Cost Reimbursable Agreements - Agency General Terms and Conditions

  1. Conditional
    1. Outside U.S. Activities
      1. International Air Travel and Transportation
      2. International Travel and the Fly America Act
      3. Investment Promotion
      4. Nondiscrimination in International Programs
      5.  Procurement of Goods and Services Outside the United States
      6.  Regulations Governing Employees
      7.  Security Issues
    2. Research and Related Assurances
      1. Agriculture Bioterrorism Protection Act
      2.  Animal Welfare Act
      3.  Copyrighting
      4.  Invention Disclosure and Utilization Reporting
      5.  Metric System Of Measurement
      6.  Patent Rights
      7.  Protection of Human Subjects
      8. Recombinant DNA Research
      9. Research Misconduct

Provision Title

Agency GT&C Provisions – Conditional

Outside U.S. Activities

CR Instructions

International Air Travel and Transportation

(a) In accordance with OMB Cost Principles, direct charges for foreign travel costs are allowable only when each foreign trip has received prior budget approval by the PM. Such approval will be deemed to have been met when:

(1) The trip is identified. Identification is accomplished by providing the following information: the number of trips, the number of individuals per trip, and the destination country(s);

(2) The information noted at (1) above is incorporated in: the Cooperator’s project narrative, or mutually agreed amendments to this Agreement; and

(3) The costs related to the travel are incorporated in the Cooperator’s revised budget, or in a subsequently approved budget to this Agreement.

(b) Post award approval may be allowed, but only if the Grants Management Officer approves the travel, in writing.

Applies to CRs that take place outside the U.S.

International Travel and the Fly America Act

The Fly America Act (49 U.S.C. 40118) requires that all air travel and shipments under this Agreement must be made on U.S. flag air carriers to the extent service by such carriers is available or reasonably available, as applicable. The Administrator of the General Services Administration (GSA) is authorized to issue regulations to implement the Act. Those regulations may be found at 41 CFR Part 301, and are hereby incorporated by reference into this Agreement.

Applies to CRs that take place outside the U.S.

Investment Promotion

(a) No funds or other support provided hereunder may be used in a project or activity reasonably likely to involve the relocation or expansion outside of the United States of an enterprise located in the United States if non-U.S. production in such relocation or expansion replaces some or all of the production of, and reduces the number of employees at, said enterprise in the United States.

(b) No funds or other support provided hereunder may be used in a project or activity the purpose of which is the establishment or development in a foreign country of any export processing zone or designated area where the labor, environmental, tax, tariff, and safety laws of the country would not apply, without the prior written approval of FAS.

Applies to CRs that take place outside the U.S.

Nondiscrimination in International Programs

No U.S. citizen or legal resident shall be excluded from participation in, be denied the benefits of, or be otherwise subjected to discrimination under any program or activity funded by this Agreement on the basis of race, color, national origin, age, handicap, or sex.

Applies to CRs that take place outside the U.S.

Procurement of Goods and Services Outside the United States

2. When the project under this Agreement takes place outside the United States, then the following apply:

(a) Authorized Source Requirement: The authorized sources for the procurement of goods and services are the United States, the District of Columbia, and areas of U.S.-associated sovereignty, including commonwealths, territories and possessions.

(b) Eligibility Rules for Goods and Services Requirement:

i. Ineligible and Restricted Goods and Services:

(i) Ineligible Goods and Services. Under no circumstances shall the Cooperator procure any of the following under this Agreement:

(A) Military equipment,

(B) Surveillance equipment,

(C) Commodities and services for support of police or other law enforcement activities,

(D) Abortion equipment and services,

(E) Luxury goods and gambling equipment, or

(F) Weather modification equipment.

(ii) Ineligible Suppliers. Funds provided under this Agreement shall not be used to procure any goods or services furnished by any firms or individuals whose name appears on the "Lists of Parties Excluded from Federal Procurement and Nonprocurement Programs." See, www.epls.gov.

