definiens: means the first product for w hich an NDA is filed containing BEMA Granisetron following the date hereof ; provided, however if BEM A Granisetron is not the first BEMA - based product f or which an NDA is filed with the FDA by or on behalf of BDSI following the date hereof, then Royalty Pro duct shall mean the first BEMA - based product for which a n NDA is filed with the FDA by or on behalf of BDSI following the date hereof ; provided, further howeve r, that Royalty Product shall ( i ) exclude any BEMA- based product containing Fentanyl or a Derivative thereof, or Buprenorphine or a Derivative thereof ; and ( ii ) exclude any product, and Net Sales related to such product, other than the specific product approved under suc h NDA or any modification of the Royalty Product using the s ame API except where a new IND requiring a clinical trial is filed