Contract Negotiation Process

1. Contract Negotiation Process Janene Peterson Shelton, CDAs Angelyn Griffing, CTAs Karen Myers, Subawards & Incoming Contracts

2. Overview Handouts Contracts Organization Chart Contract Definition Contract Conformity Confidential Disclosure Agreements Clinical Trial Agreements Subawards and Incoming Contracts

3. Handouts Contract Negotiation Process Requirements Sample CDA Sample CTA Sample SubK Agreements Signature Authorization Form UTMB Vendor Application Sample Purchase Order

4. Contracts Organization Chart Office of Sponsored Programs Toni D’Agostino, Director Susan E. Ramsey, Contracts Manager Angelyn Griffing (CDAs, CTAs) Debra Kaderka (CDAs & IS) Karen Myers (CDAs, CTAs, Federal) Janene Peterson Shelton (CDAs, CTAs, Federal)

5. What is a Contract? Agreement between two or more parties to do something in exchange for something else (consideration) Essential elements Performance period Project description (title) Scope of service or work (includes clinical protocols) Defined terms and/or definitions Budget or consideration

6. Contract Conformity Agreement conforms to the laws and regulations of the State of Texas under the authority of the Texas Attorney General and The University of Texas System (“UT System”) requirements Signature Authority for a research agreement is authorized by the UT System Principal Investigators are not authorized to commit UTMB contractually (“Read and Understood”)

7. Who Negotiates What? OSP Contracts Section negotiates human subject and non-industry sponsored basic science research agreements The Center for Technology Development negotiates industry sponsored basic science research and SBIR and STTR agreements

8. Confidential Disclosure Janene Peterson Shelton

9. Confidential Disclosure Agreement (CDA) CDA is a legally binding contract primarily with a pharmaceutical or device company or other entity Parties are legally bound to the terms and conditions of information exchange to protect trade secrets or potential intellectual property rights CDAs executed by UTMB must conform to the laws and regulations of the State of Texas and UT System requirements

10. CDA Processing Two Ways to Process a CDA UTMB negotiates, signs and PI signs as “Read & Understood” OR PI strikes all references in the document to UTMB and signs CDA

11. CDA Processing PROs and CONs UTMB Negotiates and Signs CDA conforms to State of Texas laws and regulations and UT System requirements CDA negotiated by UTMB reduces chance for litigation CDA negotiation may assist with future Clinical Trial Agreement negotiation CDA negotiation requires turnaround time

12. CDA Processing PROs and CONs PI Signs CDA is processed quickly No records to maintain for OSP Reduced workload for OSP Contracts Section Places liability on PI personally with no liability to UTMB

13. CDA Processing What we need from you Sponsor contact information (name, email & phone number) Electronic Word version of the CDA, or Hard copy of the CDA

14. CDA Processing Questions ?

15. Clinical Trial Agreement (CTA) Angelyn Griffing

16. Clinical Trial Agreement (CTA) Legally binds parties to the terms and conditions CTAs executed by UTMB must conform to the laws and regulations of the State of Texas and UT System requirements PI cannot be a party to the CTA

17. CTA Processing PI signs CTA as “Read & Understood” UTMB authorized official and private industry sponsor sign the CTA Fully executed CTA passes to Project Set up (PSU) to establish project and load budget

18. CTA Processing Why we review agreements/contracts Ensure contract conformity Ensure payment terms are specified Redefine ambiguous or unclear terms Soften contractual terms Protect UTMB and PI

19. CTA Negotiated Terms & Conditions Five (5) major areas in CTA agreements Adverse Events (includes AAHRPP) Association for the Accreditation of Human Research Protection Programs Non-profit accrediting body for participant protection AAHRPP = high ethical & professional standards Confidentiality Indemnification Intellectual Property Publication

20. CTA Adverse Events Terms Sponsor bears all research costs Subject injury results directly from study drug or device or protocol procedures Injury not result of subject’s negligence Injury not result of UTMB’s negligence Underlying illness exists

21. AAHRPP Terms UTMB must receive all adverse injury information (including site visits and registry studies) Who pays for research related injuries Modifying confidentiality carve out terms UTMB’s right to communicate study results to participants How UTMB relays information to study participants

22. Confidentiality Terms Clearly defined conditions Specify reasonable time limit (3 – 5 years)

23. Indemnification Terms Identify indemnified parties Define scope of indemnification Address exceptions (caused by indemnitee) Address survival obligations to indemnify Specify control of defense subject to Texas Attorney General

24. Intellectual Property Terms Scope of definition for inventions Invention disclosure Invention ownership (new discoveries or improvements) Discovery made in course of following protocol

