[Federal Register Volume 60, Number 45 (Wednesday, March 8, 1995)]
[Notices]
[Pages 12771-12775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-5644]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Uniform Biological Material Transfer Agreement: Discussion of
Public Comments Received; Publication of the Final Format of the
Agreement
AGENCY: National Institutes of Health (NIH), Public Health Service
(PHS), DHHS.
ACTION: Notice.
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SUMMARY: Following consideration of public comments, the NIH, as
designated lead PHS agency for technology transfer activities, is
issuing the final version of the Uniform Biological Material Transfer
Agreement (``UBMTA'') to be used by participating public and nonprofit
organizations, an implementing letter to memorialize individual
exchanges of biological material under the UBMTA, and a simple letter
agreement for transferring nonproprietary biological materials among
public and nonprofit organizations. For-profit organizations may also
choose to adopt these agreements as well. The PHS recommends that the
UBMTA be considered for general use in the exchange of biological
material for research purposes among public and nonprofit entities.
FOR FURTHER INFORMATION CONTACT: Carol C. Lavrich, Office of Technology
Transfer, National Institutes of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852-3804, phone: 301-496-7735 ext. 287, fax:
301-402-0220.
Background
Open access to the results of federally-funded research is a
cornerstone of PHS's research policy. In the case of many research
projects, this includes not only access to information provided through
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 in separate
organizations involves case-by-case negotiation of material transfer
agreements (``MTAs''). In order to guide and facilitate the increasing
number of such transfers, 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; also published at pp. 8-25-8-26 of the PHS Grants Policy
Statement, DHHS Publication No. (OASH) 94-50,000 (Rev.) April 1, 1994.
This was followed in 1989 by adoption of a standard Material Transfer
Agreement form for use by PHS scientists. MTAs are important because
they require the recipient to exercise 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 PHS
guidelines relating to recombinant DNA, protection of human subjects in
research, and the use of animals. However, while most other
organizations have adopted some standard material transfer agreement
form, they are not all consistent.
Issue
Several issues have affected the sharing of research materials.
These include delays in sharing of materials while conducting
unnecessarily extensive negotiations on individual MTAs, required
grants of invention rights to improvements to the materials or to
inventions made using the materials, and required approval for
publication. The negotiation of these complex issues has 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).
Proposal
The PHS, in conjunction 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 among public and nonprofit
organizations. Since 1990, the Association of University Technology
Managers (``AUTM''), and many individuals representing universities,
law firms, and industry, have played leadership roles in furthering the
development of common materials sharing practices. The consistent use
of the UBMTA by public and nonprofit organizations could reduce the
administrative burden of sharing materials as investigators come to
rely on common acceptance of its terms by cooperating organizations.
The PHS recommends that the UBMTA be considered for general use in
the exchange of materials for research purposes among public and
nonprofit organizations. For-profit organizations may also choose to
adopt this agreement as well. 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
organizational level, and handled in a master agreement or 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 and a statement indicating
that the material was being transferred in accordance with the terms of
the UBMTA. The Implementing Letter would be executed by the provider
scientist, the recipient scientist, and any other authorized
official(s) of the provider or recipient organization who might be
required to sign on behalf of the organization. Thus, sharing of
materials between organizations, each of which had executed the UBMTA,
would be significantly simplified. At the same time, any organization
would retain the [[Page 12772]] option to handle specific material with
unusual commercial or research value on a customized basis. Thus, the
use of the UBMTA would not be mandatory, even for signatory
organizations. Administration of the signatory process also may be
organization-specific. For example, organizational policies may require
additional, or fewer, signatures.
For non-proprietary materials, a Simple Letter Agreement also has
been developed, which incorporates many of the same principles as the
UBMTA. This Simple Letter Agreement also could be used where the
organizations have not agreed to the UBMTA.
