definiens: means ( a ) Corgentcch 's proprietary Transcription factor Decoy that hIlS ( i ) tile [ nuc!eutide sequence of ! he product [ lhat is [ the subject of tile lnvcsliga lional New Drug Application Number 51615 filed with the FDA prior to the Effective Date [ and ( ii ) 10 pnmary mechanism of action of directly bmdmg 10 thel E2F transcription factor, thereby lmodulatina the expression of the genes regulated by such trnnscripTion factorl, and ( b ) any other Tnlllscrip lion Factor Decoy that [ also has a pnmary TllC:(:hanism of action described in clause ( a)(ii ) abovel . An E2F Decoy may he [ an Intermedlnte or composed of duplexes of Intel1l1l : d iIIles [