definiens: means any Person which co ntrols, is controlled by, or is under common control with another Person . A Person shall be regarded as another Person for the purposes of this Agreement if it owns more than fifty ( 50 % ) of the voting share capital of the other Person or if i t has the legal power to direct the general management of the other Person ; ( 2 ) means this agreement, including its preamble, and all amendments made her eto by written agreement of the Parties ; ( 3 ) means, in relation to any Person, property, transaction or event, all applicable provision s in effect at the relevant time ( or mandatory applicable provisions ) of federal, provincial, territorial, state, local or foreign laws, statutes, rules, regulations, directives and orders of all Regulatory Authorities, and all judgments, orders, decrees, decisions, rulings or awards of all Regulatory Authorities to which the Person in question is a party or by which it is bound or having application to the Person, property, transaction or event ; ( 4 ) means Active Pharmaceutical Ingredient ; ( 5 ) ( or ) shall mean * * * ( 6 ) or means any day other than Saturday, Sunday or a holiday generally recognized in Germany, or in the United States ; ( 7 ) means * * * ( 8) or or means, as applicable in accordance with the Territory in which the Product is distributed in, the practices set out in the regulations ( or ) for the manufacture of pharmaceutical products and the Current Good Manufacturing Practices as defined in United States 21 CFR 210, et seq ., as amended from time to time ; ( 9 ) means the * * * ( 10 ) means the date at which DRAXIMAGE receives a Marketing Authorization for the Product from the FDA and the main patent for CardioliteÒ has expired in the U.S. * * * ( 11 ) means the United States Food and Drug Administration, or any successor to it ; ( 12 ) has the meaning set out in Section 10.01 ; ( 13 ) means * * * ( 14 ) means the goodwill associated with the Product within the Territory ; ( 15 ) has the meaning set out in Section 11.01(1 ) ; ( 16 ) shall mean, whether or not reduced to writing, all inventions, all rights to inventions, patents, patent applications and issued patents, copyright, copyright applications and registrations, processes, licenses, Marketing and Distribution Know -How ( as hereinafter defined ), technology, data, chemical structures, formulae, customer lists, discoveries, trade se crets, proprietary information and all other rights and intellectual property now or hereafter owned or held and used by DRAXIMAGE or any of its Affiliates with respect to the Product in the Territory