[Federal Register Volume 59, Number 118 (Tuesday, June 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14991]
[[Page Unknown]]
[Federal Register: June 21, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Uniform Biological Material Transfer Agreement: Request for
Comments
AGENCY: National Institutes of Health (NIH), Public Health Service,
DHHS.
BACKGROUND: Open access to the results of federally-funded research is
a cornerstone of NIH's research policy. In the case of many research
projects, this includes not only access to information as can be
provided in publications, but also access to biological research
materials necessary to replicate or build on the initial results.
Frequently, the exchange of research materials between scientists and
separate institutions involves case-by-case negotiation of material
transfer agreements (MTAs). In order to guide and facilitate the
increasing number of such transfers, the Public Health Service (PHS)
issued in 1988, a ``Policy Relating to Distribution of Unique Research
Resources Produced with PHS Funding'' (NIH GUIDE FOR GRANTS AND
CONTRACTS, Vol. 17, No. 29, September 16, 1988: pg. 1), that was
followed in 1989 by adoption of a standard Material Transfer Agreement
form for use by NIH scientists. Such agreements are important because
they require the recipient to use care in the handling of the
materials, to maintain control over the distribution of the materials,
to acknowledge the provider in publications, and to follow relevant
Public Health Service (PHS) guidelines relating to recombinant DNA,
human subjects research, use of animals, etc. However, while most
institutions have adopted some standard material transfer agreement
form, they are not all consistent.
ISSUE: Several concerns have affected the sharing of research
materials. These include delays in sharing of materials while
conducting negotiations on individual MTAs, required grants of
invention rights to improvements to the materials or to inventions made
using the materials, and required approval prior to publication. Such
problems have resulted in significant delays in sharing materials,
undue administrative barriers to sharing, and in some cases, lack of
availability of materials for further research by federal grantees.
(For reports and discussion of these issues, please refer to The New
Biologist, Vol. 2, No. 6, June 1990: pp. 495-497; and Science, Vol.
248, 25 May, 1990: pp. 952-957).
In addition, there is a desire to have a uniform agreement for the
sharing of non-proprietary materials.
PROPOSAL: The NIH, in participation with representatives of academia
and industry, has coordinated the development of a proposed uniform
biological material transfer agreement (UBMTA) to address concerns
about contractual obligations imposed by some MTAs and to simplify the
process of sharing proprietary materials between non-profit
institutions. The Association of University Technology Managers,
particularly Ms. Joyce Brinton, Harvard University; Ms. Lita Nelsen,
Massachusetts Institute of Technology; and Dr. Sandra Shotwell, Oregon
Health Sciences University, have played leadership roles in furthering
the development of common materials sharing practices. The consistent
use of this agreement by grantee institutions could reduce the
administrative burden of sharing materials as investigators come to
rely on common acceptance of the terms of the UBMTA by cooperating
institutions.
The NIH proposes that the UBMTA be considered for general use in
the exchange of materials for research purposes between non-profit
institutions. While use of the UBMTA may not be appropriate for every
material transfer, if used for the majority of transfers, it could set
standards for materials sharing that would be of long term benefit to
the research enterprise and to the public health.
As a further suggestion to simplify the process of materials
sharing, it is proposed that the UBMTA be approved at the institutional
level, and handled in a treaty format, so that individual transfers
could be made with reference to the UBMTA, without the need for
separate negotiation of an individual document to cover each transfer.
As a result, transfers of biological materials would be accomplished by
an implementing letter (see sample) containing a description of the
material, a statement indicating that the material was being
transferred in accordance with the terms of the UBMTA and signed by the
Provider Scientist and the Recipient Scientist. Thus, sharing of
materials between institutions, each of which had signed the UBMTA,
would be significantly simplified. At the same time, any institution
would retain the option to handle a specific material on a customized
basis, i.e., the use of the UBMTA would not be mandatory, even for
signatory institutions.
For non-proprietary materials, a Simple Letter Agreement has also
been developed, which incorporates many of the same principles as the
UBMTA. This Letter Agreement could be used where the institutions have
not agreed to the UBMTA.
The full text of the treaty version of the UBMTA, the implementing
letter, and a simple one-page letter agreement for non-proprietary
material follows. The NIH welcomes public comment on the documents
themselves, as well as their proposed use. Comments should be addressed
to: UBMTA Project, c/o Office of Technology Transfer, Box 13, 6011
Executive Boulevard, Rockville, MD 20852-3804. Comments may also be
sent by facsimile transmission to: UBMTA Project at (301) 402-0220.
DATES: Comments must be received by NIH on or before July 21, 1994.
Dated: May 26, 1994
Donald P. Christoferson,
Acting Director, Office of Technology Transfer.
