Title: Office of Technology Transfer and Development National Institute of Diabetes and Digestive and Kidne
1Office of Technology Transfer and
DevelopmentNational Institute of Diabetes and
Digestive and Kidney DiseasesNational Institutes
of Health and Department of Health and Human
Services
- THE CRADA PROCESS
- 12 South Drive, MSC 5632, Bethesda, MD
20892-5632 - Tel (301) 451-3636 ? Fax (301) 402-7462
- http//TechDev.NIDDK.NIH.gov
2CRADA - Cooperative Research and Development
- Exchange of Intellectual Contribution
3CRADAs
- Cooperative Research and Development Agreements
are authorized under U.S. Statute (15 U.S.C.
3710a) - Require Intellectual Exchange between
Collaborator and NIDDK/NIH - For Collaborator contributions of only
proprietary material, (preferably not
commercially available) see M-CRADAs also known
as Materials CRADAs) - Provide Industry Collaborator with option to
license inventions made solely or jointly by
NIDDK/NIH investigator during performance of
Study or Trial - May be used for Clinical Trials
- Allow for industry funding of all or part of a
Study - Submitted to the CRADA sub-committee of the NIH
Technology Transfer Policy Board for approval
before Institute can execute agreement
4CRADAs
- The CRADA is not a grant, procurement contract,
or other funding mechanism - The government laboratory is prohibited
- from transferring Congressionally-appropriated
funds - to a CRADA Collaborator, under the CRADA
5CRADA Process
- Selection of the Collaborator
- Fair Access / Conflict of Interest
- Arranging the Agreement
- Appendix A The Research Plan
- Appendix B Financial and Staffing Contributions
- Appendix C Modifications to the CRADA template
- NIH review of CRADAs
- Execution by the Parties
6CRADA ProcessSelection of the Collaborator
Fair Access
- Fair Access requirements
- By law, special consideration given to 1)
small business firms and 2) businesses located in
the U.S. - In accordance with policy, fair access for
collaborative opportunities provided to all
outside organizations - Compliance with Fair Access requirements
- Collaborators proprietary technology, unique
expertise, or unique facilities - Public announcement of the CRADA opportunity
7CRADA ProcessSelection of the Collaborator
Conflicts of Interest
- Conflicts of Interest (that can prevent a CRADA!)
- NIH PI owns stock above threshold amount in the
prospective Collaborator company - NIH PI is a paid consultant with the Collaborator
company - NIH PI is on the Board of Scientific Advisors at
the Collaborator company - Negotiating official or signatory at the
prospective Collaborator company is a former NIH
employee within the past 12 months
8CRADA ProcessArranging the CRADA
- PHS Model CRADA (legal terms) available at
http//TechDev.NIDDK.NIH.gov at CRADA.pdf - NIH CRADA Policy accessible at
http//TechDev.NIDDK.NIH.gov at techtrans.htm - Appendix A The Research Plan
- Appendix B Financial and Staffing Contributions
- Appendix C Modifications to the CRADA legal
terms - Addition of provisions for Clinical Trials
- Negotiated modifications
9CRADA ProcessArranging the CRADA - The
Research Plan (Appendix A)
- Specific Goals
- Introduction (background of the technology) and
expertise of the Parties - Workscope
- Responsibilities of the Parties
- Detailed description of the scope of the research
Prenegotiated field of use for the license is the
scope of the research plan Model Licenses
available at http//TechDev.NIDDK.NIH.gov at
forms.htm - List of publications, patents, patent
applications, prior agreements
10CRADA ProcessArranging the CRADA Financial
and Staffing Contributions (Appendix B)
- Contributions of materials, facilities,
equipment, and staff to be committed by each
Party - Funds (if any) provided by the Collaborator
- CRADAs are not intended to be primary source of
funds to the government labs - nor to provide a pair of hands for the
collaborator
11CRADA ProcessArranging the CRADA
Modifications to the Legal Terms (Appendix C)
- Certain terms in the agreement restate statutory
law and regulations -- These cannot be modified - Certain terms reflect NIH policy and can be
modified - NIDDK Office of Technology Transfer and
Development, in consultation with the NIH Office
of Technology Transfer and the NIH Office of
General Counsel may modify certain terms - Other terms can be negotiated to accommodate the
unique needs of each collaborator
12CRADA ProcessNIH Review of the Agreement
- NIDDK
- Technology Development Specialist
- Director, Technology Transfer and Development
- Principal Investigator(s) and Lab Chief
- Ethics Coordinator (for Conflicts of Interest)
- Scientific Director and/or Director or Deputy
Director/NIDDK - NIH
- CRADA Subcommittee
- meets monthly submission deadline usually
first Friday of each month - Includes representatives from
- NIH Office of Technology Transfer
- NIH Office of the General Counsel
- NIH Scientists
- Office of the Director
13CRADA ProcessExecution of the CRADA
- NIDDK
- Intramural Scientific Director
- Extramural Deputy Director/NIDDK
- Collaborator
- Authorized Signatory
14NIDDK Collaborative Opportunities and Novel NIH
Technologies
- NIDDK Technology Transfer and Development website
at http//TechDev.NIDDK.NIH.gov - NIH Office of Technology Transfer website at
http//ott.od.nih.gov/db/tech.asp - Federal Register at http//www.fedreg.gov
- Federal Business Opportunities (formerly Commerce
Business Daily) at http//www.fedbizopps.gov - TechEx at http//www.techex.com
- Knowledge Express at http//www.knowledgeexpress.c
om -
- International Conferences
- Publications