1. Winter 2008
Technology Transfer and CRADAs Office of Research and Development Department of Veterans Affairs
Jeff Moore
Technology Transfer Program, ORD
Local Accountability Training
Chicago
Technology Transfer

2. What is Technology Transfer?
Winter 2008
The process of converting scientific findings from research laboratories into useful products by the commercial sector.
Can involve
Federal Labs
Industry
University
Federal, state, and local governments
- Industry is encouraged to develop that technology via new products, processes, or materials.
Technology Transfer

3. Who has a duty to disclose an Invention?
Winter 2008
Who has a duty to disclose an Invention?
- VA salaried employee
- Without Compensation (WOC) employee who has signed a WOC IP (intellectual property) agreement
- IPA (Intergovernmental Personnel Act) Employee
Technology Transfer

4. Winter 2008
Disclosure Process
- Go to the VA TTP website (Reporting of Invention button):
- Inventor fills out the Certification and Invention Disclosure form.
- Attain proper signatures i.e., immediate supervisor and ACOS.
- Prepare a memo to the Director of TTP through the Director of the medical center.
Technology Transfer

5. What does TTP do with the disclosure?
Winter 2008
- Review disclosure for scientific/patentability and for contribution VA made to invention.
- TTP provides a recommendation to OGC
- retain rights.
- VA leaves right, title & interest to the invention with the inventor.
- VA leaves entire right, title, & interest to
the invention with the inventor subject to
the VA retaining a non-exclusive, govt.
use license.
- OGC issues determination of rights (DOR).
ADD UPDATED CHART
Technology Transfer

6. What if TTP asserts ownership?
Winter 2008
- Invention is managed pursuant to the Cooperative Technology Administration Agreement (CTAA). or
- If VA owns solely VA Technology Transfer Program patents, markets, and looks for potential licensees.
ADD UPDATED CHART
Technology Transfer

7. Licenses
Winter 2008
- Central office (TTP) negotiates Licenses CRADAs and Licenses should not be confused
- A license is a contract between licensor (e.g., VA holder of the patent) and a licensee (e.g., an industry partner) which gives the licensee certain rights
- Per Federal statue (37 CFR 404) terms below must be in a Federal license
development or marketing plan
company agrees to commercialize in a set time period
reports on efforts
Government always retains an irrevocable royalty-free right to practice the invention
Companies agree that any products developed will be manufactured substantially in the U.S.
Nonexclusive
more for late stage technologies that have been substantially developed for commercial sale or several companies offers better opportunities for broad development
Partially Exclusive
limited to a field of use or geographic area
Exclusive
gives industry partner exclusive rights to market and commercialize in U.S. (possibly world)
Technology Transfer

8. VA TTP Royalty Breakdown
Winter 2008
VA Sole owned
- First $2,000 to inventor(s)
- 40% goes to inventor(s)
- Rest of money (other 60%)
- 85% goes back to VAMC
- 50% to lab where invented
- 25% to ACOS budget
- 10% to Director budget
- 15% goes to TTP for
admin costs
University Lead
- University pays inventor
- Deducts admin fee (15%)
Spilt remaining money per
employment of inventors
VA Split
Technology Transfer

9. Introduction to CRADAs
Winter 2008
Introduction to CRADAs
What is a Cooperative Research and Development Agreement (CRADA)?
15 USC § 3710a - A legal agreement between a federal agency and one or more non-federal parties.
Purpose is to foster federal/private collaborations to bring new technology to the marketplace.
Government owns the invention rights of government employees made during work hours, using government resources or that bear a direct relation to the official duties of the inventor (Executive Order 10096).
Technology Transfer

10. Introduction to CRADAs (cont’)
Winter 2008
Introduction to CRADAs (cont’)
Government may provide personnel, services, facilities, equipment, intellectual property, and other resources, but not funds.
Non-federal party may provide funds, personnel, services, facilities, equipment, intellectual property, or other resources.
Allows government to negotiate licensing agreements and may agree to grant in advance:
- Exclusive patent licenses; or
- Non-exclusive patent licenses; or
- Assignments; or
- Options to CRADA subject inventions
Technology Transfer

11. Introduction to CRADAs (cont’) Protections to Collaborators
Winter 2008
Introduction to CRADAs (cont’) Protections to Collaborators
Protect background inventions, trade secrets and confidential information.
Establish intellectual property ownership and licensing options in advance of an invention.
Ensure enforceable terms.
Government-wide, readily understood and accepted mechanism for establishing collaborative relationships .
Technology Transfer

12. Introduction to CRADAs (cont’) VA requirements
Winter 2008
Introduction to CRADAs (cont’) VA requirements
Agency must review for conflicts of interest.
For CRADAs with foreign companies, agency must “consult” with US Trade Representative.
Must be reviewed and signed by the federal laboratory director – VA Medical Center Director.
Consists of CRADA, Statement of Work (SOW), Budget, and Appendix C.
Technology Transfer

13. Winter 2008
The New VA CRADA models
VA listened to the VA research field and sponsors.
shorter (15 pages or less)
easier to read
streamlined definitions and language
better organized
reflects more flexible interpretation of the law by OGC
Technology Transfer

