Common use of Regulatory Audits Clause in Contracts

Regulatory Audits. The Parties shall cooperate in good faith with respect to Regulatory Authority inspections of any site or facility where Clinical Studies or Manufacturing of Cost Profit Sharing Products in the Field are conducted by or on behalf a Party pursuant to this Agreement, whether such site or facility is such Party’s or its Affiliate’s or Subcontractor’s (each an “Audited Site”). Each Party shall be given a reasonable opportunity, at its own cost, (taking into account the timing and notice provided by the applicable Regulatory Authority) to assist in the preparation of the other Party’s Audited Sites for inspection, where appropriate, and to attend any inspection by any Regulatory Authority of the other Party’s Audited Sites, 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 to the other Party of Confidential Information unrelated 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 Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice or current standards for pharmacovigilance practice, the non-compliant Party shall submit to the other Party a proposed recovery plan or Corrective and Preventative Actions (“CAPA”) within [***] [***] after such non-compliant Party, its Affiliate or its Subcontractor receives notification of such non-compliance from the relevant Regulatory Authority and such non-compliant Party shall use Commercially Reasonable Efforts to implement such recovery plan or CAPA promptly after submission. Notwithstanding the foregoing, the rights of each Party under this Section 4.4.5 are subject to the terms of the applicable Subcontract, provided that each Party agrees to use Commercially Reasonable Efforts to include in the applicable Subcontract with its Subcontractors, a clause permitting the other Party to exercise its rights under this Section 4.4.5. *** Certain information has been excluded from this agreement because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

Regulatory Audits. The Parties shall cooperate in good faith with respect to Regulatory Authority inspections of any site or facility where Clinical Studies or Manufacturing of Cost Profit Sharing Products Collaboration Product in the Field are conducted by or on behalf a Party pursuant to this Agreement, whether such site or facility is such Party’s or its Affiliate’s or Subcontractor’s (each an “Audited Site”). Each Party Taiho shall be given a reasonable opportunity, at its own cost, (taking into account the timing and notice provided by the applicable Regulatory Authority) to assist in the preparation of the other Party’s Cxxxxxxx’x and its Subcontractors’ Audited Sites for inspection, where appropriate, and to attend any inspection by any Regulatory Authority of the other Party’s such Audited Sites, and the summary, or wrap-up, meeting with a Regulatory Authority at the conclusion of such inspection. Each Party will provide to the other Party a copy of the report resulting from any Regulatory Authority audit of such Party’s or its Affiliate’s or Subcontractor’s Audited Site. If providing such attendance report would result in the disclosure to the other Party of Confidential Information unrelated to the subject matter of this Agreement, the Parties shall enter into a reasonable and customary confidentiality agreement covering such unrelated subject matter. In the event that any Audited Site of a Party, its Affiliate or its Subcontractor is found to be non-compliant with one or more Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice or current standards for pharmacovigilance practice, the non-compliant such Party shall submit to the other Party a proposed recovery plan or Corrective and Preventative Actions (“CAPA”) within [***] [***] Business Days after such non-compliant Party, its Affiliate or its Subcontractor receives notification of such non-compliance from the relevant Regulatory Authority and such non-compliant Party shall use Commercially Reasonable Efforts to implement such recovery plan or CAPA promptly after submission. Notwithstanding the foregoing, the rights of each Party under this Section 4.4.5 are subject to the terms of the applicable Subcontract, provided that each Party agrees to use Commercially Reasonable Efforts to include in the applicable Subcontract with its Subcontractors, a clause permitting the other Party to exercise its rights under this Section 4.4.5. *** Certain information has been excluded from this agreement because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

