Clinical Trial Agreements

1. Clinical Trial Agreements Weill Medical College of Cornell University Institute for Clinical Research Office of Clinical Trials Administration Clinical Trial Agreements Updated September 15, 2006

2. Who negotiates contracts for my department? Where is the ICR located? When do I contact ICR? What is a Clinical Trial Agreement (CTA)? Why is it important to have a CTA? Sections Contained in a Typical CTA Challenges in Negotiating a CTA Other Types of Agreements Confidentiality Disclosure Agreement (CDA), Non-Disclosure Agreement (NDA) Registry Agreement Retrospective Studies Sponsored Research Agreement (SRA) Material Transfer Agreement (MTA) How do I work most effectively with OCTA? Outline: The best way to work with ICR Clinical Trial Agreements Updated September 15, 2006

3. Who negotiates contracts for my department? Vanessa L. Blau vlb2003@med.cornell.edu 212.746.7636 -All divisions of Pediatrics -Medicine—Hem/Onc -Pharmacology -Ophthalmology -Public Health Drew Davis abd2001@med.cornell.edu 212.746.7655 -All divisions of Medicine, excluding Hem/Onc -Anesthesiology -Neurology & Neuroscience -Cell & Developmental Biology -Otorhinolaryngology -Genetic Medicine -Surgery—Vascular M. Eugenia (Gina) Vergara mev2001@med.cornell.edu 212.746.7645 -All divisions of Surgery, excluding Vascular -Biochemistry -Pathology -Burn Center -Physiology -Complimentary & Integrative Medicine -Psychiatry -Dermatology -Radiology -Microbiology & Immunology -Transplantation -Neurosurgery -Trauma Center -OB/GYN -Urology Clinical Trial Agreements Updated September 15, 2006

4. By using the 4 IHOP Criteria. I-Intervention H-Human Interaction O-Outcomes P-Prospective Does your project meet all four criteria? Is there any easy way to determine which office handles my project? Clinical Trial Agreements Updated September 15, 2006

5. Where is OCTA? • Office of Clinical Trials Administration (OCTA) is the grants & contracts subdivision of the Institute for Clinical Research (ICR), a division of Research And Sponsored Programs (RASP). • OCTA is currently located at 1300 York Avenue, Box 305. • Our offices are located in room A-131. Clinical Trial Agreements Updated September 15, 2006

6. When do I contact OCTA? As soon as the sponsor contacts you. • We help you to understand working with the Sponsor, with previous contracts, templates and master agreements with each sponsor. • Submit a Clinical Trial Synopsis Form. Clinical Trial Agreements Updated September 15, 2006

7. What is a Clinical Trial Agreement? A legally binding agreement that manages the relationship between the Sponsor [typically Industry] who may be providing: • Study Drug or Device • Financial Support • Proprietary Information And the Institution [Weill Cornell] who may be providing: • Data and/or Results • Publication, Input into Publication • Input into further Intellectual Property Clinical Trial Agreements Updated September 15, 2006

8. Other Types of Agreements • Confidentiality Disclosure Agreements/Non-Disclosure Agreements (CDA/NDA) • Agreements to ensure confidentiality of proprietary data that Company gives to Investigator in order to make a determination as to whether or not he/she will participate in the trial/research. • WCMC prefers that CDAs be between Company & Investigator only • However, many companies request that CDAs be between Company and WCMC. Clinical Trial Agreements Updated September 15, 2006

9. Why is it important to have a CTA? • Allocation of • Risk • Responsibility • Money • Obligations • Protection of • Rights (academic, legal, intellectual property) • Academic Integrity Clinical Trial Agreements Updated September 15, 2006

10. Preamble Acknowledgements & Responsibilities Term & Termination Payment/Reimbursement of Costs HIPAA, Patient Privacy Publication Intellectual Property Confidentiality/ Proprietary Information Indemnification Insurance Subject Injury Waiver of Consequential Damages Miscellaneous Export Controls Governing Law Dispute Resolution/ Arbitration/Mediation Exhibits Sections Contained in a Typical Clinical Trial Agreement Clinical Trial Agreements Updated September 15, 2006

11. Sponsor supplies a template. Specialist redlines the document. Go back and forth with sponsor until all points are covered. Get to “Yes”. Negotiation Clinical Trial Agreements Updated September 15, 2006

12. Top 4 Hurdles Compliance with Institutional policy Indemnification If company will not indemnify If company requires mutual indemnification Insurance If company does not carry minimum levels of insurance If company cannot prove liquid assets to cover liabilities Publication If company requires “approval” of publication If company a requires a de facto publication restriction Challenges in Negotiating a CTA Clinical Trial Agreements Updated September 15, 2006

13. To Be Compliant. Contract language must be consistent with Federal, State & WCMC Laws, policies, requirements, and procedures. Uncle Sam wants You….. Clinical Trial Agreements Updated September 15, 2006

14. WCMC is a non-profit educational institution, Devoted to research and education. *WCMC will not incur liability on behalf of Cornell University that is not warranted by the normal course of our business.* There are four specific points that WCMC requires in standard indemnification: Any Provision of Services in connection with the Study Institution’s Participation in the Study Sponsor’s Manufacturing Defect of the Study Drug or Device Negligent use of data Indemnification Clinical Trial Agreements Updated September 15, 2006

15. The sponsor is responsible for the primary burden of risk, therefore they are required to have minimum levels of insurance, that are set by the Risk Management Office, before the Institution is able to participate in the Study: $3Million per Occurrence $5Million in the Annual Aggregate *REQUIRES RISK ASSESSMENT* Insurance Clinical Trial Agreements Updated September 15, 2006

16. Scholarly publication is the fundamental right and responsibility of researchers and the Institution. Sponsors may review manuscripts prior to publication, but may not require terms that allow for “approval” by the Sponsor. 30 days for the removal of confidential information additional 60 days for the filing of patent applications. Publication Clinical Trial Agreements Updated September 15, 2006

17. Additional Challenges -If company requires poor intellectual property clauses. -If company requires data/results to remain confidential or the length of confidentiality is unreasonable. -If company will not agree to pay subject injury reimbursements. -If company will not pay WCMC’s indirect cost rate of 33%. Clinical Trial Agreements Updated September 15, 2006

18. Alert your specialist ASAP We’re here to assist Communication is key Ask questions Continue to provide new information you receive Help us help you Synopsis Routing Form Financial Disclosures Human Res. Billing Analysis Form How do I work most effectively with ICR? Clinical Trial Agreements Updated September 15, 2006

19. United Front. Clear layout of Goals. Know who we are dealing with. Understand the Challenges. How to “Pump Up” our Negotiating Standpoint. Clinical Trial Agreements Updated September 15, 2006

20. Thanks for Listening… Clinical Trial Agreements Updated September 15, 2006