definiens: means all relevant factors that may affect the Development, Regulatory Approval orCommercialization of a Compound, Product, Pharmaceutical Product or Product Delivery Device, including ( as applicable):actual and potential issues of safety, efficacy or stability ; product profile ( including product modality, category and mechanismof 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 or have Manufactured any Compound, Product, Pharmaceutical Product or Product Delivery Device ; the likelihood of obtaining Regulatory Approvals ( including satisfactoryPrice Approvals ) ; the timing of such approvals ; the current guidance and requirements for Regulatory Approval for the Productand similar products and the current and projected regulatory status ; labeling or anticipated labeling ; the then - currentcompetitive environment and the likely competitive environment at the time of projected entry into the market ; past performanceof the Product or 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 of patentprotection and anticipated exclusivity ; and other relevant scientific, technical, operational and commercial factors