# Medicare Program; June 12, 1995 Meeting of the Practicing Physicians Advisory Council

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URL: https://www.frixlaw.com/law-library/documents/fr%3A95-12849

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** May 25, 1995
- **Citation:** 60 FR 27736

## Text

DEPARTMENT OF ENERGY

48 CFR Part 970

RIN 1991-AA63

Acquisition Regulation; Technology Transfer Activities of
Department of Energy (DOE) Management and Operating Contractors

AGENCY: Department of Energy.

ACTION: Proposed rule.

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SUMMARY: The Department of Energy (DOE) today proposes an amendment to
codify DOE's implementation of its technology transfer mission for DOE
laboratories (including weapon production facilities) operated by
management and operating contractors. The National Competitiveness
Technology Transfer Act of 1989 required that technology transfer be
established as a mission of each Government-owned laboratory operated
under contract by a non-Federal entity. The National Defense
Authorization Act for Fiscal Year 1994 expanded the Stevenson-Wydler
Technology Innovation Act of 1980 definition of laboratory to include
weapon production facilities of the Department of Energy that are
operated for national security purposes and are engaged in the
production, maintenance, testing, or dismantlement of a nuclear weapon
or its components. DOE is proposing to amend the Department of Energy
Acquisition Regulation to specify that each new award for or renewal of
an existing management and operating contract for the operation of a
DOE laboratory or weapon production facility shall have technology
transfer as a mission.
DATES: Written comments must be received by July 21, 1995.

ADDRESSES: Comments should be addressed to: Howard K. Mitchell, Policy
Analyst, Office of Policy (HR-51), Office of the Deputy Assistant
Secretary for Procurement and Assistance Management, Washington, D.C.,
20585, (202) 586-8190.

FOR FURTHER INFORMATION CONTACT: Howard K. Mitchell, (202) 586-8190.

SUPPLEMENTARY INFORMATION:
I. Background
II. Section by Section Analysis of the Proposed Rule
III. Procedural Requirements
A. Regulatory Review Under Executive Order 12866
B. Review Under Executive Order 12612
C. Review Under Executive Order 12778
D. Review Under the Regulatory Flexibility Act
E. Review Under the Paperwork Reduction Act
F. Review Under the National Environmental Policy Act (NEPA)
IV. Public Comments
V. Public Hearing

I. Background

Under Section 644 of the Department of Energy Organization Act,
Pub. L. 95-91 (42 U.S.C. 7254), the Secretary of Energy is authorized
to prescribe such procedural rules and regulations as may be deemed
necessary or appropriate to accomplish the functions vested in the
position. Accordingly, the Department of Energy Acquisition Regulation
was promulgated with an effective date of April 1, 1984, (49 FR 11922,
March 28, 1984), 48 CFR chapter 9. With this rule, DOE is proposing an
addition amending part 970 of the Department of Energy Acquisition
Regulation to codify DOE's implementation of its technology transfer
mission for DOE laboratories and weapon production facilities operated
by management and operating contractors.
Technology advancement is a key component in the growth of the
United States industrial economy, and a strong industrial base is an
essential element of national security. Further, there is a continuing
need to enhance United States competitiveness in both domestic and
international markets. DOE laboratories and weapon production
facilities, operated by DOE management and operating contractors, have
developed outstanding capabilities in a wide variety of advanced
technologies and are staffed with scientists, engineers, technicians
and other personnel associated with those technologies. The deployment
of these resources to work with the private sector through cooperative
efforts, consistent with the laboratory's or facility's program mission
assignments, can make a substantial contribution to the competitive
posture of United States industry.
In recognition of such capabilities, Congress enacted the National
Competitiveness Technology Transfer Act of 1989. This Act extended to
Government-owned contractor-operated laboratories the same authority to
enter into cooperative research and development agreements (CRADAs)
which the Federal Technology Transfer Act of 1986 had given to
Government-owned Government-operated laboratories and also provided for
the protection from dissemination of certain types of information
generated under CRADAs. Section 3133(d) of the Act required, by April
30, 1990, each agency which had contracted with a non-Federal entity to
operate a Government-owned laboratory to propose for inclusion in that
laboratory's operating contract, appropriate contract provisions to
implement the requirements of the Act. The National Competitiveness
Technology Transfer Act of 1989, as amended by Sections 3134 and 3160
of the National Defense Authorization Act for Fiscal Year 1994,
established technology transfer as a mission for Government-owned,
contractor-operated laboratories as well as for weapon production
facilities. It also authorized such laboratories and weapon facilities
to negotiate and award CRADAs with other Federal agencies, State and
local governments, industrial organizations, public and private
foundations, nonprofit organizations and other persons for the purposes
of transferring technology and conducting research and development.
Additionally, Sec. 3133(a)(7) of the Act allows certain types of
information generated under CRADAs to be protected from disclosure
under the Freedom of Information Act for a period of up to five years.
The promulgation and use of a final version of a technology
transfer contract clause for DOE laboratories and weapon production
facilities operated by [[Page 27070]] management and operating
contractors, which is proposed in this rulemaking, will minimize
unnecessary differences in policies and procedural requirements among
various laboratories and weapon production facilities. This is expected
to benefit the prospective CRADA or other industrial participants by
improving both the speed and certainty of the technology transfer
process.
The clause requires that the availability of technology transfer
opportunities be well publicized with enough general detail to quickly
attract private sector participants with the capabilities to fully
exploit the technology's commercial applications while benefitting the
U.S. economy. It requires that all aspects of the technology transfer
program are handled to avoid real or perceived conflict of interest and
that commercially valuable data, including marketing and financial
data, are appropriately handled and protected. As required by the Act,
the proposed rule requires that all new awards for or extensions of
existing DOE laboratory or weapon production facility management and
operating contracts will have technology transfer as a laboratory or
facility mission.

