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.
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.
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.
10. Data Rights
The Parties agree that the terms in this Article 10 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 data rights, the terms of this Article 10 will govern data rights related to that SOW. To the extent there is any conflict between this Article 11 and the data rights provision contained in a SOW, the terms of the SOW shall control.
A. For purposes of this Agreement, “Study Data” is all data generated in connection with the performance of the studies under this Agreement. Study Data shall be owned by the Awardee. The U.S. Government shall have the right to use, modify, reproduce, release, perform, display, or disclose data first produced in the performance of this Agreement within the Government and otherwise for “Unlimited Rights,” as this term is defined in DFARS 252.227–7013(a)(16). The Government may, under a separate agreement or by modification to this Agreement, obtain any rights to use or disclose the Awardee’s material or data to the extent that such material or data was produced outside the scope of this Agreement.
Notwithstanding the above, as a result of this Agreement, the Government shall obtain “Unlimited rights,” as this term is defined in DFARS 252.227–7013(a)(16) specific to any Study Data generated under, and as a result of this Agreement.
B. The Awardee agrees to retain and maintain in good condition until five (5) years after completion or termination of this Agreement, all Study Data generated under this Agreement. In the event of exercise of the Government’s rights as potentially granted under paragraph 2.C, the Awardee agrees to deliver at no additional cost to the Government, all Study Data, in Awardee’s possession and developed under this Agreement, necessary to deliver the supplies identified on the particular SOW within sixty (60) calendar days from the date of the written request.
C. Marking of Data: The Awardee will mark any Study Data delivered under this Agreement with the following legend: “Use, duplication, or disclosure is subject to the restrictions as stated in Agreement No. W911QY–20–9–XXXX between the Government and the Awardee.”
Any rights that the Awardee or the Government may have in Study Data delivered under this Agreement, whether arising under this Agreement or otherwise, will not be affected by Awardee’s failure to mark data pursuant to this Article.
D. All Technical Data and Software (each term as defined under DFARS 252.227–7013) which shall be delivered under this Agreement with less than unlimited rights shall be identified with reasonable specificity and particular rights granted (Government Purpose, Limited or Restricted (all as defined in DFARS 252.227–7013)) in a data rights assertions list supplied to the Government, for review and evaluation, prior to entering into the agreement for the applicable SOW. All other Technical Data and Software developed under funding of this Agreement shall be delivered with unlimited rights as provided for within this Article.