Api Supply Agreement Template

CONSIDERING that customer wishes to purchase from Pfizer API Bulk Substance, and Pfizer agrees to supply them under the conditions set forth in this Agreement. `quality agreement` means an agreement between the Parties that describes the Quality Control, Technical, Quality Assurance and Regulatory Responsibilities of the Parties with respect to the production and release of API Bulk Drug Substance, which are produced under this Agreement. (e) capacity. The manufacturer shall make economically reasonable efforts to provide adequate production capacity in order to be able to produce and deliver at least (b) in the event of disagreement between the parties on the compliance of the Bulk Drug Substance API with the specifications in force, the quality assurance representatives of the parties will discuss in good faith to attempt to resolve such discrepancies, and the customer and Pfizer w comply with the specifications of the Bulk Drug Substance API. If the above discussions do not resolve the disagreement within a reasonable period of time (which will not exceed [**], a sample of the USFDA sample retained by Pfizer and a sample of the relevant bulk API drug substance will be submitted for re-testing by Pfizer and customers, to definitively determine whether this API bulk substance complies with the specifications. Such re-testing shall be performed in a laboratory designated by the Customer and approved by Pfizer, using the test methods referred to in the specifications of this Agreement and with representatives of both Parties present at all repeat tests. The determination of compliance or non-compliance by such a new test concerning all or part of this Bulk Drug Substance API is final and binding on the parties. The costs of such a new test shall be borne by Pfizer if the test confirms the non-conformity and, failing that, by the customer if the test confirms compliance. (b) payments.

Payments for all deliveries shall be made in accordance with point 4.02. Subject to Section 2.02(e), Pfizer provides quantities of API Bulk Drug Substance, as in the corresponding order received by Pfizer pursuant to this Section 2.02 and in accordance with the delivery plan set out therein. In the event of any opposition between the provisions of this Agreement and the order, confirmation, invoice, bill of lading, acceptance or any other pre-printed form provided by either party, the provisions of this Agreement shall apply. If, due to an internal Pfizer production problem, Pfizer is unable to deliver the order within the limits of [***] after the desired delivery date, customer is entitled to obtain more than [***] of its annual product requirements from a supplier other than Pfizer, provided that such purchase can only take place during the period [***] in which Pfizer is temporarily unable to meet customer requirements. and is immediately discontinued if the cessation of such incapacity and, ultimately, provided that the customer`s requirements that have not satisfied PFIZER are normal and ordinary requirements, as determined by ordinary purchases of the product made by the customer in the immediately preceding months of Pfizer. . . .