definiens: as defined in this Agreement includes the following components Two sizes : 100 mL nominal container for the 1000 mg product ; 50 mL nominal container for the 500 mg ( pediatric ) product . Type II Vial qlass bottle with 32 mm neck finish, Kimble or San Gobain Stopper Helvoet, formulation 9240 FM257/2, 32 mm stopper, latex free Other closure - related Flip - off cap Label, hanqer Hanqer style label Packaging Shipper configuration 12 units per shipper Labeling Cadence approved label ; 2 shipper labels per carton Direction insert Cadence - p rovided product insert, 1 insert per shipper carton 36 EXHIBIT A ( cont ) Product Definition Assumptions / cont ): Sterilization release method . Consistent with agreements [COMPANY] has made with the FDA, all moist - heat - sterilized solutions products currently manufactured by [COMPANY] for the U.S market are released for sterility based on parametric methods rather than on the results of sterility testing