Exhibit 10.3
The
confidential portions of this exhibit have been filed separately
with the Securities and Exchange Commission pursuant to a
confidential treatment request in accordance with Rule 24b-2
of the Securities and Exchange Act of 1934, as amended. REDACTED
PORTIONS OF THIS EXHIBIT ARE MARKED BY AN ***.
ASSET PURCHASE AGREEMENT
by
and between
SYNTHON PHARMACEUTICALS, INC.
and
JDS PHARMACEUTICALS, LLC
relating to
Purchase Of PEXEVA ® Product
Line
Dated October 17, 2005
TABLE OF CONTENTS
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| 1. |
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Definitions |
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1 |
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| 2. |
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Purchase and Sale
of Purchased Assets |
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2.1. |
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Purchase and Sale |
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2.2. |
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Inventory |
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2.3. |
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Retained Assets |
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2.4. |
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Delivery of Know-How |
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2.5. |
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Contracts and NDA |
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2.6. |
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Patent License |
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7 |
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2.7. |
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Right to Use Equipment and
Machinery |
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7 |
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| 3. |
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Purchase
Price |
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3.1. |
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Payments of Purchase Price |
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3.2. |
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Purchase Price Adjustment for
Inventory |
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3.3. |
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Purchase Price Adjustment for
Distribution Channel Inventory |
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3.4. |
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Additional Fee |
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| 4. |
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Representations
and Warranties of Synthon |
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11 |
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4.1. |
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Organization; Standing |
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4.2. |
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Authorization; Binding Effect |
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4.3. |
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No Conflict; Consents |
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4.4. |
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Title to Purchased Assets; Liens and
Encumbrances |
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4.5. |
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Claims; Litigation |
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4.6. |
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Product Intellectual Property |
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4.7. |
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Contracts |
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4.8. |
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Legal and Regulatory Compliance;
Specifications |
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4.9. |
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Financial and Other Information |
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4.10. |
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Inventory |
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4.11. |
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Environmental Representation |
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4.12. |
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Employment Matters |
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4.13. |
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Full Disclosure |
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| 5. |
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Representations
and Warranties of JDS |
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5.1. |
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Organization; Standing |
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5.2. |
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Authorization; Binding Effect |
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5.3. |
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No Conflict; Consents |
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5.4. |
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No Violation; Litigation or
Regulatory Action |
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5.5. |
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Availability of Financing |
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5.6. |
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Disclosure |
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5.7. |
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Hart-Scott-Rodino Compliance |
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| 6. |
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Covenants of
Synthon and JDS |
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6.1. |
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Access |
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6.2. |
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Notice by Synthon; Statements by
Synthon Representatives |
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6.3. |
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Chargebacks, Rebates and Returns |
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6.4. |
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Manufacturing Agreements |
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6.5. |
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Stability Programs; Complaints |
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6.6. |
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Safety Data |
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6.7. |
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Transition Services |
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6.8. |
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Regulatory Matters |
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6.9. |
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Offers of Employment |
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6.10. |
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Conduct Pending Closing |
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6.11. |
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Financial Statements |
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6.12. |
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Insurance |
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6.13. |
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Synthon Covenant Regarding the
Trademarks |
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6.14. |
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Retained Asset Dispositions |
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6.15. |
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Prohibition on Assignment |
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| 7. |
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Closing |
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7.1. |
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Time and Place |
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7.2. |
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Conditions Precedent to JDS’s
Obligations |
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7.3. |
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Conditions Precedent to
Synthon’s Obligations |
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7.4. |
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Deliveries at Closing |
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| 8. |
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Confidentiality
and Cooperation; Non-Competition |
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8.1. |
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Confidential Information |
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8.2. |
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Confidentiality Obligation |
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8.3. |
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Cooperation |
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8.4. |
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Non-Competition |
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| 9. |
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Further
Assurances |
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| 10. |
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Indemnification;
Insurance |
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10.1. |
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Indemnification Obligations of the
Parties |
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10.2. |
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Limitations on Indemnification
Liability |
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10.3. |
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Procedure for Indemnification |
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10.4. |
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Representation |
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| 11. |
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Survival of
Indemnification Obligations and Covenants |
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| 12. |
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Dispute
Resolution |
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12.1. |
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Negotiation |
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12.2. |
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Arbitration |
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28 |
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12.3. |
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Interim Relief |
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28 |
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| 13. |
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Termination |
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13.1. |
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Termination |
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13.2. |
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Survival |
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| 14. |
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Specific
Performance |
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| 15. |
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Assignment |
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| 16. |
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Choice of Law |
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| 17. |
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Notices |
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29 |
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| 18. |
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Miscellaneous |
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18.1. |
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Entire Agreement |
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30 |
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18.2. |
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Amendment and Modification |
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30 |
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18.3. |
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Severability |
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30 |
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18.4. |
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Non-Disclosure |
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30 |
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18.5. |
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Brokerage Indemnity |
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30 |
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18.6. |
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Execution; Facsimile Signatures |
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30 |
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Schedule 1A
& 1B
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Licensed Patents |
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Schedule 1C
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Patents |
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Schedule 1D
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Manufacturing Agreements |
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Schedule 1E
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Inventory Costs |
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Schedule 1F
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Equipment and Machinery |
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Schedule 3.3(a)
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Intentionally Deleted |
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Schedule 3.3(c)
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Intentionally Deleted |
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Schedule 4
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Exceptions |
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Schedule 4.6(a)
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Product Intellectual Property |
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Schedule 4.7
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Contracts |
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Schedule 4.10
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Inventory As of September 30,
2005 |
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Schedule 4.12
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Employment Matters |
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Schedule 6.3(f)
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Synthon Returned Goods Policy |
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Schedule 7.2(f)
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Synthon Consents and Approvals |
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Schedule 7.3(e)
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JDS Consents and Approvals |
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Exhibit A
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Form of Transition Services
Agreement |
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Exhibit B
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Form of Pledge and Security
Agreement |
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Exhibit C
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Form of License |
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Exhibit D
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Form of Supply Agreement |
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Exhibit E
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Form of Guaranty |
iii
ASSET PURCHASE AGREEMENT
ASSET PURCHASE AGREEMENT
(“ Agreement ”) dated this 17 th day of October,
2005 by and between SYNTHON PHARMACEUTICALS, INC. , a North
Carolina corporation having its principal offices at 9000
Development Drive, Research Triangle Park, North Carolina 27709
(“ Synthon ”) and JDS PHARMACEUTICALS,
LLC , a Delaware limited liability company having its principal
offices at 122 East 42 nd Street, 41
st
Floor, New York, New York 10168 (“ JDS ”).
