Simplifying Global Compliance
Indemnification Clauses Under Clinical Trial Agreements
Held Sept. 10, 2008
FACT: With millions of dollars at stake in a clinical trial lawsuit, the American Association of Medical Colleges considers the indemnification clause to be one of the most contentious issues in clinical trial negotiations. Yet it need not be a source of conflict — there are simple ways to manage the negotiable clause elements that are widely accepted by nearly every company and institution.
How can you ensure the right language is written into clinical trial agreements (CTAs) that will protect you in the event a malpractice lawsuit is filed?
Attorney J. Michael Slocum will deliver strategies on how to efficiently and effectively negotiate problematic CTA indemnification clauses. He will provide several aspects of indemnification analysis. In addition, he will walk you through case studies and sample clauses to demonstrate what is acceptable and beneficial to all parties involved.
Order now to listen in and discover:
- Who, in a typical CTA, the sponsor indemnifies and who is held harmless
- Exceptions to indemnification — what happens when parties don't follow protocol or regulations or when acts of negligence occur
- The conditions required for indemnification (such as notification of the sponsor after notice of claim)
- Who controls defense of the lawsuit and any limits to that control
- If a settlement or judgment occurs, who pays and under what conditions
- Insurance requirements and considerations for indemnification
- Differences in CTA indemnification clauses when a study is investigator-initiated
- How to assess the risk your indemnification clause creates
Don't risk losing millions of dollars in the event a lawsuit is filed and you aren't indemnified for that loss.
This audio CD/Transcript is a must for positions in drug, biotech, biologic, diagnostics and device companies, CROs, academic research institutions and law firms, including:
- Clinical project specialists
- Clinical research associates
- Compliance officers
- Consultants/service providers
- Executive management
- General/corporate counsel
- Regulatory/legislative professionals
- Risk management specialists
toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600
J. Michael Slocum is president of Slocum & Boddie, P.C., specializing in contract law and corporate issues. He has more than 20 years of experience representing hundreds of small businesses, universities, nonprofit organizations and federal agencies, which he advised and trained on management, contract negotiation, price and cost issues, and contract administration. He has reviewed and negotiated the terms of all clinical research agreements of a large hospital research institute. He received his J.D. with honors from the George Washington University National Law Center.
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