definiens: means, with respect to the efforts to beexpended by Parent ( whether directly or through the efforts of other Milestone Parties ), thatlevel of effort that a similarly situated company operating in the pharmaceutical industry wouldundertake where it was acting in a diligent manner, taking into account the following relevantfactors to the extent applicable, including : stage of development, mechanism of action, efficacyand safety issues, characteristics of competitive products in or anticipated to be in themarketplace, process development, scale - up or manufacturing, Intellectual Property rights, actual or anticipated regulatory authority approved labeling, the nature and extent of marketexclusivity ( including patent coverage and regulatory exclusivity ), cost, likelihood of and timingfor obtaining regulatory approval from the FDA or the EMA, the projected or actual economicreturn ( taking into consideration the economic terms in this Agreement ( provided that for clarity, the obligation to make Milestone Payments will not be taken into consideration when evaluatingwhether to prioritize internal competitive products or product candidates ) ), and, with respect tothe TNT020 Product, the commercial validation of the TNT009 Product will be taken intoconsideration when evaluating satisfaction of the Parent ’s obligations pursuant to Section 5