R
E C I T A L S:
A. Synthon owns the proprietary
rights to a pharmaceutical product manufactured, marketed and sold
by or on behalf of Synthon under the trademark “PEXEVA
®
” (as more fully defined herein).
B. JDS desires to purchase
certain assets relating to the Product (as more fully defined in
Section 1, the “ Purchased Assets ”)
from Synthon for purposes of marketing and selling the Product in
the Territory (as defined herein), and Synthon has agreed to sell
the Purchased Assets to JDS, all in accordance with, and subject
to, the terms and conditions hereinafter set forth.
NOW, THEREFORE, in
consideration of the foregoing and of the terms and conditions
hereinafter set forth, and good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the
parties hereto agree as follows:
1. Definitions
. As used herein, the following terms shall have the
respective meanings set forth below:
“
Additional Fee ” shall have the meaning set forth in
Section 3.4 (a) .
“
Additional Fee Aggregate Minimum ” shall have the
meaning set forth in Section 3.4 (d) .
“
Additional Fee Credit ” shall have the meaning set
forth in Section 3.4 (f) .
“
Additional Fee Expiration Date ” shall mean the last
date on which U.S. Patent No. 5,874,447 or any divisional
thereof (provided such divisional is listed in the FDA publication
entitled “Food and Drug Administration Center for Drug
Evaluation and Research Approved Drug Products with Therapeutic
Equivalent Evaluations” with respect to the Product (the
“Orange Book”)) expires (including any patent term
extension).
“
Additional Fee Period ” shall mean the period
commencing on the Closing Date and ending on Additional Fee
Expiration Date or such earlier date as there has been a judicial
finding of invalidity of U.S. Patent No. 5,874,447 and all
divisionals thereof (provided such divisionals are listed in the
Orange Book with respect to the Product) as to which no appeal has
or can be taken.
“
Affiliate ” shall mean any person or legal entity
controlling, controlled by or under common control with the person
with respect to whom such status is at issue and shall include,
without limitation, any corporation 50% or more of the voting power
of which (or other comparable ownership interest for an entity
other than a corporation) is owned, directly or indirectly, by a
party hereto or any corporation, person or entity which owns 50% or
more of such voting power of a party hereto. With respect to
Synthon, the term “Affiliate” shall include, but not be
limited to, Synthon Holding BV, Synthon BV, Synthon BCT
Technologies, LLC and Synthon IP Inc.
1
“
API ” shall mean the compound generally referred to as
paroxetine mesylate.
“
Average Selling Price ” shall mean ***.
“
Average Wholesaler Inventory ” shall have the meaning
specified in Section 3.3(a) .
“
Chargebacks ” shall mean discounts or rebates provided
in the form of chargeback and similar payments to wholesalers or
other distributors in connection with the Product.
“
Closing ” shall have the meaning set forth in
Section 7.1 .
“
Closing Date ” shall have the meaning set forth in
Section 7.1 .
“
Closing Wholesaler Inventory ” shall have the meaning
specified in Section 3.3(b) .
“
Confidential Information ” shall have the meaning set
forth in Section 8.1 .
“
Contracts ” shall mean all contracts, agreements,
arrangements or understandings, to the extent directly related to
the Purchased Assets or the Product in the Territory or related to
the synthesis or manufacture of the Product or any component
thereof anywhere in the world to the extent exclusively related to
the marketing, sale, offer for sale, distribution, or use of the
Product in the Territory as set forth on Schedule 4.7 .
Contracts shall include, without limitation, contracts or
arrangements relating to the sale, use or marketing of the Product
in the Territory (including agreements with managed care
organizations and hospitals to the extent specifically related to
the Product in the Territory) and shall include the Manufacturing
Agreements and shall include contracts, agreements, arrangements or
understandings relating to the synthesis or manufacture of the
Product or any component thereof executed or to be performed
outside of the Territory which relate to the marketing, sale, offer
for sale, distribution or use of the Product in the
Territory.
“Credits ” shall mean credits, utilization based
rebates (other than Medicaid rebates), reimbursements, and similar
payments to buying groups, managed care organizations and benefit
managers, insurers and other institutions in connection with the
Product.
“
Damages ” shall have the meaning set forth in
Section 10.1 .
“
Dollars ” or “ $ ” shall mean U.S.
dollars.