II. Section-by-Section Analysis

A detailed list of additions and changes follows.
1. The authority citation for part 970 is revised to add a
reference to the authorities provided by the National Competitiveness
Technology Transfer Act of 1989, as amended by Sections 3134 and 3160
of Public Law 103-160.
2. The clause for a laboratory or weapon production facility
management and operating contract is added as a new section 970.5204-X,
Technology Transfer Mission.
3. A new subpart 970.73, Technology Transfer, and a new section
thereunder, 970.7310, General, are added to summarize the DOE
technology transfer mission and its conduct in DOE owned-facilities.
Two additional new sections, 970.7320, Policy, and 970.7330, Contract
Clause, are added to describe the circumstances when technology
transfer is to be made a contract requirement of a management and
operating contract for the operation of a laboratory or weapon
production facility and the clause reference to be used in a
solicitation and contract award.

III. Procedural Requirements

A. Regulatory Review Under Executive Order 12866

Today's regulatory action has been determined not to be a
``significant regulatory action'' under Executive Order 12866,
``Regulatory Planning and Review,'' (58 FR 51735, October 4, 1993).
Accordingly, today's action was not subject to review under the
Executive Order by the Office of Information and Regulatory Affairs.

B. Review Under Executive Order 12612

Executive Order 12612 (52 FR 41285, October 30, 1987) requires that
regulations, rules, legislation, and any other policy actions be
reviewed for any substantial direct effects on States, on the
relationship between the national government and the States, or in the
distribution of power and responsibilities among various levels of
government. If there are sufficient substantial direct effects, then
the Executive Order requires preparation of a federalism assessment to
be used in all decisions involved in promulgating and implementing a
policy action.
Today's proposed rule, when finalized, will revise certain policy
and procedural requirements. However, DOE has determined that none of
the revisions will have a substantial direct effect on the
institutional interests or traditional functions of the States.
C. Review Under Executive Order 12778

Section 2 of Executive Order 12778 instructs each agency to adhere
to certain requirements in promulgating new regulations and reviewing
existing regulations. These requirements, set forth in sections 2(a)
and (b)(2), include eliminating drafting errors and needless ambiguity,
drafting the regulations to minimize litigation, providing clear and
certain legal standards for affected conduct, and promoting
simplification and burden reduction. Agencies are also instructed to
make every reasonable effort to ensure that the regulation: specifies
clearly any preemptive effect, effect on existing Federal law or
regulation, and retroactive effect; describes any administrative
proceedings to be available prior to judicial review and any provisions
for the exhaustion of such administrative proceedings; and defines key
terms. DOE certifies that today's proposal meets the requirements of
sections 2(a) and (b) of Executive Order 12778.

D. Review Under the Regulatory Flexibility Act

This proposed rule was reviewed under the Regulatory Flexibility
Act of 1980, Pub. L. 96-354, which requires preparation of a regulatory
flexibility analysis for any rule which is likely to have significant
economic impact on a substantial number of small entities. This
proposed rule will have no impact on interest rates, tax policies or
liabilities, the cost of goods or services, or other direct economic
factors. It will also not have any indirect economic consequences, such
as changed construction rates. DOE certifies that this proposed rule
will not have a significant economic impact on a substantial number of
small entities and, therefore, no regulatory flexibility analysis has
been prepared.

E. Review Under the Paperwork Reduction Act

No new information collection or recordkeeping requirements are
imposed by this proposed rulemaking. Accordingly, no OMB clearance is
required under the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et
seq.).

F. Review Under the National Environmental Policy Act (NEPA)

DOE has concluded that promulgation of this rule falls into a class
of actions (categorical exclusion A5) that are categorically excluded
from NEPA review because they would not individually or cumulatively
have significant impact on the human environment, as determined by the
Department's regulations (10 CFR Part 1021, Subpart D) implementing the
National Environmental Policy Act of 1969 (42 U.S.C. 4321, 4331-4335,
4341-4347 (1976)). Therefore, this rule does not require an
environmental impact statement or an environmental assessment pursuant
to NEPA.

