Common use of Released SELECTED REAGENT Documentation Clause in Contracts

Released SELECTED REAGENT Documentation. NEKTAR AL will provide COMPANY with a signed certificate of analysis with each BATCH of SELECTED REAGENT. Manufacturing records and Quality Control test results will be reviewed by NEKTAR AL Quality Assurance for conformance to NEKTAR AL requirements. All BATCH related deviation issues will be closed prior to BATCH release by NEKTAR AL Quality Assurance. NEKTAR AL will retain all completed manufacturing records, Quality Control test records, and BATCH related documents for seven (7) years from DATE OF MANUFACTURE. These documents must be accessible for review and inspection at NEKTAR AL’S MANUFACTURING FACILITY by COMPANY during the annual quality audit or by regulatory authorities, if requested. At the end of the document retention period, NEKTAR AL will notify COMPANY in the event that the documents will no longer be retained by NEKTAR AL. COMPANY may elect to have the original records continue to be retained by NEKTAR AL or a third party as designated by NEKTAR AL at COMPANY’S expense.