definiens: means, with respect to activities of a Party in the Development or theCommercialization of a particular Product, the efforts and resources typically used by that Party ( or if the Party does not engage in that activity forother products or compounds, by biotechnology and/or pharmaceutical companies that are similar in size ) in the development of productcandidates o r the commercialization of products of comparable market potential, taking into account all relevant factors including, as applicableand without limitation, stage of development, mechanism of action, efficacy and safety relative to competitive products in the marketplace, actualor anticipated Regulatory Authority approved labeling, the nature and extent of market exclusivity ( including patent coverage and regulatoryexclusivity ), cost and likelihood o f obtaining Commercialization Regulatory Approval, and actual or projected profitability . CommerciallyReasonable Efforts shall be determined on a market - by - market and indication - by - indication basis for a particular Product, and it is anticipated thatthe level of effort will be different for different markets, and will change over time, reflecting changes in the status of the Product and themarket(s ) involved