6) months and one
(1) day after Executive’s Separation from Service or (ii) Executive’s death (the
"Delay Period"). Upon the expiration of the Delay Period, the initial payment
following the Delay Period shall include a lump sum payment equal to those
payments that otherwise would have been paid if the delay had not applied, and
any remaining payments due shall be payable in accordance with their original
payment schedule.
(b) If
either party to this Agreement reasonably determines that any amount payable
pursuant to this Agreement would result in adverse tax consequences under
Section 409A (including, but not limited to, the additional tax described in
Code Section 409A(a)(1)(B)), then such party shall deliver written notice of
such determination to the other party, and the parties hereby agree to work in
good faith to amend this Agreement so it (i) is exempt from, or compliant with,
the requirements of Section 409A and (ii) preserves as nearly as possible the
original intent and economic effect of the affected provisions.”
Please
indicate your agreement to the foregoing amendment and modification by
countersigning below where indicated.
CLEVELAND
BIOLABS, INC.
/s/ John A. Marhofer,
Jr.
By: John
A. Marhofer, Jr.
Title:
Chief Financial Officer
Acknowledged
and agreed to as of
December
31, 2008
/s/ Yakov
Kogan
Yakov
Kogan
Exhibit 23.1
Consent of Independent Registered Public
Accounting Firm
The Board of Directors and Stockholders
of
Cleveland BioLabs,
Inc.:
We consent to the use in the Form 10-K
of Cleveland BioLabs, Inc. (the “Company”) for the fiscal year ended December
31, 2008 and the incorporation by reference in
the registration statement on Form S-8 (No. 333-140687) of the Company of our report dated March
27, 2009, with respect to the balance sheets of Cleveland BioLabs, Inc. as of
December 31, 2008 and 2007, and the related statements of operations,
stockholders’ equity, and cash flows for each of the years in the three-year
period ending December 31, 2008, which report appears in the December 31, 2008
annual report on Form 10-K of the Company.
/s/ Meaden & Moore,
Ltd.
Cleveland, Ohio
March 27, 2009
Exhibit 31.1
Certification
I, Michael Fonstein, certify
that:
1. I have reviewed this annual report on
Form 10-K of Cleveland BioLabs, Inc.;
2. Based on my knowledge, this report
does not contain any untrue statement of a material fact or omit to state a
material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect
to the period covered by this report;
3. Based on my knowledge, the financial
statements, and other financial information included in this report, fairly
present in all material respects the financial condition, results of operations
and cash flows of the registrant as of, and for, the periods presented in this
report;
4. The registrant’s other certifying
officer and I are responsible for establishing and maintaining disclosure
controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and
have:
a) Designed such disclosure controls and
procedures, or caused such disclosure controls and procedures to be designed
under our supervision, to ensure that material information relating to the
registrant is made known to us by others within those entities, particularly
during the period in which this report is being prepared;
b) Designed such internal control over
financial reporting, or caused such internal control over financial reporting to
be designed under our supervision, to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting
principles;
c) Evaluated the
effectiveness of the registrant’s disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by this
report based on such evaluation; and
d) Disclosed in this report any change
in the registrant’s internal control over financial reporting that occurred
during the registrant’s most recent fiscal quarter (the issuer’s fourth fiscal
quarter in the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the registrant’s internal control over
financial reporting.
5. The registrant’s other certifying
officer and I have disclosed, based on our most recent evaluation of internal
control over financial reporting, to the registrant’s auditors and the audit
committee of the registrant’s board of directors (or persons performing the
equivalent functions):
a) All significant deficiencies and
material weaknesses in the design or operation of internal control over
financial reporting which are reasonably likely to adversely affect the
registrant’s ability to record, process, summarize and report financial
information; and
b) Any fraud, whether or not material,
that involves management or other employees who have a significant role in the
registrant’s internal control over financial reporting.
