PDE Audits Sample Clauses

PDE Audits. No more than once during any [********] period during the Term, AstraZeneca shall have the right to engage a disinterested third party auditor (an “Auditor”) to conduct an audit of Targacept’s Detailing activities to confirm the accuracy of the Detail and PDE related-information contained in the reports delivered by Targacept. Any such audit shall be at AstraZeneca’s sole expense; provided, however, that if the results of such audit identify an overstatement of PDEs in such reports by [********] more in any Calendar Period, then Targacept shall bear the expense of such audit and shall implement promptly corrective actions reasonably acceptable to AstraZeneca to ensure accurate reporting thereafter. At any time within twelve (12) months after the completion of an audit that identifies an overstatement of PDEs by [********] or more in any Calendar Period, AstraZeneca shall have the right to engage an Auditor to conduct, at Targacept’s expense, a subsequent audit of Targacept’s Detailing activities, to ensure that Targacept has corrected its reporting deficiencies.
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PDE Audits. No more than once during any twelve (12) consecutive month period during the Co-Promotion Term, each Party shall have the right to engage a disinterested third party auditor (an “Auditor”) to conduct an audit of the other Party’s Detailing activities to confirm the accuracy of the Detail and PDE related-information contained in the reports delivered by such other Party. Any such audit shall be at the auditing Party’s sole expense; provided, however, that if the results of such audit identify an overstatement of PDEs by [***] percent ([***]%) or more in such reports, then the audited Party shall (i) reimburse such excess payments within sixty (60) says after the date on which such audit is completed; and (ii) bear the expense of such audit.
Sample 1Sample 2
PDE Audits. No more than ******** during any ******** period during the Term, AstraZeneca shall have the right to engage an independent third party auditor (an “Auditor”) to conduct an audit of Targacept’s Detailing activities to confirm the accuracy of the Detail and PDE related-information contained in the reports delivered by Targacept. If the results of such audit identify an overstatement of PDEs, within ******** days after the date on which the Auditor’s report is delivered, Targacept shall reimburse the excess payment made by AstraZeneca for such overstated PDEs, with interest at an annual rate of LIBOR plus ******** basis points (or, if less, the maximum interest rate permitted by Applicable Laws) from the date such excess payment was made by AstraZeneca until such excess payment is reimbursed in full by Targacept. Any audit conducted under this Section 9(d) shall be at AstraZeneca’s sole expense; provided, however, that if the results of such audit identify an overstatement of PDEs in such reports by ******** more in any Calendar Period, then Targacept shall bear the expense of such audit and shall implement promptly corrective actions reasonably acceptable to AstraZeneca to ensure accurate reporting thereafter. At any time within ******** after the completion of an audit that identifies an overstatement of PDEs by ******** or more in any Calendar Period, AstraZeneca shall have the right to engage an Auditor to conduct, at Targacept’s reasonable expense, a subsequent audit of Targacept’s Detailing activities, to ensure that Targacept has corrected its reporting deficiencies.
Sample 1

Related to PDE Audits

  • Audits a. For the annual Fund audit, prepare appropriate schedules and materials. Provide requested information to the independent auditors, and facilitate the audit process.

  • Field Audits The Borrower shall permit the Bank to inspect the Inventory, other Tangible Assets and/or other business operations of the Borrower and each Subsidiary, to perform appraisals of the Equipment of the Borrower and each Subsidiary, and to inspect, audit, check and make copies of, and extracts from, the books, records, computer data, computer programs, journals, orders, receipts, correspondence and other data relating to Inventory, Accounts and any other Collateral, the results of which must be satisfactory to the Bank in the Bank’s sole and absolute discretion. All such inspections or audits by the Bank shall be at the Borrower’s sole expense, provided, however, that so long as no Event of Default or Unmatured Event of Default exists, the Borrower shall not be required to reimburse the Bank for inspections or audits more frequently than once each fiscal year.

