Common use of Regulatory Audits Clause in Contracts

Regulatory Audits. In addition to its rights to conduct audits pursuant to Section 5.8 (Clinical Trial Audit Rights), upon reasonable notification and no more frequently than [***] in each Calendar Year (unless Kiniksa is the Marketing Authorization Holder for the Licensed Product for a country or region in the Territory, in which case there will be no such limitation on the number of inspections or audits that may be conducted in such country or region in a given Calendar Year), Kiniksa or its representatives will be entitled to conduct audits of safety and regulatory systems, procedures, or practices of Partner or its Affiliates or Sublicensees (including Clinical Trial sites) relating to the Licensed Product. Notwithstanding any provision to the contrary set forth in this Agreement, there will be no limit on the number of “for cause” audits that Kiniksa may conduct of safety and regulatory systems, procedures, or practices of Partner or its Affiliates or Sublicensees (including Clinical Trial sites) related to the Licensed Product, and Kiniksa will use reasonable efforts to notify Partner in writing of any “for cause” audit at least [***] Business Days in advance thereof. Kiniksa or its representatives will conduct all such audits in accordance with Applicable Law. With respect to any inspection of Partner or its Affiliates or Sublicensees (including Clinical Trial sites) by any Governmental Authority relating to the Licensed Product, Partner will notify Kiniksa of such inspection (a) no later than [***] Business Days after Partner receives notice of such inspection (or in any event with as much advanced notice as is possible prior to such inspection if Partner receives notice thereof less than [***] Business Days in advance of the applicable inspection) or (b) within [***] Business Days after the completion of any such inspection of which Partner did not receive prior notice. Partner will promptly provide Kiniksa with all available information related to any such inspection (unless prohibited by Applicable Law), and Kiniksa may provide any such reports to any counterparty to any Third Party IP Agreement if required by the terms of such Third Party IP Agreement. Partner will also permit Governmental Authorities outside of the Territory to conduct inspections of Partner or its Affiliates or Sublicensees (including Clinical Trial sites) relating to the Licensed Product, and will ensure that all such Affiliates or Sublicensees permit such inspections. Kiniksa or its designee will have the right, but not the obligation (unless required by Applicable Law or any Governmental Authority), to be present at any such inspection at its sole cost and expense. Following any such regulatory inspection related to the Licensed Product, Partner will provide Kiniksa with (i) an unredacted copy of any findings, notice, or report provided by any Governmental Authority related to such inspection (to the extent related to the Licensed Product) within [***] Business Days of Partner receiving the same, and (ii) a written summary in English of any findings, notice, or report of a Governmental Authority related to such inspection (to the extent related to the Licensed Product) no later than [***] Business Days after receiving the same.

Regulatory Audits. In addition to its rights to conduct audits pursuant to Section 5.8 (Clinical Trial Audit Rights), upon reasonable notification notification, and no more frequently than [***] once in each Calendar Year (Year, unless Kiniksa an audit is otherwise reasonably required due to significant or critical issues observed during the Marketing Authorization Holder for the Licensed Product for a country regular audit or region in the Territorybrought to ImmunoGen’s attention through Clinical Trial subject complaints or claims by Regulatory Authorities, in which case there will be no such limitation on the number of inspections or audits that may be conducted in such country or region in a given Calendar Year), Kiniksa ImmunoGen or its representatives will be entitled to conduct audits of safety and regulatory systems, procedures, or practices of Partner or its Affiliates or Sublicensees (including Clinical Trial sites) relating to the any Licensed Product. Notwithstanding any provision to To the contrary set forth in this Agreement, there will be no limit on the number of “for cause” audits that Kiniksa may conduct of safety and regulatory systems, procedures, or practices of Partner or its Affiliates or Sublicensees (including Clinical Trial sites) related to the Licensed Product, and Kiniksa will use reasonable efforts to notify Partner in writing of any “for cause” audit at least [***] Business Days in advance thereof. Kiniksa or its representatives will conduct all such audits in accordance with extent permitted by Applicable Law. With , with respect to any inspection of Partner or its Affiliates or Sublicensees (including Clinical Trial sites) by any Governmental Authority relating to the any Licensed Product, Partner will notify Kiniksa ImmunoGen of such inspection (a) no later than [***] Business Days after Partner receives notice of such inspection (or in any