1. Clinical and corporate contract basics
University of Pittsburgh
Faculty Staff and Development Program
May 9, 2018

2. Clinical & Corporate Contract Team
Office of research
Clinical & Corporate Contract Team
Grants Management Team (FSDP May 24, 2018)
Federal Contracts Team (FSDP June 7, 2018)

3. Clinical & Corporate Contract Team
The Clinical and Corporate Contract team handles most industry contracts providing funding as well as many non-financial agreements to transfer materials, data and information.

4. Workshop topics
Overview of the types of agreements handled by the Clinical and Corporate team
Overview of MyRA and when to use MyRA
Brief overview of other University research agreement submission systems and when to use
Common issues among academic contracts
Reasons for contract delays
Strategies to avoid a protracted contracting process

5. Clinical and Corporate Contract Team
Associate Director for Clinical/Corporate Contracts (Helen Britt)
Assistant Director for Clinical/Corporate Contracts (Adam McDowell)
Senior Contracts Officer (Natalie Kreter)
Contracts Officers
Ariell Antonio
Nathan Bray
Scott Hess
Shane Riley
Kristy L. Rizzo
Kimberlee Ross
Contracts Analyst (Angela Colorito)
MTA Analyst (Beverly Capor)
Contracts Coordinator (Steven Haines)
Senior Contracts Coordinators
Perrie Bell
Allison Clarke
TOTAL: 14

6. Types of agreements handled by Clinical and Corporate Team
Non-financial
CDAs (Confidential Disclosure Agreement)
MTAs (Material Transfer Agreement)
DUAs (Data Transfer Agreement)
NOT (Not Sure)
Financial
Corporate Funded Agreements
Clinical Trial Agreements
Proposals
Other
Amendments
Subcontracts

7. Find your office of research contact

12. Where can I find MyRA? MyRA website (https://myra.pitt.edu)
Link on Office of Research website
Ask Cathy on my.pitt.edu

14. Non-financial Agreements
MTAs (Material Transfer Agreement)
DUAs (Data Transfer Agreement)
CDAs (Confidential Disclosure Agreement)
NOT (Not Sure/Other)
Collaborations

15. Material Transfer agreements (MTAs)

16. What's an MTA? Material Transfer Agreement
A contractual document used to acquire research materials, such as:
research animals
devices
human biological specimens
blood samples
cell lines
biopsies in the form of fixed slides and block
drugs for use in a clinical trial
compounds
protein inhibitors
Often these materials are a necessary component of a research project and are available only from a sole source, often industry.

17. Who requires an MTA?
University of Pittsburgh requires an MTA for outgoing material transfers
Other academic and non-profit institutions often require MTAs before they will send materials to other institutions
The government, such as the NIH
Commercial sector
Pharmaceutical companies
Device manufacturers

18. Incoming and outgoing mtas
Pitt investigator is sending materials to an investigator working at another university, the government, a company, etc.
“OUTGOING MTA” (MTA required by Pitt)
Pitt investigator wishes to receive materials from an investigator working at another university, the government or company
“INCOMING MTA” (MTA needed if required by the party sending the materials)

19. Why is ______requiring an MTA?
Tracking of materials and ownership
Assert terms and control use of materials
Intellectual property concerns

20. Who generates the MTA?
Generally, the provider of the materials (or data) provides the form of the contract and the parties negotiate from there
But, what if…
a small entity wants to send materials to researcher at Pitt but they don’t have an MTA agreement?
I’m sending out materials to XYZ and they provided me with a copy of their draft MTA that they want to use for the transaction, even though I’m sending them materials?

21. How do I get the Office of research to review and sign my mTA?

23. can the MTA process be streamlined?
Use of the UBMTA (see handout)
University of Pittsburgh, along with many other institutions, is a signatory to the UBMTA.
For institutions who have agreed to the terms of the UBMTA, it is not necessary to negotiate individualized terms for the transfer of biological materials
Use of repositories to distribute/obtain materials
PIs may deposit frequently requested materials into repositories to further distribute them, such as Jackson Labs or Addgene.
Will need to set up a MyRA submission for the deposit

24. MTAs with Non-Profits generally quicker
MTAs with other U.S. based non-profits generally quicker
Most universities and non-profit entities use simpler agreement with fewer restrictions and agreement is reached expeditiously.

