definiens: means the eﬀorts and resources that would reasonably be used ( including thepromptness with which such eﬀorts and resources would be applied ) by a similarly sized company within thebiopharmaceutical industry for the pharmaceutical or clinical Development, Manufacture or Commercialization of apharmaceutical product of similar market and proﬁt potential and at a similar stage in development or product life ascompared to a product or for the other activities to which this term applies, taking into account its present and future marketand commercial potential ( including competitive market conditions, patent coverage, regulatory exclusivity, the size of theparticular market in the applicable country for the relevant indication, and the probability of proﬁtability of the relevantproduct or service in light of existing and anticipated competitive products and services, as well as pricing andreimbursement issues ) and all other relevant factors, including commercial, technical, legal, scientiﬁc, regulatory, or medicalfactors, including such Product ’s eﬃcacy, safety, existing and anticipated approved labeling, and post - approvalrequirements, in each case in the applicable country