On behalf of PHS, NIH published the full text of the proposed
version of the UBMTA, the draft Implementing Letter, and the draft
Simple Letter Agreement in the Federal Register on June 21, 1994, and
invited public comment. NIH received thirteen written comments from
universities, research organizations, and various associations. The
primary concerns raised by respondents and the NIH response to these
comments are described in the comment section below.
Comments
The vast majority of the respondents were extremely supportive of
the UBMTA concept as a means of simplifying and expediting biological
material transfers among public and nonprofit organizations. Several
respondents suggested that a comparable agreement be developed for
transfers between for-profit and nonprofit organizations. The PHS fully
supports this idea and recognizes the importance of streamlining this
type of agreement with industry. The NIH, in conjunction with the
working group listed above, developed a proposed model for UBMTA
transfers from industry to nonprofit organizations which was circulated
to AUTM membership on December 31, 1992. This was an adaptation of the
original UBMTA format which grants the industrial provider an option to
negotiate a license agreement to inventions made through the use of the
provided material. It should be noted that government agencies will not
be able to use this format unless a Cooperative Research and
Development Agreement (``CRADA'') is negotiated because of limitations
in statutory authority to provide licenses or options to license
intellectual property in other types of agreements. No format was
ultimately created by the working group for the transfer of material
from nonprofit organizations to industry because it was viewed as being
essentially a license negotiation. Most organizations have license
agreement formats for internal use of biological materials by
commercial organizations, as well as for commercial sale of biological
materials. The PHS will be soliciting further public commentary on the
proposed model for UBMTA transfers from industry to nonprofit
organizations.
Several respondents indicated that some of the UBMTA definitions
were confusing. As appropriate, clarifications have been made. In
particular, the definition relating to ``Modifications'' has been
refined so that it is clear that Modifications are developed by the
Recipient and contain or incorporate the Material. While the
Modifications are owned by the Recipient who can license them for
commercial use, this new use also may require a second commercial
license or other evidence of agreement from the Provider since the
Modifications incorporate the Material. The UBMTA also acknowledges
that there may be other substances created by the Recipient through the
use of the Material which are not Modifications, Progeny, or Unmodified
Derivatives of the Material, and are owned by the Recipient, who is
free to license them. The UBMTA does not provide for any type of
``reach-through'' rights for the Provider of the Material, i.e.
property rights in products developed by the Recipient through the use
of the transferred material. Several definitions of ``nonprofit
organization'' were proposed, and the final definition used was taken
directly from the implementing regulations to the Bayh-Dole Act (37 CFR
Part 401). We have also instituted a definition of Commercial Purposes
to provide a clear distinction between academic research and activities
which are considered commercial.
Other issues raised by respondents fell into two areas: issues
regarding confidentiality with respect to protection of intellectual
property rights, and issues regarding organizational policy variance on
signature requirements from the suggested UBMTA signature requirements:
(1) Confidentiality Issues
Some respondents were concerned that the requirement for the
Provider to provide the Recipient with specific information regarding
patent status of the Material might impair an organization's ability to
obtain patent protection and questioned the necessity for the Recipient
to obtain such information. The PHS agrees that the provision of such
information is not necessary and would create an additional
administrative burden that would be inconsistent with the primary
purpose of the UBMTA. We also agree that any commercial use or improper
disclosure on the part of the Recipient could impair the Provider's
ability to obtain suitable patent protection. Therefore, we have
removed the requirement for the Provider to inform the Recipient about
patent status and have included a provision that the Material may be
the subject of a patent application. However, the Recipient is bound to
inform the Provider upon filing patent applications which claim
Modifications or method(s) of manufacture or use(s) of the Material so
that the Provider may determine whether it believes joint inventorship
is appropriate. The requirement to divulge the Provider's prior grant
of rights to a third party (other than the customary rights granted to
the federal government), that would substantially affect Recipient, has
been eliminated since the agreement specifies that this transfer is for
teaching and academic research purposes and that the Provider is under
no obligation to widen the rights granted.
