Part II: Terms and Conditions of NIH Grant Awards
Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities – File 10 of 11
Some of the terms and conditions for grants to for-profit
(commercial) organizations vary from the standard terms and conditions included
in IIA. In addition, the terms and conditions of the SBIR and STTR programs
vary from those otherwise applicable to for-profit organizations. This chapter
addresses separately the policies applicable to for-profit organizations generally,
and those that apply to SBIR and STTR awards specifically. It also highlights
several policies in IIA that apply equally to for-profit and non-profit
recipients. If an exception is not stated below or in the NoA,
the terms and conditions specified in IIA apply, including requirements for the
protection of human subjects and animal welfare.
18.2 Eligibility
For-profit organizations are eligible to apply under all NIH
programs and support mechanisms unless specifically excluded by statute.
18.3 Allowable
and Unallowable Costs
18.3.1 Cost Principles
There are no cost principles specifically applicable to
grants to for-profit organizations. Therefore, the cost principles for
commercial organizations set forth in the FAR (48 CFR part 31.2) generally are
used to determine allowable costs under NIH grants to for-profit organizations.
As provided in those costs principles, allowable travel costs may not exceed
those established by the FTR (available on-line at http://gsa.gov/portal/content/104790).
The cost principles in 45 CFR part 74, Appendix E, are used to determine
allowable costs under NIH grants to proprietary hospitals.
18.3.2 Independent Research and Development Costs
As provided in 45 CFR part 74.27(a), NIH does not allow
for-profit organizations to be reimbursed for IR&D (self-sponsored) costs.
18.3.3 Facilities and Administrative Costs (Indirect Costs)
F&A costs are allowable under awards to for-profit
organizations.
18.3.4 Profit or Fee
Except for grants awarded under the SBIR/STTR programs,
under an NIH grant, no profit or fee will be provided to a for-profit
organization, whether as a grantee or as a consortium participant. A profit or
fee under a grant is not a cost, but is an amount in excess of actual allowable
direct and F&A costs. In accordance with normal commercial practice, a
profit/fee may be paid to a contractor under an NIH grant providing routine
goods or services to the grantee.
18.4 Administrative
Requirements
For-profit organizations generally are subject to the same
administrative requirements as non-profit organizations, including those
relating to personal property title and management. Exceptions to or
elaboration of those requirements for for-profit organizations are indicated
below.
18.4.1 Equipment Accountability
For-profit grantees of NIH grants are nonexempt and subject
to the requirements in 45 CFR part 74.34, as well as the conditions set forth
in Administrative
Requirements—Management Systems and Procedures—Property Management System Standards and Administrative
Requirements—Management Systems and Procedures—Procurement Systems Standards
and Requirements in IIA. Under the conditions specified in 45 CFR part 74.34,
for-profit grantees are permitted to retain title to equipment purchased under
a research grant though NIH reserves the right to order the transfer of
equipment, including title, to NIH or an eligible third party named by the NIH
awarding office when such third party is otherwise eligible under existing
statutes. In keeping with the provisions of 45 CFR part 74.24, for-profit
grantees must not use equipment acquired with NIH funds to provide services to
non-Federal organizations for a fee to compete unfairly with private companies
that provide equivalent services, unless the terms and conditions of the award
provide otherwise, and any user charges shall be treated as program income and
must be reported on the FFR. Conditions for the sale of equipment are specified
at Administrative
Requirements—Management Systems and Procedures—Sale of Real Property, Equipment,
and Supplies in IIA.
18.4.2 Intellectual
Property
Intellectual property requirements set forth in 37 CFR part
401 apply to for-profit organizations, whether small businesses or large
businesses. However, invention reporting requirements for for-profit
organizations differ somewhat from those for non-profit organizations. When the
grantee is a for-profit organization, assignment of invention rights to a third
party does not require NIH approval, but ongoing reporting remains a
requirement for each invention. (See Administrative
Requirements—Availability of Research Results: Publications, Intellectual Property
Rights, and Sharing Research Resources in IIA.) Additional information
about the requirements of 37 CFR part 401 may be obtained from the Division of
Extramural Inventions and Technology Resources, OPERA, NIH
(see Part III for address and telephone number).
