Batch Records and Data; Release Sample Clauses
The 'Batch Records and Data; Release' clause governs the documentation and management of records related to the production batches of a product, as well as the procedures for their review and approval prior to product release. It typically requires that detailed records be maintained for each batch, including manufacturing steps, quality control results, and any deviations, and that these records are reviewed and verified for compliance with regulatory and contractual standards before the batch is released for distribution. This clause ensures traceability, accountability, and regulatory compliance in the manufacturing process, thereby reducing the risk of releasing non-conforming or unsafe products.
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 SUPPLIER completes of a Batch, SUPPLIER shall provide SPONSOR with copies of Batch records prepared in accordance with the Specifications; provided, that if testing reveals an out-of-Specification result, SUPPLIER shall provide such Batch records promptly following resolution of the out-of Specification result. After SUPPLIER completes a Batch, SUPPLIER shall also provide SPONSOR or its designee with a sample of the Product.
Batch Records and Data; Release. A. Subject to Clause 5.1B, unless otherwise agreed to by the parties in writing, within [***] after Catalent completes Processing of a Batch, Catalent shall provide Palatin with copies of executed Batch records prepared in accordance with the Specifications; provided, that if testing reveals an out-of-Specification result, Catalent shall provide such Batch records within [***] after resolution of the out-of-Specification result. After Catalent completes Processing of a Batch, Catalent shall also provide Palatin or its designee with a certificate of analysis for such Batch. Issuance of a certificate of conformance/analysis constitutes release of the Batch by Catalent to Palatin. Palatin shall be responsible for final release of Product (including testing), at its cost, to the market.
B. If testing reveals an out-of-Specification result with respect to a Batch, Catalent shall report such result to Palatin as soon as practicable, and in any event within [***] after obtaining such result. Within [***] after resolution of the out-of-Specification result, Catalent shall provide Palatin a written report detailing the cause of such out-of-Specification result and the manner in which it was resolved. Catalent shall provide Palatin with such further information as Palatin reasonably requests with respect to such out-of-Specification result.
Batch Records and Data; Release. Unless otherwise agreed to by the parties 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; provided, that if testing reveals an out-of-Specification result, Catalent shall provide such Batch records 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 certificate of analysis for such Batch. Issuance of a certificate of analysis constitutes release of the Batch by Catalent to Client. Client shall be responsible for final release of Product (including testing, at its cost) to the market.
Batch Records and Data; Release. Unless otherwise agreed to by the parties, after Catalent completes a unit operation step in the Processing of a Batch and no later than [*] thereof, Catalent shall provide Client with copies of Batch records for such step prepared in accordance with the Specifications; provided, that if testing reveals an out-ofSpecification result, Catalent shall provide such Batch records and any other documentation as reasonably requested promptly (and no later than [*]) following resolution of the out-of-Specification result. If for any reason Catalent is unable to send final copies of Batch records for Processing steps to Client within [*] of Processing, Catalent will immediately scan and electronically send to Client draft copies of such Batch records, [*], so as to allow Client to review the draft Batch records in parallel with Catalent’s review of such records. After Catalent completes Processing of a Batch and no later than [*] thereof, Catalent shall also provide Client or its designee with a certificate of analysis, certificates of compliance and conformance with cGMP, and TSE/BSE certificate in forms mutually acceptable to the parties for such Batch. Issuance of certificates of analysis, conformance and TSE/BSE certificates constitute release of the Batch by Catalent to Client. Client shall be responsible at its cost for final release of Product to the market.
Batch Records and Data; Release. Unless otherwise agreed to by the parties during their ordinary course of dealings, promptly after Catalent completes Processing of a Batch, Catalent shall provide Client with copies of Batch records prepared in accordance with the Specifications; provided, that if testing reveals an out-of-Specification result, Catalent shall provide such Batch records 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 Certificate of Analysis and Certificate of Manufacture, or a Certificate of Conformance for such Batch. Issuance of a Certificate of Analysis and Certificate of Manufacture (relating to bulk drug product), and a Certificate of Conformance (for further processing), constitutes release of the Batch by Catalent to Client; and issuance of a Certificate of Conformance constitutes a release of a Batch of finished Product by Catalent to Client (each a “Catalent Release”). Client shall be responsible for final release of Product to the market in reliance on Catalent’s Certificate of Analysis/Certificate of Manufacture or Certificate of Conformance (including testing).
Batch Records and Data; Release. Unless otherwise agreed to by the Parties, after Catalent completes Processing of a Batch, Catalent shall provide Client with (i) copies of Batch records, (ii) Catalent’s certificate of analysis for such Batch, and (iii) other documents required for release under the Quality Agreement prepared in accordance with the Specifications (collectively, “Release Documents”). All Release Documents shall constitute Client Confidential Information. Catalent shall also provide any support documents reasonably requested by Client in connection with a particular release (e.g., manufacturing chart recordings, LIMS data) at Client’s cost. Issuance of a certificate of analysis by Catalent constitutes release of the Batch by Catalent to Client. Client shall be responsible for final release of Product (including testing, at its cost) to the market.
Batch Records and Data; Release. Unless otherwise agreed to by the parties during their ordinary course of dealings, after Catalent completes Processing of a Batch, Catalent shall provide Iroko with copies of Batch records prepared in accordance with the Specifications; provided, that if testing reveals an out-of-Specification result, Catalent shall provide such Batch records promptly following resolution of the out-of Specification result and provide Iroko with notification of any anticipated delay in delivery. After Catalent completes Processing of a Batch, Catalent shall also provide Iroko or its designee with a certificate of analysis for such Batch and a "Certificate of Manufacture," which indicates that the material was manufactured under cGMP conditions. Issuance of a certificate of analysis constitutes release of the Batch by Catalent to Iroko. Iroko shall be responsible for final commercial release of Product at its cost to the market.
Batch Records and Data; Release. Unless otherwise agreed to by the parties during their ordinary course of dealings, after Catalent completes Processing of a Batch, Catalent shall provide Supernus with copies of Batch records executed. After Catalent completes Processing of a Batch, and upon confirmed agreement as provided by Supernus QA, Catalent shall also provide Supernus or its designee with Catalent’s issuance of a certificate of conformance for such Batch. Issuance of a certificate of conformance by Catalent constitutes release of the Batch by Catalent to Supernus. Supernus shall be responsible for final release of Product (including testing, at its cost) to the market. [**] = CERTAIN CONFIDENTIAL INFORMATION OMITTED
Batch Records and Data; Release. Unless otherwise agreed to by the parties during their ordinary course of dealings, after Catalent completes Processing of a Batch, Catalent shall provide Client with a copy of the Batch Record for such Batch prepared in accordance with the Specifications within [***] of manufacturing; provided that, if testing reveals an out-of-Specification result, Catalent shall provide such Batch Record promptly following resolution of the out-of-Specification result. Within [***] after Catalent completes Processing of a Batch, Catalent shall also provide Client or its designee with Catalent’s certificate of analysis for such Batch and such other Batch documentation as may be required by the Quality Agreement. Unless otherwise set forth in the Quality Agreement, issuance of a certificate of conformance/analysis by Catalent constitutes release of the Batch by Catalent to Client. Client shall be responsible for final release of Product (including testing, at its cost) to the market.