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Document Preview Development and License Agreement |
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Title: |
Development and License Agreement |
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Date: |
2003 |
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Preview shows 8KB of 148KB total |
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$40 |
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ID: |
#145677 |
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ANTARES PHARMA, INC.
AND
ELI LILLY AND COMPANY
DEVELOPMENT AND LICENSE AGREEMENT
September 12, 2003
DEVELOPMENT AND LICENSE AGREEMENT
This Development and License Agreement (Agreement) is made and entered into as of the 12th day of September, 2003 (the Effective Date) by and between Antares Pharma, Inc., a Minnesota corporation, having its principal place of business at 707 Eagleview Blvd., Suite 414, Exton, Pennsylvania 19341 (Antares) and Eli Lilly and Company, an Indiana corporation, having its principal place of business at Lilly Corporate Center, Indianapolis, Indiana 46285 (Lilly). Antares and Lilly are sometimes referred to herein individually as a Party and collectively as the Parties, and references to Antares and Lilly shall include their respective Affiliates.
Recitals
WHEREAS, Lilly is engaged in discovering, developing and marketing pharmaceutical products.
WHEREAS, Antares is engaged in the research and development of certain drug delivery devices, including needleless injector systems.
WHEREAS, Lilly desires to obtain, and Antares desires to grant to Lilly, an exclusive, worldwide license to Antares needleless injector systems for use in certain fields upon the terms and conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the foregoing and the mutual covenants and promises contained in this Agreement, the Parties hereto agree as follows:
ARTICLE 1
DEFINITIONS
As used herein, the following terms shall have the following meanings assigned to them in this Article and shall include the plural as well as the singular:
1.1 Adverse Event means any untoward happening in a patient or subject during or after administration of Compound via Device, without regard to a causal relationship between Compound, Device and the event.
1.2 Adverse Event Report means any oral, written or electronically transmitted report of any Adverse Event.
1.3 Affiliate means any Person that 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, the terms controls, controlled, and control means (i) the direct or indirect ability or power to direct or cause the direction of the management and policies of an entity or otherwise direct the affairs of such entity, whether through ownership of equity, voting securities, beneficial interest, by contract, or otherwise, or (ii) the ownership, directly or indirectly, of at least 50% of the voting securities (or other comparable ownership interest for an entity other than a corporation) of a Party.
1.4 Antares Device Development means the conduct of all activities by Antares or on its behalf consistent with the Device Development Plan that are reasonably required to complete development of the Device, including: (i) regulatory affairs, pre-clinical studies and clinical trials in accordance with the cGLPs, cGCPs and cQSRs or other designated quality standards and Applicable Laws; and (ii) all activities relating to developing the ability to manufacture Devices, including, without limitation, tooling development and delivery technologies related to Devices and components thereof, industrial and mechanical design, and manufacturing and quality assurance technical support until such time as manufacturing of Devices intended for commercial sale of Product commences and, thereafter, to the extent required under Applicable Law for continued commercial sale of Product, in the event that the Parties agree that Antares will manufacture the Product.
1.5 Antares Device Development Costs means those costs and expenses incurred by Antares, or for its account, with respect to Antares Device Development that are consistent with the Device Development Plan. Device Development costs include, but may not be limited to, those costs incurred for Device specific FTEs, Device specific Third Person costs, depreciation of Device specific capital investments, and depreciation of an allocation of general Device Development equipment directly associated with Device Development. Product specific Third Person costs include, but are not limited to, direct costs to Antares solely related to the development of Devices
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