Exhibit 10.1
Execution
Copy
COMMON SHARE PURCHASE
AGREEMENT
Dated July 23,
2010
by and between
XOMA LTD.
and
AZIMUTH OPPORTUNITY
LTD.
TABLE OF
CONTENTS
Page
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Article
I
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PURCHASE AND
SALE OF COMMON SHARES
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Purchase and
Sale of Stock
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1
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Effective Date;
Settlement Dates
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1
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2
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Current Report;
Prospectus Supplement
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2
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Article
II
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FIXED REQUEST
TERMS; OPTIONAL AMOUNT3
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3
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Section
2.1
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3
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Section
2.2
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3
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Section
2.3
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4
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Section
2.4
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Limitation of
Fixed Requests
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4
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Section
2.5
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5
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Section
2.6
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5
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Section
2.7
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5
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Section
2.8
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Reduction of
Pricing Period
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5
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Section
2.9
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7
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Section
2.10
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Calculation of
Optional Amount Shares
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7
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Section
2.11
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Exercise of
Optional Amount
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7
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Section
2.12
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7
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Section
2.13
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8
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Article
III
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REPRESENTATIONS
AND WARRANTIES OF THE INVESTOR
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9
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Section
3.1
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Organization
and Standing of the Investor
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9
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Section
3.2
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9
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Section
3.3
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9
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Section
3.4
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10
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Section
3.5
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10
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Article
IV
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REPRESENTATIONS
AND WARRANTIES OF THE COMPANY10
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Section
4.1
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Organization,
Good Standing and Power
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10
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Section
4.2
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Authorization,
Enforcement
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10
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Section
4.3
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11
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Section
4.4
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11
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Section
4.5
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11
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Section
4.6
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Commission
Documents, Financial Statements
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12
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Section
4.7
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13
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Section
4.8
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No Material
Adverse Effect
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13
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Section
4.9
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14
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Section
4.10
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14
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Section
4.11
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14
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Section
4.12
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14
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Section
4.13
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15
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Section
4.14
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15
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Section
4.15
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17
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Section
4.16
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17
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Section
4.17
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Transactions
With Affiliates.
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18
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Section
4.18
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Securities Act;
FINRA Conduct Rules
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18
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Section
4.19
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20
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Section
4.20
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20
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Section
4.21
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Investment
Company Act Status
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20
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Section
4.22
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20
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Section
4.23
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20
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Section
4.24
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21
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Section
4.25
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Acknowledgement
Regarding Investor’s Purchase of Securities
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21
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Article
V
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COVENANTS
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21
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Section
5.1
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21
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Section
5.2
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21
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Section
5.3
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21
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Section
5.4
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Keeping of
Records and Books of Account; Foreign Corrupt Practices
Act
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22
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Section
5.5
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Limitations on
Holdings and Issuances
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23
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Section
5.6
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Other
Agreements and Other Financings.
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23
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Section
5.7
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25
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Section
5.8
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Amendments to
the Registration Statement; Prospectus Supplements; Free Writing
Prospectuses
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25
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Section
5.9
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26
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Section
5.10
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27
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Section
5.11
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Effective
Registration Statement
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27
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Section
5.12
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28
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Section
5.13
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28
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Section
5.14
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28
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Article
VI
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OPINION OF
COUNSEL AND CERTIFICATE; CONDITIONS TO THE SALE AND PURCHASE OF THE
SHARES
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28
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Section
6.1
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Issuance of
Commitment Shares; Opinion of Counsel; Certificate
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28
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Section
6.2
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Conditions
Precedent to the Obligation of the Company
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29
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Section
6.3
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Conditions
Precedent to the Obligation of the Investor
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30
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Article
VII
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TERMINATION
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33
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Section
7.1
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Term,
Termination by Mutual Consent
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33
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Section
7.2
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33
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Section
7.3
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34
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Article
VIII
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INDEMNIFICATION
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34
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Section
8.1
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34
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Section
8.2
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Indemnification
Procedures
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36
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Article
IX
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MISCELLANEOUS
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37
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Section
9.1
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Fees and
Expenses.
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37
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Section
9.2
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Specific
Enforcement, Consent to Jurisdiction, Waiver of Jury
Trial
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38
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Section
9.3
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Entire
Agreement; Amendment
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39
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Section
9.4
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39
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Section
9.5
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40
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Section
9.6
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40
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Section
9.7
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40
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Section
9.8
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41
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Section
9.9
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41
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Section
9.10
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41
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Section
9.11
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41
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Section
9.12
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42
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Section
9.13
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42
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Definitions
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COMMON SHARE PURCHASE
AGREEMENT
This COMMON SHARE PURCHASE AGREEMENT ,
made and entered into on this 23 rd day of
July 2010 (this “ Agreement ”), by and between
Azimuth Opportunity Ltd., an international business company
incorporated under the laws of the British Virgin Islands (the
“ Investor ”), and XOMA Ltd., a company
organized and existing under the laws of Bermuda (the “
Company ”). Capitalized terms used but not defined
herein shall have the meanings ascribed to such terms in Annex
A hereto.
RECITALS
WHEREAS , the parties desire that, upon the terms and
subject to the conditions contained herein, the Company may issue
and sell to the Investor and the Investor shall thereupon purchase
from the Company up to $30,000,000 of newly issued common shares of
the Company, U.S. $0.0005 par value per share (“ Common
Shares ”), subject, in all cases, to the Trading Market
Limit; and
WHEREAS , the offer and sale of the Common Shares
hereunder have been registered by the Company in the Registration
Statement, which has been declared effective by order of the
Commission under the Securities Act;
WHEREAS, in consideration for the Investor’s
execution and delivery of this Agreement, the Company is
concurrently issuing to the Investor the Commitment Shares, upon
the terms and subject to the conditions set forth in this
Agreement;
NOW, THEREFORE , the parties hereto, intending to be legally
bound, hereby agree as follows:
ARTICLE I
PURCHASE AND SALE OF COMMON
SHARES
Section
1.1
Purchase and Sale of Stock . Upon the terms and subject to the conditions
of this Agreement, during the Investment Period the Company in its
discretion may issue and sell to the Investor up to $30,000,000
(the “ Total Commitment ”) of duly authorized,
validly issued, fully paid and non-assessable Common Shares
(subject in all cases to the Trading Market Limit, the “
Aggregate Limit ”), by (i) the delivery to the
Investor of not more than 18 separate Fixed Request Notices (unless
the Investor and the Company mutually agree that a different number
of Fixed Request Notices may be delivered) as provided in Article
II hereof and (ii) the exercise by the Investor of Optional
Amounts, which the Company may in its discretion grant to the
Investor and which may be exercised by the Investor, in whole or in
part, as provided in Article II hereof. The aggregate of
all Fixed Request Amounts and Optional Amount Dollar Amounts shall
not exceed the Aggregate Limit.
Section
1.2
Effective Date; Settlement Dates . This Agreement shall become
effective and binding upon the payment of the fees required to be
paid on or prior to the Effective Date pursuant to Section 9.1, the
delivery of irrevocable instructions to issue the Commitment Shares
to the Investor or its designees as provided in Sections 2.13 and
6.1, the delivery of counterpart signature pages of this Agreement
executed by each of the parties hereto,
and the delivery of all other
documents, instruments and writings required to be delivered on the
Effective Date, in each case as provided in Section 6.1 hereof, to
the offices of Greenberg Traurig, LLP, 200 Park Avenue, New York,
New York 10166, at 8:00 a.m., New York time, on the Effective
Date. In consideration of and in express reliance upon
the representations, warranties and covenants, and otherwise upon
the terms and subject to the conditions, of this Agreement, from
and after the Effective Date and during the Investment Period (i)
the Company shall issue and sell to the Investor, and the Investor
agrees to purchase from the Company, the Shares in respect of each
Fixed Request and (ii) the Investor may in its discretion elect to
purchase Shares in respect of each Optional Amount. The
issuance and sale of Shares to the Investor pursuant to any Fixed
Request or Optional Amount shall occur on the applicable Settlement
Date in accordance with Sections 2.7 and 2.9 (or on such Trading
Day in accordance with Section 2.8, as applicable), provided
in each case that all of the conditions precedent thereto set forth
in Article VI theretofore shall have been fulfilled or (to the
extent permitted by applicable law) waived.