(iii) Restricted Goods. The Cooperator shall not procure any of the following goods and services without the prior approval of the Grants Management Officer:

(A) Agricultural commodities,

(B) Motor vehicles,

(C) Pharmaceuticals,

(D) Pesticides,

(E) Used equipment,

(F) U.S. Government-owned excess property, or

(G) Fertilizer,

(iv) Restricted Goods Exceptions. Prior approval will be deemed to have been met when:

(A) The item is of U.S. source/origin;

(B) The item has been identified and incorporated in the program description or schedule of the Agreement (initial or revisions), or modifications to the Agreement; and

(C) The costs related to the item are incorporated in the approved budget of the Agreement. Where the item has not been incorporated into the Agreement as described above, a separate written authorization from the Grants Management Officer must be provided before the item is procured.

ii. Source and Nationality. When the total procurement element exceeds $250,000, the following applies: Except as may be specifically approved or directed in advance by the Grants Management Officer, all goods and services financed with U.S. dollars, which will be reimbursed under the Agreement must meet the source and origin specified in the Agreement.

iii. Printed or Audio-Visual Teaching Materials: If the effective use of printed or audio-visual teaching materials depends upon their being in the local language and if such materials are intended for technical assistance projects or activities financed by FAS in whole or in part and if other funds including U.S.-owned or U.S.-controlled local currencies are not readily available to finance the procurement of such materials, local language versions may be procured from the following sources, in order of preference:

(i) The United States,

(ii) The Cooperating Country.

iv. If FAS determines that the Cooperator has procured any of these goods or services under this Agreement contrary to these requirements, and has received payment for such purposes, the Grants Management Officer may require the Cooperator to refund the entire amount of the purchase. This requirement must be included in all subagreements which include procurement of goods or services which total over $5,000.

(c) Local Procurement Requirement:

i. Financing local procurement involves the use of funds provided under this Agreement to finance the procurement of goods and services supplied by local businesses, dealers or producers, with payment normally being in the local country currency.

ii. The Cooperator shall not finance local procurement for any goods and services unless such procurement is covered by the source and origin requirement or when one of the following exceptions applies:

(i) Locally available commodities of U.S. origin, which are otherwise eligible for financing, if the value of the transaction is estimated not to exceed $100,000 exclusive of transportation costs.

(ii) Commodities of any country origin, except foreign policy restricted countries, if the value of the transaction does not exceed the local currency equivalent of $5,000.

(iii) Professional Services Contracts estimated not to exceed $250,000.

(iv) Construction Services Contracts estimated not to exceed $5,000,000.

(v) Commodities and services available only in the local economy (no specific per transaction value applies to this category). This category includes the following items:

(A) Utilities including fuel for heating and cooking waste disposal and trash collection;

(B) Communications - telephone, telex, fax, postal and courier services;

(C) Rental costs for housing and office space;

(D) Petroleum, oils and lubricants for operating vehicles and equipment;

(E) Newspapers, periodicals and books published locally;

(F) Other commodities and services and related expenses that, by their nature or as a practical matter, can only be acquired, performed, or incurred locally, e.g., vehicle maintenance, hotel accommodations, etc. Any waiver must be approved and processed by the Grants Management Officer before the Cooperator finances such local procurement. All subagreements where local procurement of goods or services is a supported element must include this requirement.

Applies to CRs that take place outside the U.S. and procurement of goods and/or services are anticipated.

Regulations Governing Employees

(a) The Cooperator’s employees shall maintain private status and may not rely on local U.S. Government offices or facilities for support while under this Agreement.

(b) The Cooperator's employees, while in a foreign country, are expected to show respect for its conventions, customs, and institutions, to abide by its applicable laws and regulations, and not to interfere in its internal political affairs.

(c) In the event the conduct of any of the Cooperator’s employees is not in accordance with the preceding paragraphs, the Cooperator's chief of party shall consult with the employee involved and the FAS Program Manager shall recommend to the Cooperator a course of action with regard to such employee.

(d) The parties recognize the rights of the U.S. Ambassador to direct the removal from a country of any U.S. citizen or the discharge from this Agreement of any third country national when, in the discretion of the Ambassador, the interests of the United States so require.

(e) If it is determined, either under (c) or (d) above, that the services of such employee should be terminated, the Cooperator shall use its best efforts to cause the return of such employee to the United States, or point of origin, as appropriate.

Applies to CRs that take place outside the U.S.

Security Issues

(a) The Cooperator is encouraged to obtain the latest Department of State Travel Advisory Notices before traveling. These Notices are available to the general public and may be obtained directly from the State Department or via Internet. Where security is a concern in a specific region, Cooperators may choose to notify the US Embassy of their presence when they have entered the country. This may be especially important for long-term posting.

