definiens: means all relevant factors that may affect the Deve lopment, Manufacturing or Commercialization of an Agreement Product, generall y or in regard to any particular country, including ( as applicable ) to the extent not caused by the action or inaction of the applicable Party, or its Sublicensees or Affiliates : actual and potentia l issues of safety, efficacy or stability ; product profile ( including product modality, category and m echanism of action ) ; stage of development or life cycle status ; actual and projected research, d evelopment, manufacturing, and commercialization costs, timelines and budgets ; any issues regarding the ability to manufacture or have manufactured the Agreement Product ; the likelihood of obtaining Regulatory Approvals ( including satisfactory reimbursement or pricing approvals ) and the timing and costs of such approvals ; the labeling or anticipated labeling obtained or to be obtained wit h respect to the Agreement Product ; the then - current competitive environment and the likely comp etitive environment at the time of projected entry of the Agreement Product into the market ; pas t performance of the Agreement Product or similar products ; present and future market potenti al ; existing or projected pricing, sales, reimbursement and profitability, for the Agreement Product and for any competitive product or products ; proprietary position, including the stren gth and duration of patent or other intellectual property protection and the likelihood and duration of any resulting intellectual property - based exclusivity ; the potential availability of regulato ry exclusivity, the likelihood of obtaining such regulatory exclusivity and the likely length and ef fectiveness of such regulatory exclusivity ; and any other relevant scientific, technical, operation al and commercial factors