definiens: means all relevant factors that may affect the Development, RegulatoryApproval or Commercialization of a Compound or Licensed Product, including ( as applicable ): actual and potentialissues of safety, efficacy or stability ; product profile ( including product modality, category and mechanism ofaction ) ; stage of development or life cycle status ; actual and projected Development, Regulatory Approval, Manufacturing, and Commercialization costs ; any issues regarding the ability to Manufacture or haveManufactured any Compound or Licensed Product ; the likelihood of obtaining Regulatory Approvals ( includingsatisfactory Price Approvals ) ; the timing of such approvals ; the current guidance and requirements for RegulatoryApproval or Regulatory Exclusivity for the Licensed Product and similar products and the current and projectedregulatory status ; labeling or anticipated labeling ; the then - current competitive environment and the likelycompetitive environment at the time of projected entry into the market ; past performance of the Licensed Productor similar products ; present and future market potential ; existing or projected pricing, sales, reimbursement andprofitability ; pricing or reimbursement changes in relevant countries ; proprietary position, strength and duration ofpatent protection and anticipated exclusivity ; and other relevant material scientific, technical, operational andcommercial factors