To the extent authorized by law, the Federal government will
not make public any information disclosing a Federal government-supported
invention.
Awards to for-profit organizations are subject to NIH
Standard Terms of Award; however, some mechanisms do not allow automatic
carryover of unobligated balances of funds. Under those mechanisms, the NIH
awarding IC will specify the disposition of the reported unobligated balance in
the NoA. (See Administrative
Requirements—Changes in Project and Budget in IIA).
18.4.5 Audit
The requirements for non-Federal audits of for-profit
organizations are specified in 45 CFR part 74.26(d). A for-profit organization is
required to have a non-Federal audit if, during its fiscal year, it expended a
total of $500,000 or more under one or more HHS awards (as a direct grantee
and/or under a consortium participant) and at least one of those awards is an
HHS grant. 45 CFR part 74.26(d) incorporates the thresholds and deadlines of OMB
Circular A-133 but provides for-profit organizations two options regarding the
type of audit that will satisfy the audit requirements. The grantee either may
have (1) a financial-related audit (as defined in, and in accordance with, the
Government Auditing Standards (commonly known as the "Yellow Book"), GPO stock
020-000-00-265-4, of a particular award in accordance with Government Auditing
Standards, in those cases where the recipient receives awards under only one
HHS program, or (2) an audit that meets the requirements of OMB Circular A-133.
The Government Auditing Standards are available
electronically at http://www.gao.gov/govaud/ybk01.htm. Audits must be completed and
submitted to the National External Audit
Review Center within 30 days after receipt of the auditor's report(s), or 9
months after the end of the audit period, i.e., the end of the organization's
fiscal year, whichever is earlier. The address is found in Part III.
For-profit organizations expending less than $500,000 a year
are not required to have an annual audit for that year but must make their
grant-related records available to NIH or other designated officials for review
or audit.
18.5 Small Business Innovation Research and
Small Business Technology Transfer Programs
NIH is required by statute to reserve a portion of its
annual extramural budget for projects under the SBIR and STTR programs. These
programs primarily are intended to encourage private-sector commercialization
of technology and to increase small business participation in federally funded
R&D.
Both the SBIR and STTR programs consist of the following
three phases:
Phase I. The objective of this phase is
to establish the technical merit and feasibility of proposed research or
R&D efforts and to determine the quality of performance of the applicant
(small business concern or SBC) before providing further Federal support in
Phase II.
Phase II. The objective of this phase
is to continue the research or R&D efforts initiated in Phase I. Funding
will be based on the results of Phase I and the scientific and technical merit
and commercial potential of the Phase II application. Only Phase I grantees are
eligible to receive Phase II funding. Unless submitted as a Fast-Track
application (see below),
Phase II applications may be submitted only after the Phase I award is made.
NIH expects non Fast-Track Phase II applications to be submitted within the
first six receipt dates following expiration of the Phase I budget period,
i.e., normally 2 years beyond the expiration date of the Phase I award.
Phase III.
The objective of this phase, where appropriate, is for the SBC to pursue, with
non-SBIR/STTR funds, the commercialization of the results of the research or
R&D funded in Phases I and II.
There are two major
differences between the SBIR and STTR programs:
Under SBIR Program, the Project
Director/Principal Investigator (PD/PI) must have his/her primary employment
with the small business concern at the time of award and for the duration of
the project period, however, under the STTR Program, primary employment is not
stipulated in the SBIR and STTR policy directives so NIH permits the PD/PI to
have his/her primary employment with either the small business concern or the
collaborating research institution. On an STTR project, the PD/PI must devote at
least 10 percent of his/her time to the STTR project
The STTR program requires for both
phases I and II that the SBC formally partner with a single, non-profit
research institution. At least 40 percent of the STTR research project is to be
conducted by the SBC and at least 30 percent of the work is to be conducted by
the single, "partnering" research institution through a formal,
cooperative arrangement. Such organizations include universities, non-profit
hospitals, and other non-profit research organizations as well as Federally
Funded Research and Development Centers. STTR grants are awarded to the SBC,
which will receive all of the funding for the project and disburse the
appropriate funding to the research institution. The SBIR program allows
subcontracting, it does not require it so the SBC may conduct the entire SBIR
project without outside collaboration.
