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DOE O 483.1C, DOE Cooperative Research and Development Agreements

To establish Department of Energy (DOE) policy requirements and responsibilities for the oversight management and administration of Cooperative Research and Development Agreement (CRADA) activities at DOE facilities.
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Section 1

AVAILABLE ONLINE AT: INITIATED BY: www.directives.doe.gov Office of General Counsel U.S. Department of Energy ORDER Washington, D.C. Approved: 08-05-2026 SUBJECT: DOE COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENTS 1. PURPOSE. a. To establish United States (U.S.) Department of Energy’s (DOE’s) policy requirements and oversight responsibilities governing Cooperative Research and Development Agreements (CRADAs) entered into pursuant to 15 United States Code (U.S.C.) § 3710a, Utilization of Federal Technology. b. Ensure that CRADA activities are conducted in compliance with: (1) The statutes, regulations, Executive Orders, and other authorities identified in section 6, References, of this Order; and (2) The applicable facility contractor DOE prime contract, including the Management and Operating (M&O) contract and incorporated Department of Energy Acquisition Requirement (DEAR) and Federal Acquisition Requirement clauses. c. Establish a risk-based oversight framework (governance vs. compliance) under which: (1) CRADA activities that present low statutory, financial, human or animal subject, or national security risk and use a prior DOE-approved scope of work such as the Master Scope of Work (MSW) as set forth in section 4.g, may be executed under delegated authority at the facility contractor level; (2) Substitution of preapproved alternate clauses and legally sufficient changes to non-double underlined clauses may be incorporated in CRADA agreements and such agreements may be approved under an MSW or delegated authority at the federal contractor level as described in section 4; and (3) CRADAs presenting elevated risk factors or that are not using a prior DOE-approved scope of work such as a MSW, as set forth in section 4.g, require DOE review consistent with the referenced authorities and applicable contract provisions. d. Clarify that DOE oversight shall be proportionate to risk and complexity while ensuring: (1) Protection of national security interests; DOE O 483.1C 2 DOE O 483.1C 08-05-2026 (2) Adherence to U.S. competitiveness requirements; (3) Stewardship of federally funded intellectual property and data; and (4) Timely and efficient execution of technology transfer and partnership activities consistent with DOE mission objectives. 2. CANCELS/SUPERSEDES. DOE Order (O) 483.1B, DOE Cooperative Research and Development Agreements, dated October 28, 2024. Cancellation of a directive does not, by itself, modify or otherwise affect any contractual or regulatory obligation to comply with the directive. Contractor Requirements Documents (CRDs) that have been incorporated into a contract remain in effect throughout the term of the contract unless and until the contract or regulatory commitment is modified to either eliminate requirements that are no longer applicable or substitute a new set of requirements. 3. APPLICABILITY. a. Departmental Applicability. (1) Except for equivalencies/exemptions processed under paragraph c of this section, this Order applies to facility contractors negotiating and entering into CRADAs. (2) Government-owned, contractor-operated (GOCO) facility contractors including M&O contractors (or DOE facility contractors) are authorized to enter into CRADAs by inclusion of DEAR 970.5227-3, Technology Transfer Mission, in the facility contract. (3) Government-owned, government-operated (GOGO) facilities are authorized to enter into CRADAs consistent with applicable statutory and regulatory requirements.

