definiens: means the United States Food, Drug, and Cosmetic Act of 1938, as amended, and therules and regulations promulgated thereunder, or any successor act, as the same shall be in effect from time to time.11.2 means with respect to a Party ( i ) any corporation or business entity of whichmore than fifty percent ( 50 % ) of the securities or other ownership interests representing the equity, the voting stockor general partnership interest are owned, controlled or held, directly or indirectly, by such Party ; ( ii ) any corporationor business entity which, directly or indirectly, owns, controls or holds more than fifty percent ( 50 % ) ( or themaximum ownership interest permitted by law ) of the securities or other ownership interests representing theequity, voting stock or general partnership interest of such Party ; ( iii ) any corporation or business entity of which, directly or indirectly, an entity described in the immediately preceding subsection ( ii ) controls or holds more thanfifty percent ( 50 % ) ( or the maximum ownership interest permitted by law ) of the securities or other ownershipinterests representing the equity, voting stock or general partnership interest of such corporation or entity ; orFirefox https://www.lawinsider.com/contracts/dr3mJsEAJKuygj4gR6ml6/indevu ..