UNIFORM BIOLOGICAL MATERIAL TRANSFER AGREEMENT:  REQUEST FOR COMMENTS

NIH GUIDE, Volume 23, Number 24, June 24, 1994



P.T. 34



Keywords:

  Grants Administration/Policy+ 



National Institutes of Health



The following is a reprint of the Uniform Biological Material

Transfer Agreement:  Request for Comments, which was published in the

Federal Register of June 21, 1994 (59 FR 32000).



AGENCY:  National Institutes of Health (NIH), Public Health Service,

DHHS



BACKGROUND:  Open access to the results of federally-funded research is

a cornerstone of NIH's research policy.  In the case of many research

projects, this includes not only access to information as can be

provided in 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 and

separate institutions involves case-by-case negotiation of material

transfer agreements (MTAs).  In order to guide and facilitate the

increasing number of such transfers, the Public Health Service (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), that was

followed in 1989 by adoption of a standard Material Transfer Agreement

form for use by NIH scientists.  Such agreements are important because

they require the recipient to use 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

Public Health Service (PHS) guidelines relating to recombinant DNA,

human subjects research, use of animals, etc.  However, while most

institutions have adopted some standard material transfer agreement

form, they are not all consistent.



ISSUE:  Several concerns have affected the sharing of research

materials.  These include delays in sharing of materials while

conducting negotiations on individual MTAs, required grants of

invention rights to improvements to the materials or to inventions made

using the materials, and required approval prior to publication.  Such

problems have 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).



In addition, there is a desire to have a uniform agreement for the

sharing of non-proprietary materials.



PROPOSAL:  The NIH, in participation 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 between non-profit

institutions.  The Association of University Technology Managers,

particularly Ms. Joyce Brinton, Harvard University; Ms. Lita Nelsen,

Massachusetts Institute of Technology; and Dr. Sandra Shotwell, Oregon

Health Sciences University, have played leadership roles in furthering

the development of common materials sharing practices.  The consistent

use of this agreement by grantee institutions could reduce the

administrative burden of sharing materials as investigators come to

rely on common acceptance of the terms of the UBMTA by cooperating

institutions.



The NIH proposes that the UBMTA be considered for general use in the

exchange of materials for research purposes between non-profit

institutions.  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 institutional level,

and handled in a 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, a statement indicating that the material was being

transferred in accordance with the terms of the UBMTA and signed by the

PROVIDER SCIENTIST and the RECIPIENT SCIENTIST.  Thus, sharing of

materials between institutions, each of which had signed the UBMTA,

would be significantly simplified.  At the same time, any institution

would retain the option to handle a specific material on a customized

basis, i.e., the use of the UBMTA would not be mandatory, even for

signatory institutions.



For non-proprietary materials, a Simple Letter Agreement has also been

developed, which incorporates many of the same principles as the UBMTA.

This Letter Agreement could be used where the institutions have not

agreed to the UBMTA.



The full text of the treaty version of the UBMTA, the implementing

letter, and a simple one-page letter agreement for non-proprietary

material follows.  The NIH welcomes public comment on the documents

themselves, as well as their proposed use.  Comments should be

addressed to:  UBMTA Project, c/o Office of Technology Transfer, Box

13, 6011 Executive Boulevard, Rockville, MD 20852-3804.  Comments may

also be sent by facsimile transmission to:  UBMTA Project at (301)

402-0220.



DATE:  Comments must be received by NIH on or before July 21, 1994.



MASTER AGREEMENT REGARDING USE OF THE UNIFORM BIOLOGICAL MATERIAL

TRANSFER AGREEMENT (UBMTA) FOR EXCHANGES OF BIOLOGICAL MATERIAL BETWEEN

NON-PROFIT INSTITUTIONS



Upon execution of an Implementing Letter in the form attached which

specifies the materials to be transferred, this institution agrees to

be bound by the terms of the Non-Profit to Non-Profit UBMTA, dated ----

-----  also attached.



Enclosures:  Implementing Letter format

             UBMTA



Institution:



Address:



Authorized Official:



Title:



Signature:

Date:

------------------------------- (END OF PAGE ------------------------



                                  Sample UBMTA Implementing Letter



Definitions:



PROVIDER:  Institution providing the Original Material (Enter name and

address here):



Provider's Scientist (Enter name and address here):



RECIPIENT:  Institution receiving the Original Material (Enter name and

address here):



Recipient's Scientist (Enter name and address here):



Original Material (Enter description):



PROVIDER has filed patent applications claiming the MATERIAL or uses

thereof:



        Yes       No



If PROVIDER has granted any rights to a third party (other than the

customary rights granted to the federal government or non-profit

foundations) which would affect RECIPIENT, those rights are specified

below:



Termination date for this letter (if any is to be specified):



The parties executing this Implementing Letter agree to be bound by the

terms of the Non-Profit to Non- Profit UBMTA for the transfer specified

above:



AGREED:



PROVIDER



Institution:



Address:



Provider Scientist



Name:



Title:



Signature:

Date:



RECIPIENT



Institution:



Address:



Recipient Scientist



Name:



Title:



Signature:

Date:



Certification:  I hereby certify that the RECIPIENT institution has

accepted and signed an unmodified copy of the date version of the

Uniform Biological Material Transfer Agreement (UBMTA) developed in

cooperation with the National Institutes of Health.



