Records and Retained Samples Sample Clauses

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.
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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. 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. 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.

Related to Records and Retained Samples

  • Records and Record Keeping Therapist may take notes during session, and will also produce other notes and records regarding Patient’s treatment. These notes constitute Therapist’s clinical and business records, which by law, Therapist is required to maintain. Such records are the sole property of Therapist. Therapist will not alter his/her normal record keeping process at the request of any patient. Should Patient request a copy of Therapist’s records, such a request must be made in writing. Therapist reserves the right, under California law, to provide Patient with a treatment summary in lieu of actual records. Therapist also reserves the right to refuse to produce a copy of the record under certain circumstances, but may, as requested, provide a copy of the record to another treating health care provider. Therapist will maintain Patient’s records for ten years following termination of therapy. However, after ten years, Patient’s records will be destroyed in a manner that preserves Patient’s confidentiality.

  • Inspection of Records and Reports Every Trustee shall have the right at any reasonable time to inspect all books, records, and documents of every kind and the physical properties of the Trust. This inspection by a Trustee may be made in person or by an agent or attorney and the right of inspection includes the right to copy and make extracts of documents. No Shareholder shall have any right to inspect any account, book or document of the Trust that is not publicly available, except as conferred by the Trustees. The books and records of the Trust may be kept at such place or places as the Board of Trustees may from time to time determine, except as otherwise required by law.

  • Records and Reports The contractor shall keep such records as necessary to document compliance with the EEO requirements. Such records shall be retained for a period of three years following the date of the final payment to the contractor for all contract work and shall be available at reasonable times and places for inspection by authorized representatives of the contracting agency and the FHWA. a. The records kept by the contractor shall document the following: (1) The number and work hours of minority and non- minority group members and women employed in each work classification on the project; (2) The progress and efforts being made in cooperation with unions, when applicable, to increase employment opportunities for minorities and women; and (3) The progress and efforts being made in locating, hiring, training, qualifying, and upgrading minorities and women; b. The contractors and subcontractors will submit an annual report to the contracting agency each July for the duration of the project, indicating the number of minority, women, and non-minority group employees currently engaged in each work classification required by the contract work. This information is to be reported on Form FHWA-1391. The staffing data should represent the project work force on board in all or any part of the last payroll period preceding the end of July. If on-the-job training is being required by special provision, the contractor will be required to collect and report training data. The employment data should reflect the work force on board during all or any part of the last payroll period preceding the end of July.

  • Inspection and Retention of Records In addition to any other requirement under this Agreement or at law, Party must fulfill all state and federal legal requirements, and will comply with all requests appropriate to enable the Agency of Human Services, the U.S. Department of Health and Human Services (along with its Inspector General and the Centers for Medicare and Medicaid Services), the Comptroller General, the Government Accounting Office, or any of their designees: (i) to evaluate through inspection or other means the quality, appropriateness, and timeliness of services performed under this Agreement; and (ii) to inspect and audit any records, financial data, contracts, computer or other electronic systems of Party relating to the performance of services under Vermont’s Medicaid program and Vermont’s Global Commitment to Health Waiver. Party will retain for ten years all documents required to be retained pursuant to 42 CFR 438.3(u).

  • Books Records and Reports The Contractor shall establish and maintain accounts and other books and records 7 pertaining to administration of the terms and conditions of this Settlement Contract, including: 8 the Contractor's financial transactions, water supply data, and Project land and right-of-way 9 agreements; the water users' land-use (crop census), land ownership, land-leasing and water use 10 data; and other matters that the Contracting Officer may require. Reports thereon shall be 11 furnished to the Contracting Officer in such form and on such date or dates as the Contracting 12 Officer may require. Subject to applicable Federal laws and regulations, each party to this 13 Settlement Contract shall have the right during office hours to examine and make copies of each 14 other’s books and official records relating to matters covered by this Settlement Contract.

  • Retention of Records and Audit A. The Contractor shall maintain all financial data, supporting documents, and all other records relating to performance and billing under this Agreement for a period in accordance with state and federal law, a minimum retention period being no less than four (4) years after final payment under this Agreement. B. The Contractor shall permit the authorized representative of the Judicial Council or its designee or both at any reasonable time to inspect or audit all data relating to performance and billing to the Judicial Council under this Agreement. Without limiting the foregoing, this Agreement is subject to examinations and audit by the State Auditor for a period of three years after final payment.

  • ACCESS TO RECORDS AND REPORTS The Contractor must maintain an acceptable cost accounting system. The Contractor agrees to provide the Sponsor, the Federal Aviation Administration, and the Comptroller General of the United States or any of their duly authorized representatives access to any books, documents, papers, and records of the contractor which are directly pertinent to the specific contract for the purpose of making audit, examination, excerpts and transcriptions. The Contractor agrees to maintain all books, records and reports required under this contract for a period of not less than three years after final payment is made and all pending matters are closed.

  • Records and Reporting Company will maintain and preserve all records as required by law in connection with its provision of Services under this Agreement. Upon the reasonable request of Distributor, a Fund or the transfer agent for a Class, Company will provide timely copies of: (a) historical records relating to Client transactions involving the Class; (b) written communications regarding the Class to or from Clients; and (c) other materials relating to the provision of Services by Company under this Agreement.

  • Access to Records after Closing (a) For a period of ------------------------------- six years after the Closing Date, Parent and its representatives shall have reasonable access to all of the books and records of the Companies to the extent that such access may reasonably be required by Parent in connection with matters relating to or affected by the operations of the Companies prior to the Closing Date. Such access shall be afforded by Buyer upon receipt of reasonable advance notice and during normal business hours. Parent shall be solely responsible for any costs or expenses incurred by it pursuant to this Section 13.6(a). If Buyer --------------- or the Companies shall desire to dispose of any of such books and records prior to the expiration of such six-year period, Buyer shall, prior to such disposition, give Parent a reasonable opportunity, at Parent's expense, to segregate and remove such books and records as Parent may select. (b) For a period of six years after the Closing Date, Buyer and its representatives shall have reasonable access to all of the books and records relating to the Companies which Parent or any of its Affiliates may retain after the Closing Date. Such access shall be afforded by Parent and its Affiliates upon receipt of reasonable advance notice and during normal business hours. Buyer shall be solely responsible for any costs and expenses incurred by it pursuant to this Section 13.6(b). If Parent or any of its Affiliates shall --------------- desire to dispose of any of such books and records prior to the expiration of such six-year period, Parent shall, prior to such disposition, give Buyer a reasonable opportunity, at Buyer's expense, to segregate and remove such books and records as Buyer may select.

  • Records and Inspection The LLC shall maintain at its place of business the Articles of Organization, any amendments thereto, this Agreement, and all other LLC records required to be kept by the Act, and the same shall be subject to inspection and copying at the reasonable request, and the expense, of any Member.

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