Batch Records and Certificates Sample Clauses

Batch Records and Certificates. Prior to the first manufacture of Finished Product under this Section 3.9 by or on behalf of Arena, Arena shall provide Roivant with a copy of the Master Batch Record for such Finished Product for Roivant’s review and approval. Arena shall consider in good faith any reasonable comments Roivant provides regarding the Master Batch Record for such Finished Product. To the extent required for inclusion in a Regulatory Filing to be made by Roivant, its Sub-distributors or its or their Affiliates, Arena shall provide to Roivant: (a) a copy of the Batch Records for each Batch of Compound covered by the Regulatory Filing, (b) a completed and accurate Certificate of Analysis as to such Batch of Compound, and (c) copies of all other documentation required for Compound release as provided in the Quality Agreement. Arena shall provide to Roivant, accompanying each delivery of Finished Product under this Section 3.9 by Arena: (i) the Batch number of the delivered Finished Product, (ii) a copy of the Batch Records for such Finished Product, (iii) a completed and accurate Certificate of Analysis as to such Batch of Finished Product, and (iv) copies of all other documentation required for Finished Product release as provided in the Quality Agreement.
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Batch Records and Certificates. Prior to the first manufacture of a Finished Product under Article 6 of this Agreement by or on behalf of Arena, Arena shall provide Roivant with a copy of the Master Batch Record for such Finished Product for Roivant’s review and approval. Arena shall consider any reasonable comments Roivant provides regarding the Master Batch Record for the Finished Product. Arena shall provide to Roivant, accompanying each delivery of Finished Product by or on behalf of Arena: (i) the Batch number and Purchase Order number (if included on the applicable Purchase Order) of the delivered Finished Product, and (ii) a completed and accurate Certificate of Analysis as to such Batch. [***], Arena shall also provide to Roivant, accompanying each such delivery: (A) a copy of the Batch Records for the Finished Product, and (B) copies of all other documentation required for release of the Finished Product as provided in the Quality Agreement.

Related to Batch Records and Certificates

  • Disposition of Books, Records and Canceled Certificates DST may send periodically to the Fund, or to where designated by the Fund, all books, documents, and all records no longer deemed needed for current purposes, upon the understanding that such books, documents, and records will be maintained by the Fund under and in accordance with the requirements of applicable federal securities laws. Such materials will not be destroyed by the Fund without the consent of DST (which consent will not be unreasonably withheld), but will be safely stored for possible future reference.

  • Quality control records and Documents The Contractor shall hand over a copy of all its quality control records and documents to the Authority’s Engineer before the Completion Certificate is issued pursuant to Clause 12.2. The Contractor shall submit Road Signage Plans to the Authority Engineer for approval at least 6 (six) months prior to expected completion of Project Highway.

  • Licenses and Certificates Contractor shall, at all times during the term of this Contract, maintain in full force and effect such licenses as may be required by the State of California or any other governmental entity for Contractor to perform the duties specified herein and provide the services required pursuant to this Contract. Contractor shall strictly adhere to, and obey, all governmental rules and regulations now in effect or as subsequently enacted or modified, as promulgated by any local, state, or federal governmental entities.

  • Reports and Certificates Each report and certificate delivered in connection with the Issuance Advice Letter or delivered in connection with any Advice Letter made to the CPUC by the Issuer with respect to the Fixed Recovery Charges or True-Up Adjustments will constitute a representation and warranty by the Servicer that each such report or certificate, as the case may be, is true and correct in all material respects; provided, however, that to the extent any such report or certificate is based in part upon or contains assumptions, forecasts or other predictions of future events, the representation and warranty of the Servicer with respect thereto will be limited to the representation and warranty that such assumptions, forecasts or other predictions of future events are reasonable based upon historical performance (and facts known to the Servicer on the date such report or certificate is delivered).

  • 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.

  • Development Records Each Party shall maintain complete, current and accurate records of all Development activities conducted by it hereunder, and all data and other information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all non-clinical studies and Clinical Trials in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH, cGCP, cGLP, and cGMP).

