definiens: means, to the extent applicable to the Compound or Product, actual and potentialissues of safety, efficacy or stability ; product profile ( including product modality, category and mechanism of action);stage of development or life cycle status ; actual and projected development, Regulatory Approval, Pricing andReimbursement Approval, manufacturing, and commercialization costs ; any issues regarding the ability tomanufacture or have manufactured the Product ; the likelihood of obtaining Regulatory Approvals and Pricing andReimbursement Approvals ; the timing of such approvals ; the current guidance and requirements for RegulatoryApproval and Pricing and Reimbursement Approval for the Product and similar products and the current and projectedregulatory status ; labeling or anticipated labeling ; the then - current competitive environment and the likely competitiveenvironment at the time of projected entry into the market and thereafter ; present and future market potential ; existingor projected pricing, sales, reimbursement and profitability ; pricing or reimbursement changes in relevant countries;proprietary position, strength and duration of patent protection and anticipated exclusivity ; Commercialization by VITafter the expiration of the Royalty Term of both that Product that uses the [COMPANY] Trademarks and theProduct that does not use the [COMPANY] Trademarks, and other relevant scientific, technical, operational andcommercial factors