[Federal Register Volume 64, Number 246 (Thursday, December 23, 1999)]
[Notices]
[Pages 72090-72096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33292]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Principles and Guidelines for Recipients of NIH Research Grants
and Contracts on Obtaining and Disseminating Biomedical Research
Resources: Final Notice
AGENCY: National Institutes of Health (NIH), Public Health Service,
DHHS.
SUMMARY: On May 25, 1999 the National Institutes of Health (NIH)
published for public comment in the Federal Register a proposed policy
entitled SHARING BIOMEDICAL RESEARCH RESOURCES: Principles and
Guideline for Recipients of NIH Research Grants and Contracts [64 FR
28205]. This policy is designed to provide recipients of NIH funding
with guidance concerning appropriate terms for disseminating and
acquiring unique research resources developed with federal funds and is
intended to assist recipients in complying with their obligations under
the Bayh-Dole Act and NIH funding policy. Comments on the Principles
and Guidelines were requested by August 23, 1999. This Notice presents
the final Principles and Guidelines together with NIH's response to the
public comments received.
Background
The Present policy represents part of the overall implementation of
recommendations made by the Advisory Committee to the Director (ACD) to
Dr. Harlod Varmus, Director, NIH. Dr. Varmus requested that a Working
Group of the ACD look into problems encountered in the dissemination
and use of proprietary research tools, the competing interests of
intellectual property owners and research users underlying these
problems, and possible NIH responses. One of the recommendations in the
Report was that NIH issue guidance to the recipients of NIH funding.
Purpose
The present policy is a two-part document, consisting of Principles
setting forth the fundamental concepts and Guidelines providing
specific information to patent and license professionals and sponsored
research administrators for implementation. The purpose of these
Principles and Guidelines is to assist NIH funding recipients in
determining. (1) Reasonable terms and conditions for making NIH-funded
research resources available to scientists in other institutions in the
public and private sectors (disseminating research tools): and (2)
restrictions to accept as a condition of receiving access to research
tools for use in NIH-funded research (acquiring research tools). The
intent is to help Recipients ensure that the conditions they impose and
accept on the transfer of research tools will facilitate further
biomedical research, consistent with the requirements of the Bayh-Dole
Act and NIH funding agreements. It is also hoped that these Principles
and Guidelines will be adopted by the wider research community so that
all biomedical research and development can be synergistic and
accelerated.
Comments and Agency Response
The National Institutes of Health (NIH) recognizes the importance
of public involvement in the development of policy and sought
widespread comment and participation by the various stakeholders in the
biomedical research and development communities regarding the proposed
policy. To this end, NIH sought comment not only from NIH grantees, but
also from academic, not-for-profit, government, and private sector
participants in biomedical research and development. In order to
involve as many stakeholders as possible in the comment process, the
proposed policy was advertised and comments solicited in a wide variety
of venues. In addition to its publication on May 25, 1999, in the
Federal Register, the proposed policy was made available on several
different websites including the Federal Register Online, numerous NIH
websites (Edison, NIH Office of Technology Transfer, NIH Office of
Extramural Research and the NIH Director's Policy Forum), the
Association of University Technology Managers (AUTM) website and
Recombinant Capital's Signals Magazine. The proposed policy was also
advertised on a variety of e-mail lists (including Techno-L) as well as
in direct letters and e-mail to various stakeholders. In addition, the
proposed policy was profiled in articles appearing in a variety of
journals and magazines, including Science, Nature and Nature
Biotechnology.
In response to the May 25 proposal, NIH received 45 letters, each
of which contained one or more comments. Comments were received from
academic institutions, scientific foundations, pharmaceutical
companies, biotechnology companies (including providers of research
instruments, biological reagents and genomic data), an industry trade
association, professional societies, individual researchers and other
individual commenters. Below is NIH's response to comments offered,
organized by the section of the proposed policy to which they pertain.
Introduction
Several commenters suggested that sponsored research administrators
be included within the target audience to which this policy is
addressed. This suggestion has been adopted in the final policy.
Several commenters suggested that the policy is a de facto
regulation and should either be promulgated in accordance with
regulatory process or withdrawn. Several other commenters suggested
that as a policy the Principles/Guidelines are not enforceable as law
and that NIH should issue them as a regulation to ensure compliance.
The NIH does not believe that a regulation, enforceable as law, is
required at this time to facilitate sharing and access to research
tools for its Recipients. Although the final policy is issued as a
grants policy, to be incorporated into the NIH Grants Policy Statement,
the NIH has not precluded the possibility of engaging in the regulatory
process if widespread problems continue in access to NIH-funded
research tools by NIH Recipients. In addition, on a case-by-case basis,
the expectations set forth in the Principles and Guidelines may be
imposed as specific requirements of NIH funding awards where the
Recipient has failed to demonstrate sufficient progress in implementing
the Principles and Guidelines.
