[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