“
Encumbrance ” shall mean any mortgage, pledge,
security interest, deed of trust, lease, lien, adverse claim
(including any claim of adverse ownership), levy, charge, easement,
right of way, covenant, restriction, or other encumbrance,
third-party right or retained right of any kind whatsoever, or any
conditional sale or title retention agreement or other agreement to
give any of the foregoing in the future.
“
Environmental Law ” shall have the meaning set forth
in Section 4.11 .
“
ERISA ” and “ ERISA Plans ” shall
have the respective meanings assigned to those terms in
Section 4.12 .
“
FDA ” shall mean the United States Food and Drug
Administration or any successor agency having a similar
jurisdiction and the corresponding regulatory agency in
Canada.
“
Federal Program ” shall have the meaning set forth in
Section 6.3(d) .
2
“
Financial Data ” shall have the meaning set forth in
Section 4.9 .
“
Indemnifying Party ” shall have the meaning set forth
in Section 10.1(c) .
“
Indemnitee ” shall have the meaning set forth in
Section 10.1(c) .
“
Inventory ” shall mean all saleable inventory of
Product with at least twelve (12) months of remaining
shelf-life as of the Closing in finished form (and whether in bulk
tablet or final packaged form) and inventory of finished samples
which comply with the NDA on hand at Synthon as of the
Closing.
“
Inventory Cost ” with respect to a unit of Inventory
shall mean Synthon’s inventory cost determined in accordance
with US GAAP. Schedule 1E sets forth a schedule of
Inventory Cost for units of Inventory.
“
JDS Know-How ” shall have the meaning set forth in the
last sentence of the definition of “Know-How”
below.
“
Know-How ” shall mean all methods, processes,
techniques, compositions, technology, information, data, results of
tests, studies, statistical and other analyses and expertise,
whether patented or unpatented to the extent related to the Product
in the Territory or to the extent related to the synthesis or
manufacture of the Product or any component thereof anywhere in the
world to the extent exclusively related to the marketing, selling,
offering for sale, distributing or using the Product in the
Territory, now in possession of Synthon or an Affiliate of Synthon,
which are at the time of the Closing used in development,
formulation, manufacture of the Product. Know-How shall include,
without limitation, pharmacology, toxicology, drug stability,
manufacturing and formulation methodologies and techniques,
clinical and non clinical safety and efficacy studies, marketing
studies and absorption, excretion, metabolism studies, quality
control and quality assurance, and all tangible manifestations
thereof, subject to Synthon’s rights to retain a copy of
documents set forth in the definition of “Purchased
Assets” below. To the extent any of such information,
technology or know-how has applicability to products other than the
Product in the Territory or other than to the synthesis or
manufacture of the Product or any component thereof anywhere in the
world to the extent exclusively related to the marketing, selling,
offering for sale, distribution or use of the Product in the
Territory, the assignment of Know-How hereunder shall be limited to
the grant of a fully paid, exclusive (with respect to the
Territory), perpetual license to use such information, technology
or know-how only to the extent related to the Product. “
JDS Know-How ” shall mean any such Know-How now or
hereafter possessed by JDS which would be defined in this Section
if possessed or developed by Synthon.
“
Law ” shall mean all applicable laws (including,
without limitation, the Federal Food, Drug and Cosmetic Act, as
amended, corresponding Canadian law and other national, state,
provincial and local laws) governing the manufacture, marketing,
advertising, distribution and sale of the Product or any other
obligations of the parties thereunder, including regulations
promulgated thereunder.
“Licensed Patents” shall mean
(a) each
claim of each patent of Synthon or any Affiliate listed on
Schedule 1A and Schedule 1B ;
(b) each
claim of each patent issuing from or on each patent application
listed on Schedule 1A and Schedule 1B ; and
3
(c) each
claim of each application for letters patent which has been filed
by or assigned to Synthon, or any of its Affiliates, as the case
may be, and each claim of each patent issuing from or on any such
application, claiming the Product or methods for making or using
the Product and in each case (including subsections (a) and
(b) above) including extensions, continuations,
continuations-in-part, reissues and divisions thereof, and any
other patents or patent applications relating to any form or
derivative of paroxetine, including, but not limited to, salts,
esters, chelates, enantiomers, diastereoisomers, prodrugs and
metabolites.
For
purposes of this definition only, the term “Product”
shall be deemed to include any form or derivative of paroxetine,
including but not limited to, salts, esters, chelates, enantiomers,
diastereoisomers, prodrugs and metabolites. From and after the date
hereof, from time to time as appropriate, Synthon shall update
Schedules 1A and 1B to reflect any additional patents and patent
applications which fall within the scope of subsection
(c) above.
“
Manufacturing Agreements ” shall mean the contracts
and agreements identified on Schedule 1D relating to the
formulation, manufacture, packaging, testing, validation, storage
or shipment of the Product or any component thereof.
“
Marketing Authorization ” shall mean the approval by a
Regulatory Authority permitting the marketing, sale and
distribution (and, if applicable, pricing and reimbursement) of the
Product within the Territory, including, without limitation, the
NDA.
“
Marketing Information ” shall have the meaning set
forth in Section 4.9 .
“
Marketing Materials and Data ” shall mean all
physician lists, customer lists, marketing studies, market research
materials, advertising and promotional materials, other similar
information and data, including without limitation, records of
sales and cost data for the immediate three (3) years
preceding the Closing, to the extent pertaining to the marketing or
distribution of the Product in the Territory which items are in the
possession or control of Synthon or any of its Affiliates,
promotional booths and displays, and all equipment and other
materials used in connection with the sale or promotion of the
Product whether or not located at Synthon’s offices.