|
|
|
|
|
|
|
|
|
|
|
|
|
Date: March 30,
2009
|
|
|
|
By:
|
|
/s/ Michael
Fonstein
|
|
|
|
|
|
|
|
|
Michael
Fonstein
|
|
|
|
|
|
|
|
|
President and Chief
Executive Officer
|
|
|
|
|
|
|
|
|
(Principal Executive
Officer)
|
Exhibit 31.2
Certification
I, John A. Marhofer, Jr., certify
that:
1. I have reviewed this annual report on
Form 10-K of Cleveland Biolabs, Inc.;
2. Based on my knowledge, this report
does not contain any untrue statement of a material fact or omit to state a
material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect
to the period covered by this report;
3. Based on my knowledge, the financial
statements, and other financial information included in this report, fairly
present in all material respects the financial condition, results of operations
and cash flows of the registrant as of, and for, the periods presented in this
report;
4. The registrant’s other certifying
officer and I are responsible for establishing and maintaining disclosure
controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and
have:
a) Designed such disclosure controls and
procedures, or caused such disclosure controls and procedures to be designed
under our supervision, to ensure that material information relating to the
registrant is made known to us by others within those entities, particularly
during the period in which this report is being prepared;
b) Designed such internal control over
financial reporting, or caused such internal control over financial reporting to
be designed under our supervision, to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting
principles;
c) Evaluated the
effectiveness of the registrant’s disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by this
report based on such evaluation; and
d) Disclosed in this report any change
in the registrant’s internal control over financial reporting that occurred
during the registrant’s most recent fiscal quarter (the issuer’s fourth fiscal
quarter in the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the registrant’s internal control over
financial reporting.
5. The registrant’s other certifying
officer and I have disclosed, based on our most recent evaluation of internal
control over financial reporting, to the registrant’s auditors and the audit
committee of the registrant’s board of directors (or persons performing the
equivalent functions):
a) All significant deficiencies and
material weaknesses in the design or operation of internal control over
financial reporting which are reasonably likely to adversely affect the
registrant’s ability to record, process, summarize and report financial
information; and
b) Any fraud, whether or not material,
that involves management or other employees who have a significant role in the
registrant’s internal control over financial reporting.
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Date: March 30,
2009
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By:
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/s/ John A. Marhofer,
Jr.
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John A. Marhofer,
Jr.
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Chief Financial
Officer
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(Principal Financial
Officer)
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Exhibit 32.1
Certification*
In connection with the Annual Report of
Cleveland BioLabs, Inc., (the “Company”), on Form 10-K for the fiscal year
ending December 31, 2008 as filed with the Securities and Exchange Commission on
the date hereof (the “Annual Report”) pursuant to the requirement set forth in
Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18
U.S.C.§ 1350), Michael Fonstein, Chief Executive Officer of the Company, and
John A. Marhofer, Jr., Chief Financial Officer of the Company, each hereby
certifies that, to the best of his knowledge:
1. The Annual Report fully complies with
the requirements of Section 13(a) or Section 15(d) of the Exchange Act,
and
2. The information contained in the Annual
Report fairly presents, in all material respects, the financial condition and
results of operations of the Company for the period covered by the Annual
Report.
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Dated: March 30,
2009
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By:
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/s/ Michael
Fonstein
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Michael
Fonstein
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Chief Executive
Officer
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(Principal Executive
Officer)
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Dated: March 30,
2009
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By:
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/s/ John A. Marhofer,
Jr.
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John A. Marhofer,
Jr.
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Chief Financial
Officer
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(Principal Financial and
Accounting Officer)
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*
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This certification accompanies the
Annual Report to which it relates, is not deemed filed with the Securities
and Exchange Commission and is not to be incorporated by reference into
any filing of Cleveland BioLabs, Inc. under the Securities Act of 1933, as
amended, or the Securities Exchange Act of 1934, as amended (whether made
before or after the date of the Annual Report), irrespective of any
general incorporation language contained in such
filing.
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