[Federal Register Volume 62, Number 154 (Monday, August 11, 1997)]
[Notices]
[Pages 42998-43000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21148]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Notice of CRADA Opportunities
National Cancer Institute: Nitric Oxide Technology: Opportunities
for Cooperative Research and Development Agreements (CRADAs) for the
development of medicinal agents useful for treating a variety of
disorders arising from localized physiologic deficiencies of the
multifaceted bioregulatory molecule, nitric oxide. The NCI is looking
for multiple CRADA Collaborators to develop independently different
aspects of their nitric oxide technology.
AGENCY: National Institutes of Health, PHS, DHHS.
ACTION: Notice for CRADA opportunities.
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SUMMARY: Pursuant to the Federal Technology Transfer Act of 1986 (FTTA,
15 U.S.C. Sec. 3710, and Executive Order 12591 of April 10, 1987, as
amended by the National Technology Transfer and Advancement Act of
1995), the National Cancer Institute (NCI) of the National Institutes
of Health (NIH) of the Public Health Service (PHS) of the Department of
Health and Human Services (DHHS) seeks Cooperative Research and
Development Agreements (CRADAs) with pharmaceutical or biotechnology
companies to develop applications of nitric oxide technology. Any CRADA
for the biomedical use of this technology will be considered. The
CRADAs would have an expected duration of one (1) to five (5) years.
The goals of the CRADAs include the rapid publication of research
results and timely commercialization of products, diagnostics and
treatments that result from the research. The CRADA Collaborators will
have an option to negotiate the terms of an exclusive or nonexclusive
commercialization license to subject inventions arising under the
[[Page 42999]]
CRADAs, and can apply for background licenses to the existing patents
listed below, subject to any pre-existing licenses already issued for
other fields of use.
Please see accompanying announcement for Licensing opportunitites
with this technology.
ADDRESSES: 1. CRADA opportunities--Dr. Thomas Stackhouse, National
Cancer Institute, Fairview Center, Room 502, Frederick, MD 21701
(phone: 301-846-5465, fax: 301-846-6820).
2. Scientific inquiries--Dr. Larry Keefer, National Cancer
Institute, Frederick Cancer and Research Development Center, Building
538, Room 205E, Frederick, MD 21702-1201 (phone: 301-846-1467, fax:
301-846-5946).
EFFECTIVE DATE: Inquiries regarding scientific matters may be forwarded
at any time. Confidential CRADA proposals, preferably one page or less,
must be submitted to NCI on or before October 10, 1997. Guidelines for
preparing full CRADA proposals will be communicated shortly thereafter
to all respondents who have been selected.
SUPPLEMENTARY INFORMATION:
Technology Available
DHHS scientists are developing a variety of novel techniques for
delivering nitric oxide (NO) to specific organs and cell types for
therapeutic benefit. Methods for targeting lung, liver, and other
tissues have been introduced to the literature, as have NO-releasing
proteins and insoluble polymers. The compounds and drug delivery
strategies developed thus far have shown promising antimicrobial,
cytostatic, and antimetastatic activities; other activities that have
been demonstrated in experimental animals include relief of respiratory
distress, protection against toxic liver injury, radiosensitization of
hypoxic tumors, and correction of genitourinary tract dysfunction.
Publications outlining these developments are available on request, and
descriptions of other (unpublished) advances can be obtained from Dr.
Stackhouse via a Confidential Disclosure Agreement.
DHHS now seeks collaborative arrangements for the joint evaluation
and possible clinical exploitation of these agents. For collaborations
with the commercial sector, a Cooperative Research and Development
Agreement (CRADA) will be established to provide for equitable
distribution of intellectual property rights developed under the CRADA.
The successful CRADA awardee will collaboratively characterize
compounds supplied by the Government with respect to the potential
biomedical application(s) specified in the CRADA. CRADA aims will
include rapid publication of research results as well as full and
timely exploitation of any commercial opportunities.
NCI's Nitric Oxide Patents
1. Keefer, L. K., et al.: Complexes of nitric oxide with
polyamines. U.S. Patent 5,155,137, October 13, 1992.
2. Keefer, L. K., et al.: Complexes of nitric oxide with
polyamines. U.S. Patent 5,250,550, October 5, 1993.
3. Keefer, L. K., et al.: Oxygen-substituted derivatives of
nucleophile-nitric oxide adducts as nitric oxide donor prodrugs. U.S.
Patent 5,366,997, November 22, 1994.
4. Christodoulou, D. D., et al.: Mixed ligand metal complexes of
nitric oxide nucleophile adducts useful as cardiovascular agents. U.S.
Patent 5,389,675, February 14, 1995.
5. Keefer, L. K., et al.: Polymer-bound nitric oxide/nucleophile
adduct compositions, pharmaceutical compositions and methods of
treating biological disorders. U.S. Patent 5,405,919, April 11, 1995.
6. Keefer, L. K., et al.: Polymer-bound nitric oxide/nucleophile
adduct compositions, pharmaceutical compositions incorporating same and
methods of treating biological disorders using same. U.S. Patent
5,525,357, June 11, 1996.
