Clinical and Corporate Contract Services Team - overview - Esteban Mendoza Office of Research Senior Clinical/Corporate Contracts Officer UNIVERSITY OF PITTSBURGH INTERNAL USE ONLY

Clinical & Corporate Contract Services Team What Will Be Covered Organization Overview MyRA - New Intake Process for Non-Financials The Basic – CDAs, MTAs / DUAs, Collaborations Key Consideration in Contracts Tips & Resources / websites

Overview of Research Administration University of Pittsburgh - Office of Research (OR) Processing Teams Clinical and Corporate Contract Services Team Federal Contract Services Team Grants Management Services Team NON-FINANCIAL -Research Confidential Disclosure Agreement/Non-disclosure Agreement (CDA/NDA) -Material Transfer Agreement (MTA): incoming & outgoing (includes equipment loan agreements, CRADAs, drug supply agreements) -Data Use Agreement (DUA) -Non-Financial Collaboration Agreements FINANCIAL -Corporate research agreements (CRAs)- includes investigator-initiated basic research agreements as well as applicable clinical trial agreements (CTAs) -Subawards and contracted services agreements under corporate funded contracts -Proposals for corporate funding Proposals & Awards for Federal Contracts (mainly from RFP and RFQ submissions) Grant Proposals & Awards from federal sponsors/agencies (i.e. NIH, NSF, DOE, DOD, etc.)

Overview of Submission Process Financial Contracts require submission forms - see “Clinical Corporate/Forms”: http://www.research.pitt.edu/office-research-forms-0 Non-Financial Contracts (MTA/DUA/CDA) electronically submitted through MyRA: http://www.research.pitt.edu/myra TIP: Tutorials on YouTube!: https://www.youtube.com/channel/UCxKR3YXwBhlgC3KDoeJ-Kaw

Why do any type of agreements? Working together to ensure: In accord with University Principles Publication / Academic credit Encumbrances & Liability Ownership Address unique/non-standard situations

University Principles Dissemination of results Access to research materials Consideration of needs of students Compliance with funding obligations Compliance with laws and regulations HIPAA, FDA, NIH, Bayh Dole, OHRP, IRS, PA Laws

Confidentiality / Non-Disclosure Agreements (CDA/NDA) Non-financial agreements for Pitt to receive information, disclose information, or both TIP: Usually prior to collaboration discussions and before PI discloses unpublished/non-public data, research plans, etc. receives confidential information from others OTM involvement if it involves an invention disclosure Typically, not for exchanging research tools CC team handles all CDAs & NIH Certificates of Confidentiality except for: A CDA in connection with a Federal contract (FedCon) A CDA that should be handled by UPMC in connection with an industry-designed clinical trial (OSPARS)

MATERIAL TRANSFER AGREEMENTS, DATA USE AGREEMENTS, & COLLABORATIONS

Research Scenarios UPitt PI is providing, receiving, or providing & receiving clinical data to another entity UPitt PI is providing, receiving, or providing & receiving research tools or primary tissue samples to another entity UPitt PI is exchanging both materials/tools & clinical data

MTAs are: Contracts to acquire research tools from Non-profit entities like other universities or repositories The government, like the NIH The for-profit sector, like a pharmaceutical company Research materials/tools: transgenic animals, cell lines, human biological specimens, compounds/drugs, research tools, etc. TIP: Until summer enhancement to MyRA, for dual transfer on MyRA fill out one record for “sending” and one for “receiving” and put a note they are related to the same project

So when do you need an MTA? Sending materials to an investigator working at another university, the government or a company. Receiving materials from an investigator working at another University, the government or a company. Sometimes in a procurement situation. Sometimes under a collaboration. Only if no other contract exists to address the transfer! NOT Needed: Exchanging data/materials with clinical trial sponsor  instead amend the clinical trial agreement Needed: Using materials from a third party (i.e. a company) in an NIH funded project

Is a DUA the same as an MTA? No, DUAs are for exchanging certain protected clinical data & information (i.e. Limited Data Set) being shared for research purposes Required by HIPAA absent informed consent/HIPAA authorization Only if not already addressed by another agreement (i.e. clinical trial agreement) MTAs are for tangible materials. Any Pitt materials being sent outside of Pitt need an MTA or other appropriate form of contract TIP – may have a combined MTA/DUA if needed!

DUA/MTA vs COLLABORATION “Is this a collaboration with recipient?” Slogan “Use Our Materials/Data” “Let’s Work Together” Overview Sharing of our research materials /data with the recipient for recipient’s research project Involvement by both parties, often in complementary ways Pitt’s contribution: Hands-on research, data analysis, experimental design Form of contract Often streamlined w/ other universities (i.e. UBMTA / NIH SLA) More detailed Publication Generally only recipient would publish results Both parties can publish, often initial publication of results will be a joint publication Share back of research results to Pitt investigator Can be included, if desired by Pitt investigator Standard for collaborations Bi-directional transfer of materials No Sometimes, depending upon the project

Key to Success is Meeting the Different Needs of Academia & Industry Cultural differences: open vs closed Business differences: educational vs commercial Regulatory differences: university vs pharma SOLUTIONS OPEN DIALOGUE to understand sponsor’s specific needs under the project allow for review of manuscripts prior to publication to redact confidential information & protect potential discoveries grant the right to negotiate exclusive licenses to patentable discoveries from the sponsored research

Key Topics in Recent Agreements No Publication Blocks (i.e. “control”/“prior approval”) Trade Secrets – high risk, perpetual obligations Excessive control or “reach through” “Assignment” to all “arising from” Giving away “know-how” can prevent investigators from engaging in their own research in future projects Export Control info/materials excludes investigators students from certain countries from participating in our research; potential fines & incarceration for any breach of such laws! Indemnification We gladly share results and data but recipients must be responsible for their own use. PITT can’t be responsible for actions of unrelated third parties

Additional Tips – Budgets and F&A Internal Budget vs. Corporate Contract Budget In general, industry sponsors only need total or total breakdown Contact us if unsure of correct F&A (i.e. research vs. clinical) MTCD vs. TDC (clinical) http://www.research.pitt.edu/dataforproposalpreparation#facilityandadministrativecosts If sponsor refuses to pay for full F&A Written proof of sponsor’s policy limiting F&A rate, or PI can apply for waiver Direct Costs $10,000 Indirect Costs $5,900 TOTAL $15,900

Additional Tips – Scope of Work Scopes of Work Scientific description of experiments & materials NO contract terms (i.e. cost, ownership, budget) May contain estimated timelines for individual steps

Additional Tips - Amendments Amendment vs. New Agreement Different PI? Different area of research? New materials/tools? Altering nature of project i.e. in vitro ↔ human?

Who can you contact for more information? Office of Research University Club- 123 University Place, Lower Lobby http://www.research.pitt.edu/ Phone 412-624-7419 (Clinical/Corporate) Phone 412-624-7400 (General) Fax 412-624-7414 Esteban Mendoza Phone 412-624-7402 esm34@PITT.edu http://www.research.pitt.edu/orgen-stafflist

Questions?