definiens: means, with respect to a Party ( which with respec t to Legend, shall include Legend U.S. and Legend Ireland ): ( a ) completion of a merger, reorganization, amalgam ation, arrangement, share exchange, consolidation, tender or exchange offer, private purchase, business combination, recapitaliz ation or other similar transaction involving such Party a s a result of which either ( i ) the stockholders of such Party immediately preceding such transaction hold i mmediately following such transaction ( when combined with the holdings of the Affiliates of -2- such stockholders and such Party ) less than 50 % of the Beneficial Ownership ( defined below ) of the outstanding shares or less than 50 % of the Benefici al Ownership of the outstanding voting power of the ultimate company or entity resulting from such tran saction immediately after consummation thereof, or ( ii ) any single Third Party person or group of Thir d Parties ( with being defined within the meaning of the U.S. Securities Exchange Act of 1934 and the rules of the SEC thereunder as in effect ) acquires 50.1 % or more of the Beneficial Ownership of the outstanding shares or 50.1 % or more of the Beneficial Ownership of the voting power of the ult imate company or entity resulting from such transaction immediately after the consummation ther eof ; ( b ) the direct or indirect acquisition in a single or series of related transactions ( including by means of a tender offer or an exchang e offer ) by any Third Party person or Third Party Group of beneficial ownership ( within the meaning o f the U.S. Securities Exchange Act of 1934 and the rules of the SEC thereunder as in effect, it being understood that a pending transaction shall not res ult in a change in beneficial ownership until such transacti on is consummated, ) of 50.1 % or more of the outstanding voting power or outstand ing shares of such Party, in each case on a fully d iluted basis ; ( c ) the adoption of a plan relating to the liquidat ion or dissolution of such Party, other than in connection with a corporate reorganization ( without limitation of clause ( a ), above ) ; ( d ) the sale or disposition to a Third Party of all or substantially all the assets of such Party ( determined on a consolidated basis, with ass ets being valued at fair market value ), including s uch Party ’s assets related to the Products ; or ( e ) the sale or disposition to a Third Party of ass ets or businesses that generate 50.1 % or more of the total revenue of such Party ( determi ned on a consolidated basis ), including such Party ’ s assets or business related to the Products ; provided, however, that the following transactions, and any security issuance in connection therewith, shall not constitute or be taken into account in determin ing whether a has occurred : any distribution or transfer of securities or related r ights ( including a rights offering or exchange offe r ) of any Party or any of its Affiliates to the securityholde rs of such Party or its Affiliates ; [ * * * ] 1.15 means any study in which human subjects are dosed or treated with a drug, biological product, cell therapy or gene therapy, w hether approved or investigational