definiens: means, with respect to activities of each Party contemplated by this Agreement, thelevel of effort commonly used in the research - based pharmaceutical industry to conduct development, promotion orcommercialization activities for a product that is at a similar stage in its lifecycle and is of comparable market potential, profitpotential and strategic value, taking into account relevant considerations, including issues of safety ( including AdverseEvents ) and efficacy, product profile, the proprietary position, the then - current competitive environment for such product, thelikely timing of the product ’s entry into the market, the then - current market penetration, the return on investment potential ofsuch product, the regulatory environment and status of the product, and other relevant scientific, technical and commercialfactors, in each case in a manner consistent with the level of effort and expenditure contemplated for such activities by theDevelopment Plan or the Commercialization Plan, as the case may be, and as measured by the facts and circumstances at thetime such efforts are due