cGMP Compliance and QA Audits Clause Samples
The cGMP Compliance and QA Audits clause requires parties to adhere to current Good Manufacturing Practices (cGMP) and allows for quality assurance (QA) audits to verify compliance. Typically, this means that the manufacturing party must maintain facilities, processes, and documentation that meet regulatory standards, and the other party may conduct periodic inspections or request records to ensure these standards are met. The core function of this clause is to ensure product quality and regulatory compliance, thereby reducing the risk of defective products and regulatory penalties.
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. Upon written request to Eagle by MDCO and subject to the consent of Eagle, not to be unreasonably withheld, delayed or conditioned, MDCO may accompany Eagle to a Third Party Manufacturer’s Manufacturing facilities during normal business hours to discuss any issues regarding Manufacturing and management personnel, and to review and inspect (i) the Manufacturing and storage facilities, (ii) the quality control procedures, and/or (iii) any records and reports pertinent to the Manufacture, disposition or transport of Product as may be necessary to evidence the Third Party Manufacturer’s compliance with all applicable Regulatory Approvals for the Manufacture of Product supplied to MDCO hereunder, including compliance with cGMP. MDCO may make such visits with Eagle to the Third Party Manufacturer’s Manufacturing facilities once per calendar year unless MDCO identifies, during any such visit or as a result of any Form 483 received by such Third Party Manufacturer, any defects or deficiencies provided in any of the foregoing clauses (i), (ii) or (iii) above, in which case MDCO may make as many subsequent visits to such facilities as are reasonably required to determine whether such defects or deficiencies have been cured. In addition to the foregoing, the Quality Agreement shall include a provision providing MDCO with the right, during normal business hours, to conduct annual supply oversight and compliance audits of all Eagle facilities and records used in or related to the supply of Product to MDCO hereunder.
cGMP Compliance and QA Audits. Upon written request to Oakwood, Edge shall have the right to have representatives visit the Facilities during normal business hours to review Oakwood’s Manufacturing operations and assess its compliance with cGMPs and quality assurance standards and to discuss any related issues with Oakwood’s manufacturing and management personnel.
cGMP Compliance and QA Audits. Upon written request to Vical, once per Calendar Year, Astellas shall have the right to have representatives visit Vical’s and/or its Third Party manufacturer’s Manufacturing facilities during normal business hours to discuss any related issues with Vical’s and/or its Third Party manufacturer’s Manufacturing and management personnel and to review and inspect (a) Vical’s and/or its Third Party manufacturer’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 Products as may be necessary to evidence Vical’s and/or its Third Party manufacturer’s compliance with all applicable laws, rules and regulations relating to the Manufacture of Product, including compliance with cGMP; provided, however, that with respect to for-cause inspections, Astellas shall be permitted to conduct such for-cause inspections more than once per Calendar Year. Astellas shall have the right to conduct QM/QP inspection for Manufacture at Vical of Products for use in a HSCT Study no later than […***…] prior to such Manufacture (it being understood that certain amount of bulk Compound in total quantities thereof that would be used in such Manufacture has been manufactured prior to the Effective Date and provided that this Agreement has been signed with sufficient time to allow inspection within such a timeframe for finished Non-Commercial Product for such HSCT Study).
cGMP Compliance and QA Audits. Within ten days of Aviron's written request, PCI shall supply Aviron with copies of PCI's manufacturing records, including its batch records, for the purposes of assuring product quality and compliance with the Specifications. Any found discrepancies, other than discrepancies resulting from directions received from Aviron or its representatives, will be reported to PCI and PCI will within 30 days correct said discrepancies to Aviron's reasonable satisfaction. Failure to do so will give Aviron the right to terminate the Agreement pursuant to Section 10.5. Aviron's failure to exercise its right to audit PCI's Facility will not represent a waiver of any future exercise of this right or of any other rights under this Agreement, nor does it represent acceptance of any conditions past or present that might exist or result from such conditions at the Facility. Aviron acknowledges that all copies of PCI's manufacturing records shall be subject to the confidentiality provisions of Article 12.
