definiens: has the meaning given to it in Clause 3 ; means ( a ) all patents, patent applications, util ity models and design patents in any country or supranational jurisdiction, and ( b ) any provisionals, substitutions, divisions, continuations, continuations in part, reissues, renewals, registrations, confirmations, re -examinations, extensions, supplementa ry protection certificates and the like, of any such patents or patent applications ; Page 4 of 25 CONFIDENTIAL means a clinical study of an investigational product in human patients with the primary objective of characteri zing its activity in a specific disease state as well as generating more detailed safety, tolerability, and pharmacokinetics information as described in 21 CFR 312.21(b ), or a comparable clinical study prescribed by the relevant Regulatory Authority in a c ountry other than the United States including a human clinical trial that is also designed to satisfy the requirements of 21 CFR 312.21(a ) or corresponding foreign regulations and is subsequently optimized or expanded to satisfy the requirements of 21 CFR 312.21(b ) ( or corresponding foreign regulations ) or otherwise to enable a Phase 3 Clinical Trial ; means a clinical study of an investigational product in human patients that incorporates accepted endpoints for confirmation of stat istical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 CFR 312.21(c ), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States ; means any allogeneic Chimeric Antigen Receptor T -cell therapy in which cells are modified to knockdown one or more Targets by using shRNA, using Horizon Intellectual Property Rights pursuant to this Agreement, or any other product whose man ufacture, use or sale would, in the absence of a license from Horizon, constitute direct, indirect, contributory or any other type of infringement of ( one or more claims of ) Horizon Intellectual Property Rights ; shall have the meaning given to i t in Clause 8.2 ; has the meaning given to it in Clause 17.2 ; means any and all approvals, licenses ( including product and establishment licenses ), permits, certifications, registrations, or authorizations of any Regulato ry Authority necessary to use, research, develop, manufacture and sell the Product for use in the Field in the Territory, including all INDs, MAAs and the manufacturing license and marketing registration required under the Applicable Laws of such applicabl e country in the Territory, or any update thereto, as well as pre - and post -approval marketing studies, labelling approvals, technical, medical and scientific licenses ; means any national, supra -national, regional, federal, state, p rovincial or local regulatory agency, department, bureau, commission, council or other governmental entity ( including, without limitation, the EMA, the FDA, the PMDA and any governmental unit having jurisdiction over the use, research, development, manufac ture and sale of the Product in the Field in the Territory ) ; shall mean, in relation to a Party, its respective Affiliates and their officers, employees, consultants, agents, and subcontractors ; means the collaboration between the Parties for joint research and/or development in the Field in accordance with this Agreement and with the Research Plan and which has the objective to identify and optimize shRNA to knockdown the Target, and to demonst rate efficacy in the Field ; means the research plan to be agreed between the Parties, to be attached hereto as Schedule 2 and to include an itemized description of research and development activities, roles and responsibilities of the Part ies, costs and estimated timelines for the Research Collaboration ; Page 5 of 25 CONFIDENTIAL has the meaning given to it in Clause 7.4 ; has the meaning given to it in Clause 7.4 ; means any of the follow ing genes or any combination thereof : TRA, TRB, TRD, TRG, CD3 G, CD3D, CD3E, CD247 ( together ) ; TAP1, TAP2, TAPBP, B2 M, MHCI or MHCII ( together ), and these are not limited to human genes and includes homologous genes in any species ; or means any form of tax or taxation, levy, duty, charge, social security charge, contribution or withholding of whatever nature ( including any related fine, penalty, surcharge or interest ) imposed by, or payable to, any governme nt, state or municipality, or any local, state, federal or other fiscal, revenue, customs, or excise authority, body or official anywhere in the world ; means any government, state or municipality, or any local, state, federal or other fisc al, revenue, customs, or excise authority, body or official anywhere in the world, authorized to levy Tax ; has the meaning given to it in Clause 21.1 ; means the entire world ; means any person other than Horizon, [COMPANY] o r their respective Affiliates ; means a cease and desist letter or a letter or other written communication sent by a Third Party, explicitly and/or inherently ( i ) alleging that the conduct of development, commercialization or manufacturi ng activities of the Product in the Territory infringes, misappropriates, violates or makes unauthorized use of such Third Party ’s Intellectual Property Rights ; or ( ii ) questioning the Party ’s assumed right to the alleged use of such Third Party ’s Intellec tual Property Rights ; or ( iii ) including any written claim offering a license to the Party or that the Party must license or refrain from using such Third Party ’s Intellectual Property Rights ; means a patent claim of an issued patent that ha s not expired or been revoked, held invalid or unenforceable by a patent office, court or other governmental agency of competent jurisdiction in a final and non -appealable judgment ( or judgment from which no appeal was taken within the allowable time perio d ) ; means, within the EU, such Tax as may be levied in accordance with ( but subject to derogations from ) Directive 2006/112 / EC and, outside the EU, value added tax or any form of indirect tax levied by a relevant Tax Authority, as well as all other forms of indirect taxes levied by the relevant Tax Authority on the purchase of a good or a service, including sales tax and good and service tax ; means each twelve ( 12 ) month period commencing on 1 January and ending on the 31 December throughout the Term of this Agreement except that the first Year shall commence on the Effective Date and end on 31 December and the last Year shall commence on 1 January and end on the date of termination of this Agreement