9. Intellectual Property Rights
The Parties agree that the terms in this Article apply generally to this Agreement, and that the terms may be modified in any SOW issued under this Agreement by mutual agreement of the Parties. If a SOW does not address intellectual property rights, the terms of this Article will govern intellectual property rights related to that SOW. To the extent there is any conflict between this Article and the intellectual property rights provision contained in a SOW, the terms of the SOW shall control.
A. Background Intellectual Property and Materials. The Awardee and the Government each retain any intellectual property (IP) rights to their own materials, data, technology, information, documents, or know-how—or potential rights, such as issued patents, patent applications, invention disclosures, or other written documentation—that exist prior to execution of this Agreement or are developed outside the scope of this Agreement (“Background IP“). Additionally, no party to this Agreement will enter into an agreement with any manufacturer or other third party whereby the third party will obtain rights in Agreement Inventions or Study Data, as those terms are defined in this Agreement, absent the mutual consent of the parties to the awarded contract.
B.Definitions. For purposes of this agreement, an “Agreement Invention” is any invention, regardless of whether it is not patentable, or is patentable under U.S. patent law that is conceived or first reduced to practice under this Agreement.
C. Awardee’s Background IP. Prior to the issuance of any SOW, Awardee shall disclose Background IP which contain claims that are related to research contemplated under the SOW, and shall provide identifying information to the Government. No license(s) to any patent applications, issued patents, or Background IP shall be granted under this Agreement, and are specifically excluded from the definitions of “Agreement Invention” contained in this Agreement.
D. Patent indemnity. The Awardee shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of this Agreement, provided the Awardee is notified of such claims and proceedings as soon as practicable by the Government of the suit or action alleging such infringement and shall have been given such opportunity as is afforded by applicable laws, rules, or regulations to participate in its defense. Further, this
indemnity shall not apply to:
An infringement resulting from compliance with specific written instructions of the AO directing a change in the supplies to be delivered or in the materials or equipment to be used, or directing a manner of performance of the contract not normally used by theContractor;
An infringement resulting from addition to or change in supplies or components furnished subsequent to delivery or performance; or
A claimed infringement that is unreasonably settled without the consent of the Contractor, unless required by final decree of a court of competent jurisdiction.
E. Patent Prosecution. Awardee agrees to take responsibility for the preparation, filing, prosecution, and maintenance of any and all patents and patent applications listed as Awardee Background IP that are relevant to work performed under this Agreement. Awardee shall keep the Government reasonably advised on the status of Awardee Background IP by providing an annual report on the status of Awardee Background IP. Prior to acting on a decision by Awardee to abandon or not file in any country a patent or patent application covering an Agreement Invention, which is defined below, Awardee shall so inform the Government in a timely manner to allow Awardee to thoughtfully consider the Government’s comments regarding such a proposed decision. Nothing in this Article 10 shall restrict the Government in its preparation, filing, prosecution and maintenance of a patent or patent application covering an Agreement Invention.
F. Patent Enforcement. Awardee will have the first option to enforce any patent rights covering an Agreement Invention owned jointly by the Parties or solely by Awardee, at Awardee’s expense. If Awardee chooses not to exercise this option, the Government may enforce patent rights covering a joint Agreement Invention only with Awardee’s prior written approval.
G. Ownership. Ownership of any invention, regardless of whether it is not patentable, or is patentable under U.S. patent law that is conceived or first reduced to practice under this Agreement (Agreement Invention) will follow inventorship in accordance with U.S. patent law. The Bayh-Dole Act, 35 U.S.C. §§ 200-212 does not apply to this Agreement and, as such, title to Agreement Inventions will accrue to the inventor or inventor-organization. The Parties represent and warrant that each inventor will assign his or her rights in any such inventions to his or her employing organization. If either an Awardee employee or a Government employee makes a sole Agreement Invention, the entire rights to that Agreement Invention will be respectively assigned to the Awardee or the Government. If an Awardee employee and a Government employee jointly make an Agreement Invention, it will be owned jointly by the Awardee and the Government. Ownership of Agreement Inventions made in whole or in part with subawardee employees, including employees of other components of the Government, will be determined solely pursuant to an agreement between the Awardee and the applicable subawardee.
H. Patent Applications. The Parties will respectively have the option to file a patent application claiming any Agreement Invention made solely by their respective employees. The Parties will consult with each other regarding the options for filing a patent application claiming a joint Agreement Invention. Within thirty (30) calendar days of being notified of the discovery of an Agreement Invention or filing a patent application covering an Agreement Invention, each Party will provide notice of such discovery or filing to the other Party. The Parties will reasonably cooperate with each other in the preparation, filing, and prosecution of any patent application claiming an Agreement Invention. Any Party filing a patent application will bear expenses associated with filing and prosecuting the application, as well as maintaining any patents that issue from the application, unless otherwise agreed by the Parties.
I. Licenses. For each Agreement Invention made solely by the Awardee, the Government will receive a non-exclusive, worldwide, transferable, paid-up, royalty-free, irrevocable license to practice the invention and the right to sublicense same to third parties to practice the invention for any Government purpose, including but not limited to continuing research and development related to the Agreement Invention, and eventual regulatory approval and commercialization thereof. The Government will receive a right of first refusal for an exclusive license to the Agreement Invention, subject to no less than a [redacted content] royalty rate based on gross royalty revenue received by the Government. For any Agreement Invention made solely by the Government, the Awardee will receive a non-exclusive, worldwide, transferable, paid-up, royalty-free, irrevocable license to practice the Agreement Invention or allow a third party to practice the invention for any purpose. The Awardee will receive a right of first refusal for an exclusive license to the Agreement Invention for purposes of FDA licensure of the technology described herein for the indication described herein, subject to termination terms substantially similar to the events described in Section 11(e) below [Editor’s Note: The section reference to Section 11(e) may not be correct.]
J. Awardee shall report any Agreement Inventions to the Government within 60 days of the time it was conceived or first reduced to practice under this Agreement. Executive Order No. 9424 of 18 February 1944 requires all executive Departments and agencies of the Government to forward through appropriate channels to the Commissioner of Patents and Trademarks, for recording, all Government interests in patents or applications for patents.