Clinical and corporate contract basics

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

2. 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? • MyRAwebsite (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. WhYdo 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

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