Section 1.3
The Shares . The Company has or will have
duly authorized and reserved for issuance, and covenants to
continue to so reserve once reserved for issuance, free of all
preemptive and other similar rights, at all times during the
Investment Period, the requisite aggregate number of authorized but
unissued Common Shares to timely effect the issuance, sale and
delivery in full to the Investor of all Shares to be issued in
respect of all Fixed Requests and Optional Amounts under this
Agreement, in any case prior to the issuance to the Investor of
such Shares.
Section
1.4
Current Report; Prospectus Supplement
. As soon as practicable,
but in any event not later than 5:30 p.m. (New York time) on the
first Trading Day immediately following the Effective Date, the
Company shall file with the Commission a report on Form 8-K
relating to the transactions contemplated by, and describing the
material terms and conditions of, this Agreement (including, the
issuance of the Commitment Shares to the Investor) and disclosing
all information relating to the transactions contemplated hereby
required to be disclosed in the Registration Statement and the Base
Prospectus (but which permissibly has been omitted therefrom in
accordance with the Securities Act), including, without limitation,
information required to be disclosed in the section captioned
“Plan of Distribution” in the Base Prospectus (the
“ Current Report ”). The Current
Report shall include a copy of this Agreement as an
exhibit. To the extent applicable, the Current Report
shall be incorporated by reference in the Registration Statement in
accordance with the provisions of Rule 430B under the Securities
Act. The Company heretofore has provided the Investor a
reasonable opportunity to comment on a draft of such Current Report
and has given due consideration to such comments. The
Company shall file a final Base Prospectus pursuant to Rule 424(b)
under the Securities Act on or prior to the second Trading Day
immediately following the Effective Date. Pursuant to Section 5.9
and subject to the provisions of Section 5.8, on the first Trading
Day immediately following the last Trading Day of each Pricing
Period, the Company shall file with the Commission a Prospectus
Supplement pursuant to Rule 424(b) under the Securities Act
disclosing the number of Shares to be issued and sold to the
Investor thereunder, the total purchase price therefor and the net
proceeds to be received by the Company therefrom and, to the extent
required by the Securities Act, identifying the Current
Report.
ARTICLE II
FIXED REQUEST TERMS; OPTIONAL AMOUNT
Subject to the satisfaction of the conditions
set forth in this Agreement, the parties agree (unless otherwise
mutually agreed upon by the parties in writing) as
follows:
Section
2.1
Fixed Request Notice . The Company may, from time to time
in its sole discretion, no later than 9:30 a.m. (New York time) on
the first Trading Day of the Pricing Period, provide to the
Investor a Fixed Request notice, substantially in the form attached
hereto as Exhibit A (the “ Fixed Request Notice
”), which Fixed Request Notice shall become effective at 9:30
a.m. (New York time) on the first Trading Day of the Pricing Period
specified in the Fixed Request Notice; provided ,
however , that if the Company delivers the Fixed Request
Notice to the Investor later than 9:30 a.m. (New York time) on a
Trading Day, then the first Trading Day of such Pricing Period
shall not be the Trading Day on which the Investor received such
Fixed Request Notice, but rather shall be the next Trading Day
(unless a subsequent Trading Day is therein specified). The Fixed
Request Notice shall specify the Fixed Amount Requested, establish
the Threshold Price for such Fixed Request, designate the first and
last Trading Day of the Pricing Period and specify the Optional
Amount, if any, that the Company elects to grant to the Investor
during the Pricing Period and the applicable Threshold Price for
such Optional Amount (the “ Optional Amount Threshold
Price ”). The Threshold Price and the Optional
Amount Threshold Price established by the Company in a Fixed
Request Notice may be the same or different, in the Company’s
sole discretion. Upon the terms and subject to the
conditions of this Agreement, the Investor is obligated to accept
each Fixed Request Notice prepared and delivered in accordance with
the provisions of this Agreement.
Section
2.2
Fixed Requests . From time to time during the
Investment Period, the Company may in its sole discretion deliver
to the Investor a Fixed Request Notice for a specified Fixed Amount
Requested, and the applicable discount price (the “
Discount Price ”) shall be determined, in accordance
with the price and share amount parameters as set forth below or
such other parameters mutually agreed upon by the Investor and the
Company, and upon the terms and subject to the conditions of this
Agreement, the Investor shall purchase from the Company the Shares
subject to such Fixed Request Notice at the Discount Price;
provided , however , that (i) if an ex-dividend date
is established by the Trading Market in respect of the Common
Shares on or between the first Trading Day of the applicable
Pricing Period and the applicable Settlement Date, the Discount
Price shall be reduced by the per share dividend amount and (ii)
unless the parties otherwise mutually agree, the Company may not
deliver any single Fixed Request Notice for a Fixed Amount
Requested in excess of the lesser of (a) the amount in the
applicable Fixed Amount Requested column below and (b) 2.5% of the
Market Capitalization:
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Equal to or
greater than $1.75
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Not to exceed
$10,937,500
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Equal to or
greater than $1.50 and less than $1.75
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Equal to or
greater than $1.25 and less than $1.50
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95.00% of the
VWAP
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Equal to or
greater than $1.00 and less than $1.25
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Not to exceed
$6,250,000
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94.50% of the
VWAP
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Equal to or
greater than $0.85 and less than $1.00
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Not to exceed
$5,312,500
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94.00% of the
VWAP
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Equal to or
greater than $0.70 and less than $0.85
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Not to exceed
$4,375,000
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94.00% of the
VWAP
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Equal to or
greater than $0.55 and less than $0.70
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Not to exceed
$3,437,500
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94.00% of the
VWAP
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Equal to or
greater than $0.40 and less than $0.55
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Not to exceed
$2,500,000
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94.00% of the
VWAP
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Equal to or
greater than $0.25 and less than $0.40
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Not to exceed
$1,562,500
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94.00% of the
VWAP
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Anything to the contrary in this Agreement
notwithstanding, at no time shall the Investor be required to
purchase more than $10,937,500 worth of Common Shares in respect of
any Pricing Period (not including Common Shares subject to any
Optional Amount). The date on which the Company delivers
any Fixed Request Notice in accordance with this Section 2.2
hereinafter shall be referred to as a “ Fixed Request
Exercise Date ”.
Section
2.3
Share Calculation . With respect to the Trading Days during the
applicable Pricing Period for which the VWAP equals or exceeds the
Threshold Price, the number of Shares to be issued by the Company
to the Investor pursuant to a Fixed Request shall equal the
aggregate sum of each quotient (calculated for each Trading Day
during the applicable Pricing Period for which the VWAP equals or
exceeds the Threshold Price) determined pursuant to the following
equation (rounded to the nearest whole Share):
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N = the number
of Shares to be issued by the Company to the Investor in respect of
a Trading Day during the applicable Pricing Period for which the
VWAP equals or exceeds the Threshold Price,
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A = 0.10 (the
“ Multiplier ”), provided ,
however , that if the Company and the Investor mutually
agree prior to the commencement of a Pricing Period that the number
of consecutive Trading Days constituting a Pricing Period shall be
less than 10, then the Multiplier correspondingly shall be
increased to equal the decimal equivalent (in 10-millionths) of a
fraction, the numerator of which is one and the denominator of
which equals the number of Trading Days in the reduced Pricing
Period (it being hereby acknowledged and agreed that this proviso
shall not apply to any unilateral determination by the Company to
reduce a Pricing Period, but rather, Section 2.8 hereof shall
apply),
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B = the total
Fixed Amount Requested, and
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C = the
applicable Discount Price.
