Acquisition Regulations, 49015-49023 [2014-19312]
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Federal Register / Vol. 79, No. 160 / Tuesday, August 19, 2014 / Rules and Regulations
(4) Debarment and Suspension
Program, DOI–11.
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[FR Doc. 2014–19651 Filed 8–18–14; 8:45 am]
BILLING CODE 4310–RK–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 73
[MB Docket No. 05–112; MB Docket No. 05–
151; RM–11185; RM–11374; RM–11222; RM–
11258]
Radio Broadcasting Services;
Converse, Flatonia, Georgetown,
Goldthwaite, Ingram, Junction, Lago
Vista, Lakeway, Llano, McQueeney,
Nolanville, San Antonio, Waco, TX
Federal Communications
Commission.
ACTION: Final rule; denial of petition for
reconsideration.
AGENCY:
This document denies a
Petition for Reconsideration filed by
Rawhide Radio, LLC, Clear Channel
Broadcasting Licenses, Inc., CCB Texas
Licenses, LP, and Capstar TX Limited
Partnership (‘‘Joint Parties’’) of a Report
and Order that denied a
Counterproposal filed by the Joint
Parties and granted a mutually exclusive
Counterproposal filed by Munbilla
Broadcasting Properties, Ltd. See
Supplementary Information.
ADDRESSES: Federal Communications
Commission, 445 Twelfth Street SW.,
Washington, DC 20554.
DATES: August 19, 2014.
FOR FURTHER INFORMATION CONTACT:
Andrew J. Rhodes, Media Bureau (202)
418–2700.
SUPPLEMENTARY INFORMATION: This is a
synopsis of the consolidated
Memorandum Opinion and Order in MB
Docket No. 05–112 and MB Docket No.
05–151, adopted July 23, 2014, and
released July 24, 2014 The full text of
this decision is available for inspection
and copying during normal business
hours in the FCC Reference Information
Center at Portals ll, CY–A257, 445 12th
Street SW., Washington, DC 20554. The
complete text of this decision may also
be purchased from the Commission’s
copy contractor, Best Copying and
Printing, Inc. 445 12th Street SW., Room
CY–B402, Washington, DC 20554,
telephone 1–800–378–3160 or
www.BCPIWEB.com. Because the
Commission is denying the Petition for
Reconsideration, the Commission will
not send a copy of this Memorandum
Opinion and Order in a report to
Congress and the Government
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SUMMARY:
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Accountability Office pursuant to the
Congressional Review Act, see 5 U.S.C.
801(a)(1)(A).
The Memorandum Opinion and Order
denied the Joint Parties Petition for
Reconsideration because no error was
committed in the Report and Order by
requiring the Joint Parties
Counterproposal to protect a previously
filed and cut-off application. See 72 FR
37673, July 1, 2007. Although the Joint
Parties Counterproposal had been filed
and dismissed in an earlier proceeding,
the refilling of the Counterproposal does
not revive that dismissed proposal or
create cut-off rights with regard to
proposals in the present proceeding.
Likewise, the Memorandum Opinion
and Order determined that no error was
committed by processing a ‘‘cut-off’’
application and relying on the effective
but non-final dismissal of the Joint
Parties Counterproposal in the earlier
proceeding. Finally, the Memorandum
Opinion and Order concluded that an
engineering solution submitted by the
Joint Parties could not be considered
because it was filed late.
List of Subjects in 47 CFR Part 73
Radio, Radio broadcasting.
Federal Communications Commission.
Peter H. Doyle,
Chief, Audio Division, Media Bureau.
[FR Doc. 2014–19417 Filed 8–18–14; 8:45 am]
BILLING CODE 6712–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
48 CFR Parts 327 and 352
RIN 0991–AB87
Acquisition Regulations
Division of Acquisition, Office
of Grants and Acquisition Policy and
Accountability, Office of the Assistant
Secretary for Financial Resources,
Department of Health and Human
Services.
ACTION: Final rule.
AGENCY:
The Department of Health and
Human Services (HHS) is issuing a final
rule to amend its Federal Acquisition
Regulation (FAR) Supplement—the
HHS Acquisition Regulation (HHSAR)—
to add two clauses, Patent Rights—
Exceptional Circumstances and, Rights
in Data—Exceptional Circumstances,
and their prescriptions.
DATES: Effective Date: September 18,
2014.
FOR FURTHER INFORMATION CONTACT:
Cheryl Howe, Procurement Analyst,
Department of Health and Human
SUMMARY:
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49015
Services, Office of the Assistant
Secretary for Financial Resources, Office
of Grants and Acquisition Policy and
Accountability, Division of Acquisition
at (202) 690–5552.
SUPPLEMENTARY INFORMATION:
I. Background
The HHS published a proposed rule
in the Federal Register at 78 FR 2229 on
January 10, 2013, to ensure that
providers of proprietary material(s) to
the Government will retain all their
preexisting rights to their material(s),
and rights to any inventions made under
a contract or subcontract (at all tiers),
when a Determination of Exceptional
Circumstances (DEC) has been executed.
‘‘Material’’ means any proprietary
material, method, product, composition,
compound, or device, whether patented
or unpatented.
A DEC is executed consistent with the
policy and objectives of the Bayh-Dole
Act, 35 U.S.C. 200, et seq., to ensure that
subject inventions made under contracts
and subcontracts (at all tiers) are used
in a manner to promote free competition
and enterprise without unduly
encumbering future research and
discovery; to encourage maximum
participation of small business firms in
federally supported research and
development efforts; to promote
collaboration between commercial
concerns and nonprofit organizations
including universities; to ensure that the
Government obtains sufficient rights in
federally supported inventions to meet
its needs; to protect the public against
nonuse or unreasonable use of
inventions, and in the case of fulfilling
the mission of the Department of Health
and Human Services, to ultimately
benefit the public health.
Under certain circumstances, in order
to ensure that pharmaceutical
companies, academia, and others will
collaborate with HHS in identifying,
testing, developing, and
commercializing new drugs,
therapeutics, diagnostics, prognostics
and prophylactic measures affecting
human health, a DEC must be executed
and Contractor’s and subcontractor’s
rights (at all tiers) in subject inventions
should be limited accordingly,
consistent with DEC requirements and
through appropriate contract clauses.
II. Discussion and Analysis
A. Summary of Significant Changes
The comment period for the proposed
rule closed on March 11, 2013. The HHS
received responses from four
respondents with 11 comments,
collectively; however, only three of
those comments resulted in minor
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changes to the final rule. The comments
are discussed below.
B. Analysis of Public Comments
1. Definition of ‘‘Made’’
Comment: One respondent states that
while institutions are able to manage
this in terms of preserving Government
rights under the Bayh-Dole Act, it does
raise potential legal conflicts if the
institution has obligations to another
sponsor who funded the conception and
then must assign ownership rights to the
Third party assignee under these
clauses. Therefore, the commenter
strongly urged HHS to change the
definition for ‘‘made’’ to ‘‘conception
and first actual reduction to
practice. . .’’ with respect to the rights
of the Third party assignee.
Response: The final rule is acceptable
as it reflects statutory language.
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2. License Retention by Nonprofit
Organization
Comment: Two respondents stated
that U.S. nonprofit educational
institutions may retain a nonexclusive,
royalty free license for noncommercial
internal research, but not for
educational purposes, which is a key
mission for such institutions. Nor would
this allow sharing with other nonprofit
academic institutions as required under
the National Institutes of Health policy.
In addition, since most research at U.S.
universities is sponsored, it is unclear
what ‘‘internal’’ will permit. Therefore,
we recommended that the retention of
rights be clarified as ‘‘nonprofit research
and educational purposes.’’
Response: The Government agrees
that the license may be retained by U.S.
nonprofit organizations and that the
language should be modified. The
clause language was rewritten to
include: ‘‘If the Contractor is a U.S.
nonprofit organization it may retain a
royalty free, nonexclusive,
nontransferable license to practice the
invention for all nonprofit research
including for educational purposes, and
to permit other U.S. nonprofit
organizations to do so.’’
3. Patent Expenses
Comment: One respondent stated that
‘‘if required to assign an invention to a
Third party assignee who acquired the
full benefit of the invention, the
contractor can assist the Third party
assignee in securing patent protection at
the Third party’s expense. It is
important to clarify that the Third party
assignee is responsible for expenses
related to securing patent protection as
the expenses can be costly.
Response: The Government accepted
this comment and rewrote the last
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sentence of paragraph 352.227–11(c) as:
‘‘If the Contractor assigns a Subject
Invention to the Third party assignee,
then the Contractor and its employee
inventors shall assist the Third party
assignee in securing patent protection.
All costs of securing the patent,
including the cost of the Contractor’s
assistance, are at the Third party’s
expense. Any assistance provided by the
Contractor and its employee inventors
to the Third party assignee or other
costs incurred in securing patent
protection shall be solely at the Third
party’s expense and not billable to the
contract.’’
4. Six Month Filing Period
Comment: Two respondents
commented that the publication delay
sets a detrimental nationwide precedent
that a 6-month publication delay is
acceptable. The existing standard
amongst most U.S. universities
maximum of 90–120 days publication
delay provides sufficient time to file a
patent application; this is increasingly
important in the First Inventor to File
regime.
Response: The Government believes 6
months is reasonable as paragraph
352.227–14(d)(4) requires the contractor
to provide the Contracting Officer a
copy of any proposed publication or
other public disclosure at least 30 days
in advance of the disclosure but allows
the Contracting Officer to request that
publication be delayed for a reasonable
time not to exceed 6 months. The
Government expects that such a request,
which will require affirmative action by
the Contracting Officer, will be
uncommon. In view of the new first to
file provisions of the current patent
statute it is expected that patent
applications will be filed expeditiously.
5. Clarification of ‘‘Third Party
Assignee’’
Comment: One respondent stated that
the clauses contain confusing uses of
terminology. For example, the term
‘‘Third party assignee’’ to whom Class I
inventions will be assigned is used in
the sections for both Class I and Class
2 inventions (the latter class involves a
license rather than an assignment.)
Response: The Government agrees
with the respondent’s language and
changed the clause to read ‘‘However,
the Contractor shall grant a license in
the Class 2 Subject Inventions to the
provider of the ‘‘material’’ or other party
designated by the Agency as set forth in
Alternate I.’’
6. Application of Bayh-Dole Act
Comment: Two respondents
submitted the following general
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comment and subsequent related
specific comments: The basic premise of
the Bayh-Dole Act and implementing
regulations is that elimination or
restriction of a contractor’s right to
retain title to subject inventions is
intended only in the event of
‘‘exceptional circumstances.’’ Written
case-by-case determinations and
justifications are required. These must
be submitted to the Secretary of
Commerce (Commerce). Contractors
have the right to appeal (35 U.S.C. 202;
37 CFR 401.3 and 401.4; FAR 27.3).
The notice asserts but does not
demonstrate how the proposed clauses
will better address the requirements of
the Bayh-Dole Act and regulations. It
merely recites the policy and objectives
of the Bayh-Dole Act. Providing for a
‘‘class’’ deviation from the Bayh-Dole in
the HHSAR appears inconsistent with
the intent to limit the use of exceptional
circumstance deviations through
requiring individual case-by-case
justifications. The present practice of
the use of individual FAR deviations
tailored to the specific DEC
circumstances is more consistent with
the objectives of the Bayh-Dole Act. We
also note that the notice indicates that
a copy has been submitted to the Chief
Counsel for Advocacy of the Small
Business Administration. It does not
indicate whether it also has been
submitted to the National Institute of
Standards and Technology, which now
has overall oversight responsibility for
the Bayh-Dole, including responsibility
for Commerce review of DECs.
Response: The Government concurs
with the respondent that this clause
applies to exceptional circumstance;
however, the Government is proposing
this clause to implement the law for
specific types of DECs. The proposed
clause may not be appropriate for every
DEC. The clause is appropriate for this
kind of DEC, i.e., those for evaluation of
Third party materials. That is evident in
the prescriptive part of the proposed
section 327.303, which states that the
clause will be used whenever a DEC
involving the provision of materials has
been executed in accordance with
Agency policy, and procedures calls for
its use, and the clause appropriately
covers the circumstances.
7. Clause Not Self-Executing
Comment: One respondent stated that,
in regard to the proposed Patent
Rights—exceptional circumstances
HHSAR clause (352.227–11), the clause
defined 3 categories of Subject
Inventions but referred to the DEC(s) for
the definition. The respondent asserted
that this meant the clause itself is not
self-executing and that it presumes
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DECs will all contain the same three
categories, which appears inappropriate
for a HHSAR clause as DECs may vary
in this regard. This illustrates the
problems with implementing DECs
through one general clause instead of
individual deviations.
Response: The Government did not
intend for the clause to be selfexecuting. Rather, it only applies if it is
invoked by a particular DEC involving
the provision of materials. This will
insure that the clause is not used
inappropriately.
8. Clarification of Terms and Definitions
Comment: One respondent asserted
that some terms and definitions in the
proposed 352.227–11 clause were
problematic and specified as follows:
The definition of ‘‘material’’ to include
methods, whether patented or
unpatented, is over broad. The
definition of ‘‘Third party assignee’’
refers to any entity described in the
DEC, not necessarily materials providers
which according to the Supplementary
Information (IV.B.) are supposed to be
the focus. This should be clarified. The
proposed clause contains a confusing
incorporation of FAR clause 52.227–11
at b(2)(ii), which appears to be
contradicted by (e)(2)’s incorporation of
FAR 52.227–13.
Response: The Government made the
definition of ‘‘material’’ intentionally
broad to include anything that may be
provided to the Contractor under the
contract. The nature of ‘‘material’’ will
be described in the associated DEC.
Generally it is anticipated that the Third
party assignee would be the provider of
the ‘‘material;’’ however, the
Government reserves the right to require
assignment to other entities, including
the Government, when appropriate.