“
NDA ” shall mean a New Drug Application including
amendments and supplements thereto approved by the FDA in respect
of the marketing of the Product in the United States and all
corresponding applications and approvals in Canada.
“Net Sales” of the Product for a period
following the Closing shall mean the gross proceeds from sales of
the Product in the Territory by JDS and its Affiliates or permitted
licensees to unaffiliated third parties, less (i) allowances
for returns and discounts given to customers, including, without
limitation, discounts made by means of rebates, Chargebacks or
contract administration fees with customers that are directly
related to sales of Product in the Territory (and including rebates
or other payments required to be paid to governmental entities in
connection with sales of Product in the Territory pursuant to the
Omnibus Budget Reconciliation Act of 1990 and similar or other
Federal or state legislation or programs) and (ii) any taxes
or duties included in gross invoice amounts. For purposes of the
definition of Net Sales, the term “Product” shall
include all products marketed by JDS or a permitted licensee within
the Territory which contain paroxetine mesylate. The Net Sales
shall be calculated in accordance with US GAAP.
“Patents” shall mean:
(a) each
claim of each patent of Synthon or any Affiliate listed on
Schedule 1C ; and
4
(b) each
claim of each patent issuing from or on each patent application
listed on Schedule 1C .
“Product” shall mean any pharmaceutical product
containing paroxetine mesylate in all dosage forms and
formulations, including, without limitation, the pharmaceutical
product known as Pexeva ® paroxetine
mesylate approved for marketing in the United States pursuant to
NDA 21-299, whether sold under the “Pexeva ® ”
trademark, any other brand name or as a generic product.
“
Product Intellectual Property ” shall mean any and all
of the following intellectual property rights now owned or
controlled (including, without limitation, by means of in-license)
by Synthon or any Affiliate to the extent used in the development,
manufacture, sale, use, marketing and distribution of the Product
in the Territory or to the extent used in the synthesis or
manufacture of the Product or any component anywhere in the world
to the extent exclusively related to the marketing, sale, offer to
sell, distribution or use of the Product in the Territory, or in
obtaining Marketing Authorizations: (i) Patents (other than
those listed in Schedules 1A and 1B which are addressed as
“Licensed Patents” in Section 2.6);
(ii) Know-How; (iii) copyrights in any copyrightable
Marketing Material and Data; and (iv) Trademarks, proprietary
rights to universal resource locators (URLs), websites and web
pages to the extent exclusively related to the Product within the
Territory.
“
Purchase Price ” shall mean the consideration as
further defined in Section 3.1 below paid by JDS to
Synthon for the transfer of Synthon and it Affiliates’ entire
right, title, and interest in the Product in the Territory and with
respect to the synthesis and manufacture of the Product or any
component thereof anywhere in the world to the extent exclusively
related to the marketing, sale, offer for sale, distribution or use
of the Product in the Territory.
“
Purchased Assets ” shall mean the following:
(i) the Product Intellectual Property; (ii) the license
to the Licensed Patents referred to in Section 2.6 ,
(iii) all outstanding orders relating to the Product in the
Territory and Contracts; (iv) the Inventory (but only to the
extent JDS has elected to acquire Inventory at Closing pursuant to
Section 2.2 ); (v) the Marketing Material and
Data; (vi) the NDA; (vii) all rights or claims of Synthon
or any Affiliate in respect to any of the foregoing against any
third party including, without limitation, any prior owner of
Product Intellectual Property but excluding any right of Synthon to
receive payment for Product shipped prior to Closing; (viii) a
nonexclusive right to use all Synthon equipment and machinery
located at facilities where Product is manufactured (as set forth
on Schedule 1F , which Schedule includes the location
of such equipment and machinery) as long as JDS is manufacturing
Product at such facility and in accordance with the further
provisions set forth in Section 2.7 ; and (ix) all
goodwill relating to any of the above. Synthon may retain a copy of
all documents or materials included in the Purchased Assets for
archival purposes, for purposes of fulfilling its obligations under
this Agreement and under applicable Law and to the extent such
documents or materials include or relate to Retained Assets (as
hereinafter defined).
“
Quarter ” shall mean the calendar quarterly periods
ending March 31, June 30, September 30 and
December 31.
“
Regulatory Authority ” shall mean any governmental
regulatory authority involved in the granting of approvals for the
manufacture, sale, marketing, reimbursement or pricing of the
Product (including, without limitation, the FDA) in the
Territory.
“
Retained Assets ” shall mean all assets of Synthon of
any type, nature, status or description whatsoever, other than the
Purchased Assets. For purposes of clarity and not of limitation,
“Retained Assets” shall include (i) any Synthon
intellectual property other than Product Intellectual Property and
(ii) plant, equipment and fixed assets of Synthon other than
as expressly included in the Purchased Assets.
5
“Security Agreement” shall have the meaning set
forth in Section 3.1(b) .
“
Specifications ” shall have the meaning set forth in
Section 4.8 .
“Supply Agreement” shall mean that certain
supply agreement to be entered into between Synthon and JDS on the
Closing Date whereby Synthon has agreed to supply JDS with certain
quantities of API and Inventory from time to time pursuant to the
terms of such agreement in form and substance as annexed hereto as
Exhibit D .
“
Territory ” shall mean the United States and
Canada.
“
Threshold Loss Amount ” shall have the meaning set
forth in Section 10.2(a) .
“
Trademarks ” shall mean the trademarks set forth on
Schedule 4.6(a) , including all goodwill associated
therewith.
