1. KEYS TO SUCCESS NCURA Region IV Spring Meeting April 27 – 30, 2014 © 2014 National Council of University Research Administrators National Council of University Research Administrators Keys to Success! NCURA Region IV Indianapolis, Indiana April 27 – 30, 2014 NCURA Region IV Spring Meeting April 27 – 30, 2014 KEYS TO SUCCESS © 2014 National Council of University Research Administrators Large Collaborative Proposal Development and Contract Negotiations

2. KEYS TO SUCCESS NCURA Region IV Spring Meeting April 27 – 30, 2014 © 2014 National Council of University Research Administrators National Council of University Research Administrators Keys to Success! NCURA Region IV Indianapolis, Indiana April 27 – 30, 2014 NCURA Region IV Spring Meeting April 27 – 30, 2014 KEYS TO SUCCESS © 2014 National Council of University Research Administrators Jean Mercer, Director of Grant Services, Indiana University Tammy Good, Assoc. Director of Grant Services, Indiana University

3. NCURA Region IV Spring Meeting April 27 – 30, 2014 NCRUA Region IV Spring @ 2014 National Council of University Research Administrators This Session: Interactive Dependent upon your participation and input Ask questions throughout/bring up new ideas and thoughts

4. NCURA Region IV Spring Meeting April 27 – 30, 2014 NCRUA Region IV Spring @ 2014 National Council of University Research Administrators Planets: Institution of Higher Education (Sunshine University) Foreign Institution of Higher Education (Blue Moon International University) Pharmaceutical Company (Constellation Pharma) Small Business-Faculty Startup (Solar Systems, LLC) Our Universe

5. NCURA Region IV Spring Meeting April 27 – 30, 2014 NCRUA Region IV Spring @ 2014 National Council of University Research Administrators Sunshine University: Develop Protocol; prepare and submit proposal Blue Moon International University: site in Uganda, where subjects are to be enrolled Constellation Pharma: provides the Phase III experimental drug and owns IP Solar Systems, LLC: drug delivery system (nasal spray) and owns IP. Roles

6. NCURA Region IV Spring Meeting April 27 – 30, 2014 NCRUA Region IV Spring @ 2014 National Council of University Research Administrators Mission: To submit an NIH proposal for a drug delivery system of an HIV drug

7. NCURA Region IV Spring Meeting April 27 – 30, 2014 NCRUA Region IV Spring @ 2014 National Council of University Research Administrators Group Breakout: Discuss the concerns that your entity will have regarding the proposal submission and any resultant award.

8. NCURA Region IV Spring Meeting April 27 – 30, 2014 NCRUA Region IV Spring @ 2014 National Council of University Research Administrators Concerns of Sunshine University 1.) Startup: COI for faculty, Intellectual Property, Subject Injury, Indemnification 2.) Foreign University: IRB approvals, proper accounting system, possible civil unrest, danger to personnel, foreign site completing the work 3.) Pharma: Intellectual Property, Publication Rights, Subject Injury, Indemnification

9. NCURA Region IV Spring Meeting April 27 – 30, 2014 NCRUA Region IV Spring @ 2014 National Council of University Research Administrators Concerns of Blue Moon International University 1.) how to pay subjects 2.) receiving payment—cash flow 3.) facilities 4.) personnel 5.) accounting

10. NCURA Region IV Spring Meeting April 27 – 30, 2014 NCRUA Region IV Spring @ 2014 National Council of University Research Administrators Concerns of Constellation Pharma 1.) Intellectual Property (ownership of drug) 2.) Inventions 3.) Controlling Publications 4.) Subject Injury/Indemnification

11. NCURA Region IV Spring Meeting April 27 – 30, 2014 NCRUA Region IV Spring @ 2014 National Council of University Research Administrators Concerns of Solar Systems 1.) IP for drug system 2.) Controlling publications 3.) Receiving payment 4.) Logistics of getting drug delivery system to Africa

12. NCURA Region IV Spring Meeting April 27 – 30, 2014 NCRUA Region IV Spring @ 2014 National Council of University Research Administrators Proposal Preparation What information is needed to prepare the collaborative proposal?

13. NCURA Region IV Spring Meeting April 27 – 30, 2014 NCRUA Region IV Spring @ 2014 National Council of University Research Administrators For each Subcontractor: Statements of Work Budget Budget Justification COI

14. NCURA Region IV Spring Meeting April 27 – 30, 2014 NCRUA Region IV Spring @ 2014 National Council of University Research Administrators Other Concerns: Logistics: personnel to perform studies; how is drug and devise being delivered to location? Costs to include? How to keep organized/timelines? Communication

15. NCURA Region IV Spring Meeting April 27 – 30, 2014 NCRUA Region IV Spring @ 2014 National Council of University Research Administrators Group Breakout: Discuss the possible contractual mechanisms needed prior to the proposal submission or following the award.

16. NCURA Region IV Spring Meeting April 27 – 30, 2014 NCRUA Region IV Spring @ 2014 National Council of University Research Administrators Confidentiality Disclosure Agreement (CDA, NDA) Purpose: to protect a party’s confidential information when discussing a possible collaboration

17. NCURA Region IV Spring Meeting April 27 – 30, 2014 NCRUA Region IV Spring @ 2014 National Council of University Research Administrators Material Transfer Agreement (MTA) Purpose: To transfer material from one Institution to another for research purposes

18. NCURA Region IV Spring Meeting April 27 – 30, 2014 NCRUA Region IV Spring @ 2014 National Council of University Research Administrators Small Business Technology Transfer (STTR) Model Agreement Purpose: to set forth the allocation of rights in intellectual property and rights to carry out follow-on research, development, or commercialization

19. NCURA Region IV Spring Meeting April 27 – 30, 2014 NCRUA Region IV Spring @ 2014 National Council of University Research Administrators Teaming Agreement Purpose: to memorialize the plans and distribution of duties for a collaborative proposal submission.

20. NCURA Region IV Spring Meeting April 27 – 30, 2014 NCRUA Region IV Spring @ 2014 National Council of University Research Administrators Subaward Agreement Purpose: to award sponsored project funds from a Prime Recipient for work done to complete the objectives of the study.

21. NCURA Region IV Spring Meeting April 27 – 30, 2014 NCRUA Region IV Spring @ 2014 National Council of University Research Administrators Clinical Trial/Study Agreement Purpose (in this case): contractual mechanism to provide drug for the study.

22. NCURA Region IV Spring Meeting April 27 – 30, 2014 NCRUA Region IV Spring @ 2014 National Council of University Research Administrators Miscellaneous Documents: COI Management Plan IRB Affiliation Agreement

23. NCURA Region IV Spring Meeting April 27 – 30, 2014 NCRUA Region IV Spring @ 2014 National Council of University Research Administrators Questions or Other Issues to Consider?

24. NCURA Region IV Spring Meeting April 27 – 30, 2014 NCRUA Region IV Spring @ 2014 National Council of University Research Administrators Jean Mercer: jemercer@iu.edujemercer@iu.edu Tammy Good: tajgood@iu.edutajgood@iu.edu