Federal Funding Regulations (For Subrecipients)

As of 11/16/2022

As a recipient of federal funding, GBH is required to pass on the following federal terms and conditions to Subrecipient (as defined at 2 C.F.R. 200.331), which includes entities contracted by GBH to assist in performing under a federal grant award. The following terms and conditions are incorporated into this Agreement as indicated.

II. Allowable Costs

Subrecipient shall only request reimbursement for reasonable and allowable costs that were actually incurred in performance of this Agreement.  Allowable costs will be determined by the non-profit or for-profit status of the Subrecipient as applicable under Subpart E and Appendices III–IX of 2 C.F.R. Part 200 and 48 C.F.R. Part 31.  Subrecipient shall not seek reimbursement for payment for any unallowable or unsupported costs and any such costs subsequently determined to have been paid by GBH shall be refunded to GBH promptly.  In the event that new U.S. Federally negotiated indirect rate agreement is approved during the award performance period, revised negotiated rates may be applied.

Subrecipient shall ensure that no fee or profit is charged under this Agreement or any subaward under this Agreement other than with respect to standard procurements of third-party goods and services necessary for performance of this Agreement.

II. Performance and Financial Reporting

Subrecipient shall provide GBH with any information necessary to satisfy GBH’s reporting obligations under its federal financial assistance award, and Subrecipient consents to the public disclosure of such information.  Subrecipient shall retain appropriate financial and other records relating to the Agreement for three years beyond the date of submission of the Subrecipient’s final invoice.   

 III. Performance and Expenditure Notifications; Performance and Financial Management

Subrecipient shall notify GBH within five (5) business days of becoming aware of any:

1. significant change in the scope or objective or the work performed under this Agreement;
2. need for additional funding;
3. change, absence for more than three (3) months, or reduction of time devoted to performance under this Agreement by 25 percent or more with respect to any Subrecipient personnel that have been identified as a principal investigator, project director, or other key personnel;
4. subaward not otherwise approved by GBH under this Agreement; or
5. expenditure for equipment, supplies, or travel not otherwise approved by GBH.

Subrecipient shall ensure that its financial management systems comply with Generally Accepted Accounting Principles, or a non-U.S. equivalent approved by the U.S. Government, or 2 C.F.R. § 200.302–03.  In addition, Subrecipient shall establish internal controls consistent with the requirements of 2 C.F.R. § 200.303.

IV. Property and Procurement

Subrecipient shall ensure that its property management system complies with the requirements specified in 2 C.F.R. §§ 200.310–.316.  Subrecipient shall not acquire equipment or real property in the performance of this Agreement without the prior written consent of GBH.  Title and use and disposable requirements applicable to property acquired under and provided for use in performance of this Agreement will be determined by 2 C.F.R. §§ 200.310–.316.

In awarding any procurement subcontracts under this Agreement, Subrecipient will comply with the procurement standards described at 2 C.F.R. §§ 200.317-.327.

V. Site Visits and Monitoring

Subrecipient shall permit GBH to periodically monitor and audit Subrecipient’s performance under this Agreement, including by making facilities, documents, and employees reasonably available for examination or interview during Subrecipient’s normal hours of operation.

The relevant funding agency, the Comptroller General of the United States and GBH, through authorized representatives, have the right, at all reasonable times, to make site visits to review project accomplishments and management control systems and to provide such technical assistance as may be required.  If any site visit is made by any federal or GBH representative, Subrecipient shall provide, and shall require its subrecipients to provide, all reasonable facilities and assistance for the safety and convenience of the federal or GBH representatives in the performance of their duties. All site visits and evaluations shall be performed in such a manner that will not unduly delay the work.