Some commenters suggested that the policy should not be applicable
to all projects that include NIH grant funds, but that NIH should set a
minimum level of NIH funding that would trigger application of the
policy. NIH has determined that the establishment of such a threshold
would not be consistent with NIH's objective of ensuring that broad
availability of research tools.
One commenter expressed concern that the proposed policy, if
applied to recipients of Small Business Innovation Research (SBIR)
grants, would place SBIR recipients under conflicting directives. The
commenter suggests that because SBIR recipients are required, as a
condition of their grant, to focus on the commercialization of
technology, they would be unable to disseminate
[[Page 72091]]
research tools with the minimal intellectual property encumbrances
advocated by the proposed policy. SBIR Recipients, like other NIH
grantees, are subject to the dual obligations of disseminating unique
research resources while promoting utilization, commercialization and
public availability of their inventions. The NIH does not see a
conflict between these obligations. The NIH invites its SBIR grantees
to consult with their project officer in the event they encounter
difficulty in the interpretation or implementation of this policy,
either in general or with respect to particular unique research
resources developed under their grant.
Principles
1. Ensure Academic Freedom and Publication
Several commenters suggested that language be added to the
guidelines to prohibit recipients from making coauthorship a condition
of providing research tools. There appears to be general consensus
within the research community that authorship is properly based upon
significant intellectual contribution to the published paper. In most
cases, simply making available research materials will not, in the
absence of other contributions, justify coauthorship. (See e.g.,
Responsible Science, Volume I: Ensuring the Integrity of the Research
Process, Panel on Scientific Responsibility and the Conduct of
Research, National Academy Press, 1992, p. 52). The final policy has
been amended to reflect this view.
Several commenters expressed concern that the definition of
``Recipient'' in the proposed policy might not include individuals or
entities receiving NIH funds through ``cooperative agreements.'' The
policy is applicable to cooperative agreements and this has been
clarified in the Principles and Guidelines.
2. Ensure Appropriate Implementation of the Bayh-Dole Act
Virtually all commenters requested clarification on how this policy
would preserve incentives for the development and production of
research tools that are ultimately sold as products to the research
community. The policy has been clarified to ensure that where patent
protection is necessary for development of a research tool as a
potential product for sale and distribution to the research community.
Recipients are not discouraged from seeking such protection, but should
license the intellectual property in a manner that maximizes the
potential for broad distribution of the research tool. The policy is
not intended to require Recipient scientists to develop of maintain
tools for widespread distribution, to discourage development of
research tool products, nor to set or influence the price for research
tools that are commercial products.
3. Minimize Administrative Impediments to Academic Research
One commenter suggested that reach-through rights should not be
discouraged because they are sometimes helpful to Recipients by
allowing them to obtain materials and equipment at reduced or nominal
upfront cost. NIH is aware of this rationale for a Recipient agreeing
to reach-through but finds that such practices contribute not only to
specific restriction of access to subsequent tools arising out of the
NIH-funded work, but also to the general proliferation of multiple ties
and competing interests that is the source of the current access
problems. NIH does not support the coupling of procurement with
intellectual property rights and restrictions and expects Recipients to
ensure that NIH-funded tools are not restricted as a result of such
agreements. Therefore, Recipients should engage in such interactions on
an infrequent, case-by-case, and highly controlled and monitored basis.
4. Ensure Dissemination of Research Resources Developed with NIH Funds
Numerous comments were received concerning the conditions under
which research tools developed by recipients of NIH funds are to be
transferred to for-profit entities. The comments received reflected the
wide range of opinions present within the life sciences community on
this point. On the one hand, some commenters urged that transfer of
research tools to for-profit entities be carried out under the same
terms as transfers to nonprofits/academic institutions. These
commenters argue that because of the increasingly important role
research tools play in the discovery and development of new therapeutic
compounds, it is critical that these tools be made available to for-
profit entities free of onerous contractual provisions. They argue that
by adopting a transfer policy similar to that proposed for transfers to
academic laboratories, NIH will ensure that the public will reap the
benefit of its investment in government research in the form of new and
improved pharmaceuticals. Other commenters opposed the general idea
that the terms for transferring tools to for-profit entities should be
identical to those for transfers of tools to academic and non-profit
organizations. They argue that the fundamental differences in mission
between for-profit entities and academic institutions justify different
treatment with respect to the terms under which each obtains and uses
tools.
