definiens: shall mean the Federal Food Drug and Cosmetic Act of 1934, and the rules and regulations promulgatedthereunder, or any successor act, as the same shall be in effect from time to time.1.2 shall mean ( i ) any corporation or business entity of which more than fifty percent ( 50 % ) of thesecurities or other ownership interests representing the equity, the voting stock or general partnership interest areowned, controlled or held, directly or indirectly, by a Party ; ( ii ) any corporation or business entity which, directly orindirectly, owns, controls or holds more than fifty percent ( 50 % ) ( or the maximum ownership interest permitted by law)of the securities or other ownership interests representing the equity, voting stock or general partnership interest of aParty or ( iii ) any corporation or business entity of which a Party has the right to acquire, directly or indirectly, at leastfifty percent ( 50 % ) of the securities or other ownership interests representing the equity, voting stock or generalpartnership interest thereof