 VI. Government Rights in Inventions

[All references to “grantee” and “contractor” shall be deemed to refer to “Subrecipient”]

a. Definitions

1. Invention means any invention or discovery which is or may be patentable or otherwise protectable under Title 35 of the USC, to any novel variety of plant which is or may be protected under the Plant Variety Protection Act (7 USC § 2321 et seq.)
2. Subject Invention means any invention of the grantee conceived or first actually reduced to practice in the performance of work under this grant, provided that in the case of a variety of plant, the date of determination (as defined in section 41(d)) must also occur during the period of performance.
3. Practical Application means to manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and, in each case, under such conditions as to establish that the invention is being utilized and that its benefits are to the extent permitted by law or Government regulations available to the public on reasonable terms.
4. Made when used in relation to any invention means the conception or first actual reduction to practice of such invention.
5. Small Business Firm means a small business concern as defined at section 2 of Public Law 85-536 (15 USC §632) and implementing regulations of the Administrator of the Small Business Administration. For the purpose of this article, the size standards for small business concerns involved in government procurement and subcontracting at 13 CFR § 121.3-8 and 13 CFR § 121.3-12, respectively, will be used.
6. Non-profit Organization means a domestic university or other institution of higher education or an organization of the type described in Section 501(c)(3) of the Internal Revenue Code of 1954 (26 USC §501(c)) and exempt from taxation under Section 501(a) of the Internal Revenue Code (26 USC §501(a)) or any domestic non-profit scientific or educational organization qualified under a State non-profit organization statute.
7. Statutory Period means the one-year period before the effective filing date of a claimed invention during which exceptions to prior art exist per 35 USC §102(b) as amended by the Leahy-Smith America Invents Act, Public Law 112-29.
8. Contractor means any person, small business firm or nonprofit organization, or, as set forth in section 1, paragraph (b)(4) of Executive Order 12591, as amended, any business firm regardless of size, which is a party to a funding agreement.

b. Allocation of Principal Rights. The grantee may retain the entire right, title and interest throughout the world to each subject invention subject to the provisions of this Intangible Property article and 35 USC § 203. With respect to any subject invention in which the grantee retains title, the Federal Government shall have a non-exclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the U.S. the subject invention throughout the world. If the grant indicates it is subject to an identified international agreement or treaty, the relevant federal funding agency also has the right to direct the grantee to convey to any foreign participant such patent rights to subject inventions as are required to comply with that agreement or treaty.

c. Invention Disclosure, Election of Title and Filing of Patent Applications by Grantee

1. The grantee will disclose each subject invention to the relevant federal funding agency within two months after the inventor discloses it in writing to grantee personnel responsible for the administration of patent matters. The disclosure to the relevant federal funding agency shall be in the form of a written report and shall identify the grant under which the invention was made and the inventor(s). It shall be sufficiently complete in technical detail to convey a clear understanding of the nature, purpose, operation and, to the extent known, the physical, chemical, biological or electrical characteristics of the invention. The disclosure shall also identify any publication, on sale or public use of the invention and whether a manuscript describing the invention has been submitted for publication and, if so, whether it has been accepted for publication at the time of disclosure. In addition, after disclosure to the relevant federal funding agency, the grantee will promptly notify the relevant federal funding agency of the acceptance of any manuscript describing the invention for publication or of any on sale or public use planned by the grantee.
2. The grantee will elect in writing whether or not to retain title to any such invention by notifying the relevant federal funding agency within two years of disclosure to the relevant federal funding agency. However, in any case where a patent, a printed publication, public use, sale or other availability to the public has initiated the one-year statutory period wherein valid patent protection can still be obtained in the U.S., the period for election of title may be shortened by the relevant federal funding agency to a date that is no more than 60 days prior to the end of the statutory period.
3. The grantee will file its initial patent application on an invention to which it elects to retain title within one year after election of title or, if earlier, prior to the end of any statutory period wherein valid patent protection can be obtained in the U.S. after a publication, on sale, or public use. If the grantee files a provisional application as its initial patent application, it shall file a non-provisional application within 10 months of the filing of the provisional application. The grantee will file patent applications in additional countries or international patent offices within either ten months of the first filed patent application, or six months from the date when permission is granted by the Commissioner of Patents to file foreign patent applications when such filing has been prohibited by a Secrecy Order.
4. For any subject invention with the relevant federal funding agency and grantee co-inventors, where the relevant federal funding agency determines that it would be in the interest of the government, pursuant to 35 USC § 207(a)(3), to file an initial patent application on the subject invention, the relevant federal funding agency, at its discretion and in consultation with the grantee, may file such application at its own expense, provided that the grantee retains the ability to elect title pursuant to 35 U.S.C. 202(a).
5. Requests for extension of the time for disclosure to the relevant federal funding agency, election and filing under subparagraphs 1., 2. and 3 may, at the discretion of the relevant federal funding agency, be awarded. When a grantee has requested an extension for filing a non-provisional application after filing a provisional application, a one-year extension will be granted unless the relevant federal funding agency notifies the contractor within 60 days of receiving the request.