Section 2

b. DOE Facility Contractors. DOE facility contractor obligations arising under this Order shall be implemented through the applicable M&O contract via a CRD which sets forth requirements of this Order that apply to contracts included in the CRD. The CRD must be included in all DOE facility M&O contracts under which contractors negotiate and enter into CRADAs under the National Competitiveness Technology Transfer Act of 1989. c. Equivalencies/Exemptions for DOE O 483.1C. Equivalencies and exemptions to this Order are processed in accordance with DOE O 251.1D, Departmental Directives Program, and its successors. DOE O 483.1C 3 08-05-2026 4. REQUIREMENTS. The following policies and requirements must be applied in carrying out the CRADA programs: a. The proposed work is expected to result in a benefit consistent with the program missions at the facility and the facility’s mission as established by the Cognizant Secretarial Officer (CSO). The proposed work will not adversely impact DOE/National Nuclear Security Administration (NNSA) programs assigned to the facility. b. One or more non-federal collaborating parties must provide funds, personnel, services, facilities, equipment, intellectual property, or other resources toward the conduct of specified research or development efforts which are consistent with the missions of the laboratory. c. Activities must be conducted in a manner that does not compromise the national security, economic, or environmental interests of the United States. d. Export control reviews must be performed in accordance with facility contracts and DOE policy. CRADA activities can result in information and technologies that may be subject to export controls. This export-controlled information may or may not also fall under such categories as classified information or unclassified controlled nuclear information. Consistent with applicable statutes, such information may be considered for protection from public dissemination, for a period not to exceed 30 years after development of information, to retain its commercial value and provide an incentive for its commercial application. Any protectable information generated or exchanged as a result of a CRADA will be marked, handled, and safeguarded in accordance with all applicable federal laws, rules, regulations and DOE Orders or Directives, including, but not limited to, the Trade Secrets Act (18 U.S.C. § 1905), the Freedom of Information Act (FOIA) (5 U.S.C. § 552), DOE’s implementing FOIA regulations at 10 Code of Federal Regulations (CFR) § 1004, the Federal Technology Transfer Act (15 U.S.C. § 3710a[c]), and DOE O 471.7, Controlled Unclassified Information. In accordance with these rules, certain information transmitted pursuant to a CRADA may qualify for protection from disclosure under FOIA. e. DOE employees, in accordance with applicable law and the provisions of facility contracts, must protect properly marked proprietary information and data provided by private-sector collaborators and non-federal parties in the conduct of CRADA activities. f. Non-federal parties (also referred to as “participants”) are permitted to use funds previously obtained from federal sources as their contribution to fund a project, provided such use is consistent with the underlying funding agreement and aligned with the facility contractor’s M&O contract. 4 DOE O 483.1C 08-05-2026

Section 3

g. Master Scope of Work Process. With approval from the cognizant Head of Field Element, the cognizant contracting officer may approve an MSW for work with non-federal parties (e.g., participants). If the DOE facility contractor and the contracting officer agree upon an MSW, individual project transactional approval by the contracting officer is not required if the DOE facility contractor determines that the proposed transaction falls within the approved MSW. Rather, the DOE facility contractor applies the contracting officer’s MSW written certification and approval to the transaction. The DOE facility contractor must provide to the contracting officer a written determination of its decision that the project falls within the MSW, subject to contracting officer review and oversight. The contracting officer is still responsible for placing the work and funding onto the contract as required for all work at the facility using standard contracting procedures and consistent with the DOE Chief Financial Officer’s guidance. Any proposed work that has specific requirements (e.g., a foreign engagement [DOE Policy 485.1, Foreign Engagements with DOE National Laboratories, current version]) or work involving animal subjects must receive the necessary approvals for such requirements before the proposed work can enter or reenter the MSW process. The MSW process may only be authorized or utilized for any type of classified or other work requiring classification guidance with specific approval from the Officially Designated Federal Security Authority and, if appropriate, the contracting officer under the MSW. h. All proposed CRADA projects with Countries of Risk must first be reviewed by the cognizant DOE/NNSA field element, in coordination with the laboratory, to determine whether the engagement is in an area identified as restricted in the current Science and Technology (S&T) Risk Matrix. Such projects within an area identified as restricted are not pursued further unless the cognizant DOE Field Element agrees to pursue an exemption, as described in section 5. i. Contracting Officer Delegation of Authority. With approval from the cognizant Head of Field Element, the cognizant contracting officer may grant the facility contractor delegated approval authority for CRADAs according to terms based on predefined (e.g., low risk) activities, as described in section 1.c and only for prior DOE-approved scopes of work, such as an MSW. 5. RESPONSIBILITIES. a. Under Secretary of Energy, Under Secretary for Science, or their designees, in consultation with the Under Secretary for Nuclear Security, or his/her designee, as appropriate. (1) Recommend, establish, and coordinate policy and provide overall guidance, subject to the Secretary’s direction, for CRADA activities, and recommend appropriate delegations of authority for carrying out such policy and guidance. DOE O 483.1C 5 08-05-2026 (2) Serve as the focal point and provide leadership for developing policies and procedures, resolving CRADA partnering issues, and ensuring effective implementation of existing policies. (3) Approve/disapprove exemption requests based on the current S&T Risk Matrix. b. Chief Commercialization Officer, or Designee, in Consultation with the Technology Transfer Policy Board. (1) Develop policy and recommend procedures for the conduct, and be responsible for the coordination of CRADA activities at DOE facilities. (2) Provide an interagency coordination point for CRADA activities at DOE facilities, as appropriate.

