definiens: means the list of tests, references to any analyt ical procedures, and appropriate acceptance criteria ( a ) to which Product at any sta ge of Manufacture should conform to be considered acceptable for its intended use, or ( b ) to which ra w materials ( including, but not limited to, Materia ls ) should conform to be considered acceptable for thei r 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 bein g understood, however, that references herein to in the context of non - GMP Batches will not imply that such Specifications conform with the standards of GMP, and, as such, Specificat ions for non - GMP Batches will be considered for regulatory and quality control purposes to be draft Specifications . As used in this Agreement, means the Specifications applicable to a particul ar Product, and means the Specifications applicable to a particul ar raw material