definiens: means Health Canada 's Food and Drugs Act, R.S.C. 1985, c. F-27, as amended . 3 shall mean ( a ) the disposition of all or substantially all of the outstanding shares, assets or business of a Party on a consolidated basis ; or ( b ) any transaction or event ( or series of transaction s or events ) as a result of which any Person ( other than an Affiliate of such Party ), acting singly or as a part of a ( within the meaning of Section 13(d)(3 ) of the United States Securities Exchange Act of 1934, as amended ): ( i ) acquires ( by purchase, merger, consolidation or otherwise ) or for the first time controls or is able to vote ( directly or through nominees, beneficial ownership, proxy or contract ) fifty percent ( 50 % ) or more of the aggregate of all outstanding equity securities of a Party ; or ( ii ) acquires ( by purchase, merger, consolidation or otherwise ) or for the first time is able to nominate or designate ( directly or through nominees, beneficial ownership, proxy or contract ) at least fifty percent ( 50 % ) of the nominees to the board of directors of such Party, in each of ( a ) or ( b ), in the event that the Seller or the Purchaser, as the case may be, was not a party to the applicable transaction and/or such transaction was not .,