[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