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Section
2.4
Limitation of Fixed Requests . The Company shall not make more
than one Fixed Request in each Pricing Period. Not less
than five Trading Days shall elapse between the end of one Pricing
Period and the commencement of any other Pricing Period during the
Investment Period. There shall be permitted a maximum of
18 Fixed Requests during the Investment Period. Each
Fixed Request automatically shall expire immediately following the
last Trading Day of each Pricing Period.
Section
2.5
Reduction of Commitment . On the Settlement Date with respect
to a Pricing Period, the Investor’s Total Commitment under
this Agreement automatically (and without the need for any
amendment to this Agreement) shall be reduced, on a
dollar-for-dollar basis, by the total amount of the Fixed Request
Amount and the Optional Amount Dollar Amount, if any, for such
Pricing Period paid to the Company at such Settlement
Date.
Section
2.6
Below Threshold Price . If the VWAP on any Trading Day in a
Pricing Period is lower than the Threshold Price, then for each
such Trading Day the Fixed Amount Requested shall be reduced, on a
dollar-for-dollar basis, by an amount equal to the product of (x)
the Multiplier and (y) the total Fixed Amount Requested, and no
Shares shall be purchased or sold with respect to such Trading Day,
except as provided below. If trading in the Common
Shares on NASDAQ (or any other U.S. national securities exchange on
which the Common Shares are then listed) is suspended for any
reason for more than three hours on any Trading Day, the Investor
may at its option deem the price of the Common Shares to be lower
than the Threshold Price for such Trading Day and, for each such
Trading Day, the total amount of the Fixed Amount Requested shall
be reduced as provided in the immediately preceding sentence, and
no Shares shall be purchased or sold with respect to such Trading
Day, except as provided below. For each Trading Day
during a Pricing Period on which the VWAP is lower (or is deemed to
be lower as provided in the immediately preceding sentence) than
the Threshold Price, the Investor may in its sole discretion elect
to purchase such U.S. dollar amount of Shares equal
to the amount by which the Fixed Amount Requested has been reduced
in accordance with this Section 2.6, at the Threshold Price
multiplied by the applicable percentage determined in accordance
with the price and share amount parameters set forth in Section
2.2. The Investor shall inform the Company via facsimile
transmission not later than 8:00 p.m. (New York time) on the last
Trading Day of such Pricing Period as to the number of Shares, if
any, the Investor elects to purchase as provided in this Section
2.6.
Section
2.7
Settlement . The payment for, against
simultaneous delivery of, Shares in respect of each Fixed Request
shall be settled on the second Trading Day next following the last
Trading Day of each Pricing Period, or on such earlier date as the
parties may mutually agree (the “ Settlement Date
”). On each Settlement Date, the Company shall, or
shall cause its transfer agent to, electronically transfer the
Shares purchased by the Investor by crediting the Investor’s
or its designees’ account at DTC through its
Deposit/Withdrawal at Custodian (DWAC) system, which Shares shall
be freely tradable and transferable and without restriction on
resale, against simultaneous payment therefor to the
Company’s designated account by wire transfer of immediately
available funds; provided that if the Shares are received by
the Investor later than 1:00 p.m. (New York time), payment therefor
shall be made with next day funds. As set forth in Section 9.1(ii),
a failure by the Company to deliver such Shares shall result in the
payment of partial damages by the Company to the
Investor.
Section
2.8
Reduction of Pricing Period . If during a Pricing Period the
Company elects to reduce the number of Trading Days in such Pricing
Period (and thereby amend its previously delivered Fixed Request
Notice), the Company shall so notify the Investor before 9:00 a.m.
(New York time) on any Trading Day during a Pricing Period (a
“ Reduction Notice ”)
and the last Trading Day of such
Pricing Period shall be the Trading Day immediately preceding the
Trading Day on which the Investor received such Reduction Notice;
provided , however , that if the Company delivers the
Reduction Notice later than 9:00 a.m. (New York time) on a Trading
Day during a Pricing Period, then the last Trading Day of such
Pricing Period instead shall be the Trading Day on which the
Investor received such Reduction Notice.
Upon receipt of a Reduction Notice, the Investor
(i) shall purchase the Shares in respect of each Trading Day in
such reduced Pricing Period for which the VWAP equals or exceeds
the Threshold Price in accordance with Section 2.3 hereof; (ii) may
elect to purchase the Shares in respect of any Trading Day in such
reduced Pricing Period for which the VWAP is (or is deemed to be)
lower than the Threshold Price in accordance with Section 2.6
hereof; and (iii) may elect to exercise all or any portion of an
Optional Amount on any Trading Day during such reduced Pricing
Period in accordance with Sections 2.10 and 2.11 hereof.
In addition, upon receipt of a Reduction Notice,
the Investor may elect to purchase such U.S. dollar amount of
additional Shares equal to the product determined pursuant to the
following equation:
D = (A/B) x (B – C),
where:
D = the U.S. dollar amount of
additional Shares to be purchased,
A = the Fixed Amount
Requested,
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B = 10
or, for purposes of this Section 2.8, such lesser number of Trading
Days as the parties may mutually agree to, and
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C = the number of Trading Days in
the reduced Pricing Period,
at a per Share price equal to (x)
the Fixed Amount Requested attributable to the reduced Pricing
Period divided by (y) the number of Shares to be purchased during
such reduced Pricing Period pursuant to clauses (i) and (ii) (as
applicable) of the immediately preceding paragraph.
The Investor may also elect to exercise any
portion of the applicable Optional Amount which was unexercised
during the reduced Pricing Period (provided that such portion of
the applicable Optional Amount, when combined with the portion of
the Optional Amount exercised during the reduced Pricing Period,
does not exceed the total Optional Amount set forth in the Fixed
Request Notice) by issuing an Optional Amount Notice to the Company
not later than 10:00 a.m. (New York time) on the first Trading Day
next following the last Trading Day of the reduced Pricing Period.
The number of Shares to be issued upon exercise of such Optional
Amount shall be calculated pursuant to the equation set forth in
Section 2.10 hereof, except that “C” shall equal the
greater of (i) the VWAP for the Common Shares on the last Trading
Day of the reduced Pricing Period or (ii) the Optional Amount
Threshold Price.
The payment for, against simultaneous delivery
of, Shares to be purchased and sold in accordance with this Section
2.8 shall be settled on the second Trading Day next following the
Trading Day on which the Investor receives a Reduction
Notice.
Section 2.9
Optional Amount . With respect to any
Pricing Period, the Company may in its sole discretion grant to the
Investor the right to exercise, from time to time during the
Pricing Period (but not more than once on any Trading Day), all or
any portion of an Optional Amount. The maximum Optional
Amount Dollar Amount and the Optional Amount Threshold Price shall
be set forth in the Fixed Request Notice. If an
ex-dividend date is established by the Trading Market in respect of
the Common Shares on or between the first Trading Day of the
applicable Pricing Period and the applicable Settlement Date, the
applicable exercise price in respect of the Optional Amount shall
be reduced by the per share dividend amount. Each daily
Optional Amount exercise shall be aggregated during the Pricing
Period and settled on the next Settlement Date. The
Optional Amount Threshold Price designated by the Company in its
Fixed Request Notice shall apply to each Optional Amount exercised
during the applicable Pricing Period.
