Batch Disposition. For each batch, Fresenius will provide release documentation as defined in Appendix 111 which complies with the provisions set forth herein. Fresenius will provide a standard Certificate of Analysis indicating the test results and specification of each test performed, as well as a signed Certificate of Compliance confirming that the PRODUCTS have been manufactured, tested and stored according to the requirements of the Master Production Record, and in conformance to the Production Standards. Fresenius will provide copies to TransMedics of the batch documentation (Manufacturing Work Order and Packaging Work Order) for the first three commercial lots and one per year thereafter.
Appears in 3 contracts
Sources: Development and Supply Agreement (TransMedics Group, Inc.), Development and Supply Agreement (TransMedics Group, Inc.), Development and Supply Agreement (TransMedics Group, Inc.)