18.5.1 NIH Fast-Track Application Process
The NIH
Fast-Track application process expedites award decisions and funding of
SBIR and STTR Phase II applications for scientifically meritorious projects
that have a high potential for commercialization. The Fast-Track process allows
Phase I and Phase II grant applications to be submitted and reviewed together.
Fast-Track applications receive a single rating. Before submitting applications
for Fast-Track review, applicants are strongly encouraged to consult with
cognizant NIH program staff. to assure Fast-Track is appropriate. For
additional information on the submission of Fast-Track applications, see the
SF424 (R&R) SBIR/STTR Application Guide available at http://grants.nih.gov/grants/funding/sbir.htm.
18.5.2 Eligibility
Only United States small business concerns (SBCs) are
eligible to submit SBIR and STTR applications. A small business concern is one
that, at the time of award for both Phase I and Phase II SBIR awards, meets all of the following criteria. If it appears that an applicant organization does
not meet the eligibility requirements, NIH will request a size determination by
the SBA. If eligibility is unclear, NIH will not make an SBIR or STTR award
until the SBA provides a determination.
For SBIR:
Organized for
profit, with a place of business located in the United States, which operates
primarily within the United States or which makes a significant contribution to
the United States economy through payment of taxes or use of American products,
materials or
In the legal
form of an individual proprietorship, partnership, limited liability company,
corporation, joint venture, association, trust or cooperative, except that
where the form is a joint venture, there can be no more than 49 percent
participation by foreign business entities in the joint venture;
At least 51
percent owned and controlled by one or more individuals who are citizens of, or
permanent resident aliens in, the United States, or it must be a for-profit
business concern that is at least 51% owned and controlled by another
for-profit business concern that is at least 51% owned and controlled by one or
more individuals who are citizens of, or permanent resident aliens in, the
United States -- (except in the case of a joint venture);
Has,
including its affiliates, not more than 500 employees and meets the other
regulatory requirements found in 13 CFR part 121. Business concerns, other
than investment companies licensed, or state development companies qualifying
under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are
affiliates of one another when either directly or indirectly, (a) one concern
controls or has the power to control the other; or (b) a third-party/parties
controls or has the power to control both.
Control can be exercised through common ownership, common
management, and contractual relationships. The term "affiliates" is
defined in greater detail in 13 CFR part 121.3-2(a). The term "number of
employees" is defined in 13 CFR part 121.3-2(t).
Business concerns include, but are not limited to, any
individual (sole proprietorship), partnership, corporation, joint venture,
association, or cooperative. Further information may be obtained by contacting
the Small Business Administration Size District Office at http://sba.gov/size.
For STTR:
Organized for profit, with a place of
business located in the United States, which operates primarily within the
United States or which makes a significant contribution to the United States
economy through payment of taxes or use of American products, materials or
labor;
In the legal form of an individual
proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or
cooperative, except that where the form is a joint venture, there can be no
more than 49 percent participation by foreign business entities in the joint venture;
At least 51 percent owned and controlled by
one or more individuals who are citizens of, or permanent resident aliens in, the United States.
Has, including its affiliates, not more
than 500 employees and meets the other regulatory requirements found in 13
CFR part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are
affiliates of one another when either directly or indirectly, (a) one concern
controls or has the power to control the other; or (b) a third-party/parties
controls or has the power to control both.
Control can be
exercised through common ownership, common management, and contractual
relationships. The term "affiliates" is defined in greater detail in
13 CFR part 121.3-2(a). The term "number of employees" is defined in 13
CFR part 121.3-2(t).
