Common use of cGMP Compliance and QA Audits Clause in Contracts

cGMP Compliance and QA Audits. Following the Effective Date, when negotiating a CMO agreement for the Manufacture of Collaboration Compounds or Collaboration Candidates, Kymera will use Commercially Reasonable Efforts to obtain the right for Sanofi to, upon no less than [***] advance written notice to Kymera, and subject to the terms of any relevant CMO agreement, have representatives visit the locations at which Manufacturing activities are undertaken by the relevant CMO, in each case, during normal business hours to review and inspect records and reports pertinent to the Manufacture, disposition or transport of Collaboration Compounds or Collaboration Candidates. Such visits will occur no more than [***], except in the case of audits by Sanofi that are required by Applicable Laws. In addition, upon [***] written notice to Kymera, Kymera will permit Sanofi to conduct on-site visits to the relevant Kymera premises during normal business hours to review and inspect such premises, and ▇▇▇▇▇▇’s reports and records, regarding (a) Kymera’s oversight of manufacturing, quality control procedures, release, and (b) the Manufacture, disposition or transport of materials supplied by Kymera to Sanofi, in each case ((a) and (b)) to confirm Kymera’s compliance with Applicable Law; such visits to be subject to customary and reasonable due diligence procedures to preserve the confidentiality of any information obtained by Sanofi. Such visits will (a) occur no more than [***], (b) will be conducted in such a manner to minimize, to the extent reasonably possible, the period of such visit and in no case shall such period exceed [***], and (c) will be conducted by the minimum number of Sanofi employees as necessary to provide requisite subject matter expertise and conduct the review in the allotted timeframe, each of whom shall have appropriate experience in the Manufacture, quality and cGMP compliance of small molecule compounds and candidates. Upon completion of any such visit, Sanofi will provide Kymera and the JMC of Sanofi’s findings from each such visits. [***].

cGMP Compliance and QA Audits. Following the Effective Date, when negotiating a CMO agreement for the Manufacture of Collaboration Compounds or Collaboration Candidates, Kymera will use Commercially Reasonable Efforts to obtain the right for Sanofi to, upon Upon no less than [***] sixty (60) days’ advance written notice to KymeraMannKind, and subject Sanofi shall have the right to the terms of any relevant CMO agreement, have representatives visit the MannKind Facility and any other locations at which any Manufacturing activities are undertaken by the relevant CMOundertaken, in each case, during normal business hours to discuss any related issues with MannKind’s Manufacturing and management personnel and to review and inspect (a) MannKind’s Manufacturing and storage facilities, (b) the quality control procedures, and/or (c) any records and reports pertinent to the Manufacture, disposition or transport of Collaboration Compounds or Collaboration CandidatesProduct as may be necessary to evidence MannKind’s compliance with all applicable Marketing Approvals for the Manufacture of Product, including compliance with cGMP. Such visits will shall occur no more than [***]once per year, except in the case of audits by Sanofi that are required by Applicable Laws, and except that additional visit(s) may occur in the event of shortages, significant deviations, quality problems or recalls requiring resolution by the Parties. In additionSanofi shall also have the right to be present at audits and inspections conducted by MannKind of its Third Party manufacturer(s) and Raw Materials suppliers, upon [***] written and MannKind shall give Sanofi thirty (30) days’ notice of such audits and inspections. Sanofi representatives will be advised of the confidentiality obligations of Sanofi under this Agreement and will follow such security, safety and facility access procedures as are reasonably designated by MannKind and its Third Party manufacturer(s) and suppliers, as applicable. MannKind shall provide to KymeraSanofi any audit reports generated by or prepared for MannKind in the conduct of any inspections or audits, Kymera will permit Sanofi to conduct on-site visits which reports shall be deemed Confidential Information of MannKind. Each Party’s costs in conducting inspections or audits under this Section 7.4 shall be borne by the respective Party and shall be considered Allowable Expenses for purposes of Exhibit B to the relevant Kymera premises during normal business hours to review and inspect such premises, and ▇▇▇▇▇▇’s reports and records, regarding (a) Kymera’s oversight of manufacturing, quality control procedures, release, and (b) the Manufacture, disposition or transport of materials supplied by Kymera to Sanofi, in each case ((a) and (b)) to confirm Kymera’s compliance with Applicable Law; such visits to be subject to customary and reasonable due diligence procedures to preserve the confidentiality of any information obtained by Sanofi. Such visits will (a) occur no more than [***], (b) will be conducted in such a manner to minimize, to the extent reasonably possible, the period of such visit and in no case shall such period exceed [***], and (c) will be conducted by the minimum number of Sanofi employees as necessary to provide requisite subject matter expertise and conduct the review in the allotted timeframe, each of whom shall have appropriate experience in the Manufacture, quality and cGMP compliance of small molecule compounds and candidates. Upon completion of any such visit, Sanofi will provide Kymera and the JMC of Sanofi’s findings from each such visits. [***]License Agreement.

