definiens: means any untoward medical occurrence in a patien t or human clinical investigation subject administered Product, includi ng occurrences that do not necessarily have a causa l relationship with Product . 1.5 means, with respect to any Entity ( including a Pa rty to this Agreement ), any other Entity controlled by, controlling, or under common control with such Entity . For the purposes of this definit ion, the term ( including, with correlative meanings, th e terms and ) means direct or indirect ownership, including owner ship by one or more trusts with substantially the s ame beneficial interests, of 50 % or more of the outstan ding voting and equity rights of such Entity, or po ssession of the power to direct the management and policies of such Entity . [ * * * ] 1.6 means the U.S. Foreign Corrupt Practices Act ( 15 U.S.C. § § 78dd-1, et