Section 4

(3) Provide guidance to CSOs for the preparation and submission of reports, such as the annual DOE report to Congress on technology partnering program activities. (4) Coordinate the preparation of annual facility technology partnering program reports. (5) Coordinate and conduct training, in coordination with the Head of Field Element, of DOE field personnel responsible for oversight of the DOE facility contractors’ technology transfer programs to ensure consistent development and application of policy and procedures in planning and conducting CRADA activities at DOE facilities. c. Office of Management. (1) Develop, maintain, and update the standard CRADA agreements in a guide for non-federal participants. d. Cognizant Secretarial Officers. (1) Exercise primary oversight, management, and administrative responsibility for CRADA activities at facilities under their cognizance. (2) For facilities under their cognizance, provide general guidance in accordance with the terms of the facility contract or delegation of authority. (3) Ensure the availability of timely and accurate data and information about CRADAs from facilities under their cognizance for satisfying DOE reporting and information requirement. 6 DOE O 483.1C 08-05-2026 (4) Ensure that Heads of Field Element complete an appraisal of the performance of the CRADA activities under their cognizance on an established periodicity. (5) Review and concur on exemption requests for CRADA projects with foreign entities from Countries of Risk that are in areas identified as restricted in the current S&T Risk Matrix. e. Program Secretarial Officers (PSOs). (1) Exercise primary programmatic responsibility for the implementation of CRADA activities for their programs. (2) Support the CSO in the execution of the CSO’s institutional responsibilities by providing programmatic, mission area, and technical expertise in the resolution of CRADA issues. (3) Review and concur on exemption requests for CRADA projects with foreign entities from Countries of Risk, which are in areas identified as restricted in the current S&T Risk Matrix. f. Assistant General Counsel for Technology Transfer and Intellectual Property. (1) Provide legal counsel to departmental elements on all matters relating to intellectual property (including patents, copyrights, and technical data) and transfer of those rights to the private sector in accordance with established legal authorities, including from department laboratories, and provides legal counsel on issues related to the CRADA program including questions regarding the various requirements presented in this Order. (2) Establish policy on intellectual property rights, advises and provides guidance on intellectual property provisions for CRADAs, and approves waivers of patent rights and of any disposition of other intellectual property rights. g. Heads of DOE Field Elements. (1) Oversee CRADA activities conducted in DOE facilities under their purview. In this capacity, Heads of Field Elements are accountable to the CSO. (2) Ensure that federal staff and the contractors under their purview effectively carry out appropriate CRADA activities in accordance with applicable laws, regulations, departmental directives and delegations of authority. (3) Develop and implement local procedures for the review and approval of CRADA activities consistent with legislation, departmental directives, and contractual commitments and objectives. DOE O 483.1C 7 08-05-2026