  • Documentation and Record Keeping 1. Records to be Maintained Subrecipient shall maintain all records required by the Federal regulations specified in 24 CFR 570.506 that are pertinent to the activities to be funded under this Contract. Such records shall include, but not be limited to: a. Records providing a full description of each activity undertaken; b. Records demonstrating that each activity undertaken meets the one of the National Objectives of the CDBG program; c. Records required to determine the eligibility of activities; d. Records required to document the acquisition, improvement, use, or disposition of real property acquired or improved with CDBG assistance; e. Records documenting compliance with the fair housing and equal opportunity components of the CDBG program; f. Financial records as required by federal regulations 24 CFR 570.502, and 24 CFR 84.21-28; and g. Other records necessary to document compliance with Subpart K of 23 CFR.

  • Periodic Review of Costs of Environmental Compliance In the ordinary course of its business, the Company conducts a periodic review of the effect of Environmental Laws on the business, operations and properties of the Company and its subsidiaries, in the course of which it identifies and evaluates associated costs and liabilities (including, without limitation, any capital or operating expenditures required for clean-up, closure of properties or compliance with Environmental Laws or any permit, license or approval, any related constraints on operating activities and any potential liabilities to third parties). On the basis of such review and the amount of its established reserves, the Company has reasonably concluded that such associated costs and liabilities would not, individually or in the aggregate, result in a Material Adverse Change.

  • Project Records Borrower shall: Make and keep books, records, and accounts, in such reasonable detail, so as to fully, accurately, and fairly reflect the activities of Borrower. Record the Project’s assets, liabilities, revenues, expenses, receipts and disbursements in separate accounts from any other assets, liabilities, revenues, expenses, receipts and disbursements of Borrower so as to permit the production of a Statement of Financial Position, a Statement of Profit and Loss (Statement of Activities), and a Statement of Cash Flows for Borrower in which the activities of Borrower are separately identifiable from the activities of the Operator, unless Borrower is also Operator. Devise and maintain a system of internal accounting controls sufficient to provide reasonable assurances that: Transactions are executed, and access to assets is permitted, only in accordance with Xxxxxxxx’s authorization; Transactions are accurately and timely recorded to permit the preparation of quarterly and annual financial reports in conformity with applicable Program Obligations; Transactions are timely recorded in sufficient detail so as to permit an efficient audit of the Borrower’s books and records in accordance with Generally Accepted Auditing Standards (GAAS), Generally Accepted Government Auditing Standards (GAGAS), and other applicable Program Obligations; and Transactions are timely recorded in sufficient detail so as to maintain accountability of the Borrower’s assets. The recorded accountability for assets shall be compared with the existing assets at reasonable intervals, but not less than annually, and appropriate action shall be taken with respect to any differences. Make the books, records and accounts of Borrower available for inspection by HUD or its authorized representatives, after reasonable prior notice, during normal business hours, at the Project or other mutually agreeable location or, at HUD’s request, shall provide legible copies of such documents to HUD or its authorized representatives within a reasonable time after HUD or its authorized representative makes a request for such documents. Include as a requirement in any operating or management contract that the books, records, and accounts of any agent of Borrower, as they pertain to the operations of the Project, shall be kept in accordance with the requirements of this Section 19 and be available for examination by HUD or its authorized representatives after reasonable prior notice during customary business hours at the Project or other mutually agreeable location or, at HUD’s request, the Management Agent shall provide legible copies of such documents to HUD or its authorized representatives within a reasonable time after HUD or its authorized representative makes the request.

  • Books and Records; Inspection and Examination The Borrower will keep accurate books of record and account for itself pertaining to the Collateral and pertaining to the Borrower's business and financial condition and such other matters as the Lender may from time to time request in which true and complete entries will be made in accordance with GAAP and, upon the Lender's request, will permit any officer, employee, attorney or accountant for the Lender to audit, review, make extracts from or copy any and all corporate and financial books and records of the Borrower at all times during ordinary business hours, to send and discuss with account debtors and other obligors requests for verification of amounts owed to the Borrower, and to discuss the Borrower's affairs with any of its directors, officers, employees or agents. The Borrower will permit the Lender, or its employees, accountants, attorneys or agents, to examine and inspect any Collateral, other collateral covered by the Security Documents or any other property of the Borrower at any time during ordinary business hours.

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