Exhibit 10.25
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE
SUCH OMISSIONS
between
SCHERING CORPORATION
As SELLER
and
As PURCHASER
Dated as of October 12, 2009
TABLE OF CONTENTS
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Page |
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SECTION 1. DEFINITIONS |
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1 |
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1.1 |
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Definitions |
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1 |
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1.2 |
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Other Definitional Provisions |
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6 |
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SECTION 2. PURCHASE AND SALE |
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7 |
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2.1 |
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Transfer of Purchased Asset |
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7 |
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2.2 |
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Excluded Asset |
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7 |
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2.3 |
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Assumed Liabilities |
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7 |
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2.4 |
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Excluded Liabilities |
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8 |
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2.5 |
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Technical Transfer Services |
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8 |
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2.6 |
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Licenses |
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9 |
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2.7 |
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Payments |
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10 |
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2.8 |
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Purchase Price Allocation |
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10 |
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2.9 |
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Risk of Loss |
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10 |
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2.10 |
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Closing |
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10 |
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2.11 |
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Transactions at Closing |
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11 |
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SECTION 3. REPRESENTATIONS AND WARRANTIES OF SELLER |
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12 |
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3.1 |
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Organization |
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12 |
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3.2 |
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Due Authorization |
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12 |
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3.3 |
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No Conflicts; Enforceability |
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12 |
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3.4 |
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Title; Condition; Assets |
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12 |
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3.5 |
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Intellectual Property |
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12 |
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3.6 |
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Litigation |
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13 |
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(i)
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Page |
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3.7 |
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Consents |
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13 |
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3.8 |
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Taxes |
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13 |
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3.9 |
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Compliance with Laws |
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13 |
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3.10 |
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Regulatory Filings |
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13 |
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3.11 |
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Clinical Trials |
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13 |
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3.12 |
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Contracts |
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13 |
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3.13 |
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NK-1 Records |
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14 |
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3.14 |
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Brokers, Etc. |
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14 |
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3.15 |
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Disclaimer |
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14 |
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SECTION 4. REPRESENTATIONS AND WARRANTIES OF PURCHASER |
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15 |
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4.1 |
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Organization |
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15 |
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4.2 |
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Due Authorization |
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15 |
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4.3 |
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Sufficiency of Purchase |
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15 |
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4.4 |
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No Conflicts; Enforceability |
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15 |
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4.5 |
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Litigation |
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15 |
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4.6 |
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Consents |
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16 |
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4.7 |
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Financing |
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16 |
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4.8 |
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Brokers, Etc. |
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16 |
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4.9 |
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Independent Investigation |
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16 |
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4.10 |
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Efforts to Commercialize |
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17 |
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SECTION 5. COVENANTS PRIOR TO CLOSING |
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17 |
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5.1 |
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Required Approvals and Consents; Cooperation |
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17 |
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5.2 |
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Notification |
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17 |
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5.3 |
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Certification |
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17 |
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5.4 |
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Cooperation |
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18 |
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(ii)
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5.5 |
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Further Assurances; Further Documents |
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18 |
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5.6 |
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Intellectual Property |
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18 |
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SECTION 6. CONDITIONS TO CLOSING |
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18 |
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6.1 |
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Conditions Precedent to Obligations of Purchaser and Seller |
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18 |
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6.2 |
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Conditions Precedent to Purchaser’s Obligation |
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19 |
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6.3 |
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Conditions Precedent to Seller’s Obligations |
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19 |
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SECTION 7. OTHER COVENANTS |
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20 |
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7.1 |
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Confidentiality |
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20 |
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7.2 |
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Publicity |
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22 |
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7.3 |
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Availability of Records |
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22 |
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7.4 |
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Regulatory Matters |
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23 |
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7.5 |
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Tax Matters |
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23 |
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7.6 |
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Post-Closing Cooperation |
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23 |
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7.7 |
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Limited Covenant Not to Xxx |
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23 |
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7.8 |
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Periodic Reporting |
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23 |
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7.9 |
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Rescission |
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23 |
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7.10 |
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Additional Information |
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24 |
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7.11 |
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Supply |
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24 |
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SECTION 8. SURVIVAL AND INDEMNIFICATION |
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24 |
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8.1 |
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Survival of Representations |
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24 |
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8.2 |
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Indemnification by Seller |
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24 |
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8.3 |
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Indemnification of Purchaser |
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25 |
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8.4 |
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Procedures |
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25 |
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8.5 |
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Certain Limitations on Indemnification Obligations |
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26 |
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8.6 |
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Sole Remedy |
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26 |
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(iii)
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8.7 |
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Limitation on Liability |
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27 |
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SECTION 9. MISCELLANEOUS |
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27 |
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9.1 |
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Assignment; Binding Effect |
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27 |
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9.2 |
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No Third Party Beneficiaries |
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27 |
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9.3 |
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Expenses |
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27 |
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9.4 |
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Notices |
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27 |
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9.5 |
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Governing Law |
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28 |
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9.6 |
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Dispute Resolution |
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28 |
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9.7 |
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Injunctive Relief |
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29 |
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9.8 |
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Termination |
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29 |
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9.9 |
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Effect of Termination |
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30 |
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9.10 |
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Amendments; Entire Agreement |
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30 |
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9.11 |
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Waiver |
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30 |
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9.12 |
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Severability |
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30 |
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9.13 |
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Schedules |
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30 |
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9.14 |
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Construction |
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30 |
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9.15 |
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Headings |
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30 |
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9.16 |
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Counterparts |
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30 |
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(iv)
LIST OF EXHIBITS
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Exhibit A
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-
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Xxxx of Sale and Assignment and Assumption Agreement |
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Exhibit B
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NK-1 Drug Substance |
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Exhibit C
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-
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NK-1 Patents |
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Exhibit D
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-
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Patent Assignment Agreement |
LIST OF SCHEDULES
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Schedule 2.5
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-
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Technical Transfer Services |
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Schedule 2.11
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-
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Asset Transfer Schedule |
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Schedule 7.10
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-
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Key Rolapitant Employee List |
(v)
THIS ASSET PURCHASE AGREEMENT (this “
Agreement”), dated as of October 12, 2009 (the
“Execution
Date”) is entered into by and between Schering Corporation, a New Jersey corporation having a
business address at 0000 Xxxxxxxxx Xxxx Xxxx, Xxxxxxxxxx, Xxx Xxxxxx 00000 (“
Seller”); and
OPKO
Health, Inc., a
Delaware corporation having a business address at 0000 Xxxxxxxx Xxxxxxxxx, Xxxxx,
Xxxxxxx 00000 (“
Purchaser”). Seller and Purchaser are sometimes referred to, individually, as a
“
Party” and, collectively, as the “
Parties.”
PRELIMINARY STATEMENTS
A. In connection with the merger of Merck & Co., Inc. and Schering-Plough Corporation, (the
“Merger”), Schering-Plough Corporation is required by the United States Federal Trade Commission
(“FTC”) pursuant to the Consent Order to divest certain assets related to its NK-1 Program (as
defined in Section 1).
B. In order to comply with the FTC’s Consent Order (as defined in Section 1), Seller has
decided to sell certain assets and transfer certain liabilities of the NK-1 Program to Purchaser
pursuant to this Agreement and the Parties hereto intend that this Agreement be interpreted in a
manner that is consistent with the terms and remedial purposes of the Consent Order.
C. Purchaser has determined that the purchase of certain assets and assumption of certain
liabilities associated with the NK-1 Program is consistent with and in furtherance of the business
strategies of the Purchaser. Therefore, Purchaser desires to purchase such assets and assume such
liabilities from Seller, on the terms and conditions set forth in this Agreement.
D. In
accordance with these recitals, the purpose of this Agreement is to
sell and transfer to Purchaser the Purchased Assets, and license the
know-how of Seller, that it used in the NK-1 Program for the purpose
of Purchaser conducting the NK-1 Program in substantially the manner
as conducted by Seller prior to Closing.
NOW, THEREFORE, in consideration of the foregoing and the representations, warranties,
covenants, agreements and provisions set forth in this Agreement and in the BSAA Agreement, and for
other good and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, and intending to be legally bound hereby, the Parties agree as follows:
SECTION 1.
DEFINITIONS
1.1 Definitions. All capitalized terms used in this Agreement shall have the meanings
specified in this Section or elsewhere in this Agreement, as applicable. The following terms shall
have the meanings set forth below for the purposes of this Agreement:
“Action” means any claim, action, suit, arbitration, inquiry, audit, proceeding or
investigation by or before any Governmental Authority.
“Affiliate” means, with respect to any Person, any other Person that directly or indirectly
controls or is controlled by, or is under direct or indirect common control with, such Person. For
purposes of this definition, a Person shall be deemed, in any event, to control another Person if
it owns or controls, directly or indirectly, more than fifty percent (50%) of the voting equity of
the other Person or has the power to direct or cause the direction of the management of the other
Person, whether through ownership of voting securities or otherwise.
-1-
“Agreement” has the meaning set forth in the introductory paragraph of this Agreement.
“Assets” of any Person means all assets and properties of any kind, nature, character and
description (whether real, personal or mixed, whether tangible or intangible, whether absolute,
accrued, contingent, fixed or otherwise and wherever situated), including the goodwill related
thereto, operated, owned or leased by such Person, including cash, cash equivalents, accounts and
notes receivable, chattel paper, documents, instruments, general intangibles, equipment, inventory,
goods and intellectual property.
“Assumed Liabilities” has the meaning set forth in Section 2.3.
“Basket Amount” has the meaning set forth in Section 8.5.
“BSAA Agreement” means the Xxxx of Sale and Assignment and Assumption Agreement executed by
Seller and Purchaser in substantially the form of Exhibit B.
“Business Day” means any day other than a Saturday, a Sunday or any day on which banks are
authorized or required to be closed in the United States.
“Closing Date” has the meaning set forth in Section 2.10.
“Closing” means the closing of the purchase and sale of the Purchased Assets and assignment
and assumption of the Assumed Liabilities contemplated by this Agreement.
“Code” means the United States Internal Revenue Code of 1986, as amended.
“Confidential Information” has the meaning set forth in Section 7.1.2.
“Confidentiality Agreement” means that certain Secrecy Agreement, dated as of August 4, 2009,
between Seller and Purchaser, respectively.
“Consent Order” or “Decision and Order” means a written order issued by the FTC requiring
Schering-Plough Corporation to divest certain assets related to its NK-1 Program in order for it to
obtain regulatory clearance from the United States antitrust agencies to complete the Merger.
“Control” or “Controlled by” means, with respect to intellectual property, the ability of a
Party (collectively with its Affiliate(s)), whether by ownership, license or otherwise, to grant a
license or sublicense.
“Encumbrance” means any security interest, pledge, hypothecation, mortgage, lien or
encumbrance.
“Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and
regulations promulgated thereunder.
“Excluded Assets” means any Assets whether or not relating to the NK-1 Compounds or NK-1
Program, other than the Purchased Assets.
-2-
“Excluded Liabilities” has the meaning set forth in Section 2.4.
“Execution Date” has the meaning set forth in the introductory paragraph of this Agreement.
“FTC” has the meaning set forth in the Preliminary Statements.
“GAAP” means United States generally accepted accounting principles.
“Governmental Authority” means any nation or government, any provincial, state, regional,
local or other political subdivision thereof, any supranational organization of sovereign states,
and any entity, department, commission, bureau, agency, authority, board, court, official or
officer, domestic or foreign, exercising executive, judicial, regulatory or administrative
functions of or pertaining to government, whether foreign or domestic, whether federal, state,
provincial, municipal or other.
“Indemnified Party” has the meaning set forth in Section 8.4.
“Indemnifying Party” has the meaning set forth in Section 8.4.
“IRS” means the Internal Revenue Service of the United States.
“Knowledge” means the actual knowledge of Seller.
“Law” means each provision of any currently existing federal, provincial, state, local or
foreign law, statute, ordinance, order, code, rule or regulation, promulgated or issued by any
Governmental Authority, as well as any judgments, decrees, injunctions or agreements issued or
entered into by any Governmental Authority specifically with respect to Seller.
“Liability” means, collectively, any indebtedness, guaranty, endorsement, claim, loss, damage,
deficiency, cost, expense, obligation or responsibility, fixed or unfixed, known or unknown, xxxxxx
or inchoate, liquidated or unliquidated, secured or unsecured, direct or indirect, matured or
unmatured, or absolute, contingent or otherwise, including any product liability.
“Losses” means, with respect to any claim or matter, all losses, expenses, obligations and
other Liabilities or other damages (whether absolute, accrued, contingent, fixed or otherwise, or
whether known or unknown, or due or to become due or otherwise), diminution in value, monetary
damages, fines, fees, penalties, interest obligations, deficiencies, losses and expenses (including
amounts paid in settlement, interest, court costs, costs of investigators, fees and expenses of
attorneys, accountants, financial advisors and other experts, and other expenses of litigation).
“Material Adverse Effect” means any change or effect that is materially adverse to the NK-1
Program, the Purchased Assets and/or the Assumed Liabilities, taken as a whole, but shall exclude
any change, effect or circumstance resulting or arising from: (a) the announcement of or
consummation of the transactions contemplated by this Agreement and the BSAA Agreement, and/or the
Merger, (b) events, circumstances, changes or effects that generally affect the industries in which
Seller operates, (c) general economic or political conditions, or events,
circumstances, changes or effects affecting the securities markets generally, (d) any changes
in Law, and/or (e) any circumstance, change or effect that results from any action taken pursuant
to or in accordance with this Agreement, the BSAA Agreement or at the request of Purchaser.
-3-
“Merger” has the meaning set forth in the Preliminary Statements.
“NK-1 Compounds” means the neurokinin-1 (NK-1) receptor antagonists SCH **** (Rolapitant) and
SCH ****, or any product containing such compounds.
“NK-1 Drug Substance” means the amounts of active pharmaceutical ingredient (API) and
formulated drug substance for the NK-1 Compounds set forth in Exhibit B.
“NK-1 Intellectual Property” means collectively, the NK-1 Know-How and NK-1 Patents. ****.
“NK-1 Know-How” means the know-how that is exclusively used for the NK-1 Program, including
any and all specifications, processes, designs, plans, trade secrets, ideas, concepts, inventions,
manufacturing, engineering and other manuals and drawings, standard operating procedures, formulae,
flow diagrams, toxicological, biological, physical, analytical, safety, stability, supply,
selection, constitution, or use of any raw material, quality assurance, quality control and
clinical data, technical information or research records. For the sake of clarity, none of the
foregoing information shall be included in NK-1 Know-How to the extent that such information is
covered by any claim of any Patent.
“NK-1 Patents” means the Patents and patent applications which are set forth on Exhibit C,
including all patents and patent applications, and all additions, divisions, continuations,
continuations-in-part, provisionals, continued prosecution applications, substitutions, reissues,
extensions, registrations and renewals of any of the foregoing which have any claims covering the
manufacture, distribution, marketing, promoting, offering for sale and selling of the NK-1
Compounds as of the Closing Date and are reasonably necessary or useful for the conduct of the NK-1
Program.
“NK-1 Program” means Seller’s program for the commercialization of the NK-1 Compounds,
including but not limited to their research, development, manufacture, marketing and sale, as
conducted by Seller as of or prior to the Closing Date.
“NK-1 Records” means, to the extent permitted by Law, all records or recorded information
relating exclusively to the NK-l Compounds or NK-1 Program, including, but not limited to,
Regulatory Filings, clinical trial master files, final and draft clinical protocols, stability
studies, laboratory books, batch records, strategic or marketing studies, and internal analyses,
that are in Seller’s possession or control as of the Closing Date, provided, however, that: (a) in
each case, Retained Information and Retained Intellectual Property contained in any such records
shall continue to be owned by the Seller and licensed to Purchaser in accordance with the
provisions of Section 2.6.1 and may be otherwise used and exploited by such Seller in compliance
with this Agreement; (b) Seller may retain: (i) a copy of any such records to the extent necessary
for Tax, accounting, legal or regulatory purposes, (ii) all books, documents, records and files:
(A) prepared in connection with or relating to the Transactions, including bids received from other
parties and strategic, financial or Tax analyses relating to the divestiture of
the Purchased Assets, the Assumed Liabilities, the NK-l Compounds and the NK-1 Program,
including, without limitation, any attorney work-product, attorney-client communication or other
items protected by privilege relating to the outlicensing process or divestiture of the NK-1
Compounds; or (B) maintained by Seller and/or its representatives, agents or licensees in
connection with their respective Tax, legal, regulatory or reporting requirements; and (c) with
respect to any attorney work product, attorney-client communications and other items protected by
privilege, Seller and Purchaser shall enter into agreements such that the transfer of such
materials to Purchaser would not destroy or impair such privileges.
-4-
“Party” or “Parties” has the meaning set forth in the introductory paragraph of this
Agreement.
“Permitted Encumbrances” means (a) statutory liens for current Taxes of Seller not yet due and
payable or Taxes of Seller being contested in good faith by appropriate proceedings, and (b)
mechanics’, carriers’, workers’, repairers’ and other similar liens arising or incurred in the
ordinary course of business relating to obligations as to which there is no default on the part of
Seller or the validity or amount of which is being contested in good faith by appropriate
proceedings, or pledges, deposits or other liens securing the performance of bids, trade contracts,
leases or statutory obligations (including workers’ compensation, unemployment insurance or other
social security legislation.
“Person” means any individual, corporation, partnership, joint venture, limited liability
company, trust or unincorporated organization or Governmental Authority.
“Prime Rate” means the rate of interest from time to time at the prime commercial lending rate
to the most creditworthy customers by a bank of national standing agreed by the Parties.
“Purchase Price” has the meaning set forth in Section 2.7.
“Purchased Assets” means, collectively, the NK-1 Drug Substance, the Regulatory Filings, the
NK-1 Patents and the NK-1 Records.
“Purchaser Proprietary Information” has the meaning set forth in Section 7.1.2.
“Purchaser” has the meaning set forth in the introductory paragraph of this Agreement.
“Purchaser Registrations” means the permits, approvals, licenses, franchises or
authorizations, including the Regulatory Filings, from any Governmental Authority that relate to
the testing, manufacture, distribution, marketing, promoting, offering for sale and selling of the
NK-1 Compounds that are necessary for the conduct of the NK-1 Program which are granted to
Purchaser or Purchaser’s Affiliate by any Governmental Authority after the Closing Date.
“Regulatory Filings” means (a) (i) the Investigational New Drug Applications (INDs) having
numbers IND ****, filed by Seller with the United States Food and Drug Administration
(“FDA”) for the NK-1 Compounds, and (ii) any counterparts of such INDs in any other country in the
Territory, and (b) all supplements and amendments that may be filed with respect to any filings
described in the preceding clause (a).
-5-
“Representatives” means, with respect to any Person, the directors, managers, employees,
independent contractors, agents or consultants of such Person.
“Retained Information” means the records prepared and maintained by Seller or its Affiliates
including, without limitation, laboratory books, batch records, stability studies, strategic or
marketing studies, internal analyses and regulatory files (including correspondence with
Governmental Authorities) and any and all memoranda or other documents prepared by Seller or its
Affiliates related to the NK-1 Compounds, the NK-1 Program, or manufacture or distribution of the
NK-1 Compounds, but which are not exclusive to the NK-1 Program, that are in Seller’s possession or
control prior to or as of the Closing Date.
“Retained Intellectual Property” means, collectively, the know-how and patents, other than
NK-1 Intellectual Property, owned or controlled by Seller relating to the NK-1 Compounds or NK-l
Program.
“SEC” means the United States Securities and Exchange Commission.
“Seller Disclosure Schedule” means the disclosure schedules delivered by Seller to Purchaser
in connection with this Agreement (it being expressly agreed that disclosure of any item or matter
under any Section in such Seller Disclosure Schedule, or in attachments thereto, and documents
referred to in such Seller Disclosure Schedule, shall be deemed disclosure for all purposes of
Section 3).
“Seller Proprietary Information” has the meaning set forth in Section 7.1.2.
