Batch Release. ▇▇▇ shall ensure that each Product has been Manufactured in compliance with the requirements of the Registration and shall release only batches accompanied by a certificate of compliance and analysis signed by a qualified person of ▇▇▇ that the Product has been Manufactured by ▇▇▇ according to the Specifications and that ▇▇▇ is committed to inform WCCI in the event of any change in the Manufacturing process or in the analytical specification, in accordance with the terms of this Agreement, and of any noted incident occurring during the Manufacture of the Product. In preparing the certificate of compliance and analysis, a qualified person of ▇▇▇ shall take into account analytical results, essential information such as the production conditions, the results of in-process controls and the examination of Manufacturing documents. ▇▇▇ shall create and retain records relating to each batch of the Product Manufactured hereunder in accordance with applicable Law.
Appears in 2 contracts
Sources: License and Supply Agreement (Warner Chilcott CORP), License Agreement (Warner Chilcott CORP)