d. Conditions When the Government May Obtain Title. The grantee will convey to the relevant federal funding agency, upon written request, title to any subject invention:

1. if the grantee fails to disclose or elect the subject invention within the times specified in paragraph c. above, or elects not to retain title;
2. in those countries in which the grantee fails to file patent applications within the times specified in paragraph c. above, provided, however, that if the grantee has filed a patent application in a country after the times specified in paragraph c. of this article, but prior to its receipt of the written request of the relevant federal funding agency, the grantee shall continue to retain title in that country; or
3. in any country in which the grantee decides not to continue the prosecution of any non-provisional patent application for, to pay a maintenance, annuity or renewal fee on, or defend in a reexamination or opposition proceeding on, a patent on a subject invention.

e. Minimum Rights to Grantee

1. The grantee will retain a non-exclusive royalty-free license throughout the world in each subject invention to which the Government obtains title, except if the grantee fails to disclose the subject invention within the times specified in paragraph c. above. The grantee’s license extends to its domestic subsidiaries and affiliates, if any, within the corporate structure of which the grantee is a party and includes the right to award sublicenses of the same scope to the extent the grantee was legally obligated to do so at the time the award was made. The license is transferable only with the approval of the relevant federal funding agency except when transferred to the successor of that part of the grantee’s business to which the invention pertains.
2. The grantee’s domestic license may be revoked or modified by the relevant federal funding agency to the extent necessary to achieve expeditious practical application of the subject invention pursuant to an application for an exclusive license submitted in accordance with applicable provisions at 37 CFR Part 404. This license will not be revoked in that field of use or the geographical areas in which the grantee has achieved practical application and continues to make the benefits of the invention reasonably accessible to the public. The license in any foreign country may be revoked or modified at discretion of the relevant federal funding agency to the extent the grantee, its licensees or its domestic subsidiaries or affiliates have failed to achieve practical application in that foreign country.
3. Before revocation or modification of the license, the relevant federal funding agency will furnish the grantee a written notice of its intention to revoke or modify the license, and the grantee will be allowed 30 days (or such other time as may be authorized by the relevant federal funding agency for good cause shown by the grantee) after the notice to show cause why the license should not be revoked or modified. The grantee has the right to appeal, in accordance with applicable regulations in 37 CFR Part 404 concerning the licensing of Government-owned inventions, any decision concerning the revocation or modification of its license.

f. Grantee Action to Protect Government’s Interest

1. The grantee agrees to execute or to have executed and promptly deliver to the relevant federal funding agency all instruments necessary to: (i) establish or confirm the rights the Government has throughout the world in those subject inventions for which the grantee retains title; and (ii) convey title to the relevant federal funding agency when requested under paragraph d. above, and to enable the Government to obtain patent protection throughout the world in that subject invention.
2. The grantee agrees to require, by written agreement, its employees, other than clerical and non-technical employees, to disclose promptly in writing to personnel identified as responsible for the administration of patent matters and in a format suggested by the grantee each subject invention made under this grant in order that the grantee can comply with the disclosure provisions of paragraph c. above, to assign to the grantee the entire right, title and interest in and to each subject invention made under the grant, and to execute all papers necessary to file patent applications on subject inventions and to establish the Government’s rights in the subject inventions. The disclosure format should require, as a minimum, the information requested by paragraph c.1 above. The grantee shall instruct such employees through the employee agreements or other suitable educational programs on the importance of reporting inventions in sufficient time to permit the filing of patent applications prior to U.S. or foreign statutory bars.
3. For each subject invention, the grantee will no less than 60 days prior to the expiration of the statutory deadline, notify the relevant federal funding agency of any decision: not to continue the prosecution of a non-provisional patent application; not to pay a maintenance, annuity or renewal fee; not to defend in a reexamination or opposition proceeding on a patent, in any country; to request, be a party to, or take action in a trial proceeding before the Patent Trial and Appeals Board of the U.S. Patent and Trademark Office, including but not limited to post-grant review, review of a business method patent, inter partes review, and derivation proceeding; or to request, be a party to, or take action in a non-trial submission of art or information at the U.S. Patent and Trademark Office, including but not limited to a pre-issuance submission, a post-issuance submission, and supplemental.
4. The grantee agrees to include, within the specification of any U.S. patent application and any patent issuing thereon covering a subject invention, the following statement: “This invention was made with Government support under (identify the grant number) awarded by the [the relevant federal funding agency]. The Government has certain rights in this invention.”
5. The grantee or its representative will complete, execute and forward to the relevant federal funding agency a confirmation of a License to the U.S. Government and the page of a United States patent application that contains the Federal support article within two months of filing any domestic or foreign patent application.

