definiens: means, with respect to a particular Party, a person, corporation, partnership, or other entity that controls, is controlled by or isunder common control with such Party . For the purposes of this definition, the word ( including, with correlative meaning, theterms or ) means the actual power, either directly or indirectly through one or moreintermediaries, to direct or cause the direction of the management and policies of such entity, whether by the ownership of fifty per cent(50 % ) or more of the voting stock of such entity, or by contract or otherwise ; means this license agreement as entered into between the Parties ; means all federal, state, local, national and supra - national laws, statutes, rules and regulations, including any rules, regulations or orders of Regulatory Authorities, major national securities exchanges or major securities listing organizations, that maybe in effect from time to time during the Term and applicable to a particular activity or exercise of rights hereunder ; means a day, other than a Saturday or a Sunday or a public holiday, on which banking institutions in Belgium and theUnited States of America are open for business ; means 9:00 to 17:30 of each Business Day in the country of incorporation of the recipient ; means any Intellectual Property Rights owned or controlled by [COMPANY] or any of its Affiliates which ( i ) are inexistence at the Effective Date or ( ii ) are developed by [COMPANY] Representatives during the Term but independently of this Agreementand independently of the Horizon Background IP ; means any Foreground IP other than the Horizon Foreground IP ; has the meaning given to it in Clause 9.1 ; means eighteen ( 18 ) months as from the Effective Date ; means any and all information or material, whether oral, visual, in writing or in any other form, that hasbeen disclosed to the Recipient or any of its Affiliates by or on behalf of the Discloser or any of its Affiliates pursuant to this Agreementor in connection with the transactions and activities contemplated hereby or any discussions or negotiations with respect thereto, including all data, documents, drawings, test reports, operating and testing procedures, manufacturing practices and Know - how, instruction manuals, materials, recipes and formulae, tables of operating conditions, corporate organization, business plans, unpublished patent applications, marketing and sales reports, forecasts, pricing information, customer lists and the like and not as awhole readily available to the public ; has the meaning given to it in Clause 17.2 ; Page 2 of 24CONFIDENTIAL means the date on which this Agreement is signed by both Parties ; means an IND that went into effect as described in 21 CFR 312.40(b ) ; means the treatment of human diseases through Chimeric Antigen Receptor CAR - T - cell therapy in which cells are modified toknockdown Targets or Targets using shRNA ; means, with respect to any Product, the first sale for end use or consumption of such Product in a countryafter the Regulatory Authority of such country has granted Regulatory Approval . Sale to an Affiliate or Sublicensee will not constitute aFirst Commercial Sale, unless the Affiliate or Sublicensee is the end user of the Product ; means any Intellectual Property Rights generated pursuant to this Agreement through the Research Collaborationduring the Term ; means the Horizon Patents, Horizon Know - how and any other Intellectual Property Rights owned orcontrolled by Horizon or any of its Affiliates which ( i ) are in existence at the Effective Date ; and/or ( ii ) developed by or on behalf ofHorizon independently of this Agreement ; means any Foreground IP generated solely by Horizon Representatives during the course of, in furtheranceof, and/or as a direct result of such Representatives performing an activity pursuant to this Agreement ; means any Horizon Background IP and Horizon Foreground IP ; means the internally documented Know - how of Horizon relating to the Product, which is required and/or relevantto the activities that will be carried out by [COMPANY] in the context of the license granted to it under this Agreement, including theKnow - how listed in Schedule 1 ; means the Patents listed in Schedule 1 ; means an Investigational New Drug Application filed with the FDA, or the equivalent application or filing filed with any equivalentRegulatory Authority outside the United States of America ( including any supra - national agency, such as in the European Union)necessary to commence human clinical trials in such jurisdiction ; means any and all Patents and Know - how, as well any other rights, title and interest held in ( i ) patents, utility models, designs ( whether registered or unregistered ), copyrights, trade marks, trade secrets, confidentiality and other proprietaryrights including all rights to know - how and other technical information ; ( ii ) the benefit of all registrations and applications to register anyof the foregoing ; and ( iii ) any and all other rights similar or analogous to any of the foregoing whether arising or granted in anyjurisdiction ; has the meaning given to it in Clause 12.4 ; Page 3 of 24CONFIDENTIAL means ( a ) any scientific or technical information, results and data of any type whatsoever, in any tangible or intangibleform whatsoever, that is not in the public domain or otherwise publicly known, including databases, practices, methods, techniques, specifications, formulations, formulae, knowledge, know - how, skill, experience, test data, including pharmacological, medicinalchemistry, biological, chemical, biochemical, toxicological and clinical test data, analytical and quality control data, stability data, studiesand procedures, and manufacturing process and development information, results and data, and ( b ) any biological, chemical, orphysical materials, and ( c ) any industrial information that is not in the public domain or otherwise available to the public ; all to theextent not claimed or disclosed in a Patent ; means an application for authorization to market the Product in any country or group of countries outside the United States, asdefined in Applicable Laws and filed with the Regulatory Authority of a given country or group of countries ; means the Mutual Non - Disclosure Agreement executed on 12 September 2017 between the Parties ; means a New Drug Application in the United States for authorization to market a Product, as defined in Applicable Laws andfiled with the FDA ; means, with respect to any Product, the gross invoiced sales of such Product by [COMPANY] or its Affiliates, as applicable, toThird Parties after the First Commercial Sale of such Product, less the following deductions to the extent included in the gross invoicedsales price for such Product or otherwise directly paid or incurred by [COMPANY] or its Affiliates, as applicable, with respect to the sale ofsuch Product : ( i)normal and customary trade and quantity discounts, credits and allowances actually allowed and properly taken directlywith respect to sales of such Product ; ( ii)amounts repaid or credited by reason of rejections, recalls, returns, rebates, government mandated rebates andallowances ; ( iii)chargebacks and other amounts paid on sale or dispensing of such Product ; ( iv)retroactive price reductions that are actually allowed or granted ; ( v)tariffs, duties, excise, sales, value - added or other taxes ( other than taxes based on income ) ; ( vi)cash discounts for timely payment ; ( vii)delayed ship order credits ; ( viii)discounts pursuant to patient discount programs ; and ( ix)freight, shipping and insurance charges