definiens: means the sale or other supply of a Product in a given country in the Territory priorto receipt of Regulatory Approval of such Product in such country and in accordance with the applicable laws of thatcountry, directly or through an entity that is qualified to distribute unregistered pharmaceutical products in thatcountry, ( a ) on a basis to meet the special needs of particular patients under the order of, and at thespecific request of, a medical practitioner ; or ( b ) in the case solely of Kuwait, Oman, Qatar, the Kingdom of SaudiArabia, and the United Arab Emirates, pursuant to an appropriate request from a health care provider, pharmacy orgovernmental agency to treat a specific patient or group of patients and in accordance with regulatory practices thatallow import and use of a Product based on such Product having obtained Regulatory Approval in another country ( inthis case the United States or a country within the EMA Centralized Authorization Countries ), including under socalled or ; provided, however, in all cases of clauses ( a ) and ( b ) above, solely with respect to previously treated patients ( ) . ” 2