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 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, 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 in writing, after CoreRx completes Manufacturing of a Batch, CoreRx shall provide Client with copies of Batch records prepared in accordance with the Specifications; provided, that if testing reveals an out-of-Specification result, CoreRx shall provide such Batch records promptly based on QAG out-of-Specification result. After CoreRx completes Manufacturing of a Batch, CoreRx shall also provide Client with CoreRx’s certificate of analysis for such Batch. CoreRx and Acadia will release and disposition the batch per details specified in the QAG. For the avoidance of doubt, CoreRx may use third party testing Client- approved facilities to satisfy its obligations hereunder. 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 or unless otherwise included in the Quality Agreement, after Catalent completes Processing of a Batch, Catalent shall provide Client with copies of Batch Records and a Certificate of Compliance prepared in accordance with the Quality Agreement. Client shall be responsible for final release of Client Product including testing, at its cost to the market.
