Samples and Batch Records. ELITE shall prepare and maintain batch records and file samples, properly stored, for each lot or batch of Products manufactured and shipped hereunder in compliance with all GMPs and Laws in the Territory.
Samples and Batch Records. During the term hereof, NORAC shall prepare and maintain batch records and a file sample, properly stored, from each batch of product manufactured. Upon termination of this Agreement, NORAC shall offer such file samples to UNIMED, provided that NORAC shall thereafter have access to same if required for regulatory or other purposes required by law.
Samples and Batch Records. VGX shall prepare and maintain or cause to be prepared and maintained batch records and samples, properly stored, from each lot or batch of Product manufactured and shipped hereunder sufficient to perform each quality control test identified in the Specifications. Batch records will be reviewed and approved by VGX and the CUSTOMER prior to commencement of production of Contract Materials. Any material change to an approved batch record will be reviewed and approved by VGX and the CUSTOMER prior to said change being implemented. Any deviation from the manufacturing process specified in the batch record must be documented in the copy of the batch record for that batch. All batch records will be made available to CUSTOMER in English upon completion of each batch. Copies of the batch records will be sent to the CUSTOMER with the certificate of analysis. All documentation related to the manufacturing of Contract Materials shall be archived with VGX during and after the manufacturing, in accordance with its document retention policies and cGMP, for at least one (1) year after the expiration date of each respective batch manufactured. CUSTOMER shall be contacted before destruction of any specific records regarding Contract Materials and shall be given the option to retain such documents. All batch record and related documentation shall be regarded as Confidential Information hereunder. Execution Copy CONFIDENTIAL If a DMF/BMF will be required by the regulatory authorities (such as the FDA, EMEA etc), VGX will submit such a file at a time which will be sufficient enough for these authorities to approve the submission before the full release of the batch. VGX will provide the CUSTOMER with authorization letter that enables the regulatory authorities to review the DMF/BMF regarding the production process of the Product.
Samples and Batch Records. CATALYST shall prepare and maintain batch records and file samples, properly stored, for each lot or batch of Product manufactured and shipped hereunder in compliance with all GMPs and other Applicable Laws pertaining thereto. KYE will retain samples properly stored in Canada in conformity with GMP and the Quality Agreement.
Samples and Batch Records. ARx shall prepare and maintain batch records and file samples, properly stored, for each lot or batch of Product manufactured and shipped hereunder in compliance with the GMPs and Laws in the Territory pertaining thereto.
Samples and Batch Records. CATALYST or Contract Manufacturer shall prepare and maintain batch records and file samples, properly stored, for each lot or batch of Product manufactured and shipped hereunder in compliance with all GMPs and other Applicable Laws pertaining thereto. XXXX will retain samples properly stored in the Territory in conformity with GMP and Regulatory Authority requirements.
Samples and Batch Records. VGX shall prepare and maintain or cause to be prepared and maintained batch records and a file sample, properly stored, from each lot or batch of Product manufactured and shipped hereunder sufficient to perform each quality control test identified in the Specifications. All batch records will be made available to CUSTOMER in English upon completion of each batch. Such batch records will be accessible for review by CUSTOMER at mutually convenient times for both parties.
