definiens: means, with respect to activities of a Party in the Development orthe Commercialization of a particular Product, the efforts and resources typically used by that Party ( or if the Party does notengage in that activity for other products or compounds, by biotechnology and/or pharmaceutical companies that are similar insize ) in the development of product candidates or the commercialization of products of comparable market potential, taking intoaccount all relevant factors including, as applicable and without limitation, stage of development, mechanism of action, efficacyand safety relative to competitive products in the marketplace, actual or anticipated Regulatory Authority approved labeling, thenature and extent of market exclusivity ( including patent coverage and regulatory exclusivity ), cost and likelihood of obtainingCommercialization Regulatory Approval, and actual or projected profitability . Commercially Reasonable Efforts shall bedetermined on a market - by - market and indication - by - indication basis for a particular Product, and it is anticipated that the levelof effort will be different for different markets, and will change over time, reflecting changes in the status of the Product and themarket(s ) involved