definiens: shall mean the specifications which describe test ing methods and acceptance criteria for Vials as specified in the NDA, as such specificatio ns may be amended from time to time by mutual writt en agreement of the parties or as requested or require d by the FDA, including without limitation such ame ndments to the NDA . The Specifications shall include, witho ut limitation : ( a ) the specifications for materials, packaging, components, labeling, finished product and manufact uring controls for the Vials or API ( as applicable ) covered under Unigene ’s Standard Operating Procedures ( the ), Validation Documentation, policies or cove red under any other materials identified and committed to in any applicable regulatory application, and ( b ) ( i ) material and component specifications ( including ap proved suppliers and distributors ; physical, chemic al and microbiological specifications, as appropriate ) ; ( i i ) Labeling specifications ( including approved supp liers and distributors, physical attributes, art proofs ) ; ( ii i ) sampling requirements ( for physical, chemical, m icrobiological testing ) ; ( iv ) manufacturing requirements, includin g processing and equipment requirements ; ( v ) in - pro cess control specifications ; ( vi ) Packaging requirements, including processing and equipment requirements ; ( vii ) Finished Product release requirements ( includ ing testing methodology, equipment requirements, an d release specifications ) ; and ( viii ) stability specification s ( including testing methodology, equipment require ments and testing specifications ) . All Specifications must co mply with cGMP requirements and be consistent with U.S