definiens: means, as applied to the development and commercialization ofthe Milestone Products, the use of reasonable, good faith efforts and resources, consistent with the usual practices ofa similarly situated biopharmaceutical company for a biological product at a similar stage of research, development, orcommercialization and is of similar market potential, taking into account : ( i ) such product ’s profile of efficacy andsafety ; ( ii ) the results of preclinical and clinical testing and trials and such results ’ impact on the feasibility ( economicor otherwise ) of future testing or trials ; ( iii ) such product ’s proprietary position, including patent and regulatoryexclusivity ; ( iv ) the scope, timing and likelihood of Regulatory Approval of such product, regulatory status ( whetherthe product is subject to a clinical hold, recall or market withdrawal ), including anticipated or approved labeling andpost - approval requirements ; ( v ) such product ’s present and future market and commercial potential, including takinginto account its competitiveness compared to alternative products and the anticipated reimburseability and pricing ofthe product ; and ( vi ) the availability of a sufficient patient population that meets applicable Clinical Trial criterianecessary for Regulatory Approval