Certificate of Analysis. With each delivery of the Product into Consignment Inventory pursuant to Section 7.3 or to Celltech from other than Consignment Inventory, Orphan Medical shall provide to Celltech (i) a Certificate of Analysis and Certificate of Conformity confirming that the Product has been manufactured in accordance with cGMP and the Product Specifications, (ii) a copy of all batch documentation from the Product manufacturer for the first three (3) batches of Product delivered to Celltech and (iii) a copy of the annual stability test report, provided that the provision of the certificates and other documents listed in (i) - (iii) above shall not release Celltech from any of its obligations hereunder, including, without limitation, its obligation to conduct all necessary release testing to ensure that the Products distributed in the Territory comply with all applicable regulatory requirements in the Territory.
Appears in 4 contracts
Samples: License and Distribution Agreement (Celltech Group PLC), Quality Agreement (Orphan Medical Inc), License and Distribution Agreement (Orphan Medical Inc)
Certificate of Analysis. With each delivery of the Product into Consignment Inventory pursuant to Section 7.3 or to Celltech from other than Consignment Inventory, Orphan Medical shall provide to Celltech (i) a Certificate of Analysis and Certificate of Conformity confirming that the Product has been manufactured in accordance with cGMP and the Product Specifications, (ii) a copy of all batch documentation from the Product manufacturer for the first three (3) batches of Product delivered to Celltech and (iii) a copy of the annual stability test report, provided that the provision of the certificates and other documents listed in (i) - β(iii) above shall not release Celltech from any of its obligations hereunder, including, without limitation, its obligation to conduct all necessary release testing to ensure that the Products distributed in the Territory comply with all applicable regulatory requirements in the Territory.
Appears in 1 contract
Samples: License and Distribution Agreement (Orphan Medical Inc)