Technology Transfer and CRADAs Technology Transfer and CRADAs

Office of Research and DevelopmentOffice of Research and DevelopmentDepartment of Veterans AffairsDepartment of Veterans Affairs

Jeff Moore Jeff Moore

Technology Transfer Program, ORDTechnology Transfer Program, ORD

Local Accountability TrainingLocal Accountability Training

ChicagoChicago

What is Technology Transfer?What is Technology Transfer?- The process of converting scientific findings from The process of converting scientific findings from

research laboratories into useful products by the research laboratories into useful products by the commercial sector.commercial sector.

- Can involve Can involve

Federal LabsFederal Labs

IndustryIndustry

UniversityUniversity

Federal, state, and local governmentsFederal, state, and local governments

- - Industry is encouraged to develop that Industry is encouraged to develop that technology via new products, processes, or technology via new products, processes, or materials.materials.

Who has a duty to disclose an Invention?Who has a duty to disclose an Invention?

-- VA salaried employeeVA salaried employee

-- Without Compensation (WOC) employee Without Compensation (WOC) employee who has signed a WOC IP (intellectual who has signed a WOC IP (intellectual property) agreementproperty) agreement

-- IPA (Intergovernmental Personnel Act) IPA (Intergovernmental Personnel Act) EmployeeEmployee

Disclosure ProcessDisclosure Process-- Go to the VA TTP website (Reporting of Invention Go to the VA TTP website (Reporting of Invention

button): button): www.research.va.gov/programs/tech_transfer/

-- Inventor fills out the Certification and Invention Inventor fills out the Certification and Invention Disclosure form.Disclosure form.

- Attain proper signatures i.e., immediate supervisor and - Attain proper signatures i.e., immediate supervisor and ACOS.ACOS.

-- Prepare a memo to the Director of TTP through the Prepare a memo to the Director of TTP through the Director of the medical center.Director of the medical center.

What does TTP do with the disclosure?What does TTP do with the disclosure?

-- Review disclosure for scientific/patentability and Review disclosure for scientific/patentability and for contribution VA made to invention.for contribution VA made to invention.

-- TTP provides a recommendation to OGC TTP provides a recommendation to OGC - retain rights.- retain rights.

- VA leaves right, title & interest to the - VA leaves right, title & interest to the invention with the inventor. invention with the inventor. - VA leaves entire right, title, & interest to - VA leaves entire right, title, & interest to

the invention with the inventor subject to the invention with the inventor subject to the VA retaining a non-exclusive, govt.the VA retaining a non-exclusive, govt.

use license.use license.

-- OGC issues determination of rights (DOR).OGC issues determination of rights (DOR).

What if TTP asserts ownership?What if TTP asserts ownership?

-- Invention is managed pursuant to the Invention is managed pursuant to the Cooperative Technology Administration Cooperative Technology Administration Agreement (CTAA).Agreement (CTAA).

oror

-- If VA owns solely VA Technology Transfer If VA owns solely VA Technology Transfer Program patents, markets, and looks for Program patents, markets, and looks for potential licensees. potential licensees.

LicensesLicenses-- Central office (TTP) negotiates LicensesCentral office (TTP) negotiates Licenses CRADAs CRADAs

and Licenses should not be confusedand Licenses should not be confused

-- A license is a contract between licensor (e.g., VA A license is a contract between licensor (e.g., VA holder of the patent) and a licensee (e.g., an holder of the patent) and a licensee (e.g., an industry partner) which gives the licensee certain industry partner) which gives the licensee certain rightsrights

-- Per Federal statue (37 CFR 404) terms below must Per Federal statue (37 CFR 404) terms below must be in a Federal licensebe in a Federal license

development or marketing plandevelopment or marketing plancompany agrees to commercialize in a set company agrees to commercialize in a set

time periodtime periodreports on effortsreports on efforts

VA TTP Royalty BreakdownVA TTP Royalty BreakdownVA 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

Introduction to CRADAsIntroduction to CRADAsWhat is a Cooperative Research and Development What is a Cooperative Research and Development

Agreement (CRADA)?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 Purpose is to foster federal/private collaborations to bring new technology to the marketplace.new technology to the marketplace.

• Government owns the invention rights of government Government owns the invention rights of government employees made during work hours, using government employees made during work hours, using government resources or that bear a direct relation to the official duties resources or that bear a direct relation to the official duties of the inventor (Executive Order 10096).of the inventor (Executive Order 10096).

Introduction to CRADAs (cont’)Introduction to CRADAs (cont’)• Government may provide personnel, services, facilities, Government may provide personnel, services, facilities,

equipment, intellectual property, and other resources, equipment, intellectual property, and other resources, but not but not funds.funds.

• Non-federal party may provide Non-federal party may provide fundsfunds, personnel, services, , personnel, services, facilities, equipment, intellectual property, or other resources. facilities, equipment, intellectual property, or other resources.

