Records and Retained Samples. During the term hereof, MOVA shall (i) prepare and maintain Batch Records and (ii) retain samples, properly stored, from each lot or batch of Products supplied by MOVA hereunder, sufficient to perform each quality control test specified in the Specifications at least twice. DEPOMED agrees to provide for such purpose all the information, processes, analytical methods, testing procedures, and any other information reasonably requested by MOVA and in the possession of DEPOMED necessary for manufacturing the Product in accordance with cGMPs. MOVA agrees to provide DEPOMED upon release and delivery of the Product, copies of the analytical testing data such as Certificate of Analysis. MOVA agrees to provide DEPOMED copies of its executed Batch Records and related documents. Such records shall be available for audit by DEPOMED, and its designates, as well as FDA and foreign regulatory agencies, upon request. MOVA shall store the manufacture and analysis documentation for each batch of PRODUCT for the shelf life period of the respective batch and for two (2) years thereafter.
Records and Retained Samples. EyePoint will maintain all materials, data and documentation obtained or generated by EyePoint in the course of performing the Manufacturing Services under this Agreement, including all reference standards, retained samples of the Product and key intermediates, and computerized records and files (the “Records”) in a secure area reasonably protected from fire, theft and destruction for the longer of (a) five (5) years after completion of the applicable Purchase Order under which such Records were generated, or (b) two (2) years past the last expiration date of the Product supplied under this Agreement, or, in each case, such longer period as is required by Applicable Law (the “Retention Period”). At the end of the Retention Period, all Records will, at Alimera’s option, either be (i) delivered to Alimera or to its designee in such form as is then currently in the possession of EyePoint, (ii) retained by XxxXxxxx, at Alimera’s cost, until further disposition instructions are received, or (iii) disposed of, at the direction and written request of Alimera. Notwithstanding anything in this Section 6.10 to the contrary, EyePoint may retain copies of any Records as necessary to comply with Applicable Laws or its obligations under this Agreement.
Records and Retained Samples. Hovione will maintain all materials, data and documentation obtained or generated by Hovione in the course of performing the Development Services or Manufacturing Services under this Agreement, including all reference standards, retained samples of Product and key intermediates, and computerized records and files (the “Records”) in a secure area reasonably protected from fire theft and destruction for the longer of (i) * after completion of the applicable Work Plan under which such Records were generated or (ii) * past the last expiration date of Product supplied under this Agreement, or, in each case, such longer period as is required by Applicable Law (the “Retention Period”). At the end of the Retention Period, all Records will, at Client’s option, either be (a) delivered to Client or to its designee in such form as is then currently in the possession of Hovione, (b) retained by Hovione, *, until further disposition instructions are received or (c) disposed of, at the direction and written request of Client. In no event will Hovione dispose of any Records without first giving Client at least * days’ prior written notice of its intent to do so and an opportunity to have the Records transferred to Client. While in the possession and control of Hovione, Records will be available during audits or at other mutually agreed to times for inspection, examination, review or copying by Client and its representatives; provided, however, that Hovione may exclude or redact from such Records any confidential or proprietary information of Third Parties. Notwithstanding anything in this Section to the contrary, Hovione may retain copies of any Records as necessary to comply with Applicable Law, regulatory requirements or its obligations under this Agreement, subject to the obligations of confidentiality of Hovione under this Agreement.
Records and Retained Samples. During the term of this Agreement, Patheon shall (a) prepare and maintain Batch Records and (b) retain samples, properly stored, from each lot or Batch supplied by Patheon hereunder, sufficient to perform each quality control test specified in the Specifications at least twice. Depomed agrees to provide for such purpose all the information, processes, analytical methods, testing procedures, and any other information reasonably requested by Patheon and in the possession of Depomed necessary for manufacturing the Product in accordance with cGMPs. Patheon agrees to provide Depomed upon release and delivery of the Product, copies of the analytical testing data such as Certificate of Analysis. Patheon agrees to provide Depomed with copies of its executed batch production records and related documents. Such records shall be available for audit by Depomed and its designees, as well as FDA and foreign regulatory agencies, upon request. Patheon shall store the manufacture and analysis documentation for each Batch for the shelf life of the Batch and for two (2) years thereafter. Patheon will keep records of the manufacture, testing, and shipping of the Product and shall retain samples of the Product, as necessary to comply with manufacturing regulatory requirements applicable to Patheon, as well as to assist with resolving product complaints and other similar issues. Copies of the records and samples will be retained for a period of three (3) years following the date of Product expiry, or longer if required by law, at which time Depomed will be contacted concerning the delivery and destruction of the documents and/or samples of Product.
Records and Retained Samples. Adolor shall, and the Existing Product Suppliers have agreed to, retain samples and maintain records from each batch of Products and the API Compound used therein for a period required by applicable Laws for record keeping, testing and regulatory purposes or specified in the Quality Agreement. When storing Products, API Compound, Nonconforming Products or Product-derived wastes, Adolor shall, and the Existing Product Suppliers have agreed to, comply with and maintain all storage facilities in compliance with cGMPs and applicable Laws.
Records and Retained Samples. Supplier will maintain all materials, data and documentation obtained or generated by Supplier in the course of performing the Manufacturing Services under this Agreement, including all reference standards, retained samples of Product and key intermediates, and computerized records and files (the “Records”) in a secure area reasonably protected from fire theft and destruction for the longer of (a) five (5) years after completion of the applicable Purchase Order under which such Records were generated, or (b) two (2) years past the last expiration date of Product supplied under this Agreement, or, in each case, such longer period as is required by Applicable Law (the “Retention Period”). At the end of the Retention Period, all Records will, at TESARO’s option and request, either be (i) delivered to TESARO or to its designee in such form as is then currently in the possession of Supplier, (ii) retained by Supplier, at TESARO’s cost, until further disposition instructions are received, or (iii) disposed of, at the direction and written request of TESARO. In no event will Supplier dispose of any Records without first giving TESARO a reasonable opportunity to have the Records transferred to TESARO. While in the possession and control of Supplier, Records will be available during audits or at other mutually agreed to times for inspection, examination, review or copying by TESARO and its representatives; provided, however, that Supplier may exclude or redact from such Records any confidential or proprietary information of Third Parties. Notwithstanding anything in this Section to the contrary, Supplier may retain copies of any Records as necessary to comply with Applicable Law, regulatory requirements or its obligations under this Agreement, subject to the obligations of confidentiality of Supplier under this Agreement.
