Common use of Clinical Trial Audit Rights Clause in Contracts

Clinical Trial Audit Rights. (a) Upon reasonable notification by Five Prime and at Five Prime’s cost and expense, Five Prime or its representatives shall be entitled to conduct an audit of any Clinical Trial sites engaged by Zai or its Affiliates or sublicensees to conduct Zai’s obligations under (i) the Global Development Plan, to ensure that such Clinical Trials are conducted in compliance with the Global Development Plan and all Applicable Laws and (ii) the Territory Development Plan, to ensure such Clinical Trials are conducted in compliance with GCP and meet Five Prime’s global Clinical Trial standards. No later than [***] following the completion of any such audit, Five Prime will provide Zai with a written summary of Five Prime’s findings, including any deficiencies or other areas of remediation that Five Prime identifies during such audit. Zai will use Commercially Reasonable Efforts to remediate any such deficiencies within [***] following Zai’s receipt of such report, at Zai’s cost and expense. (b) With respect to the FPA144-004 Study, to the extent Five Prime reasonably determines, in its sole discretion, that any deficiencies with respect to a Clinical Trial site identified pursuant to Section 5.6(a) (each, a “Deficient Site”) may cause a Regulatory Authority to reject or otherwise deem deficient the Clinical Trial data from Zai’s conduct of the FPA144-004 Study at such Deficient Site, then Zai will use its best efforts to promptly remove such Deficient Site from the FPA144-004 Study and replace such Deficient Site with a new Clinical Trial site (a “Replacement Site”) within the Territory, which Replacement Site shall be compliant in all respects with Applicable Laws and Five Prime’s global Clinical Trial standards, at Zai’s cost and expense; provided that if Zai is unable to replace any Deficient Site with a Replacement Site or, in Five Prime’s discretion, is unable to do so in a timely manner so as not to jeopardize the Parties’ ability to meet the timelines for Regulatory Submissions set forth in the CFDA Submission Timeline, then Five Prime may replace such Deficient Site with one or more Replacement Sites outside the Territory. (c) Zai will provide Five Prime with copies of all quality oversight or audit reports, including English translations thereof, prepared in connection with any audit that Zai, its Affiliates or sublicensees conduct of a Clinical Trial site that Zai, its Affiliates or sublicensees have engaged or are evaluating to potentially engage to fulfill Zai’s obligations under the Global Development Plan or the Territory Development Plan no later than [***] after receiving or preparing, as applicable, any such report. If Five Prime believes in good faith that any such quality oversight or audit report may be necessary in connection with obtaining or maintaining Regulatory Approvals for a Licensed Product or for other communications with Regulatory Authorities outside of the Territory, then upon Five Prime’s request, any such translation shall be a certified translation; [***].

Clinical Trial Audit Rights. (a) Upon reasonable notification request by Five Prime and at Five Prime’s cost and expenseJazz [***], Five Prime Zymeworks will exercise its rights to conduct, or its representatives shall be entitled if requested by Jazz, will use reasonable efforts to obtain the right for Jazz to conduct (which may be a joint audit with Zymeworks), an audit of any Clinical Trial sites engaged engaged, or other facilities used, by Zai Zymeworks or its Affiliates or sublicensees the Ex-Territory Partner, to conduct Zai’s obligations under (i) the Global Zymeworks Development Plan, to ensure that such Clinical Trials are conducted in compliance with the Global Zymeworks Development Plan and all Applicable Laws and (ii) the Territory Development PlanLaws, to ensure such Clinical Trials are conducted in compliance with GCP and meet Five Prime’s global Clinical Trial standardsincluding GCP[***]. No later than [***] following the completion of any such auditaudit and receipt of the resulting audit report (if provided by a Third Party), Five Prime the Party conducting such audit will provide Zai the other Party with a written summary of Five Primesuch Party’s findings, including any deficiencies or other areas of remediation that Five Prime such Party reasonably identifies during such audit, and the Parties shall promptly meet to discuss any such deficiencies or other areas of remediation identified by such other Party. Zai Zymeworks will use Commercially Reasonable Efforts reasonable efforts[***] to remediate any such deficiencies promptly following receipt of such report. Any such remediation done by or on behalf of Zymeworks or its Affiliates will be [***]. [***] If Zymeworks does not remediate such deficiencies within [***] of Jazz’s written request to do so, and Jazz reasonably determines, based on such deficiencies, that the continuation of any Clinical Trial activities at such site would reasonably be expected to have an adverse effect on the continued Development or Commercialization of Licensed Products in the Territory, then Zymeworks will wind-down, or will use reasonable efforts to cause the Ex-Territory Partner to wind-down, as applicable, such Clinical Trial at such site as promptly as practicable following ZaiJazz’s receipt notice of such report, at Zai’s cost and expensedetermination. (b) With respect to the FPA144-004 Study, to the extent Five Prime reasonably determines, in its sole discretion, that any deficiencies with respect to a Clinical Trial site identified pursuant to Section 5.6(a) (each, a “Deficient Site”) may cause a Regulatory Authority to reject or otherwise deem deficient the Clinical Trial data from Zai’s conduct of the FPA144-004 Study at such Deficient Site, then Zai will use its best