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Exhibit
10.1
COMMON STOCK PURCHASE
AGREEMENT
Dated September 7,
2007
by and
between
MEDIVATION,
INC.
and
AZIMUTH OPPORTUNITY
LTD.
TABLE OF
CONTENTS
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Page |
| Article I PURCHASE AND SALE OF COMMON STOCK |
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1 |
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Section 1.1
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Purchase
and Sale of Stock |
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1 |
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Section 1.2
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Effective
Date; Settlement Dates |
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1 |
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Section 1.3
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The
Shares |
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2 |
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Section 1.4
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Current
Report; Prospectus Supplement |
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2 |
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| Article II FIXED REQUEST TERMS; OPTIONAL
AMOUNT |
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2 |
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Section 2.1
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Fixed
Request Notice |
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2 |
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Section 2.2
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Fixed
Requests |
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3 |
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Section 2.3
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Share
Calculation |
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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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Reduction
of Commitment |
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4 |
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Section 2.6
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Below
Threshold Price |
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5 |
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Section 2.7
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Settlement |
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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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Optional
Amount |
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6 |
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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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Aggregate
Limit |
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7 |
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| Article III REPRESENTATIONS AND WARRANTIES OF THE
INVESTOR |
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8 |
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Section 3.1
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Organization and Standing of the Investor |
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8 |
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Section 3.2
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Authorization and Power |
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8 |
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Section 3.3
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No
Conflicts |
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9 |
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Section 3.4
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Information |
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9 |
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Section 3.5
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Broker-Dealer |
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9 |
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| Article IV REPRESENTATIONS AND WARRANTIES OF THE
COMPANY |
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10 |
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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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Capitalization |
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10 |
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Section 4.4
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Issuance
of Shares |
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11 |
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Section 4.5
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No
Conflicts |
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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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Subsidiaries |
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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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Indebtedness |
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13 |
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Section 4.10
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Title To
Assets |
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14 |
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Section 4.11
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Actions
Pending |
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14 |
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Section 4.12
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Compliance With Law |
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14 |
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Section 4.13
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Certain
Fees |
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14 |
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Section 4.14
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Operation
of Business |
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14 |
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Section 4.15
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Environmental Compliance |
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16 |
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Section 4.16
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Material
Agreements |
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17 |
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Section 4.17
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Transactions With Affiliates |
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17 |
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Section 4.18
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Securities Act; NASD Conduct Rules |
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18 |
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Section 4.19
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Employees |
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19 |
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Section 4.20
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Use of
Proceeds |
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20 |
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Section 4.21
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Public
Utility Holding Company Act and Investment Company Act
Status |
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20 |
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Section 4.22
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ERISA |
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20 |
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Section 4.23
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Taxes |
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20 |
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Section 4.24
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Insurance |
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20 |
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Section 4.25
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Acknowledgement Regarding Investor’s Purchase of
Shares |
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21 |
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| Article V COVENANTS |
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21 |
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Section 5.1
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Securities Compliance |
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21 |
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Section 5.2
