Manufacture of API Clause Samples
The 'Manufacture of API' clause defines the responsibilities and requirements for producing the active pharmaceutical ingredient (API) used in a pharmaceutical product. It typically outlines standards for quality, compliance with regulatory guidelines, and may specify approved manufacturing sites or processes. This clause ensures that the API is consistently produced to meet agreed specifications, thereby safeguarding product quality and regulatory compliance throughout the supply chain.
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Manufacture of API. Subject to the terms and conditions of this Agreement, Chemport agrees to manufacture API at the Facility for sale to Amarin. Chemport may not manufacture API at locations other than the Facility without the prior written Consent of Amarin, such Consent not to be unreasonably withheld or delayed and as provided in the Quality Agreement. For the avoidance of doubt, the Parties agree that this Agreement does not obligate Amarin to purchase all of its requirements of the API from Chemport, nor does it obligate Amarin to purchase any particular volumes of API from Chemport except as expressly set forth herein, nor does it obligate Chemport to sell the API exclusively to Amarin except as set forth in Section 2.3. Amarin retains the right to engage or appoint additional suppliers and contract manufacturers of the API from time to time in its sole discretion and Chemport retains the right to supply API to Third Party customers and to appoint Third Party distributors of the API from time to time in its sole discretion.
Manufacture of API. DPC will manufacture API in accordance with cGMPs and other applicable rules and regulations of the FDA. If NovaCardia requires API for distribution of product outside the U.S., then NovaCardia shall so notify DPC, and the parties shall agree on any additional costs and activities required to comply with such foreign governmental or regulatory agencies with jurisdiction over the manufacture, use or sale of such API, as then in effect. In accordance with cGMPs and during the term of this Agreement, DPC shall (i) take all steps necessary to ensure that any API that may be produced by it pursuant to this Agreement shall be free of cross-contamination from any other manufacturing or similar activities and (ii) be responsible for validated cleaning and changeover procedures prior to manufacturing any API for NovaCardia. Both parties shall promptly notify each other of any new instructions or specifications required by the FDA or the Act, and of other applicable domestic or foreign rules and regulations, and shall confer with each other with respect to the best means to comply with such requirements and shall allocate any costs of implementing such changes on an equitable basis. DPC and NovaCardia shall agree on the schedule for manufacture and delivery of API and Pre-Commercial Lots. Unless otherwise agreed by DPC, NovaCardia shall provide at least [. . .***. . .] notice prior to the required shipment date for delivery of product hereunder, or [. . .***. . .].
Manufacture of API. ▇▇▇▇▇▇ ▇▇▇▇▇ will manufacture API in accordance with the API Specifications, cGMPs and other applicable rules and regulations of the FDA and other governmental or regulatory agencies with jurisdiction over the manufacture, use or sale of the API, as then in effect. ▇▇▇▇▇▇ ▇▇▇▇▇ will be responsible for manufacturing issues related to regulatory compliance. The parties shall promptly notify each other of any new instructions or specifications required by the FDA, and of other applicable United States rules and regulations. The parties shall confer with each other with respect to the best means to comply with such requirements and shall allocate any costs of implementing such changes on an equitable basis.
Manufacture of API. 3.1 SP shall Manufacture API in accordance with the terms and conditions of this Agreement and the Proposal, and in substantial compliance with applicable laws and regulations.
3.2 If the applicable Proposal objectives cannot be achieved or require modification, then the Proposal may be amended as provided herein. In the event a required modification to a Proposal is identified by Pharmasset or by BICI, the identifying party shall promptly notify the other party. BICI shall provide Pharmasset with a change order containing an estimate of the required modifications to the scope, fees and timelines specified in the Proposal within ten (10) business days, or as soon as commercially practicable, whichever is later, of receiving or providing such notice, as the case may be (a “Change Order”). If Pharmasset does not approve such Change Order and has not terminated the Proposal but requests the Proposal to be amended to take into account the modification, then Pharmasset and BICI shall use commercially reasonable efforts to agree on a Change Order that is mutually acceptable. If practicable, and at Pharmasset’s request and sole cost and expense, SP shall continue work on the Proposal during any such negotiations, but shall not commence work with respect to the Change Order unless authorized in writing by Pharmasset.
Manufacture of API. 01General. PolyPeptide shall manufacture, test, package, store, handle, label, release and ship all API in accordance with the API Specifications, applicable (c)GMPs, applicable Legal Requirements, and the terms of this Agreement and of the Quality Agreement.
Manufacture of API