“Improvements” means: (a) any and all Know-How, compounds, sequences, molecules, data, derivatives, designs, developments, discoveries, enhancements, inventions, materials, modifications, new uses, processes, products, research results, techniques, writings, or other technology rights, whether or not patentable, in each case, that are invented, conceived, reduced to practice, or otherwise developed in the course of performance of this Agreement, whether solely by or on behalf of each of the Parties or jointly by or on behalf of both Parties; and (b) any and all Patent Rights and other intellectual property rights in any of the foregoing.
“IND” means an Investigational New Drug application in the U.S. filed with the FDA or the corresponding application for the investigation of Licensed Products in any other country or group of countries, as defined in the Applicable Laws and filed with the Regulatory Authority of the relevant country or group of countries.
“IND-Enabling Studies” means studies that are reasonably required to meet the requirements for filing an IND with a Regulatory Authority, including GLP toxicology and safety studies, or studies required for the preparation of the CMC section of such IND, including studies relating to analytical methods and purity analysis, and formulation and manufacturing development studies, and which also includes ADME (absorption, distribution, metabolism, and excretion) information, all as necessary to obtain the permission of the Regulatory Authority in the relevant jurisdiction to begin human clinical testing, which, for the avoidance of doubt, include the studies and activities identified in each of the HBV Research Plan or the HIV Research Plan as IND-Enabling Studies.
“Indemnification Claim Notice” shall have the meaning set forth in Section 16.3(b).
“Indemnified Party” shall have the meaning set forth in Section 16.3(b).
“Indemnifying Party” shall have the meaning set forth in Section 16.3(b).
“Indemnitee” means a Gilead Indemnitee or a Hookipa Indemnitee, as the context requires.
“Joint Committee” means the JRC or the JSC, as the context requires.
“Joint Committee Co-Chairs” means the JRC Co-Chairs or the JSC Co-Chairs, as the context requires.
“Joint Research Committee” or “JRC” shall have the meaning set forth in Section 4.2(a).
“Joint Steering Committee” or “JSC” shall have the meaning set forth in Section 4.1(a).
“JRC Co-Chair” shall have the meaning set forth in Section 4.2(b).
“JSC Co-Chair” shall have the meaning set forth in Section 4.1(b).
“Know-How” means all tangible and intangible scientific or technical information, know-how, and data of any type whatsoever, whether or not patentable, including inventions, discoveries, trade secrets, specifications, instructions, processes, formulae, materials, expertise and other technology applicable to compounds, sequences, molecules, formulations, compositions, products or to their manufacture, development, registration, use or commercialization or methods of assaying or testing them or processes for their manufacture, formulations containing them, compositions incorporating or comprising them and including all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical, and analytical, safety, quality control, manufacturing, preclinical, and clinical data, instructions, processes, formulae, expertise, and information, Regulatory Filings, and copies thereof, relevant to the development, manufacture, use, or commercialization of, or which may be useful in studying, testing, development, production, or formulation of, products, or intermediates for the synthesis thereof,
“Knowledge” means, with respect to any Person, the [***] knowledge of such Person’s executive officers, including, with respect to each Party, its Senior Officer, after [***]. [***].
“Licensed Product” means an HBV Licensed Product or an HIV Licensed Product, as the context requires.
“Licensed Technology” means all Hookipa Patent Rights and Hookipa Know-How.
“Licensed Vaccine” means an HBV Licensed Vaccine or an HIV Licensed Vaccine, as the context requires.