Common use of Batch Records and Data; Release Clause in Contracts

Batch Records and Data; Release. Unless otherwise agreed to by the parties in writing during their ordinary course of dealings, after Catalent completes Processing of a Batch, Catalent shall provide Client with copies of Batch records prepared in accordance with the Specifications and the Quality Agreement, along with any other documentation required under the Quality Agreement; provided, that if testing reveals an out-of-Specification result, Catalent shall provide such Batch records and documentation promptly following resolution of the out-of Specification result. After Catalent completes Processing of a Batch, Catalent shall also provide Client or its designee with a sample of the Product. Issuance of a certificate of conformance, or equivalent, constitutes release of the Batch by Catalent to Client. Client shall be responsible for final release of Product, at its cost, to the market.

Batch Records and Data; Release. Unless otherwise agreed to by the parties in writing during their ordinary course of dealings, after Catalent completes Processing of a Batch, Catalent shall provide Client with copies of Batch records prepared in accordance with the Specifications and the Quality Agreement, along with any other documentation required under the Quality AgreementSpecifications; provided, that if testing reveals an out-of-Specification result, Catalent shall provide such Batch records and documentation promptly following resolution of the out-of of-Specification result. After Catalent completes Processing of a Batch, quality review and Catalent release, Catalent shall also provide Client or its designee with a sample Catalent’s certificate of the Productanalysis for such Batch. Issuance of a certificate of conformance, or equivalent, analysis and certificate of conformance by Catalent constitutes release of the Batch by Catalent to Client. Client shall be responsible for final release of Product, Product to the market (at its cost, to cost and evidenced by Catalent’s receipt of a written notification for release for the marketparticular Batch(es) from Client) in accordance with the Quality Agreement.