RECIPIENT'S INSTITUTIONAL CERTIFICATION



  (Authorized signature)         (Date)



-------------------------- (END OF PAGE) ----------------------------



NON-PROFIT TO NON-PROFIT UNIFORM BIOLOGICAL MATERIAL TRANSFER AGREEMENT

(DATE) -  TREATY VERSION DEVELOPED IN COOPERATION WITH THE NATIONAL

INSTITUTES OF HEALTH



Definitions:



PROVIDER:  Institution providing the Original Material.  (Name and

address to be specified in an implementing letter)



Provider's Scientist:  (Name and address to be specified in an

implementing letter)



RECIPIENT:  Institution receiving the Original Material.  (Name and

address to be specified in an implementing letter)



Recipient's Scientist:  (Name and address to be specified in an

implementing letter)



Original Material:  (Description to be specified in an implementing

letter)



MATERIAL:  Original Material plus Progeny and Unmodified Derivatives.

The MATERIAL shall not include:  (i) Modifications or (ii) other

substances created by the RECIPIENT through the use of the MATERIAL

which are not Progeny or Unmodified Derivatives.



Progeny:  Unmodified descendant from the MATERIAL, such as virus from

virus, cell from cell, or organism from organism.



Unmodified Derivatives:  Substances created by RECIPIENT which

constitute an unmodified functional sub-unit or an expression product

of the Original Material.  Some examples include: subclones of

unmodified cell lines, purified or fractionated sub-sets of the

Original Material, proteins expressed by DNA/RNA supplied by PROVIDER,

monoclonal antibodies secreted by a hybridoma cell line, sub-sets of

the Original Material such as novel plasmids or vectors.



Modifications:  Substances created by RECIPIENT which

contain/incorporate the MATERIAL (Original Material, Progeny or

Unmodified Derivatives).



Terms and Conditions of this Agreement:



1.  The MATERIAL is the property of PROVIDER and is to be used by

RECIPIENT solely for research purposes at RECIPIENT's institution and

only under the direction of the Recipient's Scientist.  The MATERIAL

will not be used in human subjects or in clinical trials involving

human subjects without the written permission of PROVIDER.  Patent

applications claiming the MATERIAL or uses thereof to be specified in

an implementing letter.



2.  The Recipient's Scientist agrees not to transfer the MATERIAL to

anyone who does not work under his or her direct supervision at

RECIPIENT's institution without the prior written consent of PROVIDER.

Recipient's Scientist shall refer any request for the MATERIAL to

PROVIDER.  To the extent supplies are available, PROVIDER or Provider's

Scientist agrees to make the MATERIAL available under a UBMTA to other

scientists (at least those at non-profit or governmental institutions)

who wish to replicate Recipient's Scientist's research.



3.  (a)  RECIPIENT shall have the right, without restriction to

distribute substances created by RECIPIENT through the use of the

MATERIAL only if those substances are not Progeny, Unmodified

Derivatives, or Modifications.

    (b)  Upon notice to PROVIDER and under a UBMTA (or an agreement at

least as protective of PROVIDER's rights), RECIPIENT may distribute

Modifications to non-profit or governmental organizations for research

purposes only.

    (c)  Upon written permission from PROVIDER, RECIPIENT may

distribute Modifications for commercial use.  It is recognized by

RECIPIENT that such commercial use may require a commercial license

from PROVIDER and PROVIDER has no obligation to grant such a commercial

license.  Nothing in this paragraph, however, shall prevent RECIPIENT

from granting commercial licenses under RECIPIENT's patent rights

claiming such Modifications.



4.  (a) Ownership of tangible property as between PROVIDER and

RECIPIENT is defined in Attachment A.

    (b) RECIPIENT is free to file patent applications claiming

inventions made by RECIPIENT through the use of the MATERIAL but agrees

to notify PROVIDER upon filing a patent application claiming

Modifications or uses of the MATERIAL.



5.  (a) Except as expressly provided in this Agreement, no rights are

provided to RECIPIENT under any patents, patent applications, trade

secrets or other proprietary rights of PROVIDER.  In particular, no

rights are provided to use the MATERIAL or Modifications and any

related patents of PROVIDER for profit- making or commercial purposes,

such as sale of the MATERIAL or Modifications, use in manufacturing,

provision of a service to a third party in exchange for consideration

(not including sponsored research activities except as provided for in

5(b).

    (b) If RECIPIENT desires to use the MATERIAL or Modifications for

such profit-making or commercial purposes, RECIPIENT agrees, in advance

of such use, to negotiate in good faith with PROVIDER to establish the

terms of a commercial license.  It is understood by RECIPIENT that

PROVIDER shall have no obligation to grant such a  license to

RECIPIENT, and may grant exclusive or non-exclusive commercial licenses

to others.