(2) Signature Requirement Issues
Some respondents were concerned that their organizational polices
with respect to signing MTAs are different than those suggested in the
UBMTA Implementing Letter. An organization may require an additional
signature of an authorized official of the Recipient organization if
the signatory scientist is not legally authorized to bind the
organization. In this case, the legally binding signature of the
authorized official of the Recipient organization would provide
assurance to the Provider organization that the Recipient organization
is a signatory to the UBMTA. This assurance is critical because if the
Recipient organization is not a party to the UBMTA, it may not be bound
by the terms of the UBMTA. The signatures of the scientists provide a
necessary record for both organizations of the transfer of the
Material. Of course, organizations are free to develop their own
signatory policies regarding the UBMTA.
We hope to get practical guidance and constructive feedback from
scientists and technology transfer professionals as they begin to use
the UBMTA. It is anticipated that the UBMTA will be a ``living''
document which will be further refined and streamlined over time. Many
of the definitions were intensively debated throughout the course of
drafting the UBMTA and it is expected that they will be sharpened over
time through use. We attempted to [[Page 12773]] emphasize a fair
allocation of rights between the Provider and the Recipient and had to
draw lines especially in the definitions of Modifications and
Commercial Purposes. The use of the UBMTA over time will ultimately
determine whether the right decisions were made.
The Association of University Technology Managers (``AUTM'') will
be providing assistance in implementation of the UBMTA among its
members and nonprofit organizations by notifying members of its
availability in its newsletter, providing signature copies of the
agreement at its annual meeting, assisting with training regarding
material transfers, and maintaining a master list of signatories to the
UBMTA. We anticipate that the master list of signatories will be
published in the Federal Register annually. In order for AUTM to
compile a master list of signatories, organizations should return an
executed copy of the UBMTA Master Agreement to: The UBMTA Project, AUTM
Headquarters, 71 East Avenue, Suite S, Norwalk, CT 06851-4903. A read
only version of the signatory list will be made available on the
Internet. A copy of this announcement also will be appearing in the NIH
Guide For Grants and Contracts.
Complete texts of the final version of the UBMTA, the Implementing
Letter, and the Simple Letter Agreement follow in the Appendix.
Dated: February 18, 1995.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
Appendix--Master Agreement Regarding Use of the Uniform Biological
Material Transfer Agreement March 8, 1995
Upon execution of an Implementing Letter in the form attached which
specifies the materials to be transferred, this organization agrees to
be bound by the terms of the attached Uniform Biological Material
Transfer Agreement (``UBMTA'') published in the Federal Register on
March 8, 1995.
Attachments:
UBMTA
Implementing Letter
Organization:----------------------------------------------------------
Address:---------------------------------------------------------------
Authorized Official:---------------------------------------------------
Title:-----------------------------------------------------------------
Signature:-------------------------------------------------------------
Date:------------------------------------------------------------------
Please return an executed copy of this Master Agreement to: The
UBMTA Project, Association of University Technology Managers (AUTM), 71
East Avenue, Suite S, Norwalk, CT 06851-4903. AUTM will be maintaining
signed originals and the official list of signatory organizations.
The Uniform Biological Material Transfer Agreement
March 8, 1995
I. Definitions:
1. PROVIDER: Organization providing the ORIGINAL MATERIAL. The name
and address of this party will be specified in an implementing letter.
2. PROVIDER SCIENTIST: The name and address of this party will be
specified in an implementing letter.
3. RECIPIENT: Organization receiving the ORIGINAL MATERIAL. The
name and address of this party will be specified in an implementing
letter.
4. RECIPIENT SCIENTIST: The name and address of this party will be
specified in an implementing letter.
5. ORIGINAL MATERIAL: The description of the material being
transferred will be specified in an implementing letter.
6. MATERIAL: ORIGINAL MATERIAL, PROGENY, and UNMODIFIED
DERIVATIVES. The MATERIAL 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.