Business concerns
include, but are not limited to, any individual (sole proprietorship),
partnership, corporation, joint venture, association, or cooperative. Further
information may be obtained by contacting the Small Business Administration
Size District Office at http://sba.gov/size.
18.5.2.1 Place of Performance
For
both Phase I and Phase II SBIR/STTR awards, the research or R&D project
activity must be performed in its entirety in the
United States
. (The
United States
is defined as the 50 States, the
territories and possessions of the
United States
,
the
Commonwealth of
Puerto Rico, the
Federated
States of Micronesia
, the
Republic
of
Palau, the Republic of the
Marshall Islands
, and the
District of Columbia.)
In
those rare instances where the study design requires use of a foreign site
(e.g., to conduct testing of specific patient populations), the investigator
must provide compelling scientific justification in the application for the
need/use of a foreign site. Similarly, in those rare instances where it may be
necessary to purchase materials from other countries, investigators must
thoroughly justify the request. NIH will consider these instances on a
case-by-case basis, and they should be discussed with cognizant NIH staff
before submitting an application. Approval will not be considered unless the
application is being considered for an award. IC program officials have the
authority to approve these waiver requests. Whether the request is approved or
disapproved, it will be explicitly addressed in the NoA if an award is made. Whenever possible, work outside the
United States
,
which is necessary to the completion of the project, should be supported by
funding other than SBIR/STTR.
18.5.2.2 Change in Organization Status & Change
of Grantee Institution Actions
Applicant organization eligibility is determined at the time
of the initial SBIR/STTR award. If a legal action occurs such as a merger or
successor-in-interest, that changes the organization status so that they are no
longer eligible for the SBIR/STTR programs, existing SBIR/STTR grants can
continue. However, the organization would no longer be eligible for any new
SBIR/STTR grants.
When
there is a desire to transfer an SBIR/STTR grant to a different organization,
the new organization must continue to meet the SBIR/STTR program eligibility
requirements. Grantees should contact the NIH awarding office to discuss
options when considering a move to a new organization.
18.5.2.3 Minimum
Level of Effort
Generally,
under SBIR Phase I awards, a minimum of two-thirds or 67 percent of the
research or analytical effort must be carried out by the SBC. Payments, in the
aggregate, to consultants, consortium participants and contractors for portions
of the scientific/technical effort generally may not exceed 33 percent of the
total requested amount.
Generally
under SBIR Phase II awards a minimum of one-half or 50 percent of the research
or analytical effort must be carried out by the SBC. In addition, payments, in
the aggregate, to consultants, consortium participants, and contractors for
portions of the scientific/technical effort generally may not exceed 50 percent
of the total requested amount.
For
STTR awards (both Phase I and Phase II), at least 40 percent of the work must
be performed by the SBC and at least 30 percent of the work must be performed
by the single, non-profit research institution. These percentages are
Congressionally mandated and waivers are not permitted. The basis for
determining the percentage of work to be performed by each of the cooperating
parties is the total of direct and F&A costs attributable to each party,
unless otherwise described and justified in the "Consortium/Contractual
Arrangements" portion of the of the grant application.
18.5.2.4 Multiple
Program Director/Principal Investigator Applications and Awards
The Multiple Program Director/Principal Investigator
(multiple PD/PI) option is available for NIH SBIR/STTR applicants for team
science efforts. All of the policy and requirements described in Multi PD/PI apply
to SBIR/STTR projects, with the exception of sections that are not relevant to
the SBIR/STTR program (e.g., new investigators, multi-project applications). In
addition, the following criteria apply to multiple PD/PI SBC applicants and
awards:
The small business concern (SBC) is always the applicant/awardee organization. Organizations
other than the SBC with PD/PIs participating in the multiple PD/PI project,
including the STTR non-profit research institution partner, are subcontractors
to the SBC.