cGMP Compliance and QA Audits. Following the Effective DateUpon prior written request, when negotiating a CMO agreement for the Manufacture of Collaboration Compounds or Collaboration Candidates, Kymera will use Commercially Reasonable Efforts to obtain Gilead shall have the right for Sanofi to, upon no less than [***] advance written notice per Year to Kymera, have its representatives and subject to the terms of representatives from its licensee(s) and distributor(s) for any relevant CMO agreement, have representatives Drug Product visit the locations at which Manufacturing activities are undertaken by the relevant CMO, in each case, Facility during normal business hours on business days to review and inspect records and reports pertinent to the Manufactureaudit Patheon’s manufacturing process, disposition or transport of Collaboration Compounds or Collaboration Candidates. Such visits will occur no more than [***], except in the case of audits by Sanofi that are required by Applicable Laws. In addition, upon [***] written notice to Kymera, Kymera will permit Sanofi to conduct on-site visits to the relevant Kymera premises during normal business hours to review and inspect such premises, and ▇▇▇▇▇▇’s reports and records, regarding (a) Kymera’s oversight of manufacturing, quality control procedures, release, and (b) the Manufacture, disposition or transport of materials supplied by Kymera to Sanofi, in each case ((a) and (b)) to confirm Kymeraassess Patheon’s compliance with Applicable Law; cGMPs and quality assurance standards, review records relating to the Processing of such visits Drug Product and discuss any related issues with manufacturing and management personnel as it relates to be subject such Drug Product (such activities collectively, a “cGMP/QA Audit”). Notwithstanding the foregoing, if Gilead’s representatives and/or representatives from its licensee(s) and distributor(s) for any Drug Product require cGMP/QA Audits in addition to customary and reasonable due diligence procedures to preserve the confidentiality of any information obtained by Sanofi. Such visits will (a) occur no more than [***]] per Year, (bthen they shall have the right to conduct such additional cGMP/QA Audits, in the presence of a Gilead representative, provided Gilead or such licensee(s) will be conducted in such a manner to minimize, to or distributor(s) shall pay Patheon’s reasonable costs for the extent reasonably possible, the period conduct of such cGMP/QA Audits. Gilead’s representatives and representatives from its licensee(s) and distributor(s) for any Drug Product shall be bound by an obligation of confidentiality with respect to information that such representatives may obtain during such visit to inspect and audit Patheon’s manufacturing process and the Processing of Drug Product and will comply with all standard operating policies and procedures while within the Facility or other Patheon premises. Notwithstanding the foregoing, Gilead (and its licensee(s) and distributor(s) for any Drug Product) shall have the right to conduct a “For Cause” audit at any time, when requested as a reasonable response to a FDA or other regulatory agency audit notice or inquiry regarding a Drug Product, an unresolved deviation in no case shall such period exceed [***]Processing of Drug Product by Patheon, or customer complaints or adverse events regarding a Drug Product, and Gilead (cor such licensees or distributors) will be conducted by shall bear Patheon’s expenses therefore unless as a result of such “For Cause” audit it is determined that there was non-compliance with the minimum number of Sanofi employees as necessary to provide requisite subject matter expertise and conduct the review warranties in the allotted timeframe, each of whom shall have appropriate experience in the Manufacture, quality and cGMP compliance of small molecule compounds and candidates. Upon completion of any such visit, Sanofi will provide Kymera and the JMC of Sanofi’s findings from each such visits. [***]Section 6.2.

