definiens: means the efforts and resourcesnormally used by an established pharmaceutical company for a pharmaceuticalproduct owned exclusively by such company ( i.e., without any royalty or similarobligation to another person or entity in respect of development orcommercialization of such product ) with a similar market potential at a similarstage in its development or commercialization, taking into account thecompetitiveness of the marketplace, its proprietary position with respect tosuch product, applicable regulatory circumstances, the profitability of suchproduct, the likelihood of success of commercialization, and other relevantfactors . Commercially Reasonable Efforts shall be deemed to have not occurred ifB&L, an Affiliate of B&L or sublicensee of B&L has not, within three ( 3 ) yearsfollowing the Effective Date, submitted an IND for a Licensed Product, commencedhuman clinical trials for a Licensed Product, received Registration Approval fora Licensed Product or made a commercial sale of a Licensed Product in a MajorTerritory