definiens: means all relevant factors that may affect the marketing, promotion, sale or other Commercialization of any Product, including ( as applicable ): issues ofsafety, efficacy and/or stability ; product profile ( including product modality, category andmechanism of action ) ; stage of development or life cycle status ; actual and projectedDevelopment, Manufacturing, marketing, promotion, sale or Commercialization costs ; issuesregarding the ability of a Party to Manufacture or to have a Third Party Manufacture any Product;the likelihood of obtaining Regulatory Approvals ; the timing of such Regulatory Approvals ; theregulatory environment ; labeling or anticipated labeling ; the then - current competitiveenvironment and the likely competitive environment at the time of projected entry into the market;past performance of any Product or similar products ; present and future market potential ; existingor projected pricing, sales, reimbursement and profitability ; and proprietary position, strength andduration of patent protection and anticipated exclusivity, in each case consistent with the factorsPfizer reasonably considers for its own products of market potential or profit potential similar tothe Product, at a stage in development or product life similar to the Product