definiens: shall mean, with respect to any obligation or task under thisAgreement, the carrying out by a Party, its Affiliates or Sublicensees ( or their Affiliates or sublicensees ) of suchobligation or task with a level of effort and resources consistent with the commercially reasonable practices devotedby a biotechnology company of comparable size and resources for the research, development, manufacture orcommercialization of a pharmaceutical product owned by it ( or to which it has rights ) at a similar stage of developmentor commercialization and of similar market potential, profit potential and strategic value, based on conditions thenprevailing . Such efforts may take into account, without limitation, issues of safety and efficacy, regulatory authority - approved labeling, product profile, the competitiveness 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 intothe market, the patent and other proprietary position, the likelihood of regulatory approval and other relevant scientific, technical and commercial factors including but not limited to product market potential and anticipated profitability . Forthe avoidance of doubt, it is understood and acknowledged that such issues and factors may change from time totime based upon changing scientific, business and marketing and return on investment considerations1.6 shall mean the European Medicines Agency of the European Union, or the successor thereto