definiens: means ( a ) in the United States, approval by the Food and Drug Administration of an NDA, orsimilar application for marketing approval, and ( b ) in a Major Market other than the United States, approval by the applicableregulatory authority having jurisdiction over such country of a single application or set of applications comparable to anNDA . In the event that the first Regulatory Approval for a given Aminoglycoside Product is obtained in a jurisdiction where agovernmental authority establishes pricing and reimbursement levels, Regulatory Approval with respect to suchAminoglycoside Product shall not be deemed to have been obtained until pricing and reimbursement approval for suchAminoglycoside Product in such jurisdiction has been obtained . Except as provided in the previous sentence, in [ * * * ] Certain information in this document has been omitted and filed separately with the Securities and ExchangeCommission . Confidential treatment has been requested with respect to the omitted portions