25. MTAs with For-Profits generally take longer
The transfer of materials to or from the for-profit sector is usually more complex, as the corporate entity has an often aggressive interest in protecting its proprietary rights, a stance that can lead to restrictive language in the agreement that the University of Pittsburgh cannot accept.
There are also a number of differing contractual formats for transfer of materials from industry, and MTAs can even be called by different names. Therefore, for incoming materials, we must evaluate each case individually and this takes time.

26. Problematic Terms for MTAs
Restrictions on the use of results generated
Example of unacceptable language:
“Neither party will submit the Results for publication or presentation or disclose such Results to third parties without the express written consent of the other party.”

27. Other Problematic Terms for MTAs
Publications restrictions
Overly broad language regarding ownership of inventions and/or overly broad grant of licenses
Putting all of the risk on the University/inappropriate indemnification language

28. Do I need an MTA if…?
My colleague at Pitt has materials that I also want to use and has agreed to share them with me, do I need an MTA?
Answer: Depends
Who developed the materials?
Did the materials come from an external party?
Is there an MTA associated with the materials?
Are these materials proprietary to a party?

29. Data Use Agreements (DUAs)

30. What’s a DUA?
A Data Use Agreement (DUA) is a contractual document used for the transfer of data that has been developed by non-profit, government or private industry, where the data is nonpublic or is otherwise subject to some restrictions on its use.
DUAs address important issues such as:
limitations on use of the data
liability for harm arising from the use of the data
publication
obligations to keep the data private

31. When do I need a DUA?
Examples of data that might be exchanged under a DUA:
​​Records from government agencies or corporation
Human Research Subject Data
A De-identified or Limited Data Set of Protected Health Information (PHI)
Genetic sequences
Models
Proprietary or valuable information or material that does not fit the profile of a tangible physical material

32. When do I need a DUA?
When no other contract governs the transfer (i.e. no subcontract, grant or clinical trial agreement);
When the data is protected or otherwise confidential; and
When the data being provided is to be used for research purposes.
ALL OF THE ABOVE MUST APPLY!!

33. WhY do I need a DUA?
DUA terms protect confidentiality when necessary, but permit appropriate publication and sharing of research results in accordance with University policies, applicable laws and regulations, and federal requirements.

34. Confidentiality agreements

35. CDAs/NDAs Confidentiality Agreements
Confidential Disclosure Agreements CDAs
Non-disclosure Agreements
Secrecy agreement

36. What’s a CDA?
A CDA is a legal agreement between two or more parties outlining confidential information the parties wish to share with one another only for certain evaluation purposes.
CDAs are commonly executed when two parties are considering a research relationship or collaboration and need to understand the other’s processes, methods, or technology solely for the purpose of evaluating the potential for a future relationship.

37. When to approach the office of research with a CDA
CDAs typically precede a more formal research project and are requested before an MTA, DUA or a funded agreement
But note, several offices within the University review and sign CDAs
Office of Research reviews and signs CDAs when the parties are discussing research or research and licensing/commercialization

38. University Offices that review CDAs
 PURPOSE OF CDA
OFFICE TO REVIEW
Discussions related to research
Office of Research (MyRA)
Discussions related to research AND licensing/commercialization
Office of Research and Innovation Institute (MyRA)
Discussions related to licensing/commercialization only
Innovation Institute (contact Innovation Institute directly)
Discussions related to purchasing equipment and services
Purchasing Services (contact procurement specialist)
Other
Office of University Counsel (contact directly)

39. How do I get the Office of Research to review or draft a CDA?
Make a submission within MyRA
Attach draft CDA/NDA or request to use a Pitt CDA/NDA template
Please indicate any time constraints within additional information of MyRA submission

40. CDAs ≠ DUAs
A CDA is not a data use agreement and should not be used to cover the actual conduct of research.
Our other agreements, have confidentiality provisions within them that covers the exchange of confidential information during the conduct of the research project
In some cases, a CDA format may be used as a starting point to build an appropriate DUA for the transfer of data.

41. One-way or Two-way disclosures?
One-way CDAs = when one party is disclosing information and the other party is receiving information only
Mutual or two-way CDAs = when both parties expect to exchange confidential information that should not be disclosed to a third party.
*Office of Research tip* : Even if you do not plan to disclose confidential information, plan for a two-way CDA just in case

42. Can’t I just sign my own CDA?
NO!
Doing so puts the investigator in a position of potentially being held personally (and solely) responsible for any legal or business issues related to the agreement.  
Requiring the University to sign on behalf of the investigator, or in addition to the investigator, is the safest way to proceed.  If the CDA is formatted by the other party to depict only an investigator as the party with only the investigator's signature, the Office of Research will alter the agreement as needed to include an institutional signature.

