definiens: means with respect to the conduct of Development activities, or the Commercialization of the Product by a Party, th e use of efforts and resources comparable to those undertaken by ELAN or WARATAH, as the case may be, in pursuing the development and commercialization of products that are not subject to the Collaboration and that are at an equivalent stage of development or commer cialization and have similar market potential and are at a simi lar stage in their lifecycle . All relevant factors as measured by the facts and circumstances at the time such effort s are due shall be taken into account, including, a s applicable and without limitation, mechanism of action ; effica cy and safety ; product profile ; actual or anticipat ed Regulatory Authority approved labeling ; the nature and extent of market exclusivity ( including patent coverage, proprietary position and regulatory exclusivity ; co st, time required for and likelihood of obtaining Commercialization Regulatory Approval ; competitiven ess of alternative products and market conditions ; and actual or projected profitability and availability of capacity to manufacture and supply for commercia l sale )