IV. Public Comments

Interested persons are invited to participate by submitting data,
views, or arguments with respect to the proposed Department of Energy
Acquisition Regulation amendments set forth in this notice. Three
copies of written comments should be submitted to the address indicated
in the ADDRESSES section of this notice. All comments received will be
available for public inspection in the DOE Reading Room, Room 1E-190,
Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585,
between the hours of 9 a.m. and 4 p.m., Monday through Friday, except
Federal holidays. All written comments received by the date indicated
in the DATES section of this notice and all other relevant information
in the record will be carefully assessed and fully considered prior to
publication of the proposed amendment as a final rule. Any information
considered to be confidential must be so identified and submitted in
writing, one copy only. DOE reserves the right to determine the
confidential status of the information [[Page 27071]] and to treat it
according to our determination (See 10 CFR 1004.11).

V. Public Hearing

The Department has concluded that this proposed rule does not
involve a substantial issue of fact or law and that the proposed rule
should not have substantial impact on the nation's economy or a large
number of individuals or businesses. Therefore, pursuant to Pub. L. 95-
91, the DOE Organization Act, and the Administrative Procedure Act (5
U.S.C. 553), the Department does not plan to hold a public hearing on
this proposed rule.

List of Subjects in 48 CFR Part 970

Government procurement.

Issued in Washington, DC on May 17, 1995.
Richard H. Hopf,
Deputy Assistant Secretary for Procurement and Assistance Management.

For the reasons set forth in the preamble 48 CFR Part 970 is
proposed to be amended as set forth below:

PART 970--DOE MANAGEMENT AND OPERATING CONTRACTS

1. The authority citation for Part 970 is revised to read as
follows:

Authority: Sec. 161 of the Atomic Energy Act of 1954 (42 U.S.C.
2201), Sec. 644 of the Department of Energy Organization Act, Pub.
L. 95-91 (42 U.S.C. 7254), Sec. 201 of the Federal Civilian Employee
and Contractor Travel Expenses Act of 1985 (41 U.S.C. 420), Sec.
1534 of the Department of Defense Authorization Act, 1986, Pub. L.
99-145 (42 U.S.C. 7256a), as amended; and Sec. 3131, 3132, 3133, and
3157 of the National Competitiveness Technology Transfer Act of
1989, Pub. L. 101-189 (15 U.S.C. 3710 et seq.), and as amended by
Sec. 3134 and 3160 of Pub. L. 103-160.

2. Section 970.5204-X, Technology Transfer Mission, is added to
read as follows:

970.5204-X Technology transfer mission.

As prescribed in subpart 970.73, insert the following clause:

Technology Transfer Mission (Xxx, 1995)