In the final policy, the NIH has left considerable discretion to
Recipients in determining how to achieve the principle of ensuring
appropriate distribution of NIH-funded tools. As articulated by the
policy, imposing reach-through royalty terms as a condition of use of a
research tool is inconsistent with this principle. When transferring an
NIH-funded research tool to a for-profit entity that intends to use the
tool for its own internal purposes, Recipients are entitled to capture
the value of their invention. Arrangements such as execution or annual
fees are an appropriate way for Recipients to do so. Royalties on the
sale of a final product that does not embody the tool, or other reach-
through rights directed to a final product that does not embody the
tool, discourage use of tools and are not appropriate in these
circumstances. Royalties on the sale of final products are more
appropriate to situations where a for-profit entity seeks to
commercialize the tool, e.g., by developing a marketable product or
service, or incorporating the tool into a marketable product or
service.
Appendix A Guidelines for Implementation
The final policy has been clarified with regard to NIH intent in
attaching the more specific Guidelines to the general Principles. The
Principles set forth the policy that NIH is issuing to its funding
Recipients to assist them in fulfilling the dual obligations imposed by
NIH grants policy with respect to the dissemination of unique research
resources, and the Bayh-Dole Act with respect to utilization,
commercialization and public availability of government funded
inventions. These dual obligations must be thoughtfully managed. The
Guidelines provide further information, model language, and suggested
strategies for implementing the principles. The model language and
strategies provided by the Guidelines are not intended as the sole
means by which Recipients may implement the articulated Principles. It
is the nature of advancing science and technology to present unique
factual circumstances, and NIH expects that Recipients will determine
the most appropriate means to achieve the Principles for unique
technologies when the Guidelines do not provide a workable strategy.
[[Page 72092]]
Several commenters suggested that research tools be better defined
and that more examples be used to assist in determining whether the
policy should be applied and if so, what licensing strategy is
appropriate. For example, one commenter suggested that the policy draw
a distinction between ``broad platform technologies'' and ``product-
specific technologies'' when determining whether an exclusive license
is appropriate. The final policy provides clarification of the criteria
that Recipients might apply in determining how to handle a particular
technology.
One commenter requested that the definition of research tools be
expanded to include diagnostic genetic tests performed with ``home-
brew'' reagents. The commenter suggested that the patenting and
exclusive licensing of such tests is having a deleterious effect on
clinical education, clinical research, and patient care. NIH declines
to expand the definition of research tools to include diagnostic
genetic tests. Where such tests are patented and licensed to for-profit
entities, academic medical centers wishing to use such licensed tests
in their clinical programs should negotiate terms of use with the
commercial licensee.
Many commenters were of the opinion that the thirty-day time limit
for disclosure of research findings was too short. The final policy has
been amended to state that a delay of 30-60 days is generally viewed as
reasonable. This amendment is in accord with previous NIH guidance on
sponsored research agreements, Developing Sponsored Research
Agreements: Considerations for Recipients of NIH Research Grants and
Contracts, 59 FR 55674.
Comments were received in favor of adopting the Simple Letter
Agreement as a free-standing, one page, uniform material transfer
agreement. If used by the NIH intramural program and NIH grantees,
commenters believe that the majority of transfers among and between
not-for-profits and government laboratories would be greatly
simplified. In response to specific comments, the Simple Letter
Agreement has been significantly edited and updated. Recipients are
encouraged to adopt the Simple Letter Agreement as their institution's
model Material Transfer Agreement (MTA), and are expected to use the
terms of the Simple Letter Agreement, or no more restrictive terms, for
transfers of unpatented materials developed with NIH funding to other
NIH grantees.
FOR FURTHER INFORMATION CONTACT: Ms. Barbara McGarey, J.D., NIH Office
of Technology Transfer, 6011 Executive Boulevard, Suite 325, Rockville,
MD 20852-3804; Fax: (301) 402-3257; E-mail: [email protected]
Dated: December 14, 1999.
Maria C. Freire,
Director, Office of Technology Transfer, National Institutes of Health.
Sharing Biomedical Research Resources: Principles and Guidelines
for Recipients of NIH Research Grants and Contracts
Introduction
The National Institutes of Health is dedicated to the advancement
of health through science. As a public sponsor of biomedical research,
NIH has a dual interest in accelerating scientific discovery and
facilitating product development. In 1997, Dr. Harold Varmus, Director,
NIH requested that a Working Group of the Advisory Committee to the
Director look into problems encountered in the dissemination and use of
unique research resources, the competing interests of intellectual
property owners and research tool users, and possible NIH responses.\1\
The Working Group found that intellectual property restrictions can
stifle the broad dissemination of new discoveries and limit future
avenues of research and product development. At the same time,
reasonable restrictions on the dissemination of research tools are
sometimes necessary to protect legitimate proprietary interests and to
preserve incentives for commercial development. One of the
recommendations of the Working Group was that NIH issue guidance to its
funding recipients to help them achieve the appropriate balance. That
guidance is provided in this two-part document, consisting of
Principles setting forth the fundamental concepts and Guidelines that
provide specific information to patent and license professionals and
sponsored research administrators for implementation. A copy of the
full Report of the Working Group, with more detailed background
information, is available at the NIH web site, www.nih.gov/welcome/
forum, or from the NIH Office of the Director.
