Partnership for Effective Research for Veterans Health VA

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Partnership for Effective Research for Veterans
HealthVAs Model Clinical Trial-Cooperative
Research and Development Agreement (CT CRADA)

• Our Panel
• Amy Centanni, Director, Technology Transfer
  Program (TTP), VHA
• Barbara West, Executive Director, National
  Association of Veterans Research and Education
  Foundations (NAVREF)
• Paul Hutter, Assistant General Counsel, Office of
  General Counsel (OGC)

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Partnership for Effective Research for Veterans
HealthVAs Model Clinical Trial-Cooperative
Research and Development Agreement

• Partnership (VHA, Nonprofit Research
• Corporations, Office of General Counsel)
• April 2005
• November 2005
• February 2006

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Partnership for Effective Research for Veterans
HealthVAs Model Clinical Trial-Cooperative
Research and Development Agreement

• CT-CRADA - the first product of this strong
  partnership
• Our Agenda
• The CRADA itself Amy Centanni
• The CT-CRADA Guidelines Amy Centanni

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Partnership for Effective Research for Veterans
HealthVAs Model Clinical Trial-Cooperative
Research and Development Agreement

• The Cooperative Technology Administration
  Agreement Amendments/Guidelines Paul Hutter
• The Implementation Plan Paul Hutter
• Suggested Talking Points/Conclusion Paul Hutter
• Questions throughout and at the conclusion

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CRADA BASICS
What is a Cooperative Research and Development
Agreement (CRADA)? A CRADA is a legal
agreement between VA and one or more non-Federal
parties. Title 15 USC 3710a
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CRADA BASICS
Protection of background inventions, trade
secrets and confidential information Access to
VA research resources including personnel,
services and property
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CRADA BASICS
Establishment of intellectual property ownership
and licensing options in advance of an
invention Leveraging federal expertise to
develop products with commercialization
potential Enforceable
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When to use the CT CRADA

• When the collaborator
• Holder of the investigational new drug (IND)
• Designs the protocol and
• Funds the project

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Who negotiates the CT CRADA?

• VAMC / PI (principal investigator)
• NPC (nonprofit corporation)
• RC (regional counsel) as needed

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Looking at the actual agreement
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Article 2 Definitions

• Affiliate vs. Affiliated University
• (University Partners)
• Background Invention vs. CRADA subject Invention
• Clinical Investigator PI
• Collaborator Sponsor

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Article 2 Definitions

• CRADA Data
• Dual Appointment Personnel
• Protocol and Statement of Work

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Article 2 Definitions

• Raw Data
• VA Employee(s)
• without compensation (WOCs)
• intergovernmental personnel agreement
  (IPAs)

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Article 5. Inventions and Intellectual Property

• 5.1 Ownership of CRADA Subject Inventions VA
  RETAINS OWNERSHIP
• 5.2 Reporting VA and Collaborator invention
  disclosure obligations.

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Article 6. Licensing

• 6.2 Collaborators License Option to CRADA
  Subject Inventions
• VA will grant to Collaborator a nonexclusive
  royalty free license.
• NERF available only for CT CRADAs

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Article 6. Licensing

• Rationale for the NERF
• Protects collaborators rights to use background
  intellectual property
• Grants collaborator license to use new
  intellectual property
• Does not affect ownership under language of the
  CT-CRADA

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Article 6. Licensing

• 6.3 VA also grants the Collaborator an option
  to elect an exclusive or partially exclusive
  commercialization license on any CRADA Subject
  Invention
• License will comply with Federal requirements

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Article 7. Ownership and Rights of Access to Data
and Publication

• 7.1 Ownership of Data and Records
• 7.2 Right of Access to CRADA Data and CRADA
  Materials
• 7.4 Presentations and Publications

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Article 8. Confidentiality

• 8.1 Confidential Information
• 8.2 Protection of Confidential Information
• 8.3 Disclosure of Confidential Information
• 8.4 Duration of Confidentiality Obligation

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Article 12. Liability

• 12.1 Collaborators Indemnification and
  Liability
• 12.2 VAs Indemnity and Liability

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Whats negotiable?

