definiens: shall mean a product comprised of a drug and device, wherein said drug with respect to which there has been made an authorized claim of A -rated therapeutically equivalent or otherwise therapeutically equivalent, as defined in the Ora nge Book, with respect to the United States, or the foreign equivalent thereof in the relevant country in the Territory ( outside the United States ), or similar determination of interchangeability with EGP -437, permitting the pharmacy to switch such product with EGP -437 for use in the Field together and in combination with an approved or cleared device that is substantially comparable to the EyeGate ® II Delivery System, which determination has been made by the appropriate Regulatory Authority or by Applicabl e Laws, or other claim of substitutability with the Product for use in the Field in the relevant country in the Territory for the purpose of payor reimbursement, which has been established by a grant of the competent Regulatory Authority or by Applicable L aws