“
Transition Period ” shall mean a period not to exceed
ninety (90) days from the Closing during which time Synthon
will assist JDS with certain defined services more fully set forth
in the Transition Services Agreement.
“
Transition Services ” shall mean the services provided
by Synthon during the Transition Period under the Transition
Services Agreement.
“
Transition Services Agreement ” shall mean that
certain transition services agreement entered into between Synthon
and JDS on the Closing Date whereby Synthon will provide the
Transition Services to JDS during the Transition Period in form and
substance as annexed hereto as Exhibit A .
“
United States ” shall mean the United States of
America, and its territories and possessions, including Puerto Rico
irrespective of its political status.
“US GAAP” shall mean generally accepted
accounting principles that are in effect in the United
States.
2. Purchase and Sale of
Purchased Assets .
2.1.
Purchase and Sale . Subject to the terms and conditions of
this Agreement, at the Closing, Synthon shall sell, transfer,
convey, assign and deliver, or cause to be sold, transferred,
conveyed, assigned and delivered, to JDS, free and clear of all
Encumbrances, and JDS, or any assignee or Affiliate of JDS, shall
purchase, acquire and accept from Synthon (and, to the extent
applicable, Affiliates of Synthon) all of Synthon’s (and, if
applicable, its Affiliates’) right, title and interest in and
to the Purchased Assets.
2.2.
Inventory . Prior to the Closing Date, the Parties shall
cooperate to provide information to JDS as to Inventory (including
lot numbers, dosage strengths and dating) which Synthon reasonably
expects to have available as of the Closing Date. At least two
(2) business days prior to the Closing Date, JDS will provide
Synthon with a written notice of Inventory which JDS intends to
purchase at closing (the “Inventory Notice). Promptly
following receipt of the Inventory Notice, and in any event no
later than, the business day prior to the Closing, Synthon shall
provide JDS with written notice based
6
on the
Inventory Notice indicating the number of lots of Inventory with at
least 18 months left before expiration that it will have
available at Closing, including specific dosage strengths and
dating information (the “Closing Inventory”). JDS may
elect, but shall not be obligated, to purchase some or all of the
Closing Inventory at Inventory Cost. By notice to Synthon delivered
at the Closing, JDS will indicate which lots of inventory are to be
included in the Purchased Assets. Synthon shall deliver at Closing
a Certificate stating that the Closing Inventory delivered to JDS
as part of the Purchased Assets conforms to the description of the
Closing Inventory (e.g., the number of lots, dosage strengths and
dating) set forth on the JDS Inventory Notice. To the extent JDS
has so elected to purchase Inventory at Closing, the cash portion
of the Purchase Price payable pursuant to Section 3.1
will be increased as provided by Section 3.2 . Any
remaining Inventory may be purchased by JDS from time to time
pursuant to the Supply Agreement, provided, however, Inventory with
less than twelve (12) months before expiration may be donated
to accredited or recognized charitable organizations by Synthon
outside of the Territory (subject to JDS prior written consent and
provided the recipient agrees in writing not to export the
Inventory to the Territory) or destroyed by Synthon. To the extent
that Inventory purchased by JDS at Closing or pursuant to the
Supply Agreement is not sold in the ordinary course, JDS may return
to Synthon remaining Inventory with less than twelve
(12) months left before expiration for a full refund, which
JDS may obtain by offsetting the amount thereof against payments
due to Synthon pursuant to 3.4 below, or to any other payments due
to Synthon pursuant to this Agreement or the Supply
Agreement.
2.3.
Retained Assets . Notwithstanding anything contained in this
Agreement to the contrary, from and after the Closing, Synthon
shall retain all of its right, title and interest in and to the
Retained Assets. Notwithstanding the foregoing, except as expressly
provided elsewhere in this Agreement, Synthon shall retain no
interest, royalty or intellectual property rights relating to the
Product in the Territory or relating to the synthesis or
manufacture of the Product or any component thereof anywhere in the
world to the extent exclusively related to the marketing, selling,
offering for sale, distribution or use of the Product in the
Territory.
2.4.
Delivery of Know-How . As described herein, Synthon shall
disclose to JDS any Know-How in its possession on the Closing Date
relating to the Product in the Territory or with respect to the
synthesis or manufacture of the Product or any component thereof
anywhere in the world to the extent exclusively related to the
marketing, sale, offer for sale, distribution or use of the Product
in the Territory and shall deliver to JDS at the Closing all
tangible manifestations thereof, subject to the rights of Synthon
to retain copies provided herein. From and after the Closing Date,
Synthon shall continue to cooperate with JDS, as JDS may from time
to time reasonably request, in order to more fully convey the
Know-How to JDS.
2.5.
Contracts and NDA . Subject only to the provisions of the
Transition Services Agreement and as set forth below, JDS will
assume the obligations under the Contracts and the NDA to the
extent arising from and after the Closing.
2.6.
Patent License . At the Closing, Synthon shall grant to JDS
a fully paid-up, perpetual license in form and substance as set
forth on Exhibit C .
2.7.
Right to Use Equipment and Machinery . In connection with
and during the term of the grant by Synthon to JDS of the
non-exclusive right to use the equipment and machinery listed on
Schedule 1E included in the Purchased Assets, Synthon
agrees that it shall not remove or relocate any of such equipment
or machinery from its current location or use or authorize the use
of any such equipment or machinery in any manner which would
prevent or delay the use thereof by JDS for the manufacture of
Product. To the extent Synthon uses or grants a licensee the use of
any of the equipment or machinery for any purpose, any incremental
costs incurred in connection with the use of such equipment or
machinery for the manufacture of Product, including but not limited
to costs associated with cleaning or validation of the equipment
and machinery, shall be for Synthon’s account.
