definiens: means, with respect to the performance of Development and Commercialization activities with respect to any Compound, Product or Diagnostic Product by a Party, the carrying out of such activities in a sustained manner using efforts and resources, in good faith, consistent with reasonable practices and expended in a manner and timing consistent with the exercise of prudent scientific and business judgment t hat a similarly situated company within the biopharmaceutical or pharmaceutical industry, as the case may be, would reasonably devote in a given market for the development and commercialization of a pharmaceutical product having similar market potential as a particular Compound, Product or Diagnostic Product at a similar stage in development or product life, taking into account all scientific, commercial, and other factors that such company would take into account, including issues of safety and efficacy, expected and actual cost and time to develop, expected and actual profitability, expected and actual competitiveness of alternative products [ * * ] ( including generic or biosimilar products ) ), the nature and extent of expected and actual market exclusivity ( i ncluding Patent coverage and regulatory exclusivity ), the expected likelihood of Regulatory Approval, the expected and actual reimbursability and pricing, and the expected and actual amounts of marketing and promotional expenditures required