definiens: means all relevant facto rs that may affect the development, Regulatory Approval or commercialization of a Produ ct, including ( as applicable ): actual and potential issues of safety, efficacy or stability ; product profile ( inc luding product modality, category and mechanism of action ) ; stage of development or life cycle status ; actual and pro jected development, Regulatory Approval, manufactur ing, and commercialization costs ; any issues regarding the a bility to manufacture or have manufactured any Prod uct ; the likelihood of obtaining Regulatory Approvals ; the t iming of such approvals ; the current guidance and r equirements for Regulatory Approval for the Product and similar products and the current and projected regulatory status ; labeling or anticipated labeling ; the then - current competitive environment and the likely competitive environment at the time of projected entry into the market and thereafter ; past performance of the Product or simi lar products ; present and future market potential ; existing or pr ojected pricing, sales, reimbursement and profitabi lity ; pricing or reimbursement changes in relevant countries ; pro prietary position, strength and duration of patent protection and anticipated exclusivity ; the commercialization by VF after expiration of the Royalty Term of both the Product that uses the OPKO Trademarks and a generic Product ; and other relevant scientific, technical, operati onal and commercial factors