7
3. Purchase Price
.
3.1.
Payments of Purchase Price . As full consideration
for the Purchased Assets, JDS shall pay or cause to be paid to
Synthon the following separate and distinct payments which together
constitute the Purchase Price (the “ Purchase Price
”):
(a) US
$10,000,000, subject to adjustment as set forth in
Sections 3.2 and 3.3 below, to be paid by wire transfer
of immediately available funds on the Closing Date to an account
designated by Synthon in writing;
(b) US
$2,000,000 on each of December 31, 2007 and December 31,
2008 plus (i) $1,000,000 if Net Sales during the calendar year
ending on the date of such payment equal or exceed US $7,000,000
but are less than US $8,000,000 or (ii) $2,000,000 if Net Sales
during the calendar year ending on the date of such payment equal
or exceed US $8,000,000. Any additional payment pursuant to
subclauses (i) or (ii) of this Section shall be paid by
wire transfer on the last business day of the first calendar
quarter of the year immediately following the calendar year in
respect of which such payment became due. At the Closing, JDS and
Synthon will execute and deliver a security agreement in
substantially the form and substance as annexed hereto as
Exhibit B (the “Security Agreement”)
pursuant to which JDS will provide collateral security to Synthon
for the payments contemplated by this subsection (b) in
accordance with the terms and conditions therein set forth. JDS
reserves the right to prepay all or any portion of the Purchase
Price provided by this Section 3.1(b) at any time on or after
the Closing. The parties agree that any such prepayment will be
discounted at a rate of 9.75% per annum from the original due date
of the payment to the date of payment prepaid based on the number
of days in such period, determined in the inverse order of
maturity. Notwithstanding the foregoing, any prepayment which does
not include payment with respect to amounts which may become due
pursuant to subclauses (i) or (ii) above will not discharge
the obligation to make any such payments as they otherwise become
due and payable;
(c) US
$1,250,000, payable with respect to each of the first two calendar
years, if any, from 2007 through 2017, inclusive, as to which
annual Net Sales equal or exceed US $10,000,000. Each such payment
shall be paid by wire transfer on the last business day of the
first calendar quarter of the year immediately following the
calendar year in respect of which such payment became due. In the
event one or both of the payments provided by this subsection does
not accrue before January 1, 2009, any of such payments which
subsequently become due shall be increased by a factor of 5% per
annum commencing on January 1, 2009; and
(d) US
$5,000,000, payable with respect to the first calendar year, if
any, from the Closing through and including 2017, as to which
annual Net Sales equal or exceed US $30,000,000. Such payment shall
be made by wire transfer on or before the last business day of the
first calendar quarter of the year immediately following the
calendar year in respect of which such payment became due.
3.2.
Purchase Price Adjustment for Inventory . To the extent JDS
has elected to purchase Inventory as of the Closing Date, the
Purchase Price payment pursuant to Section 3.1(a) shall be
increased by an amount equal to the product of (i) the number
and type of units of Inventory purchased multiplied by
(ii) the Inventory Cost for each such Unit.
3.3.
Purchase Price Adjustment for Distribution Channel Inventory
. In addition to the adjustment provided by Section 3.2
and whether or not JDS has elected to purchase Inventory at
the
8
Closing,
the Purchase Price payable pursuant to Section 3.1(a)
shall be adjusted to reflect Inventory of Product sold by Synthon
prior to the Closing and then held by wholesalers or other
distributors in accordance with the following provisions of this
Section:
(a) Synthon
and JDS agree that the average quantities of Product historically
maintained by wholesalers in the Territory or to the extent
exclusively maintained for sale, offer for sale, distribution or
use in the Territory (the “Average Wholesaler
Inventory”) is *** bottles.
(b) Prior
to the Closing, Synthon shall obtain and disclose to JDS inventory
reports from McKesson, Amerisource Bergen, and Cardinal, which
reports provide information as to wholesaler inventory and
in-transit in-bound quantities of Product as of the most recent
practicable date prior to the Closing Date (the “Closing
Wholesaler Inventory”). The parties agree that the sum of the
McKesson, Amerisource Bergen, and Cardinal inventory reports shall
be deemed to constitute eighty-five percent (85%) of the Closing
Wholesaler Inventory.
(c) In
the event the Closing Wholesaler Inventory exceeds the Average
Wholesaler Inventory, the Purchase Price payable pursuant to
Section 3.1 (as adjusted, to the extent required, by
Section 3.2 ) shall be reduced by an amount equal to
the product of (i) the number of bottles by which the Closing
Wholesaler Inventory exceeds the Average Wholesaler Inventory and
(ii) the Average Selling Price.
3.4.
Additional Fee .
(a) As
part of the Purchase Price delivered in consideration for the
Purchased Assets, and in addition to the amounts set forth in
Section 3.1 hereof, JDS shall pay Synthon $.075 for
each tablet of the Product or any product containing paroxetine
mesylate as an active ingredient that is sold for commercial
distribution by JDS, its agents or Affiliates (the
“Additional Fee”) during the Additional Fee Period. For
purposes of clarification, no Additional Fee shall be attributed to
the Product or any product containing paroxetine mesylate as an
active ingredient distributed as samples or held in inventory by
JDS, its agents or Affiliates. Additional Fee shall be payable
Quarterly within 45 days of the end of the Quarter to which
each payment relates. Each payment of Additional Fee shall be
accompanied by a statement setting forth the number of tablets sold
by JDS, its agent or Affiliate for the Quarter.
