Clinical Trial Contracts Office -What’s the Hold Up? Valerie Ody, JD Marque Vassar, CRA Clinical Trials Contract Negotiators UC Davis Health

Confidential Disclosure Agreement (CDA) What is a CDA? Industry sponsors have an interest in maintaining the confidentiality of their proprietary information. Many sponsors require a CDA to be on file before they will share their Protocol with the university or the PI. A Confidentiality Agreement may also be called a Confidential Disclosure Agreement (CDA), a Non Disclosure Agreement (NDA) or a Secrecy Agreement.

Confidential Disclosure Agreement (CDA) Who can sign a CDA? All CDAs for industry-funded clinical trials are the responsibility of the Clinical Trials Contracts Office in the Health Contracts Office. Delegated authority In some situations researchers may be asked to sign Confidentiality Agreements; however, no one other than the delegated individuals are authorized to sign any Confidentiality Agreement on behalf of The Regents. If someone other than the delegated authorized official signs a CDA, that individual then becomes personally responsible for all of the legal ramifications that come with signing the CDA, including any financial obligations.

Confidential Disclosure Agreement (CDA) Where do I send a CDA? All CDAs for industry-funded clinical trials should be sent to the Clinical Trials Contracts Office. Lorie Dilts is the CDA analyst for the Clinical Trials Contracts Office, and negotiates all CDAs with industry partners for clinical trials for the University. ledilts@ucdavis.edu

Clinical Trial Budget/Payment Terms Who’s responsible for the budget? Each department is responsible for negotiating the budget numbers AND the payment terms. The Clinical Trials Contracts Office has staff that can assist with budget development. BUT… It is ultimately a departmental responsibility. If you have questions or need guidance or assistance with developing your budget, contact Julie Calahan. jecalahan@ucdavis.edu

Clinical Trial Budget/Payment Terms EXERCISE (handout) Review the payment terms, and redline the terms.

Clinical Trial Contract Submission What is required? Exception to Policy for Intellectual Property Data Sheet UBT Sponsor Budget Protocol Editable Clinical Trial Agreement draft Conflict of Interest in Research (COIR) Training 700U Form 800 DID YOU KNOW?!? Your PIs (and investigators) can complete their COI disclosures (700U and Form 800) online! Visit the Online Disclosure Portal at https://or-forms.ucdavis.edu/

Common Issues in Contract Provisions Study Data Deliverables – typically CRFs Must be required by the protocol to be generated and delivered to the sponsor Study Data is different from Results, Source Documents, and medical records

Common Issues in Contract Provisions Study Data “Upon completion of the Study or earlier termination thereof, Institution and/or Principal Investigator shall prepare and forward to Sponsor a final report containing all relevant information for the Study including all data and results arising out of the performance of the Study (‘Study Data’).” XXXXXXXXXX

Common Issues in Contract Provisions Study Data Acceptable Language: “All rights, title and interest in the completed case report forms and other reports required to be generated and submitted to the Sponsor pursuant to the Protocol, and the data as compiled therein (‘Study Data’) shall be the sole and exclusive property of the Sponsor.”

Common Issues in Contract Provisions Term and Termination When does the study start? Impact of the effective date IRB approval Hard end dates listed in the agreement Who can terminate the agreement? Obligations of parties after termination

Common Issues in Contract Provisions Confidentiality Separate from the terms of the CDA (if applicable) Confidential information flows one-way from sponsor to university, and must be marked as confidential Must include exceptions (carve-outs) for when we can use confidential information what is not considered confidential information Cannot agree to keep information confidential indefinitely This section is reviewed in detail by contracts office and is based on UC-wide standards

Common Issues in Contract Provisions Confidentiality “Institution and its employees and agents, and Principal Investigator shall not disclose to any third party or use for any purpose other than in the fulfillment of their respective obligations hereunder, any data, records or other information generated as a result of this Study or relating to the Study Drug.” XXXXXXXXX

Common Issues in Contract Provisions Confidentiality Acceptable Language: “For the duration of this Agreement and for a period of five (5) years thereafter, Institution and its employees and agents, and Principal Investigator shall not disclose to any third party or use for any purpose other than in the fulfillment of their respective obligations hereunder, any data, records or other information which is disclosed to Institution or Principal Investigator by Sponsor which is marked 'confidential' in writing or which a reasonable person, given the nature and circumstances of the disclosure, would understand to be a confidential disclosure of Sponsor.”

Common Issues in Contract Provisions Publications Right to publish Publication delay no more than 90 days Sponsor’s right to review publications Multi-center publications

Common Issues in Contract Provisions Publications “University shall be free to publish subject to the following limitations: (a) University shall send Sponsor a copy of any such proposed publication sixty (60) days prior to submission for publication; (b) University shall not include raw data in such publications without Sponsor’s consent; (c) University shall, upon Sponsor’s request, delay submission for any publication while Sponsor files applications for patents or other intellectual property rights; and (d) University shall give due consideration to comments provided by Sponsor.” XXXXXXX

Common Issues in Contract Provisions Publications Acceptable Language: “University shall be free to publish subject to the following limitations: (a) University shall send Sponsor a copy of any such proposed publication thirty (30) days prior to submission for publication; (b) University, upon Sponsor’s timely request prior to submission for publication, shall delete any Sponsor Confidential Information from the proposed publication; (c) University shall, upon Sponsor’s request, delay submission for any publication up to a maximum of sixty (60) days to provide Sponsor the opportunity to file applications for patents or other intellectual property rights; and (d) Sponsor may comment upon, but may not make editorial changes to, the results and conclusions set forth in the proposed publication. University shall give due consideration to comments provided by Sponsor.”

Common Issues in Contract Provisions Inventions/Intellectual Property One of the most negotiated sections Based on UC policy Must be “in the box” No present assignment of inventions

Common Issues in Contract Provisions Indemnification One party assumes financial responsibility in the event of a specified loss by another party Transfers risk of damages or loss to the other party Required in all clinical trial agreements Indemnification should not be precisely mutual

Common Issues in Contract Provisions Subject Injury Not the same as indemnification Required in all sponsor-initiated clinical trial agreements UC Policy: requires UC to provide any injured subject with medical treatment Requires sponsors in sponsor-initiated clinical trials to pay for that medical treatment What subject injury language we CANNOT agree to

Common Issues in Contract Provisions Subject Injury “The obligations to reimburse University for subject injury is conditioned upon: (a) University ensuring that only those Study subjects who have medical insurance coverage be enrolled in the Study; (b) Sponsor being responsible only for those medical expenses that are not paid for by a third party; or (c) the Study subject not failing to comply with instructions.” XXXXXXXXXXXXXX

Common Issues in Contract Provisions Subject Injury Acceptable Language: “Sponsor shall reimburse Institution for all reasonable and necessary expenses for the diagnosis or treatment of any injury or illness that is a direct result of Study Subject’s participation in the Study.”

Common Issues in Contract Provisions When the Sponsor is not a Party to the CTA The agreement is between University and a CRO Sponsor is still required to: Provide indemnification to University Provide for subject injury reimbursement Carry insurance Typically executed between University and Sponsor through a separate “Indemnity Agreement”

Questions?