Cooperation with Audit and Inspection Sample Clauses

Cooperation with Audit and Inspection. Amgen and BeiGene shall each respond to any inspection of such Party conducted by a Regulatory Authority, and Amgen and BeiGene, as applicable, shall cooperate with the other Party in response thereto. Amgen shall use reasonable efforts to make data and documents available for such inspection pertaining to Products under this collaboration. For clarity, the foregoing obligations of cooperation are with respect to inspections by a Regulatory Authority related to the storage and distribution of Products and not with respect to an audit or inspection of the Manufacturing of Products. The Parties acknowledge that joint planning for initial audits of the Third Party contractors utilized by each Party in connection with the conduct of Development and Commercialization activities under this Agreement are expected to begin promptly after the Effective Date.
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Cooperation with Audit and Inspection. Amgen and KKC shall each respond to any inspection of such Party conducted by a Regulatory Authority, and Amgen and KKC, as applicable, shall cooperate with the other Party in response thereto. The inspected Party shall notify the other Party promptly of any request received from any applicable Regulatory Authority to inspect or otherwise gain access to the information, data or materials pertaining to the other Party’s activities hereunder. Each Party shall use reasonable efforts to make data and documents available for such inspection pertaining to the Product under this collaboration. For clarity, the foregoing obligations of cooperation are with respect to inspections by a Regulatory Authority related to the storage and distribution of the Product, and not with respect to an audit or inspection of the Manufacturing of the Product.

Related to Cooperation with Audit and Inspection

  • Audit and Inspection During the Term of this Agreement each Party and its duly authorized representatives, upon reasonable notice and during normal working hours, shall have access to the accounting records and other documents maintained by the other Party, or any of the other Party’s contractors and agents, which relate to this Agreement; provided that, neither this Section nor any other provision hereof shall entitle the Company to have access to any records concerning any xxxxxx or offsetting transactions or other trading positions or pricing information that may have been entered into with other parties or utilized in connection with any transactions contemplated hereby or by any other Transaction Document. The right to inspect or audit such records shall survive termination of this Agreement for a period of two (2) years following the Termination Date. Each Party shall preserve, and shall cause all contractors or agents to preserve, all of the aforesaid documents for a period of at least two (2) years from the Termination Date.

  • Audit and Inspection Rights During the Term of this Agreement, Prometheus shall have the right to audit and inspect those portions of the Facility used in the manufacture, packaging, storage, testing, holding, distribution or other handling, receiving or invoicing of the Products and Materials for the sole purposes of ensuring compliance with the Specifications and the Quality Agreement, and, as related to the Products and Materials, each of cGMPs, Applicable Laws, and Regulatory Acts. Prometheus shall have the right to audit and inspect all inventories of Products and Materials contained at the Facility. Such audits or inspections shall be limited to not more than [***] Business Days and shall occur during normal business hours and shall be scheduled by Prometheus at least [***] Business Days in advance by written notice outlining the purpose and focus of the audit or inspection, whereby such audit or inspection date shall be mutually agreed by the Parties; provided, however, that in the event of an Adverse Event or any proposed or actual inspection by the FDA or other Governmental Authority, Prometheus shall have the right at any time upon oral or written notice to GSK of five (5) Business Days to conduct an audit or inspection hereunder. Except in the case of an Adverse Event, Prometheus shall limit such audits to no more than once every twelve (12) months. Prometheus' audit and inspection rights under this Section 9.1 shall not extend to any portions of the Facility, documents, records or other information which do not relate to Products or Materials. GSK may redact information relating to Third Parties or their respective products or materials from any documents deliverable to Prometheus in connection with Prometheus' exercise of its audit and inspection rights hereunder. Inspection by Prometheus or documentation provided to Prometheus related to any of GSK's suppliers or *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. subcontractors related to the manufacture of Product is subject to consent of such GSK supplier or subcontractor. GSK may participate in Prometheus' audit and shall respond to any issues raised by Prometheus based on such audit, with a corrective action plan mutually acceptable to the Parties. For the avoidance of doubt, nothing in this Section 9.1 shall obligate GSK to make available to Prometheus documents indicating GSK's underlying costs related to manufacture of the Products.