Section
2.10
Calculation of Optional Amount Shares
. The number of Common
Shares to be issued in connection with the exercise of an Optional
Amount shall be the quotient determined pursuant to the following
equation (rounded to the nearest whole Share):
|
|
O = the
number of Common Shares to be issued in connection with such
Optional Amount exercise,
|
|
|
A = the
Optional Amount Dollar Amount with respect to which the Investor
has delivered an Optional Amount Notice,
|
|
|
B = the
applicable percentage determined in accordance with the price and
shares amount parameters set forth in Section 2.2 (with the
Optional Amount Threshold Price serving as the Threshold Price for
such purposes), and
|
|
|
C = the
greater of (i) the VWAP for the Common Shares on the day the
Investor delivers the Optional Amount Notice or (ii) the Optional
Amount Threshold Price.
|
Section
2.11
Exercise of Optional Amount . If granted by the Company to the
Investor with respect to a Pricing Period, all or any portion of
the Optional Amount may be exercised by the Investor on any Trading
Day during the Pricing Period, subject to the limitations set forth
in Section 2.9. As a condition to each exercise of an
Optional Amount pursuant to this Section 2.11, the Investor shall
issue an Optional Amount Notice to the Company no later than 8:00
p.m. (New York time) on the day of such Optional Amount
exercise. If the Investor does not exercise an Optional
Amount in full by 8:00 p.m. (New York time) on the last Trading Day
of the applicable Pricing Period, such unexercised portion of the
Investor’s Optional Amount with respect to that Pricing
Period automatically shall lapse and terminate.
Section
2.12
Aggregate Limit . Notwithstanding anything to the
contrary contained in this Agreement, in no event may the Company
issue a Fixed Request Notice or grant an Optional Amount to the
extent that the sale of Shares pursuant thereto and pursuant to all
prior Fixed Request Notices and Optional Amounts issued hereunder,
and as partial damages pursuant to Section 9.1(ii), would cause the
Company to sell or the Investor to purchase Shares which in the
aggregate are in excess of the Aggregate Limit. If the
Company issues a Fixed Request Notice
or Optional Amount that otherwise
would permit the Investor to purchase Common Shares which would
cause the aggregate purchases by Investor hereunder to exceed the
Aggregate Limit, such Fixed Request Notice or Optional Amount shall
be void ab initio to the extent of the amount by which the
dollar value or number, as the case may be, of Common Shares
otherwise issuable pursuant to such Fixed Request Notice or
Optional Amount together with the dollar value or number, as the
case may be, of all other Common Shares purchased by the Investor
pursuant hereto, or issued as partial damages pursuant to Section
9.1(ii), would exceed the Aggregate Limit. The Company
hereby represents, warrants and covenants that neither it nor any
of its Subsidiaries (i) has effected any transaction or series of
transactions, (ii) is a party to any pending transaction or series
of transactions or (iii) shall enter into any contract, agreement,
agreement-in-principle, arrangement or understanding with respect
to, or shall effect, any Other Financing which, in any of such
cases, would be aggregated with the transactions contemplated by
this Agreement for purposes of determining whether approval of the
Company’s shareholders is required under any bylaw, listed
securities maintenance standards or other rules of the Trading
Market; provided , however , that the Company shall
be permitted to take any action referred to in clause (iii) above
if (a) the Company has timely provided the Investor with an
Integration Notice as provided in Section 5.6(ii) hereof and (b)
unless the Investor has previously terminated this Agreement
pursuant to Section 7.2, the Company obtains any requisite
shareholder approval which may be required for the Company to
consummate such Other Financing described in such Integration
Notice.
At the Company’s sole discretion, and
effective automatically upon receipt by the Investor of notice
thereof from the Company, this Agreement may be amended by the
Company from time to time to reduce the Aggregate Limit by a
specified dollar amount of Common Shares which shall be no greater
than is required to enable the Company to utilize the Registration
Statement to consummate an underwritten public offering of Common
Shares or a registered direct public offering of Common Shares
during the Investment Period; provided , however ,
that any such amendment of this Agreement (and any such purported
amendment) shall be void and of no force and effect if the effect
thereof would restrict, materially delay, conflict with or impair
the ability or right of the Company to perform its obligations
under this Agreement, including, without limitation, the obligation
of the Company to deliver Shares to the Investor in respect of a
Fixed Request or Optional Amount on the applicable Settlement
Date. In the event the Company shall have elected to
reduce the Aggregate Limit as provided in the immediately preceding
sentence, at the Company’s sole discretion, and effective
automatically upon receipt by the Investor of notice thereof from
the Company, the Company may subsequently amend this Agreement to
increase the Aggregate Limit up to $30,000,000; provided ,
however , that in no event shall the Company be entitled to
issue Fixed Requests and grant Optional Amounts during the
remainder of the Investment Period for an aggregate amount greater
than the amount obtained by subtracting (x) the aggregate of all
Fixed Request Amounts and Optional Amount Dollar Amounts (including
any amounts paid as partial damages pursuant to Section 9.1(ii)
hereunder) covered by all Fixed Requests and Optional Amounts
theretofore issued or granted by the Company in respect of which a
settlement has occurred pursuant to Section 2.7 from (y)
$30,000,000, subject in all cases to the Trading Market
Limit.
Section
2.13
Commitment Shares . In consideration for the
Investor’s execution and delivery of this Agreement,
concurrently with the execution and delivery of this Agreement on
the Effective Date, the Company shall deliver irrevocable
instructions to its transfer agent to
electronically transfer the
Commitment Shares to the Investor, not later than 4:00 p.m. (New
York time) on the second Trading Day immediately following the
Effective Date, by crediting the Investor’s or its
designees’ account at DTC through its Deposit/Withdrawal at
Custodian (DWAC) system, which Commitment Shares shall be issued
pursuant to the Registration Statement and without any restriction
on resale. For the avoidance of doubt, all of the Commitment Shares
shall be fully earned as of the Effective Date, regardless of
whether any Fixed Requests are issued by the Company or settled
hereunder.
ARTICLE III
REPRESENTATIONS AND WARRANTIES OF
THE INVESTOR
The Investor hereby makes the following
representations and warranties to the Company:
Section
3.1
Organization and Standing of the Investor
. The Investor is an
international business company duly organized, validly existing and
in good standing under the laws of the British Virgin
Islands.
Section
3.2
Authorization and Power . The Investor has the requisite
corporate power and authority to enter into and perform its
obligations under this Agreement and to purchase the Securities in
accordance with the terms hereof. The execution,
delivery and performance of this Agreement by the Investor and the
consummation by it of the transactions contemplated hereby have
been duly authorized by all necessary corporate action, and no
further consent or authorization of the Investor, its Board of
Directors or shareholders is required. This Agreement
has been duly executed and delivered by the
Investor. This Agreement constitutes a valid and binding
obligation of the Investor enforceable against it in accordance
with its terms, except as such enforceability may be limited by
applicable bankruptcy, insolvency, reorganization, moratorium,
liquidation, conservatorship, receivership, or similar laws
relating to, or affecting generally the enforcement of,
creditor’s rights and remedies or by other equitable
principles of general application.
