Common use of Operational Audit Rights Clause in Contracts

Operational Audit Rights. At any time, during the Term and for three (3) years after this Agreement has expired or been terminated in its entirety, during normal business hours and upon reasonable prior notice (which shall be no less than ten (10) Business Days), each Pfizer Licensor may send a reasonable number of qualified representatives of such Pfizer Licensor, its Affiliates, and/or a Third Party reasonably acceptable to the applicable Company Licensee to inspect such Company Licensee’s, its Affiliates’ and its Sublicensees’ facilities used in connection with this Agreement and review the records and operations related to such Company Licensee’s, its Affiliates’ and its Sublicensees’ exercise of their rights and performance of their obligations hereunder to ensure compliance with the terms hereof. Such audits shall occur no more than once per Calendar Year except to the extent that the applicable Pfizer Licensor has a reasonable, good faith belief, or a prior audit demonstrated, that the applicable Company Licensee or any of its Affiliates or Sublicensees failed to comply with any of their obligations hereunder. The applicable Pfizer Licensor shall be responsible for all costs associated with conducting an audit pursuant to this Section, except if such audit demonstrates, or the audit immediately preceding such audit demonstrated, that the applicable Company Licensee, its Affiliates or its Sublicensees failed to comply with any obligations hereunder (and in such circumstances, the applicable Company Licensee shall be responsible for all such costs and expenses). Each Company Licensee shall, and shall cause its Affiliates and its Sublicensees to, reasonably cooperate with any representatives conducting any such audit. Such audits shall be conducted in a manner to minimize interference with such Company Licensee’s, its Affiliates’ and its Sublicensees’ performance of each of their businesses and their rights and obligations under this Agreement. Notwithstanding anything to the contrary in this Section, each Company Licensee may require that, to the extent applicable, (x) the representatives conducting an audit pursuant to this Section be accompanied by such Company Licensee’s representatives at all times during any such audit, (y) such representatives do not enter areas of any facility not involved in this Agreement and (z) all such audits are conducted in accordance with the obligations set forth in Article 7.

Operational Audit Rights. At any time, during the Term and for three (3) years after this Agreement has expired or been terminated in its entirety, during normal business hours and upon reasonable prior notice (which shall be no less than ten (10) Business Days), each Pfizer Company Licensor may send a reasonable number of qualified representatives of such Pfizer Company Licensor, its Affiliates, and/or a Third Party reasonably acceptable to the applicable Company Pfizer Licensee to inspect such Company Pfizer Licensee’s, its Affiliates’ and its Sublicensees’ facilities used in connection with this Agreement and review the records and operations related to such Company Pfizer Licensee’s, its Affiliates’ and its Sublicensees’ exercise of their rights and performance of their obligations hereunder to ensure compliance with the terms hereof. Such audits shall occur no more than once per Calendar Year except to the extent that the applicable Pfizer Company Licensor has a reasonable, good faith belief, or a prior audit demonstrated, that the applicable Company Pfizer Licensee or any of its Affiliates or Sublicensees failed to comply with any of their obligations hereunder. The applicable Pfizer Company Licensor shall be responsible for all costs associated with conducting an audit pursuant to this Section, except if such audit demonstrates, or the audit immediately preceding such audit demonstrated, that the applicable Company Pfizer Licensee, its Affiliates or its Sublicensees failed to comply with any obligations hereunder (and in such circumstances, the applicable Company Pfizer Licensee shall be responsible for all such costs and expenses). Each Company Pfizer Licensee shall, and shall cause its Affiliates and its Sublicensees to, reasonably cooperate with any representatives conducting any such audit. Such audits shall be conducted in a manner to minimize interference with such Company Pfizer Licensee’s, its Affiliates’ and its Sublicensees’ performance of each of their businesses and their rights and obligations under this Agreement. Notwithstanding anything to the contrary in this Section, each Company Pfizer Licensee may require that, to the extent applicable, (x) the representatives conducting an audit pursuant to this Section be accompanied by such Company Pfizer Licensee’s representatives at all times during any such audit, (y) such representatives do not enter areas of any facility not involved in this Agreement and (z) all such audits are conducted in accordance with the obligations set forth in Article 7.

