1.19 “Harvard Technology Transfer Materials” means the Know-How, including, without limitation, the protocols, materials, data and other information listed in Exhibit C, and described in Harvard Case No. [***], and any progeny, derivatives and modifications of such material made by or on behalf of Licensee, its Subsidiaries, Sublicensees or Strategic Partners.
1.20 “IND” means an FDA new drug application, biologics license application, clinical study application, clinical trial exemption, or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in any country in conformance with the requirements of such Regulatory Authority.
1.21 “Infringed Patent” means an issued and unexpired patent or patent application owned and controlled by a Third Party: (a) that has not been abandoned, held invalid, revoked, held or rendered unenforceable or lost through interference and (b) one or more claims of which would be infringed by Licensee’s making, using, selling, offering for sale or importing of a Licensed Product or Know-How Enabled Product; provided, however, with regard to a pending claim, such claim has not been pending longer than [***] from the date of issuance of the first substantive patent office action considering patentability of such claim by the relevant patent office in the country or territory in which such claim is pending.
1.22 “Initiation” means the first dosing of the first subject in the applicable clinical study.
1.23 “Know-How” means any and all technical information, formulas, prototypes, specifications, directions, instructions, test protocols, procedures, results, studies, analyses, data, manufacturing data, formulation or production technology, processes, methods, materials, machines, devices, formulae, equipment, enhancements, modifications, technological developments, techniques, systems, tools, designs, drawings, plans, documentation, and other knowledge, information, skills and materials, in each case owned and controlled by Harvard and pertaining to the Patent Rights and provided to Licensee by Harvard in connection with this Agreement, which are necessary or useful in the manufacture, sale or use of the Licensed Products and Know-How Enabled Products and any modifications, variations, derivative works, and improvements of or relating to any of the foregoing.
1.24 “Know-How Enabled Product License” means (a) any right granted, license given or agreement entered into by Licensee, its Subsidiaries, any Sublicensees, Strategic Partners or Know-How Enabled Product Licensees with any other person or entity, under or with respect to or permitting any use or exploitation of any Know-How Enabled Product; (b) any option or other right granted by Licensee, its Subsidiaries, any Sublicensees, Strategic Partners or Know- How Enabled Product Licensees to any other person or entity to negotiate for or receive any of the rights described under clause (a); or (c) any standstill or similar obligation undertaken by Licensee, its Subsidiaries, any Sublicensees, Strategic Partners or Know-How Enabled Product Licensees toward any other person or entity not to grant any of the rights described in clause (a) or (b) to any third party; in each case regardless of whether such grant of rights, license given or agreement entered into is referred to or is described as a license or a sublicense, and in each case that is not a “Sublicense” or “Strategic Partnership” as otherwise defined herein.
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