GMP Audits Sample Clauses

GMP Audits. Indivior shall have the right to conduct one GMP audit, at no cost to Indivior, during each twelve (12) month period during the Term (i) to observe, inspect, and audit the manner in which Curia conducts Processing of Product; and (ii) inspect Curia's Facilities and records relating to Processing of Product, including Curia's quality and other controls related to its Processing of Product. Except for "for cause" audits which shall be conducted at no cost to Indivior, Indivior shall be charged for all additional audits, including any pre-approval inspections, at rates agreed upon by the parties based on timing of the audit, resource demand and any production disruption that may be caused by such an audit. The cost of any such additional GMP audit during the applicable twelve (12) month period shall be $[***] per day for Calendar Year 2022 and thereafter such amount shall be the base cost and subject to a price increase based on PPI for each subsequent Calendar Year during the Term. To schedule any audit under this Section, except for a "for cause" audit, Indivior shall give Curia reasonable advance notice, but not less than four (4) weeks' notice. All audits shall be carried out during normal business hours, and performed in such a manner as not to unduly delay the performance of the services or interfere with Curia's business. The number of visitors during any audit is limited to two (2) persons for two (2) days. No financial information shall be made available for audit except with respect to supporting documentation for specific out-of-pocket expenses charged to Indivior. All findings from any audit conducted under this Section shall be communicated to Curia, in writing, within thirty (30) business days of such audit. Curia shall notify Indivior of any audits by a Regulatory Authority which are Productspecific. Indivior shall cooperate with Curia with respect to any Product-specific audits and, at Curia's request, shall make one or more of its employees with relevant knowledge, available on site during any such audit to answer questions in connection with any such audit.
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GMP Audits. Ascent shall have access to Upshxx-Xxxxx'x xxxilities at a mutually agreeable time for the sole purpose of auditing Upshxx-Xxxxx'x xxxpliance with current Good Manufacturing Practices and the Act. Such access shall in no way give Ascent the right to any of Upshxx-Xxxxx'x xxxfidential or proprietary information. Further, absent unusual circumstances, such audits shall be limited to ***** (**) times during the first ****** (**) months of this Agreement and ******** thereafter and a reasonable number of employees of Ascent who are subject to the same requirements of confidentiality as Ascent.
GMP Audits. Indivior shall have the right to conduct one GMP audit at the Facility, at no cost to Indivior, during each twelve (12) month period during the Term (i) to observe, inspect, and audit the manner in which Curia conducts Processing of Product; and (ii) inspect Curia and records relating to Processing of Product, including Curia to its Processing of Product. which shall be conducted at no cost to Indivior, Indivior shall be charged for all additional audits, including any pre-approval inspections, at rates agreed upon by the parties based on timing of the audit, resource demand and any production disruption that may be caused by such an audit. The cost of any such additional GMP audit during the applicable twelve (12) month period shall be $10,000 per day for Calendar Year 2023 and thereafter such amount shall be the base cost and subject to a price increase based on PPI for each subsequent Calendar Year during the Term. To schedule any audit under this Article,
GMP Audits a. Within ninety (90) days after the Effective Date, and then once per calendar year thereafter, Laureate will support 1 (one) GMP audit during an active contract. b. The audit may be performed by Customer or by a Third Party, with Third Party costs being at the sole expense of the Customer. A maximum of auditors / Customer participants will be allowed to take part in the actual audit, due to space limitations and dedicated Laureate personnel availability.
GMP Audits. Requirements are addressed as part of the Quality Agreement.
GMP Audits. [Confidential Treatment Requested] shall have the right to audit the facility of Cygnus as may be necessary to assure that all applicable FDA or similar government regulations have been met with respect to Final Product. Cygnus shall permit duly authorized representatives of [Confidential Treatment Requested] to conduct such an audit following the making of a prior appointment. Such audits may be conducted for the sole purpose of assuring compliance with all pertinent acts, regulations, and guidelines promulgated by the FDA and other regulatory authorities concerning the Final Product. The foregoing audits shall be conducted no more than one (1) time per calendar year, unless there are observations which the parties mutually agree require a further audit. Such audits will be permitted during normal business hours and will be performed with a minimum of disruption. [Confidential Treatment Requested] shall furnish Cygnus with copies of all reports prepared as a result of these audits. [Confidential Treatment Requested] agrees to notify Cygnus within ten (10) working days of any concerns that it may have which were discovered during an audit. All information disclosed by Cygnus or discovered or learned by [Confidential Treatment Requested] during such audits shall be deemed Cygnus Confidential Information governed by Section 11.

Related to GMP Audits

  • Field Audits The Agent has the right at any time and in its discretion to conduct field audits with respect to the Collateral and each Borrower’s Receivables, inventory, business and operations. All field audits shall be at the cost and expense of the Borrowers; it being understood and agreed that, in the absence of an Event of Default, the Borrowers’ maximum liability for field audit costs and expenses shall be limited to the reasonable costs and expenses of only two (2) field audits conducted during any twelve (12) month period (unless the Agent shall conduct a field audit pursuant to Section 1.10 of this Agreement in connection with the joinder of a new “Borrower” hereunder, in which event the Borrowers shall be liable for the costs and expenses of such field audit as well). Any and all field audits conducted following an Event of Default shall be at the Borrowers’ cost and expense, with the foregoing limitation on maximum costs and expense being inapplicable.

