definiens: means the following factors that may affect the research, development, Regulatory Approval, manufacturing, or commercialization of a Licensed Product ( without takinginto account any other product or products that Akebia or its Affiliates may be developing, manufacturing, or commercializing ): actual issues of safety, efficacy, or stability ; product profile(including product modality, category and mechanism of action ) ; stage of development or lifecycle status ; actual and projected research, development, Regulatory Approval, manufacturing, and commercialization costs ; issues regarding the ability to manufacture or have manufacturedany Licensed Product ; the likelihood of obtaining Regulatory Approvals for any Licensed Productin the Territory and the timing of such Regulatory Approvals ; the labeling and anticipated labelingof such Licensed Product ; past performance of such Licensed Product or similar products;present and future market potential of such Licensed Product ; existing or projected pricing, sales, reimbursement, and profitability of such Licensed Product ; pricing or reimbursement changes inrelevant countries in the Territory ; and proprietary position, strength, and duration of patentprotection and anticipated exclusivity of such Licensed Product ; and other relevant scientific, technical, operational, and commercial factors