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Registration and Listing |
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21 |
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Section 5.3
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Compliance with Laws |
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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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22 |
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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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Stop
Orders |
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24 |
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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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24 |
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Section 5.9
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Prospectus Delivery |
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25 |
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Section 5.10
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Selling
Restrictions |
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26 |
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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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Non-Public Information |
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27 |
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Section 5.13
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Broker/Dealer |
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27 |
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Section 5.14
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Update of
Disclosure Schedule |
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27 |
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Article VI OPINION OF COUNSEL AND
CERTIFICATE; CONDITIONS TO THE SALE AND PURCHASE OF THE
SHARES
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27 |
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Section 6.1
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Opinion
of Counsel and Certificate |
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27 |
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Section 6.2
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Conditions Precedent to the Obligation of the
Company |
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27 |
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Section 6.3
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Conditions Precedent to the Obligation of the
Investor |
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29 |
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| Article VII TERMINATION |
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31 |
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Section 7.1
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Term,
Termination by Mutual Consent |
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31 |
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Section 7.2
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Other
Termination |
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31 |
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Section 7.3
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Effect of
Termination |
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32 |
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| Article VIII INDEMNIFICATION |
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32 |
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Section 8.1
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General
Indemnity |
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32 |
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Section 8.2
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Indemnification Procedures |
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34 |
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| Article IX MISCELLANEOUS |
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35 |
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Section 9.1
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Fees and
Expenses |
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35 |
ii
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Section 9.2
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Specific
Enforcement, Consent to Jurisdiction, Waiver of Jury
Trial |
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36 |
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Section 9.3
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Entire
Agreement; Amendment |
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37 |
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Section 9.4
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Notices |
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37 |
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Section 9.5
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Waivers |
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38 |
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Section 9.6
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Headings |
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38 |
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Section 9.7
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Successors and Assigns |
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38 |
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Section 9.8
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Governing
Law |
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38 |
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Section 9.9
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Survival |
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38 |
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Section 9.10
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Counterparts |
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39 |
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Section 9.11
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Publicity |
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39 |
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Section 9.12
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Severability |
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39 |
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Section 9.13
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Further
Assurances |
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39 |
Annex
A. Definitions
iii
COMMON STOCK PURCHASE
AGREEMENT
This COMMON STOCK PURCHASE
AGREEMENT , made and entered into on this 7th day of September
2007 (this “ Agreement ”), by and between
Azimuth Opportunity Ltd., an international business company
incorporated under the laws of the British Virgin Islands (the
“ Investor ”), and Medivation, Inc., a
corporation organized and existing under the laws of the State of
Delaware (the “ Company ”).
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
$100,000,000 worth of newly issued shares of the Company’s
common stock, $0.01 par value (“ Common Stock
”), subject, in all cases, to the Trading Market Limit;
and
WHEREAS , the offer
and sale of the shares of Common Stock 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;
NOW, THEREFORE , the
parties hereto, intending to be legally bound, hereby agree as
follows:
ARTICLE I
PURCHASE AND SALE OF
COMMON STOCK
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 $100,000,000 (the “ Total Commitment ”) worth
of duly authorized, validly issued, fully paid and non-assessable
shares of Common Stock (subject in all cases to the Trading Market
Limit, the “ Aggregate Limit ”), by (i) the
delivery to the Investor of not more than 24 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 delivery of counterpart
signature pages of this Agreement executed by each of the parties
hereto, and by delivery of an opinion of counsel and a certificate
of the Company as provided in Section 6.1 hereof, to the
offices of Greenberg Traurig, LLP, 200 Park Avenue, New York, New
York 10166, at l0:00 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 shares of its Common
Stock 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 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 . Upon two Trading Days’ prior written
notice to the Investor, the Company may, from time to time in its
sole discretion, provide a notice to the Investor of a Fixed
Request before 9:30 a.m. (New York time) on the first Trading Day
of the Pricing Period (the “ Fixed Request Notice
