definiens: means the level of efforts required to carry out a task in a diligent and sustained manner without undue interruption, pause or delay ; which level is at least commensurate with the level of efforts that a similarly situated biotechnology company to Cullina n would devote to a product of similar potential at a similar stage in development or product life, taking into account safety and efficacy ; the competitiveness of alternative products ; the proprietary position of the Product ; pricing and reimbursement ; difficulty in and costs of developing or manufacturing the Product in the market ; regulatory strategy ; the potential profitability of the Product ; and all other relevant scientific, legal, technical, financial and commercial factors, without taking into acco unt the royalty, milestone and other payments due to [COMPANY] under this Agreement . Commercially Reasonable Efforts shall be determined on a country -by - country basis, and it is anticipated that the level of effort will change over time reflecting changes in the market and/or the status of the Product