Master Agreement Regarding Use of the Uniform Biological Material
Transfer Agreement (UMBTA) for Exchanges of Biological Material Between
Non-Profit Institutions
Upon execution of an Implementing Letter in the form attached which
specifies the materials to be transferred, this institution agrees to
be bound by the terms of the Non-Profit to Non-Profit UBMTA, dated
________ also attached.
Enclosures: Implementing Letter format UBMTA
Institution:
Address:
Authorized Official:
Title:
Signature:
Date:
Sample UBMTA Implementing Letter
Definitions:
Provider: Institution providing the Original Material (Enter name
and address here):
Provider's Scientist (Enter name and address here):
Recipient: Institution receiving the Original Material (Enter name
and address here):
Recipient's Scientist (Enter name and address here):
Original Material (Enter description):
Provider has filed patent applications claiming the Material or
uses thereof:
Yes No
If Provider has granted any rights to a third party (other than the
customary rights granted to the federal government or non-profit
foundations) which would affect Recipient, those rights are specified
below:
Termination date for this letter (if any is to be specified):
The parties executing this Implementing Letter agree to be bound by
the terms of the Non-Profit to Non-Profit UBMTA for the transfer
specified above:
Agreed:
Provider
Institution:
Address:
Provider Scientist
Name:
Title:
Signature:
Date:
Recipient
Institution:
Address:
Recipient Scientist
Name:
Title:
Signature:
Date:
Certification: I hereby certify that the Recipient institution has
accepted and signed an unmodified copy of the ______ version of the
Uniform Biological Material Transfer Agreement (UBMTA) developed in
cooperation with the National Institutes of Health.
Recipient's Institutional Certification
(Authorized signature)
(Date)
Non-Profit To Non-Profit Uniform Biological Material Transfer
Agreement
(Date)--Treaty Version
Developed In Cooperation With The National Institutes Of Health
Definitions:
Provider: Institution providing the Original Material. (Name and
address to be specified in an implementing letter)
Provider's Scientist: (Name and address to be specified in an
implementing letter)
Recipient: Institution receiving the Original Material. (Name and
address to be specified in an implementing letter)
Recipient's Scientist: (Name and address to be specified in an
implementing letter)
Original Material: (Description to be specified in an implementing
letter)
Material: Original Material plus Progeny and Unmodified
Derivatives. The Material shall not include: (i) Modifications or (ii)
other substances created by the Recipient through the use of the
Material which are not Progeny or Unmodified Derivatives.
Progeny: Unmodified descendant from the Material, such as virus
from virus, cell from cell, or organism from organism.
Unmodified Derivatives: Substances created by Recipient which
constitute an unmodified functional sub-unit or an expression product
of the Original Material. Some examples include: subclones of
unmodified cell lines, purified or fractionated sub-sets of the
Original Material, proteins expressed by DNA/RNA supplied by Provider,
monoclonal antibodies secreted by a hybridoma cell line, sub-sets of
the Original Material such as novel plasmids or vectors.
Modifications: Substances created by Recipient which contain/
incorporate the Material (Original Material, Progeny or Unmodified
Derivatives).
Terms and Conditions of this Agreement
1. The Material is the property of Provider and is to be used by
Recipient solely for research purposes at Recipient's institution and
only under the direction of the Recipient's Scientist. The Material
will not be used in human subjects or in clinical trials involving
human subjects without the written permission of Provider. Patent
applications claiming the Material or uses thereof to be specified in
an implementing letter.
2. The Recipient's Scientist agrees not to transfer the Material to
anyone who does not work under his or her direct supervision at
Recipient's institution without the prior written consent of Provider.
Recipient's Scientist shall refer any request for the Material to
Provider. To the extent supplies are available, Provider or Provider's
Scientist agrees to make the Material available under a UBMTA to other
scientists (at least those at non-profit or governmental institutions)
who wish to replicate Recipient's Scientist's research.
3. (a) Recipient shall have the right, without restriction to
distribute substances created by Recipient through the use of the
Material only if those substances are not Progeny, Unmodified
Derivatives, or Modifications.
(b) Upon notice to Provider and under a UBMTA (or an agreement at
least as protective of Provider's rights), Recipient may distribute
Modifications to non-profit or governmental organizations for research
purposes only.
(c) Upon written permission from Provider, Recipient may distribute
Modifications for commercial use. It is recognized by Recipient that
such commercial use may require a commercial license from Provider and
Provider has no obligation to grant such a commercial license. Nothing
in this paragraph, however, shall prevent Recipient from granting
commercial licenses under Recipient's patent rights claiming such
Modifications.
4. (a) Ownership of tangible property as between Provider and
Recipient is defined in Attachment A.
(b) Recipient is free to file patent applications claiming
inventions made by Recipient through the use of the Material but agrees
to notify Provider upon filing a patent application claiming
Modifications or uses of the Material.
5. (a) Except as expressly provided in this Agreement, no rights
are provided to Recipient under any patents, patent applications, trade
secrets or other proprietary rights of Provider. In particular, no
rights are provided to use the Material or Modifications and any
related patents of Provider for profit-making or commercial purposes,
such as sale of the Material or Modifications, use in manufacturing,
provision of a service to a third party in exchange for consideration
(not including sponsored research activities except as provided for in
5(b).
(b) If Recipient desires to use the Material or Modifications for
such profit-making or commercial purposes, Recipient agrees, in advance
of such use, to negotiate in good faith with Provider to establish the
terms of a commercial license. It is understood by Recipient that
Provider shall have no obligation to grant such a license to Recipient,
and may grant exclusive or non-exclusive commercial licenses to others.
6. The provision of the Material to Recipient shall not alter any
pre-existing right to the Material. If Provider has granted any rights
to a third party (other than the customary rights granted to the
Federal Government or non-profit foundations) which would affect
Recipient, those rights will be identified by Provider in an
implementing letter.
7. Any Material delivered pursuant to this Agreement is understood
to be experimental in nature and may have hazardous properties.
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.
8. Except to the extent prohibited by law, Recipient assumes all
liability for damages which may arise from its use, storage or disposal
of the Material. Provider will not be liable to Recipient for any loss,
claim or demand made by Recipient, or made against Recipient by any
other party, due to or arising from the use of the Material by
Recipient, except to the extent permitted by law when caused by the
gross negligence or willful misconduct of Provider.
9. This agreement shall not be interpreted to prevent or delay
publication of research findings resulting from the use of the Material
or Modifications. Recipient's Scientist agrees to provide appropriate
acknowledgement of the source of the Material in all publications.
10. Recipient agrees to use the Material in compliance with all
applicable statutes and regulations, including Public Health Service
and NIH regulations and guidelines such as, for example, those relating
to research involving the use of animals or recombinant DNA.
11. (a) This Agreement will terminate on the earliest of the
following dates: (1) when the Material becomes generally available from
third parties, for example, through reagent catalogs or public
depositories, or (2) on completion of Recipient's current research with
the Material, or (3) on thirty (30) days written notice by either party
to the other, or (4) on the date specified in an implementing letter.
Paragraphs 7 and 8 shall survive termination.
(b) If termination should occur under 11(a)(1), Recipient shall be
bound to the Provider by the least restrictive terms applicable to
Material obtained from the then-available sources.
(c) Except as provided in 11.(d) below, on termination of this
Agreement under 11.(a)(2), (3), or (4) above, Recipient will
discontinue its use of the Material and will, upon direction of
Provider, return or destroy any remaining Material. Recipient will also
either destroy Modifications or remain bound by the terms of paragraphs
4 and 5 as they apply to Modifications.
(d) In the event Provider terminates this Agreement under 11.(a)(3)
other than for breach of this Agreement or with cause such as an
imminent health risk or patent infringement, Provider will defer the
effective date of termination for a period of up to one year, upon
request from Recipient, to permit completion of research in progress.
12. The Material is provided free or with a fee solely to reimburse
Provider for its distribution costs. If a fee is requested, it will be
enumerated in an implementing letter.
Attachment A
Belonging to Provider
Material
Original Material
Progeny
Unmodified Derivatives
Belonging to Recipient
Modifications (however, Provider retains ownership rights to any
form of the Material included therein)
Those substances created through the use of the Material or
Modifications, but which are not Progeny, Unmodified Derivatives or
Modifications (e.g., do not contain the Original Material or Unmodified
Derivatives).
*If resulting from the collaborative efforts of Provider and
Recipient, joint ownership may be negotiated.
Simple Letter Agreement for Transfer of Non-Proprietary Biological
Material From Non-Profit to Non-Profit
(Recipient)
TO:
Address:
(Provider)
FROM:
Address:
Re: Biological Material Identified as:
In response to Recipient's request for the above-identified
Biological Material, Provider's institution asks that Recipient and
Recipient's Scientist agree to the following before Recipient receives
the Biological Material:
1. The above Biological Material is the property of Provider and is
made available as a service to the research community.
2. The Biological Material will be used for research purposes only.
3. The Biological Material will not be further distributed to
others without Provider's written permission; except such permission is
not required where Recipient agrees, upon request, to provide the
Biological Material (subject to its availability) or enabling
information to appropriate investigators solely for the purpose of
replicating or verifying Recipient's research.
4. Recipient agrees to acknowledge the source of the Biological
Material in any publications reporting use of it.
5. The Biological Material is experimental in nature and it is
provided without any warranties, express or implied, including any
warranty of merchantability or fitness for a particular purpose.
Recipient and Recipient's Scientist agree to assume all liability for
damages which arise from use, storage or disposal of the Biological
Material.
6. Recipient agrees to use 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.
Recipient and Recipient's Scientist should sign both copies of this
letter and return one signed copy to Provider. Provider will then
forward the Biological Materials.
Provider
(signature) (date)
Recipient's Scientist
(signature) (date)
Recipient Institutional Approval
(authorized signature)
(date)
Name:
Title:
Address:
[FR Doc. 94-14991 Filed 6-20-94; 8:45 am]
BILLING CODE 4140-01-P