BRIEF

Policy Summary

This policy establishes the requirements and responsibilities for the oversight, management, and administration of Cooperative Research and Development Agreement (CRADA) activities at Lawrence Berkeley National Laboratory (Berkeley Lab).

Who Should Read This Policy

Any Berkeley Lab employee involved with submitting, reviewing, or approving CRADA proposals and accepting, performing, or administering CRADA awards from non-DOE participants

Contact Information

Strategic Partnerships Office

[email protected]

POLICY

A. Purpose

This policy establishes the requirements and responsibilities for the oversight, management, and administration of Cooperative Research and Development Agreement (CRADA) activities at Lawrence Berkeley National Laboratory (Berkeley Lab). Per DOE Order, 483.1B, and consistent with the terms of Contract 31, Berkeley Lab will:

1. Facilitate the efficient and expeditious development, transfer, and exploitation of federally owned or originated technology to non-DOE entities for the public benefit and to enhance the accomplishment of the DOE mission.
2. Leverage DOE resources, through its programs and facilities, through partnering.
3. Ensure fairness of opportunity, protect the national security and promote the economic interests of the United States, and provide a variety of means to respond to private-sector concerns and interests about facility technology partnering activities.
4. Carry out CRADA activities in accordance with applicable laws and authorities.
5. Ensure consistent development and application of policy and procedures in planning and conducting CRADA activities at Berkeley Lab and ensure the availability of timely and accurate CRADA data and information to monitor, evaluate, and describe DOE CRADA activities.

B. Persons Affected

Any Berkeley Lab employee involved with submitting, reviewing, or approving CRADA proposals and accepting, performing, or administering CRADA awards from non-DOE participants.

C. Exceptions

None

D. Policy Statement

D.1 General

1. The UC-DOE Prime Contract 31 authorizes the University of California (UC) to perform CRADAs in compliance with applicable laws, regulations, and DOE policy pursuant to DEAR 970.5227-3, Technology Transfer Mission (AUG 2002) (DEVIATION AL 2022-01).

2. This includes CRADAs authorized as part of the Lab's technology transfer mission. Under the contract terms, CRADAs are defined as any agreement entered into between Berkeley Lab and one or more parties, including at least one nonfederal party, under which the Lab provides personnel, services, facilities, equipment, intellectual property, or other resources with or without reimbursement (but not funds to nonfederal parties) and the nonfederal parties provide funds, personnel, services, facilities, equipment, intellectual property, or other resources towards the conduct of specified research or development efforts consistent with the missions of the Lab, except that the term CRADA does not include "procurement contract," "grant," or "cooperative agreement," as those terms are used in sections 6303, 3304, and 6305 of Title 31 of the United States Code. CRADAs are developed with a nonfederal partner in specified research or development efforts that are consistent with the missions of the facility. The nonfederal party contribution must be more than financial and/or equipment or the development of a statement of work. That is, the nonfederal party must collaborate.
3. The President of the UC has delegated to the Berkeley Lab Director the authority for Laboratory contract and grant authority to solicit and accept or execute certain extramural grants and contracts that include CRADAs. Strategic Partnerships Office (SPO) Contract Officers (COs) have been delegated authority from the Laboratory Director to submit proposals and negotiate awards in accordance with UC policy. Accordingly, the SPO is the institutional organization responsible for submitting proposals and accepting awards from non-DOE participants and as such, all proposals and awards for sponsored research must be processed through the SPO. The SPO Chief Strategic Partnerships Officer retains the authority to sign CRADAs.