Regulatory Audits. The Parties shall cooperate in good faith with respect to Regulatory Authority inspections of any site or facility where Clinical Studies or Manufacturing of Cost Profit Sharing Products in the Field are conducted by or on behalf a Party pursuant to this Agreement, whether such site or facility is such Party’s or its Affiliate’s or Permitted Subcontractor’s (each an “Audited Site”). Each Party shall be given a reasonable opportunity, at its own cost, opportunity (taking into account the timing and notice provided by the applicable Regulatory Authority) to assist in the preparation of the other Party’s Audited Sites for inspection, where appropriate, and to attend any inspection by any Regulatory Authority of the other Party’s Audited Sites, 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 to the other Party of Confidential Information unrelated 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 Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice or current standards for pharmacovigilance practice, the non-compliant Party shall submit to the other Party a proposed recovery plan or Corrective and Preventative Actions (“CAPA”) within [***] [***] 10 Business Days after such non-compliant Party, its Affiliate or its Permitted Subcontractor receives notification of such non-compliance from the relevant Regulatory Authority and such non-compliant Party shall use Commercially Reasonable Diligent Efforts to implement such recovery plan or CAPA promptly after submission. Notwithstanding the foregoingEach Party agrees, the rights of each Party under this Section 4.4.5 are subject to the terms of the applicable Subcontractmaximum extent possible, provided that each Party agrees to use Commercially Reasonable Efforts to include in the applicable Subcontract any contract or other written arrangement with its Permitted Subcontractors, a clause permitting the other Party to exercise its rights under this Section 4.4.54.4.6. No later than [*** Certain information has been excluded from this ] after the Effective Date, the Parties shall enter into a separate agreement because it is both (the “Audit Agreement”) that (i) not material and incorporates the terms of this Section 4.4.6, (ii) would be competitively harmful if publicly disclosedsets forth a mechanism for the Parties’ sharing of Audited Site audit plans and reports (including timelines) developed in accordance with Section 4.3.6 and (iii) includes provisions that detail each Party’s responsibility with respect to notifying the other Party in advance of inspections of Audited Sites by Regulatory Authorities, providing support to the other Party with respect to inspections by Regulatory Authorities and responding to results of such inspections by Regulatory Authorities. [**] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Regulatory Audits. The Parties shall cooperate in good faith with respect to Regulatory Authority inspections of any site or facility facility, including, without limitation, where Clinical Studies Studies, CMC, or Manufacturing of Cost Profit Sharing Products in pharmacovigilance activities with respect to the Field Product are conducted by or on behalf of a Party pursuant to this Agreement, whether such site or facility is such Party’s or its Affiliate’s or Subcontractor’s Approved Sublicensee’s, subject to terms and conditions of Third Party agreements (provided that each an “Audited Site”Party shall use reasonable efforts to ensure that Third Party agreements do not prevent the exercise of such rights), and shall inform each other of such Regulatory Authority inspection within [***] from its notification. Each Party shall be given a reasonable opportunity, at its own cost, opportunity (taking into account the timing and notice provided by the applicable Regulatory Authority) to assist in the preparation of the other Party’s Audited Sites audited sites for inspection, where appropriate, and to attend any inspection by any Regulatory Authority of the other Party’s Audited Sitesaudited sites, 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 to the other Party of Confidential Information unrelated 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 audited site is found to be non-compliant with one or more Good Laboratory PracticeGLP, Good Clinical PracticeGCP, Good Manufacturing Practice or current standards for pharmacovigilance practice, the non-compliant Party shall submit to the other Party a proposed recovery plan or Corrective and Preventative Actions (“CAPA”) within [***] [***] a reasonable period after such non-compliant Party, its Affiliate Affiliate, its subcontractor, or its Subcontractor Approved Sublicensees receives notification of such non-compliance from the relevant Regulatory Authority and such non-compliant Party shall use Commercially Reasonable Efforts to implement such recovery plan or CAPA promptly after submission. Notwithstanding the foregoing, the rights of each Party under Partner shall reimburse Atara for all costs including any and all actual and documented Out-Of-Pocket Costs incurred by Atara pursuant to this Section 4.4.5 are subject 6.6 (including prior to the terms expiration of the applicable Subcontract, provided that each Party agrees to use Commercially Reasonable Efforts to include in the applicable Subcontract with its Subcontractors, a clause permitting the other Party to exercise its rights under this Section 4.4.5. *** Certain information has been excluded from this agreement because it is both (i) not material and (ii) would be competitively harmful if publicly disclosedR&D Pre-Transfer Period).

Regulatory Audits. The Parties shall cooperate in good faith with respect to in the event any Regulatory Authority inspections of inspects any site or facility where Clinical Studies clinical studies or Manufacturing of Cost Profit Sharing clinical supplies of Licensed Products in the Field are conducted by or on behalf of a Party pursuant to this Agreement, whether such site or facility Audited Sites is such Party’s or its Affiliate’s or Subcontractorcontractor’s (each such as, in the case of Geron, under an “Audited Site”)Existing Third Party Agreement) or subcontractor’s hereunder as permitted by and subject to the terms and conditions of any applicable Existing Third Party Agreement or as otherwise expressly permitted by the applicable Third Party. Each Party shall notify the other Party within [*] ([*]) Business Days after receiving notification of any Regulatory Authority inspection at any site where clinical studies or Manufacturing of clinical supplies of the Active Substance and/or Licensed Products are conducted. Each Party shall be given a reasonable opportunity, at its own cost, opportunity (taking into account the timing and notice provided by the applicable Regulatory AuthorityAuthority and the terms of any applicable Existing Third Party Agreement) to assist in the preparation of the other Party’s Audited Sites Site for inspection, where appropriate, and to attend any inspection by any Regulatory Authority of the other Party’s Audited SitesSite, 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 to of the other Party of Party’s or its Audited Site’s Confidential Information unrelated 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 Practice, or current standards for pharmacovigilance practice, the non-compliant Party (or, in the case of Geron, its applicable contractor under an Existing Third Party Agreement) shall submit to the other Party a proposed recovery CAPA plan or Corrective and Preventative Actions (“CAPA”) within [***] ([***] ]) Business Days after such non-compliant Party, its Affiliate or its Subcontractor receives receiving notification of such non-compliance from the relevant Regulatory Authority non-compliant Audited Site and shall use commercially reasonable efforts to cause such non-compliant Party shall use Commercially Reasonable Efforts Audited Site to implement such recovery CAPA plan or CAPA promptly after submission. Notwithstanding the foregoing, the rights of each Party under this Section 4.4.5 are subject to the terms of the applicable Subcontract, provided that each Each Party agrees to use Commercially Reasonable Efforts commercially reasonable efforts to include in any agreement or other written arrangement (including any amendment to any applicable Existing Third Party Agreement), entered into after the applicable Subcontract Effective Date, with its Subcontractorsapplicable contractors or subcontractors (as the case may be), a clause permitting the other Party to exercise its rights under this Section 4.4.5. *** Certain information has been excluded from this agreement because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed4.11.3.