Common use of Safety and Regulatory Audits Clause in Contracts

Safety and Regulatory Audits. Upon reasonable notification, 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. Xxxxxxxx may conduct such audit no more than [***] (unless an additional audit is warranted for cause) upon [***] 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 Xxxxxxxx of such inspection (a) no later than [***] 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 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. 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 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 [***] 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. Upon In addition to the audit rights under Section 5.7, upon reasonable notification, Xxxxxxxx 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. Xxxxxxxx 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 Xxxxxxxx TPTX 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 Xxxxxxxx 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. Xxxxxxxx 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 Xxxxxxxx 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 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. Upon In addition to Deciphera’s right to conduct Clinical Trial audits pursuant to Section 5.7, upon reasonable notification, Xxxxxxxx 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. Xxxxxxxx may conduct such audit no more than [***] (unless an additional audit is warranted for cause) upon [***] 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 Xxxxxxxx Deciphera of such inspection (a) no later than [***] 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 Xxxxxxxx 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. Xxxxxxxx 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 Xxxxxxxx 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 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 [***] such finding, notice, or report of a Governmental Authority related to such inspection (to the extent related to the Licensed Product) within [***] 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. Upon In addition to Deciphera’s right to conduct Clinical Trial audits pursuant to Section 5.7, upon reasonable notification, Xxxxxxxx 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. Xxxxxxxx may conduct such audit no more than [***] (unless an additional audit is warranted for cause) upon [***] 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 Xxxxxxxx Deciphera of such inspection (a) no later than [***] 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 Xxxxxxxx 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. Xxxxxxxx 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 Xxxxxxxx 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 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 [***] such finding, notice, or report of a Governmental Authority related to such inspection (to the extent related to the Licensed Product) within [***] 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. Upon reasonable notification, Xxxxxxxx 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. Xxxxxxxx Karuna may conduct such audit no more than [***] (unless an additional audit is warranted for cause) upon [***] 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 Xxxxxxxx Karuna of such inspection (a) no later than [***] 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 Xxxxxxxx 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. 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 ProductsLicensed Product, Zai shall provide Xxxxxxxx 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 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 [***] after receiving the same]. Zai shall provide Karuna with a copy of any proposed response to such communications and shall consider in good faith Xxxxxx’s reasonable comments with respect to such proposed response. Further details including notification, timing, response and scope of such audits shall be included in the Pharmacovigilance Agreement.

Safety and Regulatory Audits. Upon In addition to the audit rights under Section 5.7, upon reasonable notification, Xxxxxxxx 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. Xxxxxxxx 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 Xxxxxxxx TPTX 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 Xxxxxxxx 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. Xxxxxxxx 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 Xxxxxxxx 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 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. Upon In addition to the audit rights under Section 5.7, upon reasonable notification, Xxxxxxxx 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. Xxxxxxxx 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 Xxxxxxxx TPTX 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 Xxxxxxxx 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. Xxxxxxxx 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 Xxxxxxxx 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 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. Upon reasonable notificationnotification (but not less than [***] days), Xxxxxxxx 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. Xxxxxxxx may conduct such audit no more than [***] (unless an additional audit is warranted for cause) upon [***] 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 Xxxxxxxx Allogene of such inspection (a) no later than [***] Business Day after Zai Licensee receives notice of such inspection or (b) within one (1) [***] Business Day after the completion of any such inspection of which Zai Licensee did not receive prior notice. Zai Licensee shall promptly provide Xxxxxxxx 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. Xxxxxxxx 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 Xxxxxxxx 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 two (2) 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 summary 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 [***] 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. Upon reasonable advance (not less than […***…] written notification, Xxxxxxxx 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. Xxxxxxxx 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 [***] 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 any Product, Zai Licensed Products and shall notify Xxxxxxxx of such inspection (a) no later than [***] 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 Xxxxxxxx Zymeworks with all information related to any such inspectionin BeiGene’s Control pertinent thereto. Zai Without limiting the foregoing, BeiGene shall also permit Governmental Regulatory Authorities outside of the Territory to conduct inspections of Zai BeiGene, its Affiliates, CMOs, sublicenses or its Affiliates or Sublicensees subcontractors (including Clinical Trial sites) relating to the ProductLicensed Products, and shall ensure that all such Affiliates or Sublicensees Affiliates, sublicensees and subcontractors permit such inspections. Xxxxxxxx Zymeworks shall have the right, but not the obligation (unless required by Applicable Law or any Governmental Authority)obligation, to be present at and participate in any such inspectioninspection described in this Section 6.5 […***…]. Following BeiGene will provide Zymeworks with a written summary in English of any findings of a Regulatory Authority relating to Licensed Products following a regulatory audit within […***…] following any such regulatory inspection related to the Productsaudit, Zai shall and will provide Xxxxxxxx Zymeworks with (i) an unredacted copy of any findingreport issued by such Regulatory Authority, 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 Englishincluding if applicable, a written certified English summary of any material finding, notice, or report of a Governmental Authority related to such inspection (to the extent related to the Product) translation thereof within […***…] after receiving the same. Further details including notification, timing, response and scope of following such audits shall be included in the Pharmacovigilance Agreement.audit.59