definiens: Product " shall mean the Drug in final dosage form, packaged in a standard flip top vial, meeting Product Specifications . Following successful qualification, Product shall be automatically amended to include, as applicable, [ D250, D260, D350, D360, D500, and D510 ] * configurations of CUBICIN ® ( daptomycin for injection).1.8 shall mean the applicable product, labeling and performance specifications for Product, of any configuration ( e.g. the amount of Bulk Drug per vial of Product ) [ and in any current or future formulation, each ] * as filed with the FDA or other appropriate regulatory authorities, including Product formula and materials required for the manufacture of Product, which are to be purchased and supplied under this Agreement, and as are set forth on Exhibit 1.8, which specifications may be modified from time to time by mutual written agreement of the parties, without the necessity of amending this Agreement . " ' Confidential Treatment Requested . Omitted portions filed with the Securities and Exchange Commission ( the )