1.49 “Humabs Agreement” means the agreement executed between MedImmune and Humabs dated 20 March 2012, as amended, for a license granted from Humabs to MedImmune to Exploit influenza monoclonal antibodies.
1.50 “Improvements” means any invention, discovery, development or modification with respect to the Licensed Compound or a Licensed Product or relating to the Exploitation thereof, whether or not patented or patentable, including any enhancement in the efficiency, operation, Manufacture, ingredients, preparation, presentation, formulation, means of delivery or dosage of such Licensed Compound or Licensed Product, any discovery or development of any new or expanded indications for such Licensed Compound or Licensed Product, or any discovery or development that improves the stability, safety or efficacy of such Licensed Compound or Licensed Product.
1.51 “IND” means (i) an investigational new drug application filed with the FDA for authorization to commence clinical studies and its equivalent in other countries or regulatory jurisdictions and (ii) all supplements and amendments that may be filed with respect to the foregoing.
1.52 “Indemnification Claim Notice”has the meaning set forth in Section 9.3(i).
1.53 “Indemnified Party”has the meaning set forth in Section 9.3(i).
1.54“Indirect Tax(es)”has the meaning set forth in Section 5.6(ii).
1.55 “Infringement” has the meaning set forth in Section 6.4(i).
1.56 “Initiation” means, with respect to a clinical study, the first dosing of the first human subject in such clinical study.
1.57 “In-License Agreement” means any license or other agreement entered into prior to the Effective Date by and between MedImmune or any of its Affiliates, on the one hand and one (1) or more Third Parties, on the other hand, listed inSchedule 5, as such license or other agreement may be amended from time to time during the Term.
1.58 “Invoiced Sales”has the meaning set forth in the definition of “Net Sales.”
1.59 “Know-How”means all technical tangible and intangible techniques, information, technology, practices, formulae, trade secrets, inventions (whether patentable or not), methods, processes, procedures, ideas, technical assistance, knowledge,know-how, conclusions, instructions, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, skill, experience, data and results (including biological, chemical, physical, pharmacological, toxicological, safety, manufacturing,pre-clinical and clinical test data and results), Regulatory Documentation, analytical and quality control data, results or descriptions, software and algorithms, and materials, including biological materials, cell lines, compositions and the like.Know-How does not include (i) issued Patents, (ii) Trademarks or (ii) commercial marketing information.
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