definiens: shall mean a batch of PRODUCT ( a ) that ( i ) conforms to the parameters described in thevalidation protocol as agreed in writing between the parties, ( ii ) is manufactured according to cGMP, asapplicable, ( iii ) is validated in accordance with the ICH Q7A Good Manufacturing Practice Guidance forActive Pharmaceutical Ingredients ( the ) ( including, without limitation, that such batch, together with two other such sequential batches of PRODUCT, demonstrates reproducibility of thecommercial manufacturing process for PRODUCT ), ( iv ) supports the NDA ( or other filing for RegulatoryApproval ) for PRODUCT, ( v ) may be used to complete the consistency, comparability and stability studiesfor PRODUCT in connection with any such filing, and ( vi ) meets Specifications ; or ( b ) supports a filing forRegulatory Approval of the implementation of a subsequent process or equipment change with respect tothe commercial manufacture of PRODUCT