This clause has as its purpose implementation of the National
Competitiveness Technology Transfer Act of 1989 (Sections 3131,
3132, 3133, and 3157 of Pub. L. 101-189 and as amended by Pub. L.
103-160, Sections 3134 and 3160). The Contractor shall conduct
technology transfer activities with a purpose of providing benefit
from Federal research to U.S. industrial competitiveness.
(a) Authority. (1) In order to ensure the full use of the
results of research and development efforts of, and the capabilities
of, the Laboratory, technology transfer, including Cooperative
Research and Development Agreements (CRADAs), is established as a
mission of the Laboratory consistent with the policy, principles and
purposes of Sections 11(a)(1) and 12(g) of the Stevenson-Wydler
Technology Innovation Act of 1980, as amended (15 U.S.C. 3710a);
Section 3132(b) of Pub. L. 101-189, Sections 3134 and 3160 of P.L.
103-160, and of Chapter 38 of the Patent Laws (35 U.S.C. 200 et
seq.); Section 152 of the Atomic Energy Act of 1954, as amended (42
U.S.C. 2182); Section 9 of the Federal Nonnuclear Energy Research
and Development Act of 1974 (42 U.S.C. 5908); and Executive Order
12591 of April 10, 1987.
(2) In pursuing the technology transfer mission, the Contractor
is authorized to conduct activities including but not limited to:
identifying and protecting Intellectual Property made, created or
acquired at or by the Laboratory; negotiating licensing agreements
and assignments for Intellectual Property made, created or acquired
at or by the Laboratory that the Contractor controls or owns;
bailments; negotiating all aspects of and entering into CRADAs;
providing technical consulting and personnel exchanges; conducting
science education activities and reimbursable Work for Others (WFO);
providing information exchanges; and making available laboratory or
weapon production user facilities. It is fully expected that the
Contractor shall use all of the mechanisms available to it to
accomplish this technology transfer mission, including, but not
limited to, CRADAs, user facilities, WFO, science education
activities, consulting, personnel, assignments, and licensing in
accordance with this clause.
(b) Definitions. (1) Contractor's Laboratory Director means the
individual who has supervision over all or substantially all of the
Contractor's operations at the Laboratory.
(2) Intellectual Property means patents, trademarks, copyrights,
mask works, protected CRADA information, and other forms of
comparable property rights protected by Federal Law and other
foreign counterparts.
(3) Cooperative Research and Development Agreement (CRADA) means
any agreement entered into between the Contractor as operator of the
Laboratory, and one or more parties including at least one non-
Federal party under which the Government, through its laboratory,
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
missions of the Laboratory; except that such term does not include a
procurement contract, grant, or cooperative agreement as those terms
are used in sections 6303, 6304, and 6305 of Title 31 of the United
States Code.
(4) Joint Work Statement (JWS) means a proposal for a CRADA
prepared by the Contractor, signed by the Contractor's Laboratory
Director or designee which describes the following:
(i) Purpose;
(ii) Scope of Work which delineates the rights and
responsibilities of the Government, the Contractor and Third
Parties, one of which must be a non-Federal party;
(iii) Schedule for the work; and
(iv) Cost and resource contributions of the parties associated
with the work and the schedule.
(5) Assignment means any agreement by which the Contractor
transfers ownership of Laboratory Intellectual Property, subject to
the Government's retained rights.
(6) Laboratory Biological Materials means biological materials
capable of replication or reproduction, such as plasmids,
deoxyribonucleic acid molecules, ribonucleic acid molecules, living
organisms of any sort and their progeny, including viruses,
prokaryote and eukaryote cell lines, transgenic plants and animals,
and any derivatives or modifications thereof or products produced
through their use or associated biological products, made under this
contract by Laboratory employees or through the use of Laboratory
research facilities.
(7) Bailment means any agreement in which the Contractor permits
the commercial or non-commercial transfer of custody, access or use
of Laboratory Biological Materials for a specified purpose of
technology transfer or research and development, including without
limitation evaluation, and without transferring ownership to the
bailee.
(c) Allowable Costs. (1) The Contractor shall establish and
carry out its technology transfer efforts through appropriate
organizational elements consistent with the requirements for an
Office of Research and Technology Applications (ORTA) pursuant to
paragraphs (b) and (c) of Section 11 of the Stevenson-Wydler
Technology Innovation Act of 1980, as amended (15 U.S.C. 3710). The
costs associated with the conduct of technology transfer through the
ORTA including activities associated with obtaining, maintaining,
licensing, and assigning Intellectual Property rights, increasing
the potential for the transfer of technology, and the widespread
notice of technology transfer opportunities, shall be deemed
allowable provided that such costs meet the other requirements of
the allowable costs provisions of this Contract. In addition to any
separately designated funds, these costs in any fiscal year shall
not exceed an amount equal to 0.5 percent of the operating funds
included in the Federal research and development budget (including
Work For Others) of the Laboratory for that fiscal year without
written approval of the Contracting Officer.
(2) The Contractor's participation in litigation to enforce or
defend Intellectual Property claims incurred in its technology
transfer efforts shall be as provided in the clause entitled
``Litigation and Claims'' of this Contract.
(d) Conflicts of Interest--Technology Transfer. The Contractor
shall have implementing procedures that seek to avoid employee and
organizational conflicts of interest, or the appearance of conflicts
of interest, in the conduct of its technology
[[Page 27072]] transfer activities. Such implementing procedures
shall be provided to the Contracting Officer for review and approval
within sixty (60) days after execution of this contract. The
Contracting Officer shall have thirty (30) days thereafter to
approve or require specific changes to such procedures. Such
implementing procedures shall include procedures to:
(1) Inform employees of and require conformance with standards
of conduct and integrity in connection with the CRADA activity in
accordance with the provisions of paragraph (n)(5) of this clause;
(2) Review and approve employee activities so as to avoid
