definiens: means any Intellectual Property Rights generated pursuant to this Agreement through the Research Collaboration during the Term ; means the Horizon Patents, Horizon Know -how and any other Intellectual Property Rights owned or controlled by Horizon or any of its Affiliates which ( i ) are in existence at the Effective Date ; and/or ( ii ) developed by or on behalf of Horizon independently of this Agreement ; means any Foreground IP generated solely by Horizon Representatives during the course of, in furtherance of, 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 Kn ow - how of Horizon relating to the Product, which is required and/or relevant to the activities that will be carried out by [COMPANY] in the context of the license granted to it under this Agreement, including the Know -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 equivalent Regulatory 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 proprietary rights including all rights to know -how and other technical information ; ( ii ) the benefit of all registrations and applications to register any of the foregoing ; and ( iii ) any and all other rights similar or analogous to any of the foregoing whether arising or granted in any jurisdiction ; has the meaning given to it in Clause 12.4 ; Page 3 of 25 CONFI DENTIAL means ( a ) any scientific or technical information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, that is not in the public domain or otherwise publicly known, including databases, practices, m ethods, techniques, specifications, formulations, formulae, knowledge, know -how, skill, experience, test data, including pharmacological, medicinal chemistry, biological, chemical, biochemical, toxicological and clinical test data, analytical and quality c ontrol data, stability data, studies and procedures, and manufacturing process and development information, results and data, and ( b ) any biological, chemical, or physical materials, and ( c ) any industrial information that is not in the public domain or ot herwise available to the public ; all to the extent 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, as defined 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 and filed with the FDA ; means, wi th respect to any Product, the gross invoiced sales of such Product by [COMPANY] or its Affiliates, as applicable, to Third Parties after the First Commercial Sale of such Product, less the following deductions to the extent included in the gross invoiced sal es price for such Product or otherwise directly paid or incurred by [COMPANY] or its Affiliates, as applicable, with respect to the sale of such Product : ( i ) normal and customary trade and quantity discounts, credits and allowances actually allowed and properly taken directly with respect to sales of such Product ; ( ii ) amounts repaid or credited by reason of rejections, recalls, returns, rebates, government mandated rebates and allowances ; ( 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