definiens: means all relevant factors that may affect the Development, Regulatory Approval, Manufacture, or Commercialization of an Agreement Product, including ( as applicable ): actual and potential issues ofsafety, efficacy and/or stability ; product profile ( including product modality, category and mechanism of action ) ; stageof development or life cycle status ; actual and projected Development, Regulatory Approval, Manufacturing, andCommercialization costs, timelines and budgets ; any issues regarding the ability to Manufacture or have Manufacturedthe Agreement Product ; the likelihood of obtaining Regulatory Approvals ( including satisfactory reimbursement orpricing approvals ) ; the timing of such approvals ; labeling or anticipated labeling ; the then - current competitiveenvironment and the likely competitive environment at the time of projected entry into the market ; past performance ofthe product or similar products ; present and future market potential ; existing or projected pricing, sales, reimbursementand profitability ; proprietary position, strength and duration of patent protection and anticipated exclusivity ; otherrelevant scientific, technical, operational and commercial factors