definiens: means efforts at least consistent with the efforts that biotechnology or pharmaceutical companies similar in size to the applicable Party would be expected to devote to a product of similar market potential, profit potential ( without taking int o account payments under this Agreement ), or strategic value resulting from its own research efforts, and at a similar stage in its product life, taking into account, as applicable, stage of development, mechanism of action, efficacy and safety relative to competitive products in the marketplace, actual or anticipated Regulatory Authority approved labeling, expected and actual competitiveness of alternative products ( including generic products ) in the marketplace, the nature and extent of market exclusivity ( including patent coverage and regulatory exclusivity ), cost and likelihood of obtaining Marketing Authorization Approval, and availability of manufacture and supply for commercial sale . In all cases, the level of efforts required of a Party in connection with its Development and/or Commercialization efforts ( as applicable ) shall be determined without reference to any product other than Licensed Products, or any other drug development program other than the program described herein, owned by that Party, it s Affiliates or any Sublicensee, or to which any of them have any rights or interests