definiens: means ( a ) with respect to Licensee, its Affiliates or its S ublicensees, the efforts and resources typically used by biotech nology or pharmaceutical companies similar in size and scope to Licensee, its Affiliates or such Sublicensees, a nd ( b ) with respect to [COMPANY], [ ] *, in each case o f ( a ) and ( b ), to perform the obligation at issue, which efforts will not be less than those efforts made with respect t o other products at a similar stage of development or in a similar s tage of product life, with similar developmental ri sk profiles, of similar market and commercial potential, taking int o account the proprietary position of the products, the regulatory structure involved ( including regulatory or data exclusivity ), Regulatory Authority - approve d labeling, product profile, the expected and actual profitabil ity and return on investment of the applicable prod uct, issues of safety and efficacy, the likely timing of the produ ct ’s entry into the market, the likelihood of recei ving Regulatory Approval, and other relevant scientific, technical, and commercial factors