However, the Government concurs that
there are some inconsistencies in the
references and have aligned them as
follows: Paragraph (c) of FAR 52.227–
13, which specifies march-in
procedures, was invoked twice in the
clause to address greater rights
determinations—first in 352.227–11
(b)(3) (not (b)(2)(ii) as stated in the
comment) and also in 353.227–11(e)(2).
The last sentence of 352.227–11(e)(2)
was modified to improve clarity. These
provisions are applicable when greater
rights are granted and the contractor
acquires title to a Subject Invention.
9. Patent Rights Versus Copyrights
Comment: One respondent asserted
that the proposed Rights in Data—
Exceptional Circumstances clause
(352.227–14) had a number of problems:
The clause also requires approval of the
Contracting Officer to assert copyright
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in all data other than journal articles
(c)(1). Universities typically will accept
only Alternate IV of the general FAR
Rights in Data clause which permits
universities to assert copyright
generally. The proposed clause contains
several Alternates but not Alternate IV.
The Confidentiality requirement in
(d)(6)(ii) is open-ended, with no limit on
the duration of the requirement. The
Rights in Data clause does not make the
same distinctions among different
classes of inventions as in the Patent
Rights clause (52.227–11), which results
in asymmetrical treatment of
contractors’ rights. Finally the Data
Rights clause purports to cover
computer software which, since
potentially patentable, may conflict
with the Patent Rights clause.
Response: Patent rights and
copyrights are independent and the
clause needs no further clarification. No
time limits can be established in
advance for information deemed
confidential; it is handled on a case-bycase basis.
10. Outside Scope of This Rule
Comment: One respondent stated they
wished to express their opposition to
the proposed ‘‘accommodation’’ to the
HHS mandate regarding health
coverage.
Response: These comments were
outside the scope of this rule.
11. No Response Necessary
Comment: One respondent stated that
the proposed rule was ‘‘a little
complicate (sic), but good job[.]’’
Response: The Government
appreciates this comment.
III. Executive Orders 12866 and 13563
Executive Orders (E.O.s) 12866 and
13563 direct agencies to assess all costs
and benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). E.O. 13563 emphasizes the
importance of quantifying both costs
and benefits, of reducing costs, of
harmonizing rules, and of promoting
flexibility. This is not a significant
regulatory action, and therefore, is not
subject to review under section 6 of E.O.
12866, Regulatory Planning and Review,
dated September 30, 1993. This rule is
not a major rule under 5 U.S.C. 804.
IV. Regulatory Flexibility Act
The HHS has prepared a Final
Regulatory Flexibility Analysis (FRFA)
consistent with the Regulatory
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49017
Flexibility Act, 5 U.S.C. 601, et seq. No
public comments were submitted on the
Initial Regulatory Flexibility Analysis
and no comments were received from
the Office of Advocacy of the Small
Business Administration on this rule.
The FRFA is summarized as follows:
This final rule will amend the Health and
Human Services Acquisition Regulation
(HHSAR) to add two new clauses, 352.227–
11, Patent Rights—Exceptional
Circumstances and 352.227–14, Rights in
Data—Exceptional Circumstances. These
clauses will be used in lieu of FAR clause
52.227–14, Rights in Data—General and FAR
clause 52.227–11 Patent Rights—Ownership
by the Contractor to address the patent and
data rights of the Government, the prime
contractor, the subcontractors at all tiers) and
the providers of proprietary materials to the
Government (providers).
This action is being taken to ensure that
providers, the majority of which are small
businesses, will retain their preexisting rights
to material and subject inventions in which
the provider has a proprietary interest when
a Determination of Exceptional
Circumstances (DEC) has been executed. A
DEC promotes the policy and objectives of
the Bayh-Dole Act, 35 U.S.C. 200, et seq., to
ensure that subject inventions made under
contracts and subcontracts (at all tiers) are
used in a manner to promote free
competition and enterprise without unduly
encumbering future research and discovery;
to ensure that the Government obtains
sufficient rights in federally supported
inventions to meet its needs; to protect the
public against nonuse or unreasonable use of
inventions; and ultimately to benefit the
public health. In order to ensure that
pharmaceutical companies, academia, and
others will collaborate with the Department
of Health and Human Services (HHS) under
certain conditions in identifying, testing,
developing, and commercializing new drugs,
therapeutics, diagnostics, prognostics and
prophylactic measures affecting human
health, a determination that exceptional
circumstances must be executed, and
Contractor’s and subcontractor’s rights (at all
tiers) in subject inventions should be limited
accordingly through appropriate contract
clauses.
The affected contracts are usually awarded
using NAICS code 541711, Research and
Development in Biotechnology, or NAICS
code 541712 Research and Development in
the Physical, Engineering, and Life Sciences
(except Biotechnology). Both NAICS have a
small business size standard of 500
employees. It is estimated that this rule will
affect 61 prime contractors of which four will
be small businesses (6.5 percent); 76
subcontractors of which 21 will be small
businesses (27.6 percent); and 379 providers
of which 189 will be small businesses (49.87
percent). The aforementioned figures are
based on historical data from one operating
division of HHS. It is anticipated that
numbers will increase proportionally as the
clauses will be used on an HHS-wide basis.
Using the HHSAR clauses better addresses
the requirements of the Bayh-Dole Act and
provides appropriate legal protection for the
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proprietary rights of providers to ensure
providers will collaborate with the
Government and provide access to their
promising proprietary material(s) to meet
HHS program goals. The projected reporting,
recordkeeping, or other compliance
requirements projected for this rule will be
carried out by the prime contractor. Only a
small percentage (6.5 percent) of the prime
contractors will be small businesses. The
projected cost for compliance requirements
for those small businesses will be $28,924.38.
The final rule does not duplicate,
overlap, or conflict with any other
Federal rules. These clauses will be
used in lieu of FAR clause 52.227–14,
Rights in Data—General and FAR clause
52.227–11, Patent Rights—Ownership
by the Contractor.
In the past, a significant number of
FAR deviations were processed each
time a DEC was executed. Using the
final HHSAR clauses better addresses
the requirements of the Bayh-Dole Act
and provides solid legal protection for
the proprietary rights of providers to
ensure providers will collaborate with
the Government and provide access to
their promising proprietary material(s)
to meet HHS program goals. Therefore,
it is believed that the approach outlined
in the final rule is the most practical and
provides benefits to the Government,
the public health, and the industry to
ensure HHS program goals can be
achieved.
V. Paperwork Reduction Act
The Paperwork Reduction Act (44
U.S.C. Chapter 35) applies because this
final rule contains information
collection requirements under HHSAR
352.227–11, Patent Rights—Exceptional
Circumstances (approved under OMB
Control Number 0990–0419), and
HHSAR 352.227–14, Rights in Data—
Exceptional Circumstances (approved
under OMB Control Number 0990–
0419). In response to the notice of
proposed rulemaking and the request for
comment on the burden estimates, no
comments were received on the burden
estimates.
List of Subjects in 48 CFR Parts 327 and
352
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Government procurement.
For the reasons stated in the
preamble, HHS amends 48 CFR parts
327 and 352 as follows:
PART 327—PATENTS, DATA, AND
COPYRIGHTS
2. Add subpart 327.3 to read as
follows:
■
Subpart 327.3—Patent Rights Under
Government Contracts
Sec.
327.303 Solicitation provision and contract
clause.
Subpart 327.3—Patent Rights Under
Government Contracts
327.303 Solicitation provision and contract
clause.
The Contracting Officer shall insert
the clause at 352.227–11, Patent
Rights—Exceptional Circumstances and
any appropriate alternates in lieu of
FAR 52.227–11 whenever a
Determination of Exceptional
Circumstances (DEC) involving the
provision of materials has been
executed in accordance with Agency
policy and procedures calls for its use
and 352.227–11 appropriately covers
the circumstances. The Contracting
Officer should reference the DEC in the
solicitation and shall attach a copy of
the executed DEC to the contract.
327.404–70
[Amended]
3. Add section 327.409 to read as
follows:
■ 4. Amend section 327.404–70 by
removing the words ‘‘clause in’’ and
adding the words ‘‘clause at’’ in its
place.
■
327.409 Solicitation provision and
contract clause.
The Contracting Officer shall insert
the clause at 352.227–14, Rights in
Data—Exceptional Circumstances and
any appropriate alternates in lieu of
FAR 52.227–14 whenever a
Determination of Exceptional
Circumstances (DEC) executed in
accordance with Agency policy and
procedures calls for its use. Prior to
using this clause, a DEC must be
executed in accordance with Agency
policy and procedures. The Contracting
Officer should reference the DEC in the
solicitation and shall attach a copy of
the executed DEC to the contract.
PART 352—SOLICITATION
PROVISIONS AND CONTRACT
CLAUSES
1. The authority citation for 48 CFR
parts 327 and 352 continues to read as
follows:
■
5. Add section 352.227–11 to read as
follows:
■
Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).
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352.227–11 Patent Rights—Exceptional
Circumstances.
Patent Rights—Exceptional
Circumstances (SEPT 2014)
This clause applies to all Contractor and
subcontractor (at all tiers) Subject Inventions.
(a) Definitions. As used in this clause—
Agency means the Agency of the U.S.
Department of Health and Human Services
that is entering into this contract.
Class 1 Subject Invention means a Subject
Invention described and defined in the DEC
that will be assigned to a third party assignee,
or assigned as directed by the Agency.
Class 2 Subject Invention means a Subject
Invention described and defined in the DEC.
Class 3 Subject Invention means a Subject
Invention that does not fall into Class 1 or
Class 2 as defined in this clause.
DEC means the Determination of
Exceptional Circumstances signed by [insert
approving official] llll on llll
[insert date] llll and titled ‘‘[insert
description].’’
Invention means any invention or
discovery, which is or may be patentable or
otherwise protectable under Title 35 of
United States Code, or any novel variety of
plant that is or may be protectable under the
Plant Variety Protection Act (7 U.S.C. 2321,
et. seq.)
Made means: When used in relation to any
invention other than a plant variety, the
conception or first actual reduction to
practice of such invention; or when used in
relation to a plant variety, that the Contractor
has at least tentatively determined that the
variety has been reproduced with recognized
characteristics.
Material means any proprietary material,
method, product, composition, compound, or
device, whether patented or unpatented,
which is provided to the Contractor under
this contract.
Nonprofit organization means a university
or other institution of higher education or an
organization of the type described in section
501(c)(3) of the Internal Revenue Code of
1954 (26 U.S.C. 501(c)) and exempt from
taxation under section 501(a) of the Internal
Revenue Code (26 U.S.C. 501(a)) or any
nonprofit scientific or educational
organization qualified under a state nonprofit
organization statute.
Practical application means to
manufacture, in the case of a composition or
product; to practice, in the case of a process
or method, or to operate, in the case of a
machine or system; and, in each case, under
such conditions as to establish that the
invention is being utilized and that its
benefits are, to the extent permitted by law
or Government regulations, available to the
public on reasonable terms.
Small business firm means a small
business concern as defined at section 2 of
Public Law 85–536 (15 U.S.C. 632) and
implementing regulations of the
Administrator of the Small Business
Administration. For the purpose of this
clause, the size standards for small business
concerns involved in Government
procurement and subcontracting at 13 CFR
121.3–8 and 13 CFR 121.3–12, respectively,
will be used.
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Subject Invention means any invention of
the Contractor made in the performance of
work under this contract.
Third party assignee means any entity or
organization that may, as described in the
DEC, be assigned Class 1 inventions.
(b) Allocation of principal rights. (1)
Retention of pre-existing rights. Third party
assignees shall retain all preexisting rights to
Material in which the Third party assignee
has a proprietary interest.
(2) Allocation of Subject Invention rights.
(i) Disposition of Class 1 Subject Inventions.
(A) Assignment to the Third party assignee
or as directed by the Agency. The Contractor
shall assign to the Third party assignee
designated by the Agency the entire right,
title, and interest throughout the world to
each Subject Invention, or otherwise dispose
of or transfer those rights as directed by the
Agency, except to the extent that rights are
retained by the Contractor under paragraph
(b)(3) of this clause. Any such assignment or
other disposition or transfer of rights will be
subject to a nonexclusive, nontransferable,
irrevocable, paid-up license to the U.S.
Government to practice or have practiced the
Subject Invention for or on behalf of the U.S.
throughout the world. Any assignment shall
additionally be subject to the ‘‘March-in
rights’’ of 35 U.S.C. 203. If the Contractor is
a U.S. nonprofit organization it may retain a
royalty free, nonexclusive, nontransferable
license to practice the invention for all
nonprofit research including for educational
purposes, and to permit other U.S. nonprofit
organizations to do so.
(B) [Reserved]
(ii) Disposition of Class 2 and 3 Subject
Inventions. Class 2 Subject Inventions shall
be governed by FAR clause 52.227–11, Patent
Rights-Ownership (December 2007)
(incorporated herein by reference). However,
the Contractor shall grant a license in the
Class 2 Subject Inventions to the provider of
the Material or other party designated by the
Agency as set forth in Alternate I.
(iii) Class 3 Subject Inventions shall be
governed by FAR clause 52.227–11, Patent
Rights-Ownership by the Contractor
(December 2007) (previously incorporated
herein by reference).
(3) Greater Rights Determinations. The
Contractor, or an employee-inventor after
consultation by the Agency with the
Contractor, may request greater rights than
are provided in paragraph (b)(1) of this clause
in accordance with the procedures of FAR
paragraph 27.304–1(c). In addition to the
considerations set forth in paragraph 27.304–
1(c), the Agency may consider whether
granting the requested greater rights will
interfere with rights of the Government or
any Third party assignee or otherwise
impede the ability of the Government or the
Third party assignee to, for example, develop
and commercialize new compounds, dosage
forms, therapies, preventative measures,
technologies, or other approaches with
potential for the diagnosis, prognosis,
prevention, and treatment of human diseases.
