definiens: means, with respect to any Compound or Product, the level of effort, expertise and resourcesconsistent with those efforts, expertise and resources that Parent and its Affiliates would apply, in the exercise ofreasonable and good faith business judgment, to developing, seeking Marketing Authorization and making the firstsale in the United States of America of a pharmaceutical product that is of similar market potential at a similar stagein its development or product life, taking into account issues of patent and regulatory exclusivity, product profile, including efficacy, safety, tolerability and convenience, the competitiveness of alternate products in the marketplaceor under late - stage development, the launch or sales of a generic product containing the same or equivalent ( by FDAstandards ) active pharmaceutical ingredient(s ) as contained in such product sold by Parent or its Affiliate, theregulatory environment and the profitability of the product ( including pricing and reimbursement status but excludingthe payments under this Agreement ) and other relevant considerations, including technical, commercial, legal, scientific and/or medical factors