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\1\ The term ``unique research resource'' is used in its
broadest sense to embrace the full range of tools that scientists
use in the laboratory, including cell lines, monoclonal antibodies,
reagents, animal models, growth factors, combinatorial chemistry and
DNA libraries, clones and cloning tools (such as PCR), methods,
laboratory equipment and machines. The terms ``research tools'' and
``materials'' are used throughout this document interchangeably with
``unique research resources.'' Databases and materials subject to
copyright, such as software, are also research tools in many
contexts. Although the information provided here may be applicable
to such resources, the NIH recognizes that databases and software
present unique questions which cannot be fully explored in this
document.
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Principles
1. Ensure Academic Freedom and Publication
Academic research freedom based upon collaboration, and the
scrutiny of research findings within the scientific community, are at
the heart of the scientific enterprise. Institutions that receive NIH
research funding through grants, cooperative agreements or contracts
(``Recipients'') have an obligation to preserve research freedom,
safeguard appropriate authorship, and ensure timely disclosure of their
scientists' research findings through, for example, publications and
presentations at scientific meetings. Recipients are expected to avoid
signing agreements that unduly limit the freedom of investigators to
collaborate and publish, or that automatically grant co-authorship or
copyright to the provider of a material.
Reasonable restrictions on collaboration by academic researchers
involved in sponsored research agreements with an industrial partner
that avoid conflicting obligations to other industrial partners, are
understood and accepted. Similarly, brief delays in publication may be
appropriate to permit the filing of patent applications and to ensure
that confidential information obtained from a sponsor or the provider
of a research tool is not inadvertently disclosed. However, excessive
publication delays or requirements for editorial control, approval of
publications, or withholding of data all undermine the credibility of
research results and are unacceptable.
2. Ensure Appropriate Implementation of the Bayh-Dole Act
When a Recipient's research work is funded by NIH, the activity is
subject to various laws and regulations, including the Bayh-Dole Act
(35 U.S.C. 200 et seq.). Generally, Recipients are expected to maximize
the use of their research findings by making them available to the
research community and the public, and through their timely transfer to
industry for commercialization.
The right of Recipients to retain title to inventions made with NIH
funds comes with the corresponding obligations to promote utilization,
commercialization, and public availability of these inventions. The
Bayh-Dole Act encourages Recipients to patent and license subject
inventions as one means of fulfilling these obligations.
[[Page 72093]]
However, the use of patents and exclusive licenses is not the only, nor
in some cases the most appropriate, means of implementing the Act.
Where the subject invention is useful primarily as a research tool,
inappropriate licensing practices are likely to thwart rather than
promote utilization, commercialization and public availability of the
invention.
In determining an intellectual property strategy for an NIH-funded
invention useful primarily as a research tool, Recipients should
analyze whether further research, development and private investment
are needed to realize this primary usefulness. If it is not, the goals
of the Act can be met through publication, deposit in an appropriate
databank or repository, widespread non-exclusive licensing or any other
number of dissemination techniques. Restrictive licensing of such an
invention, such as to a for-profit sponsor for exclusive internal use,
is antithetical to the goals of the Bayh-Dole Act.
Where private sector involvement is desirable to assist with
maintenance, reproduction, and/or distribution of the tool, or because
further research and development are needed to realize the invention's
usefulness as a research tool, licenses should be crafted to fit the
circumstances, with the goal of ensuring widespread and appropriate
distribution of the final tool product. Exclusive licensing of such an
invention, such as to a distributor that will sell the tool or to a
company that will invest in the development of a tool from the nascent
invention, can be consistent with the goals of the Bayh-Dole Act.
3. Minimize Administrative Impediments to Academic Research
Each iteration in a negotiation over the terms of a license
agreement or materials transfer agreement delays the moment when a
research tool may be put to use in the laboratory. Recipients should
take every reasonable step to streamline the process of transferring
their own research tools freely to other academic research institutions
using either no formal agreement, a cover letter, the Simple Letter
Agreement of the Uniform Biological Materials Transfer Agreement
(UBMTA), or the UBMTA itself. The Appendix contains an updated free-
standing version of the Simple Letter Agreement that is strongly
encouraged for transfers of unpatented research materials among
Recipients.
Where they have not already done so, Recipients should develop and
implement clear policies which articulate acceptable conditions for
acquiring resources, and refuse to yield on unacceptable conditions.
NIH acknowledges the concern of some for-profit organizations that the
concept of purely academic research may be diluted by the close ties of
some not-for-profit organizations with for-profit entities, such as
research sponsors and spin-off companies in which such organizations
take equity. Of concern to would-be providers is the loss of control
over a proprietary research tool that, once shared with a not-for-
profit Recipient for academic research, results in commercialization
gains to the providers' for-profit competitors. Recipients must be
sensitive to this legitimate concern if for-profit organizations are
expected to share tools freely.