Operational Audit Rights. At any time, during the Term and for three (3) years after this Agreement has expired or been terminated in its entirety, during normal business hours and upon reasonable prior notice (which shall be no less than ten (10) Business Days), each Pfizer Licensor may send a reasonable number of qualified representatives of such Pfizer LicensorPfizer, its Affiliates, and/or a Third Party reasonably acceptable to the applicable Company Licensee to inspect such Company Licensee’sthe Company's, its Affiliates’ ' and its Sublicensees’ permitted sublicensees' (as applicable) facilities used in connection with this Agreement the Collaboration and review the records and operations related to such Company Licensee’s, its Affiliates’ and its Sublicensees’ the Company's exercise of their its rights and performance of their its obligations hereunder to ensure compliance with the terms hereof. Such audits shall occur no more than once twice per Calendar Year Year, except to the extent that the applicable (a) Pfizer Licensor has a reasonable, good faith belief, or a prior audit demonstrated, that the applicable Company Licensee or any of its Affiliates or Sublicensees its permitted sublicensees failed to comply with any of their obligations hereunderhereunder or (b) such audit is being conducted in accordance with Section 12.9.5(a)(i). The applicable Pfizer Licensor shall be responsible for all costs associated with conducting an audit pursuant to this Section, except if such audit demonstrates, or the audit immediately preceding such audit demonstrated, that the applicable Company LicenseeCompany, its Affiliates or its Sublicensees permitted sublicensees failed to comply with any obligations hereunder (and in such circumstances, the applicable Company Licensee shall be responsible for all such costs and expenses). Each The Company Licensee shall, and shall cause its Affiliates and its Sublicensees permitted sublicensees to, reasonably cooperate with any representatives conducting any such audit. Such audits shall be conducted in a manner to minimize interference with such Company Licensee’sthe Company's, its Affiliates’ ' and its Sublicensees’ permitted sublicensees' performance of each of their businesses and their rights and obligations under this Agreementbusinesses. Notwithstanding anything to the contrary in this Section, each the Company Licensee may require that, to the extent applicable, (x) the representatives conducting an audit pursuant to this Section be accompanied by such Company Licensee’s the Company's representatives at all times during any such audit, (y) such representatives do not enter areas of any facility not involved in this Agreement the Collaboration and (z) all such audits are conducted in accordance with the obligations set forth in Article 712.

Operational Audit Rights. At On an annual basis, Investors or any timeAudit Representative, during shall have the Term right, at any time and for three (3) years after this Agreement has expired or been terminated in its entirety, during normal business hours and upon with reasonable prior advance notice (which Investors shall be make commercially reasonable efforts to provide no less than ten (10) Business Dayscalendar days advance notice), each Pfizer Licensor to perform an operational audit with respect to Provider’s performance hereunder (“Internal Operational Audit”). Further, any Regulator shall also have the right, at any time to perform an operational audit with respect to Provider’s performance hereunder (“Regulatory Operational Audits”). With respect to any Internal Operational Audit or any Regulatory Operational Audits (collectively, “Operational Audits”), Provider shall grant Investors, any Regulators or any Audit Representative, full and complete access to Provider’s records and other documents of Provider and its Subcontractors, as they relate to this Agreement, or as they may send a reasonable number of qualified representatives of be required in order for Investors to ascertain any facts relative to Provider’s performance hereunder. At Investors’ request or Regulators request, Provider shall provide: (i) such Pfizer Licensordocuments, its Affiliatesdata, and/or a Third Party or information on such media as Investors might reasonably acceptable request that pertain to the applicable Company Licensee Operational Audits; (ii) copies (hard copy, optical, magnetic disk or tape, as appropriate) of all documents, data, or information on such media as Investors might reasonably request that pertain to inspect the Operational Audits; and (iii) such Company Licensee’sassistance as reasonably requested in order to perform such Operational Audits; provided, its Affiliates’ and its Sublicensees’ facilities used however, that the Parties shall endeavor to arrange such assistance in connection such a way that it does not interfere with this Agreement and review the records and operations related to such Company Licensee’s, its Affiliates’ and its Sublicensees’ exercise of their rights and performance of their Provider’s duties and obligations hereunder to ensure compliance with the terms hereof. Such audits shall occur no more than once per Calendar Year except hereunder, or Provider is excused from it’s duties or obligations to the extent that they are affected by such audit assistance and to the applicable Pfizer Licensor has extent agreed by the Parties. A request for Provider to provide assistance with Operational Audits will be considered a reasonableWork Order or Initiative if such Audit assistance results from a change in Investors’ audit requirements or information is required to be provided in a format different from the format normally used by Provider and Investors. Further, good faith beliefwith regards specifically to any Regulatory Operational Audits, or a prior audit demonstratedProvider shall endeavor to respond to any Regulator driven request within the time period specified by such Regulator (which in some cases may be twenty four (24) hours). Operational Audits under this section, that relate to the applicable Company Licensee Annual Service Fees or pricing, shall be subject to the limitations set out in Section 6.2. Provider shall make reasonable efforts to cause any of its Affiliates or Sublicensees failed Provider Subcontractor to comply with any of their obligations hereunder. The applicable Pfizer Licensor shall be responsible for all costs associated with conducting an audit pursuant to this Section, except if such audit demonstrates, or the audit immediately preceding such audit demonstrated, that the applicable Company Licensee, its Affiliates or its Sublicensees failed to comply with any obligations hereunder (and in such circumstances, the applicable Company Licensee shall be responsible for all such costs and expenses). Each Company Licensee shall, and shall cause its Affiliates and its Sublicensees to, reasonably cooperate with any representatives conducting any such audit. Such audits shall be conducted in a manner to minimize interference with such Company Licensee’s, its Affiliates’ and its Sublicensees’ performance of each of their businesses and their rights and obligations under this Agreement. Notwithstanding anything to the contrary in this Section, each Company Licensee may require that, foregoing provisions to the extent applicable, (x) necessary to complete the representatives conducting an audit pursuant to Operational Audit. Notwithstanding any other provision in this Section be accompanied by such Company Licensee16.2, Investors and its Audit Representatives shall have no access to Provider’s representatives at all times during any such audit, (y) such representatives do not enter areas of any facility not involved in this Agreement and (z) all such audits are conducted in accordance with the obligations set forth in Article 7Internal Confidential Information.