(b) If security issues are affecting the Cooperator’s ability to meet timelines and/or to substantially accomplish the goals and objectives established under this Agreement, then the Cooperator must contact FAS immediately.

Applies to CRs that take place outside the U.S.

Provision Title

Agency GT&C Provisions – Conditional

Research and Related Assurances

CR Instructions

Agriculture Bioterrorism Protection Act

The Cooperator assures compliance with the Agriculture Bioterrorism Protection Act of 2002, as implemented at 7 CFR part 331 and 9 CFR part 121, by agreeing that it will not possess, use, or transfer any select agent or toxin without a certificate of registration issued by the Agency.

Applies to all CRs.

Animal Welfare Act

The Cooperator assures compliance with the Animal Welfare Act, as amended, 7 U.S.C. 2131, et seq., and the regulations promulgated there under by the Secretary of Agriculture (9 CFR, Subchapter A) pertaining to the care, handling, and treatment of warm-blooded animals held or used for research, teaching, or other activities supported by Federal funds. The Cooperator may request registration of facilities and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the Region in which their facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this requirement, may be obtained by contacting the Senior Staff Officer, Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737.

Applies to all CRs when research, teaching, or other activities are anticipated.

Copyrighting

(a) The Cooperator may copyright any work that is subject to copyright and was developed, by the Cooperator, or jointly by the Federal Government and the Cooperator, or for which ownership was purchased, under this Agreement. FAS reserves a royalty-free, nonexclusive and irrevocable right to reproduce, publish, or otherwise use the work for Federal purposes, and to authorize others to do so for Federal purposes. The Cooperator may not copyright text, photographs, or materials created by FAS or other USG employees on Government time and/or composed on Government equipment.

(b) Cooperators are subject to applicable regulations governing patents and inventions, including governmentwide regulations issued by the Department of Commerce at 37 CFR part 401, ‘‘Rights to Inventions Made by Nonprofit Organizations and Small Business Firms Under Government Grants, Contracts and Cooperative Agreements.’

(c) FAS has the right to:

(2) Obtain, reproduce, publish or otherwise use the data first produced under this Agreement; and

(3) Authorize others to receive, reproduce, publish, or otherwise use such data for Federal purposes.

(d)

(1) In addition, in response to a Freedom of Information Act (FOIA) request for research data relating to published research findings produced under this Agreement that were used by the Federal Government in developing an Agency action that has the force and effect of law, FAS shall request, and the Cooperator shall provide, within a reasonable time, the research data so that they can be made available to the public through the procedures established under the FOIA. If FAS obtains the research data solely in response to a FOIA request, FAS may charge the requester a reasonable fee equaling the full incremental cost of obtaining the research data. This fee should reflect costs incurred by the Agency, the Cooperator, and applicable sub cooperators. This fee is in addition to any fees FAS may assess under the FOIA (5 U.S.C. 552(a)(4)(A)).

(2) The following definitions apply for purposes of paragraph (d) of this provision:

i. Research data is defined as the recorded factual material commonly accepted in the scientific community as necessary to validate research findings, but not any of the following: preliminary analyses, drafts of scientific papers, plans for future research, peer reviews, or communications with colleagues. This ‘‘recorded’’ material excludes physical objects (e.g., laboratory samples). Research data also do not include:

(A) Trade secrets, commercial information, materials necessary to be held confidential by a researcher until they are published, or similar information which is protected under law; and

(B) Personnel and medical information and similar information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, such as information that could be used to identify a particular person in a research study.

ii. Published is defined as either when:

(A) Research findings are published in a peer-reviewed scientific or technical journal;

(B) A Federal Agency publicly and officially cites the research findings in support of an Agency action that has the force and effect of law; or

Used by the Federal Government in developing an Agency action that has the force and effect of law is defined as when an Agency publicly and officially cites the research findings in support of an Agency action that has the force and effect of law.

(e) All rights, title, and interest in any Subject Invention made solely by employee(s) of FAS shall be owned by FAS. All rights, title, and interest in any Subject Invention made solely by at least one (1) employee of FAS and at least one (1) employee of the Cooperator shall be jointly owned by FAS and the Cooperator, subject to the provisions of 37 CFR part 401.

(f) FAS shall have a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States the subject invention throughout the world.

Applies to all CRs when development or publication of any printed, audiovisual, or electronic material is contemplated.

Invention Disclosure and Utilization Reporting

The Cooperator shall report Invention Disclosures and Utilization information electronically via i-Edison Web Interface at: www.iedison.gov.

