Contract Negotiation Process Janene Peterson Shelton, CDAs Angelyn Griffing, CTAs Karen Myers, Subawards & Incoming Contracts
Overview Handouts Contracts Organization Chart Contract Definition Contract Conformity Confidential Disclosure Agreements Clinical Trial Agreements Subawards and Incoming Contracts
Handouts Contract Negotiation Process Requirements Sample CDA Sample CTA Sample SubK Agreements Signature Authorization Form UTMB Vendor Application Sample Purchase Order
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)
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
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”)
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
Confidential Disclosure Janene Peterson Shelton
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
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
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
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
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
CDA Processing Questions ?
Clinical Trial Agreement (CTA) Angelyn Griffing
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
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
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
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
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
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
Confidentiality Terms Clearly defined conditions Specify reasonable time limit (3 – 5 years)
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
Intellectual Property Terms Scope of definition for inventions Invention disclosure Invention ownership (new discoveries or improvements) Discovery made in course of following protocol
Publication Terms Right to publish study results Multi-center study Reasonable time delays (30 – 90 days) Sponsor review and comment Reasonable restrictions
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)
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
Clinical Trial Agreement (CTA) Questions ?
Subaward Agreement (SubK) Karen Myers
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.
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
Subaward Agreement (SubK) Two types of Subaward Agreements Subaward Out (outgoing from UTMB) Subaward In (incoming to UTMB)
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)
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)
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
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
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
SubK Out Processing Questions ?
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
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
SubK IN Processing (Continued) What we need from you Routing Form Proposal 398 Face Page Detail budget (ECERT) Statement of Work Signature Authorization Form
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.
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
SubK IN and Incoming Contract Processing Questions ?
Summary Discussed CDAs, CTAs, Subawards and other Incoming Contracts Discussed the art of contract conformity (not compliance) Discussed what we need from you
Contact Information Susan E. Ramsey firstname.lastname@example.org Angelyn Griffing email@example.com Debra Kaderka firstname.lastname@example.org Karen Myers email@example.com Janene P. Shelton firstname.lastname@example.org
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
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