• Refer to CT-CRADA Guidelines
• Use RCs to guide determination as to whether
  negotiated changes are substantive
• Substantive changes must be cleared by TTP

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What if there are substantive changes to the
model CT CRADA?

• RC will forward those clauses to TTP for review
  and approval with a cc to the NPC.

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Steps after RC Review

• PI signs acknowledgement
• All parties sign CRADA
• Collaborator
• NPC
• Medical Center Director (last to sign)
• Disseminate originals to all parties and provide
  a copy to PI and RC.

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How are Foreign Partners/Sponsors handled under
CT CRADAs?

• CRADAs involving foreign partners have
  additional requirements.
• Prior to entering such negotiations please call
  TTP office to discuss these additional
  requirements.

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Other Resources

• CT CRADA Registry
• Registration is mandatory
• (AO or NPC)
• Consists of an Excel spreadsheet listing all past
  and current CT CRADAs updated weekly
• Complete as much as possible as soon as
  negotiations are initiated

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Other Resources

• Future of the Registry online
• submission of CT CRADAs
• Body of the CRADA and Appendix C will be
  available to VHA and RCs under password
  protection.

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Where to go for help?

• Technology Transfer Website
• www.research.va.gov/
• programs/tech_transfer/
• Technology Transfer Program
• Regional Counsels
• NPC Executive Directors

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Questions

• I would like to confirm my understanding that
  the review by the Regional Counsel and the TTP,
  if necessary, will be completed in the 30 day
  time frame?

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Questions

• Currently our clinical trial agreements
  reference the protocol and usually consider it
  one of the appendices but the actual protocol
  remains with the clinical trial investigator.
• What is VA thinking about the Statement of Work
  (SOW)?

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CTAA Amendment Guidelines

• CTAAs
• Clearly identify the relationship between VA and
  University Partners
• Establish joint ownership of potential
  intellectual property between VA and Universities
• Allowed universities to take the lead with
  respect to developing, marketing and promoting
  intellectual property

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CTAA Amendment Guidelines

• Amending the CTAAs
• Still establish relationship between VA and
  University Partners
• CRADA terms require VA to take the lead regarding
  intellectual property development

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CTAA Amendment Guidelines

• VA looks to amend existing CTAAs to ensure VA
  takes the lead for CRADAs
• No change in ownership of potential intellectual
  property
• VA and University Partners retain undivided
  interests in the intellectual property

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CTAA Amendment GuidelinesNegotiating the
Amendments

• Field partners (VHA, NPCs, OGC) should take the
  lead
• Negotiations are best initiated locally with TTP
  as backup
• VAMC negotiators notify TTP when negotiations
  begin with a particular University Partner
• Dont wait time is of the essence

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CTAA Amendment GuidelinesNegotiating the
Amendments

• Negotiation a suggested approach
• Determine what is important to the University
• Begin negotiation with the position that VA will
  take the lead (patenting, marketing, licensing
  and commercialization) in all research subject to
  CRADAs (Clinical Trials and otherwise)

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CTAA Amendment GuidelinesNegotiating the
Amendments

• Recall the language from Santa Monica
• Where the VA enters into a CRADA under the
  FTTA, then VA undertakes to file such patent
  applications and/or market and license the
  Subject Invention as it deems appropriate.

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CTAA Amendment GuidelinesNegotiating the
Amendments

• In that event, what otherwise would have been
  UNIVERSITYs financial and other rights and
  obligations to VA under this Agreement, with
  respect to such a Subject Invention, thereafter
  shall become VAs rights and obligations to
  UNIVERSITY.
• Amendments must be signed by the original
  signatories or their successors.

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CTAA Amendment GuidelinesNegotiating the
Amendments

• Should the UNIVERSITY fail to agree to the above
  clause, then propose the following alternative
  clause
• Where the VA enters into a phase II, III or IV
  clinical trial CRADA, then VA undertakes to file
  such patent applications and/or market and
  license the Subject Invention as it deems
  appropriate.