efforts to promptly remove such Deficient Site from the FPA144-004 Study and replace such Deficient Site with a new Clinical Trial site (a “Replacement Site”) within the Territory, which Replacement Site shall be compliant in all respects with Applicable Laws and Five Prime’s global Clinical Trial standards, at Zai’s cost and expense; provided that if Zai is unable to replace any Deficient Site with a Replacement Site or, in Five Prime’s discretion, is unable to do so in a timely manner so as not to jeopardize the Parties’ ability to meet the timelines for Regulatory Submissions set forth in the CFDA Submission Timeline, then Five Prime may replace such Deficient Site with one or more Replacement Sites outside the Territory. (c) Zai Zymeworks will provide Five Prime Jazz with copies of all quality oversight or audit reports, including English translations thereof, reports prepared in connection with any audit that ZaiZymeworks, its Affiliates or sublicensees (sub)licensees (including the Ex-Territory Partner) conduct of a Clinical Trial site that ZaiZymeworks or its Affiliates, its Affiliates or sublicensees (subject to confidentiality obligations) the Ex-Territory Partner have engaged or are evaluating to potentially engage to fulfill Zai’s obligations under the Global Development Plan or the Territory Zymeworks Development Plan no later than [***] after Zymeworks’ receiving or preparing, as applicable, any such report. If Five Prime believes in good faith that any such quality oversight or audit report may be necessary in connection with obtaining or maintaining Regulatory Approvals for a Licensed Product or for other communications with Regulatory Authorities outside of the Territory, then upon Five Prime’s request, any such translation shall be a certified translation; [***].

Clinical Trial Audit Rights. (a) Upon reasonable notification by Five Prime Aadi and at Five Prime’s Aadi's cost and expense, Five Prime Aadi or its representatives shall be entitled to conduct an audit of any Clinical Trial clinical trial sites engaged engaged, or other facilities used, by Zai EOC or its Affiliates or sublicensees Sublicensees to conduct Zai’s EOC's obligations under (i) the Global Development Plan, to ensure that such Clinical Trials clinical trials and obligations are conducted in compliance with the Global Development Plan and all Applicable Laws and (ii) meet Aadi's global clinical trial standards, provided that such audit shall require a [***] prior written notice and shall not interfere with the Territory Development Plan, to ensure such Clinical Trials are conducted in compliance with GCP and meet Five Prime’s global Clinical Trial standardsregular operation of the clinical trial. No later than [***] following the completion of any such audit, Five Prime Aadi will provide Zai EOC with a written summary of Five Prime’s findingsAadi's findings in English, including any deficiencies or other areas of remediation that Five Prime Aadi identifies during such auditaudit and the Parties shall promptly meet to discuss any such deficiencies or other areas of remediation identified by Aadi. Zai EOC will use Commercially Reasonable Efforts to [***] remediate any such deficiencies within [***] following Zai’s EOC's receipt of such report, at Zai’s EOC's cost and expense. (b) With respect . If EOC is unable to the FPA144-004 Study, to the extent Five Prime remediate such deficiencies within a reasonable period and EOC reasonably determines, in its sole discretionbased on such deficiencies, that any deficiencies with respect a clinical trial site engaged to a Clinical Trial site identified conduct activities pursuant to Section 5.6(a) (each, the Development Plan is inadequate to continue performing in the applicable clinical trial of a “Deficient Site”) may cause a Regulatory Authority to reject or otherwise deem deficient the Clinical Trial data from Zai’s conduct of the FPA144-004 Study at such Deficient Site, then Zai will use its best efforts to promptly remove such Deficient Site from the FPA144-004 Study and replace such Deficient Site with a new Clinical Trial site (a “Replacement Site”) within Product in the Territory, which Replacement Site shall be compliant then without limiting any other remedies under the Agreement, EOC will work with Aadi in all respects with Applicable Laws and Five Prime’s global Clinical Trial standards, good faith to wind-down such clinical trial at Zai’s cost and expense; provided that if Zai is unable to replace any Deficient Site with a Replacement Site or, in Five Prime’s discretion, is unable to do so in a timely manner so such site as not to jeopardize the Parties’ ability to meet the timelines for Regulatory Submissions set forth in the CFDA Submission Timeline, then Five Prime may replace such Deficient Site with one or more Replacement Sites outside the Territory. (c) Zai promptly as practicable. EOC will provide Five Prime Aadi with copies of all quality oversight or audit reports, including English translations thereofwith summaries in English, prepared in connection with any audit that Zai, EOC or any of its Affiliates or sublicensees conduct Sublicensees conducts of a Clinical Trial clinical trial site that Zai, EOC or any of its Affiliates or sublicensees Sublicensees have engaged or are evaluating to potentially engage to fulfill Zai’s EOC's obligations under the Global Development Plan or the Territory Development Plan no later than [***] after receiving or preparing, as applicable, any such report. If Five Prime believes in good faith that any such quality oversight or audit report may be necessary in connection with obtaining or maintaining Regulatory Approvals for a Licensed Product or for other communications with Regulatory Authorities outside of the Territory, then upon Five Prime’s request, any such translation shall be a certified translation; [***].

