definiens: means, with respect to the Development or Commerc ialization of a Product in or for a particular country, that leve l of efforts and resources commonly dedicated by a similarly situated company ( whether or not a public benefit c orporation ) in the research - based pharmaceutical in dustry to the Development or Commercialization, as the case m ay be, of a product of similar commercial potential at a similar stage in its lifecycle in or for such count ry, in each case taking into account issues of acce ss to reasonably necessary Know - How ( as identified in Schedule C ), s afety and efficacy, product profile, the proprietar y position, the then - current competitive environment for such p roduct, the likely timing of such product ’s entry i nto the market, the regulatory environment and the status o f such product, the reimbursement and pricing envir onment, and other relevant scientific, technical and commer cial factors