definiens: means initially Territory Licensed Product(s ) and from time to time, as the same may beadded to this Agreement, Additional Territory Licensed Product(s ), details of which areset out in Exhibit 7 ; means with respect to a patent or patent application, the preparing, filing, prosecuting andmaintenance of such patent or application, as well as re - examinations, reissues, requests for patent term extensions and related matters with respect to such patent orapplication, together with the conduct of interferences, the defense of oppositions andother similar proceedings with respect to the particular patent or patent application ; and‘Prosecute and Maintain ’ shall have the correlative meaning ; means a person qualified and accepted by competent authority to batch release and toassure quality and acceptance by a competent authority ; means the official materials submitted to the regulatory authority in support of theregulatory label and approval of Products ; Page - 6 - means federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the discovery, advancement, manufacture, commercialization or other use or exploitation ( including thegranting of MAA ) of the Products in any jurisdiction, including the FDA, the EuropeanMedicines Agency ( EMA ), the State Food and Drug Administration ( SFDA ) in thePeople ’s Republic of China and the Ministry of Health Labor and Welfare ( MHLW ) inJapan ; means the trademark, namely, registered in ( * ) and owned by ( * ) andsuch trademark is adopted in the manufacture, sale, marketing, promotion, distributionand advertising of the Products, details of which are set out in Exhibit 2 means the term as defined and set out in Clause 16 of this Agreement ; means the following territories:- ( i ) People ’s Republic of China ; ( ii ) Hong Kong Special Administrative Region ; and(iii ) Macau Special Administrative Region ; means any product, the research, development, manufacture, use, sale, offer for sale, import or export ( collectively, ) of which is based upon or incorporates BTITechnology or,, but for the license granted in the Agreement, would infringe any BTIPatents in any country in the Territory ; means any person or entity other than BTI, the Licensee or their respective Affiliates ; means the United States of America ; and and the signmeans United States dollars, the lawful currency of the United States of America