  • Compliance Audits Flexion and its designated representatives shall have the right to audit all applicable non-financial records of Patheon for the purpose of determining Patheon’s compliance with the obligations set forth in this Agreement and the Technical Transfer Agreement, including Sections 2.2(a) and 6.2 of this Agreement, and the terms of any Purchase Order. Such audit right shall include the right to inspect: (a) the Materials used in the Manufacture of the Product, (b) the holding facilities for such Materials and Product, (c) the Equipment used in the Manufacture of the Product, (d) all non-financial records relating to the Manufacturing Suite and the Manufacturing of the Product (subject to any other restrictions set forth in this Agreement) and (e) all other documentation set forth in the Quality Agreement. Flexion shall provide Patheon with reasonable prior advance notice of its intention to conduct such audit and the Parties will determine a mutually agreeable date for such audit. ***Confidential Treatment Requested Flexion shall include no more than […***…] of Flexion’s representatives in each such audit, with each such audit lasting no more than […***…] days without Patheon’s prior written consent. Flexion may exercise its audit rights under this Section 3.8 no more than […***…] per calendar year; provided that, in the event any of the following circumstances arise, Flexion may elect and Patheon shall permit Flexion to conduct additional audits in a timely manner: (i) where there is the occurrence of a condition or event relating to the Materials or any Product which constitutes a serious health risk; (ii) where either Party has received correspondence or a report from a Regulatory Authority pointing out a deficiency in the Product by or on behalf of Patheon; (iii) where the Specifications have not been complied with or there is otherwise evidence that compliance with the Specifications is at risk; or (iv) in the event of a recall related to the Product. The Steering Committee will discuss the findings of any audit conducted by Flexion under this Section 3.8 and shall mutually agree upon a plan to remedy any issues identified by Flexion in such audit and Patheon shall use commercially reasonable efforts to implement such plan in a timely manner. Patheon will support the first Product approval, including its inspection if required, of the FDA or equivalent regulatory launch for other jurisdictions (where applicable) (a “PAI”) (including one mock-readiness review and efforts conducted with Flexion representatives in advance of such inspection). Patheon will be prepared for the successful completion of the PAI with respect to the Manufacturing of the Product at the Facility a minimum of […***…] in advance of the anticipated date of the PAI and Patheon will cooperate with Flexion to prepare for and to complete the PAI in accordance with guidelines and requirements set forth by the applicable Regulatory Authority. Additional support (including, without limitation, subsequent regulatory launches or Product approval inspections/resulting reports for other jurisdictions) will be subject to additional fees.

  • Regulatory Audits BNY Mellon shall, upon reasonable prior notice when possible, make all books and records available to the applicable Voya or Voya Fund regulators and state government representatives or their designees to audit, evaluate and inspect BNY Mellon’s books and records for Voya and such Voya Fund. BNY Mellon agrees to reasonably cooperate with and assist Voya in meeting any regulatory requirements related to audits or inspections imposed upon Voya to the extent that Voya notifies BNY Mellon of such requirements.

  • Environmental Audits From time to time, as requested by Lender, at the sole expense of Borrower, Borrower shall provide Lender, or its designee, complete access to all of Borrower's facilities for the purpose of conducting an environmental audit of such facilities as Lender or its designees may deem necessary. Borrower agrees to cooperate with Lender with respect to any environmental audit conducted by Lender or its designee pursuant to this Section 5.10.

  • 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 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED 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.

  • Field Examinations At the Administrative Agent’s sole option, the Administrative Agent shall have completed its field examinations of the Borrower’s books and records, assets, and operations which examinations will be satisfactory to the Administrative Agent in its sole and absolute discretion.

