definiens: means, with respect to a Party in relation to an obligation under this Agreement with respect to a Licensed Pro duct, such efforts that are consistent with the eff orts and resources normally used by a comparable biotechnolo gy company in the performance of such an obligation for a similar pharmaceutical or biological product ( inclu ding the research, development, manufacture, and commercialization of a pharmaceutical or biological product ), as applicable, at a similar stage in its research, development, or commercial life as such Licensed Pr oduct, and that has commercial and market potential similar to such Licensed Product, taking into account issue s of intellectual property coverage, safety and eff icacy, stage of development, product profile, competitiveness of the marketplace, proprietary position, any issues regarding CMC and the ability to manufacture the Licensed Pro duct, regulatory exclusivity, anticipated or approv ed labeling, present and future market and commercial potential, the likelihood of receipt of Regulatory Approval, profitability ( including pricing and reimbursement status achieved or likely to be achieved ), the exis tence and developmental stages of alternative products and pr ograms, and legal issues . Commercially Reasonable E fforts shall be determined on a country - by - country basis f or a particular Licensed Product and is expected to change over time, reflecting changes in the status of such Licensed Product and the markets or countries invo lved