definiens: means, with respect to a Product, the level of efforts required to carry out a task in a diligentand sustained manner without undue interruption, pause or delay ; which level is at least commensurate with the level of efforts that asimilarly situated biopharmaceutical company would devote to a product of similar market potential at a similar stage in development orproduct life, taking into account the following factors : issues of safety and efficacy ; the competitiveness of alternative products ; the patentor other proprietary position of the Product ; pricing and reimbursement ; product profile, difficulty in and costs of developing or manufacturingthe Product, competitiveness of the Product and alternative Third Party products in the marketplace ; the regulatory structure involved indeveloping and commercializing the product ; the potential profitability of the Product marketed or to be marketed ; and all other relevantscientific, legal, technical, financial and commercial factors . Commercially Reasonable Efforts shall be determined on a country - by - countrybasis, and it is anticipated that the level of effort will change over time reflecting changes in the status of the Product and the marketinvolved