definiens: means the list of tests, test procedures, references to any analytical procedures, and appropriate acceptance criteria ( i ) to which any Manufactured Product at any stage of Manufacture must conform to be considered acceptable for its intended use, or ( ii ) to which Raw Materials ( including Materials ) must conform to be considered acceptable for their intended use, in each case that are mutually approved by the Parties, as such Specifications are amended or supplemented from time to time by mutual agreement of the Parties in writing, it being understood, however, that references herein to in the context of Non - GMP Batches shall not imply that such Specifications conform with the standards of GMP, and, as such, Specifications for Non­GMP Batches shall be considered for regulatory and quality control purposes to be draft Specifications . As used in this Supply Agreement, means the Specifications applicable to a particular Manufactured Product, means the Specifications applicable to a particular Finished Product, means the Specifications applicable to a particular Raw Material, and means the Specifications applicable to any part or whole of the Equipment . For clarity, the Product Specifications and Finished Product Specifications will identify which Lipid Nanoparticle will be used in the Manufactured Product ( e.g., SNALP - G, SNALP - H )