“Seller” has the meaning set forth in the introductory paragraph of this Agreement.
“Tax” or “Taxes” means any and all taxes, assessments, levies, tariffs, duties or other
charges or impositions in the nature of a tax (together with any and all interest, penalties,
additions to tax and additional amounts imposed with respect thereto) imposed by any Governmental
Authority.
“Tax Return” means any report, return (including any information return), claim for refund,
election, estimated Tax filing or payment, request for extension, document, declaration or other
information or filing required to be supplied to any Governmental Authority with respect to Taxes,
including attachments thereto and amendments thereof.
“Territory” means the entire world.
“Third Party Claim” has the meaning set forth in Section 8.4.
“Third Party(ies)” means any Person other than the Parties or their respective Affiliates.
“Transactions” means the transactions contemplated by this Agreement and the BSAA Agreement.
1.2 Other Definitional Provisions.
-6-
1.2.1 When a reference is made in this Agreement to a Section, Exhibit or Schedule, such
reference is to a Section of, or an Exhibit or Schedule to, this Agreement unless otherwise
indicated.
1.2.2 The terms defined in the singular has a comparable meaning when used in the plural, and
vice versa.
1.2.3 Words of one gender include the other gender.
1.2.4 References to a Person are also to its successors and permitted assigns.
1.2.5 The term “dollars” and “$” means United States dollars.
1.2.6 The word “including” means “including without limitation” and the words “include” and
“includes” have corresponding meanings.
SECTION 2.
PURCHASE AND SALE
2.1 Transfer of Purchased Assets. On the Closing Date, on the terms and subject to the
conditions contained in this Agreement and in consideration of the Purchase Price paid to Seller by
Purchaser, Seller will sell, convey, transfer and assign to Purchaser, and Purchaser will purchase
and acquire from Seller, all of Seller’s right, title and interest in and to the Purchased Assets.
2.2 Excluded Assets. Except as specifically provided in this Agreement, the Parties
acknowledge and agree that Seller is not selling, conveying, transferring, delivering or assigning
any rights whatsoever to the Excluded Assets to Purchaser, and Purchaser is not purchasing, taking
delivery of or acquiring any rights whatsoever to the Excluded Assets from Seller. Without
limiting the foregoing, Purchaser expressly acknowledges it is not acquiring any rights to the
Retained Intellectual Property and the Retained Information other than the licenses thereto granted
in Section 2.6.
2.3 Assumed Liabilities. On the Closing Date, Purchaser shall assume and pay, perform or
otherwise discharge, in accordance with their respective terms and subject to the respective
conditions thereof, the following Liabilities (collectively, the “Assumed Liabilities”):
2.3.1 any Liability, obligation and commitment that Purchaser has expressly assumed or agreed
to assume under this Agreement;
2.3.2 any Liability arising out of or relating to any NK-1 liability, breach of warranty or
similar claim for injury to person or property due to the use or misuse of the NK-1 Compounds or
the Purchased Assets, to the extent such Liabilities arise out of or are attributable to acts,
omissions or events occurring after the Closing; and
2.3.3 any other Liability, obligation and commitment of whatever kind and nature relating to
the NK-1 Program, the NK-1 Compounds, the Purchased Assets, or the
ownership, sale or lease of any of the Purchased Assets, to the extent such Liabilities arise
out of or are attributable to acts, omissions or events occurring after the Closing.
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2.3.4 Purchaser’s obligations under this Section 2.3 shall not be subject to offset or
reduction by reason of any actual or alleged breach of any representation, warranty or covenant
contained in this Agreement or the BSAA Agreement or any right or alleged right to indemnification
under this Agreement or the BSAA Agreement.
2.4 Excluded Liabilities. Seller shall retain and shall be responsible for paying, performing
and discharging when due, and Purchaser shall not assume or have any responsibility for, the
following Liabilities (the “Excluded Liabilities”):
2.4.1 any Liability, obligation and commitment that Seller has expressly assumed or agreed to
assume under this Agreement;
2.4.2 any Liabilities exclusively relating to or arising out of the Excluded Assets; and
2.4.3 any Liabilities relating to the NK-1 Program, the NK-1 Compounds, the Purchased Assets,
or otherwise with respect to the operation of Seller’s business, to the extent such Liabilities
arose or relate to circumstances or facts which occurred prior to Closing; and
2.4.4 Seller’s obligations under this Agreement.
2.5 Technical Transfer Services.
2.5.1 Within ten (10) days of the Execution Date, the Parties shall form a technical transfer
team (the “Technical Team”), who shall coordinate and oversee the transfer of the Purchased Assets
and the transfer to Purchaser of all NK-1 Know How, NK-1 Records, Retained Information, and all
technical information and support reasonably necessary to enable Purchaser to assume responsibility
for the development, testing and manufacture of the NK-1 Compounds as practiced by Seller prior to
the Execution Date. The Technical Team shall consist of representatives from each of Purchaser and
Seller or their designees.
2.5.2 Promptly following the Closing, Seller shall, with input from the Technical Team,
commence the transfer of all technical information and support reasonably necessary to enable
Purchaser to assume responsibility for the development, testing and manufacture of the NK-l
Compounds (the “Technical Transfer Services”), including the Technical Transfer Services to be
provided by Seller to Purchaser as set forth in Schedule 2.5. In connection with the foregoing,
Seller shall provide Purchaser (and/or Purchaser’s designee), at Seller’s expense:
(a) The reasonable assistance of its then current employees and reasonable access to its other
internal resources to provide Purchaser with a reasonable level of technical assistance and
consultation in connection with the transfer of the NK-1 Program to Purchaser; and
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(b) copies of all production outlines, standard testing requirements, standard operating
procedures, technology, documents, data, or other information that constitutes the NK-1 Know-How.
2.5.3 Additional Services. At any time within **** after the Closing, Purchaser may, upon
reasonable notice, request Seller to provide additional transition services, and Seller shall use
reasonable efforts to provide such services on mutually agreeable terms and conditions.
2.5.4 Term of Technical Transfer Services. The term of the Technical Transfer Services to be
provided pursuant to this Section shall commence on the Closing Date and shall continue until the
completion of all Technical Transfer Services, provided that such term shall not extend longer than
**** after the Closing Date or until Seller has fully transferred to Purchaser all of the assets
subject to this Agreement, whichever is later. Upon the **** anniversary of the Closing Date, or
the date by which Seller has fully transferred to Purchaser all of the assets subject to this
Agreement, whichever is later, the Technical Team shall be disbanded and for an additional ****
period thereafter, Seller shall make former Technical Team members (or currently employed personnel
comparably knowledgeable in the relevant functional areas) available to Purchaser to respond to
Purchaser’s questions about the Purchased Assets, NK-l Know-How, Retained Information or Retained
Intellectual Property.
2.6 Licenses.
2.6.1 In partial consideration of the Purchase Price, Seller hereby grants to Purchaser a
royalty-free, paid-up, irrevocable, transferable and sublicensable license in the Territory, under
the NK-1 Know-How, Retained Information and Retained Intellectual Property solely to research,
develop, make, have made, use, have used, offer for sale, sell, and import the NK-1 Compounds in
and into the Territory (the “License”). Such License shall be exclusive (even as to Seller).
2.6.2 For the avoidance of doubt, Seller shall have the right to use the Retained Information
and Retained Intellectual Property for all purposes in the Territory other than for the conduct of
the NK-l Program or to research, develop, make, have made, use, have used, offer for sale, sell, or
import the NK-l Compounds in and into the Territory.
2.6.3 The NK-1 Know-How, Retained Information and Retained Intellectual Property shall
continue to be owned by Seller and licensed to Purchaser only in accordance with this Section 2.6.
All rights to the NK-1 Know-How, Retained Information and Retained Intellectual Property not
expressly granted by Seller pursuant to this Section 2.6 are hereby reserved by Seller.
2.6.4 Purchaser hereby grants to Seller a royalty-free, paid-up, irrevocable, transferable and
sublicensable exclusive license in the Territory under the NK-1 Patents to research, develop, make,
have made, use, have used, offer for sale, sell, and import products for veterinary purposes. The
license shall exclude, however, all rights to use the NK-l Patents to make, have made, use, have
used, offer for sale, sell or import any product containing the NK-1 Compounds. For the avoidance
of doubt, Purchaser shall have the sole right to control and enforce the NK-l Patents.
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2.7 Payments.
2.7.1 Purchase Price. In addition to any other amounts due under this Agreement, in
consideration of the sale, assignment, conveyance, and license of the Purchased Assets and the
License under Section 2, Purchaser shall assume the Assumed Liabilities and pay to Seller in
accordance with Section 2.11.2, by wire transfer of immediately available funds directly to an
account designated by Seller, the sum of Two Million Dollars ($2,000,000) (the “Purchase Price”).
2.7.2 Development Milestone Payments. Purchaser shall make the following one time development
milestone payments to Seller upon the achievement of the indicated milestone event regarding any
New Drug Application (“NDA”) filed by Purchaser with the U.S. FDA for an NK-1 Compound:
(a) Two
Million
Dollars ($2,000,000) upon approval of such an NDA for an NK-1 Compound; and
(b) Twenty-Five
Million Dollars ($25,000,000) submission of an NDA for an NK-1 Compound.
(c) In
the event that Purchaser, within seven years after the Closing,
licenses, sells or transfers its rights in any country of
the Territory excluding the United States to one or both of the NK-1 Compounds to a Third Party (other than in respect of
the transfer or sale of all or substantially all of Purchaser’s
Assets), Purchaser shall pay to Seller Twenty-Five Percent (25%) of
any upfront or lump sum payments it receives from such Third Party for such
license, sale or transfer, provided however, that Purchaser shall not
be obligated to pay Seller any portion of royalties based on sales,
research and development funding or reimbursement, expense payments,
and other payments based directly upon the amount or value of
licensed products sold by the licensee; provided, however,
that in the event that Purchaser, within seven years after the
Closing, licenses, sells or transfers its rights in the United States
to one or both of the NK-1 Compounds to a Third Party, Purchaser
shall nevertheless remain responsible for making the development
milestone payments set forth in Sections 2.7.2(a) and (b) above to
Seller at such times as, in the case of
2.7.2(a), an NDA is submitted for an NK-l Compound, and in the case of 2.7.2(b), an NDA is approved
for an NK-1 Compound.
2.8 Purchase Price Allocation. Within sixty (60) days of the Closing Date, Purchaser and
Seller shall agree on the form of a schedule detailing the Purchase Price allocation (the “Purchase
Price Allocation”) as determined by Purchaser in accordance with Section 1060 of the Code and the
Treasury Regulations. Purchaser shall provide Seller with a draft of the Purchase Price Allocation
after the Closing Date for Seller’s review and comments. Purchaser and Seller agree, unless
otherwise required pursuant to a “determination” within the meaning of Section 1313(a) of the Code,
to be bound by the Purchase Price Allocation, to file all Tax Returns (including IRS Form 8594 and
any supplemental or amended IRS Form 8594) in accordance with the Purchase Price Allocation, and
not to take any position inconsistent with the Purchase Price Allocation in the course of any
audit, examination, other administrative or judicial proceeding.
2.9 Risk of Loss. Until the Closing, any loss of or damage to the Purchased Assets from fire,
flood, casualty or any other similar occurrence shall be the sole responsibility of Seller. As of
the Closing, title to the Purchased Assets shall be transferred to Purchaser. After the Closing
Date, Purchaser shall bear all risk of loss associated with the Purchased Assets and shall be
solely responsible for procuring adequate insurance to protect the Purchased Assets against any
such loss.
2.10 Closing. Unless this Agreement shall have been terminated, on the terms and subject to
the conditions of this Agreement, the Closing shall take place at the offices of
Schering Corporation, 0000 Xxxxxxxxx Xxxx Xxxx, Xxxxxxxxxx, Xxx Xxxxxx 00000, unless the
Parties otherwise agree, on the date following the satisfaction or waiver of all of the conditions
set forth in Section 6 (the “Closing Date”). The Parties will exchange (or cause to be exchanged)
at the Closing the funds, agreements, instruments, certificates and other documents, and do, or
cause to be done, all of the things respectively required of each Party as specified in Section
2.11.
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2.11 Transactions at Closing. At the Closing, subject to the terms and conditions of this
Agreement:
2.11.1 Seller’s Actions and Deliveries. Seller shall deliver or cause to be delivered to
Purchaser:
(a) executed counterparts of the BSAA Agreement to which the Seller or an Affiliate of Seller
is a party;
(b) a certificate of a duly authorized officer of Seller certifying as to the matters set
forth in Sections 6.2.1 and 6.2.2;
(c) such Purchased Assets designated to be delivered on the Closing Date in accordance with
the plan agreed upon by the Parties pursuant to Schedule 2.11 (the “Asset Transfer Schedule”); and
(d) such other documents and instruments as may be reasonably necessary to effect or evidence
the Transactions.
2.11.2 Purchaser’s Actions and Deliveries. Purchaser shall deliver or cause to be delivered
to Seller:
(a) the Purchase Price in full by wire transfer of immediately available funds directly to the
bank account designated by Seller in a written notice to Purchaser prior to the Closing;
(b) executed counterparts of the BSAA Agreement to which Purchaser or an Affiliate of
Purchaser is a party;
(c) a certificate of a duly authorized officer of Purchaser certifying as to the matters set
forth in Sections 6.3.1 and 6.3.2; and
(d) such other documents and instruments as may be reasonably necessary to effect or evidence
the Transactions.
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SECTION 3.
REPRESENTATIONS AND WARRANTIES OF SELLER
Except as set forth in Schedule 3, Seller hereby represents and warrants to Purchaser, as of
the Closing Date, as follows:
3.1 Organization. Seller is a corporation duly organized, validly existing and in good
standing under the laws of the state of New Jersey. Seller has all requisite corporate power and
authority to own, lease and operate, as applicable, the Purchased Assets.
3.2 Due Authorization. Seller has all requisite corporate power and authority to execute,
deliver and perform its obligations under this Agreement and the BSAA Agreement, and the execution
and delivery of this Agreement and the BSAA Agreement and the performance of all of its obligations
under this Agreement and the BSAA Agreement has been duly authorized by Seller.
3.3 No Conflicts; Enforceability. The execution, delivery and performance of this Agreement
and the BSAA Agreement by Seller (1) are not prohibited or limited by, and will not result in the
breach of or a default under, any provision of the certificate of incorporation or bylaws of
Seller, (2) do not conflict with any Law applicable to Seller, and (3) do not conflict with, result
in a breach of, constitute (with or without due notice or lapse of time or both) a default under,
result in the acceleration of obligations under, create in any party the right to terminate, modify
or cancel, or require any notice, consent or waiver under, any material agreement or instrument
binding on Seller or any applicable order, writ, injunction or decree of any court or Governmental
Authority to which Seller is a party or by which Seller is bound or to which any of its Assets is
subject. This Agreement and the BSAA Agreement have been duly executed and delivered by Seller,
and constitute the legal, valid and binding obligations of Seller, enforceable against Seller in
accordance with their respective terms, except as enforceability may be limited or affected by
applicable bankruptcy, insolvency, moratorium, reorganization or other laws of general application
relating to or affecting creditors’ rights generally.
3.4 Title; Condition; Assets. Seller owns the Purchased Assets free and clear of all
Encumbrances other than the Permitted Encumbrances, and upon consummation of the transactions
contemplated hereby, Purchaser will acquire good and marketable title to the Purchased Assets, free
and clear of all Encumbrances other than the Permitted Encumbrances. The Purchased Assets and the
NK-1 Intellectual Property constitute substantially all of the assets used by Seller in connection
with the NK-1 Program, and are sufficient for Purchaser to conduct the NK-1 Program in
substantially the manner as conducted by Seller prior to Closing. The NK-1 Drug Substance
identified for clinical use in Exhibit B hereto (i) have been manufactured in accordance with cGMP,
(ii) conform in all material respects to their specifications and are fit for use in clinical
trials pursuant to FDA guidelines and requirements, and (iii) do not include any items with an
expiration date or of a quality or quantity not usable through the clinical trials for the NK-1
Compounds.
3.5 Intellectual Property.
3.5.1 (i) Seller is not aware of any facts that would raise issues of validity or
enforceability of any of the NK-1 Patents and (ii) none of the NK-1 Patents have been or is the
subject of (A) any pending adverse judgment, injunction, order, decree or agreement restricting (x)
their use in connection with the NK-1 Compounds within the Territory or (y) assignment or license
thereof by Seller, or (B) to Seller’s Knowledge, any threatened litigation or claim of infringement
threatened or made in writing or any pending litigation to which Seller is a party.
3.5.2 All NK-1 Intellectual Property within the Territory is under the Control of Seller.
3.5.3 (i) Neither Seller, nor any of its Affiliates, have granted any licenses to the NK-1
Intellectual Property to Third Parties within the Territory that would restrict Purchaser’s use of
the NK-1 Intellectual Property, and there are no existing licenses for the NK-1 Intellectual
Property to any Third Parties; (ii) neither Seller, nor any of its Affiliates, nor to Seller’s
Knowledge, any other Person, is a party to any agreements with Third Parties that limit or restrict
use of the NK-1 Intellectual Property within the Territory or require any payments for its use; and
(iii) no other Person has any joint ownership or royalty interest in the NK-1 Intellectual Property
within the Territory.
3.5.4 Seller has not received written notice of any material misappropriation or infringement
of any of the NK-1 Intellectual Property by any Person within the Territory.
3.5.5 All issuance, renewal, maintenance and other payments that are or have become due with
respect to the NK-1 Patents have been timely paid or will be paid by or on behalf of Seller.
3.5.6 There are no inventorship challenges or interferences declared with respect to any
Patents included in the NK-1 Patents, or to the Knowledge of Seller, threatened.
3.5.7 Seller and its Affiliates have taken reasonable measures to maintain in confidence all
NK-1 Know-How.
3.5.8 Neither Seller or its Affiliates owns or Controls any trademark registrations or
applications relating to the NK-1 Compounds.
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3.6 Litigation. As of the Closing Date, there is no Action pending or, to Seller’s Knowledge,
threatened, and, to Seller’s Knowledge, there is no claim, governmental investigation or
administrative action pending or threatened as to Seller (or to Seller’s Knowledge, any Third
Party) related to the NK-1 Compounds, NK-1 Program or the Transactions.
3.7 Consents. Except for the consent of the FTC, no notice to, filing with, authorization of,
exemption by, or consent of, any Person, including any Governmental Authority, is required for
Seller to consummate the Transactions.
3.8 Taxes. There are no liens for Taxes on the Purchased Assets.
3.9 Compliance with Laws. To Seller’s Knowledge, Seller has conducted the NK-1 Program in
compliance with all applicable Laws, and the Regulatory Filings were filed in compliance with
applicable Laws.
3.10 Regulatory Filings.
3.10.1 Seller or its Affiliates are the sole and exclusive owners of the Regulatory Filings.
3.10.2 Seller has not received any written or, to Seller’s Knowledge, other notice of
proceedings from a Governmental Authority alleging that the NK-1 Compounds or any of the Purchased
Assets or the ownership, manufacturing, operation, storage, warehousing, handling and/or testing of
any NK-1 Compound is in violation of any applicable Law and such violation has not been remedied,
except for such violations that would not reasonably be expected to have a Material Adverse Effect.
3.10.3 Seller has completed and filed all reports required by the applicable Governmental
Authority in order to maintain the Regulatory Filings, except where failure to file such reports
would not have a Material Adverse Effect or any significant impact on the validity or
maintainability of the Regulatory Filings.
3.11 Clinical Trials. To Seller’s Knowledge, the clinical trials, animal studies and other
preclinical tests conducted by or on behalf of the Seller under the NK-1 Program were, and if still
pending, are, being conducted in all material respects in accordance with all experimental
protocols, informed consents, procedures and controls of the Seller and applicable FDA requirements
including, but not limited to, good clinical practice and good laboratory practice regulations.
