1.50 “Exclusive Molecules” means, for each Collaboration Target, the Lead Binders and any variants thereof that [***].
1.51 “Exclusivity Obligations” has the meaning set forth in Section 6.1.1.
1.52 “Existing IP” with reference to a Party means all Patents and Know How that it Controls as of the Effective Date.
1.53 “FDA” means the U.S. Food and Drug Administration, or any successor entity thereto performing similar functions in the United States.
1.54 “Force Majeure” means any event beyond the reasonable control of the affected Party including: embargoes; war or acts of war, including terrorism; insurrections, riots, or civil unrest; strikes, lockouts or other labor disturbances; epidemics or pandemics; or fire; floods, earthquakes, or other acts of nature; and failure of plant or machinery (provided that such failure could not have been prevented by the exercise of skill, diligence, and prudence that would be reasonably and ordinarily expected from a skilled and experienced person engaged in the same type of undertaking under the same or similar circumstances).
1.55 “GAAP” means United States generally accepted accounting principles, International Financial Reporting Standards or such other similar national standards, consistently applied by the applicable Person.
1.56 “Hutch Sublicense” has the meaning set forth in Schedule 5.5.
1.57 “Indemnifying Party” has the meaning set forth in Section 11.1.3.
1.58 “Indemnitee” has the meaning set forth in Section 11.1.3.
1.59 “Infringement” has the meaning set forth in Section 8.3.1.
1.60 “Initiation” means, with respect to a Clinical Trial, the first dosing in a human subject in such Clinical Trial.
1.61 “Internal Policies” means, with respect to a Party, such Party’s health care compliance, privacy, ethical, reputational, anti-bribery and corruption and other policies applicable to such Party’s activities under this Agreement, and any standard operating procedures implementing such policies, including the codes of conduct of any self-regulatory body of which that Party is a member.
1.62 “Joint Research Committee” or “JRC” has the meaning set forth in Section 3.1.1.
1.63 “Know How” means, in any tangible or intangible form, all proprietary and confidential technical information, methods, trade secrets, models, discoveries, ideas, data (including Data) and other types of information, databases, results, assays, instructions, processes, techniques, formulas, algorithms, materials (including Materials), inventions, computational models, human-relevant disease models, computer software (including source code), predictive model implementations, data analytic tools, biotechnology hardware and associated algorithms and methodologies, methods of use, expert knowledge and information.
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