Federal Register Materials
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.
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.
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.
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).
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.
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 email@example.com. 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.