A request for a determination of whether
the Contractor or the employee-inventor is
entitled to retain such greater rights must be
submitted to the Agency Contracting Officer
at the time of the first disclosure of the
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invention pursuant to paragraph (c)(1) of this
clause, or not later than 8 months thereafter,
unless a longer period is authorized in
writing by the Contracting Officer for good
cause shown in writing by the Contractor.
Each determination of greater rights under
this contract shall be subject to paragraph (c)
of the FAR clause at 52.227–13 (incorporated
herein by reference), and to any reservations
and conditions deemed to be appropriate by
the Agency such as the requirement to assign
or exclusively license the rights to Subject
Inventions to the Third party assignee.
A determination by the Agency denying a
request by the Contractor for greater rights in
a Subject Invention may be appealed within
30 days of the date the Contractor is notified
of the determination to an Agency official at
a level above the individual who made the
determination. If greater rights are granted,
the Contractor must file a patent application
on the invention. Upon request, the
Contractor shall provide the filing date, serial
number and title, a copy of the patent
application (including an English-language
version if filed in a language other than
English), and patent number and issue date
for any Subject Invention in any country for
which the Contractor has retained title. Upon
request, the Contractor shall furnish the
Government an irrevocable power to inspect
and make copies of the patent application
file.
(c) Invention disclosure by Contractor. The
Contractor shall disclose in writing each
Subject Invention to the Agency Contracting
Officer and to the Director, Division of
Extramural Inventions and Technology
Resources (DEITR), if directed by the
Contracting Officer, as provided in paragraph
(j) of this clause within 2 months after the
inventor discloses it in writing to Contractor
personnel responsible for patent matters. The
disclosure to the Agency Contracting Officer
shall be in the form of a written report and
shall identify the contract under which the
invention was Made and all inventors. It
shall be sufficiently complete in technical
detail to convey a clear understanding to the
extent known at the time of the disclosure,
of the nature, purpose, operation, and the
physical, chemical, biological, or electrical
characteristics of the invention. The
disclosure shall also identify any publication,
on sale (offer for sale), or public use of the
invention and whether a manuscript
describing the invention has been submitted
for publication, and if so, whether it has been
accepted for publication at the time of
disclosure.
In addition, after disclosure to the Agency,
the Contractor will promptly notify the
Contracting Officer and DEITR of the
acceptance of any manuscript describing the
invention for publication or of any on sale or
public use planned by the Contractor. If the
Contractor assigns a Subject Invention to the
Third party assignee, then the Contractor and
its employee inventors shall assist the Third
party assignee in securing patent protection.
All costs of securing the patent, including the
cost of the Contractor’s assistance, are at the
Third party’s expense. Any assistance
provided by the Contractor and its employee
inventors to the Third party assignee or other
costs incurred in securing patent protection
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shall be solely at the Third party’s expense
and not billable to the contract.
(d) Contractor action to protect the Third
party assignee’s and the Government’s
interest. (1) The Contractor agrees to execute
or to have executed and promptly deliver to
the Agency all instruments necessary to:
Establish or confirm the rights the
Government has throughout the world in
Subject Inventions pursuant to paragraph (b)
of this clause; convey title to a Third party
assignee in accordance with paragraph (b) of
this clause; and enable the Third party
assignee to obtain patent protection
throughout the world in that Subject
Invention.
(2) The Contractor agrees to require, by
written agreement, its employees, other than
clerical and nontechnical employees, to
disclose promptly in writing to personnel
identified as responsible for the
administration of patent matters and in a
format suggested by the Contractor, each
Subject Invention ‘‘Made’’ under contract in
order that the Contractor can comply with
the disclosure provisions of paragraph (c) of
this clause, and to execute all papers
necessary to file patent applications on
Subject Inventions and to establish the
Government’s rights or a Third party
assignee’s rights in the Subject Inventions.
This disclosure format should require, as a
minimum, the information required by
subparagraph (c)(1) of this clause. The
Contractor shall instruct such employees,
through employee agreements or other
suitable educational programs, on the
importance of reporting inventions in
sufficient time to permit the filing of patent
applications prior to U.S. or foreign statutory
bars.
(3) If the Contractor is granted greater
rights, the Contractor agrees to include,
within the specification of any United States
non-provisional patent application it files,
and any patent issuing thereon, covering a
Subject Invention the following statement:
‘‘This invention was made with Government
support under (identify the Contract)
awarded by (identify the specific Agency).
The Government has certain rights in the
invention.’’
(4) The Contractor agrees to provide a final
invention statement and certification prior to
the closeout of the contract listing all Subject
Inventions or stating that there were none.
(e) Subcontracts. (1) The Contractor will
include this clause in all subcontracts,
regardless of tier, for experimental,
developmental, or research work. At all tiers,
the clause must be modified to identify the
parties as follows: References to the
Government are not changed, and the
subcontractor has all rights and obligations of
the Contractor in the clause. The Contractor
will not, as part of the consideration for
awarding the contract, obtain rights in the
subcontractor’s Subject Inventions.
(2) In subcontracts, at any tier, the Agency,
the subcontractor, and the Contractor agree
that the mutual obligations of the parties
created by this clause constitute a contract
between the subcontractor and the Agency
with respect to the matters covered by the
clause; provided, however, that nothing in
this paragraph is intended to confer any
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jurisdiction under the Contract Disputes Act
in connection with proceedings under
paragraph (c)(1)(ii) of FAR clause 52.227–13.
(f) Reporting on utilization of Subject
Inventions in the event greater rights are
granted to the Contractor. The Contractor
agrees to submit, on request, periodic reports
no more frequently than annually on the
utilization of a Subject Invention or on efforts
at obtaining such utilization that are being
made by the Contractor or its licensees or
assignees when a request under subparagraph
b.3. has been granted by the Agency. Such
reports shall include information regarding
the status of development, date of first
commercial sale or use, gross royalties
received by the Contractor, and such other
data and information as the Agency may
reasonably specify. The Contractor also
agrees to provide additional reports as may
be requested by the Agency in connection
with any march-in proceeding undertaken by
the Agency in accordance with paragraph (h)
of this clause. As required by 35 U.S.C.
202(c)(5), the Agency agrees it will not
disclose such information to persons outside
the Government without permission of the
Contractor.
(g) Preference for United States industry in
the event greater rights are granted to the
Contractor. Notwithstanding any other
provision of this clause, the Contractor agrees
that neither it nor any assignee will grant to
any person the exclusive right to use or sell
any Subject Invention in the United States
unless such person agrees that any product
embodying the Subject Invention or
produced through the use of the Subject
Invention will be manufactured substantially
in the United States. However, in individual
cases, the requirement for such an agreement
may be waived by the Agency upon a
showing by the Contractor or its assignee that
reasonable but unsuccessful efforts have been
made to grant licenses on similar terms to
potential licensees that would be likely to
manufacture substantially in the United
States or that under the circumstances
domestic manufacture is not commercially
feasible.
(h) March-in rights in the event greater
rights are granted to the Contractor. The
Contractor acknowledges that, with respect to
any Subject Invention in which it has
acquired ownership through the exercise of
the rights specified in paragraph (b)(3) of this
clause, the Agency has the right to require
licensing pursuant to 35 U.S.C. 203 and
210(c), and in accordance with the
procedures in 37 CFR 401.6 and any
supplemental regulations of Agency in effect
on the date of contract award.
(i) Special provisions for contracts with
nonprofit organizations in the event greater
rights are granted to the Contractor. If the
Contractor is a nonprofit organization, it
shall:
(1) Not assign rights to a Subject Invention
in the United States without the written
approval of the Agency, except where an
assignment is made to an organization that
has as one of its primary functions the
management of inventions, provided that the
assignee shall be subject to the same
provisions as the Contractor;
(2) Share royalties collected on a Subject
Invention with the inventor, including
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Federal employee co-inventors (but through
their Agency if the Agency deems it
appropriate) when the Subject Invention is
assigned in accordance with 35 U.S.C. 202(e)
and 37 CFR 401.10;
(3) Use the balance of any royalties or
income earned by the Contractor with respect
to Subject Inventions, after payment of
expenses (including payments to inventors)
incidental to the administration of Subject
Inventions for the support of scientific
research or education;
(4) Make efforts that are reasonable under
the circumstances to attract licensees of
Subject Inventions that are small business
concerns, and give a preference to a small
business concern when licensing a Subject
Invention if the Contractor determines that
the small business concern has a plan or
proposal for marketing the invention which,
if executed, is equally as likely to bring the
invention to practical application as any
plans or proposals from applicants that are
not small business concerns; provided, that
the Contractor is also satisfied that the small
business concern has the capability and
resources to carry out its plan or proposal.
The decision whether to give a preference in
any specific case will be at the discretion of
the Contractor; and
(5) Allow the Secretary of Commerce to
review the Contractor’s licensing program
and decisions regarding small business
applicants, and negotiate changes to its
licensing policies, procedures, or practices
with the Secretary of Commerce when the
Secretary’s review discloses that the
Contractor could take reasonable steps to
more effectively implement the requirements
of paragraph (i)(4) of this clause.
(j) Communications. All invention
disclosures and requests for greater rights
shall be sent to the Agency Contracting
Officer, as directed by the Contracting
Officer. Additionally, a copy of all
disclosures, confirmatory licenses to the
Government, face page of the patent
applications, waivers and other routine
communications under this funding
agreement at all tiers must be sent to:
[Insert Agency Address]
Agency Invention Reporting Web site:
https://www.iEdison.gov.
Alternate I (Sept 2014). As prescribed in
327.303, the license to Class 2 inventions
recited in 352.227–11(b)(2)(a) is as follows:
[Insert description of license to Class 2
inventions]
(End of clause)
■ 6. Add section 352.227–14 to read as
follows:
352.227–14 Rights in Data—Exceptional
Circumstances.
As prescribed in 327.409(b)(1), insert
the following clause with any
appropriate alternates:
Rights in Data—Exceptional Circumstances
(SEPT 2014)
(a) Definitions. As used in this clause—
[Definitions may be added or modified in
paragraph (a) as applicable.]
Computer database or database means a
collection of recorded information in a form
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capable of, and for the purpose of, being
stored in, processed, and operated on by a
computer. The term does not include
computer software.
Computer software—(i) Means (A)
Computer programs that comprise a series of
instructions, rules, routines, or statements,
regardless of the media in which recorded,
that allow or cause a computer to perform a
specific operation or series of operations; and
(B) Recorded information comprising
source code listings, design details,
algorithms, processes, flow charts, formulas,
and related material that would enable the
computer program to be produced, created,
or compiled.
(ii) Does not include computer databases or
computer software documentation.
Computer software documentation means
owner’s manuals, user’s manuals, installation
instructions, operating instructions, and
other similar items, regardless of storage
medium, that explain the capabilities of the
computer software or provide instructions for
using the software.
Data means recorded information,
regardless of form or the media on which it
may be recorded. The term includes
technical data and computer software. The
term does not include information incidental
to contract administration, such as financial,
administrative, cost or pricing, or
management information.
Form, fit, and function data means data
relating to items, components, or processes
that are sufficient to enable physical and
functional interchangeability, and data
identifying source, size, configuration,
mating and attachment characteristics,
functional characteristics, and performance
requirements. For computer software it
means data identifying source, functional
characteristics, and performance
requirements but specifically excludes the
source code, algorithms, processes, formulas,
and flow charts of the software.
Limited rights means the rights of the
Government in limited rights data as set forth
in the Limited Rights Notice in Alternate II
paragraph (g)(3) if included in this clause.
‘‘Limited rights data’’ means data, other than
computer software, that embody trade secrets
or are commercial or financial and
confidential or privileged, to the extent that
such data pertain to items, components, or
processes developed at private expense,
including minor modifications.
Restricted computer software means
computer software developed at private
expense and that is a trade secret, is
commercial or financial and confidential or
privileged, or is copyrighted computer
software, including minor modifications of
the computer software.
Restricted rights, as used in this clause,
means the rights of the Government in
restricted computer software, as set forth in
a Restricted Rights Notice of Alternate III
paragraph (g)(4) if included in this clause, or
as otherwise may be provided in a collateral
agreement incorporated in and made part of
this contract, including minor modifications
of such computer software.
Technical data means recorded
information (regardless of the form or method
of the recording) of a scientific or technical
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nature (including computer databases and
computer software documentation). This
term does not include computer software or
financial, administrative, cost or pricing, or
management data or other information
incidental to contract administration. The
term includes recorded information of a
scientific or technical nature that is included
in computer databases (See 41 U.S.C. 403(8)).
Unlimited rights means the rights of the
Government to use, disclose, reproduce,
prepare derivative works, distribute copies to
the public, and perform publicly and display
publicly, in any manner and for any purpose,
and to have or permit others to do so.
(b) Allocation of rights. (1) Except as
provided in paragraph (c) of this clause, the
Government shall have unlimited rights in—
(i) Data first produced in the performance
of this contract;
(ii) Form, fit, and function data delivered
under this contract;
(iii) Data delivered under this contract
(except for restricted computer software) that
constitute manuals or instructional and
training material for installation, operation,
or routine maintenance and repair of items,
components, or processes delivered or
furnished for use under this contract; and
(iv) All other data delivered under this
contract unless provided otherwise for
limited rights data or restricted computer
software in accordance with paragraph (g) of
this clause.
(2) The Contractor shall have the right to—
(i) Assert copyright in data first produced
in the performance of this contract to the
extent provided in paragraph (c)(1) of this
clause;
(ii) Use, release to others, reproduce,
distribute, or publish any data first produced
or specifically used by the Contractor in the
performance of this contract, unless provided
otherwise in paragraph (d) of this clause;
(iii) Substantiate the use of, add, or correct
limited rights, restricted rights, or copyright
notices and to take other appropriate action,
in accordance with paragraphs (e) and (f) of
this clause; and
(iv) Protect from unauthorized disclosure
and use those data that are limited rights data
or restricted computer software to the extent
provided in paragraph (g) of this clause.
