Cecile Del Rosario, ORTA Research Agreements Officer Naval Medical Center Portsmouth

 COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT (CRADA)  MEMORANDUM OF UNDERSTANDING/AGREEMENT (MOU/MOA)  EDUCATIONAL PARTNERSHIP AGREEMENT (EPA)  NON-DISCLOSURE AGREEMENTS  DATA SHARING AGREEMENTS

 A Cooperative Research and Development Agreement (CRADA) means any agreement between one or more federal laboratories and one or more non-federal parties under which the Government, through its laboratories, provides personnel, services, facilities, equipment, intellectual property, or other resources with or without reimbursement (but not funds to non-federal parties) and the non-federal parties provide funds, personnel, services, facilities, equipment, intellectual property or other resources toward the conduct of specified research or development efforts which are consistent with the missions of the laboratory…

It’s the LAW!!!  Federal Legislation (15 USC 3710 – 3716) Describes the general authority, enumerated authority and contract considerations for CRADAs and provides themes that should be covered  DoD Directive /DoD Instruction Implements policy, assigns responsibilities and prescribes procedures for implementation of Technology Transfer (T2) program  SECNAVINT Delegates CRADA authority to Navy laboratories by the Secretary of the Navy

 Access to outside expertise, facilities, equipment, personnel and/or services  Need for high quality, timely and integrated products  Both DoN and collaborator can leverage scarce funds, personnel and facilities  Solve technical and industrial problems that support the Warrior  Sustain a critical technology capability that would otherwise be lost or continue to erode

 Lasers  GPS  Light Sticks (developed by Naval Air Warfare Center Weapons Division (NAWCWD) China Lake  Enhanced digital image technology used to detect mines underwater, also used for early detection of breast cancer cells (developed by Naval Undersea Warfare Center (NUWC), Newport Division

 FULL CRADA (Standard/Non-Standard)  Collaboration between 2 or more parties  Defines topic of research  Involves a Statement of Work (SOW)  Funded or Not Funded by the outside party  Limited Purpose (LP) CRADA  Not a collaboration  Transfer of Equipment/Material or Information  No Statement of Work (SOW)

NMCP Universities Private Companies State & Local Gov’t Individuals Federal Agencies

EITHER The non-DoN collaborator provides funds Non-DoN Collaborator DoN Collaborator OR Each collaborator funds its own efforts

 Labor  Research personnel, e.g., nurse, assistant/coordinator  Travel  training  Materials  Supplies  Subject Remuneration  Per patient cost/visit  Start-up fee  CRADA fee - $1.5K  IRB fee - $2K

 Anti-Deficiency Act prohibits federal employees from  making or authorizing an expenditure from, or creating or authorizing an obligation under, any appropriation or fund in excess of the amount available in the appropriation or fund unless authorized by law. 31 U.S.C. § 1341(a)(1)(A)  involving the government in any obligation to pay money before funds have been appropriated for that purpose, unless otherwise allowed by law. 31 U.S.C. § 1341(a)(1)(B).

 Comptroller/ Budget  CID - Grants Manager  Studies with subject compensation  Subject’s information  Name, address and date completed visit/procedure  Study title and IRB approval date

 Foreign partners: Okay if allowed by their country  Seek permission from the Office of U.S. Trade Representative prior to start of negotiations  Some controlled materials or information may require an export control license

 Each collaborator owns background/pre- existing IP that it brings to the CRADA  IP developed under the CRADA is shared by both collaborators  Each collaborator granted non-exclusive license in shared data  Option available to receive an exclusive license for inventions made under a CRADA

 An information sheet  Names of collaborators  POCs  Third Party, if any  Objective of the collaborative effort  Benefit to the Navy  Funding Budget page/Schedule of Payment  Statement of Work  Research Protocol – IRBNet

 Article 2, Objective  Article 5, Funding  Article 6, Final Report  Article 7, Marking of Data  Appendix A, Statement of Work  Appendix D, Budget

CRADA No (ODURF) (UNC and OSU) PI Review UNC 14 – OSU Partner Legal Review –UNC 98 - OSU Negotiations to Approval *NMCP Legal Review11 *Comptroller Reviewn/a *NMRC IP Review45269 Signatures950 Processing Time in days Negotiations start immediately after partner’s legal review and ends upon all parties reaching an agreement. Processing time starts from receipt of information sheet to final signature. Some steps are not reflected in table, e.g., time it takes to develop a draft, and therefore Processing Time in days is not the sum of the numbers in the table.

ORTA prepares draft CRADA PI and Non-Navy Collaborator review draft PI and Non-Navy Collaborator completes information sheet ORTA prepares final document Lab Legal Team reviews ORTA sends CRADA to Non- Navy Collaborator for review and signature Lab CO signs the CRADA ORTA forwards signed CRADA to DON T2 PM DON T2 PM reviews CRADA package for completeness CRADA accepted and entered into DON DTTIS database

 An agreement between federal agencies  Sharing of resources  Describes tasks for each party  Funded or non-funded. If funded = ISSA (Inter-Service Support Agreement)

 BUMEDINST B Promotes sharing of health care and other resources and define management responsibilities and procedures for administering support agreements Program under Director of Resource Management

OT-244 (NMCP-NMCPHC) OT-255 (NMCP-NHB- MCRD) PI REVIEW 120 NMCP L EGAL REVIEW no data (NMCPH Legal Review) 317 (NHB Legal Review) 91 (MCRD L EGAL REVIEW ) BUMED REVIEW 4245 S IGNATURES P ROCESSING T IME IN CALENDAR DAYS

RAO prepares draft Principal investigators review draft RAO submits draft to MOU coordinator Legal Review at each command MOU coordinator sends to BUMED review MOU coordinator sends to collaborators for review and signature NMCP CO signs MOU coordinator notifies RAO of executed agreement

CRADA 1. Navy Collaborator and a Non-Navy Collaborator USC 3710a and SECNAVINST Good for three to five years MOU 1. Military to military or other federal agency 2. BUMEDINST a 3. Good for five years

CONTRACT: 1. Not a collaboration; a binding agreement to have work done for the Navy 2. Competitive – Request for Proposal (RFP) 3. Intellectual property: Contractor can elect to retain title to subject invention CRADA: 1. Collaboration between Navy and Civilian 2. Noncompetitive - work directly with non-federal lab to negotiate agreement 3. Intellectual Property: Title to subject invention depends on whomever the inventors are: company, government or jointly- owned

 10 USC 2194 (b)(5) Lab equipment loans Transfer of surplus property Lab personnel available to teach science course Involving faculty and students of the institution in defense lab research projects Cooperating with the institution in developing a program under which students may be given academic credit for work on defense lab research projects Providing academic and career advice and assistance to students of the institutions  Duty Under Instructions (DUINS) students

 Non-Disclosure Agreements or Confidentiality Disclosure Agreements  18 USC 1905 – Disclosure of Confidential Information  Protects proprietary data  Only CO may sign

 DSA is a legally binding agreement between a Federal agency and an external entity (e.g., contractor, private industry, academic institution, other Federal government agency, or state agency) that clearly documents what data are being shared and how the data can be used. DSAs ensure uses and disclosures of MHS data meet the requirements for both Federal laws and Department of Defense (DoD) regulations.

 TMA/BUMED required when  Sharing PHI/PII  Using the MHS system data  Usually requested by the Business Associate (BA)  TMA POC – Ms. Barbara Hazzard  Director, TMA Privacy Office is the final approval authority  DSAA approval occurs after CRADA and IRB approval

Plan ahead. They take a lot of time. QUESTIONS???