definiens: means, with respect to a particular activity or obligationof a Party under this Agreement relating to the Development, Regulatory Approval, Reimbursement Approval, Commercialization or manufacturing of a Licensed Product, theapplicable of the following factors that likely apply to or affect such activity or obligation ( withouttaking into account any other product or products that such Party 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 projected costs of the applicable development, Regulatory Approval, manufacturing or Commercialization activities ( without taking into account any payments underthis Agreement ) ; issues regarding the ability to manufacture or have manufactured any LicensedProduct ; the likelihood of obtaining Regulatory Approvals and the timing of such RegulatoryApprovals ; the labeling and anticipated labeling of such Licensed Product ; present and futuremarket potential of such Licensed Product ; existing or projected pricing, sales, reimbursementand profitability of such Licensed Product ; pricing or reimbursement changes in the relevantcountry in the Licensed Territory ; and proprietary position, strength and duration of patentprotection and anticipated exclusivity of such Licensed Product