1.24. Governmental Authority means any court, agency, department, authority or other instrumentality of any national, supra-national, state, county, city or other political subdivision.
1.25. HIPAA has the meaning set forth in the definition of Applicable Law.
1.26. Invention means any development, modification, invention, derivative work or improvement, in each case whether or not patentable, including any Know How, and whether or not protectable as Intellectual Property, which is discovered, conceived, reduced to practice or developed or otherwise made by or on behalf of either Party or any of their Representatives in the performance of a Study Plan hereunder or otherwise generated in the performance of this Agreement.
1.27. IND means an application filed with a Regulatory Authority for authorization to commence clinical trials, including (a) an Investigational New Drug Application as defined in the FFDCA or any successor application or procedure filed with the FDA, (b) any equivalent of a United States IND in other countries or regulatory jurisdictions, (e.g., clinical trial application (CTA)), and (c) all supplements, amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing.
1.28. Intellectual Property means any and all of the following rights whether protected, created or arising under Applicable Law in the United States or any other jurisdiction: ideas, inventions, conceptions, Know-How, data, compositions, results, databases, documentation, reports, materials, writings, and other information, including Patents, trade secrets, registered designs, design rights, copyrights (including rights in computer software and database rights), whether registered or not, and all legal means of establishing rights in and to and the aforesaid rights or property similar to any of the foregoing, in any part of the world, together with the rights to apply for the registration of any such right. For the avoidance of doubt, Intellectual Property for purposes of this Agreement expressly excludes all Trademark rights.
1.29. IRB/EC has the meaning set forth in Section 4.1.
1.30. Joint Patent Application has the meaning set forth in Section 11.3.
1.31. Joint Patents has the meaning set forth in Section 11.3.
1.32. Jointly Owned Invention has the meaning set forth in Section 11.3.
1.33. Know-How means any proprietary information, innovation, improvement, development, discovery, computer program, device, trade secret, method, know-how, process, technique or the like, including manufacturing, use, process, structural, operational and other data and information, whether or not written or otherwise fixed in any form or medium, regardless of the media on which contained and whether or not patentable or copyrightable, that is not generally known or otherwise in the public domain.
1.34. Liability has the meaning set forth in Section 14.1.1.
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