definiens: means a GLP toxicology study of a duration of not less than four ( 4 ) weeks ; means the principles of good manufacturing practice in respect of medicinal productsfor human use and investigational medicinal products for human use required by thelaws of the European Union, including Clinical Trial Legislation, Eudralex Volume4, ICHQ7a Good Manufacturing Practice Guidance and ‘ EU Guidelines to GoodManufacturing Practice Medicinal Agents for Human and Veterinary Use, Annex 13 : Investigational Medicinal Agents ’ ; “ GMP Agent Materialsmeans Agent Materials identified in the Cover Sheet that will comply with GMP ; has the meaning given in clause 2.4 of the Agreement ; means the preparation of the Agent that is the subject of the Clinical Trial ; has the meaning given in clause 2.4 of the Agreement ; has the meaning given in clause 14.4.1 of the Agreement ; means [ * * * ] ; 7 [ * * * ] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HASBEEN REQUESTED . ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES ANDEXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933,AS AMENDED [ * * * ] means any of the following occurring in respect of a Party : a ) a voluntary arrangement is proposed or approved or administration order made ; b ) a receiver or administrative receiver is appointed over any of that Party ’s assets ; c ) if circumstances arise that entitle the Court or a creditor to appoint a receiver, administrator or administrative receiver or make a winding - up order or similar ; d ) undertakings or a winding - up resolution or petition is passed ( otherwise than forthe purpose of solvent reconstruction or amalgamation ) ; or e ) equivalent action is taken against or by the applicable Party due to its insolvencyor in consequence of debt ; means all Patents, Know How, copyright, database rights, design rights, rights intrade names, logos and trade and service marks, domain names, rights in Materialsand all rights or forms of protection of a similar nature or having equivalent or similareffect to any of them which may subsist anywhere in the world, whether or not any ofthem are registered, including any application for registration of any of them ; means the joint project team established pursuant to clause 4.1 of the Agreement ; has the meaning given in clause 4.2 of the Agreement ; means all technical and other information not in the public domain, includinginformation comprising or relating to concepts, discoveries, data, designs, formulae, ideas, inventions, methods, models, designs for and results of experiments and tests, processes, specifications and techniques, laboratory records, clinical data, reports, manufacturing data and information in submissions to Regulatory Authorities ; means the date the last Clinical Trial Subject completes the Clinical Trial ; has the meaning given in clause 8.1 of the Agreement ; has the meaning given in section 1 of the Licence Terms ; means the terms and conditions set out in Schedule 1, which come into effect inaccordance with clauses 8.1 - 8.2 of the Agreement ; 8 [ * * * ] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HASBEEN REQUESTED . ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES ANDEXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933,AS AMENDED means losses, damages, costs and expenses ( including legal costs and expenses ) ; means [ * * * ] means any chemical or biological substance that is included in, or used in connectionwith research, development or manufacturing of, the Agent ; means the milestones described in the Cover Sheet as ; has the meaning given in section 5.2 of the Licence Terms ; means, in relation to any Agent Product or Collaboration Product, a biologies licenceapplication, new drug application, supplementary new drug application, abbreviated newdrug application or any of their equivalents filed with the United States Food and DrugsAdministration ( ) or any successor to it, a marketing authorisation application orits equivalent filed with the European Medicines Agency ( ) or any successor toit, or a marketing authorisation application or a product licence application or equivalentfiled with the relevant Regulatory Authority in any country or region in the Territory ; means, in relation to an Agent Product or a Collaboration Product where the AgentProduct or Collaboration Product is sold or disposed of : [ * * * ] [ * * * ] 9 [ * * * ] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HASBEEN REQUESTED . ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES ANDEXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933,AS AMENDED [ * * * ] [ * * * ] has the meaning given in clause 7.1 of the Agreement ; means an Indication [ * * * ] ; means any patent application ( if pending for less than seven ( 7 ) years ) or grantedpatent ( whether or not it was previously pending as a patent application for less ormore than seven ( 7 ) years ) or similar or equivalent form of protection anywhere in theworld, including utility model and design patents and certificates of invention and alldivisional, continuations, continuations - in - part, reissues, renewals, extensions, additions, supplementary protection certificates ; means [ * * * ] after the Company has received the corresponding Milestone Payment ( ifapplicable ) from the Sub - Licensee ( the Company will give notice to CRT of receipt ofthe corresponding Milestone Payment ) ; means [ * * * ] ; has the meaning given in clause 16.2 of the Agreement ; has the meaning given in clause 16.6 of the Agreement ; means [ * * * ] ; “ [ * * * ] means [ * * * ] ; 10 [ * * * ] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HASBEEN REQUESTED . ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES ANDEXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933,AS AMENDED [ * * * ] ” [ * * * ] and means British pound sterling ; means any approval or determination of pricing or pricing reimbursement in thosecountries in the Territory where Regulatory Authorities approve or determine pricing orpricing reimbursement for pharmaceutical products ; has the meaning given in clause 2.2.1 of the Agreement ; means the individual identified in the Cover Sheet by each Party as its ‘ ProjectLeader ’, or any replacement notified to the other Parties ; means [ * * * ] ; or QP”means the person referred to in Article 48 of European Community Directive2001/83 / EC, Article 13 ( 2 ) of European Community Directive 2001/20 / EC, Article 61(2 ) of Regulation ( EU ) 536/2014 ( if and as applicable ), or any nationallegislation that implements such Directives or Regulation or is otherwise applicable, and any relevant guidance thereto, all as the same may be amended from time to time ; means any of the three - monthly periods beginning on the first day of any of January, April, July, and October in any year and has a corresponding meaning ; means all authorisations, approvals and clearances that may be required by aRegulatory Authority in any country or region in the Territory before ( as the contextmay require ) Phase II Clinical Trial Commencement or Phase III Clinical TrialCommencement or commercial sale of the Agent Product or the Collaboration Product