“Quality Agreement” means the document established by MODERNA and LONZA in conjunction with this Agreement to establish the quality requirements applicable to Manufacture in accordance with applicable guidelines issued by the Regulatory Authorities that control authorization and licensing for manufacture and sale of pharmaceutical or medicinal products.
8. Regulatory Matters
8.2 Regulatory Approvals. MODERNA shall own all Regulatory Approvals, permits, authorizations and certificates necessary for the use of Products. All DMFs [Drug Master Files] for the Products will be filed in MODERNA’s (or its designee’s) name and will be owned by MODERNA (or its designee). LONZA shall assist MODERNA in the preparation of such regulatory filings, Regulatory Approvals, permits, authorizations and certificates necessary for the use of Products or DMFs, including providing such information and data, including CMC information and data, as may reasonably be requested by MODERNA, as further detailed in the relevant Statement of Work or as agreed by the Parties in writing. The DMF for the Facility shall be owned by LONZA.
8.4 Notification of Regulatory Authority Action. Each Party shall promptly notify the other Party of any notice such Party receives regarding any threatened or pending action by any Regulatory Authority regarding the Manufacture of Product, including any Regulatory Authority non–approval or regulatory action. Upon receipt of any such information, the Parties shall consult in an effort to arrive at a mutually acceptable procedure for taking appropriate action; provided, however, that nothing contained herein shall be construed as restricting the right of either Party to make a timely report of such matter to any Regulatory Authority or take other action that it deems to be appropriate or required by Applicable Law.
8.6 Regulatory Authority Inspections. LONZA shall advise MODERNA immediately (but in no event less than [***] prior to a pre–notified or scheduled visit or inspection) of any Regulatory Authority visit or inspection that relates to Product or the Manufacture thereof at any Facility, or any written or oral inquiries by such Regulatory Authority concerning Product (including safety and efficacy claims) or the Manufacture thereof at any Facility. LONZA will permit representatives of any Regulatory Authority to inspect and audit the parts of each Facility where LONZA performs the Services, including the parts of the Facility where the Manufacture of the Product is carried out, and to inspect or audit the Project Documentation, Batch Records or other records to verify compliance with cGMP and other Applicable Laws and will promptly notify MODERNA of the scheduling of any such inspection relating to the Services, including Manufacture of Product. MODERNA shall be permitted to be on site and available for questions regarding the Product during any such inspection or audit. LONZA shall promptly (and in no event later than [***]) notify MODERNA of the results of any such inspection, and furnish MODERNA summaries of all reports, documents and correspondence with respect to any Regulatory Authority inquiries, visits or inspections, as well as a copy of each report, document and correspondence issued by or provided to any Regulatory Authority in connection with such request, visit or inquiry to the extent such documents relate to or affect the Services, Product or Manufacture of the Product. LONZA and MODERNA shall consult with one another in an effort to arrive at a mutually acceptable response to the extent related to Product, provided that if the Parties fail to timely arrive at a mutually acceptable response, LONZA shall not be required to delay or risk prejudice to LONZA’s compliance with its legal requirements. Without limiting the foregoing, LONZA shall furnish to MODERNA, (a) within [***] after receipt, any report or correspondence issued by the Regulatory Authority in connection with such visit, inspection or inquiry, including any FDA Form 483, Establishment Inspection Report, or warning letter, and (b) copies of any and all responses or explanations to any Regulatory Authority relating to items set forth above prior to the submission of such responses or explanations to any Regulatory Authority by LONZA. LONZA shall comply with all reasonable requests and comments by MODERNA with respect to all responses or explanations to, or contacts and communications, with any Regulatory Authority relating in any way to the Products or Services, and shall immediately inform MODERNA in the event any Regulatory Authority takes any regulatory action against LONZA that could have an effect on LONZA’s performance of the Services or the Manufacture of the Product.
8.7 Recall; Withdrawal. As may be further set forth in the Quality Agreement, in the event that either Party determines an event, incident or circumstance has occurred which may result in the need for a “recall”, “market withdrawal” or “field alert” of Product, as such terms are defined in the United States Code of Federal Regulations 21 CFR 7.3 and 21 CFR 314, or other Applicable Law or regulation of a country (a “Recall”), such Party shall advise and consult with the other Party regarding such event. MODERNA shall be responsible for implementing and administering any Recall, in its sole discretion [***]. LONZA shall provide reasonable assistance to MODERNA in conducting a recall or withdrawal, including providing MODERNA with all reasonably pertinent records and information. If the parties dispute whether such Recall was primarily due to LONZA providing defective Product, then either party may seek the determination of whether the Product was defective Product in accordance with the relevant Statement of Work.