“Investors’ Rights Agreement” means the Amended and Restated Investors’ Rights Agreement among the company, the Subsidiary and the purchasers named therein, dated as of March 25, 2019.
“Know-How” means any data, results, and information of any type whatsoever, whether tangible or intangible and regardless of the form or medium, including anyknow-how, trade secrets, expertise, knowledge, practices, techniques, concepts, methodologies, methods, processes, protocols, designs, ideas, inventions (whether or not patentable or reduced to practice), improvements, industrial designs and models, discoveries, developments, unpublished patent applications, specifications, formulations, formulae, materials or compositions of matter of any type or kind (patentable or otherwise), assays, screens, software, algorithms, models, data, databases, database rights, chemistry, manufacturing and control (CMC) information and data, lab notebooks, Patent data, stability, technology, test data and results (including pharmacological, biological, chemical, biochemical, toxicological,pre-clinical and clinical test data), analytical and quality control data, results or descriptions, studies and procedures, development, manufacturing and distribution costs, information contained in submissions to and information from regulatory authorities, and marketing and other reports.
“knowledge of Seller” means the actual knowledge of Scott Myers, Julie Eastland and Max Barker after due and reasonable investigation.
“Launch” means, with respect to the Product, the First Commercial Sale of the Product to an end user. For the avoidance of doubt, sales prior to receipt of all Approvals (including pricing and reimbursement approvals, where applicable), such asso-called “treatment IND sales”, “named patient sales” and “compassionate use sales”, shall not be construed as a Launch.
“Licensee” means any third party that is a party to a Contract with Purchaser or any of its Affiliates pursuant to which such third partyco-promotes,co-markets or otherwise has a license or other right to research, develop, manufacture, supply, test, distribute, promote, market, offer for sale, sell or import or to otherwise commercialize the Product.
“MAA” means an EU marketing authorization application.
“Material Adverse Effect” means any change, effect, event, circumstance, occurrence or state of facts that, individually or taken together with other changes, effects, events circumstances, occurrences or states of facts that have occurred prior to the date of the determination of the occurrence of the Material Adverse Effect, (i) is, or would reasonably be expected to be, materially adverse to the Program, the Product and the Acquired Assets, taken as a whole, or (ii) would materially impede the authority of Seller to consummate the transactions contemplated by this Agreement, provided that in no event shall any change, effect, event, circumstance, occurrence or
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