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

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

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

Winter 2008 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.   Technology Transfer

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

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

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

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

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

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

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

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

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

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

Where to find the new CRADA models Winter 2008 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”. Technology Transfer

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

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

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

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

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

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

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

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

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

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

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

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

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

Contact Information and Resources Winter 2008 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@va.gov (202) 254-0224 Jeffrey.Moore@va.gov (202) 701-7628 Saleem.Sheredos@va.gov (410) 302-0989 Kris.Burton@va.gov (202) 254-0256 Ken.Levin@va.gov (202) 254-0256 VA OGC Group III Renee.Szybala@va.gov (202) 273-6334 Jane.Gutcher@va.gov (202) 273-6348 Technology Transfer