7. PROGENY: Unmodified descendant from the MATERIAL, such as virus
from virus, cell from cell, or organism from organism.
8. UNMODIFIED DERIVATIVES: Substances created by the RECIPIENT
which constitute an unmodified functional subunit or product expressed
by the ORIGINAL MATERIAL. Some examples include: 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.
9. MODIFICATIONS: Substances created by the RECIPIENT which
contain/incorporate the MATERIAL.
10. COMMERCIAL PURPOSES: The sale, lease, license, or other
transfer of the MATERIAL or MODIFICATIONS to a for-profit organization.
COMMERCIAL PURPOSES shall also include uses of the MATERIAL or
MODIFICATIONS by any organization, including RECIPIENT, to perform
contract research, to screen compound libraries, to produce or
manufacture products for general sale, or to conduct research
activities that result in any sale, lease, license, or transfer of the
MATERIAL or MODIFICATIONS to a for-profit organization. However,
industrially sponsored academic research shall not be considered a use
of the MATERIAL or MODIFICATIONS for COMMERCIAL PURPOSES per se, unless
any of the above conditions of this definition are met.
11. NONPROFIT ORGANIZATION(S): A university or other institution of
higher education or an organization of the type described in section
501(c)(3) of the Internal Revenue Code of 1954 (26 U.S.C. 501(c)) and
exempt from taxation under section 501(a) of the Internal Revenue Code
(26 U.S.C. 501(a)) or any nonprofit scientific or educational
organization qualified under a state nonprofit organization statute. As
used herein, the term also includes government agencies.
II. Terms and Conditions of this Agreement
1. The PROVIDER retains ownership of the MATERIAL, including any
MATERIAL contained or incorporated in MODIFICATIONS.
2. The RECIPIENT retains ownership of: (a) MODIFICATIONS (except
that, the PROVIDER retains ownership rights to the MATERIAL included
therein), and (b) those substances created through the use of the
MATERIAL or MODIFICATIONS, but which are not PROGENY, UNMODIFIED
DERIVATIVES or MODIFICATIONS (i.e., do not contain the ORIGINAL
MATERIAL, PROGENY, UNMODIFIED DERIVATIVES). If either 2 (a) or 2 (b)
results from the collaborative efforts of the PROVIDER and the
RECIPIENT, joint ownership may be negotiated.
3. The RECIPIENT and the RECIPIENT SCIENTIST agree that the
MATERIAL:
(a) is to be used solely for teaching and academic research
purposes;
(b) will not be used in human subjects, in clinical trials, or for
diagnostic purposes involving human subjects without the written
consent of the PROVIDER;
(c) is to be used only at the RECIPIENT organization and only in
the RECIPIENT SCIENTIST's laboratory under the direction of the
RECIPIENT SCIENTIST or others working under his/her direct supervision;
and
(d) will not be transferred to anyone else within the RECIPIENT
organization without the prior written consent of the PROVIDER.
4. The RECIPIENT and the RECIPIENT SCIENTIST agree to refer to the
PROVIDER any request for the MATERIAL from anyone other than those
persons working under the [[Page 12774]] RECIPIENT SCIENTIST's direct
supervision. To the extent supplies are available, the PROVIDER or the
PROVIDER SCIENTIST agrees to make the MATERIAL available, under a
separate implementing letter to this Agreement or other agreement
having terms consistent with the terms of this Agreement, to other
scientists (at least those at NONPROFIT ORGANIZATION(S)) who wish to
replicate the RECIPIENT SCIENTIST's research; provided that such other
scientists reimburse the PROVIDER for any costs relating to the
preparation and distribution of the MATERIAL.
5. (a) The RECIPIENT and/or the RECIPIENT SCIENTIST shall have the
right, without restriction, to distribute substances created by the
RECIPIENT through the use of the ORIGINAL MATERIAL only if those
substances are not PROGENY, UNMODIFIED DERIVATIVES, or MODIFICATIONS.
