definiens: means with respect to a Party, any other person con trolling, controlled by, or under common control with, such Party, for only so long as such control exists . For these purposes, shall refer t o : ( i ) the possession, directly or indirectly, of the power to direct the managemen t or policies of a person, whether through the ownership of voting securities, by contract or otherwise, or ( ii ) the ownership, directly or indirectly, of m ore than 50 percent ( 50 % ) of the voting securities or other ownership interest o f a person ; means all national and local laws, ordinances, rule s and regulations as amended, re - enacted or in force from time to time a pplicable to this Agreement or activities contemplated hereunder, inc luding as applicable cGLP and cGMP and the rules and regulations of Regu latory Authorities ; means current Good Laboratory Practice promulgated by a Regulatory Authority as may be updated from time to time ; means current Good Manufacturing Practice promulgat ed by a Regulatory Authority as may be updated from time to time ; THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURIT IES AND EXCHANGE COMMISSION ( THE ) PURSUANT TO RULE 24B- 2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, GRANTING CONFIDEN TIAL TREATMENT TO SELECTED PORTIONS . ACCORDINGLY, THE CONFIDENTIAL PO RTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPA RATELY WITH THE COMMISSION . OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH