[Federal Register Volume 64, Number 100 (Tuesday, May 25, 1999)]
[Notices]
[Pages 28205-28209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13044]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Principles for Recipients of NIH Research Grants and Contracts on
Obtaining and Disseminating Biomedical Research Resources: Request for
Comments
AGENCY: National Institutes of Health (NIH), Public Health Service,
DHHS.
ACTION: Notice.
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Introduction: The National Institutes of Health (NIH) is seeking
comments on a proposed policy entitled SHARING BIOMEDICAL RESEARCH
RESOURCES: Principles and Guidelines for Recipients of NIH Research
Grants and Contracts. This policy represents part of the overall
implementation of recommendations made by the Advisory Committee to the
Director (ACD) to Dr. Harold 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: This policy is a two-part document, consisting of
Principles to set forth the fundamental concepts and Guidelines to
provide specific information to patent and license professionals 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 (importing 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.
Request for Comments: NIH is seeking comment not only from NIH
grantees, but from the full range of academic, not-for-profit,
government, and private sector participants in biomedical research and
development. Widespread comment and participation by varied
stakeholders in the biomedical research and development enterprise is
critical if these Principles, and their implementing Guidelines, are to
be effective in guiding the interactions of NIH funding recipients with
these sectors. 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.
The NIH welcomes public comment on the full text of the Principles
and Guidelines, set forth below. Comments should be addressed to:
Research Tool Guidelines Project, Ms. Barbara M. McGarey, J.D., NIH
Office of Technology Transfer, 6011 Executive Boulevard, Suite 325
Rockville, MD 20852-3804. Comments may also be sent by facsimile
transmission to the Research Tool Guidelines Project, Ms. Barbara M.
McGarey, at (301) 402-3257, or by e-mail to nihott@od.nih.gov.
DATES: Comments must be received by NIH on or before August 23, 1999.
Dated: May 18, 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
[[Page 28206]]
found that intellectual property restrictions can stifle the broad
dissemination of new discoveries and limit future avenues of research
and product development.
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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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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 assist them to achieve
the appropriate balance. This two-part document, consisting of
Principles to set forth the fundamental concepts and Guidelines to
provide specific information to patent and license professionals for
implementation, represents that guidance.
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.
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 or contracts (``Recipients'') have an
obligation to preserve research freedom 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.
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
(Public Law 96-517). Generally, Recipients must 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. 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.
Restrictive licensing, especially when coupled with indiscriminate
use of the patent system, can be antithetical to the goals of the Bayh-
Dole Act, such as where these are employed primarily for financial
gain. Utilization, commercialization and public availability of
technologies that are useful primarily as research tools rarely require
patent protection; further research, development and private investment
are not needed to realize their usefulness as research tools. In such
cases, the goals of the Act can be met through publication, deposit in
an appropriate databank or repository, widespread non-exclusive
licensing for nominal or cost-recovery fees, or any other number of
dissemination techniques.
In addition, commercialization and product development becomes more
encumbered as the number of stakeholders laying claim to prospective
revenues increases. Proprietary rights in research tools that do not
require further development may function more as a tax on commercial
development than as a source of rights to preserve the viability of end
products and to motivate further investment. While such a tax may
benefit the public by providing a financial return on the research
investment, it may not always represent the appropriate valuation of a
research tool and therefore serve as a disincentive to private sector
use of the invention.
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.
Recipients should also examine and, where possible and 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.
Recipients are encouraged to transfer research tools developed with NIH
funding to for-profit institutions with the fewest encumbrances
possible in instances where the for-profit institution is seeking
access for internal use purposes. Examples of such internal uses are
research, screening, and the use of methods or devices for product
development.
Where they have not already done so, Recipients should develop and
implement clear policies which articulate acceptable conditions for
importing 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.
[[Page 28207]]
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 conducting further research, advancing science
and serving as the new standard which itself will be improved upon and
ultimately replaced. This is accomplished by wide distribution on a
nonexclusive basis, although wide distribution on reasonable terms by
an exclusive distributor may meet these objectives as well. 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 must 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. For example, a Recipient might co-mingle NIH
funds with funds from one or more third party sponsors, or import 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.
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 to patent and
license professionals at Recipient institutions for implementing the
Principles on Obtaining and Disseminating Biomedical Resources.
Guidelines for Disseminating Research Resources Arising Out of NIH-
Funded Research
Recipients must ensure that unique research resources
arising from NIH funded research are made available to the
scientific research community. Although some licensing of research
tools to for-profit companies is necessary and appropriate, the
majority of transfers, to both not-for-profit entities and 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 of the UBMTA (text below), or
other comparable 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
such as a simple license agreement may be used, but
commercialization option rights, royalty reach-through, or product
reach-through rights back to the provider are inappropriate.
Simple Letter Agreement for Transfer of Non-Proprietary
Biological Material
PROVIDER
Authorized Official:---------------------------------------------------
Organization:----------------------------------------------------------
Address:---------------------------------------------------------------
RECIPIENT
Authorized Official:---------------------------------------------------
Organization:----------------------------------------------------------
Address:---------------------------------------------------------------
In response to the RECIPIENT's request for the BIOLOGICAL
MATERIAL identified as [insert description of material] the PROVIDER
asks that the RECIPIENT and the RECIPIENT SCIENTIST agree to the
following before the RECIPIENT receives the BIOLOGICAL MATERIAL:
1. The above BIOLOGICAL MATERIAL is the property of the provider
and is made available as a service to the research community.
2. The BIOLOGICAL MATERIAL will be used for teaching and
academic research purposes only.
3. The BIOLOGICAL MATERIAL will not be further distributed to
others without the PROVIDER'S written consent. The RECIPIENT shall
refer any request for the BIOLOGICAL MATERIAL to the PROVIDER. To
the extent supplies are available, the PROVIDER or the PROVIDER
SCIENTIST agrees to make the BIOLOGICAL MATERIAL available, under a
separate Simple Letter Agreement, to other scientists (at least
those at nonprofit organizations or government agencies) who wish to
replicate the RECIPIENT SCIENTIST'S research.
4. The RECIPIENT agrees to acknowledge the source of the
BIOLOGICAL MATERIAL in any publications reporting use of it.
5. Any BIOLOGICAL MATERIAL delivered pursuant to this simple
letter 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 BIOLOGICAL
MATERIAL WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR
OTHER PROPRIETARY RIGHTS. Except to the extent prohibited by law,
the RECIPIENT assumes all liability for damages which may arise from
its use, storage or disposal of the BIOLOGICAL MATERIAL. The
PROVIDER will not be liable to the RECIPIENT for any loss, claim or
demand made by the RECIPIENT, or made against the RECIPIENT by any
other party, due to or arising from the use of the MATERIAL by the
RECIPIENT, except to the extent permitted by law when caused by the
gross negligence or willful misconduct of the PROVIDER.
6. The RECIPIENT agrees to use the BIOLOGICAL MATERIAL in
compliance with all applicable statutes and regulations, including,
for example, those relating to research involving the use of human
and animal subjects or recombinant DNA.
7. The BIOLOGICAL 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: [insert fee].
The RECIPIENT and the RECIPIENT SCIENTIST should sign both copies of
this letter and return one signed copy to the PROVIDER SCIENTIST.
The PROVIDER will then forward the BIOLOGICAL MATERIAL.
PROVIDER SCIENTIST
Organization:----------------------------------------------------------
Address:---------------------------------------------------------------
Name:------------------------------------------------------------------
Title:-----------------------------------------------------------------
Signature:-------------------------------------------------------------
Date:------------------------------------------------------------------
RECIPIENT SCIENTIST
Organization:----------------------------------------------------------
Address:---------------------------------------------------------------
Name:------------------------------------------------------------------
Title:-----------------------------------------------------------------
Signature:-------------------------------------------------------------
Date:------------------------------------------------------------------
RECIPIENT ORGANIZATION APPROVAL
Authorized Official:---------------------------------------------------
Title:-----------------------------------------------------------------
[[Page 28208]]
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Address:---------------------------------------------------------------
Signature:-------------------------------------------------------------
Date:------------------------------------------------------------------
[Source: 60 FR 12771, March 8, 1995]
Recipients must ensure that obligations to other
sources of funding of projects in which NIH funds are co-mingled 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, which requires that
unique research resources arising out of NIH-funded research be made
widely available to third parties for further research. Provider
agrees that upon publication, unpatented unique research resources
arising out of this project may be freely redistributed.''
``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
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 401, the PHS Grants Policy Statement, and the NIH
Guidelines for Obtaining and Disseminating Biomedical Research
Resources, Recipient grants to Sponsor the following rights: * * *''
Exclusive licenses for research tools should generally
be avoided except in cases where the licensee undertakes to make the
research tool widely available at moderate cost 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 Licensee to grant
nonexclusive Research 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 above to the contrary, 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 and 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 Importing Research Resources for Use in NIH-Funded
Research
Agreements importing 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 thirty days to allow for patent
filing or review for confidential proprietary information is
generally viewed as reasonable.
Under the Bayh-Dole Act and its implementing
regulations, agreements importing 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 all modifications are
unacceptable. 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 material, 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 material 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]
Recipients are expected to avoid signing agreements to
import 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 import materials from or co-mingle
funds with non-government sources. The paragraphs are presented in a
``mix and match'' format:
[[Page 28209]]
``The project covered by this agreement is supported with
funding from the National Institutes of Health, which requires that
unique research resources arising out of NIH-funded research be made
widely available to third parties for further research. Provider
agrees that after publication, unpatented unique research resources
arising out of this project may be freely redistributed.''
``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 401, the PHS Grants Policy Statement, and the NIH
Guidelines for Obtaining and Disseminating Biomedical Research
Resources, Recipient grants to Sponsor the following rights: * * *''
Agreements importing 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 license to new inventions arising
directly from use of the material. These should be limited to
circumstances where the material sought to be imported 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 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 37 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 contribution
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 importing NIH-funded
materials from not-for-profit entities for use in NIH funded
research will not provide commercialization option rights, royalty
reach-through, or product reach-through rights back to the provider.
Such materials should be imported under the 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 the 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 the sponsored
funds do not interfere with NIH funding requirements such as open
dissemination of research tools.
[FR Doc. 99-13044 Filed 5-24-99; 8:45 am]
BILLING CODE 4140-01-U
