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Api Supply Agreement

(e) capacity. The manufacturer makes economically appropriate efforts to: to use adequate production capacity to be able to work a minimum of (b) in the event of disagreement between the parties over the bulk substances compliance with the applicable specifications, the parties` quality assurance representatives will discuss in good faith that they are working to resolve these disputes and the client and Pfizer will follow their respective standard operating procedures to determine the Bulk Drug Substance API`s compliance with the specifications. If the above discussions do not compensate for disputes within a reasonable time (which will not exceed [O), a sample of Pfizer`s USFDA occupancy sample and a sample of the API in charge of the bulk substance pfizer and the client will be re-examined to determine whether this bulk substance complies with API specifications. These new tests are conducted in a customer-designated laboratory agreed upon by Pfizer using the testing methods referred to in the specifications of this agreement, as well as with representatives of both parties present at all new trials. The verification of compliance or non-compliance by such repeated testing with respect to all or part of the bulk substance of the API is final and binding on the parties. The cost of these repeated tests is borne by Pfizer if the test confirms non-compliance, and in another way by the customer if the test confirms compliance. a) Initial forecasts. Upon completion of this delivery agreement, the customer will present to Pfizer the customer`s estimate of the customer`s forecasted requirements for the supply of bulk API substance for delivery during the first [O] (such an estimate, the “Initial Supply Forecast”). The first of the initial supply forecast is mandatory and the customer placed an order in accordance with Section 2.02 for the first of the first continuous supply forecast. The following of this first-supply forecast is a binding obligation in which the customer cannot change the quantities of more than [O` in any month. The latest of this initial supply forecast is a good faith estimate that is presented exclusively to help Pfizer plan production. For a description of the API delivery agreement, see item 3.6Ai. As part of the tesamorelin manufacturing process, the company entered into an agreement to manufacture and supply the tesamoreline drug with Draxis Pharma, a division of Draxis Specialty Pharmaceuticals, Inc.

This API supply agreement replaces and replaces an earlier agreement between the company and Bachem, the U.S. subsidiary of Swiss-based Bachem AG, for the production of tesamorelin. Recipharm and BIAL have extended their long-term delivery agreement for the production and supply of Opicapon APIs worldwide. To view the original version on PR Newswire, visit: www.prnewswire.com/news-releases/amri-announces-api-supply-agreement-with-shire-300368811.html WHEREAS, Customer is carefully purchased by Pfizer API Bulk Drug Substance and Pfizer is ready to deliver the same under the terms of this agreement. b) quality agreement. Representatives of the quality assurance divisions of the contracting parties meet to develop and approve a quality agreement.