definiens: means all relevant factors that may affect theDevelopment, Regulatory Approval, Manufacture, or Commercialization of apharmaceutical product, including ( as applicable ): actual and potential issues ofsafety, efficacy or stability ; product profile ( including product modality, category andmechanism of action ) ; stage of development or life cycle status ; actual and projectedDevelopment, Regulatory Approval, Manufacturing, and Commercialization costs, any issues regarding the ability to manufacture or have manufactured thepharmaceutical product ; the likelihood of obtaining Regulatory Approvals ( includingsatisfactory reimbursement or pricing approvals ) ; the timing of such approvals ; theregulatory environment and the current and projected regulatory status ; labeling oranticipated labeling ; the then - current competitive environment and the likelycompetitive environment at the time of projected entry into the market ; pastperformance of the pharmaceutical product or similar products ; present and futuremarket potential ; existing or projected pricing, sales, reimbursement and profitability;pricing or reimbursement changes due to budget or debt constraints or currencyissues in relevant countries ; proprietary position, strength and duration of patentprotection and anticipated exclusivity ; and other relevant scientific, technical, operational and commercial factors