(b) Subject
to sections (c), (e) and (f) below, in the event the
Additional Fee payments for a calendar year are less than $350,000,
JDS shall pay Synthon the difference between the total Additional
Fee paid with respect to such calendar year and $350,000, which
amount shall be paid together with the Additional Fee payment for
the first Quarter of the following calendar year.
(c) In
the event the Additional Fee payments for any calendar year are in
excess of $350,000, the excess shall be applied to reduce the
annual minimum Additional Fee obligation for the next (and
subsequent) calendar years until such entire excess has been so
applied.
(d) JDS’s
total payments of Additional Fees to Synthon with respect to sales
of the Product or any product containing paroxetine mesylate as an
active ingredient during the Additional Fee Period shall equal at
least the Additional Fee Aggregate Minimum (as defined below). The
Additional Fee Aggregate Minimum shall be equal to $10,000,000,
provided however, if the Additional Fee Period ends prior to the
Additional Fee Expiration Date, the Additional Fee Aggregate
Minimum shall be adjusted to equal $10,000,000 multiplied by a
fraction, the numerator of which is the number of months in the
Additional Fee Period and the denominator of which shall be the
number of months from the Closing Date until June 10, 2017. In
the event payments of Additional Fee pursuant to this Section
during the Additional Fee Period are less than the Additional Fee
Aggregate Minimum, JDS shall pay the
9
difference between the total Additional Fee paid and the Additional
Fee Aggregate Minimum within 45 days of the Additional Fee
Period. JDS reserves the right to prepay the amount of any
Additional Fee Aggregate Minimum remaining due (after taking into
account all previous payments of Additional Fee) at any time on or
after Closing. The parties agree that any such prepayment will be
discounted at a rate of 9.75% per annum from June 10, 2017 to
the date of payment prepaid based on the number of days in such
period. The prepayment of the Additional Fee Aggregate Minimum
shall constitute payment in full of all obligations pursuant to
this Section 3.4 and no further payments of Additional Fee
shall be due thereafter.
(e) With
respect to the partial calendar years at the beginning and the end
of the Additional Fee Period, that is (i) the period from the
Closing Date until the end of the first Calendar Year and
(ii) the period from January 1 of the final year of the
Additional Fee Period and the last day of the Additional Fee
Period, (assuming the last day is prior to December 31 of the
final year of the Additional Fee Period) the minimum threshold
amount described in Section 3.4(b) shall be adjusted
downward on a pro rata basis. For example, if there are only
292 days in a partial calendar year, the minimum Additional
Fees for such period shall be $280,000.
(f) To
the extent that JDS has purchased Inventory, excluding samples,
from Synthon as of the Closing Date pursuant to
Section 3.2 above, a credit in the amount of $.075
times each Tablet included in the purchased Inventory, excluding
samples, (the “Additional Fee Credit”) shall be applied
(i) to reduce any Additional Fee payment required pursuant to
Section 3.4 (a) as such Additional Fee becomes due and
payable until the entire Additional Fee Credit has been so applied
and (ii) to reduce the $350,000 Additional Fee minimum payable
pursuant to Section 3.4(b) until the entire Additional
Fee Credit has been so applied, provided, however, the Additional
Fee Credit shall not be applied to reduce the $10,000,000 total
Additional Fee Aggregate Minimum payable pursuant to
Section 3.4(d) .
(g) JDS
shall maintain accurate books and records for a period of no less
than three years from the periods covered reflecting commercial
sales of Product during the Additional Fee Period, which books and
records shall be available for audit and inspection by Synthon or
an independent auditing firm to which JDS has no reasonable
objection from time to time upon reasonable advance notice solely
for purposes of verifying the amount of Additional Fees and other
payments due under this Agreement. In the event any such audit
discloses that Additional Fee payments or other payments were
underpaid by 5% or more with respect to any consecutive six
(6) month period, JDS shall reimburse Synthon for the
reasonable cost of the audit and shall be liable for interest
equivalent to 1% compounded monthly of the aggregate amount of the
discrepancy from the date such payments were due.
3.5.
Adjustments upon Transfer . Unless otherwise waived by means
of a written waiver by Synthon, JDS shall not assign, transfer or
exclusively license (whether by means of a sale of substantially
all of JDS’s business or assets, or by merger, stock sale or
similar corporate reorganization) its rights to the Product to any
third party other than an Affiliate unless, effective with closing
of any such transaction, all Purchase Price provided by
Section 3.1(b) (except to the extent of additional payments
pursuant to subclause (i) or (ii) thereof not yet due,
which will be treated in accordance with the further provisions of
this Section) and the Additional Fee Aggregate Minimum provided by
Section 3.4(d) and not yet payable as of such date, shall have
been paid to Synthon, provided that each such payment shall be
discounted at a rate of 9.75% per annum from the original due date
of the payment to the date of payment prepaid based on the number
of days in such period, determined in the inverse order of
maturity. The prepayment of the Additional Fee Aggregate Minimum
shall constitute payment in full of all obligations pursuant to
Section 3.4 and no further payments of Additional Fee shall be
due thereafter. In addition, JDS shall be required to cause the
purchaser or transferee of JDS’s rights to the Product to
assume in writing for the benefit of Synthon the obligation to make
all other payments pursuant to Section 3.1 as and when such
payments would otherwise become due and payable hereunder. In the
event the purchaser or transferee of JDS’s rights to the
Product defaults in any payment obligation pursuant to
Section 3.1,
10
JDS
shall remain liable for the full amount of such obligation until
such time as the amount is paid in full and shall promptly, and in
no event later than ninety (90) days, remit such payment to
Synthon upon receipt of a notice of payment default on the part of
such purchaser or transferee. JDS agrees to provide notice to
Synthon of the pendency of any transaction referred to in this
Section 3.5 as promptly as practicable in advance of the
closing of any such transaction.
