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. After the Amendment Effective Date, Lilly shall not be responsible for the manufacture of COR Option Products, COR Products, Specific New Chemistry Compounds or Terminated Co-Development Products. Notwithstanding the previous sentence, after the Amendment Effective Date, Lilly shall be responsible for the manufacture of Products developed pursuant to Section 4.5 and for the completion of manufacturing of the bulk [*] lots that were commenced during the Research Term. During the first [*] the Amendment Effective Date, upon 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 [*] to (i) have representatives visit Lilly's or its subcontractors' manufacturing facilities, as applicable, (ii) review Lilly's or its subcontractors' manufacturing, operations and assess their compliance with cGMP and quality assurance standards, and (iii) discuss any related issues with Lilly's or its subcontractors' manufacturing and management personnel. During the first [*] the Amendment Effective Date, Lilly shall cooperate and cause its subcontractor to cooperate with any inspection by the FDA or other regulatory agency, including but not limited to any inspection prior to approval of 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 Lilly or its subcontractors after the expiration of [*] from the Amendment Effective Date, all parties to this agreement acknowledge the right of these agencies to do so. In view of such potential regulatory inspection or review, Lilly agrees not to destroy any records directly relating to the manufacturing of [*] by Lilly or its subcontractors without first notifying COR and giving COR a reasonable opportunity to obtain such records. In the event that such a review or inspection is requested, COR, Lilly and Lilly's subcontractors will (i) confer with each other with respect to the best means to comply with any such agency requests, and (ii) 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 Securities and Exchange Commission pursuant to Rule 24-b2 of the Securities Exchan...
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 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 Packaging 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 thirty (30) days correct said discrepancies to Aviron's reasonable satisfaction. Failure to do so will give Aviron the right to terminate this Agreement pursuant to Section 10.5. Aviron's failure to exercise its right to audit the PCI 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 PCI 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. 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. 3.5
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 written request to Medarex, IDM shall have the right to have representatives visit Medarex’s manufacturing facilities where the Antibody is manufactured no more than twice per year and during normal business hours, to review Medarex’s manufacturing operations and assess its compliance with cGMP and quality assurance standards and to discuss any related issues with Medarex’s manufacturing and management personnel. Such written request shall be made at least thirty (30) days before the requested date of IDM’s visit.
cGMP Compliance and QA Audits. 20 6.4 Change in Manufacturing Process Proposed by Gilead............................. 21 6.5 Changes to Specifications...................................................... 21 6.6 Quality Control Samples and Methods............................................ 22 6.7 Records........................................................................ 23 TABLE OF CONTENTS (CONTINUED)