Neither the Seller nor its Affiliates have received any written notice from the FDA or any other
Governmental Authority requiring the termination or suspension of any animal study, preclinical
study or clinical trial conducted by or on behalf of the Seller or its Affiliates.
3.12 Contracts. Except for confidentiality agreements that were put in place with Third
Parties interested in evaluating the NK-1 Program, neither Seller nor any of its Affiliates is a
party to any contract, agreement or understanding (other than this Agreement) relating to the
Purchased Assets or the NK-1 Program.
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3.13 NK-1 Records. To the Knowledge of Seller, the NK-1 Records are all of the records and
recorded information exclusively related to the NK-1 Program.
3.14 Brokers, Etc. No broker, investment banker, agent, finder or other intermediary acting
on behalf of Seller or under the authority of Seller, is or will be entitled to any broker’s or
finder’s fee or any other commission or similar fee directly or indirectly in connection with any
of the Transactions.
3.15 Disclaimer.
3.15.1 EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS SECTION 3:
(a) SELLER, AND ITS RESPECTIVE OFFICERS, DIRECTORS, EMPLOYEES OR REPRESENTATIVES, DOES NOT
MAKE OR HAS NOT MADE ANY OTHER REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, WRITTEN OR ORAL, AT
LAW OR IN EQUITY, IN RESPECT OF THE PURCHASED ASSETS, ASSUMED LIABILITIES, THE NK-1 COMPOUNDS, THE
NK-1 INTELLECTUAL PROPERTY OR THE NK-1 PROGRAM, INCLUDING ANY IMPLIED REPRESENTATION OR WARRANTY
WITH RESPECT TO (I) MERCHANTABILITY, NON-INFRINGEMENT, SUITABILITY OR FITNESS FOR ANY PARTICULAR
PURPOSE, (II) THE CONDUCT OF THE NK-1 PROGRAM BY PURCHASER AFTER THE CLOSING IN ANY MANNER OTHER
THAN AS USED AND OPERATED BY SELLER OR (III) THE PROBABLE SUCCESS OR PROFITABILITY OF THE NK-1
PROGRAM AFTER THE CLOSING;
(b) SELLER OR ANY OF ITS RESPECTIVE OFFICERS, DIRECTORS, EMPLOYEES OR REPRESENTATIVES WILL NOT
HAVE OR BE SUBJECT TO ANY LIABILITY OR INDEMNIFICATION OBLIGATION TO PURCHASER OR TO ANY OTHER
PERSON RESULTING FROM THE DISTRIBUTION TO PURCHASER, ITS AFFILIATES OR REPRESENTATIVES OF, OR
PURCHASER’S USE OF, ANY INFORMATION RELATING TO THE NK-1 PROGRAM, AND ANY INFORMATION, DOCUMENTS OR
MATERIAL MADE AVAILABLE TO PURCHASER, WHETHER ORALLY OR IN WRITING, IN CERTAIN ELECTRONIC AND
PHYSICAL “DATA ROOMS,” FACE-TO-FACE PRESENTATIONS, FUNCTIONAL “BREAK-OUT” DISCUSSIONS, RESPONSES TO
QUESTIONS SUBMITTED ON BEHALF OF PURCHASER OR IN ANY OTHER FORM IN EXPECTATION OF THE TRANSACTIONS.
ANY SUCH OTHER REPRESENTATION OR WARRANTY IS HEREBY EXPRESSLY DISCLAIMED; AND
3.15.2 EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS SECTION 3, SELLER’S INTEREST IN THE
PURCHASED ASSETS AND THE NK-1 PROGRAM ARE BEING TRANSFERRED THROUGH THE SALE OF THE PURCHASED
ASSETS “AS IS, WHERE IS, WITH ALL FAULTS,” AND SELLER EXPRESSLY DISCLAIMS ANY REPRESENTATIONS OR
WARRANTIES OF ANY KIND OR NATURE, EXPRESS OR IMPLIED, AS TO THE CONDITION, VALUE OR QUALITY OF THE
PURCHASED ASSETS, NK-1 PROGRAM AND THE PROSPECTS (FINANCIAL OR
OTHERWISE), RISKS AND OTHER INCIDENTS OF THE PURCHASED ASSETS AND NK-1 PROGRAM.
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SECTION 4.
REPRESENTATIONS AND WARRANTIES OF PURCHASER
Purchaser represents and warrants to Seller, as of the Closing Date, as follows:
4.1
Organization. Purchaser is a corporation duly organized and validly existing and in good
standing under the laws of
Delaware. Purchaser has all requisite corporate power and authority to
own, lease and operate its properties and to carry on the NK-1 Program as now being conducted.
4.2 Due Authorization. Purchaser has all requisite corporate power and authority to execute,
deliver and perform its obligations under this Agreement and the BSAA Agreement, and the execution
and delivery of this Agreement and the BSAA Agreement and the performance of all of its obligations
under this Agreement and under the BSAA Agreement have been duly authorized by Purchaser and, to
the extent required by Law, contract or otherwise, its stockholders.
4.3 Sufficiency of Purchaser. Purchaser is a viable competitor in the research, development,
marketing and sale of pharmaceutical products such as the NK-1 Compounds. Purchaser has, or is
able to secure access to, the expertise and financial resources to develop and commercialize the
NK-1 Compounds in the Territory following the Closing Date.
4.4 No Conflicts; Enforceability.
4.4.1 The execution, delivery and performance of this Agreement and the BSAA Agreement by
Purchaser (1) are not prohibited or limited by, and will not result in the breach of or a default
under, any provision of the certificate of incorporation or bylaws of Purchaser, (2) do not
conflict with any Law applicable to Purchaser and (3) do not conflict with, result in a breach of,
constitute (with or without due notice or lapse of time or both) a default under, result in the
acceleration of obligations under, create in any party the right to terminate, modify or cancel, or
require any notice, consent or waiver under, any material agreement or instrument binding on
Purchaser or any applicable order, writ, injunction or decree of any court or Governmental
Authority to which Purchaser is a party or by which Purchaser is bound or to which any of its
Assets is subject, except for such prohibition, limitation, default, notice, filing, permit,
authorization, consent, approval, conflict breach or default which would not prevent or delay
consummation by Purchaser of the Transactions.
4.4.2 This Agreement and the BSAA Agreement have been duly executed and delivered by
Purchaser, and constitute the legal, valid and binding obligations of Purchaser, enforceable
against Purchaser in accordance with their respective terms, except as enforceability may be
limited or affected by applicable bankruptcy, insolvency, moratorium, reorganization or other laws
of general application relating to or affecting creditors’ rights generally.
4.5 Litigation. There is no Action pending or, to Purchaser’s knowledge, threatened, directly
or indirectly involving Purchaser (or to Purchaser’s knowledge, any Third Party) that
would prohibit, hinder, delay or otherwise impair Purchaser’s ability to perform its
obligations under this Agreement or under the BSAA Agreement, including the assumption of the
Assumed Liabilities, would affect the legality, validity or enforceability of this Agreement or the
BSAA Agreement, or prevent or delay the consummation of the Transactions.
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4.6 Consents. Except for the requisite filings as may be necessary as a result of any facts
or circumstances relating solely to the Seller, no notice to, filing with, authorization of,
exemption by, or consent of, any Person, including any Governmental Authority, is required for
Purchaser to consummate the Transactions.
4.7 Financing. Purchaser has sufficient immediately available funds to pay, in cash, the
Purchase Price and all other amounts payable pursuant to this Agreement and the BSAA Agreement or
otherwise necessary to consummate all the Transactions. Upon the consummation of the Transactions
(a) Purchaser will not be insolvent, (b) Purchaser will not be left with unreasonably small
capital, (c) Purchaser will not have incurred debts beyond its ability to pay such debts as they
mature and (d) the capital of Purchaser will not be impaired.
4.8 Brokers, Etc. No broker, investment banker, agent, finder or other intermediary acting on
behalf of Purchaser or under the authority of Purchaser is or will be entitled to any broker’s or
finder’s fee or any other commission or similar fee directly or indirectly in connection with any
of the Transactions.
4.9 Independent Investigation.
4.9.1 In making the decision to enter into this Agreement and the BSAA Agreement and to
consummate the Transactions, Purchaser has conducted its own independent investigation, review and
analysis of the Purchased Assets, Assumed Liabilities, the NK-1 Compounds and NK-1 Program, which
investigation, review and analysis was done by Purchaser and its Affiliates and Representatives.
Purchaser acknowledges that it and its Representatives have been provided adequate access to the
personnel, properties, premises and records of the NK-1 Program for such purpose. In entering into
this Agreement and the BSAA Agreement, Purchaser acknowledges that Purchaser and its Affiliates
have relied solely upon the aforementioned investigation, review and analysis and not on any
factual representations or opinions of Seller or its respective Representatives (except the
specific representations and warranties of Seller set forth in Section 3).
4.9.2 Purchaser hereby acknowledges and agrees that (l) other than the representations and
warranties made in Section 3, none of Seller or its respective Affiliates, or any of its respective
Representatives make or have made any representation or warranty, express or implied, at law or in
equity, with respect to the Purchased Assets, Assumed Liabilities and NK-1 Program, including as to
(i) merchantability or fitness for any particular use or purpose, (ii) the operation of the NK-l
Program by Purchaser after the Closing in any manner other than as used and operated by Seller or
(iii) the probable success or profitability of the NK-l Compounds or NK-l Program after the
Closing, and (2) none of Seller or its respective Affiliates nor any of their respective
Representatives will have or be subject to any Liability or indemnification obligation to Purchaser
or to any other Person resulting from the distribution to Purchaser, its Affiliates or
Representatives of, or Purchaser’s use of, any information relating to the NK-1
Program, including any information, documents or material made available to Purchaser, whether
orally or in writing, in certain electronic and physical “data rooms,” face-to-face presentations,
functional “break-out” discussions, responses to questions submitted on behalf of Purchaser or in
any other form in expectation of the Transactions.
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4.10 ****
SECTION 5.
COVENANTS PRIOR TO CLOSING
5.1 Required Approvals and Consents; Cooperation.
5.1.1 As soon as reasonably practicable after the Execution Date, the Parties shall make all
filings required to be made in order to consummate the Transactions.
5.1.2 Purchaser, including its Affiliates, as applicable, shall as promptly as practicable
after the Execution Date (i) prepare and furnish all necessary information and documentation
(including furnishing all information requested by any Governmental Authorities) and make
presentations to the FTC, (ii) take all other actions that may be necessary to demonstrate to the
FTC that Purchaser is an acceptable purchaser of the Purchased Assets and that Purchaser will
effectively compete in the marketplace using the Purchased Assets (and Seller shall use its
reasonable efforts to assist Purchaser in taking such actions) and (iii) otherwise to do whatever
is necessary, proper or advisable to assist and cooperate with Seller in obtaining necessary
consents, approvals or orders of all Governmental Authorities necessary to consummate the
Transactions (on the terms and conditions of this Agreement and the BSAA Agreement) and the Merger.
Purchaser shall keep Seller apprised of the status of any inquiries made of Purchaser or its
Affiliates by the FTC or any other Governmental Authorities, including their respective staffs,
with respect to this Agreement (or any part hereof) and the Transactions (or any part hereof) and,
to the extent possible, permit Seller (and its counsel) to attend any meetings between Purchaser
(including its counsel) and the FTC and communicate with Seller in advance of any communications or
correspondence with the FTC. Without limiting the generality of the undertakings pursuant to this
Section, Purchaser agrees to assist and cooperate with Seller if it contests and resists any Action
seeking to have imposed any order, decree, judgment, injunction, ruling or other order (whether
temporary, preliminary or permanent) that would materially delay, restrain, enjoin or otherwise
prohibit consummation of the Transactions. The provisions of this Section 5.2 shall also be
applicable to any request for information from other Governmental Authorities in connection with
the NK-l Program.
5.2 Notifications. Between the Execution Date and the Closing Date, each of Seller and
Purchaser shall promptly notify the other Party in writing of any fact, change, condition,
circumstance or occurrence or nonoccurrence of any event of which it is aware that will or is
reasonably likely to result in any of the conditions set forth in Section 6 becoming incapable of
being satisfied; provided, however, that the delivery of any notice pursuant to this Section shall
not limit or otherwise affect the remedies available hereunder to the Party receiving such notice.
5.3 Certification. ****Purchaser has provided to Seller prior to the Execution Date.
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5.4 Cooperation. Purchaser understands that Seller is entering into this Agreement to comply
with the Consent Order and that Purchaser and the Transaction are subject to the prior approval of
the FTC pursuant to the Consent Order. Purchaser agrees and warrants that it will cooperate in
good faith with Seller in its efforts to obtain such approvals. Purchaser will supply all
information and take such other actions as Seller may reasonably require in connection with
Seller’s request for FTC approval of Purchaser and the Transactions.
5.5 Further Assurances; Further Documents.
5.5.1 Commencing on the Execution Date, each of the Parties shall use its commercially
reasonable efforts, in the most expeditious manner practicable, (i) to satisfy or cause to be
satisfied all the conditions precedent that are set forth in Section 6, as applicable to each of
them, (ii) to cause the Transactions to be consummated, and (iii) without limiting the generality
of the foregoing, to obtain all consents and authorizations of Third Parties and to make all
filings with, and give all notices to, Third Parties that may be necessary or reasonably required
on its part in order to consummate the Transactions.
5.5.2 Each of Purchaser and Seller shall, and shall cause its respective Affiliates to, at the
request of another Party, execute and deliver to such other Party all such further instruments,
assignments, assurances and other documents as such other Party may reasonably request in
connection with the carrying out of this Agreement and the Transactions.
5.6 Intellectual Property.
5.6.1 Until the Closing, Seller shall preserve intact the Purchased Assets and maintain and
protect its interests in each item of the NK-1 Patents. Seller further warrants to Purchaser that
all application and renewal fees, costs, charges, taxes and other steps required for the
maintenance or protection of the NK-1 Patents arising prior to the Closing Date will be duly paid
in a timely manner and to Seller’s Knowledge there are no currently outstanding patent office
response final deadlines or expiration dates in relation to the NK-1 Patents that arise after the
Execution Date and prior to December 31, 2009.
5.6.2 Seller shall execute the short-form patent assignment document attached hereto as
Exhibit D upon Closing. For one hundred eighty (180) days after the Closing Date, Seller shall
further execute and deliver to Purchaser all other documents and instruments, to be prepared by
Purchaser, as Purchaser reasonably requests, in order for Purchaser to prosecute, perfect, record
and/or enforce any of the rights that are granted to it under this Agreement, promptly after
requested by Purchaser. If Purchaser is unable, after making reasonable inquiry, to obtain
Seller’s signature on any such documents, then if and only if such documents are reasonably
necessary due to Seller having previously been the assignee of record on the NK-1 Patents, Seller
hereby appoints Purchaser as Seller’s attorney-in-fact for the sole purpose of executing and
delivering such documents, which appointment is coupled with an interest.
SECTION 6.
CONDITIONS TO CLOSING
6.1 Conditions Precedent to Obligations of Purchaser and Seller. The respective obligations
of Purchaser and Seller to consummate the Transactions on the Closing Date are
subject to the satisfaction or waiver (in accordance with Section 9.9) at or prior to the
Closing Date of the following conditions:
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6.1.1 Litigation. No preliminary or permanent injunction or other order has been issued by
any court or by any other Governmental Authority which enjoins, restrains, prohibits or makes
illegal pursuant to applicable Law the Transactions on the Closing Date.
6.1.2 Merger, FTC Consent. The Merger shall have been completed and Purchaser shall have been
approved by the FTC as an acceptable purchaser of the NK-1 Program and any consent or approval of
the Transaction by the FTC shall have been obtained.
6.1.3 Consents. All other consents and approvals of any other Governmental Authorities, if
any, necessary to permit consummation of the Transactions shall have been obtained.
6.2 Conditions Precedent to Purchaser’s Obligation. Purchaser’s obligations to consummate the
Transactions shall be subject to the fulfillment of each of the following additional conditions,
any one or more of which may be waived, at Purchaser’s sole discretion, in writing by Purchaser:
6.2.1 Representations and Warranties. Each of the representations and warranties of Seller
contained in Section 3 shall be true and correct as of the Execution Date and as of the Closing
Date as though made on and as of the Closing Date; provided, however, that the condition in this
Section shall be deemed satisfied so long as any failure of such representations and warranties to
be true and correct has not, individually or in the aggregate had a Material Adverse Effect.
6.2.2 Performance. Seller shall have performed and complied in all material respects with
each of the covenants, agreements and obligations Seller is required to perform under this
Agreement on or before the Closing.
6.2.3 Officer’s Certificate. Purchaser shall have received a certificate executed by a duly
elected, qualified and acting officer of each Seller certifying to the satisfaction of the
conditions set forth in Sections 6.2.1 and 6.2.2.
6.2.4 The BSAA Agreement. Seller shall have duly executed and delivered to Purchaser the BSAA
Agreement.
6.3 Conditions Precedent to Seller’s Obligations. Seller’s obligation to consummate the
Transactions shall be subject to the fulfillment of each of the following additional conditions,
any one or more of which may be waived, at Seller’s sole discretion, in writing by Seller:
6.3.1 Representations and Warranties. Each of the representations and warranties of Purchaser
contained in Section 4 shall be true and correct as of the Execution Date and as of the Closing
Date as though made on and as of the Closing Date.
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6.3.2 Performance. Purchaser shall have performed and complied in all material respects with
each of the covenants, agreements and obligations Purchaser is required to perform under this
Agreement on or before the Closing.
6.3.3 Officer’s Certificate. Seller shall have received a certificate executed by a duly
elected, qualified and acting officer of Purchaser certifying to the satisfaction of the conditions
set forth in Sections 6.3.1 and 6.3.2.
6.3.4 The BSAA Agreement. Purchaser shall have duly executed and delivered the BSAA Agreement
to Seller.
SECTION 7.
OTHER COVENANTS
7.1 Confidentiality.
7.1.1 Seller and Purchaser acknowledge that they may and have received confidential or
proprietary information of the other Party in connection with the due diligence and consummation of
the Transactions and have entered into the Confidentiality Agreement which sets forth the Parties’
rights and responsibilities with respect to the Confidential Information disclosed by the
respective Parties. Upon the Execution Date, the Confidentiality Agreement shall expire and be of
no further force and effect and the obligations set forth in the Confidentiality Agreement shall be
superseded by the terms of this Section, provided, however, such expiration of the Confidentiality
Agreement shall in no way prejudice or adversely affect Seller’s or Purchaser’s ability to seek
damages, or any other remedy available to Seller or Purchaser, as appropriate, with respect to a
violation by such other Party (or its Affiliates or Representatives) of the Confidentiality
Agreement prior to the Execution Date.
7.1.2 “Confidential Information” shall include know-how, scientific information, clinical
data, efficacy and safety data, adverse event information, formulas, methods and processes,
specifications, pricing information and other terms and conditions of sales, customer information,
NK-1 Program plans, and all other intellectual property relating to Seller’s and Purchaser’s NK-1
Program, and such other confidential and proprietary information which has been provided to the
other Party in contemplation of the Transactions, including information exchanged prior to the
Execution Date. Confidential Information disclosed by Seller in connection with the Transactions
is hereinafter referred to as “Seller Proprietary Information” and Confidential Information
disclosed by Purchaser in connection with the Transactions is hereinafter referred to as “Purchaser
Proprietary Information”. From and after the Closing Date, Purchaser Proprietary Information shall
also include all Confidential Information exclusively concerning the NK-1 Program, the Purchased
Assets and the Assumed Liabilities disclosed by Seller to Purchaser.
