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

2. 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

3. 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.)

4. Overview of Submission Process
Financial Contracts require submission forms - see “Clinical Corporate/Forms”:
Non-Financial Contracts (MTA/DUA/CDA) electronically submitted through MyRA:
TIP: Tutorials on YouTube!:

5. 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

6. 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

7. 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discloses unpublished/non-public data, research plans, etc.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)

8. MATERIAL TRANSFER AGREEMENTS,
DATA USE AGREEMENTS,
&
COLLABORATIONS

9. 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

10. 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

11. 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

12. 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!

13. 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

14. 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

15. 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

16. 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)
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

17. 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

18. 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?

19. Who can you contact for more information?
Office of Research
University Club-
123 University Place, Lower Lobby
Phone (Clinical/Corporate)
Phone (General)
Fax
Esteban Mendoza
Phone

20. Questions?