D.2 CRADA Requirements

1. SPO COs have the institutional review responsibility for reviewing and submitting all CRADA proposals to the Laboratory's CRADA partners, and the Joint Work Statement (JWS) and CRADA to DOE for review and approval, which are necessary to the CRADA proposal review and submittal process. The following requirements must be applied when executing the CRADA:
   1. Fairness of Opportunity. Berkeley Lab shall take all reasonable measures to ensure widespread notice of availability of technologies suited for transfer and for opportunities for exclusive licensing and joint research arrangements.
   2. Activities must be conducted in a manner that does not compromise the national security, economic, or environmental interests of the United States.
   3. Export control reviews must be performed in accordance with Contract 31. CRADA activities can result in information and technologies that may be subject to export controls, called export-controlled information (ECI). This information and/or technology may become ECI at any stage. Information and data that are commercially valuable may be developed, including some that may have associated intellectual property rights. Consistent with applicable statues, such information may be considered for protection from public dissemination for a period not to exceed five years after development of the information to retain its commercial value and provide an incentive for its commercial application. Any protectable information generated or exchanged as a result of this CRADA will be marked, handled, and safeguarded in accordance with all applicable laws, regulations, and policy.
   4. Berkeley Lab must protect properly marked proprietary information and data provided by private-sector collaborators and nonfederal parties in the conduct of CRADA activities.
   5. Nonfederal parties are permitted to use funds previously obtained from federal sources as their contribution to fund a project under certain conditions (see DOE Order O.483.1B).
   6. Work performed for non-DOE participants must be performed on a full cost recovery basis.
2. The CRADA mechanism should be used:
   1. When the proposed work is expected to result in a benefit consistent with the DOE program mission.
   2. When the proposed work represents a collaboration with one or more nonfederal parties in specified research or development efforts that is consistent with the missions of Berkeley Lab or facilities (in multi-laboratory CRADA activities). The nonfederal party contribution must be more than financial and/or equipment or the development of a statement of work. That is, the nonfederal party must collaborate. One hundred percent (100%) funds-in CRADAs are permissible and may be entered into by Berkeley Lab, as long as there is collaboration and Berkeley Lab informs the nonfederal party of the availability of alternate forms of technology partnering mechanisms in accordance with Contract 31.
   3. There must be in-kind contributions to document the partner's collaborative activities to demonstrate that the partner is providing more than money (see Valuation of In-Kind Contribution form).
3. Exceptions:
   1. If there is no direct funding from the DOE to Berkeley Lab, consideration should be given to conducting the research as a Strategic Partnership Projects (SPP) contract rather than a CRADA. The partner must be informed of the availability of the class waiver SPP in accordance with Contract 31, DEAR 970.5227-3, Technology Transfer Mission (AUG 2002) (DEVIATION AL 2022-01).

D.3 CRADA Components

1. The JWS describes the purpose, scope, schedule, and estimated cost of a proposed CRADA; assigns responsibilities among the agency, contractor, and any other party or parties to the proposed agreement; and, to the extent known, describes the allocation of rights among the various parties. Special attention should be given to the following:
   1. Fairness of Opportunity. It is important that fairness of opportunity is followed and documented. The file must describe how Berkeley Lab and the partner joined efforts for the proposed CRADA, including how the partner became aware of Berkeley Lab's capability and willingness to participate.
   2. U.S. Competitiveness. The JWS should indicate whether the partner will agree to the standard DOE clause on U.S. competitiveness. If not, a description of the alternative benefits to which the partner is willing to contractually agree must be described in a Net Benefit Statement. See Attachment 8 of DOE CRADA Order 483.1B
2. Master Scope of Work (MSW) Approach (if applicable)
   1. Background and Authority: In accordance with DOE CRADA ORDER 483.1B, upon approval of an MSW by the DOE Berkeley Site Office (BSO), Berkeley Lab may propose and enter into agreements with nonfederal participants for work that is specified under the approval MSW without obtaining additional BSO approval. Any proposed work that has specific requirements must receive the necessary approvals for such requirements before the proposed work can enter or re-enter the MSW process. Such examples include:
      • Foreign participant engagements.
      • Agreements with nonstandard terms and conditions.
      • Collaborations involving animal or human subjects.
      • Transactions that raise conflict of interest concerns.
   2. Proposal Stage: Divisions should work with the SPO to develop MSWs specific to the work performed in a respective area and may choose to have multiple MSWs depending on the different types of work. The MSW must be at a sufficient level of detail with tasks specified to allow for review by BSO. COs will review the MSW and once it is approved, submit it to BSO for review and approval. Upon approval of the MSW, BSO will provide written certification for the approved use of the MSW.
   3. Approval: Once an MSW is approved, sponsors requesting services that fall within the scope of an approved MSW can be engaged and agreements entered into without DOE approval as long as an approved SPP/CRADA agreement is used and all other requirements (e.g., advance payment) are met. If a sponsor requests any changes to standard SPP/CRADA terms or other factors in (a) above apply that would require DOE approval, the action will be processed for approval as follows:
      • The CO will request applicable activity through eSRA for review and approval. The request will include an explanation of the circumstances, associated documents, and any required LBNL approvals (i.e., LBNL Lab Counsel) as required.
      • BASO approval will be documented in eSRA by using the standard approval activities.
      • The approved agreement can then be used for sponsors under the approved MSW.
   4. DOE oversight: Changes to the MSW will require an amended MSW for review and approval by BSO. Additionally, MSW and/or specific projects under the MSW are subject to periodic review by BSO upon request.