event with as much advanced notice as is possible prior to such inspection if Partner receives notice thereof less than [***] Business Days in advance of the applicable inspection) ​ ​ or (b) within [***] Business Days after the completion of any such inspection of which Partner did not receive prior notice. To the extent permitted by Applicable Law, Partner will promptly provide Kiniksa ImmunoGen with all reasonably available information related to any such inspection (unless prohibited by Applicable Law)inspection, and Kiniksa may provide any such reports to any counterparty to any Third Party IP Agreement if required by the terms of such Third Party IP Agreement. Partner will also permit Governmental Authorities outside of the Territory to conduct inspections of Partner or its Affiliates or Sublicensees (including Clinical Trial sites) relating to the any Licensed Product, and will ensure that all such Affiliates or permit such inspections and will use reasonable efforts to ensure that all Sublicensees permit such inspections. Kiniksa or its designee ImmunoGen will have the right, but not the obligation (unless required by Applicable Law or any Governmental Authority), to be present at any such inspection at its sole cost and expenseinspection. Following any such regulatory inspection related to the one or more Licensed ProductProducts, Partner will provide Kiniksa ImmunoGen with (i) an unredacted copy of any findings, notice, or report provided by any Governmental Authority related to such inspection (to the extent related to the a Licensed Product) within [***] Business Days of Partner receiving the same, and (ii) a written summary in English of any findings, notice, or report of a Governmental Authority related to such inspection (to the extent related to the a Licensed Product) no later than [***] Business Days after receiving the same.

Regulatory Audits. In addition to its rights to conduct audits Achillion shall cooperate in good faith in the event any Regulatory Authority inspects any site where clinical studies or Manufacturing of clinical supplies of Licensed Products are conducted by or on behalf of Achillion pursuant to Section 5.8 (Clinical Trial Audit Rights), upon reasonable notification and no more frequently than [***] in each Calendar Year (unless Kiniksa is the Marketing Authorization Holder for the Licensed Product for a country or region in the Territory, in which case there will be no such limitation on the number of inspections or audits that may be conducted in such country or region in a given Calendar Year), Kiniksa or its representatives will be entitled to conduct audits of safety and regulatory systems, procedures, or practices of Partner or its Affiliates or Sublicensees (including Clinical Trial sites) relating to the Licensed Product. Notwithstanding any provision to the contrary set forth in this Agreement, there will be no limit on the number of “for cause” audits that Kiniksa may conduct of safety and regulatory systems, procedures, or practices of Partner whether such audited site is Achillion’s or its Affiliates Affiliate’s or Sublicensees contractor’s (including Clinical Trial sites) related such as under an Existing Third Party Agreement), as permitted by and subject to the Licensed Product, terms and Kiniksa will use reasonable efforts to notify Partner in writing conditions of any “for cause” audit at least [***] Business Days in advance thereof. Kiniksa applicable Existing Third Party Agreement of Achillion or its representatives will conduct all such audits in accordance with Applicable Law. With respect to any inspection of Partner or its Affiliates or Sublicensees (including Clinical Trial sites) as otherwise expressly permitted by any Governmental Authority relating to the Licensed Product, Partner will notify Kiniksa of such inspection (a) no later than [***] Business Days after Partner receives notice of such inspection (or in any event with as much advanced notice as is possible prior to such inspection if Partner receives notice thereof less than [***] Business Days in advance of the applicable inspection) or (b) Third Party. Achillion shall notify Xxxxxxx within [***] Business Days after the completion of any such inspection of which Partner did not receive prior notice. Partner will promptly provide Kiniksa with all available information related to any such inspection (unless prohibited by Applicable Law), and Kiniksa may provide any such reports to any counterparty to any Third Party IP Agreement if required by the terms of such Third Party IP Agreement. Partner will also permit Governmental Authorities outside of the Territory to conduct inspections of Partner or its Affiliates or Sublicensees (including Clinical Trial sites) relating to the Licensed Product, and will ensure that all such Affiliates or Sublicensees permit such inspections. Kiniksa or its designee will have the right, but not the obligation (unless required by Applicable Law or any Governmental Authority), to be present at any such inspection at its sole cost and expense. Following any such regulatory inspection related to the Licensed Product, Partner will provide Kiniksa with (i) an unredacted copy of any