definiens: shall mean, with respect to ( a ) the Development Activities that aMember Party is required to perform with respect to the Combination Product pursuant to the Development Plan, or(b ) the Commercialization Activities that a Member Party is required to perform with respect to the CombinationProduct pursuant to a Commercialization Plan, as the case may be, the level of effort that would generally be used bya Member Party to conduct such development or commercialization activities in a manner consistent with theminimum level of expenditure contemplated for such activities by the Development Budget or a CommercializationBudget, as the case may be, for a product or compound owned by it or to which it has rights, which is of comparablemarket potential, profit potential or strategic value to such Member Party and is at a similar stage in its developmentor product life, taking into account, without limitation, issues of safety and efficacy, product profile, the proprietaryposition, the then - current competitive environment for such product or compound ( and any individual agent comprisingpart of such product or compound ), the likely timing of the product ’s or compound ’s ( and any such individual agent’s)entry into the market, the then - current market penetration, the return on investment potential of such product ( and anyindividual agent comprising part of such product ), the regulatory environment and status of the product ( and anyindividual agent comprising part of such product ), and other relevant scientific, technical and commercial factors, ineach case as measured by the facts and circumstances at the time such efforts are due . Such determination shall bemade on a country - by - country basis