7.1.3 From and after the Execution Date, all Purchaser Proprietary Information (including
Confidential Information exclusively concerning the NK-1 Program, the Purchased Assets and the
Assumed Liabilities disclosed by Seller to Purchaser) shall be used by Seller and its Affiliates
solely as required to perform its obligations, exercise or enforce their rights under this
Agreement (or the BSAA Agreement), or comply with applicable Law, and for no other
purpose. Seller shall not disclose, or permit the disclosure of, any of the Purchaser
Proprietary Information to any Person except those Persons to whom such disclosure is necessary to
permit Seller to perform its obligations, exercise or enforce its rights under this Agreement (or
the BSAA Agreement), or comply with applicable Law. Seller shall treat, and will cause its
Affiliates and the directors, officers, employees, agents, representatives and advisors of Seller
or any of its Affiliates to treat, the Purchaser Proprietary Information as confidential, using the
same degree of care as Seller normally employs to safeguard its own confidential information from
unauthorized use or disclosure, but in no event less than a reasonable degree of care.
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7.1.4 From and after the Execution Date, all Seller Proprietary Information (which shall not
include Confidential Information exclusively concerning the NK-1 Program, the Purchased Assets and
the Assumed Liabilities disclosed by Seller to Purchaser), shall be used by Purchaser solely as
required to perform its obligations, exercise or enforce its rights under this Agreement (or the
BSAA Agreement), or comply with applicable Law, and for no other purpose. Purchaser shall not
disclose, or permit the disclosure of, any of the Seller Proprietary Information to any Person
except those Persons to whom such disclosure is necessary to permit
Purchaser to perform its
obligations, exercise or enforce its rights under this Agreement (or the BSAA Agreement), or comply
with applicable Law. Purchaser shall treat, and will cause its Affiliates and the directors,
officers, employees, agents, representatives and advisors of Purchaser or any of their Affiliates
to treat, the Seller Proprietary Information as confidential, using the same degree of care as
Purchaser normally employs to safeguard its own confidential information from unauthorized use or
disclosure, but in no event less than a reasonable degree of care.
7.1.5 Purchaser acknowledges and agrees, that Seller (and its Affiliates) may retain one (1)
or more copies of all or part of the documentation (including written or electronic records, files,
manuals, filings, etc.), including any Purchaser Proprietary Information contained in such
documentation, that Seller delivered to Purchaser as part of the Purchased Assets, in accordance
with the provisions of and solely for the purposes set forth in this Section 7.1.
7.1.6 In the event either Party is requested pursuant to, or required by, applicable Law to
disclose any of the other Party’s Confidential Information (i.e., Seller Proprietary Information or
Purchaser Proprietary Information, as applicable), it will notify the other Party in a timely
manner so that such Party may seek a protective order or other appropriate remedy or, in such
Party’s sole discretion, waive compliance with the confidentiality provisions of this Agreement.
Each Party will co-operate in all reasonable respects, in connection with any reasonable actions to
be taken for the foregoing purpose. In any event, the Party requested or required to disclose such
Confidential Information may furnish it as requested or required pursuant to applicable Law
(subject to any such protective order or other appropriate remedy) without liability under this
Agreement, provided that such Party furnishes only that portion of the Confidential Information
which such Party is advised by a reasoned opinion of its counsel is legally required, and such
Party exercises reasonable efforts to obtain reliable assurances that confidential treatment will
be accorded such Confidential Information.
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7.2 Publicity. The Parties shall jointly agree upon the necessity and content of any press
release in connection with the Transactions. Any other publication, news release or other public
announcement by a Party relating to this Agreement or to the performance under this Agreement shall
first be reviewed and consented to in writing by the other Party; provided,
however, that notwithstanding any contrary term contained in the Confidentiality Agreement,
(i) any disclosure that is required by Law as advised by the disclosing Party’s counsel may be made
without the prior written consent of the other Party and (ii) any Party may issue a press release
or public announcement if the contents of such press release or public announcement have previously
been made public other than through a breach of this Agreement by the issuing Party, without the
prior written consent of the other Party. To the extent practicable, the disclosing Party shall
give at least three (3) Business Days advance notice of any such legally required disclosure to the
other Party, and such other Party may provide any comments on the proposed disclosure during such
period and if not practicable, such lesser practicable period, if any. Notwithstanding any
contrary term contained in the Confidentiality Agreement, to the extent that either Party
determines that it or the other Party is required to file or register this Agreement, a summary
thereof or a notification thereof to comply with the requirements of an applicable stock exchange
or any Governmental Authority, including without limitation the SEC, such Party shall give at least
three (3) Business Days advance written notice of any such required disclosure to the other Party.
Prior to making any such filing, registration or notification, the Parties shall consult with
respect thereto regarding confidentiality. The Parties shall cooperate, each at its own expense,
in such filing, registration or notification, including without limitation such confidential
treatment request, and shall execute all documents reasonably required in connection therewith.
7.3 Availability of Records. After the Closing, in connection with Tax matters, governmental
contracts, litigation or potential litigation, each as it relates to the NK-1 Compounds, NK-1
Program, Purchased Assets or Assumed Liabilities, Seller, on the one hand, and Purchaser, on the
other hand, shall make available to the other Party and its Affiliates and Representatives during
normal business hours when reasonably requested, all NK-1 Records and Retained Information in its
possession and shall preserve all such information, records and documents until the later of: (i)
**** after the Closing; (ii) the expiration of all statutes of limitations for assessing or
collecting Taxes for periods ending on or prior to the Closing and periods including the Closing
Date, including extensions thereof applicable to Seller or Purchaser; or (iii) the required
retention period under any applicable Laws for all such information, records or documents (it being
understood that the Parties shall not be required to provide any Tax Returns to any Person, other
than as required by applicable Laws). Purchaser and Seller shall also make available to each other
during normal business hours, when reasonably requested, personnel responsible for preparing or
maintaining information, records and documents, in connection with Tax matters, governmental
contracts, litigation or potential litigation, each as it relates to the NK-1 Compounds, NK-1
Program, Purchased Assets or Assumed Liabilities prior to the Closing Date (with respect to Seller)
or from and after the Closing Date (with respect to Purchaser), including product liability and
general insurance liability.
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7.4 Regulatory Matters.
7.4.1 From and after the Closing Date, Purchaser, ****, shall be responsible for taking all
actions, paying all fees (if any) and conducting all communication with the appropriate
Governmental Authority required by Law in respect of the Regulatory Filings, including preparing
and filing all reports (including adverse events) with the appropriate Governmental Authority.
7.4.2 From and after the Closing, Purchaser, ****, shall be responsible for taking all actions
and conducting all communication with Governmental Authorities with respect to NK-1 Compounds sold
pursuant to the Regulatory Filings, including responding to all complaints in respect thereof,
including complaints related to tampering or contamination, and investigating all complaints and
adverse events with respect to NK-1 Compounds sold pursuant to the Regulatory Filings.
7.5 Tax Matters. Purchaser shall be solely responsible for all sales, use, transfer and other
related taxes, if any, arising out of the transfer by the Seller and its Affiliates of the
Purchased Assets to Purchaser pursuant to this Agreement, provided that Purchaser shall not be
responsible for any tax payable on any income or gain of Seller. Seller and Purchaser shall
cooperate in preparing and timely filing all Tax Returns and other documentation relating to such
Transfer Taxes as may be required by applicable Tax Law.
7.6 Post-Closing Cooperation. Purchaser and Seller shall cooperate with each other, and shall
cause their officers, employees, agents, auditors, and representatives to cooperate with each
other, for a period necessary to fulfill the Term of Technical Transfer Services as described in
Section 2.5.4 of this Agreement, to ensure the orderly transition of the NK-I Program from Seller
to Purchaser and to minimize any disruption to the NK-l Program, including without limitation
reasonable assistance in connection with Purchaser’s efforts to conduct development work under the
Regulatory Filings.
7.7
Limited Covenant Not to Xxx. Seller, its successors and assigns, covenants to Purchaser that:
(a) Seller shall not join, file, prosecute or maintain any suit, in law or equity, against the
Purchaser (or any Person controlled by or under common control with Purchaser, or any licensees,
sublicensees, manufacturers, suppliers, distributors, and customers of such Purchaser, or of such
Purchaser-affiliated entities) under:
(i) any patent owned or licensed by Seller as of the day following the effective date
of the Merger (excluding those patents that claim inventions conceived by and reduced to
practice after the effective date of the Merger) that claims a method of making, using, or
administering, or a composition of matter, relating to the NK-1 Compounds, or that claims a
device relating to the use thereof; or
(ii) any patents owned or licensed by Seller at any time after the effective date of
the Merger (excluding those patents that claim inventions conceived by and reduced to
practice after the effective date of the Merger) that claim any aspect of the research,
development, manufacture, use, import, export, distribution, or sale of the NK-1 Compounds.
in each case, if such suit would have the potential to interfere with such Purchaser’s freedom
to practice the research or development of the NK-1 Compounds.
(b) As a condition of any assignment, transfer, or license to any third party of the
above-described patents, the third party shall agree to provide a covenant whereby the third party
covenants not to xxx Purchaser (or any Person controlled by or under common control with Purchaser,
or any licensees, sublicensees, manufacturers, suppliers,
distributors, and customers.
7.8 Periodic Reporting. Purchaser shall submit to the FTC and to any interim trustee
appointed pursuant to the Consent Order any and all periodic reports required by Purchaser pursuant
to the Consent Order.
7.9 Rescission. In the event that the Merger is completed pursuant to a provisional consent
decree with the FTC and the FTC subsequently withdraws or conditions its final approval of such
provisional consent decree in a manner which requires the rescission of this Agreement as a
condition of its final approval of such provisional consent decree, Seller shall have the right to
require that the Transactions be rescinded and this Agreement be terminated. If Seller elects to
rescind the Transactions (i) Seller shall refund to Purchaser the Purchase Price plus interest from
the Closing Date to the date of rescission at a floating rate equal to the Prime Rate, (ii) Seller
shall promptly reimburse Purchaser for reasonable out-of-pocket expenses incurred by Purchaser in
connection with this Agreement, the Transactions, and the NK-1 Program, and (iii) Purchaser shall
(at Seller’s expense) promptly take all necessary steps to return title to and possessions of the
Purchased Assets to Seller. The benefits and liabilities
attributable to ownership and operation of the Purchased Assets from and after the Closing
Date to the date of rescission, if any, shall accrue to the Purchaser.
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7.10 Additional Information. Attached as Schedule 7.10 is the list of the Key Rolapitant Employees that is referred to in the
Consent Order. The “Key Rolapitant Employees” means the Product Research and Development Employees
and the Product Manufacturing Employees (both as defined in the Consent Order) who were members of
the Rolapitant Project Team since January 11, 2008. For purposes hereof, Rolapitant Project Team
means the Schering-Plough Research Institute Rolapitant development project team that was
responsible for the decision making and oversight of the Rolapitant development program, which
consisted of key functional area experts, which experts were named to such team in accordance with
Schering-Plough’s normal practices because they had the functional experience to provide needed
disciplinary technical expertise and the seniority to be empowered by their functional area to act
on its behalf.
7.11 Supply.
Purchaser acknowledges and agrees that the quantities of Rolapitant NK-1 Drug Substance being
transferred to Purchaser hereunder exceed the quantities required for Purchaser to conduct those
Phase I, Phase II or Phase III clinical trials that it expects to perform in pursuit of Purchaser’s
efforts to gain FDA approval of an NDA for Rolapitant in the United States for the treatment of
CINV or PONV in humans (the “Clinical Requirements”). However, in order to ensure that, in the
event Purchaser exhausts all of the quantities of Rolapitant NK-1 Drug Substance (the API)
transferred by Seller as a Purchased Asset hereunder in pursuit of such efforts or the API becomes
unfit for its intended purpose for any reason, Purchaser will have access to quantities of
Rolapitant NK-1 Drug Substance to continue such efforts, the Parties hereby agree to the following:
(a) Seller will retain **** of the Rolapitant NK-1 Drug Substance as back-up inventory for
Purchaser (the “Hold Back API”). In the event that Purchaser exhausts all quantities of Rolapitant
NK-1 Drug Substance as set forth above, or determines that the Rolapitant NK-1 Drug Substance is
unfit for its intended purpose, Purchaser shall so notify Seller in writing and Seller shall
release to Purchaser as soon as practicable and in accordance with the delivery instructions agreed
between the Parties, the Hold Back API, **** cost to Purchaser. In the event that Purchaser does
not require access to the Hold Back API during the period of time set forth in this Section 7.11,
Seller hereby agrees to deliver the Hold Back API to Purchaser promptly following the satisfaction
or termination of the obligation set forth herein.
(b) In the event that Seller has delivered the Hold Back API to Purchaser in accordance with
Section 7.11(a) and Purchaser exhausts all quantities of the Hold Back API or reasonably determines
that the Hold Back API is unfit for its intended purpose, and therefore Purchaser requires
additional quantities of Rolapitant NK-1 Compound for the satisfaction of Purchaser’s Clinical
Requirements, then at Purchaser’s written request:
(i) Seller hereby agrees to manufacture and deliver to Purchaser those quantities of
Rolapitant NK-1 Compound as the Parties may agree upon, on usual and customary commercially
reasonable terms and conditions of supply, including commercially reasonable
advance notice of forecasted requirements. In furtherance of the foregoing, Purchaser shall
make all commercially reasonable efforts to provide Seller with no less than **** notice of such
forecasted requirements, provided, however, that in the event Purchaser can demonstrate that
Purchaser’s need for the API is more immediate and that providing such prior written notice will
materially harm Purchaser’s conduct of the NK-1 Program, Seller will take all commercially
reasonable steps to accelerate production of such forecasted amounts of the Rolapitant NK-1
Compound for Purchaser;
(ii) The supply cost for such additional quantities of Rolapitant NK-1 Compound shall be ****;
(iii) The minimum batch size of Rolapitant NK-1 Compound that Purchaser may request hereunder
shall be **** (a “Batch”);
(iv) Purchaser hereby grants to Seller a royalty-free, non-exclusive, transferable and
sublicensable license to NK-1 Intellectual Property, Retained Information and Retained Intellectual
Property solely for the purpose of and to the extent required to make
the Rolapitant NK-l Compound to satisfy its supply obligations
hereunder; and
(v) Purchaser hereby agrees to promptly provide to Seller copies of such NK- 1 Records or
other Confidential Information as may be required to enable Seller to
manufacture the Rolapitant NK-l Compound for Purchaser hereunder.
Purchaser further agrees that Seller’s use of such NK-l Records or other Confidential Information
for the purpose of satisfying its supply obligations hereunder shall not be the basis for any claim of a breach of the confidentiality provisions
hereunder or under the terms of the Consent Order.
****;
provided,
futher, however, that the foregoing obligations shall remain in
effect only until ****: (1) the date the Purchaser ****.
SECTION 8.
SURVIVAL AND INDEMNIFICATION
8.1 Survival of Representations. The representations and warranties contained in this
Agreement, the certificates delivered by Seller and Purchaser pursuant to Section 2.11.1(b) and
2.11.2(c), respectively, shall survive the Closing and remain in full force and effect until the
**** anniversary of the Closing Date; provided, however, that if notice of any claim for
indemnification pursuant to Section 8.2 or Section 8.3 shall have been given prior to the first
anniversary of the Closing Date, the relevant representations and warranties shall survive for
purposes of such claim until such time as such claim is finally resolved.
8.2 Indemnification by Seller. Seller shall indemnify Purchaser and its Affiliates and their
respective, officers, directors, employees, stockholders, agents and Representatives against, and
hold them harmless from, any Losses, to the extent arising from:
8.2.1 any breach of any representation or warranty of Seller contained in this Agreement or
the certificate delivered by Seller pursuant to Section 2.11.1(b);
8.2.2 any breach of any covenant of Seller contained in this Agreement;
8.2.3 any Excluded Liabilities; and
8.2.4 any fees, expenses or other payments incurred or owed by Seller to any brokers,
financial advisors or comparable other Persons retained or employed by it in connection with the
Transactions.
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8.3 Indemnification by Purchaser. Purchaser shall indemnify Seller and its Affiliates and
their respective officers, directors, employees, stockholders, agents and Representatives against,
and agrees to hold them harmless from, any Losses, to the extent arising from:
8.3.1 any breach of any representation or warranty of Purchaser contained in this Agreement or
the certificate delivered by Purchaser pursuant to Section 2.11.2(c);
8.3.2 any breach of any covenant of Purchaser contained in this Agreement;
8.3.3 any Assumed Liability; and
8.3.4 any fees, expenses or other payments incurred or owed by Purchaser to any brokers,
financial advisors or other comparable Persons retained or employed by it in connection with the
Transactions.
8.4 Procedures. In order for a Party (the “Indemnified Party”) to be entitled to any
indemnification provided for under this Agreement in respect of, arising out of or involving a
claim made by any Person against the Indemnified Party (a “Third Party Claim”), such Indemnified
Party must notify the indemnifying party (the “Indemnifying Party”) in writing (and in reasonable
detail) of the Third Party Claim within fifteen (15) Business Days after receipt by such
Indemnified Party of notice of the Third Party Claim; provided, however, that failure to give such
notification shall not affect the indemnification provided under this Agreement except to the
extent the Indemnifying Party shall have been actually prejudiced as a result of such failure
(except that the Indemnifying Party shall not be liable for any expenses incurred during the period
in which the Indemnified Party failed to give such notice). Thereafter, the Indemnified Party
shall deliver to the Indemnifying Party, within five (5) Business Days’ after the Indemnified
Party’s receipt thereof, copies of all notices and documents (including court papers) received by
the Indemnified Party relating to the Third Party Claim.
8.4.1 If a Third Party Claim is made against an Indemnified Party, the Indemnifying Party
shall be entitled to participate in the defense thereof and, if it so chooses, to assume the
defense thereof with counsel selected by the Indemnifying Party. If the Indemnifying Party assumes
such defense, the Indemnified Party shall have the right to participate in the defense thereof and
to employ counsel, at its own expense, separate from the counsel employed by the Indemnifying
Party, it being understood that the Indemnifying Party shall control such defense. The
Indemnifying Party shall be liable for the reasonable fees and expenses of counsel employed by the
Indemnified Party for any period during which the Indemnifying Party has not assumed the defense
thereof (other than during any period in which the Indemnified Party shall have failed to give
notice of the Third Party Claim as provided above). If the Indemnifying Party chooses to defend or
prosecute a Third Party Claim, all Indemnified Parties shall cooperate in the defense or
prosecution thereof. Such cooperation shall include the retention and (upon the Indemnifying
Party’s request) the provision to the Indemnifying Party of records and information that are
reasonably relevant to such Third Party Claim, and making employees and Representatives available
on a mutually convenient basis to provide additional information and explanation of any material
provided under this Agreement or other matters reasonably related to such Third Party Claim.
Whether or not the Indemnifying Party assumes the defense of a Third Party Claim, the Indemnified
Party shall not admit any liability with respect to, or settle,
compromise or discharge, such Third Party Claim without the Indemnifying Party’s prior written
consent (which consent shall not be unreasonably withheld). If the Indemnifying Party assumes the
defense of a Third Party Claim, the Indemnified Party shall agree to any settlement, compromise or
discharge of a Third Party Claim that the Indemnifying Party may recommend and that by its terms
obligates the Indemnifying Party to pay the full amount of the Losses in connection with such Third
Party Claim, which releases the Indemnified Party completely in connection with such Third Party
Claim and that would not otherwise materially adversely affect the Indemnified Party.
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8.4.2 In the event any Indemnified Party should have a claim against any Indemnifying Party
under Section 8.2 or 8.3 that does not involve a Third Party Claim being asserted against or sought
to be collected from such Indemnified Party, the Indemnified Party shall deliver notice of such
claim with reasonable promptness to the Indemnifying Party, but in any event not later than fifteen
(15) Business Days after the Indemnified Party determines that it has or could have a claim to
indemnification under this Agreement, stating the amount of Loss, if known, and method of
computation thereof, and containing a specific reference to the provisions of this Agreement in
respect of which such right of indemnification is claimed or arises. The failure by any
Indemnified Party so to notify the Indemnifying Party shall not relieve the Indemnifying Party from
any indemnification obligation that it may have to such Indemnified Party under Section 8.2 or 8.3,
as applicable, except to the extent that the Indemnifying Party is prejudiced by such failure. If
the Indemnifying Party disputes that it has an indemnification obligation with respect to such
claim, the Indemnifying Party shall deliver notice of such dispute with reasonable promptness and
the Indemnifying Party and the Indemnified Party shall proceed in good faith to negotiate a
resolution of such dispute for a period of thirty (30) days following the receipt by the
Indemnified Party of such dispute notice. If the Indemnified Party and the Indemnifying Party have
not resolved such dispute during such time period through good faith negotiations, such dispute
shall be resolved by litigation in an appropriate court of competent jurisdiction or other mutually
agreeable non-judicial dispute resolution mechanism.
