Negotiating Clinical Trial Agreements: Balancing the Interests of Sponsors and Healthcare Providers
Structuring Indemnification, Subject Injury, IP Rights, Data Rights, and Other Key Provisions
Recording of a 90-minute CLE webinar with Q&A
This CLE course will review critical provisions in clinical trial agreements (CTAs), discuss variations in study site structure and potential impact on CTA signatories, outline best practices for structuring effective provisions and contracts, and guide healthcare counsel on handling the potential challenges in CTA negotiations.
Outline
- Challenges in negotiating a CTA
- Proper signatories
- Regulatory compliance
- Indemnification
- Subject injury
- Insurance
- IP ownership
- Key provisions to include in a CTA
- Compensation
- Data rights
- IP rights
- Publication
- Confidentiality
- Record retention
- Monitoring, audit, and FDA inspection
- Indemnification
- Subject injury
- Limitation of liability
- Insurance
- Use of name
- Termination
- Best practices for effective negotiation
Benefits
The panel will review these and other key issues:
- What are the significant stumbling blocks that can hinder the parties in negotiating a CTA?
- Why does it matter if you do not figure out the proper contracting parties?
- What scope of indemnification is appropriate? What is a commercialization indemnity? What does it mean to indemnify for use of study data and results?
- How do we draft a subject injury provision that protects both parties? Should insurance be billed first? What if the provider is not the research institution?
- What human subject protection language is mandated by AAHRPP?
- What CTA provisions ensure that the trial sponsor owns the intellectual property created as a result of the clinical trial? What scope of assignment would be acceptable to all parties?
- What language do you need to review to make sure the informed consent form is consistent with the CTA subject injury provision and the CTA budget?
- Do sponsors need the right to copy and remove PHI from the study site?
Faculty
Katherine Leibowitz
Attorney
Leibowitz
Ms. Leibowitz’s technology practice includes life sciences transactional work for companies seeking to develop,... | Read More
Ms. Leibowitz’s technology practice includes life sciences transactional work for companies seeking to develop, test and commercialize their FDA-regulated devices, drugs and biologics in the United States and internationally. She has developed a niche practice area encompassing the legal, regulatory and business aspects of medical device clinical research, trial start-up and study management, with a particular focus on clinical trial agreements and related trial documents, FDA financial disclosure, informed consent, subject injury, HIPAA, fraud and abuse, EDC database development and access, intellectual property, privacy and risk management issues for FDA-regulated companies. Ms. Leibowitz provides companies with a cross-disciplinary approach to transactions by addressing general contract law, FDA regulatory compliance, intellectual property, technology licensing, fraud and abuse, HIPAA, privacy, litigation risk management, and domestic and foreign legal and regulatory compliance.
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Nora Lawrence Schmitt
Attorney
Moses & Singer
Ms. Schmitt advises academic medical centers, pharmaceutical companies, hospitals, and physician organizations on the... | Read More
Ms. Schmitt advises academic medical centers, pharmaceutical companies, hospitals, and physician organizations on the conduct and oversight of clinical research, including human subject protection and the privacy of research subjects’ information. She counsels academic medical centers and other research organizations on research affiliations and contracting matters and regularly assists healthcare providers and pharmaceutical companies on matters related to HIPAA, HITECH, and state privacy laws. Ms. Schmitt supports healthcare providers in the field of managed care contracting, including in the formation and maintenance of ACOs, physician hospital organizations, and independent practice associations. She also provides counsel regarding fraud and abuse laws, including the Stark Laws and the Anti-Kickback Statute.
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