6.  The provision of the MATERIAL to RECIPIENT shall not alter any

pre-existing right to the MATERIAL.  If PROVIDER has granted any rights

to a third party (other than the customary rights granted to the

Federal Government or non-profit foundations) which would affect

RECIPIENT, those rights will be identified by PROVIDER in an

implementing letter.



7.  Any MATERIAL delivered pursuant to this Agreement is understood to

be experimental in nature and may have hazardous properties.  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.



8.  Except to the extent prohibited by law, RECIPIENT assumes all

liability for damages which may arise from its use, storage or disposal

of the MATERIAL.  PROVIDER will not be liable to RECIPIENT for any

loss, claim or demand made by RECIPIENT, or made against RECIPIENT by

any other party, due to or arising from the use of the MATERIAL by

RECIPIENT,  except to the extent permitted by law when caused by the

gross negligence or willful misconduct of PROVIDER.



9.  This agreement shall not be interpreted to prevent or delay

publication of research findings resulting from the use of the MATERIAL

or Modifications.  Recipient's Scientist agrees to provide appropriate

acknowledgement of the source of the MATERIAL in all publications.



10.  RECIPIENT agrees to use the MATERIAL in compliance with all

applicable statutes and regulations, including Public Health Service

and NIH regulations and guidelines such as, for example, those relating

to research involving the use of animals or recombinant DNA.



11.  (a) This Agreement will terminate on the earliest of the following

dates:  (1) when the MATERIAL becomes generally available from third

parties, for example, through reagent catalogs or public depositories,

or (2) on completion of RECIPIENT's current research with the MATERIAL,

or (3) on thirty (30) days written notice by either party to the other,

or (4) on the date specified in an implementing letter.  Paragraphs 7

and 8 shall survive termination.

     (b) If termination should occur under 11 (a)(1), RECIPIENT shall

be bound to the PROVIDER by the least restrictive terms applicable to

MATERIAL obtained from the then-available sources.

     (c) Except as provided in 11. (d) below, on termination of this

Agreement under 11. (a)(2), (3), or (4) above, RECIPIENT will

discontinue its use of the MATERIAL and will, upon direction of

PROVIDER, return or destroy any remaining MATERIAL.  RECIPIENT will

also either destroy Modifications or remain bound by the terms of

paragraphs 4 and 5 as they apply to Modifications.

     (d) In the event PROVIDER terminates this Agreement under

11.(a)(3) other than for breach of this Agreement or with cause such as

an imminent health risk or patent infringement, PROVIDER will defer the

effective date of termination for a period of up to one year, upon

request from RECIPIENT, to permit completion of research in progress.



12.  The MATERIAL is provided free or with a fee solely to reimburse

PROVIDER for its distribution costs.  If a fee is requested, it will be

enumerated in an implementing letter.



----------------------------- (END OF PAGE) -------------------------

                                            Attachment A



Belonging to PROVIDER



MATERIAL

Original Material

Progeny

Unmodified Derivatives



Belonging to RECIPIENT*



Modifications (however, PROVIDER retains ownership rights to any form

of the MATERIAL included therein)



Those substances created through the use of the MATERIAL or

Modifications, but which are not Progeny, Unmodified Derivatives or

Modifications (e.g., do not contain the Original Material or Unmodified

Derivatives).



* If resulting from the collaborative efforts of PROVIDER and

RECIPIENT, joint ownership may be negotiated.



------------------------------ (END OF PAGE) ------------------------



SIMPLE LETTER AGREEMENT FOR TRANSFER OF NON-PROPRIETARY BIOLOGICAL

MATERIAL FROM NON-PROFIT TO NON-PROFIT



TO:

      (RECIPIENT)

Address:





FROM:

Address:

      (PROVIDER)



Re:  Biological Material Identified as:



In response to RECIPIENT's request for the above-identified Biological

Material, PROVIDER's institution asks that RECIPIENT and Recipient's

Scientist agree to the following before RECIPIENT receives the

Biological Material:



1.  The above Biological Material is the property of PROVIDER and is

made available as a service to the research community.



2.  The Biological Material will be used for research purposes only.



3.  The Biological Material will not be further distributed to others

without PROVIDER's written permission; except such permission is not

required where RECIPIENT agrees, upon request, to provide the

Biological Material (subject to its availability) or enabling

information to appropriate investigators solely for the purpose of

replicating or verifying RECIPIENT'S research.



4.  RECIPIENT agrees to acknowledge the source of the Biological

Material in any publications reporting use of it.



5.  The Biological Material is experimental in nature and IT IS

PROVIDED WITHOUT ANY WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY

WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

RECIPIENT and Recipient's Scientist agree to assume all liability for

damages which arise from use, storage or disposal of the Biological

Material.



6.  RECIPIENT agrees to use 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.



RECIPIENT and Recipient's Scientist should sign both copies of this

letter and return one signed copy to PROVIDER.  PROVIDER will then

forward the Biological Materials.



PROVIDER                                              RECIPIENT'S

SCIENTIST



(signature)            (date)         (signature)            (date)



RECIPIENT INSTITUTIONAL APPROVAL



(authorized signature)                (date)



Name:

Title:

Address:



------------------------------ (END OF PAGE) ------------------------



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