definiens: means the first product for which an NDA is filed containing BEMA Granisetron following the datehereof ; provided, however if BEMA Granisetron is not the first BEMA - based product for which an NDA is filed with the FDAby or on behalf of BDSI following the date hereof, then Royalty Product shall mean the first BEMA - based product for whichan NDA is filed with the FDA by or on behalf of BDSI following the date hereof ; provided, further however, that RoyaltyProduct shall ( i ) exclude any BEMA - based product containing Fentanyl or a Derivative thereof, or Buprenorphine or aDerivative thereof ; and ( ii ) exclude any product, and Net Sales related to such product, other than the specific productapproved under such NDA or any modification of the Royalty Product using the same API except where a new IND requiringa clinical trial is filed