definiens: means all relevant factors that may affect the development, Regulatory Approval or commercialization of a Product, including ( as applicable ): actual andpotential issues of safety, efficacy or stability ; product profile ( including product modality, category and mechanism of action ) ; stage of development or life cycle status ; actual andprojected development, Regulatory Approval, manufacturing, and commercialization costs ; anyissues regarding the ability to manufacture or have manufactured any Product ; the likelihood ofobtaining Regulatory Approval ; the timing of such Regulatory Approval ; the current guidance andrequirements for Regulatory Approval for the Product and similar products and the current andprojected regulatory status ; labeling or anticipated labeling ; the then - current competitiveenvironment and the likely competitive environment at the time of projected entry into the marketand thereafter ; past performance of the Product or similar products ; present and future marketpotential ; existing or projected pricing, sales, reimbursement and profitability ; pricing orreimbursement changes ; and proprietary position, strength and duration of patent protection andanticipated exclusivity