Section 5

(4) In coordination with the CSO and PSOs, conduct reviews and appraisals of CRADA activities under their cognizance, including review of the use of any delegated signature authority pursuant to section 4.i, and immediately rescind the delegation upon making a determination that the delegated signature authority has been improperly used. (5) Notify appropriate Headquarters elements of higher risk CRADA activities. (6) Ensure adequate contractor review and appropriate DOE engagement in proposed CRADA activities involving human and/or animal subjects for compliance with the established regulations and departmental directives for protection of these subjects, as appropriate. (7) Ensure that CRADA activities under their purview are effectively conducted in accordance with applicable security, safeguards, and classification and controlled unclassified information policies, as appropriate. (8) Ensure the contractor appropriately notifies the Office of Intelligence and Counterintelligence of any CRADA agreements involving intelligence activities. (9) Ensure adequate DOE and contractor review of CRADA activities for compliance with applicable environmental, safety, and health requirements, including requirements of the National Environmental Protection Act, as appropriate, and to determine the applicability of 10 CFR § 851, Worker Safety and Health Program, to CRADA activities. (10) Consistent with the policies and procedures of the Department regarding CRADA activities, establish performance goals and measures to assess performance and effectiveness of local CRADA processes and impacts of subsequent improvements and/or additional requirements. (11) Ensure periodic review and appraisal of CRADA activities. (12) Ensure that summary information is maintained sufficient to respond to reporting requirements and to respond to requests for information from DOE Headquarters or outside entities. (13) In coordination with the cognizant contractor, determine whether a proposed CRADA project with a foreign entity from a Country of Risk is in an area identified as restricted in the current S&T Risk Matrix and, as appropriate, prepare exemption requests for cognizant Under Secretarial approval. 8 DOE O 483.1C 08-05-2026 h. Office of Intelligence and Counterintelligence. (1) Establish procedures for the review of all CRADA activities concerning intelligence and intelligence-related programs. (2) Approve all CRADA activities for intelligence-related programs. (3) Establish procedures for the review of CRADA activities involving classified and/or controlled unclassified technology. The list of sensitive subjects is maintained by the Office of Defense Nuclear Nonproliferation. (4) Establish procedures for the review of CRADA activities involving foreign participants. i. Contracting Officers. Once notified, incorporate the CRD into the affected contracts. 6. REFERENCES. a. Stevenson-Wydler Technology Innovation Act of 1980, P.L. 96-480 (15 U.S.C. § 3701 et seq.), established Offices of Research and Technology Applications (ORTAs) at federal laboratories. b. Bayh-Dole Act of 1980, P.L. 96-517 (35 U.S.C. § 200 et seq.), gives small businesses and nonprofit contractors the right to elect title to inventions made under funding agreements, with the government retaining a license; provides for march-in rights and U.S. preference; and contains provisions relating to licensing of inventions.

Section 6

c. The Atomic Energy Act of 1954, P.L. 83-703 (42 U.S.C. 2182), §§ 31, 32, and 33, which authorize the conduct of research and development and certain training activities for non-DOE/non-NNSA entities, provided that private facilities or laboratories are inadequate for that purpose. It authorizes such charges as may be appropriate for the conduct of those activities. Furthermore, § 152 addresses the disposition of title to inventions useful in the production or utilization of special nuclear material or atomic energy made under DOE contracts, etc., and the process for waiving title to such inventions to contractors, and § 31 (42 U.S.C. §2051) provides for the dissemination of scientific and technical information. d. Section 9 of the Federal Nonnuclear Energy Research and Development Act of 1974, P.L. 93-577 (42 U.S.C. § 5908), addresses the disposition of title to nonnuclear inventions made under DOE contracts, etc., and the process for waiving title to such inventions to contractors. DOE O 483.1C 9 08-05-2026 e. Executive Order 12591, Facilitating Access to Science and Technology, dated April 10, 1987, requires that Executive departments and agencies, to the extent permitted by law, transfer federally funded technology to the commercial sector and specifically addresses GOGOs entering into CRADAs and licensing, assigning, and waiving intellectual property developed under such CRADAs. f. Freedom of Information Act, P.L. 89-487 (5 U.S.C. §552 et seq.), provides for public access to federal agency records, which would include records containing scientific and technical information created with federal funding. g. P.L. 98-620 extended the contractors’ right to elect title to inventions provided by the Bayh-Dole Act to DOE’s facility contractors. h. Federal Technology Transfer Act of 1986, P.L. 99-502, authorizes CRADAs for GOGOs, establishes the Federal Laboratory Consortium for Technology Transfer, and allows GOGO laboratories to negotiate licensing agreements for inventions made at its laboratories. i. Department of Energy Financial Management Handbook, current version, Chapter 13, Reimbursable Work, Revenues, and Other Collections, establishes DOE/NNSA-wide financial policy and procedural guidance for certain interagency reimbursable actions and reimbursable actions with non-DOE/non- NNSA entities. j. National Competitiveness Technology Transfer Act of 1989, P.L. 101-189, establishes technology transfer as a laboratory mission and permits GOCOs to enter into CRADAs. k. National Technology Transfer and Advancement Act of 1995, P.L. 104-113, provides the CRADA collaborating party an option for reasonable compensation when appropriate to choose an exclusive license for a pre-negotiated field of use in any invention made, in whole or in part, by a laboratory employee under the CRADA. l. National Defense Authorization Act of 1999, P.L. 105-261, provides for the Secretary of Energy to impose a federal administrative charge (which includes any depreciation and imputed interest charges) in an amount not to exceed 3% of the full cost incurred in carrying out the research and activities on behalf of non- departmental persons and entities. m. Technology Transfer Commercialization Act of 2000, P.L. 106-404, directs the Secretary of Energy to require the contractors to appoint a technology partnership ombudsman to hear and help resolve complaints from outside organizations regarding the policies and actions of the laboratory with respect to technology partnerships.

