definiens: means, with respect to the obligations of a performing Party relating to the Development, Manufacture and Commercialization of a Candidate or Product under this Agreement, the carrying out of such obligations with efforts that are consistent with the efforts used by a biopharmaceutical company of similar size and market capitalization as such Party in the exercise of its commercially reasonable business practices relating to the Development, Manufacture and Commercialization of a pharmaceutical or biologic compound or product, as applicable, at a similar stage in its research, development or commercial life as the relevant Candidate or Product, and that has commercial and market potential similar to the relevant Candidate or Product, taking into account issues of intellectual property coverage, safety and effic acy, stage of development, product profile, competitiveness of the marketplace, proprietary position, regulatory exclusivity, anticipated or approved labeling, present and future market and commercial potential, the likelihood of receipt of Regulatory Appr oval and other regulatory requirements, profitability ( including pricing and reimbursement status achieved or likely to be achieved ), amounts payable to licensors of patent or other intellectual property rights, legal issues, Manufacturing, difficulty in M anufacturing the relevant Candidate or Product and alternative Third Party products in the marketplace of the relevant Candidate or Product to be marketed