definiens: means, with respect to the Development or Commercialization of a Compound or Product inor for a particular country, that level of efforts and resources commonly dedicated by a similarly situated company in the research - based pharmaceutical industry to the development or commercialization, as the case may be, of a compound or product of similarcommercial potential at a similar stage in its lifecycle in or for such country, in each case taking into account issues of safety andefficacy ; product profile ; the proprietary position ; actual and projected Development, Regulatory Approval, Manufacturing andCommercialization costs and budgets ; the then - current competitive environment for such Compound or Product and the likelytiming of such Compound ’s or Product ’s entry into the market ; present and future market potential ; the regulatory environmentand the status of such Compound or Product ; and other relevant scientific, technical, legal and commercial factors . With respectto the Development or Commercialization of a Compound [ * * * ], in addition to the foregoing factors