4. Representations and
Warranties of Synthon . Except as otherwise
disclosed on Schedule 4 (Exceptions) (which Schedule
indicates the section to which each exception relates), Synthon
hereby represents and warrants to JDS as follows:
4.1.
Organization; Standing . Synthon is duly organized, validly
existing and in good standing under the laws of its jurisdiction of
incorporation and has the corporate power and authority to execute
and deliver this Agreement, to perform its obligations hereunder
and to consummate the transactions contemplated hereby.
4.2.
Authorization; Binding Effect . The execution and delivery
by Synthon of this Agreement, the performance by Synthon of its
obligations hereunder and the consummation by Synthon of the
transactions contemplated hereby have been duly authorized by all
necessary action on the part of Synthon. This Agreement has been
duly executed and delivered by a duly authorized representative of
Synthon and constitutes the valid and legally binding obligation of
Synthon enforceable against Synthon in accordance with its
terms.
4.3.
No Conflict; Consents . The execution, delivery and
performance of this Agreement by Synthon do not (a) violate or
result in the breach of, constitute a default under, or accelerate
the performance required by, any term of any covenant, agreement or
understanding to which Synthon or any Affiliate is a party, or any
judgment, order, decree, law, rule or regulation to which Synthon
or any Affiliate is subject or (b) require the consent or
agreement of any third party (including governmental bodies).
4.4.
Title to Purchased Assets; Liens and Encumbrances . Synthon
or an Affiliate has, and on the Closing Date will have, good title
to the Purchased Assets, free and clear of all Encumbrances
whatsoever. Synthon’s disclosure and delivery of the Product
Intellectual Property, including Know-How, prior to, on or after
the Closing Date to JDS in the manner contemplated hereby will not
violate the rights of any third party.
4.5.
Claims; Litigation . There is no action, arbitration, or
other legal or administrative proceeding, pending, or, to the
knowledge of Synthon, threatened, against Synthon or any Affiliate
pertaining to the Product or the Purchased Assets (including,
without limitation, claims in the nature of product liability or
patent or other intellectual property infringement), no claims by
any individual named on Schedule 4.12 against Synthon,
and, to the best of Synthon’s knowledge, no governmental
investigation pertaining to any of the foregoing is pending or
threatened, in each such case in any country. Synthon has in good
faith made available to JDS all of its files and the files of each
Affiliate relating to the Purchased Assets and has delivered true
and complete copies thereof to JDS, all communications with
regulatory authorities in the Territory with respect to the Product
(except for purely ministerial, non-substantive
communications).
4.6.
Product Intellectual Property .
(a)
Schedule 4.6(a) constitutes a true and correct list of
all Product Intellectual Property (inclusive of such properties as
are owned, or in-licensed by Synthon or any Affiliate or presently
used by Synthon or its Affiliates). Synthon or an Affiliate owns
all right, title and interest in
11
and to
all of the Synthon or Affiliate owned properties, and the full
right and interest in and to the in-licensed properties, and is
legally entitled to transfer to JDS, all of the Product
Intellectual Property. Such transfer to JDS is free and clear of
all Encumbrances (for all properties) and free of license or
royalty obligations to any third party whatsoever (other than those
designated as in-licensed, in which case any royalty or other
obligation of Synthon or any Affiliate to any third party is
separately identified and disclosed on Schedule 4.6(a))
and free of all license or royalty obligations to any party other
than the identified licensor and obligations for in-licensed
properties identified on Schedule 4.6(a) . No third
party (including, for this purpose, directors, officers, employees
or other consultants to or agents for Synthon or any Affiliate) has
any legal or beneficial interest in the Product Intellectual
Property or any right to restrict, limit or terminate any of
Synthon’s or its Affiliates’ rights to the Product
Intellectual Property.
(b) All
necessary registration, maintenance and renewal fees due in
connection with such Product Intellectual Property have been paid
through the Closing Date and all necessary documents and
certificates in connection with such Product Intellectual Property
have been filed with the relevant patent, copyright or other
governmental or Regulatory Authorities for the purposes of
maintaining such Product Intellectual Property.
(c) Synthon
does not know of any reasonable basis for anyone to assert that the
manufacture, importation, sale, marketing, promotion or use of the
Product infringes or misappropriates the intellectual property
rights of any third party in the Territory, or anywhere in the
world with respect to Purchased Assets to the extent utilized by
Synthon for purpose of making, using, selling, offering to sell, or
distributing the Product in the Territory or synthesizing or making
the Product anywhere in the world to the extent exclusively related
to the marketing, sale, offer for sale, distribution or use of the
Product in the Territory, and has not received any notice from any
person of any claims of infringement or misappropriation with
respect thereto. Other than the patent interference proceedings
with GlaxoSmithKline described further on Schedule 4
that were resolved in Synthon’s favor, no claim of ownership,
infringement or invalidity adverse to the ownership or use by
Synthon or any Affiliate of any of the Product Intellectual
Property (including without limitation, any such claim by any
shareholder, officer, director, manager, employee, consultant or
agent of Synthon or any Affiliate) has been asserted nor does
Synthon know of any reasonable bas
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