definiens: shall mean the filing of an appli cation by the FDA as defined in the FDCA and applic able regulations, or the equivalent application to the e quivalent agency in any other country or group of c ountries, the official approval of which application is required before any lawful ( a ) commencement of clinical tria ls for with respect to INDs and ( b ) commercial sale or marketin g with respect to BLAs or NDAs, of Licensed Product s. To avoid doubt ( i ) with respect to INDs, shall mean the I ND going int o effect in accordance with 21 C.F.R. 312.40(b ) ; and ( ii ) with respect to BLAs or NDAs, does no t refer to such ultimate official approval, rather, it refers to the FDA or equivalent agency accepting the applicat ion as filed for review in order to determine wheth er or not to approve it