1. Research Agreements Jeff Cheek – Sponsored Programs & Regulatory Compliance Services

2. Guiding Principles 1. Facilitate the research enterprise 2. Protect the interests of the University, individual faculty and students 3.Abide by University policy, state and federal regulations and laws 4.Keep all parties informed of status (RADAR Progress Journal)

3. Sponsor Categories Federal Government e.g., National Science Foundation Quasi Governmental Entities e.g., Oak Ridge National Laboratory State Government e.g., NC Department of Transportation Private –Companies like DuPont, CREE Research, or Battelle –Foundations like Morris Animal Foundation

4. Federal Government Award Types (Direct Sponsorship or Flow-through) Assistance Awards = Public Purpose (fundamental research) -Grants -Cooperative Agreements Operational Requirements = Government Purpose (e.g., study effects of sonar on marine mammals) -Contracts -Purchase Orders

5. Grants are assistance awards. Generally some flexibility in scope of work; spending and outcomes are unknown. A deliverable is not always specified other than routine and final reports. If federal, OMB A-110 and A-21 apply for now (new omnicircular effective 12/26/2014). A cooperative agreement is an award of financial assistance that is used to enter into the same kind of relationship as a grant; and is distinguished from a grant in that it provides for substantial involvement between the sponsor and the recipient in carrying out the activity contemplated by the award. Grants & Cooperative Agreements

6. What is a Contract? A contract is a legally enforceable agreement between two or more parties with mutual obligations. An offer is made and accepted, and each party benefits. Prime contract (the contract between the government and its contractors) is subject to the federal law; i.e., the Federal Acquisition Regulations (FAR) Industry contracts that are flow through are also governed by FAR. Other industry contracts are governed by other laws and codes, e.g. Uniform Commercial Code (UCC).

7. What is a Gift? A Gift is a “non-reciprocal transfer with no implicit or explicit statement of exchange, procurement of services or provision of exclusive information” There is no Quid Pro Quo and benefits would accrue to the general public. The Gift’s purpose or use may be restricted or unrestricted.

8. Agreement Types → Issues & Concerns ↓ Memorandum of Agreement (MOA) Development Work Order (DWO) Sponsored Project Agreement (SPA) Bilaterally negotiated Contract (Sponsor's template) Clinical Trial for VetMed Clinical Sciences Charitable Contribution or Gift (via NCSU Foundations) Intellectual Property Terms NCSU ownership, sponsor option to negotiate royalty- bearing license Undefined, Defaults to US Patent Law, No IP Generated NCSU ownership, sponsor option to negotiate royalty- bearing license Sponsor Owned if Derived from Sponsor's Protocol 1 None (NCSU Owns) Publication Terms NCSU Retains Full Publication Rights (No Review) NCSU Retains Full Publication Rights (No Review) NCSU Retains Full Publication Rights (With Review) NCSU Retains Full Publication Rights 2 Single-Site Study - yes; Multi-Site Study - with some delays None (No Restrictions) Scope of Work Detailed/Well Defined Deliverable Description of Project Detailed SOW with specific timelines and deliverables Detailed/Well Defined Deliverable None (PI Conducts “Dept. Research" per A-21) Maximum Deliverable Final Technical Report Specified Technical Reports Specified deliverables Case Reports None-Gift Acknowledgement Only Typical Payment Mechanism Advance Payment Cost Reimburseable, Fixed Priced Cost Reimburseable Cost Reimbursable Advance Payment Documentation NCSU Standard MOA with no changes NCSU Standard DWO NCSU Sponsored Project Agreement (SPA) Legally binding contract (std. and negotiated clauses) NCSU Standard Clinical Trial Agreement Company Letter Stating Gift or Charitable Contribution Funding Restriction $25,000 per company, per PI None Min/Max Number of Subjects None F&A 15% of Total Award NCSU Federally Negotiated Rate* 28% of Total Award None (1) If not sponsor owned, then NCSU owns; sponsor has option to negotiate royalty-bearing license (2) if applicable, with removal of defined Confidential Information and/or negotiated delay for protection of patent rights (*) Rate determined based on activity, i.e., Research (51.5% on campus, 26.9% adjacent to campus, 26% off campus); Instruction (52% on campus, 26% off campus); Other Sponsored Activities (33.6% on campus, 20% off campus) Mechanisms for Industry and Private Sponsor Funded Research

9. Pre-Proposal Review Does a Proposal need a SPARCS Review? A PINS record is critical! –Some Solicitations include terms and conditions (T&C) –Must be reviewed by SPARCS prior to proposal submission –If no exceptions are given, the Sponsor assumes its T&Cs are acceptable SPARCS Needs Your Help!

10. Award T&C Terms and Conditions –Define business relationship between Sponsor and University –Time of performance and consideration –Clarify each party’s obligations & rights –How to handle changes and unexpected situations –Assign risk or liability to parties

11. Problematic T&C Publication –Retain right to publish and disseminate results –Acceptable alternative Sponsor’s prior “review & comment” rather than “review and consent ”

12. Problematic T&C Intellectual Property (IP) –Patents, copyrights, trademarks, trade secrets –Must retain ownership to any IP developed under sponsored project –“Work-for-hire” agreements require results to be owned by Sponsor

13. Award Review Process Award document reviewed in detail Identify terms that are problematic Risk Assessment (prioritize high/low risk) Prepare a letter of exception or “red- line” Sponsor’s agreement Record status in the RADAR Progress Journal

14. When the Agreement Arrives… If milestone payment method is used, is the schedule reasonable? Can I meet the reporting requirements? Is it cost reimbursable or fixed price? What about unexpended funds at close of the project? Who owns any equipment purchased? Do the Intellectual Property terms fit my project?

15. Arrives con’t… Do I need to have any publication reviewed (not approved) by the sponsor? Are there any confidentiality requirements? Are there any spending restrictions? Can I re-budget or do I need approval? The Scope of Work is generally fixed and firm, so is there any flexibility in the work plan? Do I need approval if I modify scope or method? Is the sponsor offering direct payment of travel? If so, NC State personnel could end up with additional personal liability.

16. Best Practices Review the terms carefully: discuss with your CRO and/or Dept. Administrator before the project begins. If it is a contract, it is not a grant or a gift. Make note of special conditions. Submit reports exactly as committed in the contract, these are deliverables! Follow agreed upon timelines and methodology. …or request IN WRITING a change in scope, timelines or reporting.

17. More Best Practices Do not charge expenses to the project unless they directly relate to the contracted work. If the company has title to the equipment, don’t use any NC State funds to purchase it. If you have an MTA, be sure to understand the conditions imposed. Closely monitor subawards. New OMB omnicircular imposes much stricter requirements on risk assessment prior to issuance and subrecipient monitoring. Remember that while verbal agreements may constitute a contract, they are nearly impossible to prove.

18. Questions? SPARCS Website Policies & Forms SPARCS Website SPARCS Office Contacts SPARCS Phone - 515.2444 Jeffrey M. Cheek jeff_cheek@ncsu.edu 513.2148