Common use of Moderna Regulatory Responsibilities Related to Manufacture Clause in Contracts

Moderna Regulatory Responsibilities Related to Manufacture. Consistent with the provisions of Section 4.10 of the A&R Services and Collaboration Agreement, Moderna will, at its sole cost and expense, obtain and maintain all approvals, licenses, registrations, or authorizations (other than the Regulatory Approval for a Product) that are necessary or useful in connection with the Manufacture of Collaboration mRNA Constructs, Product Candidates, and Products by or on behalf of Moderna. In addition, [***], Moderna will, when and as requested by AstraZeneca, prepare the Chemistry, Manufacturing, and Controls (“CMC”) and other Manufacturing provisions with respect to all Regulatory Filings for, or that are otherwise necessary to obtain and maintain, Regulatory Approvals for the Products, including with respect to any Manufacture and supply of Collaboration mRNA Constructs, Product Candidates, and Products by or on behalf of Moderna pursuant to Section 4 of the A&R Services and Collaboration Agreement, including any amendments with respect thereto as AstraZeneca may request from time to time. As set forth in greater detail in Section 4.10 of the A&R Services and Collaboration Agreement, the CMC section of a Regulatory Approval for a Product may reference Moderna’s DMF for such Product.