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CTAA Amendment GuidelinesNegotiating the
Amendments

• In that event, what otherwise would have been
  UNIVERSITYs financial and other rights and
  obligations to VA under this Agreement, with
  respect to such a Subject Invention, thereafter
  shall become VAs rights and obligations to
  UNIVERSITY.

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CTAA Amendment GuidelinesNegotiating the
Amendments

• The Options in Order of Preference
• 1)University allows VA to take the lead for all
  CRADAs
• 2)University agrees to VA taking the lead on
  phase II-IV Clinical Trials
• 3)University agrees to VA taking the lead in
  Phase III and IV clinical trials
• 4)University reviews on a case by case basis

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Implementation PlanVAs Model Clinical
Trial-Cooperative Research and Development
Agreement

• How do we implement the CT CRADA?
• Implementation Date March 15, 2006 - with the
  following guidance and exceptions
• All existing executed CRAs are grandfathered
• A CRA may be used for any studies for which
  negotiations were initiated before March 15, 2006

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Implementation PlanVAs Model Clinical
Trial-Cooperative Research and Development
Agreement

• If PI/Co-PI are not Dual Appointment Personnel
  (DAP), CT CRADA used for all clinical trials
  where negotiations start on or after March 15,
  2006

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Implementation PlanVAs Model Clinical
Trial-Cooperative Research and Development
Agreement
New clinical trials - PI is a DAP - negotiations
are initiated after March 15, 2006, CT CRADA used
as soon as A or B is satisfied A. Where there
is a CTAA The CTAA allows - or has been amended
to allow - VA to take the lead on intellectual
property developed under a CT CRADA.
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Implementation PlanVAs Model Clinical
Trial-Cooperative Research and Development
Agreement
B. Where there is no CTAA or where the CTAA has
not been amended A process has been worked out
between VA and the university for a case-by-case
review of CT CRADAs allowing VA to take the lead
in any intellectual property developed. A or B
above must be in place no later than June 1,
2006. If not, TTP may provide the site with a
waiver to continue to use CRAs past June 1,
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Talking PointsIntroducing the Model CT-CRADAs to
Stakeholders

• Advantages of CRADAs
• Protect background inventions, trade secrets and
  confidential information
• Offer access to VA research resources including
  personnel, services and property
• Establish intellectual property ownership and
  licensing options in advance of an invention

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CT CRADA

• Present CRADAs positively
• Track interactions
• Complete a short evaluation

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Questions

• If we dont have a CTAA, should we remove that
  paragraph from the CT-CRADA?

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Questions

• I was advised by one of the OGC Corporation
  Panel Attorneys not to sign the clinical trial
  agreement until the protocol had received IRB
  approval some NPCs do like me and wait until the
  IRB has approved the protocol whereas other NPCs
  have had a practice of signing as soon as a final
  draft has been negotiated and approved regardless
  of the status of the IRB approval.
• Is there any guidance as to the timing of
  signing the CT CRADAs?

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Questions

• Are we going to have to insist on the VAMC
  Director being the last signatory with the
  sponsors?

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Questions

• Article 3.1 Please explain the reasoning behind
  the last sentence in this paragraph?
• 3.1 Any Collaborator employee(s) who will work
  at VA facilities shall be required to have a
  Without Compensation Appointment.

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Questions

• 3.6 Human Subject Protection. We should be
  allowed to delete this paragraph if no human
  subjects are involved?

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Questions

• Appendix B. How detailed do we need to be about
  VA contributions?
• Would the lab space, admin support, IRB review,
  etc. need to be listed?
• What about the NPC contributions?

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Take Away Points!

• Familiarize yourself with the CT CRADA and CT
  CRADA Guidelines
• Review the CRADA web site
• Resolve the DAP University/CTAA issues

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Take Away Points!

• Start using the CT CRADA in accordance with the
  implementation plan
• VA Research Office or NPC must register CRADAs
  when negotiations are initiated
• Request VISN training and watch for additional
  training opportunities

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Questions

• Contact or Email
• Donald.Charapich_at_va.gov
• 202-273-8610