cGMP Compliance and QA Audits. Following the Effective Date, when negotiating a CMO agreement for the Manufacture of Collaboration Compounds or Collaboration Candidates, Kymera will use Commercially Reasonable Efforts to obtain the right for Sanofi to, upon no less than [***] advance written notice to Kymera, and subject to the terms of any relevant CMO agreement, have representatives visit the locations at which Manufacturing activities are undertaken by the relevant CMO, in each case, during normal business hours to review and inspect records and reports pertinent to the Manufacture, disposition or transport of Collaboration Compounds or Collaboration Candidates. Such visits will occur no more than [***], except in the case of audits by Sanofi that are required by Applicable Laws. In addition, upon [***] written notice to Kymera, Kymera will permit Sanofi to conduct on-site visits to the relevant Kymera premises during normal business hours to review and inspect such premises, and ▇▇▇▇▇▇Kymera’s reports and records, regarding regarding (a) Kymera’s oversight of manufacturing, quality control procedures, release, and (b) the Manufacture, disposition or transport of materials supplied by Kymera to Sanofi, in each case ((a) and (b)) to confirm Kymera’s compliance with Applicable Law; such visits to be subject to customary and reasonable due diligence procedures to preserve the confidentiality of any information obtained by Sanofi. Such visits will (a) occur no more than [***], (b) will be conducted in such a manner to minimize, to the extent reasonably possible, the period of such visit and in no case shall such period exceed [***], and (c) will be conducted by the minimum number of Sanofi employees as necessary to provide requisite subject matter expertise and conduct the review in the allotted timeframe, each of whom shall have appropriate experience in the Manufacture, quality and cGMP compliance of small molecule compounds and candidates. Upon completion of any such visit, Sanofi will provide Kymera and the JMC of Sanofi’s findings from each such visits. [***].

cGMP Compliance and QA Audits. Following After the Amendment Effective Date, when negotiating a CMO agreement Lilly shall not be responsible for the Manufacture manufacture of Collaboration COR Option Products, COR Products, Specific New Chemistry Compounds or Collaboration CandidatesTerminated Co-Development Products. Notwithstanding the previous sentence, Kymera will use Commercially Reasonable Efforts after the Amendment Effective Date, Lilly shall be responsible for the manufacture of Products developed pursuant to obtain Section 4.5 and for the right for Sanofi tocompletion of manufacturing of the bulk [*] lots that were commenced during the Research Term. During the first [*] the Amendment Effective Date, upon no less than written request to Lilly and at a mutually agreeable time during normal business hours, COR shall have the right, with respect only to such manufacture of [***] advance written notice to Kymera, and subject to the terms of any relevant CMO agreement, (i) have representatives visit the locations at which Manufacturing activities are undertaken by the relevant CMOLilly's or its subcontractors' manufacturing facilities, in each caseas applicable, during normal business hours to (ii) review and inspect records and reports pertinent to the Manufacture, disposition Lilly's or transport of Collaboration Compounds or Collaboration Candidates. Such visits will occur no more than [***], except in the case of audits by Sanofi that are required by Applicable Laws. In addition, upon [***] written notice to Kymera, Kymera will permit Sanofi to conduct on-site visits to the relevant Kymera premises during normal business hours to review and inspect such premises, and ▇▇▇▇▇▇’s reports and records, regarding (a) Kymera’s oversight of its subcontractors' manufacturing, operations and assess their compliance with cGMP and quality control procedures, releaseassurance standards, and (biii) discuss any related issues with Lilly's or its subcontractors' manufacturing and management personnel. During the Manufacturefirst [*] the Amendment Effective Date, disposition Lilly shall cooperate and cause its subcontractor to cooperate with any inspection by the FDA or transport other regulatory agency, including but not limited to any inspection prior to approval of materials supplied the NDA for a Terminated Co-Development Product containing [*]. While it is not anticipated that the FDA or other regulatory agencies will seek to inspect or review the manufacturing of [*] by Kymera Lilly or its subcontractors after the expiration of [*] from the Amendment Effective Date, all parties to Sanofithis agreement acknowledge the right of these agencies to do so. In view of such potential regulatory inspection or review, in each case ((a) Lilly agrees not to destroy any records directly relating to the manufacturing of [*] by Lilly or its subcontractors without first notifying COR and (b)) giving COR a reasonable opportunity to confirm Kymera’s compliance with Applicable Law; obtain such visits to be subject to customary records. In the event that such a review or inspection is requested, COR, Lilly and reasonable due diligence procedures to preserve the confidentiality of any information obtained by Sanofi. Such visits Lilly's subcontractors will (ai) occur no more than [***], (b) will be conducted in such a manner to minimize, confer with each other with respect to the extent reasonably possible, the period of best means to comply with any such visit and in no case shall such period exceed [***]agency requests, and (cii) will be conducted use their respective best efforts to comply with such requests. COR shall bear the reasonable direct costs incurred by Lilly in complying with this Section 9.9. * Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the minimum number Securities and Exchange Commission pursuant to Rule 24-b2 of Sanofi employees the Securities Exchange Act of 1934, as necessary to provide requisite subject matter expertise and conduct the review in the allotted timeframe, each of whom shall have appropriate experience in the Manufacture, quality and cGMP compliance of small molecule compounds and candidates. Upon completion of any such visit, Sanofi will provide Kymera and the JMC of Sanofi’s findings from each such visits. [***]amended.