43. When should I consider asking another party to complete a CDA?
Anytime you are disclosing information that is not generally available to the public, and which you wish to limit the other party's use or dissemination.

44. If I receive information under a CDA, can I give it to other University of Pittsburgh employees?
Possibly, depending upon the terms of the CDA.  
It is always a good idea to check first, because some agreements limit disclosures strictly to the point of contact referenced in the agreement- usually the primary investigator.  In this case, post doctoral fellows, students in the lab, and even other faculty collaborators would not be permitted to see the confidential information.  
A good rule of thumb to protect yourself and the University is to read your contract and even if a release is permitted, to limit exposure as much as possible.  Do not allow anyone to access the confidential materials unless they absolutely must.

45. Not Sure/Other

46. Not Sure what type of agreement?
Sometimes it’s just not clear or a research project doesn’t fit into the MTA, DUA or CDA definitions
No Problem! We have a category for that too.

47. Not Sure/Other

48. Not Sure/Other
Example of a Not Sure/Other could be a repository registration
Oftentimes with Not Sure/Other, one of our Contract Officers may reach out to you to “Request Clarification” about the project.
With many Not Sure/Other submissions, after review of the draft agreement, the Officer may determine it can be categorized into one of the other categories we have already discussed, i.e. MTA, DUA, CDA, and may request that you submit additional information to ensure an accurate submission.

49. Collaborations

50. MTA and DUA Collaborations
Let us know if your project is going to involve collaborating with the other party as we have special draft agreements that outline the terms of a collaboration

51. Summary for When to Use MyRA
Non-financial Agreements
MTAs (Material Transfer Agreement)
DUAs (Data Transfer Agreement)
CDAs (Confidential Disclosure Agreement)
NOT (Not Sure)

52. Financial Agreements

53. Financial agreements
Financial agreements with a corporate entity include agreements such as:
Sponsored Research Agreements (SRAs)
Corporate Research Agreements (CRAs)
Clinical Trial Agreements (CTAs)
The scope of research activities conducted under these kinds of agreements ranges from basic benchwork to pre-clinical animal work to interventional human subject clinical trials.

54. Financial agreements
Sponsored research agreements generally include the following:
a detailed budget related to the project plan.
a specific period of performance, typically defined with "start" and "stop" dates
a requirement to return any unexpended funds at the end of the period of performance
regular financial reporting and audit obligations
Deliverables to sponsor during or at the conclusion of the project
Budget negotiation is conducted by the PI/PI's department.

55. Procedure to Initiate Office of Research Review
At this time, Financial Agreements do not get submitted into MyRA, but instead are tracked via InfoEd
Departments need to submit the following to the Office of Research:
Principal Investigator (PI) completes the CRA submission form and stock 136 forms;
Current Conflict of Interest (COI) annual filings for all Investigator(s);
Identification of all Key Personnel; and
Sponsor policies and procedures.
If these documents are not completed, approval/submission of the agreement may be delayed.
Submission packet should be sent via to or may be hand delivered to the Office of Research

56. Sample Submission Form

57. Documents required at submission
Completed CRA submission form
Signed stock 136 forms
Draft scope of work/research plan
Draft sponsor agreement or a request for OR to use Pitt's form of template agreement
Draft budget
Any of the following, if applicable to the project and available at submission are helpful, but not required for submission.
•RBL approval letter
•IBC approval letter
•IACUC approval letter
•UPMC Fiscal approval letter
•IRB approval letter

58. Proposals

59. Proposals and potential corporate funding
For some companies desiring to financially support academic research, a formal proposal process is the primary mechanism in which the scientists convey their projects to the company. With proposals, interested PIs outline the research project they intend to conduct using the company's funding. Note that the requirements for proposals vary across companies, and even within companies. It is important to carefully read the company's guidelines to ensure submission via the correct process and inclusion of all required documentation.

60. Submit Proposals through the PERISTM portal

61. Outgoing Subawards
The Office of Research is responsible for issuing subawards from prime agreements (contract, grant, or cooperative agreement) awarded to the University.
For outgoing subawards that stem from a contract, the Clinical and Corporate Contract team draft a subaward agreement that flows down terms and conditions from Pitt's external sponsor.
The system to submit an outgoing subaward is through Contraxx.

