definiens: shall mean, with respect to the performance of De velopment, Commercialization, or Manufacturing activities with respect to a Licensed Product by a Party, the carr ying out of such activities using efforts and resources compara ble to the efforts and resources that such Party wo uld typically devote to products of similar market pote ntial at a similar stage in development or product life, taking into account all scientific, commercial, and other factors that the Party would take into account, inc luding issues of safety and efficacy, expected and actual cost an d time to develop, expected and actual profitabilit y ( including royalties and other payments required hereunder ), e xpected and actual competitiveness of alternative T hird Party products ( including generic products ) in the market place, the nature and extent of expected and actual market exclusivity ( including patent coverage and regulato ry exclusivity ), the expected likelihood of regulat ory approval, the expected and actual reimbursability a nd pricing, and the expected and actual amounts of marketing and promotional expenditures required . shall be determined on a coun try - by - country ( or region - by - region, where applicable ) and indication - by - indication basis, except that the Party may consider the impact of its efforts and resources ex pended with respect to any country ( or region ) on a ny other country ( or region )