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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