definiens: means any indicat ions in respect of tumours in humans, other than brain tumours, tha t the Parties may agree from time to time in writing shall be lice nsed to [COMPANY] as Other Indications under this Agreement ; 1.1.31 means [COMPANY] and PharmaEngi ne, and means either of them ; 1.1.32 means all necessary consent s, approvals and authorizations of all regulatory and governmental authorities and other persons in connection with the 4 Final Version 12 April 2005 Confidential development, use, importation, promot ion, marketing, sale and supply of Licensed Product in each co untry of the Territory ; 1.1.33 means a controlled pi votal clinical study of a Licensed Product which is prospective ly designed to demonstrate statistically whether such Licensed P roduct is effective and safe for use in a particular indication in a manner sufficient to obtain Marketing Authorisation for su ch Product ; 1.1.34 means the first dosing of the first patient in a Pivotal Trial ; 1.1.35 means comp letion of the final report of a Pivotal Trial ; 1.1.36 means the Development Plan an d the Marketing Plan ; 1.1.37 means any Tr ademark proprietary to [COMPANY] used on products markete d by [COMPANY] ( in addition to any Trademark identifying the product ) to identify [COMPANY] as the holder of a Marke ting Authorisation for such product ; 1.1.38 means any Tradema rk selected by [COMPANY] in respect of the Licensed Product in the Territory and notified to [COMPANY] under the terms of Clause 9 .1 ; 1.1.39 means the data from any Programme Trials and any other test data related thereto and a ny other documentation or correspondence relating to any Progra mme Trials of the Licensed Product conducted by or on behalf of either Party and all Know - how in respect of the same ; 1.1.40 means such clinica l testing ( including toxicological, stability, pharmacolog ical and clinical studies in human beings ) as may be required to b e carried out and/or produced by or on behalf of either Party in co nnection with obtaining the Marketing Authorisation for the Licen sed Product either inside or outside of the Territory, and which i n the case of such clinical testing inside the Territory shall be conducted in accordance with the Development Plan from time to tim e ; 1.1.41 means each three calendar - m onth period in any year during the term of this Agreement end ing on 31st March, 30th June, 30th September and 31st December in e ach year and has a corresponding meaning ; 1.1.42 means the body with responsibility for granting the Marketing Authorisations of the Licensed Product in each country of the Territory ; 1,1.43 means the royalties payab le to [COMPANY] in accordance with Clause 11.3 ; 1.1.44 means an Adve rse Event that : ( a ) results in death ; 5 Final Version 12 April 2005 Confidential ( b ) is life - threatening ; ( c ) requires prolongation of exist ing hospitalization ; ( d ) results in persistent or signi ficant disability or incapacity ; or ( e ) results in congenital anomaly or birth defect ; and/or other medically significant ev ents that may jeopardise the patient or may require intervention t o prevent one of the outcomes listed in the previous paragraphs of this definition ; 1.1.45 means any sub - licence a greement entered into by [COMPANY] and a Sub - Licensee, purs uant to which [COMPANY] grants such Sub - Licensee rights to co -develop, market, promote, distribute and/or sell the Licensed P roduct in the Territory, or any part thereof ; 1.1.46 means any person ( incl uding distributors ) to whom [COMPANY] has directly or indirect ly, granted rights to co - develop, market, promote, distribu te and/or sell the Licensed Product in the Territory, or any part thereof ; 1.1.47 means the supply a greement between the Parties to be entered into in accordance with Clause 8 ; 1.1.48 means the People 's Republ ic of China and the Republic of Korea and, if [COMPANY] validly exercises an option in accordance with Clause 2.4, Taiwan ; 1.1.49 means trade names, logos and marks ( both registered and unregistered ) and rights in respe ct thereof, including rights to prevent passing off, rights to pre vent unfair competition and similar rights in respect of goods an d / or services ; 1.1.50 means such rights as [COMPANY] may have ( whether as owner or licensee ) i n the Territory at the Effective Date or thereafter in any I ntellectual Property with respect to the API and/or the License d Product, and including : ( a ) any patent(s ) and patent appli cation(s ) that may be filed by [COMPANY] in the Territory dur ing the term of this Agreement with respect to the API and/or the Licensed Product, including all extensi ons, additions and divisions thereof ; and ( b ) the Know - how ; and ( c ) any other rights ( other than T rademarks ) that may protect any aspect of the API and/or t he Licensed Product or its marketing in the Territory, in cluding ( where applicable ) property rights in materials a nd data exclusivity rights