definiens: for the purposes of the Agreement shall mean agencies that enforce the regulatoryrequirements that are part of the process of drug approval . Regulatory requirements describe what is necessary for anew drug to be approved for marketing in any particular country . The FDA, EMEA or the Japanese Pharmaceuticalsand Medical Devices Agency ( PDMA ) are the Regulatory Authorities for the U.S., EU, and Japan, respectively means ( A ) a transaction or series of related transactions in which any Person, or a group ofrelated Persons, acquires from stockholders of Luna shares representing fifty percent ( 50 % ) or more of theoutstanding voting power of Luna, ( B ) a merger or consolidation in which ( a ) Luna is a constituent party or ( b ) asubsidiary of Luna is a constituent party and Luna issues shares of its capital stock pursuant to such merger orconsolidation, except any such merger or consolidation involving Luna or a subsidiary in which the shares of capitalstock of Luna outstanding immediately prior to such merger or consolidation continue to represent, or are converted orexchanged for shares of capital stock which represent, immediately following such merger or consolidation at least amajority, by voting power, of the capital stock of ( 1 ) the surviving or resulting corporation or ( 2 ) if the surviving orresulting corporation is a wholly owned subsidiary of another corporation immediately following such merger orconsolidation, the parent corporation of such surviving or resulting corporation ; ( C ) the sale, lease, exclusive license, transfer or other disposition, in a single transaction or series of related transactions, by Luna or any subsidiary of Lunaof all or substantially all theassets of Luna and its subsidiaries taken as a whole except where such sale, lease, transfer or other disposition is toa wholly owned subsidiary of Luna ; or ( D ) the liquidation, dissolution or winding up of the business and affairs of Luna;provided, however, that a shall not be deemed to have occurred if Luna completes any of theforegoing transactions with any Affiliate of Luna