findings, notice, or report provided by any Governmental Authority related to such inspection (to the extent related to the Licensed Product) within [***] Business Days of Partner receiving the same, and (ii) a written summary in English of any findings, notice, or report of a Governmental Authority related to such inspection (to the extent related to the Licensed Product) no later than [***] Business Days after receiving notification of any Regulatory Authority inspection at any site where clinical studies or Manufacturing of clinical supplies of any Achillion Single APIs and/or Licensed Products are conducted. Taking into account the sametiming and notice provided by the applicable Regulatory Authority, Applicable Law, and the terms of any applicable Existing Third Party Agreement, Xxxxxxx shall be given a reasonable opportunity to assist in the preparation of Achillion’s audited site for inspection, where appropriate, and to attend any inspection by any Regulatory Authority of the audited site, and the summary, or wrap-up, meeting with a Regulatory Authority at the conclusion of such inspection. If such attendance would result in the disclosure of Achillion’s or its audited site’s Confidential Information not related to the subject matter of this Agreement, the Parties shall enter into a confidentiality agreement covering such unrelated subject matter. In the event that any audited site is found to be non-compliant with one or more Applicable Laws, Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice, or current standards for pharmacovigilance practice, Achillion or its applicable contractor under an Existing Third Party Agreement shall submit to Xxxxxxx a CAPA plan within [**] Business Days after receiving notification of such non-compliance from the non-compliant audited site and shall use commercially reasonable efforts to cause such non-compliant audited site to implement such CAPA plan promptly after submission.

Regulatory Audits. In addition to its rights to conduct audits pursuant to Section 5.8 (Clinical Trial Audit Rights), upon reasonable notification and no more frequently than [***] in each Calendar Year (unless Kiniksa is the Marketing Authorization Holder for the Licensed Product for ​ a country or region in the Territory, in which case case, there will be no such limitation on the number of inspections or audits that may be conducted in such country or region in a given Calendar Year), Kiniksa or its representatives will be entitled to conduct audits of safety and regulatory systems, procedures, or practices of Partner or its Affiliates or Sublicensees (including Clinical Trial sites) relating to the Licensed Product. Notwithstanding any provision to the contrary set forth in this Agreement, there will be no limit on the number of “for cause” audits that Kiniksa may conduct of safety and regulatory systems, procedures, or practices of Partner or its Affiliates or Sublicensees (including Clinical Trial sites) related to the Licensed Product, and Kiniksa will use reasonable efforts to notify Partner in writing of any “for cause” audit at least [***] Business Days in advance thereof. Kiniksa or its representatives will conduct all such audits in accordance with Applicable Law. With respect to any inspection of Partner or its Affiliates or Sublicensees (including Clinical Trial sites) by any Governmental Authority relating to the Licensed Product, Partner will notify Kiniksa of such inspection (a) no later than [***] Business Days after Partner receives notice of such inspection (or in any event with as much advanced notice as is possible prior to such inspection if Partner receives notice thereof less than [***] Business Days in advance of the applicable inspection) or (b) within [***] Business Days after the completion of any such inspection of which Partner did not receive prior notice. Partner will promptly provide Kiniksa with all available information related to any such inspection (unless prohibited by Applicable Law), and Kiniksa may provide any such reports to any counterparty to any Third Party IP Agreement if required by the terms of such Third Party IP Agreement. Partner will also permit Governmental Authorities outside of the Territory to conduct inspections of Partner or its Affiliates or Sublicensees (including Clinical Trial sites) relating to the Licensed Product, and will ensure that all such Affiliates or Sublicensees permit such inspections. Kiniksa or its designee will have the right, but not the obligation (unless required by Applicable Law or any Governmental Authority), to be present at any such inspection at its sole cost and expense. Following any such regulatory inspection related to the Licensed Product, Partner will provide Kiniksa with (i) an unredacted copy of any findings, notice, or report provided by any Governmental Authority related to such inspection (to the extent related to the Licensed Product) within [***] Business Days of Partner receiving the same, and (ii) a written summary in English of any findings, notice, or report of a Governmental Authority related to such inspection (to the extent related to the Licensed Product) no later than [***] Business Days after receiving the same.

