definiens: means, with respect to a Licensed Antibody or Product, all relevant factorsthat may affect the Development, Regulatory Approval or Commercialization of such Licensed Antibody or Product, including ( as applicable ): safety, efficacy, quality or stability ; product profile ( including product modality, category andmechanism of action ) ; stage of Development or life cycle status ; Development, Regulatory Approval, manufacturing, and Commercialization costs and risk ; feasibility and cost of manufacture ; the likelihood of obtaining RegulatoryApprovals ( including satisfactory price approvals ) and the timing of such approvals ; the current guidance andrequirements for Regulatory Approval and the current and projected regulatory status, including expectations for post - approval commitments ; labeling or anticipated labeling ; the then - current competitive environment and the likelycompetitive environment at the time of projected entry into the market ; past performance ; present and future marketpotential ; 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 suchParty ’s [ * ]