8.5
Certain Limitations on Indemnification Obligations. Purchaser
shall not be entitled to receive any indemnification payments under
this Section 8 unless and until the aggregate amount of all
indemnifiable Losses incurred by Purchaser equals One percent (1%) of
the Purchase Price (the “Basket Amount”), whereupon
Purchaser shall be entitled to receive in full indemnity payments for
all such Losses that exceed the Basket Amount; provided that the
maximum aggregate amount of indemnification payments under this
Section 8 to which Purchaser shall be entitled shall not exceed
Ten percent (10%) of Purchase Price (“Indemnification
Cap”); and provided further that Purchaser shall not be
permitted to submit a claim for indemnification if aggregate Losses
with respect to such claim are less than Ten Thousand Dollars
($10,000). Notwithstanding the foregoing, any claims by Purchaser for
indemnification as a result of Excluded Liabilities shall not be
subject to the Indemnification Cap.
8.6 Sole Remedy. Except as otherwise specifically provided in this Agreement or in the BSAA
Agreement, each of the Parties acknowledge and agree that its sole and exclusive remedy after the
Closing with respect to any and all claims and causes of action under or that are reasonably
related to this Agreement, the Transactions, the NK-1 Program, the Purchased Assets and the Assumed
Liabilities (other than claims of, or causes of action arising from, fraud, other tortious acts, or
relating to breaches of covenants requiring performance after the Closing Date) shall be pursuant
to the indemnification provisions set forth in this Section 8. In furtherance of the foregoing,
each of the Parties hereby waives, from and after the Closing, to the fullest extent permitted
under applicable Law, any and all rights, claims and causes of action under or that are reasonably
related to this Agreement, the Transactions, the NK-1 Program, the Purchased Assets and the Assumed
Liabilities (other than claims of, or causes of action arising from, fraud, other tortious acts, or
relating to breaches of covenants requiring performance after the Closing Date) it may have against
any other Party arising under or based upon any applicable Law or arising under or based upon
common law or otherwise (except pursuant to the indemnification provisions set forth in Section 8.2
or 8.3, as applicable).
-26-
8.7 Limitation on Liability. EXCEPT WITH RESPECT TO THIRD PARTY CLAIMS, THE INDEMNIFICATION
OBLIGATIONS OF THE PARTIES SHALL NOT EXTEND TO INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES,
INCLUDING NK-1 PROGRAM INTERRUPTION, LOST PROFITS, LOSS OF USE, DAMAGE TO GOODWILL OR LOSS OF THE
NK-1 PROGRAM.
SECTION 9.
MISCELLANEOUS
9.1 Assignment; Binding Effect. This Agreement shall be binding upon and inure to the benefit
of the Parties and their respective successors and assigns; provided, however, that neither party
may assign this Agreement without the prior written consent of the other party hereto, except that
either party may assign its rights and obligations under this Agreement to an Affiliate without
such consent.
9.2 No Third Party Beneficiaries. This Agreement is solely for the benefit of the Parties and
their respective Affiliates and no provision of this Agreement shall be deemed to confer upon any
Third Parties any remedy, claim, liability, reimbursement, claim of action or other right in excess
of those existing without reference to this Agreement.
9.3 Expenses. Except as otherwise specified in this Agreement, and regardless of whether or
not the Transactions are consummated, each Party shall bear its own expenses with respect to the
Transactions.
9.4 Notices. All notices, requests, claims, demands and other communications under this
Agreement shall be in writing and shall be deemed to have been duly given (a) when received, if
delivered personally, (b) when transmitted, if telecopied (which is confirmed), (c) upon receipt,
if sent by registered or certified mail (postage prepaid, return receipt requested) and (d) the day
after it is sent, if sent for next-day delivery to a domestic address by overnight mail or courier,
to the Parties at the following addresses:
If to Seller, to:
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Schering-Plough Corporation
0000 Xxxxxxxxx Xxxx Xxxx
Xxxxxxxxxx, XX 00000
Attn: Senior Vice President, Business Development
Facsimile: 000-000-0000 |
with a copy sent concurrently to:
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Schering-Plough Corporation
0000 Xxxxxxxxx Xxxx Xxxx
Xxxxxxxxxx, XX 00000
Attn: Group Vice President & Associate General Counsel,
Global Human Pharmaceuticals
Facsimile: 000-000-0000 |
-27-
If to Purchaser, to:
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OPKO Health, Inc.
0000 Xxxxxxxx Xxxx.
Xxxxx, XX 00000
Attn: Xxxxx Xxxxxxxx, Executive Vice President of R&D and Business Development
Facsimile: 000-000-0000 |
With a copy sent concurrently to:
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OPKO Health, Inc.
0000 Xxxxxxxx Xxxx.
Xxxxx, XX 00000
Attn: Xxxx Xxxxx, Deputy General Counsel
Facsimile: 000-000-0000 |
provided, however, that if any Party shall have designated a different address by notice to
the others, then to the last address so designated.
9.5
Governing Law. This Agreement (including any claim or controversy arising out of or
relating to this Agreement) shall be governed by the laws of the State of
Delaware without regard
to conflict of law principles.
9.6 Dispute Resolution.
9.6.1 The Parties shall attempt in good faith to resolve any dispute arising out of or
relating to this Agreement promptly by negotiation between executives who have authority to settle
the controversy and who are at a higher level of management than the persons with direct
responsibility for administration of this Agreement. Any Party may give the other Parties written
notice of any dispute not resolved in the normal course of business. Within ten (10) days after
delivery of the notice, the receiving Party shall submit to the other Party a written response.
The notice and response shall include: (a) a statement of that Party’s position and a summary of
arguments supporting that position, and (b) the name and title of the executive who will represent
that Party and of any other person who will accompany the executive. Within thirty (30) days after
delivery of the initial notice, the executives of both Parties shall meet at a mutually acceptable
time and place, and thereafter as often as they reasonably deem necessary, to attempt to resolve
the dispute. All reasonable requests for information made by one Party to the other Party will be
honored. All negotiations pursuant to this Section are confidential and shall be treated as
compromise and settlement negotiations for purposes of applicable rules of evidence.
9.6.2 Except for disputes concerning non-payment of a development milestone payment when due
(which are not subject to the remainder of this Section 9.6), if a dispute has not been resolved by
negotiation as provided in Section 9.6.1 within forty-five (45) days after delivery of the initial
notice of negotiation, or if the parties failed to meet within thirty (30) days after delivery, the
Parties shall endeavor to settle the dispute by mediation under the CPR Mediation Procedure then
currently in effect, provided, however, that if one Party fails to participate in the negotiation
as provided in this Section, the other Party can initiate mediation
prior to the expiration of the forty-five (45) day period. Unless otherwise agreed, the
Parties will select a mediator from the CPR Panels of Distinguished Neutrals.
-28-
9.6.3 Each Party will bear its own cost of mediation, including any counsel fees; provided,
however, the cost charged by any independent Third Party mediator will be shared equally by the
Parties. In the mediation, each Party shall be represented by a business person fully authorized
to negotiate and settle the dispute and may also be represented by counsel.
9.6.4 Any dispute which has not been resolved by mediation as provided in Section 9.6.2 within
forty-five (45) days after initiation of the mediation procedure shall be finally resolved by
arbitration in accordance with the CPR Rules for Non-Administered Arbitration then currently in
effect by a sole arbitrator; provided, however, that if one Party fails to participate in either
the negotiation or mediation as provided in Section 9.6.1 or 9.6.2, the other Parties can commence
arbitration prior to the expiration of the time periods set forth above. The arbitration shall be
governed by the Federal Arbitration Act, 9 U.S.C. §§1 et seq., and judgment upon the award rendered
by the arbitrator(s) may be entered by any court having jurisdiction thereof.
9.7 Injunctive Relief. Notwithstanding anything to the contrary in this Agreement, either
Party will have the right to seek temporary injunctive relief in any court of competent
jurisdiction as may be available to such Party under the laws and rules applicable in such
jurisdiction with respect to any matters arising out of the other Party’s performance of its
obligations under this Agreement. Either Party agrees that in the event the other Party institutes
an appropriate Action seeking injunctive/equitable relief for specific performance under this
Agreement, the Party seeking such relief shall not be required to provide the other Party with
service of process of a complaint and summons under the procedures set forth in any non-United
States judicial process or system. Under such circumstances, the Party seeking such relief need
only provide the other Party with two copies of a true, correct and lawfully issued summons and
complaint, via overnight mail (next day delivery).
9.8 Termination. Without prejudice to other remedies which may be available to the Parties by
Law or this Agreement, this Agreement may be terminated at any time prior to the Closing Date:
9.8.1 by the mutual written consent of the Parties;
9.8.2 by the Purchaser by written notice to the Seller if the Closing has not occurred on or
prior to **** after the Execution Date, provided that the failure of the Closing to occur by such
date is not attributable in whole or in part to a failure of the Purchaser to fulfill any of its
obligations under this Agreement;
9.8.3 by any Party, by written notice to the other Parties if a court of competent
jurisdiction or governmental, regulatory or administrative agency or commission shall have issued
an order, decree or ruling or taken any other action, in each case permanently restraining,
enjoining or otherwise prohibiting the transactions contemplated by this Agreement, and such order,
decree, ruling or other action shall have become final and nonappealable; or
-29-
9.8.4 by any Party, if the FTC shall have disapproved of this Agreement or the Parties hereto
at any time.
9.9 Effect of Termination. In the event of termination of this Agreement pursuant to Section
9.8, this Agreement shall forthwith become null and void and there shall be no liability on the
part of any Party, or any Party’s Affiliates, with respect to this Agreement, except that such a
termination shall not preclude any party from suing any other party for breach of this Agreement.
The following Sections shall survive any termination of this Agreement: Section 1, Section 7.1,
Section 7.2, Section 7.3 and Section 9.2 which shall remain in full force and effect.
9.10 Amendments; Entire Agreement. This Agreement may not be amended, supplemented or
otherwise modified except by an instrument in writing signed by all of the Parties. This
Agreement, the BSAA Agreement and the Confidentiality Agreement contain the entire agreement of the
Parties with respect to the Transactions, superseding all negotiations, prior discussions and
preliminary agreements made prior to the Closing Date.
9.11 Waiver. The failure of any Party to enforce any condition or part of this Agreement at
any time shall not be construed as a waiver of that condition or part, nor shall it forfeit any
rights to future enforcement thereof.
9.12 Severability. If any term, provision, covenant or restriction of this Agreement is held
by a court of competent jurisdiction or other authority to be invalid, void, unenforceable or
against its regulatory policy, such determination shall not affect the enforceability of any others
or of the remainder of this Agreement.
9.13 Schedules. Purchaser agrees that any disclosure by Seller in any Schedule attached to
this Agreement shall not establish any threshold of materiality or concede the materiality of any
matter or item disclosed.
9.14 Construction. The language in all parts of this Agreement shall be construed, in all
cases, according to its fair meaning. The Parties acknowledge that each Party and its counsel have
reviewed and revised this Agreement and that any rule of construction to the effect that any
ambiguities are to be resolved against the drafting Party shall not be employed in the
interpretation of this Agreement.
9.15 Headings. The headings of the Sections of this Agreement are inserted for convenience
only and shall not be deemed to constitute a part of this Agreement.
9.16 Counterparts. This Agreement may be executed manually or by facsimile by the Parties, in
any number of counterparts, each of which shall be considered one and the same agreement and shall
become effective when a counterpart of this Agreement shall have been signed by each of the Parties
and delivered to the other Party.
-30-
IN WITNESS WHEREOF, the Parties have caused this
Asset Purchase Agreement to be executed by their
respective duly authorized representatives as of the date first above written.
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SCHERING CORPORATION
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By: |
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Name: |
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Title: |
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-31-
EXHIBIT A
XXXX OF SALE AND ASSIGNMENT AND ASSUMPTION AGREEMENT
This XXXX OF SALE AND ASSIGNMENT AND ASSUMPTION AGREEMENT (this “
Assignment
Agreement”) is dated as of October 12, 2009 and is entered into by and between Schering
Corporation, a New Jersey corporation (“
Seller”); and
OPKO Health, Inc., a
Delaware corporation
(“
Purchaser”). Seller and Purchaser are sometimes referred to herein, individually, as a “
Party”
and, collectively, as the “
Parties.”
WHEREAS, Purchaser and Seller have entered into an
Asset Purchase Agreement dated as of
October 12, 2009 (the “
APA”); and
WHEREAS, pursuant to the APA, Seller agreed to sell the Purchased Assets, and Purchaser agreed
to purchase the Purchased Assets and to assume the Assumed Liabilities from Seller.
NOW THEREFORE, in consideration of the foregoing and for good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound hereby,
the Parties agree as follows:
1. Definitions. Unless otherwise defined herein, all capitalized terms used in this
Assignment Agreement shall have the meanings set forth in the APA.
2. Conveyance and Acceptance. In accordance with the provisions of the APA, Seller
hereby sells, conveys, transfers, assigns and delivers to Purchaser, and Purchaser hereby
purchases, takes delivery of and acquires from Seller, all of Seller’s right, title and interest in
and to the Purchased Assets.
3. Assumption of Assumed Liabilities. In accordance with the provisions of the APA,
Seller hereby assigns, delegates and transfers to Purchaser the Assumed Liabilities, and Purchaser
hereby assumes, accepts and agrees to pay, perform or otherwise discharge, in accordance with their
respective terms and subject to the respective conditions thereof, the Assumed Liabilities.
4. Miscellaneous.
(a) This Assignment Agreement shall be binding upon and inure to the benefit of the Parties
hereto and their respective successors and assigns.
(b) This Assignment Agreement (including any claim or controversy arising out of or relating
to this Assignment Agreement) shall be governed by the law of the State of
Delaware without regard
to conflict of law principles. The Parties hereto agree that any disputes which may arise out of
this Assignment Agreement which relate to any Party’s rights and/or obligations hereunder shall be
resolved in accordance with the provisions of Section 9.6 of the APA.
Exhibit A-1
(c) This Assignment Agreement may be amended or modified only by a written instrument executed
by all of the Parties.
(d) If any term, provision, covenant or restriction of this Assignment Agreement is held by a
court of competent jurisdiction or other authority to be invalid, void, unenforceable or against
its regulatory policy, such determination shall not affect the enforceability of any others or the
remainder of this Assignment Agreement.
(e) This Assignment Agreement may be executed manually or by facsimile by the Parties, in any
number of counterparts, each of which shall be considered one and the same agreement and shall
become effective when a counterpart hereof shall have been signed by each of the Parties and
delivered to the other Party.
IN WITNESS WHEREOF, the Parties have caused this Assignment Agreement to be executed by their
respective duly authorized representatives as of the date first above written.
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SCHERING CORPORATION
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By: |
/s/
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Name: |
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Title: |
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Exhibit A-2
EXHIBIT B
NK-1 DRUG SUBSTANCE
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SCH 619734 - Drug Substance |
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Approximate Total Quantity (kg) |
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Quantity (kg) |
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Lot # |
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Date Mfg |
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Retest |
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Expiry |
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Use |
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Comments |
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****
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****
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07-619734-TM-201
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14-****
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2-****
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2-****
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****
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produced via **** |
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****
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07-619734-TM-202
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14-****
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6-****
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6-****
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****
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produced via **** |
****
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****
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08-619734-TM-004
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26-****
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26-****
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TBD
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****
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produced via **** |
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****
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08-619734-TM-005
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2-****
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2-****
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TBD
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****
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produced via **** |
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****
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08-619734-TM-006
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10-****
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10-****
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TBD
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****
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produced via **** |
****
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****
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08-619734-TM001R
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22-****
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22-****
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TBD
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****
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produced via **** |
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****
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08-619734-TM-003
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20-****
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12-****
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TBD
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****
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produced via **** |
****
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****
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08-619734-TM-201
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6-****
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TBD
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****
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produced via **** |
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**** (various batches ****)
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****
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R05-031
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26-****
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TBD
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****
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**** |
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****
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SZ-04-619734-TX-002
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3-****
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3-****
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**** |
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****
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SZ-04-619734-TX-005
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6-****
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6-****
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**** |
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****
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SZ-04-619734-TX-005
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6-****
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6-****
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**** |
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****
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SZ-05-619734-TX-007
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23-****
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23-****
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****
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**** |
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****
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K-H08396
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28-****
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28-****
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**** |
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****
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W-H01586
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26-****
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**** |
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****
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W-H01607
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26-****
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**** |
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****
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08-619734-TM-002
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13-****
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**** |
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SCH 619734 - Drug Product |
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Approximate Total Quantity (kg) |
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Quantity (tablets) |
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Lot # |
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Date Mfg |
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Retest |
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Expiry |
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Use |
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Comments |
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**** mg placebos
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****
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K-370428 (PII)
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22-****
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31-****
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TBD
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**** purposes
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mfg for **** |
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****
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K-370429 (PII)
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22-****
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31-****
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TBD
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**** purposes
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mfg for **** |
**** mg tablets
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****
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K-370426 (PII)
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7-****
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30-****
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TBD
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**** purposes
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mfg for **** |
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****
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K-370427 (PII)
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7-****
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30-****
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TBD
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**** purposes
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mfg for **** |
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5- |
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**** mg tablets
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****
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W-H01553
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5-****
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****
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5-****
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****
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mfg for **** |
Exhibit B-1
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SCH 619734 - Intermediates |
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Total Quantity (kg) |
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Quantity (kg) |
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Lot # |
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Date Mfg |
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Retest |
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Expiry |
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Use |
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Comments |
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****
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****
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K-H08967
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03-****
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21-****
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TBD
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****
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****intermediate; **** |
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SCH 900978 - Reference Standards |
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Total Quantity (kg) |
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Quantity (kg) |
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Lot # |
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Date Mfg |
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Retest |
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Expiry |
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Use |
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Comments |
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****
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****
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**** |
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SCH 900978 - Drug Substance |
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Total Quantity (kg) |
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Quantity (kg) |
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Lot # |
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Date Mfg |
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Retest |
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Expiry |
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Use |
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Comments |
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****
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****
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07-900978-GX-102-R1
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12-****
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12-****
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12-****
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****
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produced via **** |
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****
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07-900978-GX-102-R1
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12-****
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12-****
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12-****
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****
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produced via **** |
****
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****
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07-900978-GX-103-R1
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14-****
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14-****
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14-****
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****
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produced via **** |
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****
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07-900978-GX-103-R1
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14-****
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14-****
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14-****
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****
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produced via **** |
****
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****
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07-900978-GX-104
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7-****
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7-****
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7-****
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****
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produced via **** |
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****
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07-900978-GX-104
|
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7-****
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7-****
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7-****
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****
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produced via **** |
****
|
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****
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07-900978-GX-101
|
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7-****
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7-****
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****
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produced via **** |
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SCH 900978 - Intermediates |
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Total Quantity (kg) |
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Quantity (kg) |
|
Lot # |
|
Date Mfg |
|
Retest |
|
Expiry |
|
Use |
|
Comments |
|
weight not listed
|
|
weight not listed
|
|
07-900978-F-004
|
|
|
|
|
|
|
|
|
|
SCH 900978-F |
****
|
|
****
|
|
07-900978-G-104R
|
|
|
|
|
|
|
|
|
|
****; SCH 900978-G |
|
|
****
|
|
07-900978-G-103-R1
|
|
|
|
|
|
|
|
|
|
****; SCH 900978-G |
|
|
|
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|
|
|
|
|
SCH 900978 - Starting Materials |
|
|
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|
|
|
|
|
|
|
|
|
Total Quantity (kg) |
|
Quantity (kg) |
|
Lot # |
|
Date Mfg |
|
Retest |
|
Expiry |
|
Use |
|
Comments |
|
****
|
|
****
|
|
070167D
|
|
|
|
29-****
|
|
|
|
****
|
|
SCH 900978-C |
****
|
|
****
|
|
070167E
|
|
|
|
29-****
|
|
|
|
****
|
|
SCH 900978-C |
****
|
|
****
|
|
071080A
|
|
|
|
4-****
|
|
|
|
****
|
|
SCH 900978-M |
****
|
|
****
|
|
070180B01
|
|
|
|
|
|
|
|
****
|
|
SCH 900978-M |
|
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|
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|
|
|
|
SCH 900978 - Reference Standards |
|
|
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|
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|
|
|
|
|
|
|
|
Total Quantity (kg) |
|
Quantity (kg) |
|
Lot # |
|
Date Mfg |
|
Retest |
|
Expiry |
|
Use |
|
Comments |
|
****
|
|
****
|
|
BJ-85296-33
|
|
|
|
****
|
|
|
|
|
|
900978-C Reference
|
****
|
|
****
|
|
BJ-83274-151
|
|
|
|
****
|
|
|
|
|
|
900978-M Reference ****
|
****
|
|
****
|
|
80340-76
|
|
|
|
|
|
2****
|
|
|
|
|
900978 |
|
In accordance with Section 7.11 of the Agreement, Seller shall retain the Hold Back API until its
obligations under Section 7.11 have been met in accordance with the terms thereof.
