Common use of Regulatory Audits Clause in Contracts

Regulatory Audits. Prior to the Regulatory Responsibility Transfer Date, as the holder of the Regulatory Approval for the Licensed Product in the Field in the Territory, BioCryst or its representatives will be entitled to conduct audits of safety and regulatory systems, procedures, practices, or records of Torii or its Controlled Affiliates or Sublicensees relating to the Licensed Product. With respect to any inspection of Torii or its Controlled Affiliates or Sublicensees by any Governmental Authority relating to the Licensed Product, Torii will notify BioCryst of such inspection (a) no later than [***] after Torii receives notice of such inspection (or in any event with as much advanced notice as is possible prior to such inspection if Torii receives notice thereof less than two Business Days in advance of the applicable inspection) or (b) within [***] after the completion of any such inspection of which Torii did not receive prior notice. Torii will promptly provide BioCryst with all information related to any such inspection. BioCryst will have the right, but not the obligation (unless required by Applicable Law or any Governmental Authority), to be present at any such regulatory inspection. Following any such regulatory inspection related to the Licensed Product in the Territory, Torii will provide 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 a Licensed Product) within [***] of 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 a Licensed Product) within [***] 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.

Regulatory Audits. Prior 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 once in each Calendar Year, unless an audit is otherwise reasonably required due to significant or critical issues observed during the regular audit or brought to ImmunoGen’s attention through Clinical Trial subject complaints or claims by Regulatory Responsibility Transfer DateAuthorities, as the holder of the Regulatory Approval for the Licensed Product in the Field in the Territory, BioCryst ImmunoGen or its representatives will be entitled to conduct audits of safety and regulatory systems, procedures, practices, or records practices of Torii Partner or its Controlled Affiliates or Sublicensees relating to the any Licensed Product. With To the extent permitted by Applicable Law, with respect to any inspection of Torii Partner or its Controlled Affiliates or Sublicensees (including Clinical Trial sites) by any Governmental Authority relating to the any Licensed Product, Torii Partner will notify BioCryst ImmunoGen of such inspection (a) no later than [***] after Torii Partner receives notice of such inspection (or in any event with as much advanced notice as is possible prior to such inspection if Torii Partner receives notice thereof less than two Business Days [***] in advance of the applicable inspection) ​ ​ or (b) within [***] after the completion of any such inspection of which Torii Partner did not receive prior notice. Torii To the extent permitted by Applicable Law, Partner will promptly provide BioCryst ImmunoGen with all reasonably available information related to any such inspection, and Partner will also permit Governmental Authorities outside of the Territory to conduct inspections of Partner or its Affiliates or Sublicensees relating to any Licensed Product, and will ensure that all such Affiliates permit such inspections and will use reasonable efforts to ensure that all Sublicensees permit such inspections. BioCryst ImmunoGen will have the right, but not the obligation (unless required by Applicable Law or any Governmental Authority), to be present at any such regulatory inspection. Following any such regulatory inspection related to the one or more Licensed Product in the TerritoryProducts, Torii Partner will provide BioCryst 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 a Licensed Product) within [***] of Torii 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 a Licensed Product) within no later than [***] 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.

Regulatory Audits. Prior 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 Regulatory Responsibility Transfer Date, as the holder of the Regulatory Approval Marketing Authorization Holder for the Licensed Product in the Field for a country or region in the Territory, BioCryst 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, practices, or records practices of Torii Partner 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 Torii Partner or its Controlled Affiliates or Sublicensees (including Clinical Trial sites) by any Governmental Authority relating to the Licensed Product, Torii Partner will notify BioCryst Kiniksa of such inspection (a) no later than [***] Business Days after Torii Partner receives notice of such inspection (or in any event with as much advanced notice as is possible prior to such inspection if Torii Partner 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 Torii Partner did not receive prior notice. Torii Partner will promptly provide BioCryst Kiniksa with all available information related to any such inspectioninspection (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. BioCryst 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 regulatory inspectioninspection at its sole cost and expense. Following any such regulatory inspection related to the Licensed Product in the TerritoryProduct, Torii Partner will provide BioCryst 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 a the Licensed Product) within [***] Business Days of Torii 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 a the Licensed Product) within no later than [***] 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.