For Phase I and Phase II SBIR projects, the
Contact PD/PI must meet the primary employment requirement; other PD/PIs are
not required to meet the requirement. Primary employment means that more than
one half of the PD/PI's time is spent in the employ of the SBC at the time of
award and during the conduct of the proposed project. Deviations from this
requirement are rare and must be approved in writing by the grants management
officer after consultation with the NIH SBIR/STTR Program Coordinator.
For
Phase I and Phase II STTR projects, the PD/PI is not required to be
employed by the SBC. However, the Contact PD/PI, the first PD/PI listed, must
have a formal appointment with, or commitment to, the SBC, which must be in the
form of an official relationship between the parties, but need not include a
salary or other form of remuneration. Each PD/PI on a multiple PD/PI award must
commit a minimum of 1.2 calendar months
(10% effort) to the project.
An STTR applicant organization must officially
affiliate a PD/PI with the SBC in the eRA Commons if
the PD/PI is not an employee of the SBC.
A Phase II Competing Renewal submitted as a
multiple PD/PI application requesting support for a project previously
supported through a single PD/PI award should state the changes in the
Project's direct and management that led to the proposed multiple PD/PI model.
18.5.3 Public
Policy Requirements and Objectives
For-profit organizations receiving SBIR/STTR awards
generally are subject to the same public policy requirements as non-profit
organizations. However, the requirements concerning reporting of financial
conflicts of interest (see Public Policy Requirements,
Objectives, and Other Appropriation Mandates—Financial Conflict of Interest in IIA) do not apply to applications or awards under Phase I of the SBIR/STTR
programs. The requirements do, however, apply to Phase II applications and
awards.
18.5.4 Allowable
Costs and Fee
18.5.4.1 Program
Levels (Total Costs)
SBA
SBIR and STTR Policy Directives provide program levels for SBIR and STTR
programs based on statutory guidelines. However, these directives also give
agencies discretion to exceed these levels when the proposed budget and
requested period of support are fully justified and scientifically appropriate
in relation to the proposed research. In general the levels are:
SBIR Phase I: $150,000 Total Costs; 6 months
SBIR Phase II: $1,000,000 Total Costs; 2 years
STTR Phase I: $100,000 Total Costs; 1 year
STTR Phase II: $750,000 Total Costs; 2 years
Some
ICs offer Phase II SBIR/STTR awardees the opportunity to apply for Phase II
Competing Renewal awards. These are available for those projects that require
extraordinary time and effort in the R&D phase and may or may not require
FDA approval for the development of such projects, including drugs, devices,
vaccines, therapeutics, and medical implants related to the mission of the IC.
Only those small business concerns who have been awarded a Phase II are
eligible to apply for the Phase II Competing Renewal award. Program levels are:
SBIR Phase II Competing Renewals (Phase II
"B"): $3,000,000; 3 years
STTR Phase II Competing Renewals (Phase II
"B"): $3,000,000; 3 years
Applicants
must request an appropriate level in the competing application; applications
will not be adjusted after submission.
18.5.4.2 Profit
or Fee
A
reasonable profit or fee may be paid to a SBC receiving an award under Phase I
or Phase II of the SBIR and STTR programs. The profit or fee is not considered
a "cost" for purposes of determining allowable use, program income
accountability, or audit thresholds. The profit or fee may be used by the SBC
for any purpose, including additional effort under the SBIR/STTR award. It is
intended to provide a reasonable profit consistent with normal profit margins
for for-profit organizations for R&D work; however, the amount of the
profit or fee normally will not exceed seven (7) percent of total costs (direct
and F&A) for each phase of the project. The profit or fee should be drawn
from PMS in increments proportional to the drawdown of funds for direct and
F&A costs. The profit or fee applies solely to the SBC receiving the
SBIR/STTR award and not to any other participant; however, in accordance with
normal commercial practice, the SBC may pay a profit or fee to a contractor
providing routine goods or services to the SBC under the grant.