Section 7

10 DOE O 483.1C 08-05-2026 n. Title X, section 1001 of Energy Policy Act of 2005 (EPACT 2005) (P.L. 109-58) calls for the appointment of the Technology Transfer Coordinator to serve as the principal advisor to the Secretary of Energy on all matters relating to the technology transfer and commercialization. EPACT 2005 also stipulates that the Secretary shall establish a Technology Transfer Working Group to coordinate technology transfer activities occurring at the national laboratories and single- purpose research facilities. o. On February 28, 2011, the Secretary of Energy signed a Secretarial Policy Statement on Technology Transfer at DOE facilities. The Policy Statement is designed to help guide and strengthen DOE’s technology transfer efforts and to heighten awareness of the importance of technology transfer activities throughout DOE. DOE may issue updated Policy Statements from time to time. p. Section 3196(a) of the Floyd D. Spence National Defense Authorization Act for Fiscal Year 2001, P.L. 106-398, streamlines the approval process for CRADAs at GOCO facilities by authorizing federal agencies to substitute an annual strategic plan for individual joint work statements. q. Presidential Memorandum—Accelerating Technology Transfer and Commercialization of Federal Research in Support of High-Growth Businesses, October 28, 2011. r. Section 3120 of the National Defense Authorization Act for Fiscal Year 2013, directs the Secretary of Energy and the Administrator of NNSA, to the extent practicable, to streamline the approval process for CRADAs. s. DOE O 241.1, Scientific and Technical Information Management, current version, provides requirements and responsibilities for the appropriate management and reporting of scientific and technical information. t. DOE O 471.3, Identifying and Protecting Official Use Only Information, current version, and DOE Manual 471.3-1, Manual for Identifying and Protecting Official Use Only Information, current version, establish requirements for DOE program to identify, mark, and protect documents containing such information. u. 10 CFR § 1045, Nuclear Classification and Declassification, establishes the government-wide policies and procedures for implementing Sections 141 and 142 of the Atomic Energy Act of 1954 for classifying and declassifying restricted data (RD) and formerly restricted data (FRD) and implements those requirements of Executive Order 13526, “Classified National Security Information,” that affect the public. v. Executive Order 13526, “Classified National Security Information,” prescribes the government-wide system for classifying, safeguarding, and declassifying National Security Information. DOE O 483.1C 11 08-05-2026 w. DOE O 475.2, Identifying Classified Information, current version, establishes requirements for managing the DOE program including details for classifying and declassifying information, documents, and material classified under the Atomic Energy Act (RD, FRD, and Transclassified Foreign Nuclear Information) or under Executive Order 13526 so that it can be protected against unauthorized dissemination. x. 10 CFR § 1017, Identification and Protection of Unclassified Controlled Nuclear Information, establishes government-wide policies and procedures for implementing the requirements of section 148 of the Atomic Energy Act of 1954 concerning the identification and protection of certain unclassified but sensitive government information concerning atomic energy defense programs.

