definiens: ) . means a product that ( i ) is a pharmaceuticalequivalent ( as that term is defined in 21 C.F.R. § 314.3(b ) ) to, and displays bioequivalence ( as that term isdefined in 21 C.F.R. § 314.3(b ) ) with, another drug product, or ( ii ) has been listed in the Orange Book ashaving therapeutic equivalence ( i.e., is designated with a therapeutic equivalence code starting with ) with, and has the same combination of active ingredients as, another drug product . means the FDApublication as may be amended fromtime to time ; 6.6.2invest in, own, manage, operate, finance, control, or participate in the ownership, management, operation, financing, or control of, or have any interest in, or earn compensation from, or render services to, or guaranteethe obligations of, any Person that engages in a Competitive Business in the Territory ; provided, that, Sellermay own, directly or indirectly, solely as a passive investment, securities of any entity traded on any nationalsecurities exchange ( a ) engaged in a Competitive Business if Seller is not a controllingperson of, or a member of a group which controls, such entity and does not, directly or indirectly, ( as defined in Rule 13d-3 of the Securities Exchange Act of 1934 without regard to the sixty ( 60)-dayperiod referred to in Rule 13d-3(d)(1)(i ) ) five percent ( 5 % ) or more of any class of securities of such otherentity