  • Information and Inspection Pledgor shall (i) promptly furnish Bank any information with respect to the Collateral requested by Bank; (ii) allow Bank or its representatives to inspect and copy, or furnish Bank or its representatives with copies of, all records relating to the Collateral and the Obligation; and (iii) promptly furnish Bank or its representatives with any other information Bank may reasonably request.

  • Audits and Inspections The Parties’ audit and inspection rights related to this Agreement shall be governed by the terms of the Clinical Quality Agreement.

  • Visitation and Inspection The Borrower will, and will cause each of its Subsidiaries to, permit any representative of the Administrative Agent or any Lender to visit and inspect its properties, to examine its books and records and to make copies and take extracts therefrom, and to discuss its affairs, finances and accounts with any of its officers and with its independent certified public accountants, all at such reasonable times as the Administrative Agent or any Lender may reasonably request after reasonable prior notice to the Borrower; provided that (a) so long as no Event of Default shall have occurred and be continuing, the Administrative Agent and the Lenders shall not make more than one (1) such visit and inspection in any Fiscal Year; (b) if an Event of Default has occurred and is continuing, no prior notice shall be required and the limitation on the number of visits and inspections shall no longer apply; (c) any such inspection and examination, copies and discussions shall not be permitted to the extent it would violate confidentiality agreements or result in a loss of attorney-client privilege or claim of attorney work product so long as the Borrower notifies the Administrative Agent of such limitation and the reason therefor; and (d) any such inspection and examination, copies and discussions shall be subject to the terms of any applicable Master Lease and the accompanying Collateral Access Agreement.

  • Audit, Inspection and Visitation The Adviser shall make available to the Trust during regular business hours all records and other data created and maintained pursuant to the foregoing provisions of this Agreement for reasonable audit and inspection by the Trust or any regulatory agency having authority over the Trust.

  • Maintenance of Books and Records; Inspection The Company shall maintain its books, accounts and records in accordance with generally accepted accounting principles consistently applied, and permit the Secured Party, its officers and employees and any professionals designated by the Secured Party in writing, at any time to visit and inspect any of its properties (including but not limited to the collateral security described in the Transaction Documents and/or the Loan Instruments), corporate books and financial records, and to discuss its accounts, affairs and finances with any employee, officer or director thereof.

  • Audits/Inspections Upon reasonable notice and during normal business hours, the Borrower will, and will cause each of its Subsidiaries to, permit representatives appointed by the Administrative Agent, including, without limitation, independent accountants, agents, attorneys, and appraisers to visit and inspect its property, including its books and records, its accounts receivable and inventory, its facilities and its other business assets, and to make photocopies or photographs thereof and to write down and record any information such representative obtains and shall permit the Administrative Agent or its representatives to investigate and verify the accuracy of information provided to the Lenders and to discuss all such matters with the officers, employees and representatives of such Person.

  • Visits and Inspections Permit representatives of the Administrative Agent or any Lender, from time to time upon reasonable prior notice to visit and inspect its properties; inspect and make extracts from its books, records and files, including, but not limited to, management letters prepared by independent accountants; and discuss with its principal officers, and its independent accountants, its business, assets, liabilities, financial condition, results of operations and business prospects.

  • Inspection of Property; Books and Records; Discussions Keep proper books of records and account in which full, true and correct entries in conformity with GAAP and all Requirements of Law shall be made of all dealings and transactions in relation to its business and activities; and permit representatives of any Lender (upon reasonable advance notice coordinated through the Administrative Agent) to visit and inspect any of its properties and examine and make abstracts from any of its books and records at any reasonable time and as often as may reasonably be desired and to discuss the business, operations, properties and financial and other condition of the Borrower and its Subsidiaries with officers and employees of the Borrower and its Subsidiaries and with its independent certified public accountants.

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