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: ____________





.




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