DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

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

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 materials 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 materials 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 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
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.
Appendix

MASTER AGREEMENT REGARDING USE OF
THE UNIFORM BIOLOGICAL MATERIAL TRANSFER AGREEMENT
(dated 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
(dated 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 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 Agreement
("UBMTA") (dated 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: ____________