(c) Copyright. (1) Data first produced in the
performance of this contract. (i) Unless
provided otherwise in paragraph (d) of this
clause, the Contractor may, without prior
approval of the Contracting Officer, assert
copyright in scientific and technical articles
based on or containing data first produced in
the performance of this contract and
published in academic, technical or
professional journals, symposia proceedings,
or similar works. The prior, express written
permission of the Contracting Officer is
required to assert copyright in all other data
first produced in the performance of this
contract.
(ii) When authorized to assert copyright to
the data, the Contractor shall affix the
applicable copyright notices of 17 U.S.C. 401
or 402, and an acknowledgment of
Government sponsorship (including contract
number).
(iii) For data other than computer software,
the Contractor grants to the Government and
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others acting on its behalf, a paid-up,
nonexclusive, irrevocable, worldwide license
in such copyrighted data to reproduce,
prepare derivative works, distribute copies to
the public, and perform publicly and display
publicly by or on behalf of the Government.
For computer software, the Contractor grants
to the Government, and others acting on its
behalf, a paid-up, nonexclusive, irrevocable,
worldwide license in such copyrighted
computer software to reproduce, prepare
derivative works, and perform publicly and
display publicly (but not to distribute copies
to the public) by or on behalf of the
Government.
(2) Data not first produced in the
performance of this contract. The Contractor
shall not, without the prior written
permission of the Contracting Officer,
incorporate in data delivered under this
contract any data not first produced in the
performance of this contract unless the
Contractor—
(i) Identifies the data; and
(ii) Grants to the Government, or acquires
on its behalf, a license of the same scope as
set forth in paragraph (c)(1) of this clause or,
if such data are restricted computer software,
the Government shall acquire a copyright
license as set forth in paragraph (g)(4) of this
clause (if included in this contract) or as
otherwise provided in a collateral agreement
incorporated in or made part of this contract.
(3) Removal of copyright notices. The
Government will not remove any authorized
copyright notices placed on data pursuant to
this paragraph (c), and will include such
notices on all reproductions of the data.
(d) Release, publication, and use of data.
The Contractor shall have the right to use,
release to others, reproduce, distribute, or
publish any data first produced or
specifically used by the Contractor in the
performance of this contract, except—
(1) As prohibited by Federal law or
regulation (e.g., export control or national
security laws or regulations);
(2) As expressly set forth in this contract;
or
(3) If the Contractor receives or is given
access to data necessary for the performance
of this contract that contain restrictive
markings, the Contractor shall treat the data
in accordance with such markings unless
specifically authorized otherwise in writing
by the Contracting Officer or in the following
paragraphs.
(4) In addition to any other provisions, set
forth in this contract, the Contractor shall
ensure that information concerning possible
inventions made under this contract is not
prematurely published thereby adversely
affecting the ability to obtain patent
protection on such inventions. Accordingly,
the Contractor will provide the Contracting
Officer a copy of any publication or other
public disclosure relating to the work
performed under this contract at least 30
days in advance of the disclosure. Upon the
Contracting Officer’s request the Contractor
agrees to delay the public disclosure of such
data or publication of a specified paper for
a reasonable time specified by the
Contracting Officer, not to exceed 6 months,
to allow for the filing of domestic and
international patent applications in
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accordance with Clause 352.227–11, Patent
Rights—Exceptional Circumstances
(abbreviated month and year of Final Rule
publication).
(5) Data on Material(s). The Contractor
agrees that in accordance with paragraph
(d)(2), proprietary data on Material(s)
provided to the Contractor under or through
this contract shall be used only for the
purpose for which they were provided,
including screening, evaluation or
optimization and for no other purpose.
(6) Confidentiality. (i) The Contractor shall
take all reasonable precautions to maintain
Confidential Information as confidential, but
no less than the steps Contractor takes to
secure its own confidential information.
(ii) Contractor shall maintain Confidential
Information as confidential unless
specifically authorized otherwise in writing
by the Contracting Officer. Confidential
Information includes/does not include
[Government may define confidential
information here.]
(e) Unauthorized marking of data. (1)
Notwithstanding any other provisions of this
contract concerning inspection or
acceptance, if any data delivered under this
contract are marked with the notices
specified in paragraph (g)(3) or (4) of this
clause (if those alternate paragraphs are
included in this clause), and use of the
notices is not authorized by this clause, or if
the data bears any other restrictive or limiting
markings not authorized by this contract, the
Contracting Officer may cancel or ignore the
markings. However, pursuant to 41 U.S.C.
253d, the following procedures shall apply
prior to canceling or ignoring the markings.
(i) The Contracting Officer will make
written inquiry to the Contractor affording
the Contractor 60 days from receipt of the
inquiry to provide written justification to
substantiate the propriety of the markings;
(ii) If the Contractor fails to respond or fails
to provide written justification to
substantiate the propriety of the markings
within the 60-day period (or a longer time
approved in writing by the Contracting
Officer for good cause shown), the
Government shall have the right to cancel or
ignore the markings at any time after said
period and the data will no longer be made
subject to any disclosure prohibitions.
(iii) If the Contractor provides written
justification to substantiate the propriety of
the markings within the period set in
paragraph (e)(1)(i) of this clause, the
Contracting Officer will consider such
written justification and determine whether
or not the markings are to be cancelled or
ignored. If the Contracting Officer determines
that the markings are authorized, the
Contractor will be so notified in writing. If
the Contracting Officer determines, with
concurrence of the head of the contracting
activity, that the markings are not authorized,
the Contracting Officer will furnish the
Contractor a written determination, which
determination will become the final Agency
decision regarding the appropriateness of the
markings unless the Contractor files suit in
a court of competent jurisdiction within 90
days of receipt of the Contracting Officer’s
decision. The Government will continue to
abide by the markings under this paragraph
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(e)(1)(iii) until final resolution of the matter
either by the Contracting Officer’s
determination becoming final (in which
instance the Government will thereafter have
the right to cancel or ignore the markings at
any time and the data will no longer be made
subject to any disclosure prohibitions), or by
final disposition of the matter by court
decision if suit is filed.
(2) The time limits in the procedures set
forth in paragraph (e)(1) of this clause may
be modified in accordance with Agency
regulations implementing the Freedom of
Information Act (5 U.S.C. 552) if necessary to
respond to a request there under.
(3) Except to the extent the Government’s
action occurs as the result of final disposition
of the matter by a court of competent
jurisdiction, the Contractor is not precluded
by this paragraph (e) from bringing a claim,
in accordance with the Disputes clause of
this contract, that may arise as the result of
the Government removing or ignoring
authorized markings on data delivered under
this contract.
(f) Omitted or incorrect markings. (1) Data
delivered to the Government without any
restrictive markings shall be deemed to have
been furnished with unlimited rights. The
Government is not liable for the disclosure,
use, or reproduction of such data.
(2) If the unmarked data has not been
disclosed without restriction outside the
Government, the Contractor may request,
within 6 months (or a longer time approved
by the Contracting Officer in writing for good
cause shown) after delivery of the data,
permission to have authorized notices placed
on the data at the Contractor’s expense. The
Contracting Officer may agree to do so if the
Contractor—
(i) Identifies the data to which the omitted
notice is to be applied;
(ii) Demonstrates that the omission of the
notice was inadvertent;
(iii) Establishes that the proposed notice is
authorized; and
(iv) Acknowledges that the Government
has no liability for the disclosure, use, or
reproduction of any data made prior to the
addition of the notice or resulting from the
omission of the notice.
(3) If data has been marked with an
incorrect notice, the Contracting Officer
may—
(i) Permit correction of the notice at the
Contractor’s expense if the Contractor
identifies the data and demonstrates that the
correct notice is authorized; or
(ii) Correct any incorrect notices.
(g) Protection of limited rights data and
restricted computer software.
(1) The Contractor may withhold from
delivery qualifying limited rights data or
restricted computer software that are not data
identified in paragraphs (b)(1)(i) through (iii)
of this clause. As a condition to this
withholding, the Contractor shall—
(i) Identify the data being withheld; and
(ii) Furnish form, fit, and function data
instead.
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(2) Limited rights data that are formatted as
a computer database for delivery to the
Government shall be treated as limited rights
data and not restricted computer software.
(3) [Reserved]
(h) Subcontracting. The Contractor shall
obtain from its subcontractors all data and
rights therein necessary to fulfill the
Contractor’s obligations to the Government
under this contract. If a subcontractor refuses
to accept terms affording the Government
those rights, the Contractor shall promptly
notify the Contracting Officer of the refusal
and shall not proceed with the subcontract
award without authorization in writing from
the Contracting Officer.
(i) Relationship to patents or other rights.
Nothing contained in this clause shall imply
a license to the Government under any patent
or be construed as affecting the scope of any
license or other right otherwise granted to the
Government.
(End of clause)
Alternate I (SEPT 2014). As prescribed in
327.409, substitute the following definition
for ‘‘limited rights data’’ in paragraph (a) of
the basic clause:
Limited rights data means data, other than
computer software, developed at private
expense that embody trade secrets or are
commercial or financial and confidential or
privileged.
Alternate II (SEPT 2014). As prescribed in
327.409, insert the following paragraph (g)(3)
in the basic clause:
(g)(3) Notwithstanding paragraph (g)(1) of
this clause, the contract may identify and
specify the delivery of limited rights data, or
the Contracting Officer may require by
written request the delivery of limited rights
data that has been withheld or would
otherwise be entitled to be withheld. If
delivery of that data is required, the
Contractor shall affix the following ‘‘Limited
Rights Notice’’ to the data and the
Government will treat the data, subject to the
provisions of paragraphs (e) and (f) of this
clause, in accordance with the notice:
Limited Rights Notice (SEPT 2014)
(a) These data are submitted with limited
rights under Government Contract No. lll
l (and subcontract llll, if appropriate).
These data may be reproduced and used by
the Government with the express limitation
that they will not, without written
permission of the Contractor, be used for
purposes of manufacture nor disclosed
outside the Government; except that the
Government may disclose these data outside
the Government for the following purposes,
if any; provided that the Government makes
such disclosure subject to prohibition against
further use and disclosure: [Agencies may list
additional purposes or if none, so state.]
(b) This notice shall be marked on any
reproduction of these data, in whole or in
part.
(End of notice)
PO 00000
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Fmt 4700
Sfmt 4700
Alternate III (SEPT 2014). As prescribed in
327.409, insert the following paragraph (g)(4)
in the basic clause: (g)(4)(i) Notwithstanding
paragraph (g)(1) of this clause, the contract
may identify and specify the delivery of
restricted computer software, or the
Contracting Officer may require by written
request the delivery of restricted computer
software that has been withheld or would
otherwise be entitled to be withheld. If
delivery of that computer software is
required, the Contractor shall affix the
following ‘‘Restricted Rights Notice’’ to the
computer software and the Government will
treat the computer software, subject to
paragraphs (e) and (f) of this clause, in
accordance with the notice:
Restricted Rights Notice (SEPT 2014)
(a) This computer software is submitted
with restricted rights under Government
Contract No. llll (and subcontract ll
ll, if appropriate). It may not be used,
reproduced, or disclosed by the Government
except as provided in paragraph (b) of this
notice or as otherwise expressly stated in the
contract.
(b) This computer software may be—
(1) Used or copied for use with the
computer(s) for which it was acquired,
including use at any Government installation
to which the computer(s) may be transferred;
(2) Used or copied for use with a backup
computer if any computer for which it was
acquired is inoperative;
(3) Reproduced for safekeeping (archives)
or backup purposes;
(4) Modified, adapted, or combined with
other computer software, provided that the
modified, adapted, or combined portions of
the derivative software incorporating any of
the delivered, restricted computer software
shall be subject to the same restricted rights;
(5) Disclosed to and reproduced for use by
support service Contractors or their
subcontractors in accordance with
paragraphs (b)(1) through (4) of this notice;
and
(6) Used or copied for use with a
replacement computer.
(c) Notwithstanding the foregoing, if this
computer software is copyrighted computer
software, it is licensed to the Government
with the minimum rights set forth in
paragraph (b) of this notice.
(d) Any other rights or limitations
regarding the use, duplication, or disclosure
of this computer software are to be expressly
stated in, or incorporated in, the contract.
(e) This notice shall be marked on any
reproduction of this computer software, in
whole or in part.
(End of notice)
(ii) Where it is impractical to include the
Restricted Rights Notice on restricted
computer software, the following short-form
notice may be used instead:
E:\FR\FM\19AUR1.SGM
19AUR1
Federal Register / Vol. 79, No. 160 / Tuesday, August 19, 2014 / Rules and Regulations
wreier-aviles on DSK5TPTVN1PROD with RULES
Restricted Rights Notice Short Form (SEPT
2014)
Use, reproduction, or disclosure is subject
to restrictions set forth in Contract No. ll
ll (and subcontract, if appropriate) with l
lll (name of Contractor and
subcontractor).
(End of notice)
(iii) If restricted computer software is
delivered with the copyright notice of 17
U.S.C. 401, it will be presumed to be licensed
to the Government without disclosure
prohibitions, with the minimum rights set
forth in paragraph (b) of this clause.
Alternate IV (SEPT 2014). As prescribed in
327.409, substitute the following paragraph
(c)(1) for paragraph (c)(1) of the basic clause:
(c) Copyright—(1) Data first produced in
the performance of the contract. Except as
otherwise specifically provided in this
contract, the Contractor may assert copyright
in any data first produced in the performance
of this contract. When asserting copyright,
the Contractor shall affix the applicable
copyright notice of 17 U.S.C. 401 or 402, and
an acknowledgment of Government
sponsorship (including contract number), to
the data when such data are delivered to the
Government, as well as when the data are
published or deposited for registration as a
published work in the U.S. Copyright Office.
For data other than computer software, the
Contractor grants to the Government, and
others acting on its behalf, a paid-up,
nonexclusive, irrevocable, worldwide license
for all such data to reproduce, prepare
derivative works, distribute copies to the
public, and perform publicly and display
publicly, by or on behalf of the Government.