For-profit organizations, in turn, must minimize the encumbrances
they seek to impose upon not-for-profit organizations for the academic
use of their tools. Reach-through royalty or product rights,
unreasonable restraints on publication and academic freedom, and
improper valuation of tools impede the scientific process whether
imposed by a not-for-profit or for-profit provider of research tools.
While these Principles are directly applicable only to recipients of
NIH funding, it is hoped that other not-for-profit and for-profit
organizations will adopt similar policies and refrain from seeking
unreasonable restrictions or conditions when sharing materials.
4. Ensure Dissemination of Research Resources Developed With NIH Funds
Progress in science depends upon prompt access to the unique
research resources that arise from biomedical research laboratories
throughout government, academia, and industry. Ideally, these new
resources flow to others who advance science by conducting further
research. Prompt access can be accomplished in a number of ways,
depending on the type of resource that has been developed, whether it
has broad or specific uses, and whether it is immediately useful or
private sector investment is needed to realize its usefulness. The goal
is widespread, timely distribution of tools for further discovery. When
research tools are used only within one or a small number of
institutions, there is a great risk that fruitful avenues of research
will be neglected.
Unique research resources arising from NIH-funded research are to
be made available to the scientific research community. Recipients are
expected to manage interactions with third parties that have the
potential to restrict Recipients' ability to disseminate research tools
developed with NIH funds.\2\ For example, a Recipient might use NIH
funds with funds from one or more third party sponsors, or acquire a
research tool from a third party provider for use in an NIH-funded
research project. Either situation may result in a Recipient incurring
obligations to a third party that conflict with Recipient's obligations
to the NIH. To avoid inconsistent obligations, Recipients are
encouraged to share these Principles with potential co-sponsors of
research projects and third party providers of materials.
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\2\ Research tools obtained or derived from human tissues
constitute a special case. Certain restrictions on the use and
further dissemination of such tools may be appropriate to ensure
consistency with donor consent and human subjects protection. See 45
CFR Part 46.
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Recipients should also examine and, where appropriate, simplify the
transfer of materials developed with NIH funds to for-profit
institutions for internal use by those institutions. NIH endorses
distinguishing internal use by for-profit institutions from the right
to commercial development and sale or provision of services. In
instances where the for-profit institution is seeking access for
internal use purposes, Recipients are encouraged to transfer research
tools developed with NIH funding to such institutions without seeking
option rights or royalties on the final product.
Summary
Access to research tools is a prerequisite to continuing scientific
advancement. Ensuring broad access while preserving opportunities for
product development requires thoughtful, strategic implementation of
the Bayh-Dole act. The NIH urges Recipients to develop patent, license,
and material sharing policies with this goal in mind, realizing both
product development as well as the continuing availability of new
research tools to the scientific community.
Appendix--Guidelines for Implementation
The following Guidelines provide specific information, strategies,
and model language for patent and license professionals and sponsored
research administrators at Recipient institutions to assist in
implementing the Principles on Obtaining and Disseminating Biomedical
Resources. Recipients are encouraged to use the strategies below, other
strategies developed at their own institutions, or any other
appropriate means of achieving the Principles.
[[Page 72094]]
Guidelines for Disseminating Research Resources Arising Out of NIH-
Funded Research
Definition of Research Tools
The definition of research tools is necessarily broad, and it is
acknowledged that the same material can have different uses, being a
research tool in some contexts and a product in others. In determining
how an NIH-funded resource that falls within the definition should be
handled, Recipients should determine whether: (1) The Primary
usefulness of the resource is as a tool for discovery rather than an
FDA-approved product or integral component of such a product; (2) the
resource is a broad, enabling invention that will be useful to many
scientists (or multiple companies in developing multiple products),
rather than a project or product-specific resource; and (3) the
resource is readily useable or distributable as a tool rather than the
situation where private sector involvement is necessary or the most
expedient means for developing or distributing the resource. Recipients
should ensure that their intellectual property strategy for resources
fitting one or more of the above criteria enhances rather than
restricts the ultimate availability of the resource. If Recipient
believes private sector involvement is desirable to achieve this goal,
Recipient should strategically license the invention under terms
commensurate with the goal.
Use of Simple Letter Agreement
Recipients are expected to ensure that unique research resources
arising from NIH-funded research are made available to the scientific
research community. The majority of transfers to not-for-profit
entities should be implemented under terms no more restrictive than the
UBMTA. In particular, Recipients are expected to use the Simple Letter
Agreement provided below, or another document with no more restrictive
terms, to readily transfer unpatented tools developed with NIH funds to
other Recipients for use in NIH-funded projects. If the materials are
patented or licensed to an exclusive provider, other arrangements may
be used, but commercialization option rights, royalty reach-through, or
product reach-through rights back to the provider are inappropriate.
