Common use of Safety and Regulatory Audits Clause in Contracts

Safety and Regulatory Audits. In addition to the audit rights under Section 5.7, upon reasonable notification, TPTX shall be entitled to conduct an audit of safety and regulatory systems, procedures and practices of Zai, including on-site evaluations to the extent permitting such on-site evaluations is in the control of Zai. TPTX may conduct such audit no more than […***…] (unless an additional audit is warranted for cause) upon […***…] days’ prior written notice to Zai. With respect to any inspection of Zai or its Affiliates or Sublicensees (including Clinical Trial sites) by any Governmental Authority relating to any Product, Zai shall notify TPTX of such inspection (a) no later than […***…] Business Days after Zai receives notice of such inspection or (b) within […***…] Business Day after the completion of any such inspection of which Zai did not receive prior notice. Zai shall promptly provide TPTX with all information related to any such inspection. Zai shall also permit Governmental Authorities outside of the Territory to conduct inspections of Zai or its Affiliates or Sublicensees (including Clinical Trial sites) relating to the Product, and shall ensure that all such Affiliates or Sublicensees permit such inspections. TPTX shall have the right, but not the obligation (unless required by Applicable Law or any Governmental Authority), to be present at any such inspection. Following any such regulatory inspection related to the Products, Zai shall provide TPTX with (i) an unredacted copy of any finding, notice, or report provided by any Governmental Authority related to such inspection (to the extent related to the Product) within […***…] days of Zai receiving the same, and (ii) in the event that such findings, notice, or report […***…] of any material finding, notice, or report of a Governmental Authority related to such inspection (to the extent related to the Product) within […***…] days after receiving the same. Further details including notification, timing, response and scope of such audits shall be included in the Pharmacovigilance Agreement.

Safety and Regulatory Audits. In addition to the audit rights under Section 5.7, upon Upon reasonable notification, TPTX Xxxxxxxx shall be entitled to conduct an audit of safety and regulatory systems, procedures and practices of Zai, including on-site evaluations to the extent permitting such on-site evaluations is in the control of Zai. TPTX Xxxxxxxx may conduct such audit no more than […***…] (unless an additional audit is warranted for cause) upon […***…] days’ prior written notice to Zai. With respect to any inspection of Zai or its Affiliates or Sublicensees (including Clinical Trial sites) by any Governmental Authority relating to any Product, Zai shall notify TPTX Xxxxxxxx of such inspection (a) no later than […***…] Business Days after Zai receives notice of such inspection or (b) within […***…] one (1) Business Day after the completion of any such inspection of which Zai did not receive prior notice. Zai shall promptly provide TPTX Xxxxxxxx with all information related to any such inspection. Zai shall also permit Governmental Authorities outside of the Territory to conduct inspections of Zai or its Affiliates or Sublicensees (including Clinical Trial sites) relating to the Product, and shall ensure that all such Affiliates or Sublicensees permit such inspections. TPTX Xxxxxxxx shall have the right, but not the obligation (unless required by Applicable Law or any Governmental Authority), to be present at any such inspection. Following any such regulatory inspection related to the Products, Zai shall provide TPTX Xxxxxxxx with (i) an unredacted copy of any finding, notice, or report provided by any Governmental Authority related to such inspection (to the extent related to the Product) within […***…] two (2) days of Zai receiving the same, and (ii) in the event that such findings, notice, or report […***…] is in a language other than English, a written English summary of any material finding, notice, or report of a Governmental Authority related to such inspection (to the extent related to the Product) within […***…] days after receiving the same. Further details including notification, timing, response and scope of such audits shall be included in the Pharmacovigilance Agreement.