conflicts of interest arising from commercial utilization activities
relating to Contractor-developed Intellectual Property;
(3) Conduct work performed using royalties so as to avoid
interference with or adverse effects on ongoing DOE projects and
programs;
(4) Conduct activities relating to commercial utilization of
Contractor-developed Intellectual Property so as to avoid
interference with or adverse effects on user facility or WFO
activities of the Contractor;
(5) Conduct DOE-funded projects and programs so as to avoid the
appearance of conflicts of interest or actual conflicts of interest
with non-Government funded work;
(6) Notify the Contracting Officer with respect to any new work
to be performed or proposed to be performed under the Contract for
DOE or other Federal agencies where the new work or proposal
involves Intellectual Property in which the Contractor has obtained
or intends to request or elect title;
(7) Except as provided elsewhere in this Contract, obtain the
approval of the Contracting Officer for any licensing of or
assignment of title to Intellectual Property rights by the
Contractor to any business or corporate affiliate of the Contractor;
(8) Obtain the approval of the Contracting Officer prior to any
assignment, exclusive licensing, or option for exclusive licensing,
of Intellectual Property to any person who has been a Laboratory
employee within the previous two years or to the company in which he
or she is a principal; and
(9) Notify non-Federal sponsors of WFO activities, or non-
Federal users of user facilities, of any relevant Intellectual
Property interest of the Contractor prior to execution of WFOs or
user agreements.
(10) Notify DOE prior to evaluating a proposal submitted by a
third party or DOE, when the subject matter of the proposal involves
an elected or waived subject invention or one in which the
Contractor intends to elect to retain title.
(e) Fairness of Opportunity. In conducting its technology
transfer activities, the Contractor shall prepare procedures and
take all reasonable measures to ensure widespread notice of
availability of technologies suited for transfer and opportunities
for exclusive licensing and joint research arrangements. The
requirement to widely disseminate the availability of technology
transfer opportunities does not apply to a specific application
originated outside of the Laboratory and by entities other than the
Contractor.
(f) U.S. Industrial Competitiveness. (1) In the interest of
enhancing U.S. Industrial Competitiveness, the Contractor shall, in
its licensing and assignments of Intellectual Property, give
preference in such a manner as to enhance the accrual of economic
and technological benefits to the U.S. domestic economy. The
Contractor shall consider the following factors in all of its
licensing and assignment decisions:
(i) Whether any resulting design and development will be
performed in the United States and whether resulting products,
embodying parts, including components thereof, will be substantially
manufactured in the United States; or
(ii) (A) Whether the proposed licensee or assignee has a
business unit located in the United States and whether significant
economic and technical benefits will flow to the United States as a
result of the license or assignment agreement; and
(B) In licensing any entity subject to the control of a foreign
company or government, whether such foreign government permits
United States agencies, organizations or other persons to enter into
cooperative research and development agreements and licensing
agreements, and has policies to protect United States Intellectual
Property rights.
(2) If the Contractor determines that neither of the conditions
in paragraphs (f)(1) (i) or (ii) of this clause are likely to be
fulfilled, the Contractor, prior to entering into such an agreement,
must obtain the approval of the Contracting Officer. The Contracting
Officer shall act on any such requests for approval within thirty
(30) days.
(3) The Contractor agrees to be bound by the provisions of 35
U.S.C. 204.
(g) Indemnity--Product Liability. In entering into written
technology transfer agreements, including but not limited to,
research and development agreements, licenses, assignments and
CRADAs, the Contractor agrees to include in such agreements a
requirement that the U.S. Government and the Contractor, except for
any negligent acts or omissions of the Contractor, be indemnified
for all damages, costs, and expenses, including attorneys' fees,
arising from personal injury or property damage occurring as a
result of the making, using or selling of a product, process or
service by or on behalf of the Participant, its assignees or
licensees which was derived from the work performed under the
agreement. The Contractor shall identify and obtain the approval of
the Contracting Officer for any proposed exceptions to this
requirement such as where State or local law expressly prohibit the
Participant from providing indemnification or where the research
results will be placed in the public domain.
(h) Disposition of Income. (1) Royalties or other income earned
or retained by the Contractor as a result of performance of
authorized technology transfer activities herein shall be used by
the Contractor for scientific research, development, technology
transfer, and education at the Laboratory, consistent with the
research and development mission and objectives of the Laboratory
and subject to Section 12(b)(5) of the Stevenson-Wydler Technology
Innovation Act of 1980, as amended (15 U.S.C. 3710a(b)(5)) and
Chapter 38 of the Patent Laws (35 U.S.C. 200 et seq.) as amended
through the effective date of this contract award or modification.
If the amounts of such royalties and income received during any
fiscal year exceed 5 percent of the Laboratory's budget for that
fiscal year, 75 percent of such excess amounts shall be paid to the
Treasury of the United States, and the remaining amount of such
excess shall be used by the Contractor for the purposes as described
above in this paragraph. Any inventions arising out of such
scientific research and development activities shall be deemed to be
``Subject Inventions'' under the Contract.
(2) The Contractor shall include as a part of its annual
Laboratory Institutional Plan or other such annual document a plan
setting out those uses to which royalties and other income received
as a result of performance of authorized technology transfer
activities herein will be applied at the Laboratory, and at the end
of the year, provide a separate accounting for how the funds were
actually used. Under no circumstances shall these royalties and
income be used for an illegal augmentation of funds furnished by the
U.S. Government.
(3) The Contractor shall establish subject to the approval of
the Contracting Officer a policy for making awards or sharing of
