Execution Version
1.20. “DMF” means a Drug Master File as more fully defined in 21 C.F.R. §314.420 in the United States or similar documents filed with a Regulatory Authority in another jurisdiction.
1.21. “Field” means all human therapeutic uses of the Licensed Compound that derives therapeutic effect from ROS proto-oncogene 1 (ROS1), the neurotrophic receptor tyrosine kinase (NTRK), and/or [**Redacted**] pathways for the diagnosis, prevention, or treatment of any indication.
1.22. “First Commercial Sale” means the date on which the Product is first shipped by Innovent, or its Affiliate to Third Parties for commercial sale in the Territory after all required Marketing Approvals have been granted, or such sale is otherwise permitted, by the Regulatory Authority in the Territory, excluding (a) any sale to an Affiliate or sublicensee of Innovent, unless such Affiliate or sublicensee is the last Person in the distribution chain of the Product; or (b) any use of such Product in clinical trials or non-clinical development activities with respect to such Product by or on behalf of a Party, or disposal or transfer of such Product for a bona fide charitable purpose, compassionate use, or samples if no monetary consideration is received for such use or transfer.
1.23. “Governmental Authority” means any agency, department, authority, body, institution or other instrumentality of any national, state, country, city or other political subdivision.
1.24. “IND” means, in the United States, an effective Notice of a Claimed Investigational New Drug Application filed with the FDA as more fully defined in 21 C.F.R. §312.3, and, with respect to every other region in the Territory, the equivalent application (i.e., a filing that must be made prior to commencing clinical testing of Product in humans) for such country, filed with the applicable Regulatory Authority in such region.
1.25. “Invention” means any new or useful process, machine, manufacture, or composition of matter relating to or comprising the Licensed Compound or a Product, and any improvement, enhancement, modification, or derivative work to any AnHeart Technology, that is conceived or first reduced to practice or first demonstrated to have utility during the Term in connection with the Parties’ activities to develop, manufacture and commercialize the Licensed Compound and Product(s) worldwide.
1.26. “Joint Technology” means the Joint Patents and Joint Know-how.
1.26.1. “Joint Know-how” means Know-how, including any Invention, that is related to the Licensed Compound and conceived of discovered, developed, made and/or reduced to practice jointly by or on behalf of employees, agents, or consultants of Innovent or its Affiliates, on the one hand, and employees, agents, or consultants of AnHeart, its Affiliates, or its Sublicensees, on the other hand.
1.26.2. “Joint Patents” means Patents with a Valid Claim Covering an Invention that is related to the Licensed Compound or a Product, or that is otherwise reasonably necessary or useful for researching, developing, manufacturing, using, selling, offering for sale, or importing the Licensed Compound or a Product, or that would otherwise Cover manufacturing, using, selling, offering for sale, or importing a Product, that is conceived of discovered, developed, made and/or reduced to practice jointly by or on behalf of employees, agents, or consultants of Innovent or its Affiliates, on the one hand, and employees, agents, or consultants of AnHeart, its Affiliates, or its Sublicensees, on the other hand.
1.27. “Know-how” means a Party’s confidential and/or proprietary technical or business information, including without limitations (a) any proprietary scientific or technical information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, including databases, safety information, practices, methods, techniques, specifications, instructions, processes, formulations, formulae, methods, protocols, expertise, knowledge, know-how, inventions, discoveries, improvements, trade secrets, skill, experience, test data including pharmacological, pharmaceutical, physical, medicinal
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