Section 8

y. DOE O 471.1, Identification and Protection of Unclassified Controlled Nuclear Information, current version, establishes requirements for managing the DOE program for identifying and protecting unclassified controlled nuclear information. 7. DEFINITIONS. a. Cognizant Secretarial Officer. Headquarters Assistant Secretaries, Deputy Administrators, and Directors responsible for oversight or institutional management of DOE/NNSA facilities. b. Cooperative Research and Development Agreement (CRADA). Any agreement between one or more federal facilities and one or more non-federal parties under which the government, through its facilities, provides personnel, services, facilities, equipment, intellectual property, or other resources with or without reimbursement (but not funds to non-federal parties) and the non-federal parties provide funds, personnel, services, facilities, equipment, intellectual property, or other resources toward the conduct of specified research or development efforts which are consistent with the mission of the facility; except that such terms do not include a procurement contract or cooperative agreement. c. DOE Facility. Government-owned laboratory or production facility or other facility operated under DOE program cognizance. d. DOE Facility Contractor. Entity that operates and maintains a DOE facility under contract with, and for the benefit of, DOE and has the responsibility and authority to conduct technology partnering activities. e. Heads of Field Elements. Federal managers of Field Elements and Directors of DOE facility contractor. Heads of Field Elements have line accountability for all site program/project execution and contract management. “Field Element” can refer to operations office, integrated support center, field office or site office. 12 DOE O 483.1C 08-05-2026 f. Program Secretarial Officer (PSO). Headquarters Assistant Secretaries, Deputy Administrators, and Directors who have management responsibility for program planning, budgeting, and execution of DOE/NNSA mission program activities. For purposes of this Order, the PSO funds work at a particular site or laboratory via a “customer” relationship with the Field Element. g. Technology Transfer Coordinator. Principal advisor to the Secretary on all matters relating to technology transfer and commercialization. This office was created under Title X, Section 1001 of the Energy Policy Act of 2005. h. Technology Transfer Policy Board. Board consisting of representatives of DOE Program Offices, the Office of General Counsel, and other parts of DOE that, in consultation with the Technology Transfer Coordinator, develop DOE policy on technology transfer. 8. CONTACT. For information about this Order, contact the Office of the Assistant General Counsel for Technology Transfer and Intellectual Property at (202) 586-2802. BY ORDER OF THE SECRETARY OF ENERGY: JAMES P. DANLY Deputy Secretary DOE O 483.1C Attachment 1 – CRD, Contractors Only 08-05-2026 Page 1-1 ATTACHMENT 1 CONTRACTOR REQUIREMENTS DOCUMENT DOE O 483.1C, DOE COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENTS Regardless of the performer of the work, the contractor is responsible for complying with the requirements of this Contractor Requirements Document (CRD). The contractor is responsible for flowing down the requirements of this CRD to subcontractors at any tier to the extent necessary to ensure the contractor’s compliance with the requirements. Contractors must:

Section 9

1. Comply with 15 United States Code (U.S.C.) § 3710a: a. A Cooperative Research and Development Agreement (CRADA): defined as a contract between at least one federal laboratory and at least one non- federal entity. b. Government use rights on any intellectual property developed during performance of the CRADA. c. A CRADA participant’s right to exercise an option to any laboratory subject inventions. d. A preclusion to the lab sending funds to a CRADA participant via or in support of a CRADA. e. Proper handling of proprietary information. f. Special consideration for small businesses. g. Preference to U.S.-owned businesses. h. Records maintained of CRADAs executed under this legislation. i. A joint work statement (statement of work) that contains: (1) purpose, (2) scope, (3) description of responsibilities, and (4) funding. 2. Include the U.S. competitiveness provision (or any justified modifications approved by the contracting officer, cognizant funding program, and cognizant DOE Patent Counsel) and follow requirements included in their Management and Operating (M&O) contract, such as fairness of opportunity. 3. Extended protection for protected CRADA information (PCI). As authorized by 15 U.S.C. § 3710a(c)(7)(B) and any other available authority, a facility contractor and a CRADA participant may request PCI extended data protection for up to 30 years for commercialization purposes. Such requests may be approved as part of a Master Scope of Work (MSW), delegated authority, copyright assertion request under the prime contract data clause (e.g., Department of Energy Acquisition Requirement Attachment 1 – CRD, Contractors Only DOE O 483.1C Page 1-2 08-05-2026 [DEAR] 970.5227-2) or comparable process in coordination with the cognizant contracting officer and DOE Patent Counsel. The written request must justify that the nature of the information (e.g., its technology maturity, development timeline, or national security implications) could reasonably require the requested period to reach commercialization. DOE’s statutory determination and approval is made with concurrence from the contracting officer and DOE Patent Counsel that the written justification is sufficient. 4. Establish and maintain a management system, including policy and procedures that ensure CRADA activity requirements are satisfied. 5. If the contractor is not using an approved MSW or approval authority delegation subject to DOE conditions, the contractor must submit to the DOE contracting officer CRADAs and joint work statements for review and approval, or in the alternative, appropriate certification for a request for a preliminary determination to work at the contractor’s own risk. For an MSW or approval authority delegation, the contractor shall provide a report of all CRADAs approved by the contractor in the last period (e.g., month). 6. Ensure proposed work involving human and/or animal subjects is in compliance with established regulations as well as coordinated in accordance with program and contractual requirements for protection of these subjects. 7. Ensure projects are in compliance with DOE environmental, safety, and health requirements, including the National Environmental Protection Act, and 10 CFR § 851, if applicable. 8. Ensure projects are protected in accordance with applicable security, safeguards, and classification and controlled unclassified information policies and procedures, including the site security plan or supplemental security plan specific to a project, as well as CRDs for other departmental directives governing the identification and protection of classified and controlled unclassified information.

