Batch Documentation. 4.1 Originals of all batch documents will be retained by the Contractor according to regulatory and Contractor requirements; these records will be maintained for a period of one (1) year following the Product lot’s expiration date.
Batch Documentation. 4.1 Originals of all batch documentation and associated retain samples will be retained by Patheon for a period of one year past the expiry date of the Product at which time the Client will be contacted concerning the future storage or destruction of the documentation. Client to have option of taking ownership of completed batch records, copies of analytical data, and product retains at the end of the storage period.
Batch Documentation. 8.1 The Contractor will deliver to the Customer a Certificate of Analysis with all the release records signed and approved by the Contractor for each batch of Products, certifying that the Contractor has the Batch Documentation and supportive test results with respect to each batch of Products manufactured and delivered to the Customer pursuant to this Agreement, demonstrating that the product release specifications, as defined in the quality agreement, have been met. The Contractor represents and warrants that the Certificate of Analysis, the Batch Documentation and other documentation supplied to the Customer under this Agreement will be accurate and complete. If the Customer requires supplemental documents from the Contractor, including and without limitation in order to obtain or in connection with any Regulatory Authority approvals for the Product, or in connection with any Product recall, the Contractor agrees to cooperate with the Customer and to make available to the Customer such additional or supplemental documentation as may reasonably be requested by the Customer. The Customer shall bear all pre-approved costs and expenses related to obtaining the above mentioned supplemental documents. The Contractor will retain originals of all Batch Documentation, any and all other documentation generated by it in connection with the processing and testing of the Products under the terms of this Agreement, and all records which may be reasonably necessary to assist the Customer in the event of a product recall or otherwise, for not less than five (5) years after the date of expiration of date of the Batch of Product to which they pertain and, if longer, such period as is required by local regulations in force in the Territory.
Batch Documentation. Company will maintain original batch documentation for each Batch as set forth in the Quality Agreement.
Batch Documentation. 6.1. ELAN will retain batch records and related documents in accordance with regulatory and corporate retention requirements.
Batch Documentation. Sanofi shall ensure that KaloBios is provided with copies of all of the batch release documentation (as defined in Section 6.3) for Bulk Substance Manufactured by Sanofi or its subcontractor at the time of delivery to KaloBios of the Bulk Substance, except when KaloBios has agreed to have Bulk Substance shipped to it under quarantine; in which case Sanofi shall provide all outstanding documentation to KaloBios as soon as it is available.
Batch Documentation. Within seven (7) business days following completion of the Quality Review and Approval for each Production Batch, Paragon shall provide Client with a copy of all applicable Batch Documentation, which shall be in Paragon’s standard formats, unless otherwise mutually agreed in writing by the Parties. In addition, Paragon shall provide Client with such information as is reasonably requested in writing by Client relating to the Manufacturing Process, the Master Manufacturing Record, Paragon services performed under this Agreement or other Product-related documentation. Upon Client’s written acceptance of the Batch Documentation (or fourteen (14) business days following delivery to Client of the Batch Documentation or additional information, if Client makes no response) (“Client Approval”) the Batch Documentation shall be deemed approved and the Product shall be delivered as provided in Section 5.3. Any Client requests for documents or other work product that are not specified or contemplated in the Project Plan or produced by Paragon in the ordinary course of business, or other substantive requests for assistance in compiling any Regulatory Filing shall constitute Additional Services, and Paragon shall notify Client of the same, and, if Client authorizes such services, Paragon shall prepare a Change Order and invoice Client for such Additional Services in accordance with the Project Rates.
Batch Documentation. 6.3.1 All original Batch documents will be retained by CBSMA in accordance with regulatory and company requirements for a minimum period equal to [****(*)] or any other period agreed upon in writing between CBSMA and GTC. Such information shall be maintained in confidence by CBSMA in accordance with the terms of the Service Agreement. If CBSMA decides to destroy out of date documents, it must notify GTC in writing of such decision. GTC reserves the right to have the documents transferred to the possession of GTC, upon GTC's written request.
Batch Documentation. A Certificate of Analysis, the Specifications, and a copy of the Batch records (collectively, the “Batch Documentation”) for each Batch (in all cases generated by Cognate in accordance with cGMP and the Quality Agreement) will be delivered by Cognate to Asterias in accordance with the schedule and procedures stated in the applicable SOW and/or the Quality Agreement. If Asterias requires additional copies of such Batch Documentation, these will be provided by Cognate to Asterias at Asterias’s sole cost and expense following Asterias’ written request.
Batch Documentation. 4.1 GTC shall prepare or have prepared relevant written Source Material Collection, clarification, purification, and quality control documents according to its internal procedures and standards. These documents shall be approved by GTC, and made reasonably available to MERRIMACK upon written request. MERRIMACK shall at its option review and approve all MERRIMACK specific batch documentation and release testing documentation.