Safety and Regulatory Audits. In addition to the audit rights under Section 5.7, upon reasonable notification, TPTX shall be entitled to conduct an audit of safety and regulatory systems, procedures and practices of Zai, including on-site evaluations to the extent permitting such on-site evaluations is in the control of Zai. TPTX may conduct such audit no more than […***…X***XX] (unless an additional audit is warranted for cause) upon […***…] days’ prior written notice to Zai. With respect to any inspection of Zai or its Affiliates or Sublicensees (including Clinical Trial sites) by any Governmental Authority relating to any Product, Zai shall notify TPTX of such inspection (a) no later than […***…] Business Days after Zai receives notice of such inspection or (b) within […***…] Business Day after the completion of any such inspection of which Zai did not receive prior notice. Zai shall promptly provide TPTX with all information related to any such inspection. Zai shall also permit Governmental Authorities outside of the Territory to conduct inspections of Zai or its Affiliates or Sublicensees (including Clinical Trial sites) relating to the Product, and shall ensure that all such Affiliates or Sublicensees permit such inspections. TPTX shall have the right, but not the obligation (unless required by Applicable Law or any Governmental Authority), to be present at any such inspection. Following any such regulatory inspection related to the Products, Zai shall provide TPTX with (i) an unredacted copy of any finding, notice, or report provided by any Governmental Authority related to such inspection (to the extent related to the Product) within […***…] days of Zai receiving the same, and (ii) in the event that such findings, notice, or report […***…] of any material finding, notice, or report of a Governmental Authority related to such inspection (to the extent related to the Product) within […***…] days after receiving the same. Further details including notification, timing, response and scope of such audits shall be included in the Pharmacovigilance Agreement.

Safety and Regulatory Audits. In addition to the audit rights under Section 5.7Upon reasonable notification (but not less than [***] days), upon reasonable notification, TPTX Allogene shall be entitled to conduct an audit of safety and regulatory systems, procedures and practices of ZaiLicensee, including on-site evaluations to the extent permitting such on-site evaluations is in the control of Zai. TPTX may conduct such audit no more than […***…] (unless an additional audit is warranted for cause) upon […***…] days’ prior written notice to ZaiLicensee. With respect to any inspection of Zai Licensee or its Affiliates or Sublicensees (including Clinical Trial sites) by any Governmental Authority relating to any Product, Zai Licensee shall notify TPTX Allogene of such inspection (a) no later than […***…] Business Days Day after Zai Licensee receives notice of such inspection or (b) within […***…] Business Day after the completion of any such inspection of which Zai Licensee did not receive prior notice. Zai Licensee shall promptly provide TPTX Allogene with all information in Licensee’s control related to any such inspection. Zai Licensee shall also permit Governmental Authorities outside of the Licensee Territory to conduct inspections of Zai Licensee or its Affiliates or Sublicensees (including Clinical Trial sites) relating to the Product, and shall ensure that all such Affiliates or Sublicensees permit such inspections. TPTX Allogene shall have the right, but not the obligation (unless required by Applicable Law or any Governmental Authority), to be present at any such inspectioninspection at its sole cost and expense. Following any such regulatory inspection related to the Products, Zai Licensee shall provide TPTX Allogene with (i) an unredacted copy of any finding, notice, or report provided by any Governmental Authority related to such inspection (to the extent related to the Product) within […***…] days Business Days of Zai Licensee receiving the same, and (ii) in the event that such findings, notice, or report […***…] is in a language other than English, a written English translation of any material such finding, notice, or report of a Governmental Authority related to such inspection (to the extent related to the Product) within […***…] days Business Days after receiving the samesame (or, with respect to any such finding, notice, or report that is large, such additional period of time as may be reasonably necessary for Licensee to obtain such translation or provide such information in another format reasonably agreed by the Parties). Further details including notification, timing, response and scope of such audits shall be included in the Pharmacovigilance Agreement.