  • Tax Audits A. The Parties acknowledge and agree that the Parent is, and shall continue to be, authorized to undertake any and all actions that are within the scope of Parent’s authority under the Code or the applicable Treasury Regulations, as the common parent corporation of the Consolidated Group in connection with the filing of any Consolidated Returns and any U.S. federal income tax audit, examination or other tax proceeding involving Taxes filed on a group basis. Parent shall have the authority to control, settle and resolve any dispute relating to any Consolidated Returns with the Internal Revenue Service (the “IRS”) or any other Taxing Authority; provided, however, that Parent shall keep NBH duly informed of the progress thereof to the extent that such Tax Proceeding (as defined below in Section 2.5B) or Tax Claim (as defined below in Section 2.5B) could directly or indirectly affect (adversely or otherwise) any member of the NBH Group and that NBH shall have the right to review and comment on any and all submissions made to the IRS, a court, or other Taxing Authority with respect to such Tax Claim or Tax Proceeding and that Parent will consider such comments in good faith. If Parent provides written notice to NBH of its intent to settle or resolve any such Tax Proceeding or Tax Claim (the “Proposed Resolution”), NBH shall have thirty (30) days (or such shorter time as is necessary to avoid material prejudice to Parent or any member of the Affiliated Group, which shorter period Parent shall provide notice of to NBH) within which to provide any objection thereto in writing. If the Parties are unable to reach an agreement within thirty (30) days (or such shorter time as is necessary to avoid material prejudice to Parent or any member of the Affiliated Group, which shorter period Parent shall provide notice of to NBH) after Parent’s receipt of NBH’s written objection to any potential settlement or resolution by Parent of any such Tax Claim or Tax Proceeding, the objection shall be resolved by an independent, nationally recognized accounting firm mutually selected by the Parties (the “Accounting Firm”). The Accounting Firm shall determine whether it is “more likely than not” that an alternative settlement or resolution of such Tax Proceeding or Tax Claim could reasonably be obtained that imposes less liability on the NBH Group (either under this Agreement or applicable law) than the Proposed Resolution and no greater liability on Parent or its affiliates (either under this Agreement or applicable law) than the Proposed Resolution (such settlement or resolution, the “Alternative Resolution”). If the Accounting Firm determines that an Alternative Resolution is reasonably available, Parent shall not enter into the Proposed Resolution. The determination by the Accounting Firm shall be final and binding upon the Parties. Each of Parent and NBH shall bear all fees and costs incurred by it in connection with the resolution of any such Tax Proceeding or Tax Claim, except that (i) the Parties shall each pay one-half (50%) of the fees and expenses of the Accounting Firm, and (ii) without prejudice to Parent’s rights under Section 3.3B, if the Alternative Resolution requires pursuing the settlement or resolution of such Tax Claim or Tax Proceeding in a different forum than the forum in which the Proposed Resolution arose, NBH shall bear all fees and costs incurred in connection with the Tax Proceeding or Tax Claim following the Accounting Firm’s determination.

  • Audit Not more than once per year, or at any time a Party has a reasonable, good faith belief that the other Party has materially breached this Agreement, or (to the extent with respect to this Agreement) the Umbrella Secrecy Agreement, and provides written notice to such other Party as well as detailed documentation or other evidence of such alleged breach, upon thirty (30) days’ advance written notice, such first Party may cause an independent Third Party auditor that is reasonably acceptable to the audited Party and subject to written confidentiality obligations that are reasonably acceptable to the audited Party to audit, during regular business hours and in a manner that complies with the reasonable building and security requirements of the audited Party and its Affiliates, the books, records and facilities of such audited Party and its Affiliates to the extent reasonably necessary to determine such audited Party’s and its Affiliates’ compliance with this Agreement or (to the extent with respect to this Agreement) the Umbrella Secrecy Agreement. Any audit conducted under this Section 2.13 shall not interfere unreasonably with the operations of such audited Party or any of its Affiliates. The Party requesting the audit shall pay the costs of conducting such audit; provided that if such audit reveals a material breach of this Agreement or (to the extent with respect to this Agreement), the Umbrella Secrecy Agreement, the audited Party shall pay all such costs. Upon conclusion of the audit, the Third Party auditor shall furnish to both Parties a report stating only its findings during such audit as to whether or not the audited Party is in compliance with this Agreement, and if such audit has revealed a breach, shall include no more information than is reasonably necessary to provide the basis for such finding. All information learned or obtained from such audit shall be deemed Confidential Information for purposes of this Agreement. Notwithstanding anything to the contrary in this Section, the audited Party may require that the Third Party conducting the audit pursuant to this Section 2.13 be accompanied by the audited Party’s (and in the case of an audit of its Affiliates or Sublicensees, its Affiliate’s or its Sublicensee’s, respectively) representatives at all times during such audit. For clarity, Licensee shall cause its Affiliates that are Sublicensees to comply with this Section 2.13.

  • Environmental Audits and Reports As soon as practicable following receipt thereof, copies of all final environmental audits, investigations, analyses and reports of any kind or character, whether prepared by personnel of Holdings or any of its Subsidiaries or by independent consultants, Government Authorities or any other Persons, with respect to significant environmental matters at any Facility that, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Effect or with respect to any Environmental Claims that, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Effect.

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