(b) Under a separate implementing letter to this Agreement (or an
agreement at least as protective of the PROVIDER's rights), the
RECIPIENT may distribute MODIFICATIONS to NONPROFIT ORGANIZATION(S) for
research and teaching purposes only.
(c) Without written consent from the PROVIDER, the RECIPIENT and/or
the RECIPIENT SCIENTIST may NOT provide MODIFICATIONS for COMMERCIAL
PURPOSES. It is recognized by the RECIPIENT that such COMMERCIAL
PURPOSES may require a commercial license from the PROVIDER and the
PROVIDER has no obligation to grant a commercial license to its
ownership interest in the MATERIAL incorporated in the MODIFICATIONS.
Nothing in this paragraph, however, shall prevent the RECIPIENT from
granting commercial licenses under the RECIPIENT's intellectual
property rights claiming such MODIFICATIONS, or methods of their
manufacture or their use.
6. The RECIPIENT acknowledges that the MATERIAL is or may be the
subject of a patent application. Except as provided in this Agreement,
no express or implied licenses or other rights are provided to the
RECIPIENT under any patents, patent applications, trade secrets or
other proprietary rights of the PROVIDER, including any altered forms
of the MATERIAL made by the PROVIDER. In particular, no express or
implied licenses or other rights are provided to use the MATERIAL,
MODIFICATIONS, or any related patents of the PROVIDER for COMMERCIAL
PURPOSES.
7. If the RECIPIENT desires to use or license the MATERIAL or
MODIFICATIONS for COMMERCIAL PURPOSES, the RECIPIENT agrees, in advance
of such use, to negotiate in good faith with the PROVIDER to establish
the terms of a commercial license. It is understood by the RECIPIENT
that the PROVIDER shall have no obligation to grant such a license to
the RECIPIENT, and may grant exclusive or non-exclusive commercial
licenses to others, or sell or assign all or part of the rights in the
MATERIAL to any third party(ies), subject to any pre-existing rights
held by others and obligations to the Federal Government.
8. The RECIPIENT is free to file patent application(s) claiming
inventions made by the RECIPIENT through the use of the MATERIAL but
agrees to notify the PROVIDER upon filing a patent application claiming
MODIFICATIONS or method(s) of manufacture or use(s) of the MATERIAL.
9. 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.
10. 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 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.
11. This agreement shall not be interpreted to prevent or delay
publication of research findings resulting from the use of the MATERIAL
or the MODIFICATIONS. The RECIPIENT SCIENTIST agrees to provide
appropriate acknowledgement of the source of the MATERIAL in all
publications.
12. The RECIPIENT agrees to use the MATERIAL in compliance with all
applicable statutes and regulations, including Public Health Service
and National Institutes of Health regulations and guidelines such as,
for example, those relating to research involving the use of animals or
recombinant DNA.
13. This Agreement will terminate on the earliest of the following
dates: (a) When the MATERIAL becomes generally available from third
parties, for example, through reagent catalogs or public depositories,
or (b) on completion of the RECIPIENT's current research with the
MATERIAL, or (c) on thirty (30) days written notice by either party to
the other, or (d) on the date specified in an implementing letter,
provided that:
(i) If termination should occur under 13(a), the RECIPIENT shall be
bound to the PROVIDER by the least restrictive terms applicable to the
MATERIAL obtained from the then-available sources; and
(ii) If termination should occur under 13 (b) or (d) above, the
RECIPIENT will discontinue its use of the MATERIAL and will, upon
direction of the PROVIDER, return or destroy any remaining MATERIAL.
