Inventions, Discoveries and Patents. 8.1. It is recognized and understood that certain existing inventions and technologies, and those arising outside of the research conducted under this Agreement, are the separate property of Company or Institution and are not affected by this Agreement, and neither Company nor Institution shall have any claims to or rights in such separate inventions and technologies. 8.2. Title to any new inventions, developments, or discoveries arising during and in the course of the performance of the Study under this Agreement (“Inventions”) that are made solely by Institution personnel ("Institution Inventions") shall be in Institution, in accordance with U.S. Patent Law, Title 35 United States Code, and shall be promptly disclosed in writing to Company. Inventorship shall be determined in accordance with U.S. Patent Law or by mutual agreement if the invention is not patentable. Title to any Inventions made solely by Company personnel ("Company Inventions") shall be in Company, in accordance with U.S. Patent Law, Title 35 United States Code or by mutual agreement if the invention is not patentable. Each Invention conceived, made or reduced to practice jointly by employees of both Institution and Company shall be jointly owned (“Joint Invention”). Inventorship shall be determined in accordance with U.S. Patent Law or by mutual agreement if the invention is not patentable. Institution’s obligations under Section 8 shall be performed by institution’s appropriate office with technology transfer responsibilities, if required by and in accordance with its respective policies. 8.3. Company shall have an option to negotiate an exclusive, subject to any third party rights, worldwide, royalty-bearing license to Institution's rights to any Institution or Joint Invention, which option shall extend for ninety (90) days after Company's receipt of an invention disclosure. Upon Company's exercise of the option, the parties shall promptly negotiate a license agreement in good faith. If, after one hundred twenty (120) days from Company's receipt of an invention disclosure, Company and Institution are unable to execute a license pursuant to the option, then Institution is free to license its rights to said Institution or Joint Invention to a third party, and Institution shall have no further obligations to Company under such Institution or Joint Invention. 8.4. Nothing contained in this Agreement shall be deemed to grant either directly by implication, estoppel, or otherwise any license under any patents, patent applications, or other proprietary interest to any other inventions, discovery or improvement of either Party. 8.5. The Parties agree that the provisions of this Agreement are intended to be interpreted and implemented so as to comply with all applicable federal laws, rules, and regulations, including without limitation the requirements of Rev. Proc. 2007-47; provided, however, if it is determined by the Internal Revenue Service or any other federal agency or instrumentality (the "Government") that the provisions of this Agreement are not in such compliance, then the Parties agree to modify the provisions and the implementation of this Agreement so as to be in compliance with all applicable federal laws, rules, and regulations as determined by the Government.
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Sources: Investigator Initiated Clinical Study Agreement, Clinical Trial Agreement