Bulk API definition
Examples of Bulk API in a sentence
No Bulk API or Finished Product may be reprocessed without the prior written consent of Santarus.
The Quantity Dispensed shall only include Bulk API received and dispensed in connection with commercial manufacturing of Finished Product and, for certainty, shall not include any Bulk API received or dispensed in connection with technical transfer activities or development activities during the applicable period, including, without limitation, any regulatory, stability, validation or test batches manufactured during the applicable period.
The Quantity Dispensed is calculated by adding the Quantity Received to the inventory of Bulk API that complies with the Specifications and is held at the beginning of the applicable period, less the inventory of Bulk API that complies with the Specifications and is held at the end of such period.
The Parties shall negotiate in good faith and enter into a quality agreement governing the quality control, quality assurance and validation of the commercial and clinical supply of Bulk API and Product.
The Non-Opt-Out Party automatically owns one-half (1/2) of any or all of the inventory in existence as of the Opt-Out Effective Date of Bulk API and/or finished Product for such Royalty Product (such inventory, the “Existing Inventory”).
If either Party becomes aware of information relating to any Product that indicates that a unit or batch of Finished Product or Bulk API may not conform to the specifications therefor, or that potential adulteration, misbranding, or other issues have arisen that relate to the safety or efficacy of the Product, it shall promptly so notify the other Party.
QUANTITY DISPENSED: The total quantity of Bulk API dispensed at the Facility during the applicable period.
Subject to the terms and conditions of this Agreement, Rhizen retains the exclusive right to manufacture the Product, including the Bulk API and Finished Product in the Territory.
The Parties shall negotiate in good faith and enter into a quality agreement governing the quality control, quality assurance and validation of the commercial and clinical supply of the Bulk API to Takeda by or on behalf of Affymax and the commercial and clinical supply of Finished Product by or on behalf of Takeda.
The Supply Agreement shall include additional rights of audit and inspection of facilities used to manufacture Bulk API to be supplied to Takeda in circumstances other than those described in this Section 7.5, to the extent and on such terms as the Parties may reasonably agree.