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 POZENs 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

CONFIDENTIAL TREATMENT HAS BEEN GRANTED FOR THE REDACTED PORTIONS OF THE AGREEMENT THAT ARE MARKED WITH ASTERISKS AND BRACKETS ([***]). A COMPLETE COPY OF THIS AGREEMENT, INCLUDING THE REDACTED PORTIONS, HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.

entity, whether through the ownership of voting securities or by contract relating to voting rights 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 any formulation of dihydroergotamine in any dosage strength in combination with one or more additional pharmaceutically active ingredients administered by [***] or [***], and specifically without limitation excluding any formulation administered by any [***].

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.

1.9 Commercially Reasonable Efforts mean, as to either Party relative to any Licensed Product, those efforts and resources normally used by such Party for a product owned by it which has a similar market potential and is at a similar stage in its product life cycle as the Licensed Product at issue; provided, however, that such efforts and resources will be no less than those typically applied by a pharmaceutical company of similar size as such Party as of the Effective Date (or any larger size that such Party may have at such later time) for a product owned by such company which has a similar market potential and is at a similar stage in its product life cycle as the Licensed Product at issue.

Home        Intelligence        Services        Subscriptions        News        About Us

Contact Us       Terms of Use       Resend Documents       Shopping Cart

Copyright © 2008 The Consus Group LLC