definiens: shall mean, with respect to Purchaser ’s obligations under this Agreement to Develop a Product, the level of effort s that are similar to the efforts normally deployed by Purchaser and its Affiliates to the development of a product of a similar market potential or profit p otential or strategic importance and that is at a similar stage in development or product life as such Product, ba sed on conditions then prevailing and taking into consider ation all payments due under this Agreement and all other potentially relevant factors that may affect the de ployment of efforts to Development, including actua l and potential issues of safety and efficacy ; stage of D evelopment or product lifecycle status ; the nature and extent of market exclusivity ( including regulatory exclusivit y and the patent and other proprietary position of such Product ) ; Product profile ; all costs, budgets and e xpenses associated with the Development of such Pro duct ( including both actual or projected costs ) based on conditions then prevailing ; any expected issues re lating to the Manufacture of such Product ; timing and likelihood of success of technology transfer, process developm ent and Manufacturing validation and scale - up ; the competit iveness of alternative products in the marketplace ; the likely timing of such Product ’s entry into the market ; the likelihood and cost of obtaining Regulatory Approv al and of the anticipated or actual approved labeling ; the ti ming of such approvals ; the regulatory environment and the current and projected regulatory status ; legal cons iderations ; the anticipated overall commercial succ ess of such Product and other relevant scientific, technical an d commercial factors . The level of effort with resp ect to Commercially Reasonable Efforts will be determined on a country - by - country basis and is expected to ch ange over time, reflecting changes in the status of such Product and the markets or countries involved . Sel ler expressly understands and accepts that the use of Commerciall y Reasonable Efforts may result in ceasing Developm ent of a Product ( in whole or in part ), and that once Deve lopment for a Product has ceased in compliance with this Agreement, Commercially Reasonable Efforts does not require the continued re - evaluation of whether Development must be re - initiated for such Product