Similarly, when for-profit entities are seeking access to NIH-
funded tools for internal use purposes, Recipients should ensure that
the tools are transferred with the fewest encumbrances possible. The
Simple Letter Agreement may be expanded for use in transferring tools
to for-profit entities, or simple internal use license agreements with
execution or annual use fees may be appropriate.
Simple Letter Agreement for the Transfer of Materials
In response to RECIPIENT's request for the MATERIAL [insert
description] __________ the PROVIDER asks that the RECIPIENT and the
RECIPIENT SCIENTIST agree to the following before the RECIPIENT
receives the MATERIAL:
1. The above MATERIAL is the property of the PROVIDER and is made
available as a service to the research community.
2. THIS MATERIAL IS NOT FOR USE IN HUMAN SUBJECTS.
3. The MATERIAL will be used for teaching or not-for-profit
research purposes only.
4. The MATERIAL will not be further distributed to others without
the PROVIDER's written consent. The RECIPIENT shall refer any request
for the MATERIAL to the PROVIDER. To the extent supplies are available,
the PROVIDER or the PROVIDER SCIENTIST agree to make the MATERIAL
available, under a separate Simple Letter Agreement to other scientists
for teaching or not-for-profit research purposes only.
5. The RECIPIENT agrees to acknowledge the source of the MATERIAL
in any publications reporting use of it.
6. Any MATERIAL delivered pursuant to this Agreement is understood
to be experimental in nature and may have hazardous properties. THE
PROVIDER MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY
KIND, EITHER EXPRESSED OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR
THAT THE USE OF THE MATERIAL WILL NOT INFRINGE ANY PATENT, COPYRIGHT,
TRADEMARK, OR OTHER PROPRIETARY RIGHTS. Unless prohibited by law,
Recipient assumes all liability for claims for damages against it by
third parties which may arise from the use, storage or disposal of the
Material except that, to the extent permitted by law, the Provider
shall be liable to the Recipient when the damage is caused by the gross
negligence or willful misconduct of the Provider.
7. The RECIPIENT agrees to use the MATERIAL in compliance with all
applicable statutes and regulations.
8. The MATERIAL is provided at no cost, or with an optional
transmittal fee solely to reimburse the PROVIDER for its preparation
and distribution costs. If a fee is requested, the amount will be
indicated here: __________
The PROVIDER, RECIPIENT and RECIPIENT SCIENTIST must sign both
copies of this letter and return one signed copy to the PROVIDER. The
PROVIDER will then send the MATERIAL.
Provider Information and Authorized Signature
Provider Scientist:----------------------------------------------------
Provider Organization:-------------------------------------------------
Address:---------------------------------------------------------------
Name of Authorized Official:-------------------------------------------
Title of Authorized Official:------------------------------------------
Certification of Authorized Official: This Simple Letter Agreement
____ has ____ has not [check one] been modified. If modified, the
modification are attached.
----------------------------------------------------------------------
(Signature of Authorized Official) (Date)
Recipient Information and Authorized Signature
Recipient Scientist: --------------------------------------------------
Recipient Organization: -----------------------------------------------
Address: --------------------------------------------------------------
Name of Authorized Official: ------------------------------------------
Title of Authorized Official: -----------------------------------------
Signature of Authorized Official:--------------------------------------
Date:------------------------------------------------------------------
Certification of Recipient Scientist: I have read and understood the
conditions outlined in this Agreement and I agree to abide by them
in the receipt and use of the MATERIAL.
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(Recipient Scientist) (Date)
Ensuring Consistent Obligations
Recipients must ensure that obligations to other sources of funding
of projects in which NIH funds are used are consistent with the Bayh-
Dole Act and NIH funding requirements. Unique research resources
generated under such projects are expected to be made available to the
research community. Recipients are encouraged to share these Guidelines
with potential co-sponsors. Any agreements covering projects in which
NIH funds will be used along with other funds are expected to contain
language to address the issue of dissemination of unique research
resources. Examples of possible language follow. The paragraphs are
presented in a ``mix and match'' format:
``The project covered by this agreement is supported with
funding from the National Institutes of Health. Provider agrees that
upon publication, unpatented unique research resources arising out
of this project may be freely distributed.''
``In the event an invention is primarily useful as a research
tool, any option granted shall either be limited to a non-exclusive
license or the terms of any resulting exclusive license shall
include provisions that ensure that the research tool will be
[[Page 72095]]
available to the academic research community on reasonable terms.''
``Provider agrees that Recipient shall have the right to make
any materials and inventions developed by Recipient in the course of
the collaboration (including materials and inventions developed
jointly with Provider, but not including any Provider materials (or
parts thereof) or Provider sole inventions available to other
scientists at not-for-profit organizations for use in research,
subject to Provider's independent intellectual property rights.''