Section
3.3
No Conflicts . The execution, delivery and
performance by the Investor of this Agreement and the consummation
by the Investor of the transactions contemplated herein do not and
shall not (i) result in a violation of such Investor’s
charter documents, bye-laws or other applicable organizational
instruments, (ii) conflict with, constitute a default (or an event
which, with notice or lapse of time or both, would become a
default) under, or give rise to any rights of termination,
amendment, acceleration or cancellation of, any material agreement,
mortgage, deed of trust, indenture, note, bond, license, lease
agreement, instrument or obligation to which the Investor is a
party or is bound, (iii) create or impose any lien, charge or
encumbrance on any property of the Investor under any agreement or
any commitment to which the Investor is party or under which the
Investor is bound or under which any of its properties or assets
are bound, or (iv) result in a violation of any federal, state,
local or foreign statute, rule, or regulation, or any order,
judgment or decree of any court or governmental agency applicable
to the Investor or by which any of its properties or assets are
bound or affected, except, in the case of clauses (ii), (iii) and
(iv), for such conflicts, defaults, terminations, amendments,
acceleration, cancellations and violations as would not,
individually or in the aggregate, prohibit or otherwise interfere
with the ability of the Investor to enter into and perform its
obligations under this Agreement in any material
respect. The Investor is not required under federal,
state, local or foreign law, rule or
regulation to obtain any consent,
authorization or order of, or make any filing or registration with,
any court or governmental agency in order for it to execute,
deliver or perform any of its obligations under this Agreement or
to purchase the Securities in accordance with the terms
hereof.
Section
3.4
Information . The Investor and its advisors have
been furnished with all materials relating to the business,
financial condition, management and operations of the Company and
materials relating to the offer and sale of the Securities which
have been requested by the Investor. The Investor and
its advisors have been afforded the opportunity to ask questions of
representatives of the Company. The Investor has sought
such accounting, legal and tax advice as it has considered
necessary to make an informed investment decision with respect to
its acquisition of the Securities. The Investor
understands that it (and not the Company) shall be responsible for
its own tax liabilities that may arise as a result of this
investment or the transactions contemplated by this
Agreement.
Section
3.5
Financial Capability . The Investor has the financial
capability to perform all of its obligations under this Agreement,
including the capability to purchase the Securities in accordance
with the terms hereof.
ARTICLE IV
REPRESENTATIONS AND WARRANTIES OF
THE COMPANY
Except as set forth in the disclosure schedule
delivered by the Company to the Investor (which is hereby
incorporated by reference in, and constitutes an integral part of,
this Agreement) (the “ Disclosure Schedule ”),
the Company hereby makes the following representations and
warranties to the Investor:
Section
4.1
Organization, Good Standing and Power
. The Company is duly
continued to, validly existing and in good standing under the laws
of Bermuda and has the requisite corporate power and authority to
own, lease and operate its properties and assets and to conduct its
business as it is now being conducted. The Company and
each Subsidiary is duly qualified as a foreign corporation to do
business and is in good standing in every jurisdiction in the
United States in which the nature of the business conducted or
property owned by it makes such qualification necessary, except for
any jurisdiction in which the failure to be so qualified would not
have a Material Adverse Effect.
Section
4.2
Authorization, Enforcement . The Company has the requisite
corporate power and authority to enter into and perform this
Agreement and to issue and sell the Securities in accordance with
the terms hereof. Except for approvals of the
Company’s Board of Directors or a committee thereof as may be
required in connection with any issuance and sale of Securities to
the Investor hereunder (which approvals shall be obtained prior to
the delivery of any Fixed Request Notice), the execution, delivery
and performance by the Company of this Agreement and the
consummation by it of the transactions contemplated hereby have
been duly and validly authorized by all necessary corporate action
and no further consent or authorization of the Company or its Board
of Directors or shareholders is required. This Agreement
has been duly executed and delivered by the Company and constitutes
a valid and binding obligation of the Company enforceable against
the Company in accordance with its terms, except as such
enforceability may be limited by
applicable bankruptcy, insolvency, reorganization, moratorium,
liquidation, conservatorship, receivership or similar laws relating
to, or affecting generally the enforcement of, creditor’s
rights and remedies or by other equitable principles of general
application.
Section
4.3
Capitalization . The authorized share capital of the
Company and the shares thereof issued and outstanding are as set
forth in the Commission Documents as of the dates reflected
therein. All of the issued and outstanding Common Shares
have been duly authorized and validly issued, and are fully paid
and nonassessable. Except as set forth in the Commission
Documents, as of the Effective Date, no Common Shares were entitled
to preemptive rights or registration rights and there were no
outstanding options, warrants, scrip, rights to subscribe to, call
or commitments of any character whatsoever relating to, or
securities or rights convertible into or exchangeable for, any
share capital of the Company, other than those issued or granted in
the ordinary course of business and consistent with past
practice. Except as set forth in the Commission
Documents, there were no contracts, commitments, understandings, or
arrangements by which the Company is or may become bound to issue
additional share capital of the Company or options, securities or
rights convertible into or exchangeable for any share capital of
the Company. Except for customary transfer restrictions
contained in agreements entered into by the Company to sell
restricted securities or as set forth in the Commission Documents,
as of the Effective Date, the Company was not a party to, and it
had no knowledge of, any agreement restricting the voting or
transfer of any of the share capital of the
Company. Except as set forth in the Commission
Documents, the offer and sale of all share capital, convertible or
exchangeable securities, rights, warrants or options of the Company
issued prior to the Effective Date complied with all applicable
federal and state securities laws, and no shareholder has any right
of rescission or damages or any “put” or similar right
with respect thereto that would have a Material Adverse
Effect. The Company has furnished or made available to
the Investor via the Commission’s Electronic Data Gathering,
Analysis and Retrieval System (“ EDGAR ”) true
and correct copies of the Company’s Memorandum of Continuance
as in effect on the Effective Date (the “ Charter
”), and the Company’s Bye-laws as in effect on the
Effective Date (the “ Bye-laws ”).
Section
4.4
Issuance of Securities . The Commitment Shares have been,
and the Shares to be issued under this Agreement have been or will
be (prior to the delivery of any Fixed Request Notice to the
Investor hereunder), duly authorized by all necessary corporate
action on the part of the Company. The Commitment Shares, when
issued in accordance with the terms of this Agreement, and the
Shares, when paid for in accordance with the terms of this
Agreement, shall be validly issued and outstanding, fully paid and
nonassessable and free from all liens, charges, taxes, security
interests, encumbrances, rights of first refusal, preemptive or
similar rights and other encumbrances with respect to the issue
thereof.
Section
4.5
No Conflicts . The execution, delivery and
performance by the Company of this Agreement and the consummation
by the Company of the transactions contemplated herein do not and
shall not (i) result in a violation of any provision of the
Company’s Charter or Bye-laws, (ii) conflict with, constitute
a default (or an event which, with notice or lapse of time or both,
would become a default) under, or give rise to any rights of
termination, amendment, acceleration or cancellation of, any
material agreement, mortgage, deed of trust, indenture, note, bond,
license, lease agreement, instrument or obligation to which the
Company or any of its
Significant Subsidiaries is a party
or is bound (including, without limitation, any listing agreement
with the Trading Market), (iii) create or impose a lien, charge or
encumbrance on any property of the Company or any of its
Significant Subsidiaries under any agreement or any commitment to
which the Company or any of its Significant Subsidiaries is a party
or under which the Company or any of its Significant Subsidiaries
is bound or under which any of their respective properties or
assets are bound, or (iv) result in a violation of any federal,
state, local or foreign statute, rule, regulation, order, judgment
or decree applicable to the Company or any of its Subsidiaries or
by which any property or asset of the Company or any of its
Subsidiaries are bound or affected, except, in the case of clauses
(ii), (iii) and (iv), for such conflicts, defaults, terminations,
amendments, acceleration, cancellations, liens, charges,
encumbrances and violations as would not, individually or in the
aggregate, have a Material Adverse Effect. The Company
is not required under federal, state, local or foreign law, rule or
regulation to obtain any consent, authorization or order of, or
make any filing or registration with, any court or governmental
agency in order for it to execute, deliver or perform any of its
obligations under this Agreement, or to issue and sell the
Securities to the Investor in accordance with the terms hereof
(other than any filings which may be required to be made by the
Company with the Commission or the Trading Market subsequent to the
Effective Date, including but not limited to a Prospectus
Supplement under Sections 1.4 and 5.9 of this Agreement, and any
registration statement, prospectus or prospectus supplement which
has been or may be filed pursuant to this Agreement).
