definiens: means any medical devi ~ e that ( i ) is manufaclUrcd by or for Purchaser, iii ) which contains one or more Comp < ln ~ nts, and ( iii ) is designed to b~ permanently Or temporarily implmlted inside the human body _ ( Cl means thc datc first above wriUen, ( D ) means a corpor ~ lion or other busines < ; entity that directly or indirectly through One or lTIure intermediaries, controls, or is controlled by, or under COmmOn control with a pany to this Agreement . For this purpose, means beneficial o\'il1ership of more than fifty percent ( 50 % ) of the voting stock or more tlJa.ll fifty percent ( 50 % ) intnest illihe income of that corporation or other husine8, ~ntity, II . Pur ~ hascr 's Rcpr : e.~e.!!~~tions PtLrchas ~ r represents and warraIllS 10 BARD PERIPHERAL VASCULAR that : (, ' \ ) Purchaser is a ll1anuEtctur er of Imp ! anter . ! Devices, ( 3 ) Purchaser has determined thal the C()mponent5 ure suitable for the appliC - J.li()no in which it uses the Components in Implanted Devices " ( C ) Purchaser has in its cmploy or ha~ retained con ~ ultanb who are experienced and knowledgeable in the properti ", . pnlCe .., ing tedlJ1iqu ~ s mui potential hazards ofth~ CnrnpnnelllS [ 1I1(j Ih ~ ir use in Implanted Devices, P\Il'chascr has a regulatory stall ' properly trllined ill the requirelILent ., of the 11l, ited Stales Fedeml F,,,,, { ), Drug and Cosmetic Act Jnd pertinent regulations nnd ~i milar ~latute ., and regulations of states and other cmmtries ill which Implanted Devk ~ s may he ~()Id and qaalified medical staff, consultants and or clinical invcstigators to Gomlu ~ l such ~tadie~ a~ ilre needed to evaluate the safety and efficacy of and tile proper labeling I'or the Implanted Devices