14. New VA CRADA Models (cont’)
Winter 2008
New VA CRADA Models (cont’)
Clinical Trial Phase I & II CRADA
Clinical Trial Phase III & IV CRADA
Clinical Trial Investigational Device CRADA
Material Transfer CRADA
Basic CRADA
In development:
Principal Investigator Initiated Clinical Study CRADA
Technology Transfer

15. Where to find the new CRADA models
Winter 2008
Where to find the new CRADA models
VA intranet website
Or go to the TTP CRADA model page and replace the first “w” with “va”.
Technology Transfer

16. Winter 2008
When to use the CT CRADA for Phase I & II and Phase III & IV clinical trials?
When the collaborator:
1. Owns the investigational new drug (IND);
2. Designs the protocol; and
3. Funds the project.
Technology Transfer

17. When to use the Investigational Device CT CRADA.
Winter 2008
When to use the Investigational Device CT CRADA.
When to use the Investigational Device CT CRADA CRADA:
When the research involves a collaborative research, development, engineering, testing or evaluation studies involving devices.
Maybe PI initiated or not.
Technology Transfer

18. Basic Research CRADA When to use the Basic Research CRADA:
Winter 2008
Basic Research CRADA
When to use the Basic Research CRADA:
Used only for collaborative research, development, engineering, testing or evaluation studies.
VA investigator designs or contributes substantively to the design of the statement of work.
Study does not involve human subjects VA.
Technology Transfer

19. MT CRADA When to use the MT CRADA:
Winter 2008
MT CRADA
When to use the MT CRADA:
VA is the recipient of a material and the company would like the right to license any improvement or intellectual property (IP) that stems from the research.
If IP is not an issue please use the basic MTA.
Technology Transfer

20. VA CRADA Common Provisions Throughout
Winter 2008
VA CRADA Common Provisions Throughout
Article 2: Definitions
Background Invention
CRADA Subject Invention
CRADA Data
Clinical Investigator = PI
Statement of Work (maybe protocol)
Technology Transfer

21. VA CRADA (cont’)
Winter 2008
Article 5. Inventions and Intellectual Property
5.2 Ownership of CRADA Subject Inventions – VA Retains Ownership.
5.3 Reporting – VA and Collaborator invention disclosure obligations.
Article 6. Licensing continued
6.1 License Options. VA grants to Collaborator an option to elect a nonexclusive, partially exclusive or exclusive license on any CRADA Subject Invention made solely by VA Employee(s) or made jointly by VA and Collaborator employees.
* In the CT III & IV CRADA a nonexclusive license is granted up front
License will comply with Federal requirements.
Technology Transfer

22. Article 7. Ownership and Rights of Access to Data and Publication.
Winter 2008
VA CRADA (cont’)
Article 7. Ownership and Rights of Access to Data and Publication.
7.1 Case Report Forms and Records
For CT CRADAs.
7.2 CRADA Data and CRADA Materials.
7.3 Presentations and Publications.
Technology Transfer

23. VA CRADA (cont’) Article 8. Confidentiality
Winter 2008
VA CRADA (cont’)
Article 8. Confidentiality
8.1 Confidential Information.
8.2 Disclosure of Confidential Information.
8.3 Duration of Confidential Information.
Technology Transfer

24. VA CRADA (cont’) Article 12. Liability
Winter 2008
VA CRADA (cont’)
Article 12. Liability
12.1 Collaborator’s Indemnification and Liability
12.2 VA’s Indemnity and Liability
Technology Transfer

25. Winter 2008
VA CRADA Options
Single-study CRADA
Negotiated for a single study at a single site; signed locally.
Over time, single-study CRADAs may become de facto templates.
Master/template CRADA
- negotiations are in process with major pharmaceuticals companies.
- Could apply to all Phase I & II or III & IV clinical trials with a specific sponsor.
- Only variables are the Statement of Work (may be the protocol) and budget.
Technology Transfer

26. Process for negotiating CRADAs
Winter 2008
Process for negotiating CRADAs
Follow the SOPs that are on the TTP website for the specific CRADA.
Who is involved:
Principal Investigator (PI)
VA Medical Center (VAMC) R&D Office
VA Nonprofit Research Corporation (NPC)
VA Regional Counsel (RC)
TTP if it is a Basic CRADA
Technology Transfer

27. The Role of the NPC in CRADAs
Winter 2008
The Role of the NPC in CRADAs
PI and NPC jointly negotiate CRADA.
PI and NPC jointly negotiate budget.
NPC coordinates VA approvals (R&D Committee, IRB, RC, MCD, etc.).
NPC administers the study and funds.
NPC manages receipts and expenditures.
Contact NPC personnel for assistance in identifying PIs and assessing potential VAMC subject pool.
Technology Transfer

28. VA CRADA Closing the Deal
Winter 2008
VA CRADA
Closing the Deal
Agency review within 15 to 30 days if needed.
PI signs acknowledgement.
Parties sign CRADA.
- Collaborator
- NPC
- Medical Center Director (last to sign)
Disseminate originals to all parties and provide a copy to PI.
Send a copy to TTP to enter into the CRADA Registry
Technology Transfer

29. Contact Information and Resources
Winter 2008
Questions about Technology Transfer or CRADAs:
TTP Website
CRADA Registry
VA Technology Transfer Program
(202)
(202)
(410)
(202)
(202)
VA OGC Group III
(202)
(202)
Technology Transfer