18.5.4.3 Facilities
and Administrative Costs (Indirect Costs)
18.5.4.3.1 Phase I
If the applicant SBC has a currently effective F&A cost
rate(s) with a Federal agency, such rate(s) should be used when calculating
proposed F&A costs for an NIH application. NIH ICs use the term F&A
costs for all types of applicants and recipients; however, for-profit
organizations will find that DFAS and organizations external to NIH refer to
these costs as indirect costs. (However, the
rates(s) must be adjusted for IR&D expenses, which are not allowable under
HHS awards.) If the applicant SBC does not have a currently effective
negotiated indirect cost rate with a Federal agency, the applicant should
propose estimated F&A costs at a rate not to exceed 40 percent of the total
direct costs. However, SBCs are reminded that only actual F&A costs are to
be charged to projects. (If awarded at a rate of 40 percent or less, the rate
used to charge actual F&A costs to projects cannot exceed the awarded rate
unless the SBC negotiates an indirect cost rate(s) with a Federal agency.) NIH
will not negotiate indirect cost rates for Phase I awards.
18.5.4.3.2 Phase II
If the applicant SBC has a currently effective negotiated
indirect cost rate(s) with a Federal agency, such rate(s) should be used when
calculating proposed F&A costs for an NIH application. (However, the
rates(s) must be adjusted for IR&D expenses, which are not allowable under
HHS awards.) If the applicant SBC does not have a currently effective
negotiated indirect cost rate with a Federal agency, the applicant should
propose an estimated F&A rate in the application. If the requested F&A
cost rate is 40 percent of total direct costs or less, no further justification
is required at the time of award, and F&A costs will be awarded at the
requested rate. However, SBCs are reminded that only actual F&A costs may
be charged to projects. If awarded at a rate of 40 percent or less of total direct
costs, the rate used to charge actual F&A costs to projects cannot exceed
the awarded rate unless the SBC negotiates an indirect cost rate(s) with DFAS.
DFAS—the office authorized to negotiate indirect cost rates with SBC's
receiving NIH SBIR/STTR awards—will negotiate indirect cost rates for SBCs
receiving Phase II awards that requested a rate greater than 40 percent of
total direct costs.
Upon request, the applicant SBC should provide DFAS with an
indirect cost proposal and supporting financial data for its most recently
completed fiscal year. If financial data is not available for the most recently
completed fiscal year, the applicant should submit a proposal showing estimated
rates with supporting documentation. Further information about DFAS is available at its Web site or by telephone (see Part III).
18.5.5 Administrative
Requirements
For-profit organizations that receive SBIR/STTR awards
generally are subject to the same administrative requirements as non-profit
organizations.
18.5.5.1 Market
Research
NIH will not support market research, including studies of
the literature that lead to a new or expanded statement of work, under the
grant. For purposes of the SBIR/STTR programs, "market research" is the
systematic gathering, editing, recording, computing, and analyzing of data
about problems relating to the sale and distribution of the subject of the
proposed research. It includes various types of research, such as the size of
potential markets and potential sales volume, the identification of consumers
most apt to purchase the products, and the advertising media most likely to
stimulate their purchases. However, "market research" does not include
activities under a research plan or protocol that include a survey of the
public as part of the objectives of the project to determine the impact of the
subject of the research on the behavior of individuals.
18.5.5.2 Intellectual
Property
Rights to data, including software developed under the terms
of any funding agreement resulting from an NIH award, shall remain with the
grantee except that any such copyrighted material shall be subject to a
royalty-free, nonexclusive and irrevocable license to the Federal government to
reproduce, publish or otherwise use the material, and to authorize others to do
so for Federal purposes. In addition, under the SBIR/STTR programs, in contrast
to awards to for-profit organizations under other support mechanisms, such data
shall not be released outside the Federal government without the grantee's
permission for a period of 4 years from completion of the project.
Rights in Data Developed Under SBIR Funding
Agreement. The Small Business Innovation Research Program
Reauthorization Act of 2000, Public Law 106-554, amended section 9 of the Act
(15 U.S.C. 638), referred to as the "Act" provides for "retention by an SBC of
the rights to data generated by the concern in the performance of an SBIR
award."
