definiens: means(i ) direct or indirect ownership of fifty percent ( 50 % ) or more ( or, if less than fifty percent(50 % ), the maximum ownership interest permitted by applicable law ) of the stock orshares having the right to vote for the election of directors of such corporate entity, or(ii ) the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of such entity, whether through the ownership of votingsecurities, by contract or otherwise ; Any proprietary information, trade secrets, documented techniques, materials and dataowned or controlled by BTI during the Term or which are acquired by or developed for BTIby a Third Party during the Term, including but not limited to discoveries, formulae, materials, reagents, proprietary methods, processes, test data ( includingpharmacological, toxicological, clinical and manufacturing information and test data ), andanalytic and quality control data, which is necessary or useful to research, develop, make, have made, use, sell, offer for sale, import or export the Products, providedhowever, that BTI Know - How that is the subject of the licenses and other rights grantedto Licensee hereunder shall extend only to those applications of any of the foregoingitems that are associated with specifically defined carbohydrate chemistry formulation;BTI Know - How does not include BTI Patent Rights . ; Page - 4 - means the patents which includes:(i ) All patents and patent applications of any kind anywhere in the world as moreparticularly listed in the Exhibit 6 owned or controlled by BTI during the Term or which areacquired by or developed for BTI by a Third Party during the Term ( together with alldivisions, continuations, patents of addition, substitutions, registrations, re - issues, re - examinations or extensions of the foregoing ) and which are necessary or useful toresearch, develop, make, have made, use, sell, offer for sale, import or export theProducts, provided, however, that BTI Patents that are the subject of the licenses andother rights granted Licensee hereunder shall extend only to those applications of any ofthe foregoing items that are associated with SUGARDOWN or its drug candidateequivalent;(ii ) All patent applications that may hereafter be filed by or on behalf of BTI which eitherare based on or claim priority from any of the foregoing patents and applications ; and(iii ) All patents which may be granted pursuant to any of the foregoing patentapplications ; means BTI Patents and BTI Know - How relating to SUGARDOWN or its drug candidateequivalent only ; means a day ( other than a Saturday or a Sunday ) on which licensed banks are generallyopen for business in Hong Kong ; means the date of this Agreement as set forth above ; means the European Medicines Authority ; means external contracted costs resulting in a specific fee charged and a deliverabledocumented output for EMA meetings, animal tests, and human tests, resulting in acompetent authority submission only ; means the United States Food and Drug Administration, or any successor agencythereto ; Page - 5 - means external contracted costs resulting in a specific fee charged and a deliverabledocumented output for FDA meetings, animal tests, and human tests, resulting in acompetent Regulatory Authority submission only ; means the force majeure as referred to and defined in Clause 20.7 of this Agreement ; means the Hong Kong Special Administrative Region of the People ’s Republic of China ; means the Marketing Authorization Approval of a new drug application for permission toinitiate marketing, sale, testing and food supplement registration ), licenses, registrationsor authorizations necessary for the marketing and sale of such Product, filed with : ( i ) the FDA in accordance to the FDA Code of Federal Regulation Title 21 Part 314Section 50 et . Seq ( 21 C.F.R. 314.50 et . Seq ) ; ( ii ) the EMA ; or ( iii ) any other Competent Regulatory Authority