royalties with Contractor employees, other coinventors and
coauthors, including Federal employee coinventors when deemed
appropriate by the Contracting Officer.
(i) Transfer to Successor Contractor In the event of termination
or upon the expiration of this Contract, any unexpended balance of
income received for use at the Laboratory shall be transferred, at
the Contracting Officer's request, to a successor contractor, or in
the absence of a successor contractor, to such other entity as
designated by the Contracting Officer. The Contractor shall transfer
title, as one package, to the extent the Contractor retains title,
in all patents and patent applications, licenses, accounts
containing royalty revenues from such license agreements, including
equity positions in third party entities, and other Intellectual
Property rights which arose at the Laboratory, to the successor
contractor or to the Government as directed by the Contracting
Officer.
(j) Technology Transfer Affecting the National Security. (1) The
Contractor shall notify and obtain the approval of the Contracting
Officer, prior to entering into any technology transfer arrangement,
when such technology or any part of such technology is classified or
sensitive under Section 148 of the Atomic Energy Act (42 U.S.C.
2168). Such notification shall include sufficient information to
enable DOE to determine the extent that commercialization of such
technology would enhance or diminish security interests of the
United States, or diminish communications within DOE's nuclear
weapon production complex. DOE shall use its best efforts to
complete its determination within sixty (60) days of the
Contractor's notification, and provision of any supporting
information, and DOE shall promptly notify the Contractor as to
whether the technology is transferable. [[Page 27073]]
(2) The Contractor shall include in all of its technology
transfer agreements with third parties, including, but not limited
to, CRADAs, licensing agreements and assignments, notice to such
third parties that the export of goods and/or Technical Data from
the United States may require some form of export control license or
other authority from the U.S. Government and that failure to obtain
such export control license may result in criminal liability under
U.S. laws.
(3) For other than fundamental research as defined in National
Security Decision Directive 189, the Contractor is responsible to
conduct internal export control reviews and assure that technology
is transferred in accordance with applicable law.
(k) Records. The Contractor shall maintain records of its
technology transfer activities in a manner and to the extent
satisfactory to the DOE and specifically including, but not limited
to, the licensing agreements, assignments and the records required
to implement the requirements of paragraphs (e), (f), and (h) of
this clause and shall provide reports to the Contracting Officer to
enable DOE to maintain the reporting requirements of Section
12(c)(6) of the Stevenson-Wydler Technology Innovation Act of 1980,
as amended (15 U.S.C. 3710a(c)(6)). Such reports shall be made
annually in a format to be agreed upon between the Contractor and
DOE and in such a format which will serve to adequately inform DOE
of the Contractor's technology transfer activities while protecting
any data not subject to disclosure under the Rights in Technical
Data clause and paragraph (n) of this clause. Such records shall be
made available in accordance with the clauses of this Contract
pertaining to inspection, audit and examination of records.
(l) Reports to Congress. To facilitate DOE's reporting to
Congress, the Contractor is required to submit annually to DOE a
technology transfer plan for conducting its technology transfer
function for the upcoming year, including plans for securing
Intellectual Property rights in Laboratory innovations with
commercial promise and plans for managing such innovations so as to
benefit the competitiveness of United States industry. This plan
shall be provided to the Contracting Officer on or before October
1st of each year.
(m) Oversight and Appraisal. The Contractor is responsible for
developing and implementing effective internal controls for all
technology transfer activities consistent with the audit and record
requirements of this Contract. Laboratory Contractor performance in
implementing the technology transfer mission and the effectiveness
of the Contractor's procedures will be evaluated by the Contracting
Officer as part of the annual appraisal process, with input from the
cognizant Secretarial Officer or program office.
(n) Technology Transfer Through Cooperative Research and
Development Agreements. Upon approval of the Contracting Officer and
as provided in a DOE approved Joint Work Statement (JWS), the
Laboratory Director or his designee may enter into CRADAs on behalf
of the DOE subject to the requirements set forth herein.
(1) Review and Approval of CRADAs. (i) Except as otherwise
directed in writing by the Contracting Officer, each JWS shall be
submitted to the Contracting Officer for approval. The Contractor's
Laboratory Director or designee shall provide a program mission
impact statement and shall include an impact statement regarding
related Intellectual Property rights known by the Contractor to be
owned by the Government to assist the Contracting Officer in his
approval determination.
(ii) The Contractor shall also include (specific to the proposed
CRADA), a statement of compliance with the Fairness of Opportunity
requirements of paragraph (e) of this clause.
(iii) Within ninety (90) days after submission of a JWS, the
Contracting Officer shall approve, disapprove or request
modification to the JWS. If a modification is required, the
Contracting Officer shall approve or disapprove any resubmission of
the JWS within thirty (30) days of its resubmission, or ninety (90)
days from the date of the original submission, whichever is later.
The Contracting Officer shall provide a written explanation to the
Contractor's Laboratory Director or designee of any disapproval or
requirement for modification of a JWS.
(iv) Upon approval of a JWS, the Contractor's Laboratory
Director or designee may submit a CRADA, based upon the approved
JWS, to the Contracting Officer. The Contracting Officer, within
thirty (30) days of receipt of the CRADA, shall approve or request
modification of the CRADA. If the Contracting Officer requests a
modification of the CRADA, an explanation of such request shall be
provided to the Laboratory Director or designee.
(v) Except as otherwise directed in writing by the Contracting
Officer, the Contractor shall not enter into, or begin work under, a
CRADA until approval of the CRADA has been granted by the
Contracting Officer. The Contractor may submit its proposed CRADA to
the Contracting Officer at the time of submitting its proposed JWS