Section
4.6
Commission Documents, Financial Statements
. (a) The
Common Shares are registered pursuant to Section 12(b) or 12(g) of
the Exchange Act and, except as disclosed in the Commission
Documents, as of the Effective Date the Company had timely filed
(giving effect to permissible extensions in accordance with Rule
12b-25 under the Exchange Act) all Commission
Documents. The Company has delivered or made available
to the Investor via EDGAR or otherwise true and complete copies of
the Commission Documents filed with the Commission prior to the
Effective Date (including, without limitation, the 2009 Form 10-K)
and has delivered or made available to the Investor via EDGAR or
otherwise true and complete copies of all of the Commission
Documents heretofore incorporated by reference in the Registration
Statement and the Prospectus. The Company has not
provided to the Investor any information which, according to
applicable law, rule or regulation, should have been disclosed
publicly by the Company but which has not been so disclosed, other
than with respect to the transactions contemplated by this
Agreement. As of its filing date, each Commission
Document filed with the Commission and incorporated by reference in
the Registration Statement and the Prospectus (including, without
limitation, the 2009 Form 10-K) complied in all material respects
with the requirements of the Securities Act or the Exchange Act, as
applicable, and other federal, state and local laws, rules and
regulations applicable to it, and, as of its filing date (or, if
amended or superseded by a filing prior to the Effective Date, on
the date of such amended or superseded filing), such Commission
Document did 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, not
misleading. Each Commission Document to be filed with
the Commission after the Effective Date and incorporated by
reference in the Registration Statement, the Prospectus and any
Prospectus Supplement required to be filed pursuant to Sections 1.4
and 5.9 hereof during the Investment Period (including, without
limitation, the Current Report), when such document becomes
effective or is filed with the Commission, as the case may be,
shall comply in all
material respects with the
requirements of the Securities Act or the Exchange Act, as
applicable, and other federal, state and local laws, rules and
regulations applicable to it, and shall 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, not misleading.
(b) The
financial statements, together with the related notes and
schedules, of the Company included in the Commission Documents
comply as to form in all material respects with all applicable
accounting requirements and the published rules and regulations of
the Commission and all other applicable rules and regulations with
respect thereto. Such financial statements, together
with the related notes and schedules, have been prepared in
accordance with GAAP applied on a consistent basis during the
periods involved (except (i) as may be otherwise indicated in such
financial statements or the notes thereto or (ii) in the case of
unaudited interim statements, to the extent they may not include
footnotes or may be condensed or summary statements), and fairly
present in all material respects the financial condition of the
Company and its consolidated Subsidiaries as of 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
year-end audit adjustments).
(c) The
Company has timely filed with the Commission and made available to
the Investor via EDGAR or otherwise all certifications and
statements required by (x) Rule 13a-14 or Rule 15d-14 under the
Exchange Act or (y) 18 U.S.C. Section 1350 (Section 906 of the
Sarbanes-Oxley Act of 2002 (“ SOXA ”)) with
respect to all relevant Commission Documents. The
Company is in compliance in all material respects with the
provisions of SOXA applicable to it as of the date
hereof. The Company maintains disclosure controls and
procedures required by Rule 13a-15 or Rule 15d-15 under the
Exchange Act; such controls and procedures are effective to ensure
that all material information concerning the Company and its
Subsidiaries is made known on a timely basis to the individuals
responsible for the timely and accurate preparation of the
Company’s Commission filings and other public disclosure
documents. As used in this Section 4.6(c), the term
“file” shall be broadly construed to include any manner
in which a document or information is furnished, supplied or
otherwise made available to the Commission.
(d) Ernst
& Young LLP, who have expressed their opinions on the audited
financial statements and related schedules included or incorporated
by reference in the Registration Statement and the Base Prospectus
are, with respect to the Company, independent public accountants as
required by the Securities Act and is an independent registered
public accounting firm within the meaning of SOXA as required by
the rules of the Public Company Accounting Oversight
Board.
Section
4.7
Subsidiaries . The 2009 Form 10-K sets forth each
Subsidiary of the Company as of the Effective Date, showing its
jurisdiction of incorporation or organization, and the Company owns
all of the outstanding capital stock or other ownership interests
of each such Subsidiary and does not have any other Subsidiaries as
of the Effective Date.
Section
4.8
No Material Adverse Effect . Since December 31, 2009, the
Company has not experienced or suffered any Material Adverse
Effect, and there exists no current state of
facts, condition or event which
would have a Material Adverse Effect, except (i) as disclosed in
any Commission Documents filed since December 31, 2009 or (ii)
continued losses from operations.
Section
4.9
Indebtedness . The Company’s Quarterly
Report on Form 10-Q for its fiscal quarter ended March 31, 2010
sets forth, as of March 31, 2010, all outstanding secured and
unsecured Indebtedness of the Company or any Subsidiary, or for
which the Company or any Subsidiary has commitments through such
date. For the purposes of this Agreement, “
Indebtedness ” shall mean (a) any liabilities for
borrowed money or amounts owed in excess of $10,000,000 (other than
trade accounts payable incurred in the ordinary course of
business), (b) all guaranties, endorsements, indemnities and other
contingent obligations in respect of Indebtedness of others in
excess of $10,000,000, 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 (c) the present value of any
lease payments in excess of $10,000,000 due under leases required
to be capitalized in accordance with GAAP. There is no
existing or continuing default or event of default in respect of
any Indebtedness of the Company or any of its
Subsidiaries.
Section
4.10
Title To Assets . Each of the Company and its
Subsidiaries has good and marketable title to all of their
respective real and personal property reflected in the Commission
Documents, free of mortgages, pledges, charges, liens, security
interests or other encumbrances, except for those indicated in the
Commission Documents or those that would not have a Material
Adverse Effect. To the Company’s knowledge, all
real property leases of the Company are valid and subsisting and in
full force and effect in all material respects.
Section
4.11
Actions Pending . There is no action, suit, claim,
investigation or proceeding pending, or to the knowledge of the
Company threatened in writing, against the Company or any
Subsidiary which questions the validity of this Agreement or the
transactions contemplated hereby or any action taken or to be taken
pursuant hereto or thereto. Except as set forth in the
Commission Documents, there is no action, suit, claim,
investigation or proceeding pending, or to the knowledge of the
Company threatened, against or involving the Company, any
Subsidiary or any of their respective properties or assets, or
involving any officers or directors of the Company or any of its
Subsidiaries, including, without limitation, any securities class
action lawsuit or shareholder derivative lawsuit, in each case
which, if determined adversely to the Company, its Subsidiary or
any officer or director of the Company or its Subsidiaries, would
have a Material Adverse Effect. With respect to each of
those certain actions under the caption “Item 3. Legal
Proceedings” in the 2009 Form 10-K, there has been no event
or change required to be disclosed in a filing under the Exchange
Act that has not been so disclosed.