7. Mitchell J. B. et al.: Use of nitric oxide releasing compounds
as hypoxic cell radiation sensitizers. U.S. Patent Application 08/
133,574, filed October 8, 1993
8. Korthuis, R. J., et al.: Use of nitric oxide-releasing agents
for reducing metastasis risk. U.S. Patent Application 08/344,341, filed
November 22, 1994.
9. Saavedra, J. E., et al.: Biopolymer-bound nitric oxide-releasing
compositions, pharmaceutical compositions incorporating same and
methods of treating biological disorders using same. U.S. Patent
Application 08/344,157, filed November 22, 1994.
10. Keefer, L. K., et al.: Polymer-bound nitric oxide/nucleophile
adduct compositions, pharmaceutical compositions incorporating same and
methods of treating biological disorders using same. U.S. Patent
Application 08/417,913, filed April 6, 1995.
11. Keefer, L. K., et al.: Polymer-bound nitric oxide/nucleophile
adduct compositions, pharmaceutical compositions incorporating same and
methods of treating biological disorders using same. U.S. Patent
Application 08/417,917, filed April 6, 1995.
12. Keefer, L. K., et al.: Use of nitric oxide-releasing agents to
treat impotency. U.S. Patent Application 08/419,044, filed April 10,
1995.
13. Smith, D. J., et al.: Polysaccharide-bound nitric oxide/
nucleophile adducts. U.S. Patent Application 08/419,424, filed April
10, 1995.
14. Keefer, L. K., et al.: Pharmaceutical compositions of secondary
amine-nitric oxide adducts. U.S. Patent Application 08/476,601, filed
June 6, 1995.
15. Keefer, L. K., et al.: N-substituted piperazine NONOates. U.S.
Patent Application 08/475,732, filed June 7, 1995.
16. Saavedra, J. E., et al.: Selective prevention of organ injury
in sepsis and shock using selective release of nitric oxide in
vulnerable organs. U.S. Patent Application 08/509,558, filed July 31,
1995.
17. Hrabie, J. A., et al.: Method of generating nitric oxide gas
using nitric oxide complexes. U.S. Patent Application 08/522,405, filed
September 12, 1995.
18. Saavedra, J. E., et al.: O\2\-aryl substituted
diazeniumdiolates. U.S. Patent Application 60/026,816, filed September
27, 1996.
19. Green, S. et al.: Encapsulated and non-encapsulated nitric
oxide generators used as antimicrobial agents. U.S. Patent Application
08/428,632, filed April 24, 1995.
The role of the National Cancer Institute in this CRADA will
include, but not be limited to:
1. Providing intellectual, scientific, and technical expertise and
experience to the research project.
2. Providing the Collaborator with samples of the subject compounds
for pharmacological evaluation and assist in the development of new
compounds, as determined by the research project.
3. Planning research studies and interpreting research results.
4. Publishing research results.
The role of the CRADA Collaborator may include, but not be limited
to:
1. Providing significant intellectual, scientific, and technical
expertise or experience to the research project.
2. Planning research studies and interpreting research results.
3. Providing technical and/or financial support for ongoing CRADA-
related research in the development of the particular application of
nitric oxide technology outlined in the agreement.
4. Publishing research results.
Selection criteria for choosing the CRADA Collaborator may include,
but not be limited to:
1. The ability to collaborate with NCI on further research and
development of
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this technology. This ability can be demonstrated through experience
and expertise in this or related areas of technology indicating the
ability to contribute intellectually to ongoing research and
development.
2. The demonstration of adequate resources to perform the research,
development and commercialization of this technology (e.g. facilities,
personnel and expertise) and accomplish objectives according to an
appropriate timetable to be outlined in the CRADA Collaborator's
proposal.
3. The willingness to commit best effort and demonstrated resources
to the research, development and commercialization of this technology.
4. The demonstration of expertise in the commercial development,
production, marketing and sales of products related to this area of
technology.
5. The level of financial support the CRADA Collaborator will
provide for CRADA-related Government activities.
6. The willingness to cooperate with the National Cancer Institute
in the timely publication of research results.
7. The agreement to be bound by the appropriate DHHS regulations
relating to human subjects, and all PHS policies relating to the use
and care of laboratory animals.
8. The willingness to accept the legal provisions and language of
the CRADA with only minor modifications, if any. These provisions
govern the equitable distribution of patent rights to CRADA inventions.
Generally, the rights of ownership are retained by the organization
that is the employer of the inventor, with (1) the grant of a license
for research and other Government purposes to the Government when the
CRADA Collaborator's employee is the sole inventor, or (2) the grant of
an option to elect an exclusive or nonexclusive license to the CRADA
Collaborator when the Government employee is the sole inventor.
Dated: July 21, 1997.
Kathleen Sybert,
Acting Director, Office of Technology Development, National Cancer
Institute, National Institutes of Health.
[FR Doc. 97-21148 Filed 8-8-97; 8:45 am]
BILLING CODE 4140-01-P