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Title: |
Collaboration & License Agreement |
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Date: |
2003 |
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$71 |
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ID: |
#320184 |
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COLLABORATION AND LICENSE AGREEMENT
THIS COLLABORATION AND LICENSE AGREEMENT (the ?Agreement?) is made and entered into as of September 3, 2003 (the ?Effective Date?), by and between POZEN INC., a Delaware corporation (?POZEN?), with a business address of 1414 Raleigh Road, Suite 400, Chapel Hill, NC 27517, and XCEL PHARMACEUTICALS, INC., a Delaware corporation (?Xcel?), located at 6363 Greenwich Drive, Suite 100, San Diego, CA 92122. POZEN and Xcel are sometimes referred to in this Agreement individually as a ?Party? and collectively as ?Parties.?
RECITALS
A. Xcel is a specialty pharmaceutical company focused on the treatment of disorders of the central nervous system and possesses substantial expertise in the marketing of pharmaceutical products for the treatment of migraine.
B. POZEN is a pharmaceutical development company currently specializing in the development of products for migraine therapy.
C. Xcel desires to obtain, and POZEN is willing to grant, the exclusive right to market, promote, sell and distribute POZEN?s MT 300? product within the United States of America and its territories in accordance with this Agreement.
AGREEMENT
In consideration of the mutual covenants contained in this Agreement and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:
| 1. | DEFINITIONS |
The capitalized terms used herein will have the meanings given to them in this Section 1 and throughout this Agreement. Unless the context indicates otherwise, the singular will include the plural and the plural will include the singular.
1.1 ?Affiliate? means a corporation or other business entity which, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with a Party. For purposes of this definition only, ?control? and, with corresponding meanings, the terms ?controlled by? and ?under common control with,? means (a) the possession, directly or indirectly, of the power to direct the management or policies of a legal entity, whether through the ownership of voting securities or by contract relating to voting rights
-1-
CONFIDENTIAL TREATMENT REQUESTED
or corporate governance, or (b) the ownership, directly or indirectly, of more than 50% of the voting securities or other ownership interest of a legal entity; provided, however, that if local law restricts foreign ownership, control will be established by direct or indirect ownership of the maximum ownership percentage that may, under such local law, be owned by foreign interests.
1.2 ?ANDA? means an abbreviated NDA filed pursuant to 21 C.F.R. ?? 314.92 et seq. (2003), or any equivalent filing as may be available at the time.
1.3 ?Autoinjector? means the automatic injection device for multiple uses selected by the Parties in accordance with Section 3.2.1.
1.4 ?Autoinjector Presentation? means the Initial Licensed Product in the Autoinjector.
1.5 ?CMC? has the meaning as set forth in Section 2.1.
1.6 ?Combination Product? means [CONFIDENTIAL TREATMENT REQUESTED].
1.7 ?Commercial Launch? means nationwide launch of commercial sale, promotion and distribution of a Licensed Product in the Territory following Marketing Approval for such Licensed Product.
1.8 ?Commercialization? means (a) pre-launch market development activities conducted with a product in anticipation of Marketing Approval, and (b) marketing, promotion, use, advertising, selling, having sold, distributing or importing a product after Marketing Approval has been obtained. The term ?Commercialize? has a correlative meaning.
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