Applies to all CRs when research activities are anticipated.

Metric System of Measurement

Wherever measurements are required or authorized, they must be made, computed, and recorded in metric system units of measurement, unless otherwise authorized by the FAS Program Manager in writing when it has found that such usage is impractical or is likely to cause United States firms to experience significant inefficiencies or the loss of markets. Where the metric system is not the predominant standard for a particular application, measurements may be expressed in both the metric and the traditional equivalent units, provided the metric units are listed first.

Applies to all CRs involving research and/or publications.

Patent Rights

Each agreement awarded by the Cooperator to a small business firm, non-profit organization, or university which is to be performed in the United States, its possessions, or Puerto Rico and has as a purpose the performance of experimental, development, or research work, must contain the Patents Rights Provision.

(a) Definitions:

(1) Invention. Any invention or discovery which is or may be patentable, or otherwise protectable under Title 35 of the United States Code (U.S.C.), or any novel variety of plant which is or may be protected under the Plant Variety Protection Act (7 U.S.C. 2321 et seq.).

(2) Subject Invention. Any invention of the Cooperator conceived or first actually reduced to practice in the performance of work under this Agreement, provided that in the case of a variety of plant, the date of determination (as defined in section 41(d) of the Plant Variety Protection Act, 7 U.S.C. 2401(d) must also occur during the period of the Agreement performance.

(3) Practical Application. 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, the conception or first actual reduction to practice of such invention.

(5) Small Business Firm. A small business concern as defined at section 2 of Public Law 85-536 (15 U.S.C. 632) and implementing regulations of the administrator of the Small Business Administration. For the purpose of this provision, the size standard for small business concerns involved in Government procurement and subgranting as 13 CFR 121.3-8 and 13 CFR 121.3-12, respectively, will be used.

(6) Non-Profit Organization. A 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 Internal Revenue Code (26 U.S.C. 501c) and exempt from taxation under section 501(a) of the Internal Revenue Code (26 U.S.C. 501(a)) or any nonprofit scientific or educational organization qualified under a State nonprofit organization statute.

(b) Allocation of Principal Rights.

(1) All rights, title, and interest in any Subject Invention made solely by employee(s) of FAS shall be owned by FAS.

(2) All rights, title, and interest in any Subject Invention made solely by employee(s) of the Cooperator shall be owned by the Cooperator.

(3) All rights, title, and interest in any Subject invention made jointly by at least one (1) employee of FAS and at least one (1) employee of the Cooperator shall be jointly owned by FAS and the Cooperator.

(4) With respect to any subject invention in which the Cooperator retains title, the Federal Government shall have a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States any subject invention throughout the world.

(c) Invention Disclosure, Election of Title and Filing of Patent Applications by the Cooperator.

(1) The Cooperator shall disclose each subject invention to FAS within 2 months after the inventor discloses it in writing to personnel responsible for patent matters. The disclosure to FAS shall be in the form of a written report and must identify the agreement under which the invention was made and the inventor(s). It must be sufficiently complete in technical detail to convey a clear understanding, to the extent known at the time of the disclosure, of the nature, purpose, operation, and the physical, chemical, biological or electric characteristics of the invention. The disclosure must also identify any publication, on sale of 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 FAS, the Cooperator shall promptly notify FAS of the acceptance of any manuscript describing the invention for publication or of any on sale or public use planned by the Cooperator.

(2) The Cooperator shall elect in writing whether or not to retain title to any such invention by notifying FAS within 2 years of disclosure by the Cooperator; provided that in any case where publication, on sale or public use has initiated the 1 year statutory period wherein valid patent protection can still be obtained in the United States, the period for election of title may be shortened by FAS to a date that is no more than 60 days prior to the end of the statutory period.

(3) The Cooperator shall file its initial patent application on an elected invention within 1 year after election or, if earlier, prior to the end of any statutory period wherein valid protection can be obtained in the United States after publication, on sale, or public use. The Cooperator shall file patent applications in additional countries within either 10 months from the corresponding initial patent application or 6 months from the date permission is granted by the Commissioner of Patents and trademarks to file foreign patent applications where such filing has been prohibited by a Secrecy Order.

(4) Requests for extension of the time for disclosure to FAS, election, and filing may, at the discretion of FAS, be granted.

