Documentation and Release Sample Clauses
Documentation and Release. 16.10.1 Targacept shall maintain, or cause any Third Party that Manufactures Materials to maintain, all records necessary to comply with all Applicable Laws relating to the Manufacture of the Materials, including Manufacturing records, standard operating procedures, equipment log books, batch records, laboratory notebooks and all raw data relating to the Manufacturing of such Materials. All such records shall be retained for such period as may be required by Applicable Laws. Prior to destruction of any such records, Targacept shall offer custody of such records to AstraZeneca.
16.10.2 Each delivery of Materials shall be accompanied by (a) a certificate of analysis setting forth the tests conducted and the results thereof with respect to such Materials (other than Research Compound Materials) and (b) a certificate of compliance stating that such Materials comply with the applicable Specifications and have been Manufactured and tested in accordance with Applicable Laws.
16.10.3 In addition, Targacept shall provide, or cause any Third Party that Manufactures any Materials to provide, as applicable, to AstraZeneca such other records and documentation in its possession or control relating to each delivery of Materials as AstraZeneca reasonably may request, including completed batch records, deviation reports, out-of-specification reports, and investigation reports.
16.10.4 If required by AstraZeneca pursuant to any Purchase Order, Targacept shall, or shall cause the Third Party that Manufactures the applicable Materials to, (a) perform release as required by Applicable Law for each delivery of Materials and (b) if so requested by AstraZeneca, cause a Qualified Person as described in Articles 48 and 49 of Directive 2001/83/EC to release each delivery of Materials to be distributed in Europe as described in Article 13 of Directive 2001/20 /EC.
Documentation and Release. Prior to each shipment of BX7 and/or API Compound, Supplier shall provide Adolor with a Certificate of Analysis and Certificate of Compliance, and, at Adolor’s request, Supplier shall provide Adolor with reasonable access to any applicable supporting data. Prior to release of the BX7, Validation Batches and/or API Compound, Supplier shall test the BX7 and/or API Compound in accordance with the testing procedures described in the Specifications, and shall provide Adolor with a copy of the applicable Executed Batch Record for each batch shipped and a copy of the applicable deviation or other investigatory report, if any. Adolor shall review the Certificate of Analysis and Certificate of Compliance, and indicate to Supplier, within fifteen (15) days after receipt of such certificates, whether to release each batch of API Compound, Validation Batch or BX7 for shipment. If Adolor does not provide notice to Supplier within such fifteen (15) day period, Supplier shall be entitled to ship the API Compound, Validation Batch or BX7 to the designation indicated pursuant to Section 6.1. With each shipment of BX7, Validation Batch and/or API Compound, Supplier shall provide Adolor with commercially appropriate shipping documentation, including bills of lading.
Documentation and Release. Prior to each shipment of Drug Product, PII shall provide Adolor with a Certificate of Analysis and a Certificate of Compliance, as required by the Quality Agreement, and, at Adolor’s request, PII shall provide Adolor with reasonable access to any applicable supporting data. Prior to release of the Drug Product, PII shall test the Drug Product in accordance with the testing procedures described in Schedule 1.42 and against the Specifications, and shall provide Adolor with a copy of the applicable Executed Batch Record for each batch shipped and a copy of the applicable deviation or other investigatory report, if any. Adolor shall review the Certificate of Analysis and the Certificate of Compliance and indicate to PII, within fifteen (15) days after receipt of such certificates, whether to release each batch of Drug Product for shipment. If Adolor does not provide notice to PII within such fifteen (15) day period, PII shall be entitled to ship the Drug Product to the designated location indicated pursuant to Section 6.1. With each shipment of Drug Product, PII shall provide Adolor with commercially appropriate shipping documentation, including bills of lading.
Documentation and Release. Prior to each shipment of Drug Product, CRL shall provide Client with a Certificate of Analysis and a Certificate of Compliance, as required by the Quality Agreement, and, at Client’s request, CRL shall provide Client with reasonable access to any applicable supporting data. Prior to release of the Drug Product, CRL shall test the Drug Product in accordance with the testing procedures described in Schedule 1.62 and against the Specifications, and shall provide Client with a copy of the applicable Executed Batch Record for each batch shipped and a copy of the applicable deviation or other investigatory report, if any. Client shall review the Certificate of Analysis and the Certificate of Compliance and indicate to CRL within [***] ([***]) days after receipt of such certificates, whether to release each batch of Drug Product for shipment in accordance with the Quality Agreement. If Client does not provide notice to CRL within such [***] ([***]) day period, CRL shall store the Drug Product pursuant to Section 6.6.2 or until such time as the Drug Product is released. With each shipment of Drug Product, CRL shall provide Client with commercially appropriate shipping documentation, including bills of lading.
Documentation and Release. Prior to each shipment of API Compound, Supplier shall provide Adolor with a Certificate of Analysis and a Certificate of Compliance, and, at Adolor’s request, Supplier shall provide Adolor with reasonable access to any applicable supporting data. Prior to release of the API Compound, Supplier shall test the API Compound in accordance with the testing procedures described in Schedule 1.44 and against the Specifications, and shall provide Adolor with a copy of the applicable Executed Batch Record for each batch shipped and a copy of the applicable deviation or other investigatory report, if any. Adolor shall review the Certificate of Analysis and the Certificate of Compliance, and indicate to Supplier, within fifteen (15) days after receipt of such certificates, whether to release each batch of API Compound for shipment. If Adolor does not provide notice to Supplier within such fifteen (15) day period, Supplier shall be entitled to ship the API Compound to the designation indicated pursuant to Section 6.1. With each shipment of API Compound, Supplier shall provide Adolor with commercially appropriate shipping documentation, including bills of lading,