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Office of Technology Transfer and Development National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health and Department of Health and Human Services THE CRADA PROCESS 12 South Drive, MSC 5632, Bethesda, MD 20892-5632

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Office 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

crada cooperative research and development
CRADA - Cooperative Research and Development
  • Exchange of Intellectual Contribution
cradas
CRADAs
  • 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
cradas4
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

CRADAs
crada 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

CRADA Process
crada process selection 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

Collaborator’s proprietary technology, unique expertise, or unique facilities

Public announcement of the CRADA opportunity

CRADA Process:Selection of the Collaborator –Fair Access
crada process selection 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

CRADA Process:Selection of the Collaborator – Conflicts of Interest
crada process arranging 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

CRADA Process:Arranging the CRADA
crada process arranging 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 athttp://TechDev.NIDDK.NIH.gov at forms.htm

List of publications, patents, patent applications, prior agreements

CRADA Process:Arranging the CRADA -The Research Plan (Appendix A)
crada process arranging 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

CRADA Process:Arranging the CRADA –Financial and Staffing Contributions (Appendix B)
crada process arranging 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

CRADA Process:Arranging the CRADA – Modifications to the Legal Terms (Appendix C)
crada process nih 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

CRADA Process:NIH Review of the Agreement
crada process execution of the crada
NIDDK

Intramural: Scientific Director

Extramural: Deputy Director/NIDDK

Collaborator

Authorized Signatory

CRADA Process:Execution of the CRADA
niddk collaborative opportunities and novel nih technologies
NIDDK 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.com

*********************

  • International Conferences
  • Publications