Regulatory Audits. Prior 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 this Agreement, whether such audited site is Achillion’s or its Affiliate’s or contractor’s (such as under an Existing Third Party Agreement), as permitted by and subject to the Regulatory Responsibility Transfer Date, terms and conditions of any applicable Existing Third Party Agreement of Achillion or as the holder of the Regulatory Approval for the Licensed Product in the Field in the Territory, BioCryst or its representatives will be entitled to conduct audits of safety and regulatory systems, procedures, practices, or records of Torii or its Controlled Affiliates or Sublicensees relating to the Licensed Product. With respect to any inspection of Torii or its Controlled Affiliates or Sublicensees otherwise expressly permitted by any Governmental Authority relating to the Licensed Product, Torii will notify BioCryst of such inspection (a) no later than [***] after Torii receives notice of such inspection (or in any event with as much advanced notice as is possible prior to such inspection if Torii receives notice thereof less than two Business Days in advance of the applicable inspection) or (b) Third Party. Achillion shall notify Xxxxxxx within [***] Business Days after the completion receiving notification of any such Regulatory Authority inspection at any site where clinical studies or Manufacturing of which Torii did not receive prior noticeclinical supplies of any Achillion Single APIs and/or Licensed Products are conducted. Torii will promptly provide BioCryst Taking into account the timing 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 all information related to any a Regulatory Authority at the conclusion of such inspection. BioCryst will have If such attendance would result in the right, but disclosure of Achillion’s or its audited site’s Confidential Information not the obligation (unless required by Applicable Law or any Governmental Authority), to be present at any such regulatory inspection. Following any such regulatory inspection related to the Licensed Product in subject matter of this Agreement, the TerritoryParties 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, Torii will provide BioCryst with (i) an unredacted copy of any findingsGood Laboratory Practice, noticeGood Clinical Practice, Good Manufacturing Practice, or report provided by any Governmental Authority related current standards for pharmacovigilance practice, Achillion or its applicable contractor under an Existing Third Party Agreement shall submit to such inspection (to the extent related to Xxxxxxx a Licensed Product) CAPA plan within [***] of 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 a Licensed Product) within [***] Business Days after receiving notification of such non-compliance from the same. Until the Regulatory Responsibility Transfer Date, BioCryst will have the final decisionnon-making authority with respect compliant audited site and shall use commercially reasonable efforts to the content of any responses cause such non-compliant audited site 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 implement 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 sameCAPA plan promptly after submission.

Regulatory Audits. Prior 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 Regulatory Responsibility Transfer Date, as the holder of the Regulatory Approval Marketing Authorization Holder for the Licensed Product in the Field for ​ a country or region in the Territory, BioCryst 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, practices, or records practices of Torii Partner 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 Torii Partner or its Controlled Affiliates or Sublicensees (including Clinical Trial sites) by any Governmental Authority relating to the Licensed Product, Torii Partner will notify BioCryst Kiniksa of such inspection (a) no later than [***] Business Days after Torii Partner receives notice of such inspection (or in any event with as much advanced notice as is possible prior to such inspection if Torii Partner 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 Torii Partner did not receive prior notice. Torii Partner will promptly provide BioCryst Kiniksa with all available information related to any such inspectioninspection (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. BioCryst 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 regulatory inspectioninspection at its sole cost and expense. Following any such regulatory inspection related to the Licensed Product in the TerritoryProduct, Torii Partner will provide BioCryst 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 a the Licensed Product) within [***] Business Days of Torii 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 a the Licensed Product) within no later than [***] 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.