Section 10

9. Ensure contractor employees protect proprietary information and data provided by private-sector collaborators and participants in the conduct of CRADA activities as well as any generated data marked in accordance with the CRADA provisions. Any protectable data generated or exchanged as a result of this CRADA and will be marked, handled, and safeguarded in accordance with all applicable federal laws, rules, regulations and DOE Orders or Directives, including but not limited to, the Trade Secrets Act (18 U.S.C. § 1905), the Freedom of Information Act (FOIA) (5 U.S.C. § 552), DOE’s implementing FOIA regulations at 10 CFR § 1004, the Federal Technology Transfer Act (15 U.S.C. § 3710a(c)), and DOE O 471.7, Controlled Unclassified Information. 10. Provide a final technical report, appropriately marked, to DOE’s Office of Scientific and Technical Information, at the completion or termination of the CRADA. 11. Submit information on CRADAs as part of the annual technology transfer report. 12. For CRADAs involving foreign participation, consult with the U.S. Trade Representative as contractually required. DOE O 483.1C Attachment 1 – CRD, Contractors Only 08-05-2026 Page 1-3 13. Non-federal parties (also referred to as “participants”) are permitted to use funds previously obtained from federal sources to finance a project. However, when federal funds are being used by a non-federal party, such use must be consistent with the underlying funding agreement and special considerations must be taken into account including: a. Whether the non-federal party’s previous award contains authority for special data protection that justifies enhanced protection of information generated under the CRADA (i.e., protection of protected CRADA information) or, in the alternative, limits data protection to a period of protection less than that provided under 15 U.S.C. § 3710a; b. Any potential inconsistencies in the U.S. Competitiveness clauses between the non-federal party’s award and the DOE model CRADA language; c. In case of inconsistencies between the non-federal party’s award and the CRADA, include a statement that indicates which agreement controls or ensure that such inconsistencies are addressed during negotiations; and d. Whether the non-federal party has clear election rights to inventions made under its previous award. e. In the event that the terms of the federal funding award include terms that are inconsistent with the terms of the M&O contract, the M&O contract terms will prevail unless specifically waived with DOE approval. 14. Liability and Indemnification Management. The contractor must manage liability risks associated with CRADA activities. Unless an exception is documented and approved by the contracting officer, the contractor shall ensure that agreements include provisions requiring the non-federal party to indemnify the government and the contractor against general and product liability claims arising from the agreement. The contractor is authorized to negotiate or reserve indemnification provisions based on a risk assessment that considers factors, such as: a. The participant’s legal inability to indemnify (e.g., a U.S. state agency); or b. The non-commercial, public-domain nature of the work Any deviation (e.g., other factors that present a low risk to the contractor and the government) from standard indemnification, especially when liability could revert to the contractor, requires specific documented approval from the contracting officer, with concurrence from Field Counsel, which may be included in an MSW or delegated authority.

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