Clinical Trial Audit Rights. (a) Upon reasonable notification request by Five Prime and at Five Prime’s cost and expenseJazz [***], Five Prime Zymeworks will exercise its rights to conduct, or its representatives shall be entitled if requested by Jazz, will use reasonable efforts to obtain the right for Jazz to conduct (which may be a joint audit with Zymeworks), an audit of any Clinical Trial sites engaged engaged, or other facilities used, by Zai or its Affiliates or sublicensees the Ex-Territory Partner, to conduct Zai’s obligations under (i) the Global Development PlanZymeworks Ongoing Studies and, if applicable, the Zymeworks Korean Studies, to ensure that such Clinical Trials are conducted in compliance with the Global Jazz Development Plan and all Applicable Laws and (ii) the Territory Development PlanLaws, to ensure such Clinical Trials are conducted in compliance with including GCP and meet Five Prime’s global Clinical Trial standards[***]. No later than [***] following the completion of any such auditaudit and receipt of the resulting audit report (if provided by a Third Party), Five Prime the Party conducting such audit will provide Zai the other Party with a written summary of Five Primesuch Party’s findings, including any deficiencies or other areas of remediation that Five Prime such Party reasonably identifies during such audit, and the Parties shall promptly meet to discuss any such deficiencies or other areas of remediation identified by such other Party. Zai Zymeworks will [***] to use Commercially Reasonable Efforts reasonable efforts to remediate any such deficiencies promptly following receipt of such report. Any such remediation done by or on behalf of Zymeworks or its Affiliates will [***]. If Zymeworks does not remediate such deficiencies within [***] of Jazz’s written request to do so, and Jazz reasonably determines, based on such deficiencies, that the continuation of any Clinical Trial activities at such site would reasonably be expected to have an adverse effect on the continued Development or Commercialization of Licensed Products in the Territory, then Zymeworks will use reasonable efforts to cause the Ex-Territory Partner to wind-down such Clinical Trial at such site as promptly as practicable following ZaiJazz’s receipt notice of such report, at Zai’s cost and expensedetermination. (b) With respect to the FPA144-004 Study, to the extent Five Prime reasonably determines, in its sole discretion, that any deficiencies with respect to a Clinical Trial site identified pursuant to Section 5.6(a) (each, a “Deficient Site”) may cause a Regulatory Authority to reject or otherwise deem deficient the Clinical Trial data from Zai’s conduct of the FPA144-004 Study at such Deficient Site, then Zai will use its best efforts to promptly remove such Deficient Site from the FPA144-004 Study and replace such Deficient Site with a new Clinical Trial site (a “Replacement Site”) within the Territory, which Replacement Site shall be compliant in all respects with Applicable Laws and Five Prime’s global Clinical Trial standards, at Zai’s cost and expense; provided that if Zai is unable to replace any Deficient Site with a Replacement Site or, in Five Prime’s discretion, is unable to do so in a timely manner so as not to jeopardize the Parties’ ability to meet the timelines for Regulatory Submissions set forth in the CFDA Submission Timeline, then Five Prime may replace such Deficient Site with one or more Replacement Sites outside the Territory. (c) Zai Zymeworks will provide Five Prime Jazz with copies of all quality oversight or audit reports, including English translations thereof, reports prepared in connection with any audit that ZaiZymeworks, its Affiliates or sublicensees (sub)licensees (including the Ex-Territory Partner) conduct of a Clinical Trial site that Zai, its Affiliates or sublicensees have the Ex-Territory Partner has engaged or are evaluating to potentially engage to fulfill Zai’s obligations under for purposes of the Global Development Plan or the Territory Development Plan Zymeworks Ongoing Studies no later than [***] after Zymeworks’ receiving or preparing, as applicable, any such report. If Five Prime believes in good faith that any such quality oversight or audit report may be necessary in connection with obtaining or maintaining Regulatory Approvals for a Licensed Product or for other communications with Regulatory Authorities outside of the Territory, then upon Five Prime’s request, any such translation shall be a certified translation; [***].