  • Contract Audits Eligible Purchaser represents and warrants that it shall cooperate with Enterprise Services, the Office of the State Auditor, federal officials, and/or any third party authorized by law or contract, in any audit conducted by such party pertaining to any Contracts that Eligible Purchaser has made purchases from pursuant to this Agreement, including providing records related to any purchases from such Contracts.

  • Audits No more than once a year, or following unauthorized access, upon receipt of a written request from the LEA with at least ten (10) business days’ notice and upon the execution of an appropriate confidentiality agreement, the Provider will allow the LEA to audit the security and privacy measures that are in place to ensure protection of Student Data or any portion thereof as it pertains to the delivery of services to the LEA . The Provider will cooperate reasonably with the LEA and any local, state, or federal agency with oversight authority or jurisdiction in connection with any audit or investigation of the Provider and/or delivery of Services to students and/or LEA, and shall provide reasonable access to the Provider’s facilities, staff, agents and XXX’s Student Data and all records pertaining to the Provider, LEA and delivery of Services to the LEA. Failure to reasonably cooperate shall be deemed a material breach of the DPA.

  • Annual Audits Each fiscal year, the School shall provide for an independent annual financial audit conducted in accordance with Generally Accepted Auditing Standards and Governmental Auditing Standards and performed by a certified public accountant (CPA); provided the Commission may establish an alternative reporting requirement in accordance with State law. The Commission shall provide the guidelines and/or scope of the audit or alternative report and may require minimum CPA qualifications or that the School select from a list of qualified CPAs as provided by the Commission. The School shall provide the completed audit or alternative report to the Commission by November 15 after the conclusion of the fiscal year; provided that the Commission, with reasonable notice to the School, may change the deadline depending on circumstances. The School shall pay for the audit or alternative report if an appropriation is not made by the Legislature for such purpose.

  • SAO AUDIT A. The state auditor may conduct an audit or investigation of any entity receiving funds from the state directly under the Contract or indirectly through a subcontract under the Contract. The acceptance of funds directly under the Contract or indirectly through a subcontract under the Contract acts as acceptance of the authority of the state auditor, under the direction of the legislative audit committee, to conduct an audit or investigation in connection with those funds. Under the direction of the legislative audit committee, an entity that is the subject of an audit or investigation by the state auditor must provide the state auditor with access to any information the state auditor considers relevant to the investigation or audit. B. Grantee shall comply with any rules and procedures of the state auditor in the implementation and enforcement of Section 2262.154 of the Texas Government Code.

  • City Audits The CITY may perform an independent audit. Such audits may cover programmatic as well as fiscal matters. GRANTEE will be afforded an opportunity to respond to any audit findings, and have the responses included in the final audit report. Costs of such audits will be borne by the CITY.

  • Records; Audits Merck will keep, and will cause each of the other Selling Parties, as applicable, to keep, and Moderna will keep, adequate books and records of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] following the end of the Calendar Year to which each will pertain, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party to have access during normal business hours to such of the records as may be reasonably necessary to verify the accuracy of the payments due hereunder for any Calendar Year ending not more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreement.

  • OIG INSPECTION, AUDIT, AND REVIEW RIGHTS ‌ In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine or request copies of Xxxxxx’x books, records, and other documents and supporting materials and/or conduct on-site reviews of any of Xxxxxx’x locations for the purpose of verifying and evaluating: (a) Xxxxxx’x compliance with the terms of this IA and (b) Xxxxxx’x compliance with the requirements of the Federal health care programs. The documentation described above shall be made available by Xxxxxx to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview Xxxxxx and any of Xxxxxx’x employees or contractors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Xxxxxx shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. Xxxxxx’x employees and contractors may elect to be interviewed with or without a representative of Xxxxxx present.

  • Compliance Audits D. 4.1 Compliance Audit(s). Without limiting the generality of section A.7.4 (Records Review), if requested by the Province from time to time, which request shall be at the Province’s sole discretion, the Recipient, at its own expense, will forthwith retain an independent third party auditor to conduct one or more compliance audits of the Recipient or any Project. The audit will be conducted in accordance with Canadian Generally Accepted Auditing Standards, as adopted by the Canadian Institute of Chartered Accountants, applicable as of the date on which a record is kept or required to be kept under such standards. In addition, the audit will assess the Recipient’s compliance with the terms of the Agreement and will address, with respect to each Project, without limitation, the following: (a) whether the Funds were spent in accordance with the Agreement and with due regard to economy, efficiency, and effectiveness; (b) the Project’s progress or state of completion; (c) whether the financial information the Recipient provided is complete, accurate, and timely, and in accordance with the Agreement; (d) whether the Recipient’s information and monitoring processes and systems are adequate to identify, capture, validate, and monitor the achievement of intended benefits of the Project; (e) the overall management and administration of the Project; (f) recommendations for improvement or redress; and (g) whether prompt and timely corrective action is taken on prior audit findings.

  • Cost of Audits Customer shall bear the costs of any audit unless such audit reveals a material breach by SAP of this DPA, then SAP shall bear its own expenses of an audit. If an audit determines that SAP has breached its obligations under the DPA, SAP will promptly remedy the breach at its own cost.

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