The RECIPIENT, at its discretion, will also either destroy the
MODIFICATIONS or remain bound by the terms of this agreement as they
apply to MODIFICATIONS; and
(iii) In the event the PROVIDER terminates this Agreement under
13(c) other than for breach of this Agreement or for cause such as an
imminent health risk or patent infringement, the PROVIDER will defer
the effective date of termination for a period of up to one year, upon
request from the RECIPIENT, to permit completion of research in
progress. Upon the effective date of termination, or if requested, the
deferred effective date of termination, RECIPIENT will discontinue its
use of the MATERIAL and will, upon direction of the PROVIDER, return or
destroy any remaining MATERIAL. The RECIPIENT, at its discretion, will
also either destroy the MODIFICATIONS or remain bound by the terms of
this agreement as they apply to MODIFICATIONS.
14. Paragraphs 6, 9, and 10 shall survive termination.
15. 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 by the PROVIDER, the
amount will be indicated in an implementing letter.
Implementing Letter
The purpose of this letter is to provide a record of the biological
material transfer, to memorialize the agreement between the PROVIDER
SCIENTIST (identified below) and the RECIPIENT SCIENTIST (identified
below) to abide by all terms and conditions of the Uniform Biological
Material Transfer [[Page 12775]] Agreement (``UBMTA'') March 8, 1995,
and to certify that the RECIPIENT (identified below) organization has
accepted and signed an unmodified copy of the UBMTA. The RECIPIENT
organization's Authorized Official also will sign this letter if the
RECIPIENT SCIENTIST is not authorized to certify on behalf of the
RECIPIENT organization. The RECIPIENT SCIENTIST (and the Authorized
Official of RECIPIENT, if necessary) should sign both copies of this
letter and return one signed copy to the PROVIDER. The PROVIDER
SCIENTIST will forward the material to the RECIPIENT SCIENTIST upon
receipt of the signed copy from the RECIPIENT organization.
Please fill in all of the blank lines below:
1. PROVIDER: Organization providing the ORIGINAL MATERIAL:
Organization:----------------------------------------------------------
Address: -------------------------------------------------------------
----------------------------------------------------------------------
2. RECIPIENT: Organization receiving the ORIGINAL MATERIAL:
Organization: --------------------------------------------------------
Address: -------------------------------------------------------------
----------------------------------------------------------------------
3. ORIGINAL MATERIAL (Enter description):
----------------------------------------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
4. Termination date for this letter (optional):
5. Transmittal Fee to reimburse the PROVIDER for preparation and
distribution costs (optional).
Amount:----------------------------------------------------------------
This Implementing Letter is effective when signed by all
parties. The parties executing this Implementing Letter certify that
their respective organizations have accepted and signed an
unmodified copy of the UBMTA, and further agree to be bound by its
terms, for the transfer specified above.
PROVIDER SCIENTIST
Name:------------------------------------------------------------------
Title:-----------------------------------------------------------------
Address:---------------------------------------------------------------
----------------------------------------------------------------------
Signature:-------------------------------------------------------------
Date:------------------------------------------------------------------
RECIPIENT SCIENTIST
Name:------------------------------------------------------------------
Title:-----------------------------------------------------------------
Address:---------------------------------------------------------------
----------------------------------------------------------------------
Signature:-------------------------------------------------------------
Date:------------------------------------------------------------------
RECIPIENT ORGANIZATION CERTIFICATION
Certification: I hereby certify that the RECIPIENT organization
has accepted and signed an unmodified copy of the UBMTA (May be the
RECIPIENT SCIENTIST if authorized by the RECIPIENT organization):
Authorized Official:---------------------------------------------------
Title:-----------------------------------------------------------------
Address:---------------------------------------------------------------
----------------------------------------------------------------------
Signature:-------------------------------------------------------------
Date:------------------------------------------------------------------
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
----------------------------------------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
---------------------------------------------------------------------
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: ________
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:-----------------------------------------------------------------
Address:---------------------------------------------------------------
Signature:-------------------------------------------------------------
Date:------------------------------------------------------------------
[FR Doc. 95-5644 Filed 3-7-95; 8:45 am]
BILLING CODE 4140-01-P