THE CRADA PROCESS 12 South Drive, MSC 5632, Bethesda, MD 20892-5632 Tel: (301) 451-3636 ● Fax: (301) 402-7462 TechDev

1. 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

2. CRADA - Cooperative Research and Development • Exchange of Intellectual Contribution

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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)

10. 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)

11. 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)

12. 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

13. NIDDK Intramural: Scientific Director Extramural: Deputy Director/NIDDK Collaborator Authorized Signatory CRADA Process:Execution of the CRADA

14. 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