or any time thereafter. However, the Contracting Officer is not
obligated to respond under paragraph (n)(1)(iv) of this clause until
within thirty (30) days after approval of the JWS or thirty (30)
days after submittal of the CRADA, whichever is later.
(2) Selection of Participants The Contractor's Laboratory
Director or designee in deciding what CRADA to enter into shall:
(i) Give special consideration to small business firms, and
consortia involving small business firms;
(ii) Give preference to business units located in the United
States which agree that products or processes embodying Intellectual
Property will be substantially manufactured or practiced in the
United States and, in the case of any industrial organization or
other person subject to the control of a foreign company or
government, take into consideration whether or not such foreign
government permits United States agencies, organizations, or other
persons to enter into cooperative research and development
agreements and licensing agreements;
(iii) Provide Fairness of Opportunity in accordance with the
requirements of paragraph (e) of this clause; and
(iv) Give consideration to the Conflicts of Interest
requirements of paragraph (d) of this clause.
(3) Withholding of Data
(i) Data that is first produced as a result of research and
development activities conducted under a CRADA and that would be a
trade secret or commercial or financial data that would be
privileged or confidential, if such data had been obtained from a
non-Federal third party, may be protected from disclosure under the
Freedom of Information Act as provided in the Stevenson-Wydler
Technology Innovation Act of 1980, as amended (15 U.S.C.
3710a(c)(7)) for a period as agreed in the CRADA of up to five (5)
years from the time the data is first produced. The DOE shall
cooperate with the Contractor in protecting such data.
(ii) Unless otherwise expressly approved by the Contracting
Officer in advance for a specific CRADA, the Contractor agrees, at
the request of the Contracting Officer, to transmit such data to
other DOE facilities for use by DOE or its Contractors by or on
behalf of the Government. When data protected pursuant to paragraph
(n)(3)(i) of this clause is so transferred, the Contractor shall
clearly mark the data with a legend setting out the restrictions
against private use and further dissemination, along with the
expiration date of such restrictions.
(iii) In addition to its authority to license Intellectual
Property, the Contractor may enter into licensing agreements with
third parties for data developed by the Contractor under a CRADA
subject to other provisions of this Contract. However, the
Contractor shall neither use the protection against dissemination
nor the licensing of data as an alternative to the submittal of
invention disclosures which include data protected pursuant to
paragraph (n)(3)(i) of this clause.
(4) Work For Others and User Facility Programs. (i) WFO and User
Facility Agreements (UFAs) are not CRADAs and will be available for
use by the Contractor in addition to CRADAs for achieving
utilization of employee expertise and unique facilities for
maximizing technology transfer. The Contractor agrees to inform
prospective CRADA participants, which are intending to substantially
pay full cost recovery for the effort under a proposed CRADA, of the
availability of alternative forms of agreements, i.e., WFO and UFA,
and of the Class Patent Waiver provisions associated therewith.
(ii) Where the Contractor believes that the transfer of
technology to the U. S. domestic economy will benefit from, or other
equity considerations dictate, an arrangement other than the Class
Waiver of patent rights to the sponsor in WFO and UFAs, a request
may be made to the Contracting Officer for an exception to the Class
Waivers.
(iii) Rights to inventions made under agreements other than
funding agreements with third parties shall be governed by the
appropriate provisions incorporated, with DOE approval, in such
agreements, and the provisions in such agreements take precedence
over any disposition of rights [[Page 27074]] contained in this
Contract. Disposition of rights under any such agreement shall be in
accordance with any DOE class waiver (including Work for Others and
User Class Waivers) or individually negotiated waiver which applies
to the agreement.
(5) Conflicts of Interest. (i) Except as provided in paragraph
(n)(5)(iii) of this clause, the Contractor shall assure that no
employee of the Contractor shall have a substantial role (including
an advisory role) in the preparation, negotiation, or approval of a
CRADA, if, to such employee's knowledge:
(A) Such employee, or the spouse, child, parent, sibling, or
partner of such employee, or an organization (other than the
Contractor) in which such employee serves as an officer, director,
trustee, partner, or employee--
(1) Holds financial interest in any entity, other than the
Contractor, that has a substantial interest in the preparation,
negotiation, or approval of the CRADA;
(2) Receives a gift or gratuity from any entity, other than the
Contractor, that has a substantial interest in the preparation,
negotiation, or approval of the CRADA; or
(B) A financial interest in any entity, other than the
Contractor, that has a substantial interest in the preparation,
negotiation, or approval of the CRADA, is held by any person or
organization with whom such employee is negotiating or has any
arrangement concerning prospective employment.
(ii) The Contractor shall require that each employee of the
Contractor who has a substantial role (including an advisory role)
in the preparation, negotiation, or approval of a CRADA certify
through the Contractor to the Contracting Officer that the
circumstances described in paragraph (n)(5)(i) of this clause do not
apply to that employee.
(iii) The requirements of paragraphs (n)(5)(i) and (n)(5)(ii) of
this clause shall not apply in a case where the Contracting Officer
is advised by the Contractor in advance of the participation of an
employee described in those paragraphs in the preparation,
negotiation or approval of a CRADA of the nature of and extent of
any financial interest described in paragraph (n)(5)(i) of this
clause, and the Contracting Officer determines that such financial
interest is not so substantial as to be considered likely to affect
the integrity of the Contractor employee's participation in the
process of preparing, negotiating, or approving the CRADA.
(o) Technology Transfer in Other Cost-Sharing Agreements. In
conducting research and development activities in cost-shared
agreements not covered by paragraph (n) of this clause, the
Contractor, with prior written permission of the Contracting
Officer, may provide for the withholding of data produced thereunder
in accordance with the applicable provisions of paragraph (n)(3) of
this clause.

