UNIFORM BIOLOGICAL MATERIAL TRANSFER AGREEMENT FINALIZED

NIH GUIDE, Volume 24, Number 14, April 14, 1995

P.T.

Keywords:

Public Health Service

National Institutes of Health

After consideration of public comments, the NIH, as designated lead
PHS agency for technology transfer activities, has issued the final
version of the Uniform Biological Material 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.  Background, discussion
of public comments received, and the final agreement were published
in the Federal Register on March 8, 1995 (FR 60 12771).  The complete
text of this notice is also available on the electronic edition of
the NIH Guide to Grants and Contracts available via anonymous ftp
from ftp.cu.nih.gov.

INQUIRIES

If you would like a copy of the Master Agreement for execution, an
Implementing Letter, or a Simple Letter Agreement for Transfer of
Non-Proprietary Biological Material, please contact:

Penny Dalziel
AUTM
71 East Avenue, Suite S
Norwalk, CT  06851-4903
Telephone: 203/852-7168
Fax: 203/838-5714
Email: autm@ao1.com

Technical questions may be addressed to:

Carol Lavrich
Technology Licensing Specialist
Office of Technology Transfer
National Institutes of Health
6011 Executive Boulevard, Suite 325
Rockville, MD 20852-3804
Telephone: 301/496-7735 ext 287
Fax: 301/402-0220
Email: lavrichc@od6100m1.od.nih.gov
________________________________________________________________________________

Full Text N2

UNIFORM BIOLOGICAL MATERIAL TRANSFER AGREEMENT:  DISCUSSION OF PUBLIC COMMENTS 
RECEIVED; PUBLICATION OF THE FINAL FORMAT OF THE AGREEMENT

(as published in the Federal Register, March 8, 1995)

NIH GUIDE, Volume 24, Number 14, April 14, 1995

P.T.


Keywords: 


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 Materials
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.


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: ____________

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.