[Federal Register Volume 64, Number 217 (Wednesday, November 10, 1999)]
[Notices]
[Pages 61361-61362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29367]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Drug Research and Development of a
Novel Vacuolar-Type (H+)-ATPase-Inhibitory Compound Class
AGENCY: National Cancer Institute, National Institute of Health, PHS,
DHHS.
ACTION: Notice of opportunity for cooperative research and development
(CRADA).
-----------------------------------------------------------------------
An opportunity is available for a Cooperative Research and
Development Agreement (CRADA) for the purpose of collaborating with the
NCI intramural Laboratory of Drug Discovery Research & Development
(LDDRD) on further research and development of U.S. government-owned
technology encompassed within U.S. Patent Application Serial No. 60/
122,953, entitled ``Novel Vacuolar-Type (H+)-ATPase-Inhibitory
Compounds and Compositions, and Uses Thereof.''
SUMMARY: Pursuant to the Federal Technology Transfer Act of 1986 (FTTA,
15 U.S.C. 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 a Cooperative Research and Development
Agreement ((CRADA) with a pharmaceutical or biotechnology company to
develop new drugs, therapeutic and/or preventative methods based on
selective inhibition of vacuolar-type (H+) ATPases. The CRADA would
have an expected duration of one (1) to five (5) years. The goals of
the CRADA include the rapid publication of research results and timely
commercialization of products, methods of treatment or prevention that
may result from the research. The CRADA Collaborator will have an
option to negotiate the terms of an exclusive or non-exclusive
commercialization license to subject inventions arising under the CRADA
and which are subject of the CRADA Research Plan, and can apply for
background licenses to the existing patent described above, subject to
any pre-existing licenses already issued for other fields of use.
ADDRESSES: Proposals and questions about this CRADA opportunity may be
addressed to Dr. Bjarne Gabrielsen, Technology Development &
Commercialization Branch, National Cancer Institute-Frederick Cancer
Research & Development Center, Fairview Center, Room 502, Frederick, MD
21701 (phone: 301-846-5465, fax: 301-846-6820).
Scientific inquiries should be directed to Dr. Michael R. Boyd,
Chief Laboratory of Drug Discovery Research & Development, National
Cancer Institute- Frederick Cancer Research & Development Center, Bldg.
1052, Rm 121, Frederick, MD 21702-1201 (phone: 301-846-5391; fax: 301-
846-6919; e-mail [email protected]).
EFFECTIVE DATE: Inquiries regarding CRADA proposals and scientific
matters may be forwarded at any time. Confidential preliminary CRADA
proposals, preferably two pages or less,
[[Page 61362]]
must be submitted to the NCI on or before December 10, 1999. Guidelines
for preparing final CRADA proposals will be communicated shortly
thereafter to all respondents with whom initial confidential
discussions will have established sufficient mutual interest.
SUPPLEMENTARY INFORMATION:
Technology Available
DHHS scientists within the LDDRD, NCI have discovered a novel class
of compounds that may have diverse uses in therapy of prophylaxis, or
other medical uses, that require inhibition of pathophysiological or
physiological processes mediated by vacuolar-type (H+)-ATPases (V-
ATPases). Details are in U.S. Patent Application Serial No. 60/122,953,
available under an appropriate Confidential Disclosure Agreement.
Technology Sought
Accordingly, DHHS now seeks collaborative arrangements for the
joint elucidation, evaluation and development of novel compounds and
methods to selectively inhibit phyiological and/or disease processes
that are mediated, at least in part, through specific isoform(s) of V-
ATPases. For collaboration 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. CRADA aims will include rapid publication of
research results as well as full and timely exploitation of any
commercial opportunities.
NCI and Collaborator Responsibilities
The role of the LDDRD, NCI 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 pertinent available compounds
for investigation/evaluation.
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 expertise and/or financial support for
CRADA-related research as outlined in the CRADA Research Plan.
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 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 on-going
research and development.
2. Expertise and experience in the following areas: preclinical
research and drug development of selective vacuolar-type ATPase-
inhibitory compounds; ability to perform appropriate chemical synthetic
efforts to support V-ATPase-directed structure/activity (SAR) studies,
lead-optimization, drug candidate selection and development;
performance of in vitro and/or in vivo assays of V-ATPase inhibition
employing distinctive V-ATPases from diverse human and other mammalian
tissues and cells.
3. 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.
4. The willingness to commit best effort and demonstrated resources
to the research, development and commercialization of this technology.
5. The demonstration of expertise in the commercial development,
production, marketing and sales of products related to this area of
technology.
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 non-exclusive license to the CRADA
Collaborator when the Government employee is the sole inventor.
Dated: October 29, 1999.
Kathleen Sybert,
Chief, Technology Development & Commercialization Branch, National
Cancer Institute, National Institutes of Health.
[FR Doc. 99-29367 Filed 11-9-99; 8:45 am]
BILLING CODE 4140-01-M