definiens: means, with respect to the efforts to be expended by a Party orits Affiliate with respect to any objective, activity or decision to be undertaken under this Agreement, those effortsthat a company within the bio - pharmaceutical industry would reasonably use to accomplish such objective, activity ordecision, and specifically means the carrying out of Development and Commercialization activities using efforts that acompany within the bio - pharmaceutical industry would reasonably devote to a product at a similar stage in itsdevelopment or product life and of similar market potential, profit potential, based on conditions then prevailing andtaking into account efficacy, safety, approved labeling, the competitiveness of alternative products sold by ThirdParties in the marketplace, the patent and other proprietary position of the product, and the likelihood of regulatoryapproval given the regulatory structure involved . Commercially Reasonable Efforts shall be determined on a country - by - country and indication - by - indication basis for the Licensed Product, and it is anticipated that the level of effort willchange over time, reflecting changes in the status of the Licensed Product and the market(s ) or country(ies ) involved