(d) Conditions when the Government May Obtain Title. The Cooperator shall convey to FAS, upon written request, title to any subject invention:

(1) If the Cooperator fails to disclose or elect the subject invention within the times specified in item c herein or elects not to retain title; provided that FAS may only request title within 60 days after learning of the failure of the Cooperator to disclose or elect within the specified times.

(2) In those countries in which the Cooperator fails to file patent applications within the times specified in item (c)(3) herein; provided, however, that if the Cooperator has/have filed a patent application in a country after the times specified in item (c)(3), but prior to its receipt of the written request of FAS, the Cooperator shall continue to retain title in that country.

(3) In any country in which the Cooperator decides not to continue the prosecution of any application for, to pay the maintenance fees on, or defend in reexamination or opposition proceeding on, a patent on a subject invention.

(e) Minimum Rights to the Cooperator and Protection of the Contractor Right to File.

(1) The Cooperator shall retain a nonexclusive, royalty-free license throughout the world in each subject invention to which the Government obtains title, except if the Cooperator fails to disclose the subject invention within the times specified in item (c) herein. The Cooperator’s license extends to its domestic subsidiaries and affiliates, if any, within the corporate structure of which the Cooperator is a party and includes the right to grant sublicenses of the same scope to the extent the Cooperator was legally obligated to do so at the time the agreement was awarded. The license is transferable only with approval of FAS, except when transferred to the successor of that party of the Cooperator’s business to which the invention pertains.

(2) The Cooperator‘s domestic license may be revoked or modified by FAS 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 Cooperator 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 the discretion of FAS to the extent the Cooperator, 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 FAS shall furnish the Cooperator a written notice of its intention to revoke or modify the license, and the Cooperator shall be allowed 30 days (or such other time as may be authorized by FAS for good cause shown by the Cooperator) after the notice to show cause why the license should not be revoked or modified. The Cooperator has the right to appeal, in accordance with applicable regulations in 37 CFR Part 404 concerning the licensing Government-owned inventions, any decision concerning the revocation or modification of its license.

(f) Action to Protect the Government's Interest

(1) The Cooperator agrees to execute, or to have executed, and promptly deliver to FAS all agreements necessary to

(i) Establish or confirm the rights the Government has throughout the world in those subject inventions to which the Cooperator elects to retain title, and

(ii) Convey title to FAS when requested under paragraph (c) herein and to enable the Government to obtain patent protection throughout the world in that subject invention.

(iii) The Cooperator 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 Cooperator each subject invention made under the disclose provisions of paragraph c herein and to execute all papers necessary to file patent applications on subject inventions and to establish the Government's rights in the subject invention. This disclosure format should require, as a minimum, the information required by paragraph (c) above, and to execute all papers necessary to file patent applications on subject inventions and to establish the government's rights in the subject inventions. This disclosure format should require, as a minimum, the information required by paragraph (c)(1). The Cooperator shall instruct such employees' agreements or other suitable educational programs on the importance of reporting inventions in sufficient time to permit the filing of patent applications prior to United States or foreign statutory bars.

(2) The Cooperator shall notify FAS of any decision not to continue the prosecution of a patent application, pay maintenance fees, or defend in a reexamination or opposition proceeding on a patent, in any country, not less than 30 days before the expiration of the response period required by the relevant patent office.

(3) The Cooperator agrees to include, within the specification of any United States patent application and any patent issuing thereon covering a subject invention, the following statement: This invention was made with the Government support under (insert FAS agreement number) awarded by FAS. The Government has certain rights in this invention.

(g) Subcontracts

(1) The Cooperator shall include this provision, suitably modified to identify the parties, in all subcontracts, regardless of tier, for experimental, developmental, or research work to be performed by a small business firm or domestic nonprofit organization. The subcontractor shall retain all rights provided for the Cooperator in this provision, and the Cooperator shall not, as part of the consideration for awarding the subgrant or subcontract under the Agreement, obtain rights in the subgrantee's or subcontractor's subject inventions.

(2) The Cooperator shall include in all other subcontracts the patent rights provision, regardless of tier, for experimental, developmental, or research work.

(3) In the case of subcontracts, at any tier, when the prime award with the Federal agency was a contract (but not a grant or cooperative agreement), the agency, subcontractors, and the contractor agree that the mutual obligations of the parties created by this provision constitute a contract between the subcontractor and the Federal agency with respect to those matters covered by this provision; provided, however, that nothing in this paragraph is intended to confer any jurisdiction under the Contract Disputes Act in connection with proceedings under paragraph (j) of this provision.