For computer software, the Contractor grants
to the Government and others acting on its
behalf, a paid-up, nonexclusive, irrevocable,
worldwide license for all such computer
software to reproduce, prepare derivative
works, and perform publicly and display
publicly (but not to distribute copies to the
public), by or on behalf of the Government.
Alternate V (SEPT 2014). As prescribed in
327.409, add the following paragraph (j) to
the basic clause:
(j) The Contractor agrees, except as may be
otherwise specified in this contract for
specific data deliverables listed as not subject
to this paragraph, that the Contracting Officer
may, up to 3 years after acceptance of all
deliverables under this contract, inspect at
the Contractor’s facility any data withheld
pursuant to paragraph (g)(1) of this clause, for
purposes of verifying the Contractor’s
VerDate Mar<15>2010
14:25 Aug 18, 2014
Jkt 232001
assertion of limited rights or restricted rights
status of the data or for evaluating work
performance. When the Contractor whose
data are to be inspected demonstrates to the
Contracting Officer that there would be a
possible conflict of interest if a particular
representative made the inspection, the
Contracting Officer shall designate an
alternate inspector.
49023
50 CFR Part 17
Register on August 12, 2014 (79 FR
47222), that determined endangered
species status under the Act (16 U.S.C.
1531 et seq.) for two butterflies: the
Florida leafwing (Anaea troglodyta
floridalis) and Bartram’s scrubhairstreak (Strymon acis bartrami). In
the amendatory language of that rule, for
the two butteflies’ entries, we
inadvertently added a ‘‘Family’’ column
to the List of Endangered and
Threatened Wildlife (List) at title 50,
section 17.11(h), of the Code of Federal
Regulations. The List does not have a
‘‘Family’’ column. In order to have the
two butterflies’ entries set forth
accurately in the List, we are publishing
this correction, which newly and
correctly sets forth the Regulation
Promulgation section of the final we
published at 79 FR 47222 (August 12,
2014).
[Docket No. FWS–R4–ES–2013–0084;
4500030113]
List of Subjects in 50 CFR Part 17
RIN 1018–AZ08
Endangered and threatened species,
Exports, Imports, Reporting and
recordkeeping requirements,
Transportation.
Dated: August 11, 2014.
Angela Billups,
Associate Deputy Assistant Secretary for
Acquisition.
[FR Doc. 2014–19312 Filed 8–18–14; 8:45 am]
BILLING CODE 4150–24–P
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
Endangered and Threatened Wildlife
and Plants; Endangered Status for the
Florida Leafwing and Bartram’s ScrubHairstreak Butterflies; Correction
AGENCY:
Fish and Wildlife Service,
Interior.
Final rule; correction.
Regulation Promulgation
Accordingly, we amend part 17,
subchapter B of chapter I, title 50 of the
Code of Federal Regulations, as follows:
ACTION:
We, the U.S. Fish and
Wildlife Service, published a final rule
in the Federal Register on August 12,
2014, that determined endangered
species status under the Endangered
Species Act of 1973, as amended (Act),
for the Florida leafwing (Anaea
troglodyta floridalis) and Bartram’s
scrub-hairstreak (Strymon acis
bartrami), two butterflies endemic to
South Florida. In that rule, we made an
error in our amendatory language. With
this document, we correct our error.
DATES: Effective September 11, 2014.
FOR FURTHER INFORMATION CONTACT:
Anissa Craghead, (703) 358–2445.
SUPPLEMENTARY INFORMATION: We
published a final rule in the Federal
SUMMARY:
PO 00000
Frm 00083
Fmt 4700
Sfmt 4700
PART 17—[AMENDED]
1. The authority citation for part 17
continues to read as follows:
■
Authority: 16 U.S.C. 1361–1407; 16 U.S.C.
1531–1544; 16 U.S.C. 4201–4245, unless
otherwise noted.
2. Amend § 17.11(h) by adding entries
for ‘‘Butterfly, Bartram’s scrubhairstreak’’ and ‘‘Butterfly, Florida
leafwing’’ to the List of Endangered and
Threatened Wildlife in alphabetical
order under INSECTS to read as set
forth below:
■
§ 17.11 Endangered and threatened
wildlife.
*
*
*
(h) * * *
E:\FR\FM\19AUR1.SGM
19AUR1
*
*
Agencies
[Federal Register Volume 79, Number 160 (Tuesday, August 19, 2014)]
[Rules and Regulations]
[Pages 49015-49023]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19312]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
48 CFR Parts 327 and 352
RIN 0991-AB87
Acquisition Regulations
AGENCY: Division of Acquisition, Office of Grants and Acquisition
Policy and Accountability, Office of the Assistant Secretary for
Financial Resources, Department of Health and Human Services.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services (HHS) is issuing a
final rule to amend its Federal Acquisition Regulation (FAR)
Supplement--the HHS Acquisition Regulation (HHSAR)--to add two clauses,
Patent Rights--Exceptional Circumstances and, Rights in Data--
Exceptional Circumstances, and their prescriptions.
DATES: Effective Date: September 18, 2014.
FOR FURTHER INFORMATION CONTACT: Cheryl Howe, Procurement Analyst,
Department of Health and Human Services, Office of the Assistant
Secretary for Financial Resources, Office of Grants and Acquisition
Policy and Accountability, Division of Acquisition at (202) 690-5552.
SUPPLEMENTARY INFORMATION:
I. Background
The HHS published a proposed rule in the Federal Register at 78 FR
2229 on January 10, 2013, to ensure that providers of proprietary
material(s) to the Government will retain all their preexisting rights
to their material(s), and rights to any inventions made under a
contract or subcontract (at all tiers), when a Determination of
Exceptional Circumstances (DEC) has been executed.
``Material'' means any proprietary material, method, product,
composition, compound, or device, whether patented or unpatented.
A DEC is executed consistent with the policy and objectives of the
Bayh-Dole Act, 35 U.S.C. 200, et seq., to ensure that subject
inventions made under contracts and subcontracts (at all tiers) are
used in a manner to promote free competition and enterprise without
unduly encumbering future research and discovery; to encourage maximum
participation of small business firms in federally supported research
and development efforts; to promote collaboration between commercial
concerns and nonprofit organizations including universities; to ensure
that the Government obtains sufficient rights in federally supported
inventions to meet its needs; to protect the public against nonuse or
unreasonable use of inventions, and in the case of fulfilling the
mission of the Department of Health and Human Services, to ultimately
benefit the public health.
Under certain circumstances, in order to ensure that pharmaceutical
companies, academia, and others will collaborate with HHS in
identifying, testing, developing, and commercializing new drugs,
therapeutics, diagnostics, prognostics and prophylactic measures
affecting human health, a DEC must be executed and Contractor's and
subcontractor's rights (at all tiers) in subject inventions should be
limited accordingly, consistent with DEC requirements and through
appropriate contract clauses.
II. Discussion and Analysis
A. Summary of Significant Changes
The comment period for the proposed rule closed on March 11, 2013.
The HHS received responses from four respondents with 11 comments,
collectively; however, only three of those comments resulted in minor
[[Page 49016]]
changes to the final rule. The comments are discussed below.
B. Analysis of Public Comments
1. Definition of ``Made''
Comment: One respondent states that while institutions are able to
manage this in terms of preserving Government rights under the Bayh-
Dole Act, it does raise potential legal conflicts if the institution
has obligations to another sponsor who funded the conception and then
must assign ownership rights to the Third party assignee under these
clauses. Therefore, the commenter strongly urged HHS to change the
definition for ``made'' to ``conception and first actual reduction to
practice. . .'' with respect to the rights of the Third party assignee.
Response: The final rule is acceptable as it reflects statutory
language.
2. License Retention by Nonprofit Organization
Comment: Two respondents stated that U.S. nonprofit educational
institutions may retain a nonexclusive, royalty free license for
noncommercial internal research, but not for educational purposes,
which is a key mission for such institutions. Nor would this allow
sharing with other nonprofit academic institutions as required under
the National Institutes of Health policy. In addition, since most
research at U.S. universities is sponsored, it is unclear what
``internal'' will permit. Therefore, we recommended that the retention
of rights be clarified as ``nonprofit research and educational
purposes.''
Response: The Government agrees that the license may be retained by
U.S. nonprofit organizations and that the language should be modified.
The clause language was rewritten to include: ``If the Contractor is a
U.S. nonprofit organization it may retain a royalty free, nonexclusive,
nontransferable license to practice the invention for all nonprofit
research including for educational purposes, and to permit other U.S.
nonprofit organizations to do so.''
3. Patent Expenses
Comment: One respondent stated that ``if required to assign an
invention to a Third party assignee who acquired the full benefit of
the invention, the contractor can assist the Third party assignee in
securing patent protection at the Third party's expense. It is
important to clarify that the Third party assignee is responsible for
expenses related to securing patent protection as the expenses can be
costly.
Response: The Government accepted this comment and rewrote the last
sentence of paragraph 352.227-11(c) as: ``If the Contractor assigns a
Subject Invention to the Third party assignee, then the Contractor and
its employee inventors shall assist the Third party assignee in
securing patent protection. All costs of securing the patent, including
the cost of the Contractor's assistance, are at the Third party's
expense. Any assistance provided by the Contractor and its employee
inventors to the Third party assignee or other costs incurred in
securing patent protection shall be solely at the Third party's expense
and not billable to the contract.''
4. Six Month Filing Period
Comment: Two respondents commented that the publication delay sets
a detrimental nationwide precedent that a 6-month publication delay is
acceptable. The existing standard amongst most U.S. universities
maximum of 90-120 days publication delay provides sufficient time to
file a patent application; this is increasingly important in the First
Inventor to File regime.
Response: The Government believes 6 months is reasonable as
paragraph 352.227-14(d)(4) requires the contractor to provide the
Contracting Officer a copy of any proposed publication or other public
disclosure at least 30 days in advance of the disclosure but allows the
Contracting Officer to request that publication be delayed for a
reasonable time not to exceed 6 months. The Government expects that
such a request, which will require affirmative action by the
Contracting Officer, will be uncommon. In view of the new first to file
provisions of the current patent statute it is expected that patent
applications will be filed expeditiously.
5. Clarification of ``Third Party Assignee''
Comment: One respondent stated that the clauses contain confusing
uses of terminology. For example, the term ``Third party assignee'' to
whom Class I inventions will be assigned is used in the sections for
both Class I and Class 2 inventions (the latter class involves a
license rather than an assignment.)
Response: The Government agrees with the respondent's language and
changed the clause to read ``However, the Contractor shall grant a
license in the Class 2 Subject Inventions to the provider of the
``material'' or other party designated by the Agency as set forth in
Alternate I.''
6. Application of Bayh-Dole Act
Comment: Two respondents submitted the following general comment
and subsequent related specific comments: The basic premise of the
Bayh-Dole Act and implementing regulations is that elimination or
restriction of a contractor's right to retain title to subject
inventions is intended only in the event of ``exceptional
circumstances.'' Written case-by-case determinations and justifications
are required. These must be submitted to the Secretary of Commerce
(Commerce). Contractors have the right to appeal (35 U.S.C. 202; 37 CFR
401.3 and 401.4; FAR 27.3).
The notice asserts but does not demonstrate how the proposed
clauses will better address the requirements of the Bayh-Dole Act and
regulations. It merely recites the policy and objectives of the Bayh-
Dole Act. Providing for a ``class'' deviation from the Bayh-Dole in the
HHSAR appears inconsistent with the intent to limit the use of
exceptional circumstance deviations through requiring individual case-
by-case justifications. The present practice of the use of individual
FAR deviations tailored to the specific DEC circumstances is more
consistent with the objectives of the Bayh-Dole Act. We also note that
the notice indicates that a copy has been submitted to the Chief
Counsel for Advocacy of the Small Business Administration. It does not
indicate whether it also has been submitted to the National Institute
of Standards and Technology, which now has overall oversight
responsibility for the Bayh-Dole, including responsibility for Commerce
review of DECs.
Response: The Government concurs with the respondent that this
clause applies to exceptional circumstance; however, the Government is
proposing this clause to implement the law for specific types of DECs.
The proposed clause may not be appropriate for every DEC. The clause is
appropriate for this kind of DEC, i.e., those for evaluation of Third
party materials. That is evident in the prescriptive part of the
proposed section 327.303, which states that the clause will be used
whenever a DEC involving the provision of materials has been executed
in accordance with Agency policy, and procedures calls for its use, and
the clause appropriately covers the circumstances.
7. Clause Not Self-Executing
Comment: One respondent stated that, in regard to the proposed
Patent Rights--exceptional circumstances HHSAR clause (352.227-11), the
clause defined 3 categories of Subject Inventions but referred to the
DEC(s) for the definition. The respondent asserted that this meant the
clause itself is not self-executing and that it presumes
[[Page 49017]]
DECs will all contain the same three categories, which appears
inappropriate for a HHSAR clause as DECs may vary in this regard. This
illustrates the problems with implementing DECs through one general
clause instead of individual deviations.
Response: The Government did not intend for the clause to be self-
executing. Rather, it only applies if it is invoked by a particular DEC
involving the provision of materials. This will insure that the clause
is not used inappropriately.
8. Clarification of Terms and Definitions
Comment: One respondent asserted that some terms and definitions in
the proposed 352.227-11 clause were problematic and specified as
follows: The definition of ``material'' to include methods, whether
patented or unpatented, is over broad. The definition of ``Third party
assignee'' refers to any entity described in the DEC, not necessarily
materials providers which according to the Supplementary Information
(IV.B.) are supposed to be the focus. This should be clarified. The
proposed clause contains a confusing incorporation of FAR clause
52.227-11 at b(2)(ii), which appears to be contradicted by (e)(2)'s
incorporation of FAR 52.227-13.