Regulatory Audits. In addition to its rights to conduct audits pursuant to Section 5.8 (Clinical Trial Audit Rights)7.3.1 Not more than [***], upon reasonable notification notice, and subject to the terms of the Quality Agreement and the applicable agreements between Zogenix and Patheon, Zogenix shall under Endo's direction or shall permit Endo (or, alternatively, an agent or consultant who has been retained by Endo to conduct such activity and who is bound by written confidentiality provisions no less strict that those set out herein) to conduct, at Endo's Cost, cGMP audits of the Facility, and the Parties shall share with each other the complete results of such audits. Endo will be permitted to have no more frequently than [***] in each Calendar Year (unless Kiniksa is present at all times during the Marketing Authorization Holder for audit and Zogenix shall have the Licensed Product for a country right to have its own personnel accompany such Endo representatives at the Facility. 7.3.2 Zogenix shall or region in the Territory, in which case there will be no such limitation on the number of inspections or audits that may be conducted in such country or region in a given Calendar Year), Kiniksa or its representatives will be entitled shall cause Patheon to also permit Governmental Authorities to conduct any required audits of safety and regulatory systems, procedures, or practices the Facility. Each Party shall promptly notify the other of Partner or its Affiliates or Sublicensees (including Clinical Trial sites) relating to any notification by any Governmental Authority regarding Manufacture of the Licensed Product. Notwithstanding any provision to the contrary set forth in this Agreement, there will be no limit on the number of “for cause” audits that Kiniksa may conduct of safety and regulatory systems, procedures, or practices of Partner or its Affiliates or Sublicensees (including Clinical Trial sites) related to the Licensed Product, and Kiniksa will use reasonable efforts to notify Partner in writing of any “for cause” audit at least including cGMP investigation or inspection associated with the Product. 7.3.3 Zogenix shall [***] Business Days to cause such Contract Manufacturers to promptly correct any deficiencies or other adverse findings as reasonably determined by Endo or the Governmental Authorities. 7.3.4 Notwithstanding the foregoing, in advance thereof. Kiniksa the event of a recall of the Products, or its representatives will conduct all circumstances giving rise to an Audit for Cause (as such audits term is defined in accordance with Applicable Law. With respect to any inspection of Partner or its Affiliates or Sublicensees (including Clinical Trial sites) by any Governmental Authority relating the Quality Agreement), subject to the Licensed Productterms of the Quality Agreement and the applicable notice provisions for such an Audit for Cause in the agreements between Zogenix and Patheon, Partner will notify Kiniksa Endo shall have the right to promptly perform an audit of such inspection (a) no later the Facility on less than the notice period of time specified above and more frequently [***] Business Days after Partner receives notice ]. Endo shall bear the Costs of such inspection (or in any event with as much advanced notice as is possible prior to such inspection if Partner receives notice thereof less than [its observers. ***] Business Days in advance of Certain information on this page has been omitted and filed separately with the applicable inspection) or (b) Commission. Confidential treatment has been requested with respect to the omitted portions. 7.3.5 If deficiencies are discovered during an audit, Zogenix will provide Endo with an appropriate action plan within [***] Business Days after the completion of any such inspection of which Partner did not receive prior notice. Partner will promptly provide Kiniksa with all available information related to any such inspection written notice thereof (unless prohibited otherwise required by Applicable Law), ) addressing how Zogenix and Kiniksa may provide any its Contract Manufacturers plans to resolve such reports to any counterparty to any Third Party IP Agreement if required by the terms of deficiencies and Zogenix shall implement such Third Party IP Agreement. Partner will also permit Governmental Authorities outside of the Territory to conduct inspections of Partner or its Affiliates or Sublicensees (including Clinical Trial sites) relating to the Licensed Product, and will ensure that all such Affiliates or Sublicensees permit such inspections. Kiniksa or its designee will have the right, but not the obligation (unless required by Applicable Law or any Governmental Authority), to be present at any such inspection at its sole cost and expense. Following any such regulatory inspection related to the Licensed Product, Partner will provide Kiniksa with (i) an unredacted copy of any findings, notice, or report provided by any Governmental Authority related to such inspection (to the extent related to the Licensed Product) within [***] Business Days of Partner receiving the same, and (ii) a written summary in English of any findings, notice, or report of a Governmental Authority related to such inspection (to the extent related to the Licensed Product) no later than [***] Business Days after receiving the sameplan.