Section
4.12
Compliance With Law . The business of the Company and the
Subsidiaries has been and is presently being conducted in
compliance with all applicable federal, state, local and foreign
governmental laws, rules, regulations and ordinances, except as set
forth in the Commission Documents and except for such
non-compliance which, individually or in the aggregate, would not
have a Material Adverse Effect.
Section
4.13
Certain Fees . Except for the placement fee
payable by the Company to Reedland Capital Partners, an
Institutional Division of Financial West Group, Member FINRA/SIPC
(“ Reedland ”), which shall be set forth in a
separate engagement letter between the Company and Reedland (a true
and complete fully executed copy of which has heretofore been
provided to the Investor), no brokers, finders or financial
advisory fees or commissions shall be payable by the Company or any
Subsidiary (or any of their respective affiliates) with respect to
the transactions contemplated by this Agreement.
Section
4.14
Operation of Business . (a) The Company or one
or more of its Subsidiaries possesses such permits, licenses,
approvals, consents and other authorizations (including licenses,
accreditation and other similar documentation or approvals of any
local health departments) (collectively, “ Governmental
Licenses ”) issued by the appropriate federal, state,
local or foreign regulatory agencies or bodies, including, without
limitation, the United States Food and Drug Administration (“
FDA ”), necessary to conduct the business now operated
by it, except where the failure to possess such Governmental
Licenses, individually or in the aggregate, would not have a
Material Adverse Effect. The Company and its
Subsidiaries are in compliance with the terms and conditions of all
such Governmental Licenses and all applicable FDA rules and
regulations, guidelines and policies, and all applicable rules and
regulations, guidelines and policies of any governmental authority
exercising authority comparable to that of the FDA (including any
non-governmental authority whose approval or authorization is
required under foreign law comparable to that administered by the
FDA), except where the failure to so comply, individually or in the
aggregate, would not have a Material Adverse Effect. All
of the Governmental Licenses are valid and in full force and
effect, except where the invalidity of such Governmental Licenses
or the failure of such Governmental Licenses to be in full force
and effect, individually or in the aggregate, would not have a
Material Adverse Effect. As to each product that is
subject to FDA regulation or similar legal provisions in any
foreign jurisdiction that is developed, manufactured, tested,
packaged, labeled, marketed, sold, distributed and/or
commercialized by the Company or any of its Subsidiaries, each such
product is being developed, manufactured, tested, packaged,
labeled, marketed, sold, distributed and/or commercialized in
compliance with all applicable requirements of the FDA (and any
non-governmental authority whose approval or authorization is
required under foreign law comparable to that administered by the
FDA), including, but not limited to, those relating to
investigational use, investigational device exemption, premarket
notification, premarket approval, good clinical practices, good
manufacturing practices, record keeping, filing of reports, and
patient privacy and medical record security, except where such
non-compliance, individually or in the aggregate, would not have a
Material Adverse Effect. As to each product or product
candidate of the Company or any of its Subsidiaries subject to FDA
regulation or similar legal provision in any foreign jurisdiction,
all manufacturing facilities of the Company and its Subsidiaries
are operated in compliance with the FDA’s Quality System
Regulation requirements at 21 C.F.R. Part 820, as applicable,
except where such non-compliance, individually or in the aggregate,
would not have a Material Adverse Effect. Except as set
forth in the Commission Documents or the Registration Statement,
neither the Company nor any of its Subsidiaries has received any
notice of proceedings relating to the revocation or modification of
any such Governmental Licenses or relating to a potential violation
of, failure to comply with, or request to produce additional
information under, any FDA rules and regulations, guidelines or
policies
which, if the subject of any
unfavorable decision, ruling or finding, individually or in the
aggregate, would have a Material Adverse Effect. Except
as set forth in the Commission Documents or the Registration
Statement, neither the Company nor any of its Subsidiaries has
received any correspondence, notice or request from the FDA,
including, without limitation, notice that any one or more products
or product candidates of the Company or any of its Subsidiaries
failed to receive approval from the FDA for use for any one or more
indications, and neither the Company nor any of its Subsidiaries
knows of any basis therefor. This Section 4.14 does not
relate to environmental matters, such items being the subject of
Section 4.15.
(b) The
Company or one or more of its Subsidiaries owns or possesses
adequate patents, patent rights, licenses, inventions, copyrights,
know-how (including trade secrets and other unpatented and/or
unpatentable proprietary or confidential information, systems or
procedures), trademarks, service marks, trade names, trade dress,
logos, copyrights and other intellectual property, including,
without limitation, all of the intellectual property described in
the Commission Documents as being owned or licensed by the Company
(collectively, “ Intellectual Property ”),
necessary to carry on the business now operated by
it. Except as set forth in the Commission Documents or
on Schedule 4.14(b) hereto, there are no actions, suits or judicial
proceedings pending, or to the Company’s knowledge
threatened, relating to patents or proprietary information to which
the Company or any of its Subsidiaries is a party or of which any
property of the Company or any of its Subsidiaries is subject, and
neither the Company nor any of its Subsidiaries has received any
notice or is otherwise aware of any infringement of or conflict
with asserted rights of others with respect to any Intellectual
Property or of any facts or circumstances which could render any
Intellectual Property invalid or inadequate to protect the interest
of the Company and its Subsidiaries therein, and which infringement
or conflict (if the subject of any unfavorable decision, ruling or
finding) or invalidity or inadequacy, individually or in the
aggregate, would have a Material Adverse Effect.
(c) All
pre-clinical and clinical trials conducted by, or on behalf of, the
Company or any of its Subsidiaries, or in which the Company or any
of its Subsidiaries has participated that are described in the
Registration Statement or the Commission Documents, or the results
of which are referred to in the Registration Statement or the
Commission Documents, if any, are the only pre-clinical and
clinical trials currently being conducted by or on behalf of the
Company and its Subsidiaries. To the Company’s
knowledge, all such pre-clinical and clinical trials conducted,
supervised or monitored by, or on behalf of, the Company or any of
its Subsidiaries have been conducted in compliance with all
applicable federal, state, local and foreign laws, and the
regulations and requirements of any applicable governmental entity,
including, but not limited to, FDA good clinical practice and good
laboratory practice requirements. Except as set forth in
the Registration Statement or the Commission Documents or as would
not be likely to result in a Material Adverse Effect, neither the
Company nor any of its Subsidiaries has received any notices or
correspondence from the FDA or any other governmental agency
requiring the termination, suspension, delay or modification of any
pre-clinical or clinical trials conducted by, or on behalf of, the
Company or any of its Subsidiaries or in which the Company or any
of its Subsidiaries has participated that are described in the
Registration Statement or the Commission Documents, if any, or the
results of which are referred to in the Registration Statement or
the Commission Documents. To the Company’s
knowledge, all pre-clinical and clinical trials previously
conducted by, or on behalf of, the Company or any of its
Subsidiaries while conducted by or on behalf of the Company or any
of its Subsidiaries,
were conducted
in compliance with all applicable federal, state, local and foreign
laws, and the regulations and requirements of any applicable
governmental entity, including, but not limited to, FDA good
clinical practice and good laboratory practice
requirements.