Exhibit B-2
EXHIBIT C
NK-1 PATENTS
|
|
|
|
|
|
|
|
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|
|
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|
|
|
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|
|
|
|
Case Number |
|
|
Country |
|
|
Status |
|
|
Appln Number |
|
|
Appln Date |
|
|
Patent Number |
|
|
Grant Date |
|
|
Exp Date |
|
|
6187 |
|
|
AR |
|
|
FILED |
|
|
P050102686 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
0000 |
|
|
XX |
|
|
FILED |
|
|
2005262330 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
BR |
|
|
FILED |
|
|
XX0000000-3 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
CA |
|
|
FILED |
|
|
2570197 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
CL |
|
|
FILED |
|
|
1643-2005 |
|
|
06/30/2005 |
|
|
|
|
|
|
|
|
|
|
|
0000 |
|
|
XX |
|
|
FILED |
|
|
200580028596.5 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
CO |
|
|
FILED |
|
|
06-128.357 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
EC |
|
|
FILED |
|
|
SP-06-7123 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
EP |
|
|
FILED |
|
|
05787862.1 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
HK |
|
|
FILED |
|
|
07107432.4 |
|
|
07/11/2007 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
IN |
|
|
FILED |
|
|
4817/CHENP/2006 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
ID |
|
|
FILED |
|
|
W00200603796 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
IL |
|
|
FILED |
|
|
180329 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
JP |
|
|
FILED |
|
|
2007-519458 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
KR |
|
|
FILED |
|
|
2006-7027877 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
MY |
|
|
FILED |
|
|
PI20052967 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
MX |
|
|
FILED |
|
|
MX/A/2007/000030 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
0000 |
|
|
XX |
|
|
FILED |
|
|
552059 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
NO |
|
|
FILED |
|
|
20070588 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
WO |
|
|
INACTIVE |
|
|
US2005/023427 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
0000 |
|
|
XX |
|
|
FILED |
|
|
764.2005 |
|
|
06/30/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
PH |
|
|
FILED |
|
|
0-0000-000000 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
RU |
|
|
FILED |
|
|
2007103611 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
0000 |
|
|
XX |
|
|
GRANTED |
|
|
2006/10666 |
|
|
06/29/2005 |
|
|
2006/10666 |
|
|
06/25/2008 |
|
|
06/29/2025 |
|
|
0000 |
|
|
XX |
|
|
FILED |
|
|
200608755-5 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
TW |
|
|
FILED |
|
|
094122193 |
|
|
06/30/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
TH |
|
|
FILED |
|
|
0501003040 |
|
|
06/30/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
US |
|
|
INACTIVE |
|
|
60/584502 |
|
|
07/01/2004 |
|
|
|
|
|
|
|
|
07/01/2005 |
|
|
6187 |
|
|
US |
|
|
FILED |
|
|
11/172289 |
|
|
06/30/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
VE |
|
|
FILED |
|
|
2005-001318 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
Exhibit C-1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case Number |
|
|
Status |
|
|
Appln Number |
|
|
Appln Date |
|
|
Patent No. |
|
|
Grant Date |
|
|
Exp Date |
|
|
CN01524K AL |
|
|
GRANTED |
|
|
1463716 |
|
|
12/17/2002 |
|
|
AL/P/2008/2601 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K AR |
|
|
FILED |
|
|
P020104877 |
|
|
12/16/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K AU |
|
|
GRANTED |
|
|
2002357264 |
|
|
12/17/2002 |
|
|
2002357264 |
|
|
12/07/2006 |
|
|
12/17/2022 |
|
|
CN01524K AT |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
E386023 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K BE |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K BR |
|
|
FILED |
|
|
PI0215158-8 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K BG |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K CA |
|
|
FILED |
|
|
2470476 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K CL |
|
|
FILED |
|
|
2884-2002 |
|
|
12/16/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K CN |
|
|
FILED |
|
|
02825561.5 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K CO |
|
|
FILED |
|
|
04054290 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K CY |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K CZ |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K DK |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K EC |
|
|
FILED |
|
|
04-5159 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K EP/PCT |
|
|
INACTIVE |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524KB EP |
|
|
FILED |
|
|
07118674.6 |
|
|
10/17/2007 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K EE |
|
|
GRANTED |
|
|
E002138 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K FI |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K FR |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K GB |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K DE |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
60225067.6 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K GR |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
3065365 |
|
|
02/13/2008 |
|
|
12/18/2022 |
|
|
CN01524K HK |
|
|
GRANTED |
|
|
04107784.1 |
|
|
10/09/2004 |
|
|
HK1065036 |
|
|
07/18/2008 |
|
|
12/17/2022 |
|
|
CN01524KB HK |
|
|
FILED |
|
|
08105913.5 |
|
|
05/27/2008 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K HU |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K HU |
|
|
FILED |
|
|
P0402679 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K IN |
|
|
GRANTED |
|
|
01329/CHENP/2004 |
|
|
12/17/2002 |
|
|
218814 |
|
|
04/16/2008 |
|
|
12/17/2022 |
|
|
CN01524K ID |
|
|
FILED |
|
|
W00200401295 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K IE |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K IL |
|
|
FILED |
|
|
162484 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K IT |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K JP |
|
|
FILED |
|
|
2003-552727 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K KR |
|
|
FILED |
|
|
2004-7009445 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K LV |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K LT |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K LU |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/18/2022 |
|
|
CN01524K MK |
|
|
GRANTED |
|
|
P-2008/65 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K MY |
|
|
GRANTED |
|
|
PI20024703 |
|
|
12/16/2002 |
|
|
MY-136697-A |
|
|
11/28/2008 |
|
|
12/16/2022 |
|
|
CN01524KB MY |
|
|
FILED |
|
|
PI20064327 |
|
|
10/13/2006 |
|
|
|
|
|
|
|
|
|
|
|
CN01524KB MX |
|
|
FILED |
|
|
MX/A/2007/009703 |
|
|
08/10/2007 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K MX |
|
|
GRANTED |
|
|
PA/a/2004/005910 |
|
|
12/17/2002 |
|
|
250638 |
|
|
10/22/2007 |
|
|
12/17/2022 |
|
|
CN01524K MC |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K NL |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
Exhibit C-2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case Number |
|
|
Status |
|
|
Appln Number |
|
|
Appln Date |
|
|
Patent No. |
|
|
Grant Date |
|
|
Exp Date |
|
|
CN01524K NZ |
|
|
GRANTED |
|
|
532975 |
|
|
12/17/2002 |
|
|
532975 |
|
|
06/07/2007 |
|
|
12/17/2022 |
|
|
CN01524KB NZ |
|
|
GRANTED |
|
|
551997 |
|
|
12/12/2006 |
|
|
551997 |
|
|
11/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K NO |
|
|
FILED |
|
|
20043041 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K WI |
|
|
INACTIVE |
|
|
US02/40203 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524KB PE |
|
|
FILED |
|
|
1006.2006 |
|
|
08/18/2006 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K PE |
|
|
GRANTED |
|
|
1200.2002 |
|
|
12/12/2002 |
|
|
4880 |
|
|
02/07/2008 |
|
|
12/12/2022 |
|
|
CN01524K PH |
|
|
FILED |
|
|
0-0000-000000 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K PL |
|
|
FILED |
|
|
P370841 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K PT |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K RO |
|
|
GRANTED |
|
|
1015273 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K RU |
|
|
GRANTED |
|
|
0000000000 |
|
|
12/17/2002 |
|
|
2326120 |
|
|
06/10/2008 |
|
|
12/17/2022 |
|
|
CN01524K ZA |
|
|
GRANTED |
|
|
2004/04583 |
|
|
12/17/2002 |
|
|
2004/4583 |
|
|
02/22/2006 |
|
|
12/17/2022 |
|
|
CN01524K CH |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K SG |
|
|
GRANTED |
|
|
200402928-6 |
|
|
12/17/2002 |
|
|
104238 |
|
|
07/31/2006 |
|
|
12/17/2022 |
|
|
CN01524KB SG |
|
|
FILED |
|
|
200604791-4 |
|
|
07/14/2006 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K SI |
|
|
GRANTED |
|
|
1463716 |
|
|
12/17/2002 |
|
|
P-200230671 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K SK |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K ES |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
2299637 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K SE |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K TW |
|
|
FILED |
|
|
091136267 |
|
|
12/16/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K TH |
|
|
FILED |
|
|
078807 |
|
|
12/16/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K TR |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K1 US |
|
|
GRANTED |
|
|
10/321687 |
|
|
12/17/2002 |
|
|
7049320 |
|
|
05/23/2006 |
|
|
12/08/2023 |
|
|
CN01524K1B US |
|
|
FILED |
|
|
11/358827 |
|
|
02/21/2006 |
|
|
|
|
|
|
|
|
|
|
|
CN01524P US |
|
|
INACTIVE |
|
|
60/341452 |
|
|
12/18/2001 |
|
|
|
|
|
|
|
|
12/18/2002 |
|
|
CN01524K VE |
|
|
FILED |
|
|
2002-02437 |
|
|
12/13/2002 |
|
|
|
|
|
|
|
|
|
|
|
PC1524/TA |
|
|
DOCKETED |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exhibit C-3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case Number |
|
|
Country |
|
|
Status |
|
|
Appln Number |
|
|
Appln Date |
|
|
Patent No. |
|
|
Grant Date |
|
|
Exp Date |
|
|
6453 |
|
|
AR |
|
|
FILED |
|
|
P070101438 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
CA |
|
|
FILED |
|
|
2648604 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
CL |
|
|
FILED |
|
|
2007-946 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
CN |
|
|
FILED |
|
|
200780015817.4 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
EP |
|
|
FILED |
|
|
07774640.2 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
HK |
|
|
DOCKETED |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
JP |
|
|
FILED |
|
|
2009-504269 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
MX |
|
|
FILED |
|
|
MX/a/2008/012935 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
WO |
|
|
INACTIVE |
|
|
US2007/008344 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
0000 |
|
|
XX |
|
|
FILED |
|
|
413.2007 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
0000 |
|
|
XX |
|
|
FILED |
|
|
2008/08464 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
0000 |
|
|
XX |
|
|
FILED |
|
|
200807320-7 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
TW |
|
|
FILED |
|
|
096112166 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
TH |
|
|
FILED |
|
|
0701001645 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
US |
|
|
INACTIVE |
|
|
60/789280 |
|
|
04/05/2006 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
US |
|
|
FILED |
|
|
11/732548 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
VE |
|
|
FILED |
|
|
2007-000685 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
Exhibit C-4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case Number |
|
|
Status |
|
|
Appn Number |
|
|
Appln Date |
|
|
Patent No. |
|
|
Grant Date |
|
|
Exp Date |
|
|
6458 AR |
|
|
FILED |
|
|
P070101440 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
0000 XX |
|
|
FILED |
|
|
2007233389 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 BR |
|
|
FILED |
|
|
PI0710577-0 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 CA |
|
|
FILED |
|
|
2648640 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 CL |
|
|
FILED |
|
|
2007-945 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 CN |
|
|
FILED |
|
|
200780020640.7 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 CO |
|
|
FILED |
|
|
08-105.792 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 EP |
|
|
FILED |
|
|
07774641.0 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 HK |
|
|
DOCKETED |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6458 IN |
|
|
FILED |
|
|
5300/CHENP/2008 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 ID |
|
|
FILED |
|
|
W00200803268 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 JP |
|
|
FILED |
|
|
2009-504270 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 KR |
|
|
FILED |
|
|
2008-7026488 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 MX |
|
|
FILED |
|
|
MX/a/2008/012936 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
0000 XX |
|
|
FILED |
|
|
571693 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 NO |
|
|
FILED |
|
|
20084660 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 WO |
|
|
INACTIVE |
|
|
US2007/008345 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
0000 XX |
|
|
FILED |
|
|
412.2007 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 PH |
|
|
FILED |
|
|
0-0000-000000 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
0000 XX |
|
|
FILED |
|
|
2008/08465 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
0000 XX |
|
|
FILED |
|
|
200807321-5 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 TW |
|
|
FILED |
|
|
096112177 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 TH |
|
|
FILED |
|
|
0701001644 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 US |
|
|
GRANTED |
|
|
11/732663 |
|
|
04/04/2007 |
|
|
7563801 |
|
|
07/21/2009 |
|
|
04/04/2027 |
|
|
6458 US |
|
|
FILED |
|
|
12/487263 |
|
|
06/18/2009 |
|
|
|
|
|
|
|
|
|
|
|
6458 US |
|
|
INACTIVE |
|
|
60/789514 |
|
|
04/05/2006 |
|
|
|
|
|
|
|
|
04/05/2007 |
|
|
6458 VE |
|
|
FILED |
|
|
2007-000684 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
Exhibit C-5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Next Tax |
|
|
Publication |
|
|
Publication |
|
|
No. |
|
|
Country |
|
|
Status |
|
|
Appln No. |
|
|
Appln Date |
|
|
Date |
|
|
Date |
|
|
No. |
|
|
6459 |
|
|
AR |
|
|
Inactive |
|
|
P070101435 |
|
|
04/04/2007 |
|
|
|
|
|
06/11/2008 |
|
|
AR060352A1 |
|
|
6459 |
|
|
CL |
|
|
Inactive |
|
|
2007-947 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6459 |
|
|
WO |
|
|
Inactive |
|
|
US2007-008346 |
|
|
04/04/2007 |
|
|
|
|
|
10/11/2007 |
|
|
WO07/114922 |
|
|
0000 |
|
|
XX |
|
|
Inactive |
|
|
415.2007 |
|
|
04/04/2007 |
|
|
04/30/2010 |
|
|
|
|
|
|
|
|
6459 |
|
|
TW |
|
|
Inactive |
|
|
096112181 |
|
|
04/04/2007 |
|
|
|
|
|
02/01/2008 |
|
|
200806666 |
|
|
0000 |
|
|
XX |
|
|
Inactive |
|
|
0701001643 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6459 |
|
|
US |
|
|
Expired Prov. |
|
|
60/789513 |
|
|
04/05/2006 |
|
|
|
|
|
|
|
|
|
|
|
6459 |
|
|
VE |
|
|
Inactive |
|
|
2007-000683 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
Exhibit C-6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case Number |
|
|
Status |
|
|
Appln Number |
|
|
Appln Date |
|
|
Patent Number |
|
|
Grant Date |
|
|
Exp Date |
|
|
6627 AR |
|
|
FILED |
|
|
P080101153 |
|
|
03/19/2008 |
|
|
|
|
|
|
|
|
|
|
|
6627 CL |
|
|
FILED |
|
|
0819-2008 |
|
|
03/20/2008 |
|
|
|
|
|
|
|
|
|
|
|
6627 PK |
|
|
FILED |
|
|
304/2008 |
|
|
03/20/2008 |
|
|
|
|
|
|
|
|
|
|
|
6627 WO |
|
|
FILED |
|
|
US2008/003653 |
|
|
03/20/2008 |
|
|
|
|
|
|
|
|
|
|
|
0000 XX |
|
|
FILED |
|
|
515.2008 |
|
|
03/19/2008 |
|
|
|
|
|
|
|
|
|
|
|
6627 TW |
|
|
FILED |
|
|
097109944 |
|
|
03/20/2008 |
|
|
|
|
|
|
|
|
|
|
|
6627 TH |
|
|
FILED |
|
|
0801001384 |
|
|
03/20/2008 |
|
|
|
|
|
|
|
|
|
|
|
6627 US |
|
|
INACTIVE |
|
|
60/919501 |
|
|
03/22/2007 |
|
|
|
|
|
|
|
|
03/22/2008 |
|
|
6627 VE |
|
|
FILED |
|
|
00543 |
|
|
03/19/2008 |
|
|
|
|
|
|
|
|
|
|
|
Case Number |
|
|
Status |
|
|
Appln Number |
|
|
Appln Date |
|
|
Patent Number |
|
|
Grant Date |
|
|
Exp Date |
|
|
6628 AR |
|
|
FILED |
|
|
P080101154 |
|
|
03/19/2008 |
|
|
|
|
|
|
|
|
|
|
|
6628 WO |
|
|
FILED |
|
|
US2008/003640 |
|
|
03/20/2008 |
|
|
|
|
|
|
|
|
|
|
|
6628 US |
|
|
INACTIVE |
|
|
60/919666 |
|
|
03/22/2007 |
|
|
|
|
|
|
|
|
03/22/2008 |
|
|
Case Number |
|
|
Status |
|
|
Appln Number |
|
|
Appln Date |
|
|
Patent Number |
|
|
Grant Date |
|
|
Exp Date |
|
|
6840 US |
|
|
FILED |
|
|
61/094474 |
|
|
09/05/2008 |
|
|
|
|
|
|
|
|
09/05/2009 |
|
|
Case Number |
|
|
Status |
|
|
Appln Number |
|
|
Appln Date |
|
|
Patent Number |
|
|
Grant Date |
|
|
Exp Date |
|
|
**** |
|
|
**** |
|
|
**** |
|
|
**** |
|
|
|
|
|
|
|
|
|
|
|
Exhibit C-7
Exhibit D
Form of Recordation Document
Short-Form Patent Assignment
Schering Corporation, a New Jersey corporation having a business address at 0000
Xxxxxxxxx Xxxx Xxxx, Xxxxxxxxxx, Xxx Xxxxxx 00000 (“ASSIGNOR”) was heretofore the owner of the
entire right, title and interest in the patent applications referred to in Annex 1 to this
Short-Form Patent Assignment (“Assigned Families”).
By prior assignment pursuant to that certain
Asset Purchase Agreement executed between
ASSIGNOR and
OPKO Health, Inc., a
Delaware corporation having a business address at 0000 Xxxxxxxx
Xxxxxxxxx, Xxxxx 0000, Xxxxx, Xxxxxxx 00000 (“OPKO”) effective October 12, 2009, ASSIGNOR
transferred, assigned and conveyed to OPKO, the entire right, title, and interest in and to the
Assigned Families and Letters Patent that may be issued on any of the Assigned Families in the
United States, Australia, Canada, Japan, the countries in the European Patent Organisation, and
everywhere else in the world.
