body, branch, bureau, commission, council, department, entity, governmental division, instrumentality, office, officer, official, organization, representative, subdivision, unit, and any court or other tribunal); (c) multinational governmental organization or body; or (d) entity or body exercising, or entitled to exercise, any executive, legislative, judicial, administrative, regulatory, police, military, or taxing authority or power of any nature.
1.53 “IFRS” is defined in Section 1.1 (Accounting Standards).
1.54 “IND” means an investigational new drug application (including any amendment or supplement thereto) submitted to the FDA pursuant to U.S. 21 C.F.R. Part 312, including any amendments thereto. References herein to IND shall include, to the extent applicable, any comparable filing(s) outside the U.S. for the investigation of any product in any other country or group of countries (such as a Clinical Trial Application in the EU).
1.55 “Indemnification Claim Notice” is defined in Section 11.3.1 (Procedure).
1.56 “Indemnitee” is defined in Section 11.3 (Procedure).
1.57 “Indemnitor” is defined in Section 11.3 (Procedure).
1.58 “Indication” means a specific disease or medical condition in humans. For purposes of determining whether an Indication for a Licensed Product is distinct from another Indication, an Indication (“New Indication”) is distinct from an existing Indication (“Existing Indication”) if the Licensed Product could not be lawfully promoted for the treatment of the New Indication under the Regulatory Approval for the Existing Indication.
1.59 “Initiation” means, with respect to a Clinical Trial, the dosing of the first patient with the Licensed Product (or placebo) in such Clinical Trial.
1.60 “Invention” means any process, invention, method, composition of matter, article of manufacture, discovery, or finding that is conceived or reduced to practice.
1.61 “Joint IP” is defined in Section 8.1 (Ownership of Inventions).
1.62 “JRC” is defined in Section 3.6.1 (JRC Membership).
1.63 “JRC Chair” is defined in Section 3.6.1 (JRC Membership).
1.64 “Know-How” means technical, scientific and other data, know-how and information, including trade secrets, specifications, biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols, assays and biological methodology, in each case (whether or not confidential, proprietary, patented or patentable) in written, electronic or any other form.
1.65 “Licensed Know-How” means the proprietary Know-How (including clinical data, chemical structures, manufacturing methods and data, materials and Regulatory Materials (including all data set forth therein)) described on Exhibit B that is owned or Controlled by Plexxikon as of the Effective Date or during the Term.
1.66 “Licensed IP” means the Licensed Patents and the Licensed Know-How, including all Derivative Molecule IP.
1.67 “Licensed Molecules” means the Plexxikon Molecules and the Derivative Molecules.
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