cGMP Compliance and QA Audits. Upon written request with reasonable advance notice to Kureha, Ocera shall have the right to have representatives visit Kureha’s manufacturing facilities during normal business hours to review Kureha’s manufacturing operations and assess its compliance with cGMP and quality assurance standards and to discuss any related issues with Kureha’s manufacturing and management personnel.
cGMP Compliance and QA Audits. Within ten days of MedImmune’s written request, Cardinal Health shall supply MedImmune with copies of Cardinal Health’s manufacturing records, including its batch records, for the purposes of assuring product quality and compliance with the Packaging Specifications. Any found discrepancies, other than discrepancies resulting from directions received from MedImmune or its representatives, will be reported to Cardinal Health and Cardinal Health will within thirty (30) days correct said discrepancies to MedImmune’s reasonable satisfaction. Failure to do so will give MedImmune the right to terminate this Agreement pursuant to Section 10.5. MedImmune’s failure to exercise its right to audit the Cardinal Health Facility will not represent a waiver of any future exercise of this right or of any other rights under this Agreement, nor does it represent acceptance of any conditions past or present that might exist or result from such conditions at the Cardinal Health Facility. MedImmune acknowledges that all copies of Cardinal Health’s manufacturing records shall be subject to the confidentiality provisions of Article 12.
cGMP Compliance and QA Audits. Upon no less than sixty (60) days’ advance written notice to Optimer, Partner shall have the right to have representatives visit Optimer’s (but not, for clarity, its Third Party Manufacturer’s) Manufacturing facilities during normal business hours to discuss any related issues with Optimer’s (but not, for clarity, its Third Party Manufacturer’s) Manufacturing and management personnel and to review and inspect (a) Optimer’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 Optimer’s compliance with all applicable 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 Partner that are required by Applicable Laws, and except that additional visit(s) may occur in the event of significant deviations, quality problems or recalls requiring resolution by the Parties. Partner shall also have the right to be present at audits and inspections conducted by Optimer of its Third Party Manufacturer(s) if permitted under the applicable agreement between Optimer and its 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 ▇▇▇▇ or Partner shall participate in such audit or inspection, and if Partner or ▇▇▇▇ has the right to so participate, Partner and ▇▇▇▇ shall decide which of Partner or ▇▇▇▇ shall participate in such audit or inspection. For clarity, in no event shall both Partner and ▇▇▇▇ 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 (10) days after receiving a written notice of such audits and inspections. Partner representatives will be advised of the confidentiality obligations of Partner under this Agreement and will follow such security, safety and facility access procedures...
cGMP Compliance and QA Audits. Upon written request to Gilead and at reasonable intervals (but in any event no more frequently than once per calendar year), OSI shall have the right to have an Industry Expert (either one that is mutually agreed by the Parties or a single Industry Expert that would be the third Industry Expert if a panel were being established pursuant to Section 16.4) visit Gilead's manufacturing facilities during normal business hours to observe and inspect their -------------- ** This portion has been redacted pursuant to a confidential treatment request. manufacturing operations and the facilities and procedures used in the manufacture and storage of API and Products to be supplied to OSI hereunder, and to assess their compliance with cGMP, QA standards and other requirements under this Manufacturing Agreement; provided, however, that notwithstanding anything to the contrary in this Section 6.3, OSI's rights pursuant to this Section 6.3 with respect to manufacturing facilities used to manufacture each Product shall specifically exclude the right to observe the following trade secret-related steps in the manufacture of any Liposomal Product using its API: (i) manufacture of intermediates; and (ii) production of bulk Liposomal Product.
cGMP Compliance and QA Audits. Upon SciClone's written request to Patheon, SciClone shall have the right to have representatives visit Patheon's manufacturing facilities during normal business hours to review Patheon's manufacturing operations, to have access to any relevant records in connection with such manufacture and assess its compliance with cGMP and quality assurance standards and to discuss any related issues with Patheon's manufacturing and management personnel. Upon completion of Patheon's internal review and product batch release, SciClone shall have the right to request copies of Patheon's manufacturing records, including its batch records and analytical records, for the purposes of assuring product quality and compliance with agreed-upon manufacturing procedures and specifications. SciClone acknowledges that all copies of Patheon's manufacturing records shall be protected under the confidentiality provisions of Article 11.