Response: The Government made the definition of ``material''
intentionally broad to include anything that may be provided to the
Contractor under the contract. The nature of ``material'' will be
described in the associated DEC. Generally it is anticipated that the
Third party assignee would be the provider of the ``material;''
however, the Government reserves the right to require assignment to
other entities, including the Government, when appropriate. However,
the Government concurs that there are some inconsistencies in the
references and have aligned them as follows: Paragraph (c) of FAR
52.227-13, which specifies march-in procedures, was invoked twice in
the clause to address greater rights determinations--first in 352.227-
11 (b)(3) (not (b)(2)(ii) as stated in the comment) and also in
353.227-11(e)(2). The last sentence of 352.227-11(e)(2) was modified to
improve clarity. These provisions are applicable when greater rights
are granted and the contractor acquires title to a Subject Invention.
9. Patent Rights Versus Copyrights
Comment: One respondent asserted that the proposed Rights in Data--
Exceptional Circumstances clause (352.227-14) had a number of problems:
The clause also requires approval of the Contracting Officer to assert
copyright in all data other than journal articles (c)(1). Universities
typically will accept only Alternate IV of the general FAR Rights in
Data clause which permits universities to assert copyright generally.
The proposed clause contains several Alternates but not Alternate IV.
The Confidentiality requirement in (d)(6)(ii) is open-ended, with no
limit on the duration of the requirement. The Rights in Data clause
does not make the same distinctions among different classes of
inventions as in the Patent Rights clause (52.227-11), which results in
asymmetrical treatment of contractors' rights. Finally the Data Rights
clause purports to cover computer software which, since potentially
patentable, may conflict with the Patent Rights clause.
Response: Patent rights and copyrights are independent and the
clause needs no further clarification. No time limits can be
established in advance for information deemed confidential; it is
handled on a case-by-case basis.
10. Outside Scope of This Rule
Comment: One respondent stated they wished to express their
opposition to the proposed ``accommodation'' to the HHS mandate
regarding health coverage.
Response: These comments were outside the scope of this rule.
11. No Response Necessary
Comment: One respondent stated that the proposed rule was ``a
little complicate (sic), but good job[.]''
Response: The Government appreciates this comment.
III. Executive Orders 12866 and 13563
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess
all costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). E.O.
13563 emphasizes the importance of quantifying both costs and benefits,
of reducing costs, of harmonizing rules, and of promoting flexibility.
This is not a significant regulatory action, and therefore, is not
subject to review under section 6 of E.O. 12866, Regulatory Planning
and Review, dated September 30, 1993. This rule is not a major rule
under 5 U.S.C. 804.
IV. Regulatory Flexibility Act
The HHS has prepared a Final Regulatory Flexibility Analysis (FRFA)
consistent with the Regulatory Flexibility Act, 5 U.S.C. 601, et seq.
No public comments were submitted on the Initial Regulatory Flexibility
Analysis and no comments were received from the Office of Advocacy of
the Small Business Administration on this rule. The FRFA is summarized
as follows:
This final rule will amend the Health and Human Services
Acquisition Regulation (HHSAR) to add two new clauses, 352.227-11,
Patent Rights--Exceptional Circumstances and 352.227-14, Rights in
Data--Exceptional Circumstances. These clauses will be used in lieu
of FAR clause 52.227-14, Rights in Data--General and FAR clause
52.227-11 Patent Rights--Ownership by the Contractor to address the
patent and data rights of the Government, the prime contractor, the
subcontractors at all tiers) and the providers of proprietary
materials to the Government (providers).
This action is being taken to ensure that providers, the
majority of which are small businesses, will retain their
preexisting rights to material and subject inventions in which the
provider has a proprietary interest when a Determination of
Exceptional Circumstances (DEC) has been executed. A DEC promotes
the policy and objectives of the Bayh-Dole Act, 35 U.S.C. 200, et
seq., to ensure that subject inventions made under contracts and
subcontracts (at all tiers) are used in a manner to promote free
competition and enterprise without unduly encumbering future
research and discovery; to ensure that the Government obtains
sufficient rights in federally supported inventions to meet its
needs; to protect the public against nonuse or unreasonable use of
inventions; and ultimately to benefit the public health. In order to
ensure that pharmaceutical companies, academia, and others will
collaborate with the Department of Health and Human Services (HHS)
under certain conditions in identifying, testing, developing, and
commercializing new drugs, therapeutics, diagnostics, prognostics
and prophylactic measures affecting human health, a determination
that exceptional circumstances must be executed, and Contractor's
and subcontractor's rights (at all tiers) in subject inventions
should be limited accordingly through appropriate contract clauses.
The affected contracts are usually awarded using NAICS code
541711, Research and Development in Biotechnology, or NAICS code
541712 Research and Development in the Physical, Engineering, and
Life Sciences (except Biotechnology). Both NAICS have a small
business size standard of 500 employees. It is estimated that this
rule will affect 61 prime contractors of which four will be small
businesses (6.5 percent); 76 subcontractors of which 21 will be
small businesses (27.6 percent); and 379 providers of which 189 will
be small businesses (49.87 percent). The aforementioned figures are
based on historical data from one operating division of HHS. It is
anticipated that numbers will increase proportionally as the clauses
will be used on an HHS-wide basis. Using the HHSAR clauses better
addresses the requirements of the Bayh-Dole Act and provides
appropriate legal protection for the
[[Page 49018]]
proprietary rights of providers to ensure providers will collaborate
with the Government and provide access to their promising
proprietary material(s) to meet HHS program goals. The projected
reporting, recordkeeping, or other compliance requirements projected
for this rule will be carried out by the prime contractor. Only a
small percentage (6.5 percent) of the prime contractors will be
small businesses. The projected cost for compliance requirements for
those small businesses will be $28,924.38.
The final rule does not duplicate, overlap, or conflict with any
other Federal rules. These clauses will be used in lieu of FAR clause
52.227-14, Rights in Data--General and FAR clause 52.227-11, Patent
Rights--Ownership by the Contractor.
In the past, a significant number of FAR deviations were processed
each time a DEC was executed. Using the final HHSAR clauses better
addresses the requirements of the Bayh-Dole Act and provides solid
legal protection for the proprietary rights of providers to ensure
providers will collaborate with the Government and provide access to
their promising proprietary material(s) to meet HHS program goals.
Therefore, it is believed that the approach outlined in the final rule
is the most practical and provides benefits to the Government, the
public health, and the industry to ensure HHS program goals can be
achieved.
V. Paperwork Reduction Act
The Paperwork Reduction Act (44 U.S.C. Chapter 35) applies because
this final rule contains information collection requirements under
HHSAR 352.227-11, Patent Rights--Exceptional Circumstances (approved
under OMB Control Number 0990-0419), and HHSAR 352.227-14, Rights in
Data--Exceptional Circumstances (approved under OMB Control Number
0990-0419). In response to the notice of proposed rulemaking and the
request for comment on the burden estimates, no comments were received
on the burden estimates.
List of Subjects in 48 CFR Parts 327 and 352
Government procurement.
For the reasons stated in the preamble, HHS amends 48 CFR parts 327
and 352 as follows:
0
1. The authority citation for 48 CFR parts 327 and 352 continues to
read as follows:
Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).
PART 327--PATENTS, DATA, AND COPYRIGHTS
0
2. Add subpart 327.3 to read as follows:
Subpart 327.3--Patent Rights Under Government Contracts
Sec.
327.303 Solicitation provision and contract clause.
Subpart 327.3--Patent Rights Under Government Contracts
327.303 Solicitation provision and contract clause.
The Contracting Officer shall insert the clause at 352.227-11,
Patent Rights--Exceptional Circumstances and any appropriate alternates
in lieu of FAR 52.227-11 whenever a Determination of Exceptional
Circumstances (DEC) involving the provision of materials has been
executed in accordance with Agency policy and procedures calls for its
use and 352.227-11 appropriately covers the circumstances. The
Contracting Officer should reference the DEC in the solicitation and
shall attach a copy of the executed DEC to the contract.
327.404-70 [Amended]
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3. Add section 327.409 to read as follows:
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4. Amend section 327.404-70 by removing the words ``clause in'' and
adding the words ``clause at'' in its place.
327.409 Solicitation provision and contract clause.
The Contracting Officer shall insert the clause at 352.227-14,
Rights in Data--Exceptional Circumstances and any appropriate
alternates in lieu of FAR 52.227-14 whenever a Determination of
Exceptional Circumstances (DEC) executed in accordance with Agency
policy and procedures calls for its use. Prior to using this clause, a
DEC must be executed in accordance with Agency policy and procedures.
The Contracting Officer should reference the DEC in the solicitation
and shall attach a copy of the executed DEC to the contract.
PART 352--SOLICITATION PROVISIONS AND CONTRACT CLAUSES
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5. Add section 352.227-11 to read as follows:
352.227-11 Patent Rights--Exceptional Circumstances.
Patent Rights--Exceptional Circumstances (SEPT 2014)
This clause applies to all Contractor and subcontractor (at all
tiers) Subject Inventions.
(a) Definitions. As used in this clause--
Agency means the Agency of the U.S. Department of Health and
Human Services that is entering into this contract.
Class 1 Subject Invention means a Subject Invention described
and defined in the DEC that will be assigned to a third party
assignee, or assigned as directed by the Agency.
Class 2 Subject Invention means a Subject Invention described
and defined in the DEC.
Class 3 Subject Invention means a Subject Invention that does
not fall into Class 1 or Class 2 as defined in this clause.
DEC means the Determination of Exceptional Circumstances signed
by [insert approving official] -------- on -------- [insert date] --
------ and titled ``[insert description].''
Invention means any invention or discovery, which is or may be
patentable or otherwise protectable under Title 35 of United States
Code, or any novel variety of plant that is or may be protectable
under the Plant Variety Protection Act (7 U.S.C. 2321, et. seq.)
Made means: When used in relation to any invention other than a
plant variety, the conception or first actual reduction to practice
of such invention; or when used in relation to a plant variety, that
the Contractor has at least tentatively determined that the variety
has been reproduced with recognized characteristics.
Material means any proprietary material, method, product,
composition, compound, or device, whether patented or unpatented,
which is provided to the Contractor under this contract.
Nonprofit organization means a university or other institution
of higher education or an organization of the type described in
section 501(c)(3) of the Internal Revenue Code of 1954 (26 U.S.C.
501(c)) and exempt from taxation under section 501(a) of the
Internal Revenue Code (26 U.S.C. 501(a)) or any nonprofit scientific
or educational organization qualified under a state nonprofit
organization statute.
Practical application means to manufacture, in the case of a
composition or product; to practice, in the case of a process or
method, or to operate, in the case of a machine or system; and, in
each case, under such conditions as to establish that the invention
is being utilized and that its benefits are, to the extent permitted
by law or Government regulations, available to the public on
reasonable terms.
Small business firm means a small business concern as defined at
section 2 of Public Law 85-536 (15 U.S.C. 632) and implementing
regulations of the Administrator of the Small Business
Administration. For the purpose of this clause, the size standards
for small business concerns involved in Government procurement and
subcontracting at 13 CFR 121.3-8 and 13 CFR 121.3-12, respectively,
will be used.
[[Page 49019]]
Subject Invention means any invention of the Contractor made in
the performance of work under this contract.
Third party assignee means any entity or organization that may,
as described in the DEC, be assigned Class 1 inventions.
(b) Allocation of principal rights. (1) Retention of pre-
existing rights. Third party assignees shall retain all preexisting
rights to Material in which the Third party assignee has a
proprietary interest.
(2) Allocation of Subject Invention rights. (i) Disposition of
Class 1 Subject Inventions. (A) Assignment to the Third party
assignee or as directed by the Agency. The Contractor shall assign
to the Third party assignee designated by the Agency the entire
right, title, and interest throughout the world to each Subject
Invention, or otherwise dispose of or transfer those rights as
directed by the Agency, except to the extent that rights are
retained by the Contractor under paragraph (b)(3) of this clause.
Any such assignment or other disposition or transfer of rights will
be subject to a nonexclusive, nontransferable, irrevocable, paid-up
license to the U.S. Government to practice or have practiced the
Subject Invention for or on behalf of the U.S. throughout the world.
Any assignment shall additionally be subject to the ``March-in
rights'' of 35 U.S.C. 203. If the Contractor is a U.S. nonprofit
organization it may retain a royalty free, nonexclusive,
nontransferable license to practice the invention for all nonprofit
research including for educational purposes, and to permit other
U.S. nonprofit organizations to do so.
(B) [Reserved]
(ii) Disposition of Class 2 and 3 Subject Inventions. Class 2
Subject Inventions shall be governed by FAR clause 52.227-11, Patent
Rights-Ownership (December 2007) (incorporated herein by reference).
However, the Contractor shall grant a license in the Class 2 Subject
Inventions to the provider of the Material or other party designated
by the Agency as set forth in Alternate I.
(iii) Class 3 Subject Inventions shall be governed by FAR clause
52.227-11, Patent Rights-Ownership by the Contractor (December 2007)
(previously incorporated herein by reference).
(3) Greater Rights Determinations. The Contractor, or an
employee-inventor after consultation by the Agency with the
Contractor, may request greater rights than are provided in
paragraph (b)(1) of this clause in accordance with the procedures of
FAR paragraph 27.304-1(c). In addition to the considerations set
forth in paragraph 27.304-1(c), the Agency may consider whether
granting the requested greater rights will interfere with rights of
the Government or any Third party assignee or otherwise impede the
ability of the Government or the Third party assignee to, for
example, develop and commercialize new compounds, dosage forms,
therapies, preventative measures, technologies, or other approaches
with potential for the diagnosis, prognosis, prevention, and
treatment of human diseases.
A request for a determination of whether the Contractor or the
employee-inventor is entitled to retain such greater rights must be
submitted to the Agency Contracting Officer at the time of the first
disclosure of the invention pursuant to paragraph (c)(1) of this
clause, or not later than 8 months thereafter, unless a longer
period is authorized in writing by the Contracting Officer for good
cause shown in writing by the Contractor. Each determination of
greater rights under this contract shall be subject to paragraph (c)
of the FAR clause at 52.227-13 (incorporated herein by reference),
and to any reservations and conditions deemed to be appropriate by
the Agency such as the requirement to assign or exclusively license
the rights to Subject Inventions to the Third party assignee.