62. Contraxx system for outgoing subawards
The system to submit an outgoing subaward is through Contraxx
User Guide for Contraxx on Office of Research website

63. Amendments

64. Amendments
Amendments generally flow through the same system in which the submission was created.
For example, amendments for a submission in MyRA go through MyRA; amendments for a corporate funded agreement are processed via the same process, and amendments for an outgoing subaward may be submitted via Contraxx.

65. Summary of Types of agreements handled by Clinical and Corporate Team

66. Summary of Types of agreements handled by Clinical and Corporate Team
Non-financial (MyRA)
CDAs (Confidential Disclosure Agreement)
MTAs (Material Transfer Agreement)
DUAs (Data Transfer Agreement)
NOT (Not Sure/Other)
Financial
Corporate Funded Agreements (Paper submission/InfoEd)
Clinical Trial Agreements (Paper submission/InfoEd)
Proposals (PERISTM)
Other
Subcontracts (Contraxx)
Amendments

67. Contracting basics

68. Contracting Basics
The University of Pittsburgh is designated as the office to enter into research contracts on behalf of the University and its researchers.
Investigators are not authorized to sign a contract as the authorized signatory on behalf of the University.
Doing so puts the investigator in a position of potentially being held personally (and solely) responsible for legal and business issues that may arise from the agreement.

69. Contracting Basics
Each agreement is tailored to the project as described on the completed submission form.
Many of our agreements provide for a “read and acknowledged signature line for the PI. It is important to read the terms of the finalized agreement and keep the provided copy of the executed agreement on file for reference purposes.

70. Most commonly negotiated contract provisions

71. Commonly negotiated contract provisions
Publication restrictions
Intellectual property and associated licenses
Data use and ownership
Indemnification

72. Common reasons for contract delay

73. Common reasons for contract delay
Incomplete or inaccurate submission
Incorrect or no information about the entity with whom we are establishing the contract
Please note that we cannot conduct University business using Gmail or other unsecure accounts.
Requesting that Pitt draft the agreement when the sponsor or contracting party provided a draft agreement
If a sponsor template is provided, please ensure that it is in an editable Word version in order to facilitate negotiation.
Within MyRA, PI indicates he/she wants to review final draft before the signature process

74. Common reasons for contract delay
Appropriate compliance documents have not been submitted.
Ancillary reviews (IRB, COI, IACUC, IBC, Innovation Institute, etc.) can be done during the negotiation process. However, failure to submit or obtain compliance approvals may delay the processing of an agreement.

75. Common reasons for contract delay
"Work-For-Hire" agreements
Key identifying factors of work-for-hire agreement are that the sponsor outright owns all the data, reports, drawings, and materials and inventions developed under the agreement. Publication is often prohibited.
The Office of Research cannot sign these types of agreements without substantial modification designed to reflect the fact that the University of Pittsburgh and its researchers conduct academic research.

76. Common reasons for contract delay
Other party's unwillingness to respond or negotiate.
Overly restrictive or one-sided terms relating to Intellectual Property, Publication, or Indemnification.
Incomplete or Inaccurate budget
Failure to provide a scope of work
Incomplete COI training modules
Foreign entities
Language barrier
Jurisdiction and governance of law issues
Different set of rules and regulations (ex. GDPR vs. HIPAA)

77. Common reasons for contract delay
Requesting lower F&A/Indirect Cost Rates
Budget negotiators should always begin their negotiation by seeking the proper F&A rate for the research project
Some sponsors have a policy limiting the F&A rate to a certain maximum percentage, which may be less than the University determined F&A rate for Industrial and Commercial Grants and Contracts. If so, please provide appropriate documentation of the Sponsor’s published F&A limiting policy.
If the Sponsor does not have a formal F&A policy and the department has elected to accept an F&A rate that is less than the Industrial and Commercial Grants and Contracts F&A rate, an F&A waiver must be completed.

78. Different philosophies
University Principles
Academia vs. Industry
Dissemination of results
Access to research materials
Consideration of needs of students
Compliance with funding obligations (NIH)
Compliance with laws and regulations
Cultural differences – open vs. closed
Business differences – educational vs. commercial and restrictive control over IP
Regulatory differences – university vs. pharma

79. End