definiens: means, with respect to the performance of Develop ment, Medical Affairs Activities, Commercialization, or Manufacturing activities with respect to the Licensed Compound or a Product by a Party, thecarrying out of such activities using the level of effort required to carry out an obligation in a sus tained, active anddiligent manner consistent with such level of effor t that companies in the pharmaceutical industry gen erally devote atthe same stage of development or commercialization, as applicable, for their own internally developed 8pharmaceutical products in a similar therapeutic or disease area with similar market potential at a si milar stage ofproduct life, taking into account the regulatory st ructure involved, the anticipated profitability of the Product and otherrelevant factors, including safety and efficacy of the Product, the potential for additional indicatio ns, the level ofcompetition in the market for the Product generally or for any particular indication, changes in clini cal or regulatorystrategy justified by compliance with the requireme nts of regulatory feedback from any Regulatory Auth ority, failed orinconclusive clinical studies, discovery of unantic ipated toxicity or any significant adverse event or condition relatingto the safety or efficacy of a Product, significant adverse changes in the targeted market conditions which affect themarket potential of a Product, and the need for add itional Clinical Studies to achieve appropriate lab eling of a Product