University Contracting

1. University Contracting The University of Arizona Office of Research and Contract Analysis (ORCA)

2. ORCA Services CONTRACT – Utilized for the acquisition of property/services/information. Establishes the rules for a relationship between the University and another party – how it is structured, how it is implemented, and how it is evaluated. ORCA is the unit that negotiates contracts and grants on behalf of the University. ORCA works with Sponsored Projects but is separate from them. ORCA ensures the University does not commit itself or its employees to terms and conditions which are outside of State and/or Federal law and the policy of the Arizona Board of Regents. GRANT – Utilized to transfer money, property, things of value from a sponsor (usually the federal government) to a recipient usually to accomplish a public purpose. Recipient works independently and reports results to the sponsor at the end of the project. Little input from sponsor.

3. Types of Agreements • Grants • Industry Contracts • Collaborative Agreements • Clinical Trial Contracts • Material Transfer Agreements • Confidentiality / Non-Disclosure Agreements • Sales and Service Contracts • Memoranda of Understanding • Interagency Agreements • Teaming Agreements • Incoming and Outgoing SubAwards

4. Who can Sign? Only University Signatories, approved by the University of Arizona President’s Office, are authorized to bind the University. • ORCA has two signatories, Lewis Barbieri, Director and Lee Anne T. Peters, Contract Officer.

5. Inherent Conflict Companies want: • To protect proprietary rights and information • To maximize economic gain • Rights in data or results Universities want: • To broadly disseminate scientific knowledge • To openly collaborate with other scientists • Maintain obligations to research funding sources

6. Discussion Points In general, across all agreement types, there are several areas where sticking points can happen. Some of these points are: • Indemnification • Intellectual Property • Data Ownership • Publication

7. Discussion Points Additional sticking points are: • Confidentiality • Mandatory Language

8. Ways to Help There are ways you can help the process move more efficiently. • Provide ORCA with a budget and scope of work for the project. • This will assist us in determining what type of agreement you need. • If your Sponsor has provided you with an agreement, send it to ORCA as soon as you receive it. If your Sponsor asks for an Agreement, notify ORCA as soon as it is requested. • If the Sponsor sends an Agreement, please make sure it is a modifiable Word document. • Please provide us with the name and contact information for the individual you are working with at the Sponsor organization. • Remember, ORCA needs time to review and negotiate. The earlier we receive the request, the better for all parties.

9. Ways to Help Continued: • Route your budget and scope of work through SPS while ORCA is reviewing the agreement. • This will prevent your completed agreement from being held while these things are routed. • Inform ORCA of any compliance issues, such as Export Control, Conflict of Interest, etc. • These issues should be know prior to ORCA receiving the agreement and ORCA needs to be aware to allow appropriate negotiation of the agreement. • Have a clear understanding of how Students will be involved in the Project. • How the Student interacts and his/her role in the research can affect negotiations and other processes.

10. Compliance • Each Sponsor/Agreement can have its own compliance requirements. • It is important to understand the requirements for your individual Project. • Not being aware of Compliance Requirements at the agreement stage can cause delays in the negotiation and signing of an agreement. • There are many resources available to you to assist you in the understanding and completion of your individual compliance requirements.

11. Students • Paid Employee Students: • Are bound by the terms of their employment, similar to that of the PI or other Staff. • Are obligated to terms of Confidentiality and Intellectual Property Rights, similar to PI and other Staff. • Are obligated to the terms of the Agreement for the Project, similar to PI and other Staff. • Unpaid, Non-Employee Students: • The University has no power to bind the Student to the terms of the Agreement for the Project. • The University cannot obligate the student to the confidentiality or intellectual property requirements of the Agreement for the Project. • The Student may have to sign an individual agreement with the Sponsor for the Project. • ORCA cannot negotiate these individual Agreements. Students working on Projects Paid Employee vs. Unpaid, Non-Employee Students

12. Overview

13. ORCA Information • Alina Morrison, ORCA’s Office Specialist 626-3050, orca@email.arizona.edu; • Website for additional contact information http://www.orca.arizona.edu/; • ORCA negotiates and/or signs the agreements that Sponsored Projects administers; • ORCA’s Director, Lewis Barbieri, and Contract Officer Lee Anne T. Peters are authorized to sign agreements that legally bind the University; • ORCA negotiates the terms of an agreement with outside entities; we are the contact point for Sponsors and departments/PI’s; • SPS approves budgets within an agreement, not ORCA; • If there is a chance of receiving funding from an industry sponsor, provide the sponsor ORCA’s contact information – the sooner, the better (no PRS required);

14. Case Study 1 A Company has approached you and wishes to sponsor a Clinical Trial in which they have authored the Protocol and will provide the drug. You have received a Budget, a copy of the Protocol and a PDF copy of a Clinical Trial Template for signature. What are the first three steps you should take with the information and documents that the company has provided?

15. Case Study 2 As a Principal Investigator, you are interesting in entering into discussions with a company to work on new funded research. The company has provided a Confidentiality agreement for the University of Arizona to sign. The company is requesting that the PI and any students that would have access to the proposed information sign the agreement. There are two graduate students and one undergraduate student who will need to have access to this information. The two graduate students are paid employee students and the undergraduate student is an unpaid intern. What is the first step you would take with the agreement you received from the company? Of the PI and students, who will be able to sign the agreement in acknowledgement? And who will be required to sign his/her own agreement?

16. Case Study 3 The University of Arizona has a Master Services Agreement with a large for-profit company for the purpose of involving non-employee students in experimental learning/internship programs and student projects. These are usually semester long projects, and the students present the product of their program work to the company at the end of the semester. The company receives ownership of the deliverables produced from this program work. A department now wishes to use this Master Services Agreement in order to engage University of Arizona Faculty in sponsored research. Is it possible to use the existing Master agreement for this purpose? Are there any issues you can identify that might arise out of such a situation?