g. Subawards

1. The grantee will include this Intangible Property article, suitably modified to identify the parties, in all subawards, regardless of tier, for experimental, developmental or research work. The subawardee will retain all rights provided for the grantee in this Intangible Property article, and the grantee will not, as part of the consideration for awarding the subaward, obtain rights in the subawardees’ subject inventions.
2. In the case of subawards, at any tier, when the prime award by the relevant federal funding agency was a contract (but not a cooperative agreement), the relevant federal funding agency, subawardee and contractor agree that the mutual obligations of the parties created by this Intangible Property article constitute a contract between the subawardee and the relevant federal funding agency with respect to those matters covered by this Intangible Property article.

h. Reporting on Utilization of Subject Inventions. Upon request, the grantee agrees to submit on request periodic reports no more frequently than annually on the utilization of a subject invention or on efforts at obtaining such utilization that are being made by the grantee or its licensees or assignees. Such reports shall include information regarding the status of development, date of first commercial sale or use, gross royalties received by the grantee and such other data and information as the relevant federal funding agency may reasonably specify. The grantee also agrees to provide additional reports in connection with any march-in proceeding undertaken by the relevant federal funding agency in accordance with paragraph j. of this Intangible Property article. As required by 35 USC § 202(c)(5), the relevant federal funding agency agrees it will not disclose such information to persons outside the Government without the permission of the grantee.

i. Preference for United States Industry. Notwithstanding any other provision of this Intangible Property article, the grantee agrees that neither it nor any assignee will grant to any person the exclusive right to use or sell any subject invention in the U.S. unless such person agrees that any products embodying the subject invention or produced through the use of the subject invention will be manufactured substantially in the U.S. However, in individual cases, the requirement for such an agreement may be waived by the relevant federal funding agency upon a showing by the grantee or its assignee that reasonable but unsuccessful efforts have been made to award licenses on similar terms to potential licensees that would be likely to manufacture substantially in the U.S. or that under the circumstances domestic manufacture is not commercially feasible.

j. March-in Rights. The grantee agrees that with respect to any subject invention in which it has acquired title, the relevant federal funding agency has the right to require the grantee, an assignee or exclusive licensee of a subject invention to grant a non-exclusive, partially exclusive or exclusive license in any field of use to a responsible applicant or applicants, upon terms that are reasonable under the circumstances and if the grantee, assignee or exclusive licensee refuses such a request, the relevant federal funding agency has the right to grant such a license itself if the relevant federal funding agency determines that such action is necessary:

1. because the grantee or assignee has not taken or is not expected to take within a reasonable time, effective steps to achieve practical application of the subject invention in such field of use;
2. to alleviate health or safety needs which are not reasonably satisfied by the grantee, assignee, or their licensees;
3. to meet requirements for public use specified by Federal regulations and such requirements are not reasonably satisfied by the grantee, assignee, or licensee; or
4. because the agreement required by paragraph l. of this Intangible Property article has not been obtained or waived or because a licensee of the exclusive right to use or sell any subject invention in the U.S. is in breach of such agreement.

k. Special Provisions for Grants with Non-profit Organizations. If the grantee is a non-profit organization, it agrees that:

