definiens: means all relevant factors that may affect the Development, Regulatory Approval orCommercialization of an Agreement Compound or Covered Product, including ( as applicable ): actual and potential issues ofsafety, efficacy or stability ; product profile ( including product modality, category and mechanism of action ) ; stage ofdevelopment or life cycle status ; actual and projected Development, Regulatory Approval, Manufacturing, andCommercialization costs ; any issues regarding the ability to Manufacture or have Manufactured any Agreement Compound orCovered Product ; the likelihood of obtaining Regulatory -13 - Marketing Approvals ( including satisfactory Price Approvals ) ; the timing of such approvals ; the current guidance andrequirements for Regulatory Approvals for the Covered Product and similar products and the current and projected regulatorystatus ; labeling or anticipated labeling ; the then - current competitive environment and the likely competitive environment atthe time of projected entry into the market ; past performance of the Covered Product or similar products ; present and futuremarket potential ; existing or projected pricing, sales, reimbursement and profitability ; pricing or reimbursement changes inrelevant countries ; proprietary position, strength and duration of patent protection and anticipated exclusivity ; and otherrelevant scientific, technical, operational and commercial factors