25. Publication Terms Right to publish study results Multi-center study Reasonable time delays (30 – 90 days) Sponsor review and comment Reasonable restrictions

26. CTA Processing What we need from you Signed Clinical Trials Routing Form Department and sponsor contact information Electronic Word version of the CTA Specific payment terms and budget Who developed protocol (Continued on next slide)

27. CTA Processing What we need from you (Continued) Drug compound/device information and other study related information Receipt of any information on an upcoming study as soon as possible Concurrent IRB approval/budget development/contract negotiation to ensure smooth transition and avoid delays

28. Clinical Trial Agreement (CTA) Questions ?

29. Subaward Agreement (SubK) Karen Myers

30. Subaward Agreement (SubK) Agreement between UTMB and other universities, foundations, non-profit organizations, state or federal agencies or private industry for collaborative basic or clinical research funded by public or private dollars.

31. Subaward Agreement (SubK) Subaward agreement or subcontract agreement are used interchangeably Federal funding is the usual source SubK must be conforming Requires greater departmental and OSP administrative and financial management

32. Subaward Agreement (SubK) Two types of Subaward Agreements Subaward Out (outgoing from UTMB) Subaward In (incoming to UTMB)

33. SubK Out UTMB submits a proposal directly to the funding agency UTMB’s proposal includes a complete 398 package from the collaborative/subawardee organization(s) UTMB receives the award directly from the funding agency (UTMB Prime Award) and issues a SubK Out and Purchase Order to the collaborative/ subawardee organization(s)

34. SubK Out Processing What we need from you to issue SubK SubK Out subawardee(s) 398 Face Page Revised detail budget(s) (subrecipient monitoring) Checklist(s) Statement of Work for subawardee(s) (continued on next slide)

35. SubK Out Processing (continued) What we need from you to issue PO Signature Authorization Form processed for subawardee project UTMB PI name entered as Inquirer Only—Access by Proposal user in PeopleSoft (PS) Grants Module; Logistics adds to ePRO Requestor Table Subawardee(s) established in PS Vendor Table

36. SubK Out Processing (Continued) Processing delays occur when Revised detail budget is not submitted Signature Authorization Form is not processed for each subawardee(s) PI’s name is not in PS Requestor Table SubK Out Subawardee(s) organization is not listed in the PS Vendor Table

37. SubK Out Processing(Adding New Projectin Middle of Budget Period) New SubK Out in middle of budget period Contact your OSP Post-Award Specialist to discuss the requirements for adding a new project in the middle of a budget period

38. SubK Out Processing Questions ?

39. SubK IN UTMB submits a 398 package proposal routed through OSP to a collaborating university or other entity UTMB receives a SubK IN from the collaborating university or other entity

40. SubK IN Processing Contracts reviews PreAward File & SubK In for conformity Contracts negotiates any non-conforming terms PI receives final negotiated SubK In for review & reply e-mail as “Read & Understood” Contracts either partially or fully executes

41. SubK IN Processing (Continued) What we need from you Routing Form Proposal 398 Face Page Detail budget (ECERT) Statement of Work Signature Authorization Form

42. Award vs. Contract How do I know the difference? Safe rule of thumb – don’t sign or process any award or grant notice requiring a signature or any award letter of notification to PI or OSP stating a contract is forthcoming without contacting the Contracts Section first UTMB cannot accept a contract which does not conform to State of Texas law or regulations and UT System requirements.

43. Incoming Contract Backstop Spending Source of funding Dotting the “i” and crossing the “t” to conform to the State of Texas laws and regulations and UT System requirements Negotiate to the end

44. SubK IN and Incoming Contract Processing Questions ?

45. Summary Discussed CDAs, CTAs, Subawards and other Incoming Contracts Discussed the art of contract conformity (not compliance) Discussed what we need from you

46. What do you need from us?

47. Contact Information Susan E. Ramsey seramsey@utmb.edu Angelyn Griffing acgriffi@utmb.edu Debra Kaderka dakaderk@utmb.edu Karen Myers kmmyers@utmb.edu Janene P. Shelton japeters@utmb.edu

48. Links Clinical Trials Routing Form Proposal Routing Form Signature Authorization Form http://research.utmb.edu/osp/forms.shtm Vendor Application http://www.utmb.edu/logistics/forms_library/Acquisitions%20Forms%20-%20KB/purchasing_forms.htm

49. Thank You For electronic copy of the presentation or any handout, contact Heidi Lutz at helutz@utmb.edu Please complete the course evaluation Please remember to sign the attendance roster