• Allows government to negotiate licensing agreements and may Allows government to negotiate licensing agreements and may agree to grant in advanceagree to grant in advance:

- Exclusive patent licenses; or

- Non-exclusive patent licenses; or

- Assignments; or

- Options to CRADA subject inventions

Introduction to CRADAs (cont’) Introduction to CRADAs (cont’) Protections to CollaboratorsProtections to Collaborators

• Protect background inventions, trade secrets and Protect background inventions, trade secrets and confidential information.confidential information.

• Establish intellectual property ownership and Establish intellectual property ownership and licensing options in advance of an invention.licensing options in advance of an invention.

• Ensure enforceable terms.Ensure enforceable terms.

• Government-wide, readily understood and Government-wide, readily understood and accepted mechanism for establishing collaborative accepted mechanism for establishing collaborative relationshipsrelationships . .

Introduction to CRADAs (cont’)Introduction to CRADAs (cont’)VA requirementsVA requirements

• Agency must review for conflicts of interest.Agency must review for conflicts of interest.

• For CRADAs with foreign companies, agency For CRADAs with foreign companies, agency must “consult” with US Trade Representative.must “consult” with US Trade Representative.

• Must be reviewed and signed by the federal Must be reviewed and signed by the federal laboratory director – VA Medical Center Director.laboratory director – VA Medical Center Director.

• Consists of CRADA, Statement of Work (SOW), Consists of CRADA, Statement of Work (SOW), Budget, and Appendix C.Budget, and Appendix C.

The New VA CRADA modelsThe New VA CRADA models

VA listened to the VA research field and sponsors.VA listened to the VA research field and sponsors.• shorter (15 pages or less)shorter (15 pages or less)• easier to readeasier to read• streamlined definitions and languagestreamlined definitions and language• better organizedbetter organized• reflects more flexible interpretation of the law reflects more flexible interpretation of the law

by OGCby OGC

New VA CRADA Models (cont’)New VA CRADA Models (cont’)

• Clinical Trial Phase I & II CRADA Clinical Trial Phase I & II CRADA • Clinical Trial Phase III & IV CRADAClinical Trial Phase III & IV CRADA• Clinical Trial Investigational Device CRADA Clinical Trial Investigational Device CRADA • Material Transfer CRADA Material Transfer CRADA • Basic CRADABasic CRADA

• In development:In development:Principal Investigator Initiated Clinical Study Principal Investigator Initiated Clinical Study CRADACRADA

Where to find the new CRADA Where to find the new CRADA modelsmodels

VA VA intranetintranet website website

http://vaww.research.va.gov/programs/tech_http://vaww.research.va.gov/programs/tech_transfer/model_agreements/default.cfmtransfer/model_agreements/default.cfm

Or go to the TTP CRADA model page and Or go to the TTP CRADA model page and replace the first “w” with “va”.replace the first “w” with “va”.

When to use the CT CRADA for When to use the CT CRADA for Phase I & II and Phase III & IV Phase I & II and Phase III & IV

clinical trials?clinical trials?

When the collaborator:When the collaborator:

1.1. Owns the investigational new drug (IND); Owns the investigational new drug (IND);

2.2. Designs the protocol; and Designs the protocol; and

3.3. Funds the project.Funds the project.

When to use the Investigational When to use the Investigational Device CT CRADA.Device CT CRADA.

When to use the Investigational Device CT CRADA When to use the Investigational Device CT CRADA CRADA:CRADA:

1.1. When the research involves a collaborative When the research involves a collaborative research, development, engineering, testing or research, development, engineering, testing or evaluation studies involving devices. evaluation studies involving devices.

2.2. Maybe PI initiated or not.Maybe PI initiated or not.

Basic Research CRADABasic Research CRADA

When to use the Basic Research CRADA:When to use the Basic Research CRADA:

1.1. Used only for collaborative research, development, Used only for collaborative research, development, engineering, testing or evaluation studies.engineering, testing or evaluation studies.

2.2. VA investigator designs or contributes substantively VA investigator designs or contributes substantively to the design of the statement of work.to the design of the statement of work.

3.3. Study does not involve human subjects VA. Study does not involve human subjects VA.

MT CRADAMT CRADA

When to use the MT CRADA:When to use the MT CRADA:

1.1. VA is the recipient of a material and the company VA is the recipient of a material and the company would like the right to license any improvement or would like the right to license any improvement or intellectual property (IP) that stems from the intellectual property (IP) that stems from the research.research.

2.2. If IP is not an issue please use the basic MTA.If IP is not an issue please use the basic MTA.

VA CRADAVA CRADACommon Provisions ThroughoutCommon Provisions Throughout

Article 2: DefinitionsArticle 2: Definitions

• Background Invention Background Invention • CRADA Subject InventionCRADA Subject Invention• CRADA Data CRADA Data • Clinical Investigator = PIClinical Investigator = PI• Statement of Work (maybe protocol)Statement of Work (maybe protocol)

VA CRADA (cont’)VA CRADA (cont’)Article 5. Inventions and Intellectual PropertyArticle 5. Inventions and Intellectual Property

5.2 Ownership of CRADA Subject Inventions – VA Retains 5.2 Ownership of CRADA Subject Inventions – VA Retains Ownership.Ownership.

5.3 Reporting – VA and Collaborator invention disclosure 5.3 Reporting – VA and Collaborator invention disclosure obligations.obligations.

