1. University Contracting The University of Arizona Contracting & Research Services (CRS)

2. Contracting & Research Services (CRS) is the unit that negotiates contracts and grants on behalf of the University. CRS works with Sponsored Projects Services but is separate from them. CRS 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. 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. 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. Contracting & Research Services

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.  The University of Arizona has two signatories, Lewis Barbieri, Director of Contracting & Research Services, and Gary Esham, Director of Research Operations.

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 Indemnification: The UA cannot warrant, indemnify or hold harmless per Arizona Law (A.R.S. §35-154). The UA requires that Sponsor’s provide some level of Indemnification. Intellectual Property: UA may not allow industry partner to own inventions that are anticipated by Investigator’s scope of work or which necessarily use or incorporate Investigator’s ideas or know-how. Data Ownership: UA retains ownership of all original/raw data. Industry partner may own the deliverable or report. Publication: UA will acknowledge an industry partner’s financial or material contribution; however, UA must be able to freely disseminate/publish results without restrictions.

7. Discussion Points Confidentiality: Arizona has a very broad Public Records Act which prompts UA policy to require information sent to UA by an industry sponsor to be marked as “confidential.” Mandatory Language: UA is required by Arizona legislation to include four distinct clauses in all of its contracts. Equal Opportunity and non- discrimination Arbitration or mediation Conflict of interest State Obligation Additional sticking points are:  Confidentiality  Mandatory Language

8. Ways to Help There are ways you can help the process move more efficiently.  Provide Contracting & Research Services 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 Contracting & Research Services as soon as you receive it. If your Sponsor asks for an Agreement, notify Contract & Research Services 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, Contracting & Research Services needs time to review and negotiate. The earlier we receive the request, the better for all parties.

9. Ways to Help Ways to Help (continued):  Route your budget and scope of work through Sponsored Project Services while Contracting & Research Services is reviewing the agreement.  This will prevent your completed agreement from being held while these things are routed.  Inform Contracting & Research Services of any compliance issues, such as Export Control, Conflict of Interest, etc.  These issues should be know prior to Contracting & Research Services receiving the agreement and Contracting & Research Services 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 Students Working on Projects 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.  Contracting & Research Services cannot negotiate these individual Agreements.

12. CRS Information  Contracting & Research Services contact: 626-3050, orca@email.arizona.edu orca@email.arizona.edu  Contracting & Research Services website for additional contact information: http://rgw.arizona.edu/directoryhttp://rgw.arizona.edu/directory  Contracting & Research Services negotiates and/or signs the agreements that Sponsored Projects administers  Lewis Barbieri, Director of Contracting & Research Services, and Gary Esham, Director of Research Operations, are authorized to sign agreements that legally bind the University  Contracting & Research Services negotiates the terms of an agreement with outside entities; we are the contact point for Sponsors and departments/PI’s  Sponsored Projects Services approves budgets within an agreement, not Contracting & Research Services  If there is a chance of receiving funding from an industry sponsor, provide the sponsor Contracting & Research Services contact information – the sooner, the better (no PRS required)

13. 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?

14. 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?

15. 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?