Each agency
must refrain from disclosing SBIR technical data to outside the Government
(except reviewers) and especially to competitors of the SBC, or from using the
information to produce future technical procurement specifications that could
harm the SBC that discovered and developed the innovation.
SBIR agencies
must protect from disclosure and non-governmental use all SBIR technical data
developed from work performed under an SBIR funding agreement for a period of
not less than four years from delivery of the last deliverable under that
agreement (either Phase I, Phase II, or Federally-funded SBIR Phase III) unless, subject to (b)(3) of
this section, the agency obtains permission to disclose such SBIR technical
data from the awardee or SBIR applicant. Agencies are
released from obligation to protect SBIR data upon expiration of the protection
period except that any such data that is also protected and referenced under a
subsequent SBIR award must remain protected through the protection period of
that subsequent SBIR award. For example, if a Phase III award is issued within
or after the Phase II data rights protection period and the Phase III award
refers to and protects data developed and protected under the Phase II award,
then that data must continue to be protected through the Phase III protection
period. Agencies have discretion to adopt a protection period longer than four
years. The Government retains a royalty-free license for Government use of any
technical data delivered under an SBIR award, whether patented or not. This
section does not apply to program evaluation.
SBIR
technical data rights apply to all SBIR awards, including subcontracts to such
awards, that fall within the statutory definition of Phase I, II, or III of the
SBIR Program, as described in Section 4 of this Policy Directive. The scope and
extent of the SBIR technical data rights applicable to Federally-funded Phase
III awards is identical to the SBIR data rights applicable to Phases I and II
SBIR awards. The data rights protection period lapses only: (i) Upon expiration of the protection period applicable to
the SBIR award, or (ii) by agreement between the awardee and the agency.
Agencies must
insert the provisions of (b)(1), (2), and (3) immediately above as SBIR data
rights clauses into all SBIR Phase I, Phase II, and Phase III awards. These
data rights clauses are non- negotiable and must not be the subject of
negotiations pertaining to an SBIR Phase III award, or diminished or removed
during award administration. An agency must not, in any way, make issuance of
an SBIR Phase III award conditional on data rights. If the SBIR awardee wishes to transfer its SBIR data rights to the
awarding agency or to a third party, it must do so in writing under a separate
agreement. A decision by the awardee to relinquish,
transfer, or modify in any way its SBIR data rights must be made without
pressure or coercion by the agency or any other party. Following issuance of an
SBIR Phase III award, the awardee may enter into an
agreement with the awarding agency to transfer or modify the data rights
contained in that SBIR Phase III award. Such a bilateral data rights agreement
must be entered into only after the SBIR Phase III award, which includes the
appropriate SBIR data rights clause, has been signed. SBA must immediately
report to the Congress any attempt or action by an agency to condition an SBIR
award on data rights, to exclude the appropriate data rights clause from the
award, or to diminish such rights.
The STTR program requires that the small business grantee
and the single, non-profit research institution execute an agreement allocating
between the parties intellectual property rights and rights, if any, to carry
out follow-on research, development, or commercialization of the subject
research. (A model agreement, entitled "Allocation of Rights in Intellectual
Property and Rights to Carry Out Follow-On Research, Development, or
Commercialization," is available at the NIH Web site at http://grants.nih.gov/grants/funding/sbir.htm.)
By signing the face page of the grant application, the SBC's AOR certifies that
the agreement with the research institution will be effective at the time the
grant award is made. A copy of the agreement must be furnished upon request to
the NIH awarding IC.
Applicants for SBIR Phase II funding of $500,000 or more of
direct costs in any single year must comply with the NIH policy on data sharing
as modified by the Small Business Act. If the final data would not be amenable
to sharing, e.g., proprietary data, the SBC should explain that in the
application. In addition, as indicated under Intellectual
Property in this chapter, whether or not the award meets the threshold for
data sharing, NIH will not release data outside the Federal government without
the grantee's permission for a period of 4 years from completion of the
project. The entire policy may be found at http://grants.nih.gov/grants/policy/data_sharing.
Grants Policy
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