”), substantially in the form attached hereto as
Exhibit
2
A . The Fixed Request Notice
shall specify the Fixed Amount Requested, establish the Threshold
Price for such Fixed Request, designate the first 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; provided , however , that (i) if
an ex-dividend date is established by the Trading Market in respect
of the Common Stock 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) 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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Threshold
Price
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Fixed Amount
Requested
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Discount
Price
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| Equal to or
greater than $25.00 |
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Not to
exceed $12,500,000 |
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96.35% of
the VWAP |
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| Equal to or
greater than $24.00 and less than $25.00 |
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Not to
exceed $12,000,000 |
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96.30% of
the VWAP |
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| Equal to or
greater than $23.00 and less than $24.00 |
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Not to
exceed $11,500,000 |
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96.25% of
the VWAP |
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| Equal to or
greater than $22.00 and less than $23.00 |
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Not to
exceed $11,000,000 |
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96.20% of
the VWAP |
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| Equal to or
greater than $21.00 and less than $22.00 |
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Not to
exceed $10,500,000 |
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96.15% of
the VWAP |
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| Equal to or
greater than $20.00 and less than $21.00 |
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Not to
exceed $10,000,000 |
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96.10% of
the VWAP |
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| Equal to or
greater than $19.00 and less than $20.00 |
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Not to
exceed $9,500,000 |
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96.05% of
the VWAP |
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| Equal to or
greater than $18.00 and less than $19.00 |
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Not to
exceed $9,000,000 |
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96.00% of
the VWAP |
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| Equal to or
greater than $17.00 and less than $18.00 |
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Not to
exceed $8,500,000 |
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95.90% of
the VWAP |
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| Equal to or
greater than $16.00 and less than $17.00 |
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Not to
exceed $8,000,000 |
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95.75% of
the VWAP |
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| Equal to or
greater than $15.00 and less than $16.00 |
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Not to
exceed $7,500,000 |
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95.60% of
the VWAP |
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| Equal to or
greater than $14.00 and less than $15.00 |
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Not to
exceed $7,000,000 |
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95.45% of
the VWAP |
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| Equal to or
greater than $13.00 and less than $14.00 |
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Not to
exceed $6,500,000 |
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95.30% of
the VWAP |
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|
| Equal to or
greater than $12.00 and less than $13.00 |
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Not to
exceed $6,000,000 |
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95.15% of
the VWAP |
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|
| Equal to or
greater than $11.00 and less than $12.00 |
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Not to
exceed $5,500,000 |
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95.00% of
the VWAP |
|
|
|
| Equal to or
greater than $10.00 and less than $11.00 |
|
Not to
exceed $5,000,000 |
|
94.85% of
the VWAP |
3
Anything to the contrary in
this Agreement notwithstanding, at no time shall the Investor be
required to purchase more than $12,500,000 worth of Common Stock in
respect of any Pricing Period (not including Common Stock 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 . Subject to Section 2.6, 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):
| 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, |
| A = |
0.10 (the “ Multiplier ”); provided ,
however , that if the number of Trading Days constituting a
Pricing Period is decreased as set forth in Section 2.8
hereof, 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 Pricing Period as so
decreased, |
| B = |
the Fixed Amount Requested, and |
| C = |
the applicable Discount Price. |
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 24 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 last Trading Day of
each 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 the Settlement
Date.
4
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 total amount of 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 original
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 Stock on NASDAQ (or any national securities
exchange on which the Common Stock is 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 Stock 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 (or is deemed to be) lower
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 deliver the Shares
purchased by the Investor to the Investor or its designees via
DTC’s Deposit Withdrawal Agent Commission (DWAC) system,
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
liquidated 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.
5
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 quotient 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, |
| B = |
10 or, for purposes of this Section 2.8, such lesser
number of Trading Days as the parties may mutually agree to,
and |
| 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 clause
(i) 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 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 Stock 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 Stock on or between the
first Trading Day of the applicable Pricing Period and the
applicable Settlement Date, the applicable exercise price
in
6
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 during the applicable Pricing
Period.
Section 2.10
Calculation of Optional Amount Shares . The number of
shares of Common Stock 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 shares of Common Stock 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 Stock 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 liquidated 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 shares of Common
Stock 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 of shares or number of shares,
as the case may be, of Common Stock otherwise issuable pursuant to
such Fixed Request Notice or Optional Amount together with the
dollar value of shares or number of shares, as the case may be, of
all other Common Stock purchased by the Investor pursuant hereto
would exceed the Aggregate Limit. The
7
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, may be integrated with the transactions contemplated by this
Agreement for purposes of determining whether approval of the
Company’s stockholders 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 the Company has timely provided the Investor
with an Integration Notice as provided in Section 5.6(ii)
hereof.
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 Stock 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 Stock or a registered direct public offering of
Common Stock 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; provided , however ,
that in no event shall the Aggregate Limit thereby be increased to
an 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 liquidated
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) $100,000,000, subject in
all cases to the Trading Market Limit.
