definiens: means all relevant factors that may affect the Development, Regulatory Approval orCommercialization of a Compound, Product, Pharmaceutical Product or Product Delivery Device, including ( asapplicable ): actual and potential issues 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, Manufacturing, and Commercialization costs ; any issues regarding the ability to Manufacture orhave Manufactured any Compound, Product, Pharmaceutical Product or Product Delivery Device ; the likelihood ofobtaining Regulatory Approvals ( including satisfactory Price Approvals ) ; the timing of such approvals ; the currentguidance and requirements for Regulatory 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 ; past performance of the Product or similar products;present and future market potential ; existing or projected pricing, sales, reimbursement and profitability ; pricing orreimbursement changes in relevant countries ; proprietary position, strength and duration of patent protection andanticipated exclusivity ; and other relevant scientific, technical, operational and commercial factors