Regulatory Audits. In addition Prior to its rights to conduct audits pursuant to Section 5.8 (Clinical Trial Audit Rights)the Regulatory Responsibility Transfer Date, upon reasonable notification and no more frequently than [***] in each Calendar Year (unless Kiniksa is as the Marketing Authorization Holder holder of the Regulatory Approval for the Licensed Product for a country or region in the Field in the Territory, in which case there will be no such limitation on the number of inspections or audits that may be conducted in such country or region in a given Calendar Year), Kiniksa BioCryst or its representatives will be entitled to conduct audits of safety and regulatory systems, procedures, practices, or practices records of Partner Torii or its Controlled Affiliates or Sublicensees (including Clinical Trial sites) relating to the Licensed Product. Notwithstanding any provision to the contrary set forth in this Agreement, there will be no limit on the number of “for cause” audits that Kiniksa may conduct of safety and regulatory systems, procedures, or practices of Partner or its Affiliates or Sublicensees (including Clinical Trial sites) related to the Licensed Product, and Kiniksa will use reasonable efforts to notify Partner in writing of any “for cause” audit at least [***] Business Days in advance thereof. Kiniksa or its representatives will conduct all such audits in accordance with Applicable Law. With respect to any inspection of Partner Torii or its Controlled Affiliates or Sublicensees (including Clinical Trial sites) by any Governmental Authority relating to the Licensed Product, Partner Torii will notify Kiniksa BioCryst of such inspection (a) no later than [***] Business Days after Partner Torii receives notice of such inspection (or in any event with as much advanced notice as is possible prior to such inspection if Partner Torii receives notice thereof less than [***] two Business Days in advance of the applicable inspection) or (b) within [***] Business Days after the completion of any such inspection of which Partner Torii did not receive prior notice. Partner Torii will promptly provide Kiniksa BioCryst with all available information related to any such inspection (unless prohibited by Applicable Law), and Kiniksa may provide any such reports to any counterparty to any Third Party IP Agreement if required by the terms of such Third Party IP Agreementinspection. Partner will also permit Governmental Authorities outside of the Territory to conduct inspections of Partner or its Affiliates or Sublicensees (including Clinical Trial sites) relating to the Licensed Product, and will ensure that all such Affiliates or Sublicensees permit such inspections. Kiniksa or its designee BioCryst will have the right, but not the obligation (unless required by Applicable Law or any Governmental Authority), to be present at any such inspection at its sole cost and expenseregulatory inspection. Following any such regulatory inspection related to the Licensed ProductProduct in the Territory, Partner Torii will provide Kiniksa BioCryst with (i) an unredacted copy of any findings, notice, or report provided by any Governmental Authority related to such inspection (to the extent related to the a Licensed Product) within [***] Business Days of Partner Torii receiving the same, and (ii) a written summary in English of any findings, notice, or report of a Governmental Authority related to such inspection (to the extent related to the a Licensed Product) no later than within [***] Business Days after receiving the same. Until the Regulatory Responsibility Transfer Date, BioCryst will have the final decision-making authority with respect to the content of any responses to Regulatory Authorities or other Governmental Authorities that relate to a Licensed Product in the Field in the Territory and will consider Torii’s reasonable comments to such responses. After the Regulatory Responsibility Transfer Date, Torii will have the final decision-making authority with respect to such responses to the extent relating solely to the Commercialization of a Licensed Product in the Field in the Territory and BioCryst will have the right to review and comment on any such response. Other than with respect to Post-Marketing Activities, the costs and expenses of any regulatory action for the Licensed Product in the Field in the Territory will be borne by the Party that has the final decision-making authority with respect to the same.