Technology Transfer and CRADAs Office of Research and Development Department of Veterans Affairs

1
Technology Transfer and CRADAs Office of
Research and DevelopmentDepartment of Veterans
Affairs

• Jeff Moore
• Technology Transfer Program, ORD
• Local Accountability Training
• Chicago

2
What is Technology Transfer?

• 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.

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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

4
Disclosure Process

• - Go to the VA TTP website (Reporting of
  Invention button) www.research.va.gov/programs/
  tech_transfer/
• - 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.

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What does TTP do with the disclosure?

• - 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).

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What if TTP asserts ownership?

• - 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.

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Licenses

• - 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

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VA TTP Royalty Breakdown
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
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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).

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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

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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 .

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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.

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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

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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

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Where to find the new CRADA models

• VA intranet website
• http//vaww.research.va.gov/programs/tech_transfer
  /model_agreements/default.cfm
• Or go to the TTP CRADA model page and replace the
  first w with va.

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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.

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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.

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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.

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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.

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VA CRADACommon Provisions Throughout

• Article 2 Definitions
• Background Invention
• CRADA Subject Invention
• CRADA Data
• Clinical Investigator PI
• Statement of Work (maybe protocol)

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VA CRADA (cont)

• 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

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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.

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VA CRADA (cont)

• Article 8. Confidentiality
• 8.1 Confidential Information.
• 8.2 Disclosure of Confidential Information.
• 8.3 Duration of Confidential Information.

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VA CRADA (cont)

• Article 12. Liability
• 12.1 Collaborators Indemnification and Liability
  
• 12.2 VAs Indemnity and Liability

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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.

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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) RD Office
• VA Nonprofit Research Corporation (NPC)
• VA Regional Counsel (RC)
• TTP if it is a Basic CRADA

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The Role of the NPC in CRADAs

• PI and NPC jointly negotiate CRADA.
• PI and NPC jointly negotiate budget.
• NPC coordinates VA approvals (RD 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.

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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

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Contact Information and Resources

• Questions about Technology Transfer or CRADAs
• TTP Website
• http//www.research.va.gov/programs/tech_transfer/
  default.cfm
• CRADA Registry
• http//www.research.va.gov/programs/tech_transfer/
  crada/registry.cfm
• VA Technology Transfer Program
• Amy.Centanni_at_va.gov [phone]
• Jeffrey.Moore_at_va.gov [phone]
• Saleem.Sheredos_at_va.gov [phone]
• Kris.Burton_at_va.gov [phone]
• Ken.Levin_at_va.gov [phone]
• VA OGC Group III
• Renee.Szybala_at_va.gov [phone]
• Jane.Gutcher_at_va.gov [phone]