definiens: means all relevant factors that may affect the Development, Regulatory Approval orCommercialization of a Antibody or Product, including ( as applicable ): actual and potential issues of safety, efficacy orstability ; product profile ( including product modality, category and mechanism of action ) ; stage of development or life cyclestatus ; actual and projected Development, Regulatory Approval, Manufacturing, and Commercialization costs ; any issuesregarding the ability to Manufacture or have Manufactured any Antibody or Product ; the likelihood of obtaining RegulatoryApprovals ( including satisfactory Price Approvals ) ; the timing of such approvals ; the current guidance and requirements forRegulatory Approval for the Product and similar products and the current and projected regulatory status ; labeling oranticipated labeling ; the then - current competitive environment and the likely competitive environment at the time ofprojected 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 or reimbursement changes in relevant countries;proprietary position, strength and duration of patent protection and anticipated exclusivity ; and other relevant scientific, technical, operational and commercial factors