1. rights to a subject invention in the U.S. may not be assigned without the approval of the relevant federal funding agency, except where such assignment is made to an organization which has as one of its primary functions the management of inventions, provided that such assignee will be subject to the same provisions as the grantee;
2. the grantee will share royalties collected on a subject invention with the inventor, including Federal employee co-inventors (when the relevant federal funding agency deems it appropriate) when the subject invention is assigned in accordance with 35 USC § 202(e) and 37 CFR § 401.10;
3. the balance of any royalties or income earned by the grantee with respect to subject inventions, after payment of expenses (including payments to inventors) incidental to the administration of subject inventions, will be utilized for the support of scientific or engineering research or education; and
4. it will make efforts that are reasonable under the circumstances to attract licensees of subject inventions that are small business firms and that it will give preference to a small business firm if the grantee determines that the small business firm has a plan or proposal for marketing the invention which, if executed, is equally likely to bring the invention to practical application as any plans or proposals from applicants that are not small business firms; provided that the grantee is also satisfied that the small business firm has the capability and resources to carry out its plan or proposal.
5. The decision whether to give a preference in any specific case will be at the discretion of the grantee. However, the grantee agrees that the relevant federal funding agency may review the grantee’s licensing program and decisions regarding small business applicants, and the grantee will negotiate changes to its licensing policies, procedures or practices with the relevant federal funding agency when the relevant federal funding agency’s review discloses that the grantee could take reasonable steps to implement more effectively the requirements of this paragraph k.4. In accordance with 37 CFR § 401.7, the relevant federal funding agency or the grantee may request that the federal funding agency review the grantee’s licensing program and decisions regarding small business applicants.

l. All communications required by this Intangible Property article must be submitted through the iEdison Invention Information Management System maintained by the National Institutes of Health unless prior permission for another form of submission is obtained.

VII. Copyright Ownership, and Government License

Subrecipient agrees that if it or anyone else does own copyright in (1) any material that is or may be copyrightable and (2) is produced by Subrecipient or its employees in the performance of work under this Agreement, the Federal government will have a nonexclusive, nontransferable, irrevocable, royalty-free

license to exercise or have exercised for or on behalf of the U.S. throughout the world all the exclusive rights provided by copyright.  Such license, however, will not include the right to sell copies or phonorecords of the copyrighted works to the public.

VIII. Reporting of Matters Related to Recipient Integrity and Performance

As required by Appendix XII to 2 C.F.R. Part 200, Subrecipient will maintain the currency of information reported to the System for Award Management (“SAM”) that is made available in the designated integrity and performance system (currently the Federal Awardee Performance and Integrity Information System (“FAPIIS”)) regarding relevant civil, criminal, or administrative proceedings in connection with the award or performance of a grant, cooperative agreement, or procurement contract from the Federal Government for the most recent five year period.

IX. Research Misconduct

Subrecipient will comply with the research misconduct regulations in 45 C.F.R. Part 689, and will notify GBH of any allegation of research misconduct that it concludes has substance and requires an investigation.

X. Information Collection

Subrecipient shall not represent to respondents of any survey or questionnaire that such information is being collected for or in association with any Government agency without the specific written approval of such information collection plan or device by the relevant Government agency.

XI. Domestic Sourcing

Subrecipient may be subject to the Buy America Sourcing requirements under the Build America, Buy America provisions of the Infrastructure Investment and Jobs Act (IIJA) (P.L. 117-58, §§ 70911-70917) if using Agreement funds for any form of construction, alteration, maintenance, or repair of infrastructure in the United States.  These sourcing requirements require that all iron, steel, manufactured products, and construction materials used in Federally funded infrastructure projects must be produced in the United States. If applicable, Subrecipient will comply with the IIJA and relevant implementing regulations.

XII. Personally Identifiable Information

If Subrecipient uses or operates a Federal information system or creates, collects, uses, processes, stores, maintains, disseminates, discloses, or disposes of Personally Identifiable Information (PII) within the scope of the Award, Subrecipient must have procedures in place to respond to a breach of PII. Subrecipient must notify GBH upon learning that a breach of PII within the scope of the Agreement has occurred within 24 hours.