definiens: has the meaning given to it in Clause 3 ; means ( a ) all patents, patent applications, utility 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, supplementary protection certificates and the like, of any such patents or patent applications ; Page 4 of 24CONFIDENTIAL means a clinical study of an investigational product in human patients with the primary objective ofcharacterizing its activity in a specific disease state as well as generating more detailed safety, tolerability, and pharmacokineticsinformation as described in 21 CFR 312.21(b ), or a comparable clinical study prescribed by the relevant Regulatory Authority in acountry other than the United States including a human clinical trial that is also designed to satisfy the requirements of 21 CFR312.21(a ) or corresponding foreign regulations and is subsequently optimized or expanded to satisfy the requirements of 21 CFR312.21(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 forconfirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in21 CFR 312.21(c ), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the UnitedStates ; means any Chimeric Antigen Receptor T - cell therapy in which cells are modified to knockdown Targets or Targets theuse of shRNA using Horizon Intellectual Property Rights pursuant to this Agreement, or any other product whose manufacture, use orsale would, in the absence of a license from Horizon, constitute direct, indirect, contributory or any other type of infringement of ( one ormore claims of ) Horizon Intellectual Property Rights ; shall have the meaning given to it 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 Regulatory Authority necessary to use, research, develop, manufacture and sell the Product foruse in the Field in the Territory, including all INDs, MAAs and the manufacturing license and marketing registration required under theApplicable Laws of such applicable 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, provincial or local regulatory agency, department, bureau, commission, council or other governmental entity ( including, without limitation, the EMA, the FDA, the PMDA and anygovernmental unit having jurisdiction over the use, research, development, manufacture and sale of the Product in the Field in theTerritory ) ; shall mean, in relation to a Party, its respective Affiliates and their officers, employees, consultants, agents, andsubcontractors ; means the collaboration between the Parties for joint research and/or development in the Field inaccordance with this Agreement and with the Research Plan and which has the objective to identify and optimize shRNA to knockdownthe Target, and to demonstrate efficacy in the Field ; means the research plan to be agreed between the Parties, to be attached hereto as Schedule 2 and to include anitemized description of research and development activities, roles and responsibilities of the Parties, costs and estimated timelines forthe Research Collaboration ; Page 5 of 24CONFIDENTIAL has the meaning given to it in Clause 7.4 ; has the meaning given to it in Clause 7.4 ; means any of the following genes or any combination thereof : MICA, MICB, ULBP1, ULBP2, ULPBP3, ULPBP4, ULPBP5 orULPBP6, 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 ofwhatever nature ( including any related fine, penalty, surcharge or interest ) imposed by, or payable to, any government, state ormunicipality, 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 fiscal, revenue, customs, or exciseauthority, 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] or their respective Affiliates ; means a cease and desist letter or a letter or other written communication sent by a Third Party, explicitly and / orinherently ( i ) alleging that the conduct of development, commercialization or manufacturing activities of the Product in the Territoryinfringes, misappropriates, violates or makes unauthorized use of such Third Party ’s Intellectual Property Rights ; or ( ii ) questioning theParty ’s assumed right to the alleged use of such Third Party ’s Intellectual Property Rights ; or ( iii ) including any written claim offering alicense 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 has not expired or been revoked, held invalid or unenforceable by a patentoffice, court or other governmental agency of competent jurisdiction in a final and non - appealable judgment ( or judgment from which noappeal was taken within the allowable time period ) ; means, within the EU, such Tax as may be levied in accordance with ( but subject to derogations from ) Directive 2006/112 / ECand, 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 indirecttaxes 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 thisAgreement except that the first Year shall commence on the Effective Date and end on 31 December and the last Year shallcommence on 1 January and end on the date of termination of this Agreement