Safety and Regulatory Audits. In addition to the audit rights under Deciphera’s right to conduct Clinical Trial audits pursuant to Section 5.7, upon reasonable notification, TPTX Deciphera shall be entitled to conduct an audit of safety and regulatory systems, procedures and practices of Zai, including on-site evaluations to the extent permitting such on-site evaluations is in the control of Zai. TPTX may conduct such audit no more than […***…] (unless an additional audit is warranted for cause) upon […***…] days’ prior written notice to Zai. With respect to any inspection of Zai or its Affiliates or Sublicensees (including Clinical Trial sites) by any Governmental Authority relating to any Licensed Product, Zai shall notify TPTX Deciphera of such inspection (a) no later than […***…] Business Days after Zai receives notice of such inspection or (b) within […***…] Business Day after the completion of any such inspection of which Zai did not receive prior notice. Zai shall promptly provide TPTX Deciphera with all information related to any such inspection. Zai shall also permit Governmental Authorities outside of the Territory to conduct inspections of Zai or its Affiliates or Sublicensees (including Clinical Trial sites) relating to the Licensed Product, and shall ensure that all such Affiliates or Sublicensees permit such inspections. TPTX Deciphera shall have the right, but not the obligation (unless required by Applicable Law or any Governmental Authority), CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. to be present at any such inspection. Following any such regulatory inspection related to the Licensed Products, Zai shall provide TPTX Deciphera with (i) an unredacted copy of any finding, notice, or report provided by any Governmental Authority related to such inspection (to the extent related to the Licensed Product) within […***…] days of Zai receiving the same, and (ii) in the event that such findings, notice, or report […***…] of any material such finding, notice, or report of a Governmental Authority related to such inspection (to the extent related to the Licensed Product) within […***…] days after receiving the same. Further details including notification, timing, response and scope of such audits shall be included in the Pharmacovigilance Agreement.

Safety and Regulatory Audits. In addition to the audit rights under Section 5.7, upon reasonable notification, TPTX shall be entitled to conduct an audit of safety and regulatory systems, procedures and practices of Zai, including on-site evaluations to the extent permitting such on-site evaluations is in the control of Zai. TPTX may conduct such audit no more than […***…] (unless an additional audit is warranted for cause) upon […***…] days’ prior written notice to Zai. With respect to any inspection of Zai or its Affiliates or Sublicensees (including Clinical Trial sites) by any Governmental Authority relating to any Product, Zai shall notify TPTX of such inspection (a) no later than […***…] Business Days after Zai receives notice of such inspection or (b) within […***…] Business Day after the completion of any such inspection of which Zai did not receive prior notice. Zai shall promptly provide TPTX with all information related to any such inspection. Zai shall also permit Governmental Authorities outside of the Territory to conduct inspections of Zai or its Affiliates or Sublicensees (including Clinical Trial sites) relating to the Product, and shall ensure that all such Affiliates or Sublicensees permit such inspections. TPTX shall have the right, but not the obligation (unless required by Applicable Law or any Governmental Authority), to be present at any such inspection. Following any such regulatory inspection related to the Products, Zai shall provide TPTX with (i) an unredacted copy of any finding, notice, or report provided by any Governmental Authority related to such inspection (to the extent related to the Product) within […***…] days of Zai receiving the same, and (ii) in the event that such findings, notice, or report […***…] of any material finding, notice, or report of a Governmental Authority related to such inspection (to the extent related to the Product) within […***…] days after receiving the same. Further details including notification, timing, response and scope of such audits shall be included in the Pharmacovigilance Agreement.

Safety and Regulatory Audits. In addition to the audit rights under Section 5.7, upon Upon reasonable notification, TPTX Karuna shall be entitled to conduct an audit of safety and regulatory systems, procedures and practices of Zai, its Affiliates, and Sublicensees (including Clinical Trial sites), in each case, relating to the Development of the Licensed Product in the Field in the Licensed Territory, including on-site evaluations to the extent permitting such on-site evaluations is in the control of Zaievaluations. TPTX Karuna may conduct such audit no more than […***…] (unless an additional audit is warranted for cause) upon […***…] days’ prior written notice to Zai. With respect to any inspection of Zai or its Affiliates or Sublicensees (including Clinical Trial sites) by any Governmental Authority relating to any the Licensed Product, Zai shall notify TPTX Karuna of such inspection (a) no later than […***…] Business Days after Zai receives notice of such inspection or (b) within […***…] Business Day after the completion of any such inspection of which Zai did not receive prior notice. Zai shall promptly provide TPTX Karuna with all information related to any such inspection. Zai shall also permit Governmental Authorities outside of the Licensed Territory to conduct inspections of Zai or its Affiliates or Sublicensees (including Clinical Trial sites) relating to the Licensed Product, and shall ensure that all such Affiliates or Sublicensees permit such inspections. TPTX shall have the right, but not the obligation (unless required by Applicable Law or any Governmental Authority), to be present at any such inspection[***]. Following any such regulatory inspection related to the ProductsLicensed Product, Zai shall provide TPTX Karuna with (i) an unredacted copy of any finding, notice, or report provided by any Governmental Authority related to such inspection (to the extent related to the Licensed Product) within […***…] days of Zai receiving the same, and (ii) in the event that such findings, notice, or report […***…] ]. Zai shall provide Karuna with a copy of any material finding, notice, or report of a Governmental Authority related proposed response to such inspection (communications and shall consider in good faith Xxxxxx’s reasonable comments with respect to the extent related to the Product) within […***…] days after receiving the samesuch proposed response. Further details including notification, timing, response and scope of such audits shall be included in the Pharmacovigilance Agreement.