A determination by the Agency denying a request by the
Contractor for greater rights in a Subject Invention may be appealed
within 30 days of the date the Contractor is notified of the
determination to an Agency official at a level above the individual
who made the determination. If greater rights are granted, the
Contractor must file a patent application on the invention. Upon
request, the Contractor shall provide the filing date, serial number
and title, a copy of the patent application (including an English-
language version if filed in a language other than English), and
patent number and issue date for any Subject Invention in any
country for which the Contractor has retained title. Upon request,
the Contractor shall furnish the Government an irrevocable power to
inspect and make copies of the patent application file.
(c) Invention disclosure by Contractor. The Contractor shall
disclose in writing each Subject Invention to the Agency Contracting
Officer and to the Director, Division of Extramural Inventions and
Technology Resources (DEITR), if directed by the Contracting
Officer, as provided in paragraph (j) of this clause within 2 months
after the inventor discloses it in writing to Contractor personnel
responsible for patent matters. The disclosure to the Agency
Contracting Officer shall be in the form of a written report and
shall identify the contract under which the invention was Made and
all inventors. It shall be sufficiently complete in technical detail
to convey a clear understanding to the extent known at the time of
the disclosure, of the nature, purpose, operation, and the physical,
chemical, biological, or electrical characteristics of the
invention. The disclosure shall also identify any publication, on
sale (offer for sale), or public use of the invention and whether a
manuscript describing the invention has been submitted for
publication, and if so, whether it has been accepted for publication
at the time of disclosure.
In addition, after disclosure to the Agency, the Contractor will
promptly notify the Contracting Officer and DEITR of the acceptance
of any manuscript describing the invention for publication or of any
on sale or public use planned by the Contractor. If the Contractor
assigns a Subject Invention to the Third party assignee, then the
Contractor and its employee inventors shall assist the Third party
assignee in securing patent protection. All costs of securing the
patent, including the cost of the Contractor's assistance, are at
the Third party's expense. Any assistance provided by the Contractor
and its employee inventors to the Third party assignee or other
costs incurred in securing patent protection shall be solely at the
Third party's expense and not billable to the contract.
(d) Contractor action to protect the Third party assignee's and
the Government's interest. (1) The Contractor agrees to execute or
to have executed and promptly deliver to the Agency all instruments
necessary to: Establish or confirm the rights the Government has
throughout the world in Subject Inventions pursuant to paragraph (b)
of this clause; convey title to a Third party assignee in accordance
with paragraph (b) of this clause; and enable the Third party
assignee to obtain patent protection throughout the world in that
Subject Invention.
(2) The Contractor agrees to require, by written agreement, its
employees, other than clerical and nontechnical employees, to
disclose promptly in writing to personnel identified as responsible
for the administration of patent matters and in a format suggested
by the Contractor, each Subject Invention ``Made'' under contract in
order that the Contractor can comply with the disclosure provisions
of paragraph (c) of this clause, and to execute all papers necessary
to file patent applications on Subject Inventions and to establish
the Government's rights or a Third party assignee's rights in the
Subject Inventions. This disclosure format should require, as a
minimum, the information required by subparagraph (c)(1) of this
clause. The Contractor shall instruct such employees, through
employee agreements or other suitable educational programs, on the
importance of reporting inventions in sufficient time to permit the
filing of patent applications prior to U.S. or foreign statutory
bars.
(3) If the Contractor is granted greater rights, the Contractor
agrees to include, within the specification of any United States
non-provisional patent application it files, and any patent issuing
thereon, covering a Subject Invention the following statement:
``This invention was made with Government support under (identify
the Contract) awarded by (identify the specific Agency). The
Government has certain rights in the invention.''
(4) The Contractor agrees to provide a final invention statement
and certification prior to the closeout of the contract listing all
Subject Inventions or stating that there were none.
(e) Subcontracts. (1) The Contractor will include this clause in
all subcontracts, regardless of tier, for experimental,
developmental, or research work. At all tiers, the clause must be
modified to identify the parties as follows: References to the
Government are not changed, and the subcontractor has all rights and
obligations of the Contractor in the clause. The Contractor will
not, as part of the consideration for awarding the contract, obtain
rights in the subcontractor's Subject Inventions.
(2) In subcontracts, at any tier, the Agency, the subcontractor,
and the Contractor agree that the mutual obligations of the parties
created by this clause constitute a contract between the
subcontractor and the Agency with respect to the matters covered by
the clause; provided, however, that nothing in this paragraph is
intended to confer any
[[Page 49020]]
jurisdiction under the Contract Disputes Act in connection with
proceedings under paragraph (c)(1)(ii) of FAR clause 52.227-13.
(f) Reporting on utilization of Subject Inventions in the event
greater rights are granted to the Contractor. The Contractor agrees
to submit, on request, periodic reports no more frequently than
annually on the utilization of a Subject Invention or on efforts at
obtaining such utilization that are being made by the Contractor or
its licensees or assignees when a request under subparagraph b.3.
has been granted by the Agency. Such reports shall include
information regarding the status of development, date of first
commercial sale or use, gross royalties received by the Contractor,
and such other data and information as the Agency may reasonably
specify. The Contractor also agrees to provide additional reports as
may be requested by the Agency in connection with any march-in
proceeding undertaken by the Agency in accordance with paragraph (h)
of this clause. As required by 35 U.S.C. 202(c)(5), the Agency
agrees it will not disclose such information to persons outside the
Government without permission of the Contractor.
(g) Preference for United States industry in the event greater
rights are granted to the Contractor. Notwithstanding any other
provision of this clause, the Contractor agrees that neither it nor
any assignee will grant to any person the exclusive right to use or
sell any Subject Invention in the United States unless such person
agrees that any product embodying the Subject Invention or produced
through the use of the Subject Invention will be manufactured
substantially in the United States. However, in individual cases,
the requirement for such an agreement may be waived by the Agency
upon a showing by the Contractor or its assignee that reasonable but
unsuccessful efforts have been made to grant licenses on similar
terms to potential licensees that would be likely to manufacture
substantially in the United States or that under the circumstances
domestic manufacture is not commercially feasible.
(h) March-in rights in the event greater rights are granted to
the Contractor. The Contractor acknowledges that, with respect to
any Subject Invention in which it has acquired ownership through the
exercise of the rights specified in paragraph (b)(3) of this clause,
the Agency has the right to require licensing pursuant to 35 U.S.C.
203 and 210(c), and in accordance with the procedures in 37 CFR
401.6 and any supplemental regulations of Agency in effect on the
date of contract award.
(i) Special provisions for contracts with nonprofit
organizations in the event greater rights are granted to the
Contractor. If the Contractor is a nonprofit organization, it shall:
(1) Not assign rights to a Subject Invention in the United
States without the written approval of the Agency, except where an
assignment is made to an organization that has as one of its primary
functions the management of inventions, provided that the assignee
shall be subject to the same provisions as the Contractor;
(2) Share royalties collected on a Subject Invention with the
inventor, including Federal employee co-inventors (but through their
Agency if the Agency deems it appropriate) when the Subject
Invention is assigned in accordance with 35 U.S.C. 202(e) and 37 CFR
401.10;
(3) Use the balance of any royalties or income earned by the
Contractor with respect to Subject Inventions, after payment of
expenses (including payments to inventors) incidental to the
administration of Subject Inventions for the support of scientific
research or education;
(4) Make efforts that are reasonable under the circumstances to
attract licensees of Subject Inventions that are small business
concerns, and give a preference to a small business concern when
licensing a Subject Invention if the Contractor determines that the
small business concern has a plan or proposal for marketing the
invention which, if executed, is equally as likely to bring the
invention to practical application as any plans or proposals from
applicants that are not small business concerns; provided, that the
Contractor is also satisfied that the small business concern has the
capability and resources to carry out its plan or proposal. The
decision whether to give a preference in any specific case will be
at the discretion of the Contractor; and
(5) Allow the Secretary of Commerce to review the Contractor's
licensing program and decisions regarding small business applicants,
and negotiate changes to its licensing policies, procedures, or
practices with the Secretary of Commerce when the Secretary's review
discloses that the Contractor could take reasonable steps to more
effectively implement the requirements of paragraph (i)(4) of this
clause.
(j) Communications. All invention disclosures and requests for
greater rights shall be sent to the Agency Contracting Officer, as
directed by the Contracting Officer. Additionally, a copy of all
disclosures, confirmatory licenses to the Government, face page of
the patent applications, waivers and other routine communications
under this funding agreement at all tiers must be sent to:
[Insert Agency Address]
Agency Invention Reporting Web site: https://www.iEdison.gov.
Alternate I (Sept 2014). As prescribed in 327.303, the license
to Class 2 inventions recited in 352.227-11(b)(2)(a) is as follows:
[Insert description of license to Class 2 inventions]
(End of clause)
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6. Add section 352.227-14 to read as follows:
352.227-14 Rights in Data--Exceptional Circumstances.
As prescribed in 327.409(b)(1), insert the following clause with
any appropriate alternates:
Rights in Data--Exceptional Circumstances (SEPT 2014)
(a) Definitions. As used in this clause--[Definitions may be
added or modified in paragraph (a) as applicable.]
Computer database or database means a collection of recorded
information in a form capable of, and for the purpose of, being
stored in, processed, and operated on by a computer. The term does
not include computer software.
Computer software--(i) Means (A) Computer programs that comprise
a series of instructions, rules, routines, or statements, regardless
of the media in which recorded, that allow or cause a computer to
perform a specific operation or series of operations; and
(B) Recorded information comprising source code listings, design
details, algorithms, processes, flow charts, formulas, and related
material that would enable the computer program to be produced,
created, or compiled.
(ii) Does not include computer databases or computer software
documentation.
Computer software documentation means owner's manuals, user's
manuals, installation instructions, operating instructions, and
other similar items, regardless of storage medium, that explain the
capabilities of the computer software or provide instructions for
using the software.
Data means recorded information, regardless of form or the media
on which it may be recorded. The term includes technical data and
computer software. The term does not include information incidental
to contract administration, such as financial, administrative, cost
or pricing, or management information.
Form, fit, and function data means data relating to items,
components, or processes that are sufficient to enable physical and
functional interchangeability, and data identifying source, size,
configuration, mating and attachment characteristics, functional
characteristics, and performance requirements. For computer software
it means data identifying source, functional characteristics, and
performance requirements but specifically excludes the source code,
algorithms, processes, formulas, and flow charts of the software.
Limited rights means the rights of the Government in limited
rights data as set forth in the Limited Rights Notice in Alternate
II paragraph (g)(3) if included in this clause. ``Limited rights
data'' means data, other than computer software, that embody trade
secrets or are commercial or financial and confidential or
privileged, to the extent that such data pertain to items,
components, or processes developed at private expense, including
minor modifications.
Restricted computer software means computer software developed
at private expense and that is a trade secret, is commercial or
financial and confidential or privileged, or is copyrighted computer
software, including minor modifications of the computer software.
Restricted rights, as used in this clause, means the rights of
the Government in restricted computer software, as set forth in a
Restricted Rights Notice of Alternate III paragraph (g)(4) if
included in this clause, or as otherwise may be provided in a
collateral agreement incorporated in and made part of this contract,
including minor modifications of such computer software.
Technical data means recorded information (regardless of the
form or method of the recording) of a scientific or technical
[[Page 49021]]
nature (including computer databases and computer software
documentation). This term does not include computer software or
financial, administrative, cost or pricing, or management data or
other information incidental to contract administration. The term
includes recorded information of a scientific or technical nature
that is included in computer databases (See 41 U.S.C. 403(8)).
Unlimited rights means the rights of the Government to use,
disclose, reproduce, prepare derivative works, distribute copies to
the public, and perform publicly and display publicly, in any manner
and for any purpose, and to have or permit others to do so.
(b) Allocation of rights. (1) Except as provided in paragraph
(c) of this clause, the Government shall have unlimited rights in--
(i) Data first produced in the performance of this contract;
(ii) Form, fit, and function data delivered under this contract;
(iii) Data delivered under this contract (except for restricted
computer software) that constitute manuals or instructional and
training material for installation, operation, or routine
maintenance and repair of items, components, or processes delivered
or furnished for use under this contract; and
(iv) All other data delivered under this contract unless
provided otherwise for limited rights data or restricted computer
software in accordance with paragraph (g) of this clause.
(2) The Contractor shall have the right to--
(i) Assert copyright in data first produced in the performance
of this contract to the extent provided in paragraph (c)(1) of this
clause;
(ii) Use, release to others, reproduce, distribute, or publish
any data first produced or specifically used by the Contractor in
the performance of this contract, unless provided otherwise in
paragraph (d) of this clause;
(iii) Substantiate the use of, add, or correct limited rights,
restricted rights, or copyright notices and to take other
appropriate action, in accordance with paragraphs (e) and (f) of
this clause; and
(iv) Protect from unauthorized disclosure and use those data
that are limited rights data or restricted computer software to the
extent provided in paragraph (g) of this clause.
(c) Copyright. (1) Data first produced in the performance of
this contract. (i) Unless provided otherwise in paragraph (d) of
this clause, the Contractor may, without prior approval of the
Contracting Officer, assert copyright in scientific and technical
articles based on or containing data first produced in the
performance of this contract and published in academic, technical or
professional journals, symposia proceedings, or similar works. The
prior, express written permission of the Contracting Officer is
required to assert copyright in all other data first produced in the
performance of this contract.
(ii) When authorized to assert copyright to the data, the
Contractor shall affix the applicable copyright notices of 17 U.S.C.
401 or 402, and an acknowledgment of Government sponsorship
(including contract number).
