definiens: means, with respect to the efforts to be expended by [COMPANY] or its Affiliate with respect to any Development or Commercialization objective, activity, or goal related to a Compound or Product under this Agreement, those efforts that [COMPANY] would normally use to accomplish such objective, activity, or decision, and specifically means the carrying out of Development and Commercializat ion activities using efforts that [COMPANY] would normally devote to a product at a similar stage in its development or product life and of similar market potential, strategic importance, and profit potential ( taking into account payments under this Agreement and any agreements entered into pursuant to Section 7.4.4(b ) ( Third Party Payments ) ), based on conditions then prevailing and taking into account efficacy, safety, approved labeling, the competitiveness of alternative products sold by Third Parties in the marketplace, the patent and other proprietary position of the product, the likelihood of 3 regulatory approval given the regulatory structure involved, and all other relevant factors . Commercially Reasonable Efforts will be determined on a country -by - country and indication -by - indication basis for the applicable Compound or Product, and it is anticipated that the level of effort will change over time, reflecting changes in the status of such Compound or Product ( as applicable ) and the market or country involved . Catalyst expressly understands and accepts that the use of Commercially Reasonable Efforts may result in [COMPANY] ceasing the Development or Commercialization of a Compound or Product ( in whole or in part ), and that once Development or Commerciali zation for a Compound or Product has ceased in compliance with this Agreement, Commercially Reasonable Efforts does not require the continued re -evaluation of whether Development or Commercialization must be re -initiated for such Compound or Product