definiens: means, with respect to the Product, efforts of a Person to carry out its obligations, and to cause itscontrolled Affiliates and Product licensees, if any, to carry out their respective obligations, using such efforts and employingsuch resources normally used by Persons in the pharmaceutical business similar in size and resources to Parent relating toseeking regulatory approval for a product candidate or commercialization of an approved product that is of similar marketpotential at a similar stage in its development or product life, taking into account issues of market exclusivity, product profile, including efficacy, safety, tolerability and convenience, the competitiveness of alternate products in the marketplace or underdevelopment, the availability of existing forms or dosages of the Product for other indications, the launch or sales of ageneric or biosimilar product, the regulatory environment and the profitability of the Product ( including pricing andreimbursement status ) and other relevant considerations, including technical, commercial, legal, scientific and/or medicalfactors