Operational Audit Rights. At any time, during the Term and for three (3) years after this Agreement has expired or been terminated in its entirety, during normal business hours and upon reasonable prior notice (which shall be no less than ten (10) Business Days), each Pfizer Licensor may send a reasonable number of qualified representatives of such Pfizer Licensor, its Affiliates, and/or a Third Party reasonably acceptable to the applicable Company Licensee to inspect such Company Licensee’s's, its Affiliates’ ' and its Sublicensees’ ' facilities used in connection with this Agreement and review the records and operations related to such Company Licensee’s's, its Affiliates’ ' and its Sublicensees’ ' exercise of their rights and performance of their obligations hereunder to ensure compliance with the terms hereof. Such audits shall occur no more than once per Calendar Year except to the extent that the applicable Pfizer Licensor has a reasonable, good faith belief, or a prior audit demonstrated, that the applicable Company Licensee or any of its Affiliates or Sublicensees failed to comply with any of their obligations hereunder. The applicable Pfizer Licensor shall be responsible for all costs associated with conducting an audit pursuant to this Section, except if such audit demonstrates, or the audit immediately preceding such audit demonstrated, that the applicable Company Licensee, its Affiliates or its Sublicensees failed to comply with any obligations hereunder (and in such circumstances, the applicable Company Licensee shall be responsible for all such costs and expenses). Each Company Licensee shall, and shall cause its Affiliates and its Sublicensees to, reasonably cooperate with any representatives conducting any such audit. Such audits shall be conducted in a manner to minimize interference with such Company Licensee’s's, its Affiliates’ ' and its Sublicensees’ ' performance of each of their businesses and their rights and obligations under this Agreement. Notwithstanding anything to the contrary in this Section, each Company Licensee may require that, to the extent applicable, (x) the representatives conducting an audit pursuant to this Section be accompanied by such Company Licensee’s 's representatives at all times during any such audit, (y) such representatives do not enter areas of any facility not involved in this Agreement and (z) all such audits are conducted in accordance with the obligations set forth in Article 7.

Operational Audit Rights. At any time, during the Term and for three (3) years after this Agreement has expired or been terminated in its entirety, during normal business hours and upon reasonable prior notice (which shall be no less than ten (10) Business Days), each Pfizer Licensor may send a reasonable number of qualified representatives of such Pfizer LicensorPfizer, its Affiliates, and/or a Third Party reasonably acceptable to the applicable Company Licensee to inspect such Company Licenseethe Company’s, its Affiliates’ and its Sublicenseespermitted sublicensees’ (as applicable) facilities used in connection with this Agreement the Collaboration and review the records and operations related to such Company Licensee’s, its Affiliates’ and its Sublicensees’ the Company’s exercise of their its rights and performance of their its obligations hereunder to ensure compliance with the terms hereof. Such audits shall occur no more than once twice per Calendar Year Year, except to the extent that the applicable (a) Pfizer Licensor has a reasonable, good faith belief, or a prior audit demonstrated, that the applicable Company Licensee or any of its Affiliates or Sublicensees its permitted sublicensees failed to comply with any of their obligations hereunderhereunder or (b) such audit is being conducted in accordance with Section 12.9.5(a)(i). The applicable Pfizer Licensor shall be responsible for all costs associated with conducting an audit pursuant to this Section, except if such audit demonstrates, or the audit immediately preceding such audit demonstrated, that the applicable Company LicenseeCompany, its Affiliates or its Sublicensees permitted sublicensees failed to comply with any obligations hereunder (and in such circumstances, the applicable Company Licensee shall be responsible for all such costs and expenses). Each The Company Licensee shall, and shall cause its Affiliates and its Sublicensees permitted sublicensees to, reasonably cooperate with any representatives conducting any such audit. Such audits shall be conducted in a manner to minimize interference with such Company Licensee’s, its Affiliates’ and its Sublicensees’ the Company’s performance of each of their its businesses and their rights and obligations under this Agreement. Notwithstanding anything to the contrary in this Section, each the Company Licensee may require that, to the extent applicable, (x) the any representatives conducting an audit pursuant to this Section be accompanied by such Company Licenseethe Company’s representatives at all times during any such audit, (y) such representatives do not enter areas of any facility not involved in this Agreement the Collaboration and (z) all such audits are conducted in accordance with the obligations set forth in Article 712.