definiens: means, with respect to the development, manufactu re and/or commercialization of a Product and any other activi ties conducted under the Agreement with respect to such Product, the level of efforts and resources commonl y used in the pharmaceutical or biotechnology indus try by a similarly situated company of similar size and reso urces in the exercise of its reasonable business di scretion with respect to a product at a similar stage in its deve lopment or product life, that is of similar commerc ial potential, taking into account actual or potential issues incl uding, but not limited to, issues relating to effic acy, safety, manufacturing, quality, supply, regulatory or marke t exclusivity, patents and intellectual property pr otection, product profile, labeling, pricing, reimbursement, distribution, market potential, competitive conditi ons, the regulatory environment, and any other technical, le gal, scientific, medical, operational or commercial factors that could reasonably be expected to affect profitabilit y of the product