(h) Reporting on Utilization of Subject Invention. The Cooperator 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 Cooperator or its licensees or assignees. Such reports must include information regarding the status of development, date of first commercial sale or use, gross royalties received by the Cooperator, and such other data and information as FAS may reasonably specify. The Cooperator also agrees to provide additional reports as may be requested by FAS in connection with any march-in proceeding undertaken by FAS in accordance with paragraph (j) of this provision. As required by 35 U.S.C. 202(c)(5), FAS agrees it shall not disclose such information to persons outside the government without permission of the Cooperator.

(i) Preference for United States Industry. Notwithstanding any other provision of this provision, the Cooperator agrees that neither it nor any assignee shall grant to any person the exclusive right to use or sell any subject invention in the United States unless such person agrees that any product embodying the subject invention will be manufactured substantially in the United States. However, in individual cases the requirement for such an agreement may be waived by FAS upon a showing by the Cooperator or its assignee that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States, or that under the circumstances, domestic manufacture is not commercially feasible.

(j) March-in-Rights. The Cooperator agrees that with respect to any subject invention in which it has acquired title, FAS has the right in accordance with the procedures in 37 CFR 401.6 and any supplemental regulations of FAS to require the Cooperator, an assignee or exclusive licensee of a subject invention to grant a nonexclusive, 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 Cooperator assignee, or exclusive licensee refuses such a request, FAS has the right to grant such a license itself if FAS determines that:

(1) Such action is necessary because the Cooperator 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) Such action is necessary to alleviate health or safety needs which are not reasonably satisfied by the Cooperator, assignee, or their licensees;

(3) Such action is necessary to meet requirements for public use specified by Federal regulations and such requirements are not reasonably satisfied by the Cooperator, assignee, or licensees; or

(4) Such action is necessary because the agreement required by paragraph i of this provision has not been obtained or waived, or because a licensee of the exclusive right to use or sell any subject invention in the United States is in breach of such agreement.

(k) Special Provisions for Contracts with Non-profit Organizations. If the Cooperator/contractor is a non-profit organization, it agrees that:

(1) Rights to a subject invention in the United States may not be assigned without the approval of FAS, 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 shall be subject to the same provisions as the Cooperator.

(2) The Cooperator shall share royalties collected on a subject invention with the inventor, including Federal employee coinventors (when FAS deems it appropriate) when the subject invention is assigned in accordance with 35 U.S.C. 202(e) and 37 CFR 401.10.

(3) The balance of any royalties or income earned by the Cooperator with respect to subject inventions, after payment of expense (including payments to inventor) incidental to the administration of subject inventions will be utilized for the support of scientific research or education; and

(4) It shall make efforts that are reasonable under the circumstances to attract licensees of subject invention that are small business firms and that it shall give preference to a small business firm when licensing a subject invention if the Cooperator determines that the small business firm has a plan or proposal for marketing the invention which, if executed, is equally as likely to bring the invention to practical application as any plans or proposals from applicants that are not small business firms; provided, that the Cooperator is also satisfied that the small business firm has the capability and resources to carry out its plan or proposal. The decision whether to give preference in any specific case will be at the discretion of the Cooperator. However, the Cooperator agrees that the Secretary may review the Cooperator’s licensing program and decisions regarding small business applicants, and the Cooperator shall negotiate changes to its licensing policies, procedures, or practices with the Secretary when the Secretary's review discloses that the Cooperator could take reasonable steps to implement more effectively the requirements of this paragraph.

(l) Communication

(1) Communications relating to the administration of this provision and disclosure statements should be directed to the GMO.

(2) Practice statements are also made to the Patent Advisor.
NOTE: Exceptions for Not Using the Patent Rights Provision:

i. When the agreement is for the operation of a federally funded research and development center of a government-owned production facility;

ii. In exceptional circumstances when it is determined by FAS that restriction or elimination of the right to retain title to any subject invention shall better promote the policy and objective of Title 35, Chapter 18 of the United States Code; or

iii. When it is determined by a Government authority which is authorized by statute or Executive Order to conduct foreign intelligence or counter intelligence activities that the restriction or elimination of the right to retain title to any subject invention is necessary to protect the security of such activities.

