definiens: means, with respect to the research, development, Manufacture or commercialisation of a Licensed Compound or Licensed Product, as the case may be, efforts and resources commonly used in the research - based pharmaceutical industry for compounds or products with similar commercial and scientific potential at a similar stage in their lifecycle, taking into consideration their safety and efficacy, their cost to develop, the competitiveness of alternative products, the anticipated or, if applicable, actual claim structure and the nature and extent of their market exclusivity ( including Patent coverage and regulatory exclusivity ), the likelihood of regulatory approval, their estimated f I I i i r r ! [ t t f I I ! t t f I r f " i f ~ f [ [ ~ f l Page 6 of 100 profitability, including the amounts of marketing and promotional expenditures with respect to the Licensed Products and Competing Products and all other relevant factors . Commercially Reasonable Efforts shall be determined on a market - by - market basis for each Licensed Compound and each Licensed Product, as applicable ; provided, however, that should what would otherwise constitute Commercially Reasonable Efforts with respect to an individual market conflict with, or otherwise not constitute, Commercially Reasonable Efforts with respect to a group of markets out of which such market is a part then Commercially Reasonable Efforts shall be determined for such group of markets as a whole