definiens: shall mean the occurrence of any of the following : 0 ) Columbia or its licensees shall withdraw, or be required by the FDA or other goverumental authority to withdraw, Crinone or Prochieve from the mar ~ iIlIio.llill;.ao~ ~.:iI;li~~~~eriod that is, or is reasonably expected to be, greater th one hundred days ; or ( ii ) Columbia or its licensees shall fail to have a supp y 0 none -~o ~ r ~ r ~ o"!'ic ~ l ~ ev ~ e~, or any ingredients or components thereof, consistent with past quantj, lies and .l!rafticesJor a ~ eriod of time that is, or is reasonably expected to be, greater ~ hunmed twen1y 02O§'iays . • 1.3 shall mean, as to any person or entity, any corporation or business entity controlled by, controlling, or under common control with such person or entity . For this purpose, shall mean direct or indirect beneficial ownership of at least fifty percent ( 50 % ) of the voting stock or income interest in such corporation or other business entity, or such other relationship as, in fact, constitutes actual control