definiens: means, with respect to the performance of Development, Commercialization or Manufacturing activities with respect to the Licensed Compo und or a Licensed Product by a Party, the carrying out of such activities using efforts and resources comparable to the efforts and resources that such Party would typically devote to compounds or products of similar market potential at a similar stage in development or product life, taking into account all scientific, commercial and other factors that such Party would take into account, including issues of safety and efficacy, expected and actual cost and time to develop, expected and actual profitability ( including royalties and other payments required hereunder ), expected and actual competitiveness of alternative Third Party products ( including generic or biosimilar products ) in the marketplace, the nature and extent of expected and actual market exclusiv ity ( including patent coverage and regulatory exclusivity ), the expected likelihood of regulatory approval, the expected and actual reimbursability and pricing, and the expected and actual amounts of marketing and promotional expenditures required