CHANGES IN SPECIFICATIONS. Each Party shall promptly notify the other Party of (i) any change of the Specifications as well as any analytical methods that is required by any Regulatory Authority or in order to comply with any Regulatory Requirement, and/or (ii) any other material modifications to the Manufacturing process, applicable to the Product for use in the Field in the Territory, and the Parties shall discuss such change of Specifications, analytical methods and/or other material modification to the Manufacturing process prior to its implementation. (i) Prior to the receipt of the first Marketing Approval of the Product for the Territory, [ * ]. (ii) After the receipt of the first Marketing Approval of the Product for the Territory, such regulatory required Specification changes that are not conditions to the receipt of the first Marketing Approval of the Product for the Territory shall, [ * ] and the Parties shall coordinate and collaborate in making all necessary Regulatory Filings with the application Regulatory Authority in the Territory to effect such change. Grünenthal shall be responsible for making such Regulatory Filing in the Territory and paying filing fees required for such Regulatory Filing.
Appears in 3 contracts
Sources: Manufacture and Supply Agreement, Manufacture and Supply Agreement (Acelrx Pharmaceuticals Inc), Manufacture and Supply Agreement (Acelrx Pharmaceuticals Inc)