# Presentation: 212978

## 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**
**Tel: (301) 451-3636 ****●  Fax: (301) 402-7462**
***http://TechDev.NIDDK.NIH.gov***

## CRADA -  Cooperative Research and Development

- Exchange of Intellectual Contribution

**Notes:**
NIDDK may collaborate with industry through a CRADA – a Cooperative Research and Development Agreement.  During a CRADA, our investigators may develop the technology to a stage with commercial applications.  These may take the form of the basis for an assay, a compound, or a therapeutic, for example.  Having the CRADA in place allows us to offer an exclusive or non-exclusive license to the company, at its option, without NIDDK first having to advertise its availability.  Companies like this because it removes a layer of competition in obtaining the license.  It’s similar to a right of first refusal.  The government likes it because the technology has a greater chance of being commercialized – that is, getting into public use – reaching the bedside.

## 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

## CRADAs

***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

## 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: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 – 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:Arranging the CRADA

- PHS Model CRADA (legal terms) available at _[http://](http://techdev.niddk.nih.gov/)__[TechDev.NIDDK.NIH.gov](http://techdev.niddk.nih.gov/)__[ ](http://techdev.niddk.nih.gov/)_at _[CRADA.pdf](http://techdev.niddk.nih.gov/CRADA.pdf)_
- 	NIH CRADA Policy accessible at _[http://](http://techdev.niddk.nih.gov/)__[TechDev.NIDDK.NIH.gov](http://techdev.niddk.nih.gov/)__[ ](http://techdev.niddk.nih.gov/)_at _[techtrans.htm](http://techdev.niddk.nih.gov/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 - 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](http://techdev.niddk.nih.gov/)_ at _[forms.htm](http://techdev.niddk.nih.gov/forms.htm)_
- List of publications, patents, patent applications, prior agreements

## 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 – 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: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:Execution of the CRADA

**NIDDK**
- Intramural:  Scientific Director
- Extramural: Deputy Director/NIDDK
**Collaborator**
- Authorized Signatory

## NIDDK Collaborative Opportunities and Novel NIH Technologies

- NIDDK Technology Transfer and Development website at _[http://](http://techdev.niddk.nih.gov/)__[TechDev.NIDDK.NIH.gov](http://techdev.niddk.nih.gov/)_
- NIH Office of Technology Transfer website at _[http://](http://ott.od.nih.gov/db/tech.asp)__[ott.od.nih.gov/db/tech.asp](http://ott.od.nih.gov/db/tech.asp)_
- Federal Register at _[http://](http://www.fedreg.gov/)__[www.fedreg.gov](http://www.fedreg.gov/)_
- Federal Business Opportunities (formerly Commerce Business Daily) at _[http://](http://www.fedbizopps.gov/)__[www.fedbizopps.gov](http://www.fedbizopps.gov/)_
- TechEx at _[http://](http://www.techex.com/)__[www.techex.com](http://www.techex.com/)_
- Knowledge Express at _[http://](http://www.knowledgeexpress.com/)__[www.knowledgeexpress.com](http://www.knowledgeexpress.com/)_
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