Negotiating Clinical Trial Agreements: Balancing the Interests of Sponsors and Healthcare Providers

Structuring Indemnification, IP Rights, Confidentiality and Other Key Provisions

Recording of a 90-minute CLE webinar with Q&A


Conducted on Thursday, May 5, 2016

Recorded event now available

or call 1-800-926-7926
Program Materials

This CLE webinar will review key provisions in clinical trial agreements (CTAs), outline best practices for structuring effective provisions and agreements, and provide guidance for healthcare counsel on handling the potential challenges in CTA negotiations.

Description

CTAs are critical to allocate risk and protect parties’ rights, including intellectual property rights. Negotiating issues such as indemnification and insurance can pose hurdles that may delay or even kill negotiations.

A major concern is confidentiality. Materials provided by the sponsor, all results and data arising from the clinical study, and all inventions owned by the sponsor must remain confidential. Counsel must thus include clear and specific confidentiality provisions in the CTA.

Counsel to healthcare providers, and pharmaceutical and medical device companies, must anticipate potential obstacles that can impede negotiations. Careful structuring of the CTA is crucial to ensure risk allocation and protection of rights.

Listen as our panel of healthcare attorneys examines the potential obstacles in CTA negotiations, key provisions that should be included in CTAs, and the critical issues surrounding those provisions. The panel will outline best practices for effectively crafting those provisions.

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Outline

  1. Challenges in negotiating a CTA
    1. Compliance
    2. Indemnification
    3. Insurance
    4. Publication
  2. Key provisions to include in a CTA
    1. Principal investigator
    2. Publication
    3. IP rights
    4. Confidentiality
    5. Record retention
    6. Assignment
    7. Indemnification
    8. Patient injury compensation
    9. Termination
  3. 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?
  • What steps should counsel take to prevent wholesale publication of the study results and limit publication of the trial data?
  • What CTA provisions ensure that the trial sponsor owns any intellectual property created as a result of the clinical trial? What scope of assignment would be acceptable to all parties?

Faculty

Julie Rusczek, Esq.
Julie Rusczek, Esq.

Health Sciences Law Group

Ms. Rusczek focuses her practice on research compliance issues, representing institutions, pharmaceutical and device...  |  Read More

Robyn S. Shapiro
Robyn S. Shapiro

Partner
Health Sciences Law Group

Ms. Shapiro has significant experience in handling matters with respect to bioethics issues, medical staff...  |  Read More

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