Common use of Documentation and Reports Clause in Contracts

Documentation and Reports. 21.1 Flamel shall: (a) complete the documentation relative to the Manufacture of each batch of the Intermediate Product in accordance with Good Manufacturing Practice and any other reasonable requirements of GSK and shall retain such documentation in accordance with Section 9 of the Technical Agreement; (b) supply to GSK one (1) completed copy of the Certificate of Analysis relating to the Intermediate Product which is the subject of any Batch Record at the time that such Intermediate Product is delivered; (c) permit GSK access to all Manufacturing, regulatory and quality control records in respect of the Intermediate Product and the Materials used in their Manufacture; (d) supply to GSK a report for the validation batches for each batch of Intermediate Product Manufactured summarizing, but not limited to, the analytical results for each batch Manufactured, the stability results, details of any batch failures, process deviations and any out of specification results as provided for in this Agreement; and (e) complete and lodge with the appropriate authorities where required all documentation relating to the export of intermediate Product where delivery involves export from the country of Manufacture.