Article 6. Licensing continuedArticle 6. Licensing continued

6.1 License Options. VA grants to Collaborator an option to elect 6.1 License Options. VA grants to Collaborator an option to elect a nonexclusive, partially exclusive or exclusive license on any a nonexclusive, partially exclusive or exclusive license on any CRADA Subject Invention made solely by VA Employee(s) or CRADA Subject Invention made solely by VA Employee(s) or made jointly by VA and Collaborator employees. made jointly by VA and Collaborator employees.

* * In the CT III & IV CRADA a nonexclusive license is granted up frontIn the CT III & IV CRADA a nonexclusive license is granted up front

VA CRADA (cont’)VA CRADA (cont’)

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

7.1 Case Report Forms and Records 7.1 Case Report Forms and Records For CT CRADAs.For CT CRADAs.

7.2 CRADA Data and CRADA Materials.7.2 CRADA Data and CRADA Materials.

7.3 Presentations and Publications. 7.3 Presentations and Publications.

VA CRADA (cont’)VA CRADA (cont’)

Article 8. ConfidentialityArticle 8. Confidentiality

8.1 Confidential Information. 8.1 Confidential Information.

8.2 Disclosure of Confidential Information. 8.2 Disclosure of Confidential Information.

8.3 Duration of Confidential Information.8.3 Duration of Confidential Information.

VA CRADA (cont’)VA CRADA (cont’)

Article 12. LiabilityArticle 12. Liability

12.112.1 Collaborator’s Indemnification and Liability Collaborator’s Indemnification and Liability

12.212.2 VA’s Indemnity and Liability VA’s Indemnity and Liability

VA CRADA OptionsVA CRADA Options• Single-study CRADASingle-study CRADA

Negotiated for a single study at a single site; signed Negotiated for a single study at a single site; signed locally.locally.

Over time, single-study CRADAs may become Over time, single-study CRADAs may become de factode facto templates.templates.

• Master/template CRADAMaster/template CRADA- negotiations are in process with major pharmaceuticals - negotiations are in process with major pharmaceuticals companies.companies.

- Could apply to all Phase I & II or III & IV clinical trials - Could apply to all Phase I & II or III & IV clinical trials with a specific sponsor.with a specific sponsor.- Only variables are the Statement of Work (may be the - Only variables are the Statement of Work (may be the protocol) and budget.protocol) and budget.

Process for negotiating CRADAsProcess for negotiating CRADAs

Follow the SOPs that are on the TTP website for Follow the SOPs that are on the TTP website for the specific CRADA.the specific CRADA.

Who is involved:Who is involved:• Principal Investigator (PI) Principal Investigator (PI) • VA Medical Center (VAMC) R&D OfficeVA Medical Center (VAMC) R&D Office• VA Nonprofit Research Corporation (NPC)VA Nonprofit Research Corporation (NPC)• VA Regional Counsel (RC)VA Regional Counsel (RC)• TTP if it is a Basic CRADA TTP if it is a Basic CRADA

The Role of the NPC in CRADAsThe Role of the NPC in CRADAs

• PI and NPC jointly negotiate CRADA.PI and NPC jointly negotiate CRADA.• PI and NPC jointly negotiate budget.PI and NPC jointly negotiate budget.• NPC coordinates VA approvals (R&D NPC coordinates VA approvals (R&D

Committee, IRB, RC, MCD, etc.).Committee, IRB, RC, MCD, etc.).• NPC administers the study and funds.NPC administers the study and funds.• NPC manages receipts and expenditures.NPC manages receipts and expenditures.

• Contact NPC personnel for assistance in Contact NPC personnel for assistance in identifying PIs and assessing potential VAMC identifying PIs and assessing potential VAMC subject pool.subject pool.

VA CRADAVA CRADA

Closing the DealClosing the Deal

• Agency review within 15 to 30 days if needed.Agency review within 15 to 30 days if needed.• PI signs acknowledgement.PI signs acknowledgement.• Parties sign CRADA.Parties sign CRADA.

- Collaborator- Collaborator- NPC- NPC- Medical Center Director (last to sign)- Medical Center Director (last to sign)

• Disseminate originals to all parties and provide a Disseminate originals to all parties and provide a copy to PI.copy to PI.

• Send a copy to TTP to enter into the CRADA Send a copy to TTP to enter into the CRADA RegistryRegistry

Contact Information and ResourcesContact Information and ResourcesQuestions about Technology Transfer or CRADAs:

TTP Websitehttp://www.research.va.gov/programs/tech_transfer/default.cfm

CRADA Registryhttp://www.research.va.gov/programs/tech_transfer/crada/registry.cfm

VA Technology Transfer ProgramAmy.Centanni@va.gov (202) 254-0224Jeffrey.Moore@va.gov (202) 701-7628

Saleem.Sheredos@va.gov (410) 302-0989Kris.Burton@va.gov (202) 254-0256Ken.Levin@va.gov (202) 254-0256

VA OGC Group IIIRenee.Szybala@va.gov (202) 273-6334Jane.Gutcher@va.gov (202) 273-6348