definiens: means, with respect to an app lication submitted by or on behalf of the Purchaser ( including on behalf of the Purchaser by its Affiliates and sublicensees ) for Aeroquin for a particular indication : ( a ) in the United States, the approval of the FDA necessary for the lawful ma rketing and sale of Aeroquin in the United States for such indi cation ; ( b ) in the European Union, the approval of the EMA necessary for the lawful marketing and sale of Aero quin in at least one country in the European Union for such indication ; and ( c ) in any other jurisdiction, the approval of the relevant Governmental Body necessar y for the lawful marketing and sale of Aeroquin in such juris diction for such indication ; provided, however, that, Regulatory Approval of Aeroquin shall not be deemed to have been obtained or to have occurred in the U nited States unless the FDA sends an wi thin the meaning of 21CFR § 314.105