Common use of cGMP Compliance and QA Audits Clause in Contracts

cGMP Compliance and QA Audits. Upon no less than sixty (60) days’ advance written notice to MannKind, Sanofi shall have the right to have representatives visit the MannKind Facility and any other locations at which any Manufacturing activities are undertaken, 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 Product 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 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. Sanofi 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, 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 Sanofi any audit reports generated by or prepared for MannKind in the conduct of any inspections or audits, 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 License Agreement.

cGMP Compliance and QA Audits. Upon 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 sixty (60) days’ [***] advance written notice to MannKindKymera, Sanofi shall have and subject to the right to terms of any relevant CMO agreement, have representatives visit the MannKind Facility and any other locations at which any Manufacturing activities are undertakenundertaken by the relevant CMO, 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 Product as may be necessary to evidence MannKind’s compliance with all applicable Marketing Approvals for the Manufacture of Product, including compliance with cGMPCollaboration Compounds or Collaboration Candidates. Such visits shall will occur no more than once per year[***], 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 except that additional visit(sXxxxxx’s reports and records, regarding (a) may 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 CONFIDENTIAL [***], (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 event allotted timeframe, each of shortages, significant deviationswhom shall have appropriate experience in the Manufacture, quality problems or recalls requiring resolution by the Partiesand cGMP compliance of small molecule compounds and candidates. Sanofi 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, 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 Sanofi any audit reports generated by or prepared for MannKind in the conduct Upon completion of any inspections or auditssuch visit, which reports shall be deemed Confidential Information Sanofi will provide Kymera and the JMC of MannKindSanofi’s findings from each such visits. 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 License Agreement[***].

cGMP Compliance and QA Audits. Upon no less than sixty (60) days’ advance written notice to MannKindOptimer, Sanofi Partner shall have the right to have representatives visit the MannKind Facility and any other locations at which any Optimer’s (but not, for clarity, its Third Party Manufacturer’s) Manufacturing activities are undertaken, in each case, facilities during normal business hours to discuss any related issues with MannKindOptimer’s (but not, for clarity, its Third Party Manufacturer’s) Manufacturing and management personnel and to review and inspect (a) MannKindOptimer’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 Supplied Product as may be necessary to evidence MannKindOptimer’s compliance with all applicable Marketing Regulatory Approvals for the Manufacture of Supplied Product, including compliance with cGMP. Such visits shall occur no more than once per year, except in the case of audits by Sanofi Partner 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. Sanofi Partner shall also have the right to be present at audits and inspections conducted by MannKind Optimer of its Third Party manufacturer(sManufacturer(s) if permitted under the applicable agreement between Optimer and Raw Materials suppliersits Third Party Manufacturer(s); provided, that if such agreement contains limits on the number of individuals or entities that may be present during such audit or inspection, Optimer shall use its reasonable discretion in determining which individuals or entities may participate in such audit or inspection (which may or may not include Affiliates, employees, licensees or independent consultants of Partner); provided further, that Optimer shall use reasonable efforts to ensure that a representative of XXXX or Partner shall participate in such audit or inspection, and MannKind if Partner or XXXX has the right to so participate, Partner and XXXX shall give Sanofi thirty decide which of Partner or XXXX shall participate in such audit or inspection. For clarity, in no event shall both Partner and XXXX have the right to participate in any audit or inspection under this Section 8.2 unless otherwise agreed in writing by Optimer and, if applicable, the Third Party Manufacturer. Optimer shall notify Partner within ten (3010) days’ days after receiving a written notice of such audits and inspections. Sanofi Partner representatives will be advised of the confidentiality obligations of Sanofi Partner under this Agreement and will follow such security, safety and facility access procedures as are reasonably designated by MannKind Optimer and its Third Party manufacturer(s) and suppliers), as applicable. MannKind shall provide to Sanofi any audit reports generated by or prepared for MannKind in the conduct of any inspections or audits, 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 License Agreement.