definiens: means the efforts and resources reasonably used by [ * * * ] with respect to the research, development, manufacture, commercialization, use or other exploitation, as applicable, of its own products at a similar stage in development, taking intoaccount all in effect at the time such efforts are to be expended . As used herein, shall mean allrelevant factors that may affect the development, regulatory approval or commercialization of the Product, including ( as applicable ): actualand potential issues of safety, 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, and commercialization costs ; anyissues regarding the ability to manufacture or have manufactured the Product ; the likelihood of obtaining regulatory approvals ( includingsatisfactory price approvals ) ; the timing of such approvals ; the current guidance and requirements for regulatory approval for the Product andsimilar products and the current and projected regulatory status ; labeling or anticipated labeling ; the then - current competitive environmentand the likely competitive environment at the time of projected entry into the market ; past performance of the Product or similar products;present and future risk - adjusted market potential ; existing or projected risk - adjusted pricing, sales, reimbursement and profitability ; pricing orreimbursement changes in relevant countries ; proprietary position, strength and duration of patent protection and anticipated exclusivity ; andother relevant scientific, technical, operational and commercial factors