NOW, THEREFORE, ASSIGNOR hereby acknowledges that, in consideration of the foregoing and the
good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, set
forth in such Assignment and License Agreement, ASSIGNOR has heretofore transferred, assigned and
conveyed to OPKO all right, title and interest in and to the Assigned Families and Letters Patent
that may be issued on any of the Assigned Families in the United States, Australia, Canada, Japan,
the countries in the European Patent Organisation, and everywhere else in the world.
ASSIGNOR authorizes and requests the Commissioner of Patents and Trademarks of the United
States and of Australia, Canada, Japan, the countries in the European Patent Organisation, and
anywhere else in the world to issue any Letters Patent granted on the Assigned Families, whether on
any subsequently filed division, continuation, continuation-in-part, reexamination, or reissue
application, to OPKO, its successors and assigns, as the assignee of the entire interest in the
Assigned Families.
Exhibit D-1
IN TESTIMONY WHEREOF, the undersigned has executed this instrument on the day of
2009.
|
|
|
|
|
SCHERING CORPORATION
|
|
By: |
|
|
|
Name: |
|
|
|
Title: |
|
|
|
On before me,
,
personally appeared
o personally known to me — OR- o proved to me on the basis of satisfactory
evidence to be the person whose name is subscribed to the within instrument and
acknowledged to me that he executed the same in his authorized capacity, and that by his
signature on the instrument the person, or the entity upon behalf of which the person
acted, executed the instrument.
|
|
|
|
|
|
WITNESS my hand and official seal.
|
|
|
|
Signature of Notary |
|
|
|
|
|
Exhibit D-2
ANNEX 1 TO SHORT-FORM PATENT ASSIGNMENT
|
|
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|
|
Case No. |
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|
Country |
|
|
Status |
|
|
Appln Number |
|
|
Appln Date |
|
|
Patent No. |
|
|
Grant Date |
|
|
Exp Date |
|
|
6187 |
|
|
AR |
|
|
FILED |
|
|
P050102686 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
0000 |
|
|
XX |
|
|
FILED |
|
|
2005262330 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
BR |
|
|
FILED |
|
|
XX0000000-3 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
CA |
|
|
FILED |
|
|
2570197 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
CL |
|
|
FILED |
|
|
1643-2005 |
|
|
06/30/2005 |
|
|
|
|
|
|
|
|
|
|
|
0000 |
|
|
XX |
|
|
FILED |
|
|
200580028596.5 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
CO |
|
|
FILED |
|
|
06-128.357 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
EC |
|
|
FILED |
|
|
SP-06-7123 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
EP |
|
|
FILED |
|
|
05787862.1 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
HK |
|
|
FILED |
|
|
07107432.4 |
|
|
07/11/2007 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
IN |
|
|
FILED |
|
|
4817/CHENP/2006 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
ID |
|
|
FILED |
|
|
W00200603796 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
IL |
|
|
FILED |
|
|
180329 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
JP |
|
|
FILED |
|
|
2007-519458 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
KR |
|
|
FILED |
|
|
2006-7027877 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
MY |
|
|
FILED |
|
|
PI20052967 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
MX |
|
|
FILED |
|
|
MX/A/2007/000030 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
0000 |
|
|
XX |
|
|
FILED |
|
|
552059 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
NO |
|
|
FILED |
|
|
20070588 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
WO |
|
|
INACTIVE |
|
|
US2005/023427 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
0000 |
|
|
XX |
|
|
FILED |
|
|
764.2005 |
|
|
06/30/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
PH |
|
|
FILED |
|
|
0-0000-000000 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
RU |
|
|
FILED |
|
|
2007103611 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
0000 |
|
|
XX |
|
|
GRANTED |
|
|
2006/10666 |
|
|
06/29/2005 |
|
|
2006/10666 |
|
|
06/25/2008 |
|
|
06/29/2025 |
|
|
0000 |
|
|
XX |
|
|
FILED |
|
|
200608755-5 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
TW |
|
|
FILED |
|
|
094122193 |
|
|
06/30/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
TH |
|
|
FILED |
|
|
0501003040 |
|
|
06/30/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
US |
|
|
INACTIVE |
|
|
60/584502 |
|
|
07/01/2004 |
|
|
|
|
|
|
|
|
07/01/2005 |
|
|
6187 |
|
|
US |
|
|
FILED |
|
|
11/172289 |
|
|
06/30/2005 |
|
|
|
|
|
|
|
|
|
|
|
6187 |
|
|
VE |
|
|
FILED |
|
|
2005-001318 |
|
|
06/29/2005 |
|
|
|
|
|
|
|
|
|
|
|
Exhibit D-3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case Number |
|
|
Status |
|
|
Appln Number |
|
|
Appln Date |
|
|
Patent No. |
|
|
Grant Date |
|
|
Exp Date |
|
|
CN01524K AL |
|
|
GRANTED |
|
|
1463716 |
|
|
12/17/2002 |
|
|
AL/P/2008/2601 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K AR |
|
|
FILED |
|
|
P020104877 |
|
|
12/16/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K AU |
|
|
GRANTED |
|
|
2002357264 |
|
|
12/17/2002 |
|
|
2002357264 |
|
|
12/07/2006 |
|
|
12/17/2022 |
|
|
CN01524K AT |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
E386023 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K BE |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K BR |
|
|
FILED |
|
|
PI0215158-8 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K BG |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K CA |
|
|
FILED |
|
|
2470476 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K CL |
|
|
FILED |
|
|
2884-2002 |
|
|
12/16/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K CN |
|
|
FILED |
|
|
02825561.5 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K CO |
|
|
FILED |
|
|
04054290 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K CY |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K CZ |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K DK |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K EC |
|
|
FILED |
|
|
04-5159 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K EP/PCT |
|
|
INACTIVE |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524KB EP |
|
|
FILED |
|
|
07118674.6 |
|
|
10/17/2007 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K EE |
|
|
GRANTED |
|
|
E002138 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K FI |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K FR |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K GB |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K DE |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
60225067.6 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K GR |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
3065365 |
|
|
02/13/2008 |
|
|
12/18/2022 |
|
|
CN01524K HK |
|
|
GRANTED |
|
|
04107784.1 |
|
|
10/09/2004 |
|
|
HK1065036 |
|
|
07/18/2008 |
|
|
12/17/2022 |
|
|
CN01524KB HK |
|
|
FILED |
|
|
08105913.5 |
|
|
05/27/2008 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K HU |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K HU |
|
|
FILED |
|
|
P0402679 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K IN |
|
|
GRANTED |
|
|
01329/CHENP/2004 |
|
|
12/17/2002 |
|
|
218814 |
|
|
04/16/2008 |
|
|
12/17/2022 |
|
|
CN01524K ID |
|
|
FILED |
|
|
W00200401295 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K IE |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K IL |
|
|
FILED |
|
|
162484 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K IT |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K JP |
|
|
FILED |
|
|
2003-552727 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K KR |
|
|
FILED |
|
|
2004-7009445 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K LV |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K LT |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K LU |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/18/2022 |
|
|
CN01524K MK |
|
|
GRANTED |
|
|
P-2008/65 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K MY |
|
|
GRANTED |
|
|
PI20024703 |
|
|
12/16/2002 |
|
|
MY-136697-A |
|
|
11/28/2008 |
|
|
12/16/2022 |
|
|
CN01524KB MY |
|
|
FILED |
|
|
PI20064327 |
|
|
10/13/2006 |
|
|
|
|
|
|
|
|
|
|
|
CN01524KB MX |
|
|
FILED |
|
|
MX/A/2007/009703 |
|
|
08/10/2007 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K MX |
|
|
GRANTED |
|
|
PA/a/2004/005910 |
|
|
12/17/2002 |
|
|
250638 |
|
|
10/22/2007 |
|
|
12/17/2022 |
|
|
CN01524K MC |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K NL |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
Exhibit D-4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case Number |
|
|
Status |
|
|
Appln Number |
|
|
Appln Date |
|
|
Patent No. |
|
|
Grant Date |
|
|
Exp Date |
|
|
CN01524K NZ |
|
|
GRANTED |
|
|
532975 |
|
|
12/17/2002 |
|
|
532975 |
|
|
06/07/2007 |
|
|
12/17/2022 |
|
|
CN01524KB NZ |
|
|
GRANTED |
|
|
551997 |
|
|
12/12/2006 |
|
|
551997 |
|
|
11/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K NO |
|
|
FILED |
|
|
20043041 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K WI |
|
|
INACTIVE |
|
|
US02/40203 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524KB PE |
|
|
FILED |
|
|
1006.2006 |
|
|
08/18/2006 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K PE |
|
|
GRANTED |
|
|
1200.2002 |
|
|
12/12/2002 |
|
|
4880 |
|
|
02/07/2008 |
|
|
12/12/2022 |
|
|
CN01524K PH |
|
|
FILED |
|
|
0-0000-000000 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K PL |
|
|
FILED |
|
|
P370841 |
|
|
12/17/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K PT |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K RO |
|
|
GRANTED |
|
|
1015273 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K RU |
|
|
GRANTED |
|
|
0000000000 |
|
|
12/17/2002 |
|
|
2326120 |
|
|
06/10/2008 |
|
|
12/17/2022 |
|
|
CN01524K ZA |
|
|
GRANTED |
|
|
2004/04583 |
|
|
12/17/2002 |
|
|
2004/4583 |
|
|
02/22/2006 |
|
|
12/17/2022 |
|
|
CN01524K CH |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K SG |
|
|
GRANTED |
|
|
200402928-6 |
|
|
12/17/2002 |
|
|
104238 |
|
|
07/31/2006 |
|
|
12/17/2022 |
|
|
CN01524KB SG |
|
|
FILED |
|
|
200604791-4 |
|
|
07/14/2006 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K SI |
|
|
GRANTED |
|
|
1463716 |
|
|
12/17/2002 |
|
|
P-200230671 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K SK |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K ES |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
2299637 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K SE |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K TW |
|
|
FILED |
|
|
091136267 |
|
|
12/16/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K TH |
|
|
FILED |
|
|
078807 |
|
|
12/16/2002 |
|
|
|
|
|
|
|
|
|
|
|
CN01524K TR |
|
|
GRANTED |
|
|
02805167.0 |
|
|
12/17/2002 |
|
|
1463716 |
|
|
02/13/2008 |
|
|
12/17/2022 |
|
|
CN01524K1 US |
|
|
GRANTED |
|
|
10/321687 |
|
|
12/17/2002 |
|
|
7049320 |
|
|
05/23/2006 |
|
|
12/08/2023 |
|
|
CN01524K1B US |
|
|
FILED |
|
|
11/358827 |
|
|
02/21/2006 |
|
|
|
|
|
|
|
|
|
|
|
CN01524P US |
|
|
INACTIVE |
|
|
60/341452 |
|
|
12/18/2001 |
|
|
|
|
|
|
|
|
12/18/2002 |
|
|
CN01524K VE |
|
|
FILED |
|
|
2002-02437 |
|
|
12/13/2002 |
|
|
|
|
|
|
|
|
|
|
|
PC1524/TA |
|
|
DOCKETED |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exhibit D-5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case Number |
|
|
Country |
|
|
Status |
|
|
Appln Number |
|
|
Appln Date |
|
|
Patent No. |
|
|
Grant Date |
|
|
Exp Date |
|
|
6453 |
|
|
AR |
|
|
FILED |
|
|
P070101438 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
CA |
|
|
FILED |
|
|
2648604 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
CL |
|
|
FILED |
|
|
2007-946 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
CN |
|
|
FILED |
|
|
200780015817.4 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
EP |
|
|
FILED |
|
|
07774640.2 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
HK |
|
|
DOCKETED |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
JP |
|
|
FILED |
|
|
2009-504269 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
MX |
|
|
FILED |
|
|
MX/a/2008/012935 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
WO |
|
|
INACTIVE |
|
|
US2007/008344 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
0000 |
|
|
XX |
|
|
FILED |
|
|
413.2007 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
0000 |
|
|
XX |
|
|
FILED |
|
|
2008/08464 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
0000 |
|
|
XX |
|
|
FILED |
|
|
200807320-7 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
TW |
|
|
FILED |
|
|
096112166 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
TH |
|
|
FILED |
|
|
0701001645 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
US |
|
|
INACTIVE |
|
|
60/789280 |
|
|
04/05/2006 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
US |
|
|
FILED |
|
|
11/732548 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6453 |
|
|
VE |
|
|
FILED |
|
|
2007-000685 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
Exhibit D-6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case Number |
|
|
Status |
|
|
Appn Number |
|
|
Appln Date |
|
|
Patent No. |
|
|
Grant Date |
|
|
Exp Date |
|
|
6458 AR |
|
|
FILED |
|
|
P070101440 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
0000 XX |
|
|
FILED |
|
|
2007233389 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 BR |
|
|
FILED |
|
|
PI0710577-0 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 CA |
|
|
FILED |
|
|
2648640 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 CL |
|
|
FILED |
|
|
2007-945 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 CN |
|
|
FILED |
|
|
200780020640.7 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 CO |
|
|
FILED |
|
|
08-105.792 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 EP |
|
|
FILED |
|
|
07774641.0 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 HK |
|
|
DOCKETED |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6458 IN |
|
|
FILED |
|
|
5300/CHENP/2008 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 ID |
|
|
FILED |
|
|
W00200803268 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 JP |
|
|
FILED |
|
|
2009-504270 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 KR |
|
|
FILED |
|
|
2008-7026488 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 MX |
|
|
FILED |
|
|
MX/a/2008/012936 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
0000 XX |
|
|
FILED |
|
|
571693 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 NO |
|
|
FILED |
|
|
20084660 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 WO |
|
|
INACTIVE |
|
|
US2007/008345 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
0000 XX |
|
|
FILED |
|
|
412.2007 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 PH |
|
|
FILED |
|
|
0-0000-000000 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
0000 XX |
|
|
FILED |
|
|
2008/08465 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
0000 XX |
|
|
FILED |
|
|
200807321-5 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 TW |
|
|
FILED |
|
|
096112177 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 TH |
|
|
FILED |
|
|
0701001644 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
6458 US |
|
|
GRANTED |
|
|
11/732663 |
|
|
04/04/2007 |
|
|
7563801 |
|
|
07/21/2009 |
|
|
04/04/2027 |
|
|
6458 US |
|
|
FILED |
|
|
12/487263 |
|
|
06/18/2009 |
|
|
|
|
|
|
|
|
|
|
|
6458 US |
|
|
INACTIVE |
|
|
60/789514 |
|
|
04/05/2006 |
|
|
|
|
|
|
|
|
04/05/2007 |
|
|
6458 VE |
|
|
FILED |
|
|
2007-000684 |
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
Exhibit D-7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Next Tax |
|
|
Publication |
|
|
Publication |
|
|
No. |
|
|
Country |
|
|
Status |
|
|
Appln No. |
|
|
Appln Date |
|
|
Date |
|
|
Date |
|
|
No. |
|
|
|
6459 |
|
|
|
AR
|
|
|
Inactive
|
|
|
P070101435
|
|
|
04/04/2007
|
|
|
|
|
|
06/11/2008
|
|
|
AR060352A1
|
|
|
|
6459 |
|
|
|
CL
|
|
|
Inactive
|
|
|
2007-947
|
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6459 |
|
|
|
WO
|
|
|
Inactive
|
|
|
US2007-008346
|
|
|
04/04/2007
|
|
|
|
|
|
10/11/2007
|
|
|
WO07/114922
|
|
|
|
0000 |
|
|
|
XX
|
|
|
Inactive
|
|
|
415.2007
|
|
|
04/04/2007
|
|
|
04/30/2010 |
|
|
|
|
|
|
|
|
|
|
|
6459 |
|
|
|
TW
|
|
|
Inactive
|
|
|
096112181
|
|
|
04/04/2007
|
|
|
|
|
|
02/01/2008
|
|
|
|
200806666 |
|
|
|
|
0000 |
|
|
|
XX
|
|
|
Inactive
|
|
|
0701001643
|
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6459 |
|
|
|
US
|
|
|
Expired Prov.
|
|
|
60/789513
|
|
|
04/05/2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6459 |
|
|
|
VE
|
|
|
Inactive
|
|
|
2007-000683
|
|
|
04/04/2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Exhibit D-8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case Number |
|
|
Status |
|
|
Appln Number |
|
|
Appln Date |
|
|
Patent Number |
|
|
Grant Date |
|
|
Exp Date |
|
|
6627 AR |
|
|
FILED |
|
|
P080101153 |
|
|
03/19/2008 |
|
|
|
|
|
|
|
|
|
|
|
6627 CL |
|
|
FILED |
|
|
0819-2008 |
|
|
03/20/2008 |
|
|
|
|
|
|
|
|
|
|
|
6627 PK |
|
|
FILED |
|
|
304/2008 |
|
|
03/20/2008 |
|
|
|
|
|
|
|
|
|
|
|
6627 WO |
|
|
FILED |
|
|
US2008/003653 |
|
|
03/20/2008 |
|
|
|
|
|
|
|
|
|
|
|
0000 XX |
|
|
FILED |
|
|
515.2008 |
|
|
03/19/2008 |
|
|
|
|
|
|
|
|
|
|
|
6627 TW |
|
|
FILED |
|
|
097109944 |
|
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03/20/2008 |
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|
|
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6627 TH |
|
|
FILED |
|
|
0801001384 |
|
|
03/20/2008 |
|
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|
|
|
|
|
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|
6627 US |
|
|
INACTIVE |
|
|
60/919501 |
|
|
03/22/2007 |
|
|
|
|
|
|
|
|
03/22/2008 |
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6627 VE |
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FILED |
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00543 |
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|
03/19/2008 |
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Case Number |
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Status |
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Appln Number |
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Appln Date |
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Patent Number |
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Grant Date |
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Exp Date |
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6628 AR |
|
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FILED |
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|
P080101154 |
|
|
03/19/2008 |
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6628 WO |
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FILED |
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US2008/003640 |
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|
03/20/2008 |
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6628 US |
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|
INACTIVE |
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60/919666 |
|
|
03/22/2007 |
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|
03/22/2008 |
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Case Number |
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|
Status |
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|
Appln Number |
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|
Appln Date |
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|
Patent Number |
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Grant Date |
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Exp Date |
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6840 US |
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FILED |
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61/094474 |
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09/05/2008 |
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09/05/2009 |
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Case Number |
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Status |
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Appln Number |
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Appln Date |
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Patent Number |
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Grant Date |
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Exp Date |
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**** |
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**** |
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**** |
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**** |
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Exhibit D-9
SCHEDULE 2.5
TECHNICAL TRANSFER SERVICES
Seller shall conduct a technology transfer to Purchaser of all NK-1 Know How, the applicable
Retained Information, and all other technical information and support embodied therein reasonably
necessary to enable Purchaser to assume responsibility for the development, testing and manufacture
of the NK-1 Compounds (the “Technical Transfer Services”) and shall otherwise provide ongoing
assistance to Purchaser as described in Section 2.5 hereof. Seller shall provide such services to
Purchaser (and/or Purchaser’s designee), including the services
set forth below, at **** expense, during the
period commencing on the Closing Date and continuing until the ****
or ****, whichever is ****. Upon the **** year anniversary of the Closing Date
or the date by which Seller has fully transferred to Purchaser the Purchased Assets, ****, the
Technical Team shall be disbanded and for **** thereafter, Seller shall make former Technical Team
members (or currently employed personnel comparably knowledgeable in the relevant functional areas)
available to Purchaser to respond to Purchaser’s questions about the Purchased Assets, NK-1
Know-How, Retained Information or Retained Intellectual Property. The Parties’ representatives
comprising the Technical Team shall have the ability to mutually agree to modify in writing the
schedule and mechanism for transfer outlined below as reasonably required and in the event the
Parties deem it in their mutual interest. Seller shall inform the FTC of such modifications to
such schedule and mechanism for transfer in the compliance reports Seller is required to submit
under the terms of the Consent Order, provided, however, if any such modification impacts Seller’s
obligations under the Consent Order, Seller shall notify the FTC of such modification as soon as
practicable.
|
1. |
|
The reasonable assistance of Seller’s then current employees and reasonable
access to its other internal resources to provide Purchaser (and/or Purchaser’s
designee) with a reasonable level of technical assistance and consultation in
connection with the transfer of the NK-1 Program to Purchaser, including the provision
and explanation, on request, to Purchaser and its Affiliates of all technology,
materials, reports, data, documents and materials describing or embodying the Purchased
Assets. |
|
|
2. |
|
Provision and explanation to Purchaser (and/or Purchaser’s designee), of all
production outlines, standard testing requirements, standard operating procedures,
technology, documents, data, or other information that constitutes the NK-1 Know How. |
|
|
3. |
|
Development and implementation of a technology transfer protocol for the
transfer of the manufacturing process (including in-process methods) and formulation
process for API and formulated drug substance for the NK-1 Compounds to Purchaser
and/or its designees. |
|
|
4. |
|
Transfer clinical drug assay methodologies and know-how for the NK-1 Compounds,
including parent and metabolites, to Purchaser and/or its designees. |
Schedule 2.5-1
|
5. |
|
Seller and Purchaser shall establish a prompt communication and interaction
process to ensure the orderly transfer of all Regulatory Filings
as promptly as practicable following Closing. Within **** following
Closing, or as otherwise agreed by the Parties, the Parties shall file with
the FDA and any other applicable Governmental Authority, such information as
may be required to transfer the Regulatory Filings from Seller to Purchaser.
