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 (eNFA!!) Streamlining Negotiations – recent efforts

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

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

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

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

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 Loan Agreement 2 0.6% Investigator Initiated Research Agreement Expanded Access Use Agreement 1 0.3% Training Program Agreement Academic Program Agreement Grand Total 325 100.0% *Excludes ~60 MTAs (Addgene & MTAs In Process at time of Transition/not in ResearchUVA)

Total by School/Center 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 VP for Research 1 0.3% Frank Batten School Grand Total 325 100.0% *Excludes ~60 MTAs (Addgene & MTAs In Process at time of Transition/not in ResearchUVA)

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% Grand Total* 325 100.0% *Excludes ~60 MTAs (Addgene & MTAs In Process at time of Transition/not in ResearchUVA)

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 1st Page Incomplete Forms Check Offs Right Justified Smart Form Format Misinterpreted Grayed Out vs. Highlighted Text Box Additional Information Notes Section Added Addgene MTAs – Form Too Complex Addgene NFA Types ‘Smart Form’

eNFA (!!!) Model the ePRF 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 Accelerated Clinical Trial Agreement (ACTA) Accelerated Confidential Disclosure Agreement (ACDA) Uniform Biological Material Transfer Agreement (UBMTA) Revised UVA Confidential Disclosure Agreement (CDA) Templates – bilateral & unilateral Revised UVA Research Funding Agreement (RFA) Template – underway 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