definiens: means, with respect to the performance of Develop ment, Commercialization, or Manufacturing activities with respect to a New Collaboration Compound or a Produ ct 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 products of similar market potential at a similar stage in d evelopment or product life, taking into account all scientific, commercial, and other factors that the Party woul d take into account, including issues of safety and efficacy, e xpected and actual cost and time to develop, expect ed and actual profitability ( including royalties and other payments required hereunder ), expected and actual competitiveness of alternative Third Party products ( including generic products ) in the marketplace, t he nature and extent of expected and actual market exclusivit y ( including patent coverage and Regulatory Exclusi vity ), the expected likelihood of regulatory approval, the exp ected and actual reimbursability and pricing, and t he expected and actual amounts of marketing and promotional exp enditures required . shall be determined on a country - by - country ( or reg ion - by - region, where applicable ) and indication - by - indication basis, except that the Party may conside r the impact of its efforts and resources expended with respect to any country ( or region ) on any other country ( or region )