Safety and Regulatory Audits. In addition to the audit rights under Section 5.7, upon Upon reasonable advance (not less than […***…] written notification, TPTX Zymeworks or its representatives shall be entitled to conduct an audit of the manufacturing, safety and regulatory systems, procedures and or practices of ZaiBeiGene, including on-site evaluations its Affiliates, and CMOs relating to the extent permitting such on-site evaluations is in the control of Zai. TPTX may conduct such audit Licensed Products no more often than […***…] ]; and upon Zymeworks’ reasonable request, BeiGene will conduct such audits of its sublicensees and subcontractors hereunder (unless an additional audit is warranted for causesubject to the terms and conditions of BeiGene’s agreements with such sublicensees and subcontractors) upon […***…] days’ prior written notice to Zaiand provide Zymeworks with the results of such audits. With respect to BeiGene shall promptly notify Zymeworks of any inspection of Zai BeiGene, its Affiliates, CMOs, sublicenses or its Affiliates or Sublicensees subcontractors (including Clinical Trial sites) by any Governmental Regulatory Authority relating to Licensed Products and shall provide Zymeworks with all information in BeiGene’s Control pertinent thereto. Without limiting the foregoing, BeiGene shall permit Regulatory Authorities outside the Territory to conduct inspections of BeiGene, its Affiliates, CMOs, sublicenses or subcontractors (including Clinical Trial sites) relating to Licensed Products, and shall ensure that such Affiliates, sublicensees and subcontractors permit such inspections. Zymeworks shall have the right, but not the obligation, to be present at and participate in any Product, Zai shall notify TPTX of such inspection (a) no later than described in this Section 6.5 […***…] Business Days after Zai receives notice ]. BeiGene will provide Zymeworks with a written summary in English of such inspection or (b) any findings of a Regulatory Authority relating to Licensed Products following a regulatory audit within […***…] Business Day after the completion of following any such inspection of which Zai did not receive prior notice. Zai shall promptly provide TPTX with all information related to any such inspection. Zai shall also permit Governmental Authorities outside of the Territory to conduct inspections of Zai or its Affiliates or Sublicensees (including Clinical Trial sites) relating to the Productaudit, and shall ensure that all such Affiliates or Sublicensees permit such inspections. TPTX shall have the right, but not the obligation (unless required by Applicable Law or any Governmental Authority), to be present at any such inspection. Following any such regulatory inspection related to the Products, Zai shall will provide TPTX Zymeworks with (i) an unredacted copy of any findingreport issued by such Regulatory Authority, noticeincluding if applicable, or report provided by any Governmental Authority related to such inspection (to the extent related to the Product) a certified English translation thereof within […***…] days of Zai receiving the same, and (ii) in the event that following such findings, notice, or report […***…] of any material finding, notice, or report of a Governmental Authority related to such inspection (to the extent related to the Product) within […***…] days after receiving the same. Further details including notification, timing, response and scope of such audits shall be included in the Pharmacovigilance Agreement.audit.59

