A Clinical Trial Agreement defines the conduct of research between a sponsor and study site. This playbook emphasizes regulatory compliance, data ownership, and subject safety responsibilities.
Why This Matters: Inadequate confidentiality can facilitate unauthorized disclosures, damaging competitive positions and breaching regulatory duties.
Negotiation strategy
If you're the Sponsor:
Ensure the confidentiality clause is comprehensive, covering all proprietary information and specifying a survival period post-termination.
If you're the Institution:
Negotiate clear exceptions to confidentiality obligations, such as disclosures required by law, to avoid undue restrictions.
Essential elements
1
Confidential Information Definition
Defines what is considered confidential.
2
Obligations of Receiving Party
Details duties to protect information.
3
Exceptions to Confidentiality
Lists circumstances allowing disclosure.
Action framework
ACCEPT
Propose edits if the clause lacks a survival period or clear exceptions.
EDIT
Reject if the clause allows discretionary disclosure without consent.
ADD
Add language if no confidentiality clause exists.
PRO TIP
Always specify a survival period for confidentiality obligations, typically 3-5 years post-contract.
Example clauses
FAVORABLE
Preferred Confidentiality Clause
"The receiving party shall treat all information received as confidential and shall not disclose it to any third party without the disclosing party's prior written consent, except as required by law or regulation."
NEUTRAL
Fallback Confidentiality Clause
"Confidential information may be disclosed to third parties only if necessary for the performance of this agreement and with prior written consent from the disclosing party."
UNFAVORABLE
Unfavorable Confidentiality Clause
"The receiving party may disclose confidential information at its discretion, provided it notifies the disclosing party."
Fallbacks
High-Risk Projects
In high-risk projects, ensure confidentiality clauses are more stringent to protect sensitive data from potential leaks.
Cross-Border Transactions
Consider additional compliance with international data protection laws, such as GDPR, in cross-border transactions.
Healthcare & Life Sciences
Include specific references to healthcare regulations like HIPAA to ensure compliance and protect patient data.
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