(End of clause)

Alternate I (Xxx 1995). As prescribed in 970.7330(b), add the
following definition under paragraph (b) and new paragraph (p):
(b)(8) Privately funded technology transfer means the
prosecuting, maintaining, licensing, and marketing of inventions
which are not owned by the Government (and not related to CRADAs)
when such activities are conducted entirely without the use of
Government funds.
(p) Nothing in paragraphs (c) Allowable Costs, (e) Fairness of
Opportunity, (f) U.S. Industrial Competitiveness, (g) Indemnity--
Product Liability, (h) Disposition of Income, and (i) Transfer to
Successor Contractor above are intended to apply to the contractor's
privately funded technology transfer activities if such privately
funded activities are addressed elsewhere in the contract.
Alternate II (Xxx 1995). As prescribed in 970.7330(c), the
phrase ``weapon production facility'' may be substituted wherever
the word ``laboratory'' appears in the clause.

3. A new subpart 970.73, Technology Transfer, consisting of
sections 970.7310, 970.7320, and 970.7330, is added to read as follows:

Subpart 970.73 Technology Transfer

Secs.
970.7310 General.
970.7320 Policy.
970.7330 Contract Clause.

Subpart 970.73--Technology Transfer

970.7310 General.

This subpart prescribes policies and procedures for implementing
the National Competitiveness Technology Transfer Act of 1989. The Act
required that technology transfer be established as a mission of each
Government-owned laboratory operated under contract by a non-Federal
entity. The National Defense Authorization Act for Fiscal Year 1994
expanded the definition of laboratory to include weapon production
facilities that are operated for national security purposes and are
engaged in the production, maintenance, testing, or dismantlement of a
nuclear weapon or its components.

970.7320 Policy.

All new awards for or extensions of existing DOE laboratory or
weapon production facility management and operating contracts shall
have technology transfer, including authorization to award Cooperative
Research and Development Agreements (CRADAs), as a laboratory or
facility mission under Section 11(a)(1) of the Stevenson-Wydler
Technology Innovation Act of 1980, as amended. A management and
operating contractor for a facility not deemed to be a laboratory or
weapon production facility may be authorized on a case-by-case basis to
support the DOE technology transfer mission including, but not limited
to, participating in CRADAs awarded by DOE laboratories and weapon
production facilities.

970.7330 Contract clause.

(a) The contracting officer shall insert the clause at 970.5204-X,
Technology transfer mission, in each solicitation for a new or an
extension of an existing laboratory or weapon production facility
management and operating contract.
(b) If the contractor is a nonprofit organization or small business
eligible under 35 U.S.C. 200 et seq., to receive title to any
inventions under the contract and proposes to fund at private expense
the maintaining, licensing, and marketing of the inventions, the
contracting officer shall use the basic clause with its Alternate I.
(c) The contracting officer may substitute the Alternate II phrase
``weapon production facility'' wherever the word ``laboratory'' appears
in the clause where the facility is operated for national security
purposes and engaged in the production, maintenance, testing, or
dismantlement of a nuclear weapon or its components.

[FR Doc. 95-12849 Filed 5-19-95; 8:45 am]
BILLING CODE 6450-01-P

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A95-12849. Public record. Not legal advice.