(iii) For data other than computer software, the Contractor
grants to the Government and others acting on its behalf, a paid-up,
nonexclusive, irrevocable, worldwide license in such copyrighted
data to reproduce, prepare derivative works, distribute copies to
the public, and perform publicly and display publicly by or on
behalf of the Government. For computer software, the Contractor
grants to the Government, and others acting on its behalf, a paid-
up, nonexclusive, irrevocable, worldwide license in such copyrighted
computer software to reproduce, prepare derivative works, and
perform publicly and display publicly (but not to distribute copies
to the public) by or on behalf of the Government.
(2) Data not first produced in the performance of this contract.
The Contractor shall not, without the prior written permission of
the Contracting Officer, incorporate in data delivered under this
contract any data not first produced in the performance of this
contract unless the Contractor--
(i) Identifies the data; and
(ii) Grants to the Government, or acquires on its behalf, a
license of the same scope as set forth in paragraph (c)(1) of this
clause or, if such data are restricted computer software, the
Government shall acquire a copyright license as set forth in
paragraph (g)(4) of this clause (if included in this contract) or as
otherwise provided in a collateral agreement incorporated in or made
part of this contract.
(3) Removal of copyright notices. The Government will not remove
any authorized copyright notices placed on data pursuant to this
paragraph (c), and will include such notices on all reproductions of
the data.
(d) Release, publication, and use of data. The Contractor shall
have the right to use, release to others, reproduce, distribute, or
publish any data first produced or specifically used by the
Contractor in the performance of this contract, except--
(1) As prohibited by Federal law or regulation (e.g., export
control or national security laws or regulations);
(2) As expressly set forth in this contract; or
(3) If the Contractor receives or is given access to data
necessary for the performance of this contract that contain
restrictive markings, the Contractor shall treat the data in
accordance with such markings unless specifically authorized
otherwise in writing by the Contracting Officer or in the following
paragraphs.
(4) In addition to any other provisions, set forth in this
contract, the Contractor shall ensure that information concerning
possible inventions made under this contract is not prematurely
published thereby adversely affecting the ability to obtain patent
protection on such inventions. Accordingly, the Contractor will
provide the Contracting Officer a copy of any publication or other
public disclosure relating to the work performed under this contract
at least 30 days in advance of the disclosure. Upon the Contracting
Officer's request the Contractor agrees to delay the public
disclosure of such data or publication of a specified paper for a
reasonable time specified by the Contracting Officer, not to exceed
6 months, to allow for the filing of domestic and international
patent applications in accordance with Clause 352.227-11, Patent
Rights--Exceptional Circumstances (abbreviated month and year of
Final Rule publication).
(5) Data on Material(s). The Contractor agrees that in
accordance with paragraph (d)(2), proprietary data on Material(s)
provided to the Contractor under or through this contract shall be
used only for the purpose for which they were provided, including
screening, evaluation or optimization and for no other purpose.
(6) Confidentiality. (i) The Contractor shall take all
reasonable precautions to maintain Confidential Information as
confidential, but no less than the steps Contractor takes to secure
its own confidential information.
(ii) Contractor shall maintain Confidential Information as
confidential unless specifically authorized otherwise in writing by
the Contracting Officer. Confidential Information includes/does not
include [Government may define confidential information here.]
(e) Unauthorized marking of data. (1) Notwithstanding any other
provisions of this contract concerning inspection or acceptance, if
any data delivered under this contract are marked with the notices
specified in paragraph (g)(3) or (4) of this clause (if those
alternate paragraphs are included in this clause), and use of the
notices is not authorized by this clause, or if the data bears any
other restrictive or limiting markings not authorized by this
contract, the Contracting Officer may cancel or ignore the markings.
However, pursuant to 41 U.S.C. 253d, the following procedures shall
apply prior to canceling or ignoring the markings.
(i) The Contracting Officer will make written inquiry to the
Contractor affording the Contractor 60 days from receipt of the
inquiry to provide written justification to substantiate the
propriety of the markings;
(ii) If the Contractor fails to respond or fails to provide
written justification to substantiate the propriety of the markings
within the 60-day period (or a longer time approved in writing by
the Contracting Officer for good cause shown), the Government shall
have the right to cancel or ignore the markings at any time after
said period and the data will no longer be made subject to any
disclosure prohibitions.
(iii) If the Contractor provides written justification to
substantiate the propriety of the markings within the period set in
paragraph (e)(1)(i) of this clause, the Contracting Officer will
consider such written justification and determine whether or not the
markings are to be cancelled or ignored. If the Contracting Officer
determines that the markings are authorized, the Contractor will be
so notified in writing. If the Contracting Officer determines, with
concurrence of the head of the contracting activity, that the
markings are not authorized, the Contracting Officer will furnish
the Contractor a written determination, which determination will
become the final Agency decision regarding the appropriateness of
the markings unless the Contractor files suit in a court of
competent jurisdiction within 90 days of receipt of the Contracting
Officer's decision. The Government will continue to abide by the
markings under this paragraph
[[Page 49022]]
(e)(1)(iii) until final resolution of the matter either by the
Contracting Officer's determination becoming final (in which
instance the Government will thereafter have the right to cancel or
ignore the markings at any time and the data will no longer be made
subject to any disclosure prohibitions), or by final disposition of
the matter by court decision if suit is filed.
(2) The time limits in the procedures set forth in paragraph
(e)(1) of this clause may be modified in accordance with Agency
regulations implementing the Freedom of Information Act (5 U.S.C.
552) if necessary to respond to a request there under.
(3) Except to the extent the Government's action occurs as the
result of final disposition of the matter by a court of competent
jurisdiction, the Contractor is not precluded by this paragraph (e)
from bringing a claim, in accordance with the Disputes clause of
this contract, that may arise as the result of the Government
removing or ignoring authorized markings on data delivered under
this contract.
(f) Omitted or incorrect markings. (1) Data delivered to the
Government without any restrictive markings shall be deemed to have
been furnished with unlimited rights. The Government is not liable
for the disclosure, use, or reproduction of such data.
(2) If the unmarked data has not been disclosed without
restriction outside the Government, the Contractor may request,
within 6 months (or a longer time approved by the Contracting
Officer in writing for good cause shown) after delivery of the data,
permission to have authorized notices placed on the data at the
Contractor's expense. The Contracting Officer may agree to do so if
the Contractor--
(i) Identifies the data to which the omitted notice is to be
applied;
(ii) Demonstrates that the omission of the notice was
inadvertent;
(iii) Establishes that the proposed notice is authorized; and
(iv) Acknowledges that the Government has no liability for the
disclosure, use, or reproduction of any data made prior to the
addition of the notice or resulting from the omission of the notice.
(3) If data has been marked with an incorrect notice, the
Contracting Officer may--
(i) Permit correction of the notice at the Contractor's expense
if the Contractor identifies the data and demonstrates that the
correct notice is authorized; or
(ii) Correct any incorrect notices.
(g) Protection of limited rights data and restricted computer
software.
(1) The Contractor may withhold from delivery qualifying limited
rights data or restricted computer software that are not data
identified in paragraphs (b)(1)(i) through (iii) of this clause. As
a condition to this withholding, the Contractor shall--
(i) Identify the data being withheld; and
(ii) Furnish form, fit, and function data instead.
(2) Limited rights data that are formatted as a computer
database for delivery to the Government shall be treated as limited
rights data and not restricted computer software.
(3) [Reserved]
(h) Subcontracting. The Contractor shall obtain from its
subcontractors all data and rights therein necessary to fulfill the
Contractor's obligations to the Government under this contract. If a
subcontractor refuses to accept terms affording the Government those
rights, the Contractor shall promptly notify the Contracting Officer
of the refusal and shall not proceed with the subcontract award
without authorization in writing from the Contracting Officer.
(i) Relationship to patents or other rights. Nothing contained
in this clause shall imply a license to the Government under any
patent or be construed as affecting the scope of any license or
other right otherwise granted to the Government.
(End of clause)
Alternate I (SEPT 2014). As prescribed in 327.409, substitute
the following definition for ``limited rights data'' in paragraph
(a) of the basic clause:
Limited rights data means data, other than computer software,
developed at private expense that embody trade secrets or are
commercial or financial and confidential or privileged.
Alternate II (SEPT 2014). As prescribed in 327.409, insert the
following paragraph (g)(3) in the basic clause:
(g)(3) Notwithstanding paragraph (g)(1) of this clause, the
contract may identify and specify the delivery of limited rights
data, or the Contracting Officer may require by written request the
delivery of limited rights data that has been withheld or would
otherwise be entitled to be withheld. If delivery of that data is
required, the Contractor shall affix the following ``Limited Rights
Notice'' to the data and the Government will treat the data, subject
to the provisions of paragraphs (e) and (f) of this clause, in
accordance with the notice:
Limited Rights Notice (SEPT 2014)
(a) These data are submitted with limited rights under
Government Contract No. -------- (and subcontract --------, if
appropriate). These data may be reproduced and used by the
Government with the express limitation that they will not, without
written permission of the Contractor, be used for purposes of
manufacture nor disclosed outside the Government; except that the
Government may disclose these data outside the Government for the
following purposes, if any; provided that the Government makes such
disclosure subject to prohibition against further use and
disclosure: [Agencies may list additional purposes or if none, so
state.]
(b) This notice shall be marked on any reproduction of these
data, in whole or in part.
(End of notice)
Alternate III (SEPT 2014). As prescribed in 327.409, insert the
following paragraph (g)(4) in the basic clause: (g)(4)(i)
Notwithstanding paragraph (g)(1) of this clause, the contract may
identify and specify the delivery of restricted computer software,
or the Contracting Officer may require by written request the
delivery of restricted computer software that has been withheld or
would otherwise be entitled to be withheld. If delivery of that
computer software is required, the Contractor shall affix the
following ``Restricted Rights Notice'' to the computer software and
the Government will treat the computer software, subject to
paragraphs (e) and (f) of this clause, in accordance with the
notice:
Restricted Rights Notice (SEPT 2014)
(a) This computer software is submitted with restricted rights
under Government Contract No. -------- (and subcontract --------, if
appropriate). It may not be used, reproduced, or disclosed by the
Government except as provided in paragraph (b) of this notice or as
otherwise expressly stated in the contract.
(b) This computer software may be--
(1) Used or copied for use with the computer(s) for which it was
acquired, including use at any Government installation to which the
computer(s) may be transferred;
(2) Used or copied for use with a backup computer if any
computer for which it was acquired is inoperative;
(3) Reproduced for safekeeping (archives) or backup purposes;
(4) Modified, adapted, or combined with other computer software,
provided that the modified, adapted, or combined portions of the
derivative software incorporating any of the delivered, restricted
computer software shall be subject to the same restricted rights;
(5) Disclosed to and reproduced for use by support service
Contractors or their subcontractors in accordance with paragraphs
(b)(1) through (4) of this notice; and
(6) Used or copied for use with a replacement computer.
(c) Notwithstanding the foregoing, if this computer software is
copyrighted computer software, it is licensed to the Government with
the minimum rights set forth in paragraph (b) of this notice.
(d) Any other rights or limitations regarding the use,
duplication, or disclosure of this computer software are to be
expressly stated in, or incorporated in, the contract.
(e) This notice shall be marked on any reproduction of this
computer software, in whole or in part.
(End of notice)
(ii) Where it is impractical to include the Restricted Rights
Notice on restricted computer software, the following short-form
notice may be used instead:
[[Page 49023]]
Restricted Rights Notice Short Form (SEPT 2014)
Use, reproduction, or disclosure is subject to restrictions set
forth in Contract No. -------- (and subcontract, if appropriate)
with -------- (name of Contractor and subcontractor).
(End of notice)
(iii) If restricted computer software is delivered with the
copyright notice of 17 U.S.C. 401, it will be presumed to be
licensed to the Government without disclosure prohibitions, with the
minimum rights set forth in paragraph (b) of this clause.
Alternate IV (SEPT 2014). As prescribed in 327.409, substitute
the following paragraph (c)(1) for paragraph (c)(1) of the basic
clause:
(c) Copyright--(1) Data first produced in the performance of the
contract. Except as otherwise specifically provided in this
contract, the Contractor may assert copyright in any data first
produced in the performance of this contract. When asserting
copyright, the Contractor shall affix the applicable copyright
notice of 17 U.S.C. 401 or 402, and an acknowledgment of Government
sponsorship (including contract number), to the data when such data
are delivered to the Government, as well as when the data are
published or deposited for registration as a published work in the
U.S. Copyright Office. For data other than computer software, the
Contractor grants to the Government, and others acting on its
behalf, a paid-up, nonexclusive, irrevocable, worldwide license for
all such data to reproduce, prepare derivative works, distribute
copies to the public, and perform publicly and display publicly, by
or on behalf of the Government. For computer software, the
Contractor grants to the Government and others acting on its behalf,
a paid-up, nonexclusive, irrevocable, worldwide license for all such
computer software to reproduce, prepare derivative works, and
perform publicly and display publicly (but not to distribute copies
to the public), by or on behalf of the Government.
Alternate V (SEPT 2014). As prescribed in 327.409, add the
following paragraph (j) to the basic clause:
(j) The Contractor agrees, except as may be otherwise specified
in this contract for specific data deliverables listed as not
subject to this paragraph, that the Contracting Officer may, up to 3
years after acceptance of all deliverables under this contract,
inspect at the Contractor's facility any data withheld pursuant to
paragraph (g)(1) of this clause, for purposes of verifying the
Contractor's assertion of limited rights or restricted rights status
of the data or for evaluating work performance. When the Contractor
whose data are to be inspected demonstrates to the Contracting
Officer that there would be a possible conflict of interest if a
particular representative made the inspection, the Contracting
Officer shall designate an alternate inspector.
Dated: August 11, 2014.
Angela Billups,
Associate Deputy Assistant Secretary for Acquisition.
[FR Doc. 2014-19312 Filed 8-18-14; 8:45 am]
BILLING CODE 4150-24-P