D.5 Other Important Considerations

1. Use of Students. The use of students is allowed as long as there is no protected generated information (standard Berkeley Lab language).
2. Advance Funds. If the CRADA partner is providing funds, an advance must be obtained prior to starting the CRADA (see the Desk Guide for eSRA) for the process to obtain an advance invoice).
3. Option to Exclusive License. The National Technology Transfer and Advancement Act of 1995, Public Law 104-113, requires that a CRADA partner have an option for reasonable compensation to choose an exclusive license for a pre-negotiated field of use in any Berkeley Lab subject inventions under the CRADA.
4. Institutional Approvals: The CO confirms applicable policies and approvals:
   1. Use of human subjects approved by the Human and Animal Regulatory Committee (HARC) (see the "Human and Animal Subjects Research" policy area).
   2. Use of animal subjects approved by HARC and submitted to BSO for Office of Science approval (see the "Human and Animal Subjects Research" policy area).
   3. Conflict of Interest (COI) Review (see the Conflict of Interest in Research — CRADAs RPM policy).
   4. Foreign participant approval by export control and DOE HQ approval through BASO.
   5. Nonstandard terms approval by BSO (see the DOE CRADA order).
   6. Nonstandard financial terms (NSFT) approval by the Office of the Chief Financial Officer (see the NSFT RPM policy).

E. Roles and Responsibilities

F. Definitions/Acronyms

G. Recordkeeping Requirements

• Permanent
• Cut off at termination of agreement
• Offer to NARA 25 years after cut off

H. Implementing Documents

I. Contact Information

Strategic Partnerships Office

[email protected]

J. Revision History

DOCUMENT INFORMATION

Source Requirements Documents

• Contract 31, Clause I.137, DEAR 970-5227-2, “Rights in Data — Technology Transfer (DEC 2000) [SC alternate SEP 2018] (prev. I.091”

• Contract 31, Clause I.138, DEAR 970.5227-3, Technology Transfer Mission (AUG 2019) [SC alternate APR 2018] (prev. I.092)

• DOE O 483.1B Chg 1 (MinChg), "DOE Cooperative Research and Development Agreements." The order establishes policy, requirements, and responsibilities for the oversight, management, and administration of CRADA activities at DOE facilities. Supersedes DOE O 483.1B.
• National Competitiveness Technology Transfer Act of 1989. The law that created the CRADA mechanism for use by GOCO laboratories such as Berkeley Lab. It is part of DOE Order 483.1.

• Class Waiver — Patent Rights, DOE 2/25/91 letter. A class waiver of the government's U.S. and foreign patent rights for inventions made in the performance of CRADAs entered into by the Regents of the University of California under Contract 31 between the DOE and UC (W[C]-91-001; SAN 587). This provides the waiver of the government's rights in participant CRADA inventions.

• Cost Sharing of CRADAs, DOE 3/14/94 memorandum. Reiterates DOE policy that prior work cannot be counted as in-kind CRADA contributions.
• DOE Memo EXEC-2018-004586 dated 10/23/2018 from the Deputy Secretary, "Decision on Recommended Technology Transition Reforms Authorizing the Implementation of a Risk-Based, Master Scope of Work Approach for the Approval of Routine Laboratory Partnering Agreements without Requiring DOE Transaction Approval"
• DOE Order DOE P 485.1 "Foreign Engagements with DOE National Laboratories"
• DOE Order 522.1A "Pricing of Departmental Materials and Services"'

Other Driving Requirements

Other References

• DOE O 483.1B Chg 1 (LtdChg), DOE Cooperative Research and Development Agreements. The order establishes policy, requirements, and responsibilities for the oversight, management, and administration of CRADA activities at DOE facilities.