definiens: means using such effort and employing such resour ces that are substantially similar to the effort and resources t hat a biopharmaceutical company similarly situated to Licensee would devote to a product of similar market potenti al, profit potential and strategic value at a simil ar stage of its product life, taking into consideration all relevan t factors, including the nature of the product, the clinical setting in which it is expected to be used, stage of develo pment, mechanism of action, efficacy and safety rel ative to competitive products in or expected to be introduce d into the marketplace, difficulties associated wit h technology transfer, process development, scale - up or manufacturing, safety issues, legal difficulties and intellectual property ownership, actual or anticipa ted regulatory authority approved labeling, the nat ure and extent of market exclusivity ( including patent cove rage and Regulatory Exclusivity ), cost and likeliho od of obtaining regulatory approval, but excluding from s uch consideration all payments due to Purdue under this Agreement . Commercially Reasonable Efforts will be determined on a market - by - market and indication - by - indication basis for a particular product, and it i s anticipated that the level of effort will be diff erent for different markets, and will change over time, reflecting chan ges in the status of the product and the market(s ) involved