definiens: means all relevant factors that may affect the Development, Regulatory Approval or Commercialization of a Compound, Product, Pharmaceu tical Product or Product Delivery Device, including ( as applicable ): actual and potential issues of safety, efficacy or stability ; product profile ( including product modality, category and mechanism of action ) ; stage of develop ment or life cycle status ; actual and projected Dev elopment, Regulatory Approval, Manufacturing, and Commerciali zation costs ; any issues regarding the ability to Manufacture or have Manufactured any Compound, Prod uct, Pharmaceutical Product or Product Delivery Dev ice ; the likelihood of obtaining Regulatory Approvals ( i ncluding satisfactory Price Approvals ) ; the timing of such approvals ; the current guidance and requirements fo r Regulatory Approval for the Product and similar p roducts and the current and projected regulatory status ; la beling or anticipated labeling ; the then - current co mpetitive environment and the likely competitive environment at the time of projected entry into the market ; pas t performance of the Product or similar products ; pre sent and future market potential ; existing or proje cted pricing, sales, reimbursement and profitability ; pricing or reimbursement changes in relevant countries ; propri etary position, strength and duration of patent protectio n and anticipated exclusivity ; and other relevant s cientific, technical, operational and commercial factors