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 Shares 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
8
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
stockholders 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, bylaws 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 Shares 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 Shares 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 Shares.
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
Broker-Dealer . The Broker-Dealer will receive
commissions from the Investor which shall not exceed customary
brokerage commissions.
9
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 a
corporation duly organized, validly existing and in good standing
under the laws of the State of Delaware 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 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 Shares 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 Shares 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 stockholders 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 capital stock 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 outstanding shares of Common Stock 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 shares of Common Stock 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
shares of capital stock of the Company. 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 shares of the capital stock of the
Company or options, securities or rights convertible into or
exchangeable for any shares of capital stock of the Company. Except
for customary transfer restrictions contained in agreements entered
into by the Company to sell restricted
10
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 shares of the capital stock of the
Company. Except as set forth in the Commission Documents, the offer
and sale of all capital stock, 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 stockholder has any right of
rescission or damages or any “put” or similar right
with respect thereto which 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 Certificate of Incorporation as in
effect on the Effective Date (the “ Charter ”),
and the Company’s Bylaws as in effect on the Effective Date
(the “ Bylaws ”), and true and correct copies
(redacted as appropriate) of all executed resolutions of the
Company’s Board of Directors (and committees thereof)
relating to the capital stock of the Company (and transactions in
respect thereof) since December 31, 2004 (except with respect
to issuances of shares of capital stock of the Company to directors
or employees of, or other service providers to, the Company as fees
or compensation that were duly approved by the Company’s
Board of Directors or a committee thereof).
Section 4.4
Issuance of Shares . The Shares to be issued under this
Agreement have been or will be duly authorized by all necessary
corporate action and, when paid for or issued in accordance with
the terms hereof, the Shares shall be validly issued and
outstanding, fully paid and nonassessable, and, when the Shares
have been issued to the Investor, the Investor shall be entitled to
all rights accorded to a holder and beneficial owner of Common
Stock.
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 Bylaws, (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 Shares
to the Investor in accordance with the terms
11
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 Stock is 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 2006 Form
10-KSB) 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 2006 Form 10-KSB) 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, 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
12
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) Singer Lewak
Greenbaum & Goldstein 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 2006 Form 10-KSB sets forth each
Subsidiary of the Company as of the Effective Date, showing its
jurisdiction of incorporation or organization and the percentage of
the Company’s ownership of the outstanding capital stock or
other ownership interests of such Subsidiary, and the Company does
not have any other Subsidiaries as of the Effective
Date.
Section 4.8 No
Material Adverse Effect . Since December 31, 2006, 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, 2006 or (ii) continued losses from
operations.
Section 4.9
Indebtedness . The Company’s Quarterly Report on
Form 10-QSB for its fiscal quarter ended June 30, 2007 sets
forth, as of June 30, 2007, 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 $1,000,000 (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 $1,000,000, whether or not the same are or should be
reflected in the Company’s balance sheet (or the notes
thereto), except guaranties by
13
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 $1,000,000 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.
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, 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 stockholder 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.
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 the Financial West Group, Member NASD/SIPC (“
Reedland ”), which shall be set forth in a separate
placement agency agreement 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
14
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 operated by 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, except where such correspondence,
notice or request, individually or in the aggregate, would not have
a Material Adverse Effect. This Section 4.14 does not relate
to environmental matters, such items being the subject of
Section 4.15.
(b) Except as set forth in
the Registration Statement and the Commission Documents, to the
knowledge of the Company, 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,
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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,
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, 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 for such non-compliance as
would not, individually or in the aggregate, have a Material
Adverse Effect. Except as set forth in the Registration Statement
or the Commission Documents, 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, except for such termination, suspension, delay or
modification as would not, individually or in the aggregate, have a
Material Adverse Effect. 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, except for such non-compliance as
would not, individually or in the aggregate, have a Material
Adverse Effect.
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
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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 best of 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
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