definiens: shall mean the carrying out by I PH, or its Affiliates, Sub - licensees or Out - licensees of such obligations or t asks with a level of effort and resources consistent with the commercially reasonab le practices devoted by the applicable entity for the research, development, ma nufacture or commercialization of a pharmaceutical product owned by it ( or to whic h it has rights ) at a similar stage of development or commercialization and of similar market potential, profit potential and strategic value, based on conditions then prevailing . Such efforts may take into account, without limitation, issues of sa fety and efficacy, regulatory authority - approved labeling, product profile, the c ompetitiveness of alternative products in the marketplace, pricing / reimbursement for the product in a country relative to other markets, the likely timing of the product ’s entry into the market, the patent and other proprietary position, the like lihood of regulatory approval and other relevant scientific, technical and commercial factors