``Subject to Recipient's obligations to the U.S. government,
including 37 CFR Part 401, the NIH Grants Policy Statement, and the
NIH Guidelines for Obtaining and Disseminating Biomedical Research
Resources, Recipient grants to Sponsor the following rights: * * *''
Limiting Exclusive Licenses to Appropriate Field of Use
Exclusive licenses for research tools (where no further research
and development is needed to realize the invention's usefulness as a
tool) should generally be avoided except in cases where the licensee
undertakes to make the research tool widely available to researchers
through unrestricted sale, or the licensor retains rights to make the
research tool widely available. When an exclusive license is necessary
to promote investment in commercial applications of a subject invention
that is also a research tool, the Recipient should ordinarily limit the
exclusive license to the commercial field of use, retaining rights
regarding use and distribution as a research tool. Examples of possible
language include:
``Research License'' means a nontransferable, nonexclusive
license to make and to use the Licensed Products or Licensed
Processes as defined by the Licensed Patent Rights for purposes of
research and not for purposes of commercial manufacture,
distribution, or provision of services, or in lieu of purchase, or
for developing a directly related secondary product that can be
sold. Licensor reserves the right to grant such nonexclusive
Research Licenses directly or to require Licenses on reasonable
terms. The purpose of this Research License is to encourage basic
research, whether conducted at an academic or corporate facility. In
order to safeguard the Licensed Patent Rights, however, Licensor
shall consult with Licensee before granting to commercial entities a
Research License or providing to them research samples of the
materials.''
``Licensor reserves the right to provide the Biological
Materials and to grant licenses under Patent Rights to not-for-
profit and governmental institutions for their internal research and
scholarly use.''
``Notwithstanding anything to the contrary in this agreement,
Licensor shall retain a paid-up, nonexclusive, irrevocable license
to practice, and to sublicense other not-for-profit research
organizations to practice, the Patent Rights for internal research
use.''
``The grant of rights provided herein is subject to the rights
of the United States government pursuant to the Bayh-Dole Act and is
limited by the right of the Licensor to use Patent Rights for its
own research and educational purposes and to freely distribute
Materials to not-for-profit entities for internal research
purposes.''
``Licensor reserves the right to supply any or all of the
Biological materials to academic research scientists, subject to
limitation of use by such scientists for research purposes and
restriction from further distribution.''
``Licensor reserves the right to practice under the Patent
Rights and to use and distribute to third parties the Tangible
Property for Licensor's own internal research purposes.''
Guidelines for Acquiring Research Resources for Use in NIH-Funded
Research
Prompt Publication
Agreements to acquire materials for use in NIH-funded research are
expected to address the timely dissemination of research results.
Recipients should not agree to significant publication delays, any
interference with the full disclosure of research findings, or any
undue influence on the objective reporting of research results. A delay
of 30-60 days to allow for patent filing or review for confidential
proprietary information is generally viewed as reasonable.
Definition of Materials
Under the Bayh-Dole Act and its implementing regulations,
agreements to acquire materials for use in NIH-funded projects cannot
require that title to resulting inventions be assigned to the provider.
For this reason, definitions of ``materials'' that include all
derivatives or modifications are unacceptable. Other unacceptable
variations include definitions of ``materials'' that include any
improvements, or any other materials that could not have been made
without the provided material. Conversely, it is important for
providers of materials to be aware that a Recipient does not gain any
ownership or interest in a provider's material by virtue of the
Recipient using the material in an NIH-funded activity. Examples of
acceptable definitions for ``materials'' include:
`` `Materials' means the materials provided as specified in this
document.''
`` `Materials' means the materials provided as specified in this
document. Materials may also include Unmodified Derivatives of the
materials provided, defined as substances created by the Recipient
which constitute an unmodified functional subunit or product
expressed by the original material, such as subclones of unmodified
cell lines, purified or fractionated subsets of the original
materials, proteins expressed by DNA/RNA supplied by the Provider,
or monoclonal antibodies secreted by a hybridoma cell line.''
`` `Materials' means the materials provided as specified in this
document. Materials may also include Progeny and Unmodified
Derivatives of the materials provided. Progeny is an unmodified
descendant from the original material, such as virus from virus,
cell from cell, or organism from organism. Unmodified Derivatives
are substances created by the Recipient which constitute an
unmodified functional subunit or product expressed by the original
material, such as subclones of unmodified cell lines, purified or
fractionated subsets of the original material, proteins expressed by
DNA/RNA supplied by the Provider, or monoclonal antibodies secreted
by a hybridoma cell line.''
