API Bulk Drug Substance definition
Examples of API Bulk Drug Substance in a sentence
If such recall is initiated because of any failure of the Product to conform to the warranties set forth in this Section 6.05, Pfizer shall promptly reimburse Customer the Purchase Price paid by Customer with respect to the recalled API Bulk Drug Substance.
The selection of such API Bulk Drug Substance Supplier and the terms and conditions of the agreement to be entered into with the API Bulk Drug Substance Supplier shall be subject to approval by the MSC.
In addition, for any binding [***] of a Rolling Supply Forecast, the sum of quantities of API Bulk Drug Substance in Purchase Orders must meet the quantity PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [***] DENOTES OMISSIONS.
Pfizer further represents, warrants and covenants that, at the time of delivery to Customer, the API Bulk Drug Substance manufactured under this Agreement will have been manufactured in accordance with cGMP and all other applicable law, the Quality Agreement, and Specifications.
Pfizer will ensure that all Records of the Manufacture of API Bulk Drug Substance under this Agreement will be retained and archived in accordance with cGMP and applicable law, but in no case for less than a period of five (5) years following completion of the applicable Manufacturing cycle.
By the last business day of the [***] and each [***] thereafter during the term of this Agreement, Customer shall provide Pfizer with Customer’s good faith estimate of Customer’s updated projected monthly requirements for supply of API Bulk Drug Substance for delivery during the following [***] (each such estimate, a “Rolling Supply Forecast”).
Each Purchase Order will set forth the quantities of API Bulk Drug Substance desired, the shipping location and dates by which delivery is to be made, said delivery dates to be no earlier than [***] and no later than [***] after delivery of such Purchase Order.
The invoices shall reflect the price per kilogram of API Bulk Drug Substance provided in Section 4.01(a).
Upon any termination of this Agreement, Customer will promptly return to Pfizer all relevant records, materials or Pfizer Confidential Information relating to the API Bulk Drug Substance in its (or any of its Affiliates’ or contractors’) possession or control.
The determination of conformance or nonconformance by such retesting with respect to all or part of such API Bulk Drug Substance will be final and binding on the Parties.