Common use of Documentation and Release Clause in Contracts

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.