`` `Materials' means the materials being transferred as
specified in this document. Materials shall not include: (a)
Modifications, or (b) other substances created by the recipient
through the use of the Material which are not Modifications,
Progeny, or Unmodified Derivatives. Progeny is an unmodified
descendant from the Material, such as virus from virus, cell from
cell, or organism from organism. Unmodified Derivatives are
substances created by the Recipient which constitute an unmodified
functional subunit or product expressed by the original Material,
such as subclones of unmodified cell lines, purified or fractionated
subsets of the original Material, proteins expressed by DNA/RNA
supplied by the Provider, or monoclonal antibodies secreted by a
hybridoma cell line.'' [Source: Uniform Biological Materials
Transfer Agreement; terms defined therein]
Ensuring Consistent Obligations
Recipients are expected to avoid signing agreements to acquire
research tools that are likely to restrict Recipients' ability to
promote broad dissemination of additional tools that may arise from the
research. This might occur when an agreement gives a provider an
exclusive license option to any new intellectual property arising out
of the project. A new transgenic mouse developed during the project
could fall under this license option and become unavailable to third
party scientists as a result. Examples of agreements to examine include
material transfer agreements (MTAs), memoranda of understanding (MOU),
research or collaboration agreements, and sponsored research
agreements. Recipients should consider adopting standard language to
place in such agreements to address this issue. The following are
examples of possible language to include in MTAs, sponsored research
agreements, and other agreements that either acquire materials from or
co-mingle funds with non-government sources. The paragraphs are
presented in a ``mix and match'' format:
[[Page 72096]]
``The project covered by this agreement is supported with
funding from the National Institutes of Health. Provider agrees that
after publication, unpatented unique research resources arising out
of this project may be freely distributed.''
``In the event an invention is primarily useful as a research
tool, any option granted shall either be limited to a non-exclusive
license or the terms of any resulting exclusive license shall
include provisions which insure that the research tool will be
available to the academic research community on reasonable terms.''
``Provider agrees that Recipient shall have the right to make
any materials and inventions developed by Recipient in the course of
the collaboration (including materials and inventions developed
jointly with Provider, but not including any Provider materials (or
parts thereof) or Provider sole inventions available to other
scientists at not-for-profit organizations for use in research,
subject to Provider's independent intellectual property rights.''
``Subject to Recipient's obligations to the U.S. government,
including 37 CFR Part 401, the NIH Grants Policy Statement, and the
NIH Guidelines for Obtaining and Disseminating Biomedical Research
Resources, Recipient grants to Sponsor the following rights: * * *''
Grantbacks and Option Rights
Agreements to acquire materials from for-profit entities
for use in NIH-funded research may provide a grant back of non-
exclusive, royalty-free rights to the provider to use improvements and
new uses of the material that, if patented, would infringe any patent
claims held by the provider. They may also provide an option for an
exclusive or non-exclusive commercialization license to new inventions
arising directly from use of the material. These should be limited to
circumstances where the material sought to be acquired is unique, such
as a patented proprietary material, and not reasonably available from
any other source. A non-exclusive ``grant-back'' might be used, for
example, to protect a for-profit entity that provides a proprietary
compound from being blocked from using new uses or improvements of that
compound discovered during the NIH-funded project. In providing license
options, Recipients must ensure that licenses granted to providers
under such options are consistent with Bayh-Dole requirements,
including the preference for U.S. industry requirements and reservation
of government rights under 47 CFR part 401.
In determining the scope of license or option rights that
are granted in advance to a provider of materials, Recipient should
balance the relative value of the provider's contributions against the
value of the rights granted, cost of the research, and importance of
the research results. The rights granted to providers should be limited
to inventions that have been made directly through the use of the
materials provided. In addition, Recipients should reserve the right to
negotiate license terms that will ensure: (1) continuing availability
to the research community if the new invention is a unique research
resource; (2) that the provider has the technical and financial
capability and commitment to bring all potential applications to the
marketplace in a timely manner; and (3) that if an exclusive license is
granted, the provider will provide a commercial development plan and
agree to benchmarks and milestones for any fields of use granted.
It is expected that agreements to acquire NIH-funded
materials from not-for-profit entities for use in NIH-funded research
will not include commercialization option rights, royalty reach-
through, or product reach-through rights back to the provider. Such
materials should be acquired under the Simple Letter Agreement or
UBMTA, or, if the materials are patented,a simple license agreement
that does not request reach-through to either future products or
royalties. If the providing not-for-profit organization is constrained
in sharing the material due to a pre-existing sponsored research
agreement or license, NIH expects that not-for-profit provider to
negotiate a suitable resolution with the private research sponsor or
licensee. The co-mingling of NIH and sponsored research funds is
allowed, however, Recipient is responsible for ensuring that conditions
on the use of the sponsored funds do not interfere with the open
dissemination of research tools.
[FR Doc. 99-33292 Filed12-22-99; 8:45 am]
BILLING CODE 4140-01-M