Safety and Regulatory Audits. In addition to the audit rights under Section 5.7, upon Upon reasonable advance (not less than […***…] written notification, TPTX Zymeworks or its representatives shall be entitled to conduct an audit of the manufacturing, safety and regulatory systems, procedures and or practices of ZaiBeiGene, including on-site evaluations its Affiliates, and CMOs relating to the extent permitting such on-site evaluations is in the control of Zai. TPTX may conduct such audit Licensed Products no more often than […***…] ]; and upon Zymeworks’ reasonable request, BeiGene will conduct such audits of its sublicensees and subcontractors hereunder (unless an additional audit is warranted for causesubject to the terms and conditions of BeiGene’s agreements with such sublicensees and subcontractors) upon […***…] days’ prior written notice to Zaiand provide Zymeworks with the results of such audits. With respect to BeiGene shall promptly notify Zymeworks of any inspection of Zai BeiGene, its Affiliates, CMOs, sublicenses or its Affiliates or Sublicensees subcontractors (including Clinical Trial sites) by any Governmental Regulatory Authority relating to Licensed Products and shall provide Zymeworks with all information in BeiGene’s Control pertinent thereto. Without limiting the foregoing, BeiGene shall permit Regulatory Authorities outside the Territory to conduct inspections of BeiGene, its Affiliates, CMOs, sublicenses or subcontractors (including Clinical Trial sites) relating to Licensed Products, and shall ensure that such Affiliates, sublicensees and subcontractors permit such inspections. Zymeworks shall have the right, but not the obligation, to be present at and participate in any Product, Zai shall notify TPTX of such inspection (a) no later than described in this Section 6.5 […***…] Business Days after Zai receives notice ]. BeiGene will provide Zymeworks with a written summary in English of such inspection or (b) any findings of a Regulatory Authority relating to Licensed Products following a regulatory audit within […***…] Business Day after the completion of following any such inspection of which Zai did not receive prior notice. Zai shall promptly provide TPTX with all information related to any such inspection. Zai shall also permit Governmental Authorities outside of the Territory to conduct inspections of Zai or its Affiliates or Sublicensees (including Clinical Trial sites) relating to the Productaudit, and shall ensure that all such Affiliates or Sublicensees permit such inspectionswill 58 Competitive Information – Discovery Information and Commercially Sensitive Terms. TPTX shall have the right, but not the obligation (unless required by Applicable Law or any Governmental Authority), to be present at any such inspection. Following any such regulatory inspection related to the Products, Zai shall provide TPTX Zymeworks with (i) an unredacted copy of any findingreport issued by such Regulatory Authority, noticeincluding if applicable, or report provided by any Governmental Authority related to such inspection (to the extent related to the Product) a certified English translation thereof within […***…] days of Zai receiving the same, and (ii) in the event that following such findings, notice, or report […***…] of any material finding, notice, or report of a Governmental Authority related to such inspection (to the extent related to the Product) within […***…] days after receiving the same. Further details including notification, timing, response and scope of such audits shall be included in the Pharmacovigilance Agreement.audit.59

Safety and Regulatory Audits. In addition to the audit rights under Deciphera’s right to conduct Clinical Trial audits pursuant to Section 5.7, upon reasonable notification, TPTX Deciphera shall be entitled to conduct an audit of safety and regulatory systems, procedures and practices of Zai, including on-site evaluations to the extent permitting such on-site evaluations is in the control of Zai. TPTX may conduct such audit no more than […***…] (unless an additional audit is warranted for cause) upon […***…] days’ prior written notice to Zai. With respect to any inspection of Zai or its Affiliates or Sublicensees (including Clinical Trial sites) by any Governmental Authority relating to any Licensed Product, Zai shall notify TPTX Deciphera of such inspection (a) no later than […***…] Business Days after Zai receives notice of such inspection or (b) within […***…] Business Day after the completion of any such inspection of which Zai did not receive prior notice. Zai shall promptly provide TPTX Deciphera with all information related to any such inspection. Zai shall also permit Governmental Authorities outside of the Territory to conduct inspections of Zai or its Affiliates or Sublicensees (including Clinical Trial sites) relating to the Licensed Product, and shall ensure that all such Affiliates or Sublicensees permit such inspections. TPTX Deciphera shall have the right, but not the obligation (unless required by Applicable Law or any Governmental Authority), to be present at any such inspection. Following any such regulatory inspection related to the Licensed Products, Zai shall provide TPTX Deciphera with (i) an unredacted copy of any finding, notice, or report provided by any Governmental Authority related to such inspection (to the extent related to the Licensed Product) within […***…] days of Zai receiving the same, and (ii) in the event that such findings, notice, or report […***…] of any material such finding, notice, or report of a Governmental Authority related to such inspection (to the extent related to the Licensed Product) within […***…] days after receiving the same. Further details including notification, timing, response and scope of such audits shall be included in the Pharmacovigilance Agreement.