From the Federal Register, March 8, 1995
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.
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'') provides
assistance in implementation of the UBMTA among its members and
nonprofit organizations by notifying members of its availability,
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, 111 Deer Lake Road, Suite 100,
Deerfield, IL, 60015 or email a copy to info@autm.net. A read only version of
the signatory list will be made available on the Internet.
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.