(3) Any determination under this provision must be in writing and accompanied by a written statement of facts and must contain such information as FAS field office deems relevant and, at a minimum, must:

i. Identify the small business firm or nonprofit organization involved.

ii. Describe the extent to which FAS action restricted or eliminated the right to retain title to a subject invention.

iii. State the facts and rationale supporting FAS action.

iv. Provide supporting documentation for those facts and rationale.

v. Indicate the nature of any objections to FAS action and provide any documentation in which those objections appear. A copy of each such determination and written statement of facts must be sent to the Director, Fiscal and Public Safety, Washington Office, for review and forwarded to the Comptroller General of the United States within 30 days after the award of the applicable agreement. In some cases of determinations applicable to agreements with small business firms, copies must also be sent to the Chief Counsel for advocacy of the Small Business Administration.

Applies to all CRs when patents are anticipated.

Protection of Human Subjects

The Cooperator assures compliance with the following provisions regarding the rights and welfare of human subjects:

(a) The Cooperator is responsible for safeguarding the rights and welfare of any human subjects involved in research, development, and related activities supported by this Agreement. The Cooperator may conduct research involving human subjects only as prescribed in the statement of work and as approved by the Cooperator’s Cognizant Institutional Review Board.

Prior to conducting such research, the Cooperator shall obtain and document a legally sufficient informed consent from each human subject involved. No such informed consent shall include any exculpatory language through which the subject is made to waive, or to appear to waive, any of his or her legal rights, including any release of the Cooperator or its agents from liability for negligence.

(b) The Cooperator agrees to comply with U.S. Department of Health and Human Services’ regulations regarding human subjects, appearing in 45 CFR part 46 (as amended).

(c) It will comply with FAS policy, which is to assure that the risks do not outweigh either potential benefits to the subjects or the expected value of the knowledge sought.

(d) Selection of subject or groups of subjects shall be made without regard to sex, race, color, religion, or national origin unless these characteristics are factors to be studied.

Applies to all CRs when research, development , and related activities are anticipated.

Recombinant DNA Research

The Cooperator assures that it will assume primary responsibility for implementing proper conduct on recombinant DNA research and it will comply with the National Institute of Health Guidelines for Recombinant DNA Research, as revised.

If the Cooperator wishes to send or receive registered recombinant DNA material which is subject to quarantine laws, permits to transfer this material into the U.S. or across state lines may be obtained by contacting USDA/APHIS/PPQ, Scientific Services— Biotechnology Permits, 4700 River Road, Unit 133, Riverdale, Maryland 20737. In the event that the Cooperator has not established the necessary biosafety committee, a request for guidance or assistance may be made to the USDA Recombinant DNA Research Officer.

Applies to all CRs when DNA research is anticipated.

Research Misconduct

(a) The Cooperator bears the primary responsibility for prevention and detection of research misconduct and for the inquiry, investigation and adjudication of research misconduct alleged to have occurred in association with their own institution.

(b) The Cooperator and its employees shall comply with the Code of Scientific Ethics of USDA. See, http://www.fs.fed.us/research/publications/fs_code_of%20_scientific_ethics.pdf.

(c) The Cooperator shall:

(1) Maintain procedures for responding to allegations or instances of research misconduct that has the following components:

(i) Objectivity;

 

(ii) Due process;

 

(iii) Whistle blower protection;

 

(iv) Confidentiality;

 

(v) Timely resolution;

 

(2) Promptly conduct an inquiry into any allegation of research misconduct;

(3) Conduct an investigation if an inquiry determines that the allegation or apparent instance of research misconduct has substance;

(4) Provide appropriate separation of responsibilities between those responsible for inquiry and investigation, and those responsible for adjudication;

(5) Advise FAS of outcome at end of inquiries and investigations into allegations or instances of research misconduct; and

(6) Upon request, provide FAS, upon request, hard copy (or website address) of their policies and procedures related to research misconduct.

 

(d) Research misconduct or allegations of research misconduct shall be reported to the USDA Research Integrity Officer (RIO) and/or to the USDA, Office of Inspector General (OIG) Hotline.

(1) The USDA RIO can be reached at: USDA Research Integrity Officer, 214–W Whitten Building, Washington, DC 20250, Telephone: 202–720–5923, Email: researchintegrity@usda.gov

(2) The USDA OIG Hotline can be reached on: 1–800–424–9121.

Applies to all CRs when research activities are anticipated.