OSP Contracts Update Research Administrators Forum AUGUST 23

OSP Contracts Update Research Administrators’ Forum AUGUST 23, 2017

Today’s Contracts Team Topics • Non-Funded Agreement (NFA) Process – Brief Retrospective • NFAs by the Numbers • NFA Form v. 2. 0 & beyond (e. NFA!!) • Streamlining Negotiations – recent efforts

Non-Funded Agreements (NFAs) Types v Academic Program Agreement v Material Transfer Agreement (MTA) - Incoming, Outgoing v Collaboration Agreement v Non-Disclosure Agreement (NDA)/Confidential Disclosure Agreement (CDA) v Data Use Agreement (DUA) - Incoming, Outgoing v Memorandum of Understanding (MOU) v Data Security Plan Agreement v License Agreement v Teaming Agreement (TA) v Loan Agreement v Other (Expanded Access Use Agreement, Data Security Plan Agreement, etc. )

Previous NFA “Process” v Different forms for different NFA types. v Emails functioned as NFA requests. v No standard approval process for non-SOM NFAs. v No tracking during negotiation. v No central repository accessible to the PI/Department.

NFAs by the Numbers …. (that we never had before)

Transition of NFAs into Research. UVA v Transition • All Major Research-Intensive Schools – January 25, 2017 – March 31, 2017 v Partial Fiscal Year Comparison School of Medicine Only Fiscal Year 2016 January 25, 2017 – May 11, 2017 (~3 months) Type Total % Extrapolated to Full Year MTA 550 67% MTA 109* 57% 436* CDA 268 33% CDA 84 43% 336 Total 818 --- Total 193* --- 772* *Excludes ~60 MTAs (Addgene & MTAs In Process at time of Transition/not in Research. UVA)

NFAs: January 25 – May 11, 2017 NFA Type Total by Type % of Total CDA 101 31. 1% MTA, Incoming* 95 29. 2% MOU 42 12. 9% MTA, Outgoing 25 7. 7% DUA, Incoming 23 7. 1% DUA, Outgoing 13 4. 0% Collaboration Agreement 11 3. 4% License Agreement 4 1. 2% Teaming Agreement 4 1. 2% Loan Agreement 2 0. 6% Investigator Initiated Research Agreement 2 0. 6% Expanded Access Use Agreement 1 0. 3% Training Program Agreement 1 0. 3% Academic Program Agreement 1 0. 3% 325 100. 0% Grand Total *Excludes ~60 MTAs (Addgene & MTAs In Process at time of Transition/not in Research. UVA)

NFAs: January 25 – May 11, 2017 School/Center Total by School/Center % of Total SOM* 231 71. 1% Curry School 51 15. 7% SEAS 17 5. 2% School of Arts and Sciences 11 3. 4% Applied Research Institute 9 2. 8% School of Nursing 2 0. 6% College at Wise 2 0. 6% VP for Research 1 0. 3% Frank Batten School 1 0. 3% 325 100. 0% Grand Total *Excludes ~60 MTAs (Addgene & MTAs In Process at time of Transition/not in Research. UVA)

NFAs: January 25 – May 11, 2017 Entity Type Total by Entity Type % of Total Industry 117 36. 0% University/Institution 78 24. 0% Other 44 13. 5% Foundation 40 12. 3% Foreign/International 31 9. 5% Federal 13 4. 0% State 2 0. 6% 325 100. 0% Grand Total* *Excludes ~60 MTAs (Addgene & MTAs In Process at time of Transition/not in Research. UVA)

NFA Form – Version 2. 0 Feedback (sample) Version 2. 0 Submission Instructions Varied (in reality) Updated Instructions in Form Header Electronic Signature Click Feature Missing Electronic Signature Feature Added Question Interpretation by Users Reworded for Clarification Outside PI Information – No Entry Added Outside PI Field UVa PI Information Not Prominent Moved to 1 st Page Incomplete Forms Check Offs Right Justified Smart Format Misinterpreted Grayed Out vs. Highlighted Text Box Additional Information Notes Section Added Addgene MTAs – Form Too Complex Addgene NFA Types ‘Smart Form’

e. NFA (!!!) • Model the e. PRF • Asking questions specifically related to previous data entered & lead through the process • Pulling information from other sources, if possible • Helpful hover instructions • Timing …. Contracts Team is mapping, creating decision trees & acceptance criteria – for 15 different types of NFAs

Streamlining Negotiations v Accelerated Clinical Trial Agreement (ACTA) v Accelerated Confidential Disclosure Agreement (ACDA) v Uniform Biological Material Transfer Agreement (UBMTA) v Revised UVA Confidential Disclosure Agreement (CDA) Templates – bilateral & unilateral v Revised UVA Research Funding Agreement (RFA) Template – underway v More to come … including revised UVA Material Transfer Agreement template, Data Use Templates, Collaboration Templates, etc.

Thank you! It takes all of us. “The way a team plays as a whole determines its success. You may have the greatest bunch of individual stars in the world, but if they don't play together, the club won't be worth a dime. ” –Babe Ruth