Both Seller and Purchaser agree to use commercially reasonable efforts to
take any actions required by the FDA or other applicable Governmental
Authority to affect the transfer of the Regulatory Filings to Purchaser. |
|
|
6. |
|
Seller shall cooperate, and cause its officers, employees, agents, contractors,
and others under its direction or control, to cooperate with Purchaser in (a) filing or
prosecuting any patent applications included in the NK-1 Patents or maintaining any
patents included in the NK-1 Patents, (b) executing any further legal documents,
including any further assignments, such as individual assignments for recordation in
any U.S. or foreign offices or agencies, to evidence the assignment of the applicable
NK-1 Patents, and (c) performing all reasonable acts that may be necessary to complete
the assignment of Seller’s interest in and to the NK-1 Patents |
Schedule 2.5-2
SP Technical Transfer Team
|
|
|
|
|
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Functional Area Represented |
|
|
Role |
|
|
SP Team Chair
|
|
|
Lead SP’s efforts and address
commercial/marketing |
|
|
Regulatory
|
|
|
Implement transfer of the INDs |
|
|
Clinical Research — XXXX
|
|
|
Xxxxxxx xxxxx 0 XXXX study |
|
|
Clinical Research — PONV
|
|
|
Address phase 2 PONV study |
|
|
Toxicology
|
|
|
Address preclinical toxicology |
|
|
Chemistry, Manufacturing, and Controls
|
|
|
Oversee CMC efforts and activities |
|
|
Early Clinical Research and Experimental Medicine
|
|
|
Address phase 1, drug metabolism,
pharmacology, and pharmacokinetic
studies |
|
|
IT
|
|
|
Information transfer |
|
|
Patents
|
|
|
Oversee transfer of NK-1 patent estate |
|
|
OPKO Technical Transfer Team
|
|
|
|
|
|
|
|
Functional Area Represented |
|
|
Role |
|
|
OPKO Team Chair ****
|
|
|
Lead OPKO’s efforts |
|
|
Regulatory
|
|
|
Receipt of IND and other regulatory docs |
|
|
Clinical Research
|
|
|
Lead Clinical Program |
|
|
Chemistry, Manufacturing, and Controls
|
|
|
Oversee OPKO CMC efforts and activities |
|
|
PreClinical Research
|
|
|
Oversee PreClinical research activities |
|
|
IT
|
|
|
Oversee information transfer |
|
|
Patents
|
|
|
Oversee patent portfolio |
|
|
Schedule 2.5-3
|
|
|
|
|
Function |
|
Service to be Provided by Sellers |
|
Comments |
Technical Operations
|
|
Seller shall provide the
reasonable assistance of Seller’s
then current employees and
reasonable access to its other
internal resources to provide
Purchaser (and/or Purchaser’s
designee) with a reasonable level
of technical assistance and
consultation in connection with
the transfer of the NK-1 Program
to Purchaser, including the
provision and explanation, on
request, to Purchaser and its
Affiliates of all technology,
electronic files, materials,
reports, data, documents and
materials describing or embodying
the Purchased Assets. |
|
|
|
|
|
|
|
|
|
Purchaser will be given the
reasonable opportunity to meet
with, and receive assistance and
services of, the Seller’s
knowledgeable personnel in
connection with Purchaser gaining
competent knowledge of the
contents of the Purchased Assets,
NK-1 Know-How, Retained
Information and Retained
Intellectual Property and Seller’s
conduct of its NK-1 Program,
including meeting with: |
|
|
|
|
|
|
|
|
|
- manufacturing personnel to
discuss all facets of the
manufacture of the NK-1 Compounds |
|
|
|
|
|
|
|
|
|
- regulatory personnel to discuss
regulatory files and
correspondence with regulatory
authorities |
|
|
|
|
|
|
|
|
|
-Formulation research and
development personnel to discuss
specifically the ****. |
|
|
|
|
|
|
|
|
|
- Nonclinical (GLP) research
personnel, specifically study
directors or their managers, to
discuss ****. |
|
|
|
|
|
|
|
|
|
- Clinical research and
development personnel to discuss
past and current research and
development efforts specific for
the NK-1 Compounds |
|
|
|
|
|
|
|
|
|
-Drug Metabolism personnel to
assist as required in the transfer
of the ****. |
|
|
|
|
|
|
|
|
|
-Quality Assurance personnel to
review and/or provide relevant
information particularly audit
reports related to this project to
ensure all studies were conducted
in accordance with GLP, GMP & GCP. |
|
|
|
|
|
|
|
|
|
-IT personnel to discuss format,
systems utilized and transfer of
non-clinical, clinical and CMC
data. |
|
|
|
|
|
|
|
|
|
Seller will provide list
consistent with language of FTC
order. |
|
|
|
|
|
|
|
|
|
(Note: all such meetings and
communication will be coordinated
through a point of contact) |
|
|
|
|
|
|
|
Regulatory Services
|
|
Seller and Purchaser
shall establish a prompt
communication and interaction
process to ensure the orderly
transfer of all Regulatory Filings
as promptly as practicable
following Closing. Within ****
following Closing, or as otherwise
agreed by the Parties, the ****.
Both Seller and Purchaser agree to
use commercially reasonable
efforts to take any actions
required by the FDA or other
applicable Governmental Authority
to affect the ****. |
|
|
|
|
|
|
|
Manufacturing Process
|
|
Development and implementation of
a technology transfer protocol for
the transfer of the manufacturing
process (including in-process
methods) and formulation process
for API and formulated drug
substance for the NK-1 Compounds
to Purchaser and/or its designees.
Purchaser will receive training by
Seller’s knowledgeable personnel
in the manufacturing and testing
of the NK-1 Compounds. Such
training will be conducted on
mutually agreeable dates and times
with reasonable notice and during
normal business hours. |
|
|
|
|
|
|
|
Intellectual Property
|
|
Seller shall assist Purchaser in
(a) filing or prosecuting any
patent applications included in
the NK-1 Patents or maintaining
any patents included in the NK-1
Patents, (b) executing any further
legal documents, including any
further assignments, such as
individual assignments for
recordation in any U.S. or foreign
offices or agencies, to evidence
the assignment of the applicable
NK-1 Patents, and (c) performing
all reasonable acts that may be
necessary to complete the
assignment of Seller’s interest in
and to the NK-1 Patents. |
|
|
Schedule 2.5-4
SCHEDULE 2.11
ASSET TRANSFER SCHEDULE
The Parties’ representatives comprising the Technical Team shall have the ability to mutually
agree to modify in writing the Asset Transfer Schedule as reasonably required and in the event
the Parties deem it in their mutual interest provided that written notification of any such
modification(s) is provided to the Federal Trade Commission as part of any compliance report
regularly filed with the FTC pursuant to the Consent Order.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asset |
|
|
Delivery Time |
|
|
Delivery Method |
|
|
Discussion / Comments |
|
|
****
in the Data Room
|
|
|
SP
will provide within **** days of the Closing Date.
|
|
|
To be delivered on CD or DVD via
commercial carrier.
|
|
|
Will contain the
**** contents of the **** that was
available to
purchaser during due
diligence. |
|
|
****
|
|
|
Parties will work together to effect the
**** transfer as soon as possible with an
expectation this will occur within **** of the Closing Date.
|
|
|
To be delivered on CD or DVD via
commercial carrier.
|
|
|
SP can transfer the
**** only after
Purchaser notifies
SP that they are
prepared to accept
transfer and notify
FDA that they will
accept Sponsorship. |
|
|
****
|
|
|
Parties will work together to effect the
**** transfer as soon as possible with
an expectation this will occur **** of the Closing Date.
|
|
|
To be delivered on CD or DVD via
commercial carrier.
|
|
|
SP can transfer the
**** only after
Purchaser notifies
SP that they are
prepared to accept
transfer and notify
FDA that they will
accept Sponsorship. |
|
|
Regulatory Documents |
|
|
|
|
|
|
|
|
|
|
|
• ****
|
|
|
To
be delivered **** calendar **** of the Closing Date.
|
|
|
Hard copy of all correspondence to
and from regulatory agencies and
attachments arranged in
chronological order. The original **** and **** to be delivered on CD
or DVD. |
|
|
|
|
|
Pharmacovigilance |
|
|
|
|
|
|
|
|
|
|
|
• ****
|
|
|
To
be transferred to Purchaser within **** calendar days of the Closing
Date.
|
|
|
To be delivered on CD or DVD via
commercial carrier.
|
|
|
Purchaser will
notify SP when they
become the sponsor
of the **** and at
this point,
Purchaser will
assume all
pharmacovigilance
requirements. |
|
|
Schedule 2.11-1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asset |
|
|
Delivery Time |
|
|
Delivery Method |
|
|
Discussion / Comments |
|
|
Discovery Biology |
|
|
|
|
|
|
|
|
|
|
|
• ****
|
|
|
To be delivered within **** calendar days of the Closing Date.
|
|
|
To be delivered on CD or DVD via
commercial carrier.
|
|
|
If hardcopy
signatures were
obtained for final
reports, the
original signed
report should be
provided. |
|
|
Drug Metabolism & Pharmacokinetics |
|
|
|
|
|
|
|
|
|
|
|
• ****
|
|
|
To be delivered within **** calendar days of the Closing Date.
|
|
|
To be delivered on CD or DVD via
commercial carrier.
|
|
|
If hardcopy
signatures were
obtained for final
reports, the
original signed
report should be
provided. |
|
|
Drug Safety |
|
|
|
|
|
|
|
|
|
|
|
• ****
|
|
|
To be delivered within **** calendar days of the Closing Date.
|
|
|
To be delivered on CD or DVD via
commercial carrier.
|
|
|
If hardcopy
signatures were
obtained for final
reports, the
original signed
report should be
provided. |
|
|
• ****
• ****
|
|
|
**** reports are being completed.
SP will transfer reports within **** calendar days of
completion, subsequent to the Closing
Date, and no later than **** days after
completion.
|
|
|
To be delivered on CD or DVD via
commercial carrier.
|
|
|
If hardcopy
signatures were
obtained for final
reports, the
original signed
report should be
provided. |
|
|
• ****
|
|
|
To be delivered within **** calendar days of the Closing Date.
|
|
|
To be delivered on CD or DVD as
electronic transport file via
commercial carrier. |
|
|
|
|
|
Early Clinical Research & Experimental
Medicine |
|
|
|
|
|
|
|
|
|
|
|
• ****
|
|
|
To be delivered within **** calendar days of the Closing Date.
|
|
|
To be delivered on CD or DVD via
commercial carrier. |
|
|
|
|
|
• ****
|
|
|
To
be delivered within **** calendar days of the Closing Date.
|
|
|
To be delivered on CD or DVD as a
SAS transport file via commercial
carrier. |
|
|
|
|
|
Schedule 2.11-2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asset |
|
|
Delivery Time |
|
|
Delivery Method |
|
|
Discussion / Comments |
|
|
Clinical Research |
|
|
|
|
|
|
|
|
|
|
|
• ****
|
|
|
****
• To be delivered within **** calendar days of the
Closing Date.
****
• **** draft scheduled to be completed in ****; this draft will be delivered within
**** calendar days of report completion, subsequent to the Closing Date.
• Final **** report will be delivered when completed but no later than **** calendar days subsequent to the Closing Date.
****
• To be delivered within **** calendar
days of the Closing Date.
|
|
|
To be delivered on CD or DVD via |
|
|
|
|
|
• ****
|
|
|
To be delivered within **** calendar days of the
Closing Date.
|
|
|
To be delivered on CD or DVD as a
SAS transport file via commercial
carrier. |
|
|
|
|
|
Chemistry, Manufacturing, and Controls |
|
|
|
|
|
|
|
|
|
|
|
• ****
|
|
|
To be delivered within **** calendar days of the Closing Date.
|
|
|
To be delivered on CD or DVD via
commercial carrier. |
|
|
|
|
|
• Drug
**** summary report
|
|
|
To be delivered within **** calendar days of the Closing Date.
|
|
|
To be delivered on CD or DVD via
commercial carrier. |
|
|
|
|
|
• ****
and **** specifications
|
|
|
To be delivered within **** calendar days of the Closing Date.
|
|
|
To be delivered on CD or DVD via
commercial carrier. |
|
|
|
|
|
• Audit
reports of vendors that supplied **** drug **** and drug ****.
|
|
|
To be delivered within **** calendar days of the closing date.
|
|
|
To be delivered on CD or DVD via
commercial carrier.
|
|
|
Materials will need to be redacted for information not relevant to the NK-1 programs. |
|
|
Occupational & Environmental Toxicology |
|
|
|
|
|
|
|
|
|
|
|
• **** and **** with governmental authorities
|
|
|
To be delivered within **** calendar days of the Closing Date.
|
|
|
To be delivered on CD or DVD via
commercial carrier. |
|
|
|
|
|
Market Research |
|
|
|
|
|
|
|
|
|
|
|
• **** market research data.
|
|
|
To be delivered within **** calendar days of the Closing Date.
|
|
|
To be delivered on CD or DVD via
commercial carrier. |
|
|
|
|
|
Schedule 2.11-3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asset |
|
|
Delivery Time |
|
|
Delivery Method |
|
|
Discussion / Comments |
|
|
• **** market research data.
|
|
|
To be delivered within **** calendar days of the Closing Date.
|
|
|
To be delivered on CD or DVD via
commercial carrier. |
|
|
|
|
|
• **** meeting presentations and minutes. |
|
|
To be delivered within **** calendar days of the Closing Date.
|
|
|
To be delivered on CD or DVD via
commercial carrier. |
|
|
|
|
|
• **** searches.
|
|
|
To be delivered within **** calendar days of the Closing Date.
|
|
|
To be delivered on CD or DVD via
commercial carrier. |
|
|
|
|
|
• ****
|
|
|
To be delivered within **** calendar days of the Closing Date.
|
|
|
To be delivered on CD or DVD via
commercial carrier. |
|
|
|
|
|
• ****
|
|
|
To be delivered within **** calendar days of the Closing Date.
|
|
|
To be delivered on CD or DVD via
commercial carrier. |
|
|
|
|
|
• ****
|
|
|
To be delivered within **** calendar days of the Closing Date.
|
|
|
To be delivered on CD or DVD via
commercial carrier. |
|
|
|
|
|
Physical chemical inventory1 |
|
|
|
|
|
|
|
|
|
|
|
• API (drug substance):
o **** SCH 619734 API
o **** SCH 619734 API
o **** SCH 900978 API
|
|
|
To be delivered within **** calendar days of Purchaser
providing SP with the shipping
instructions and location, or as
otherwise agreed by the parties.
|
|
|
SP will ship via commercial carrier.
|
|
|
Material located at SP in New Jersey.
Purchaser will need a facility suitable for maintaining controlled room temperature storage conditions. |
|
|
• Drug Product:
o **** active **** and
matching****
|
|
|
To be delivered within **** calendar days of Purchaser
providing SP with the shipping
instructions and location, or as
otherwise agreed by the parties.
|
|
|
SP will ship via commercial carrier.
|
|
|
Material located at SP in New Jersey.
Purchaser will need a facility suitable for maintaining controlled room temperature storage conditions. |
|
|
• ****
|
|
|
To be delivered within **** calendar days of Purchaser
providing SP with the shipping
instructions and location, or as
otherwise agreed by the parties.
|
|
|
SP will ship via commercial carrier.
|
|
|
Material located at SP in New Jersey and Rathdrum. Ireland. |
|
|
• ****
|
|
|
To be delivered within **** calendar days of Purchaser
providing SP with the shipping
instructions and location, or as
otherwise agreed by the parties.
|
|
|
SP will ship via commercial carrier.
|
|
|
Material located at SP in New Jersey and Rathdrum. Ireland. |
|
|
|
|
|
1 |
|
Seller will retain the Hold Back API as provided for in
Section 7.11 of the Agreement |
Schedule 2.11-4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asset |
|
|
Delivery Time |
|
|
Delivery Method |
|
|
Discussion / Comments |
|
|
• ****
|
|
|
To be delivered within **** calendar days of Purchaser
providing SP with the shipping
instructions and location, or as
otherwise agreed by the parties.
|
|
|
SP will ship via commercial carrier.
|
|
|
Material located at SP in New Jersey and Rathdrum, Ireland. |
|
|
• On-station **** (drug substance and drug product).
|
|
|
To be delivered within **** calendar days of Purchaser
providing SP with the shipping
instructions and location, or as
otherwise agreed by the parties.
|
|
|
SP will ship via commercial carrier.
|
|
|
Materials located in Summit, New Jersey (drug product).
Materials currently located in Kenilworth, NJ but are in the process of being transferred to Summit, New Jersey (drug substance).
Purchaser will need suitable ICH stability xxxxxxxx. |
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• On-station **** of **** drug product.
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To be delivered within **** calendar days of Purchaser
providing SP with the shipping
instructions and location, or as
otherwise agreed by the parties.
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SP will ship via commercial carrier.
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Materials located in Werthenstein Chemie AG (WAG), Switzerland.
Purchaser will need suitable ICH stability xxxxxxxx. |
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• Remaining **** articles of ****.
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To be delivered within **** calendar days of Purchaser
providing SP with the shipping
instructions and location, or as
otherwise agreed by the parties.
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SP will ship via commercial carrier.
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Stored at Summit, NJ at ambient conditions and 5°C. |
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NK-1 Patents |
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• All **** for the NK-1 Records, NK-1 Patents,
trademarks and other IP related to the NK-1 Program, including a **** which includes **** and ****
for the NK-1 Patents, the complete
**** for all patent applications and patents comprising the NK-1
Patents (including, without limitation, all ****,
official **** with patent offices and copies of **** (whether patents, patent applications, publications, or events raising a statutory bar to patentability), all
**** with Seller’s **** counsel relating to any or all NK-1 Patents, all **** forms and original executed assignment(s)
from inventor(s) pertaining to the NK-1 Patents, the **** of the each issued patent under the NK-1 Patents)
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Transfer of the **** will occur within **** calendar days of
the Closing Date.
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To be delivered on CD or DVD or
hard copy format via commercial
carrier. |
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**** (even draft form). |
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• Originals or copies of all **** and other primary ****,
research results, records and documentation, research plans, **** and plan documents, proposals, conclusions, know-how, specifications and information (including ****, relationships with prospective ****, etc),
to the extent any of the foregoing are recorded in any tangible form (including, without limitation, electronic files and paper documents).
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To be delivered within **** calendar days of the closing date.
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To be delivered on CD or DVD or
hard copy format via commercial
carrier.
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Materials
will need to be redacted for information not releveant to the NK-1
programs. |
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Schedule 2.11-5
“Key Rolapitant Employees”
Name
Role
****
Schedule 7.10