Clinical Manufacturing definition

Clinical Manufacturing or “Clinical Manufacture” means Manufacture of a Licensed Product (including the cost of Manufacturing Licensed Antibody contained in Licensed Product) or acquisition of such Licensed Antibody and Licensed Product from a CMO, in each case, for use in Clinical Trials.
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Clinical Manufacturing means the Manufacture of the Compound or any Product (including the cost of Manufacturing the Compound contained in any Product) or acquisition of the Compound or any Product from a CMO, in each case, for use in Clinical Trials. “Clinical Manufacture” shall have a correlative meaning.
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Clinical Manufacturing or “Clinical Manufacture” means the Manufacture of a Licensed Product (including Manufacturing the Licensed Compound contained in such Licensed Product) or the acquisition of such Licensed Compound and Licensed Product from a CMO, in each case, for use in Clinical Trials.
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Examples of Clinical Manufacturing in a sentence

  • Notwithstanding the foregoing, the disclaimers set forth in this Section 4.2.2 (Takeda Materials Disclaimer) will not negate any express warranties made by Takeda in the Takeda Clinical Manufacturing and Supply Agreement.

  • The Parties will negotiate the terms and conditions of such Takeda Clinical Manufacturing and Supply Agreement in good faith for a period of [***] days (as may be extended upon agreement of the Parties).

  • Within [***] days after the Effective Date, the Parties will enter into a manufacturing and supply agreement (the “Takeda Clinical Manufacturing and Supply Agreement”), which will govern the terms and conditions of the Manufacturing and supply of the TAK-385 Licensed Compound and TAK-385 Licensed Products (including the Initial Clinical Supply) by Takeda to Licensee for Development purposes, including the exact quantities and the timelines for delivery.

  • As part of the negotiation related to the Takeda Clinical Manufacturing and Supply Agreement, the Parties shall discuss in good faith the ability of Takeda to supply to Licensee [***].

  • BMPI and Chiron are parties to an exclusive, Clinical Manufacturing Supply Agreement effective March 28, 2001, under which Chiron has manufactured and supplied BMPI with purified bulk recombinant human platelet derived growth factor (PDGF), as described in Chiron's FDA-approved Biological License Application therefor ("CHIRON'S BLA"), for use in product development and clinical testing and in the Fields (as defined below).

  • For avoidance of doubt, nothing in this Agreement changes the Development and Clinical Manufacturing Agreement dated [***], together with any amendments thereto.

  • Such Party shall be solely responsible for the Clinical Manufacturing Costs for such Independent Studies, [***].

  • The "Clinical Manufacturing Cost" shall be equal to [*], calculated in accordance with reasonable cost accounting methods that comply with generally accepted accounting principles.

  • I3 shall perform all maintenance required to maintain the Clinical Manufacturing Facility and Process in good operating condition as required by the Construction Specifications, Requirements, cGMP and all other applicable federal, state and local laws, regulations, rules or orders.

  • The parties agree that during the final two weeks of December of each year, I3 will cease production of the Product to conduct maintenance to the Clinical Manufacturing Facility and Process.