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Title: |
Manufacturing and Supply Agreement |
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Date: |
2007 |
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Preview shows 7KB of 71KB total |
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Price: |
$45 |
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ID: |
#2985579 |
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MANUFACTURING AND SUPPLY AGREEMENT
THIS MANUFACTURING AND SUPPLY AGREEMENT (the ?Agreement?) is made and entered into as of the 26th day of April, 2006 (the ?Effective Date?) by and between Xemplar Pharmaceuticals, LLC (?XEMPLAR?), and MAP PHARMACEUTICALS, INC., a Delaware corporation (?MAP?). XEMPLAR and MAP are sometimes referred to herein individually as a ?Party? and collectively as the ?Parties.?
RECITALS
WHEREAS, MAP is engaged in the research and development of proprietary delivery systems, including its proprietary Tempo? device, and formulations suitable for use with such delivery systems for administering drugs by inhalation;
WHEREAS, XEMPLAR is a contract services company focusing on the development of inhalation products and has a facility that, with some modifications, is suitable for the commercial production of pressurized metered dose aerosol canisters for use in such proprietary delivery systems of MAP, including the Tempo? device;
WHEREAS, MAP desires to purchase, and XEMPLAR is willing to manufacture and supply, MAP?s clinical and commercial requirements of Product in accordance with the terms of this Agreement.
AGREEMENT
NOW, THEREFORE, in consideration of the foregoing and the covenants and promises contained in this Agreement, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
1. DEFINITIONS. As used herein, the following terms shall have the following meanings:
?Active Agent? means a component(s) in any particular formulation that provides the formulation with its effectiveness, as opposed to the inactive ingredients, propellant(s), excipient(s) and carrier(s), present in the formulation; the Parties agree that the initial Active Agent shall be dihydroergotamine [ * ] and that additional Active Agents for use with additional Products may be specified from time to time by the mutual written agreement of the parties by incorporation of an Appendix setting forth the specifications for such additional Product.
1.1 ?Affiliate? means a corporation, partnership, trust or other entity that directly, or indirectly through one or more intermediates, controls, is controlled by or is under common control with a Party to this Agreement. For such purposes, ?control,? ?controlled by? and ?under common control with? shall mean the possession of the power to direct or cause the direction of the management and policies of an entity, whether through the ownership of voting stock or partnership interest, by contract or otherwise. In the case of a corporation, the direct or indirect ownership of more than fifty percent (50%) of its outstanding voting shares or the ability otherwise to elect a majority of the board of directors or other managing authority of the entity shall in any event be deemed to confer control, it being understood that the direct or indirect
ownership of a lesser percentage of such shares shall not necessarily preclude the existence of control.
1.2 ?Applicable Laws? means any then current local, state or federal rule, regulation, statute or law in any jurisdiction relevant to the activities undertaken pursuant to this Agreement or applicable to either of the Parties with respect to any matters set forth herein, including, but not limited to, the rules, requirements and regulations of any Regulatory Authority.
1.3 ?Certificate of Analysis? means a document containing the information contemplated by the Quality Agreement and certifying that the Product meets the terms set forth in the Quality Agreement, the Product Specification, GMP and other Applicable Law.
1.4 ?Certificate of Compliance? means a manufacturing compliance report containing the information contemplated by the Quality Agreement and indicating that the XEMPLAR facility is in compliance with all specifications necessary to produce the Product in compliance with the Quality Agreement, the Product Specification, GMP and other Applicable Laws.
1.5 ?Confidential Information? means formulas, practices, procedures, processes, methods, knowledge, know-how, trade secrets, skill, experience, documents, apparatus, results, clinical and regulatory strategies, test data, including pharmacological, toxicological and clinical test data, analytical and quality control data, manufacturing data and descriptions, patent and legal data, market data, financial data or descriptions, devices, assays, chemical formulations, specifications, compositions of matter, product samples and other samples, physical, chemical and biological materials and compounds, and the like, whether or not patentable; provided, however, that Confidential Information shall not include any of the foregoing to the extent it is:
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