Section
4.15
Environmental Compliance . Except as disclosed in the
Commission Documents, the Company and each of its Subsidiaries have
obtained all material approvals, authorization, certificates,
consents, licenses, orders and permits or other similar
authorizations of all governmental authorities, or from any other
person, that are required under any Environmental Laws, except for
any approvals, authorization, certificates, consents, licenses,
orders and permits or other similar authorizations the failure of
which to obtain does not or would not have a Material Adverse
Effect. “ Environmental Laws ” shall
mean all applicable laws relating to the protection of the
environment including, without limitation, all requirements
pertaining to reporting, licensing, permitting, controlling,
investigating or remediating emissions, discharges, releases or
threatened releases of hazardous substances, chemical substances,
pollutants, contaminants or toxic substances, materials or wastes,
whether solid, liquid or gaseous in nature, into the air, surface
water, groundwater or land, or relating to the manufacture,
processing, distribution, use, treatment, storage, disposal,
transport or handling of hazardous substances, chemical substances,
pollutants, contaminants or toxic substances, material or wastes,
whether solid, liquid or gaseous in nature. Except for
such instances as would not, individually or in the aggregate, have
a Material Adverse Effect, to the Company’s knowledge, there
are no past or present events, conditions, circumstances,
incidents, actions or omissions relating to or in any way affecting
the Company or its Subsidiaries that violate or could reasonably be
expected to violate any Environmental Law after the Effective Date
or that could reasonably be expected to give rise to any
environmental liability, or otherwise form the basis of any claim,
action, demand, suit, proceeding, hearing, study or investigation
(i) under any Environmental Law, or (ii) based on or related to the
manufacture, processing, distribution, use, treatment, storage
(including without limitation underground storage tanks), disposal,
transport or handling, or the emission, discharge, release or
threatened release of any hazardous substance.
Section
4.16
Material Agreements . Except as set forth in the
Commission Documents, neither the Company nor any Subsidiary of the
Company is a party to any written or oral contract, instrument,
agreement commitment, obligation, plan or arrangement, a copy of
which would be required to be filed with the Commission as an
exhibit to an annual report on Form 10-K (collectively, “
Material Agreements ”). Except as set forth
in the Commission Documents, the Company and each of its
Subsidiaries have performed in all material respects all the
obligations required to be performed by them under the Material
Agreements, have received no notice of default or an event of
default by the Company or any of its Subsidiaries thereunder and
are not aware of any basis for the assertion thereof, and neither
the Company or any of its Subsidiaries nor, to the knowledge of the
Company, any other contracting party thereto are in default under
any Material Agreement now in effect, the result of which would
have a Material Adverse Effect. Except as set forth in
the Commission Documents, each of the Material Agreements is in
full force and effect, and constitutes a legal, valid and binding
obligation enforceable in accordance with its terms against the
Company and/or any of its Subsidiaries and, to the knowledge of the
Company, each other contracting party thereto, except as such
enforceability may be limited by applicable bankruptcy, insolvency,
reorganization, moratorium, liquidation, conservatorship,
receivership or similar laws relating to, or affecting generally
the
enforcement of, creditor’s
rights and remedies or by other equitable principles of general
application.
Section 4.17
Transactions With Affiliates . Except as
set forth in the Commission Documents, there are no loans, leases,
agreements, contracts, royalty agreements, management contracts,
service arrangements or other continuing transactions exceeding
$120,000 between (a) the Company or any Subsidiary, on the one
hand, and (b) any person or entity who would be covered by Item
404(a) of Regulation S-K, on the other hand. Except as
disclosed in the Commission Documents, there are no outstanding
amounts payable to or receivable from, or advances by the Company
or any of its Subsidiaries to, and neither the Company nor any of
its Subsidiaries is otherwise a creditor of or debtor to, any
beneficial owner of more than 5% of the outstanding Common Shares,
or any director, employee or affiliate of the Company or any of its
Subsidiaries, other than (i) reimbursement for reasonable expenses
incurred on behalf of the Company or any of its Subsidiaries or
(ii) as part of the normal and customary terms of such
persons’ employment or service as a director with the Company
or any of its Subsidiaries.
Section
4.18
Securities Act; FINRA Conduct Rules . The Company has complied with all
applicable federal and state securities laws in connection with the
offer, issuance and sale of the Securities hereunder.
(i) The
Company has prepared and filed with the Commission in accordance
with the provisions of the Securities Act the Registration
Statement, including a base prospectus relating to the
Securities. The Registration Statement was declared
effective by order of the Commission on May 29, 2008. As
of the date hereof, no stop order suspending the effectiveness of
the Registration Statement has been issued by the Commission or is
continuing in effect under the Securities Act and no proceedings
therefor are pending before or, to the Company’s knowledge,
threatened by the Commission. No order preventing or
suspending the use of the Prospectus or any Permitted Free Writing
Prospectus has been issued by the Commission.
(ii) The
Company satisfies all of the requirements for the use of Form S-3
under the Securities Act for the offering and sale of the
Securities contemplated by this Agreement (without reliance on
General Instruction I.B.6. of Form S-3). The Commission
has not notified the Company of any objection to the use of the
form of the Registration Statement pursuant to Rule 401(g)(1) under
the Securities Act. The Registration Statement complied
in all material respects on the date on which it was declared
effective by the Commission, and will comply in all material
respects at each deemed effective date with respect to the Investor
pursuant to Rule 430B(f)(2) of the Securities Act, with the
requirements of the Securities Act, and the Registration Statement
(including the documents incorporated by reference therein) did not
on the date it was declared effective by the Commission, and shall
not at each deemed effective date with respect to the Investor
pursuant to Rule 430B(f)(2) of the Securities Act, 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 not misleading; provided that this
representation and warranty does not apply to statements in or
omissions from the Registration Statement made in reliance upon and
in conformity with information relating to the Investor furnished
to the Company in writing by or on behalf of the Investor expressly
for use therein. The Registration Statement, as of the Effective
Date, meets the requirements set forth in Rule 415(a)(1)(x) under
the Securities Act. The Base Prospectus complied in all
material respects on
its date and on
the Effective Date, and will comply in all material respects on
each applicable Fixed Request Exercise Date and, when taken
together with the applicable Prospectus Supplement and any
applicable Permitted Free Writing Prospectus, on each applicable
Settlement Date, with the requirements of the Securities Act and
did not on its date and on the Effective Date and shall not on each
applicable Fixed Request Exercise Date and, when taken together
with the applicable Prospectus Supplement and any applicable
Permitted Free Writing Prospectus, on each applicable Settlement
Date 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 the light of the circumstances
under which they were made, not misleading; provided that
this representation and warranty does not apply to statements in or
omissions from the Base Prospectus made in reliance upon and in
conformity with information relating to the Investor furnished to
the Company in writing by or on behalf of the Investor expressly
for use therein.
(iii) The
offering of the Securities pursuant to this Agreement qualifies for
the exemption from the filing requirements of Rule 5110 of the
Financial Industry Regulatory Authority (the “ FINRA
”) afforded by FINRA Rule 5110(b)(7)(C)(i).
(iv) Each
Prospectus Supplement required to be filed pursuant to Sections 1.4
and 5.9 hereof, when taken together with the Base Prospectus and
any applicable Permitted Free Writing Prospectus, on its date and
on the applicable Settlement Date, shall comply in all material
respects with the provisions of the Securities Act and shall not on
its date and on the applicable Settlement Date 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 the light of the circumstances under which they are
made, not misleading, except that this representation and warranty
does not apply to statements in or omissions from any Prospectus
Supplement made in reliance upon and in conformity with information
relating to the Investor furnished to the Company in writing by or
on behalf of the Investor expressly for use therein.
(v) At
the earliest time after the filing of the Registration Statement
that the Company or another offering participant made a bona fide
offer (within the meaning of Rule 164(h)(2) under the Securities
Act) relating to the Securities, the Company was not and is not an
“ineligible issuer” (as defined in Rule 405 under the
Securities Ac
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