A Research Collaboration Agreement outlines cooperative research activities between institutions or companies. This playbook discusses IP ownership, publication rights, and funding obligations.
Why This Matters: Strict regulatory compliance prevents enforcement actions, fines and product delays in highly regulated healthcare and life sciences sectors.
Negotiation strategy
If you're the Institution A:
Ensure all compliance measures are clearly outlined and agreed upon. Regularly review and update compliance protocols to align with current regulations.
If you're the Institution B:
Negotiate for clear indemnification clauses to protect against potential non-compliance. Ensure audit rights are reasonable and do not disrupt operations.
Essential elements
1
Compliance Obligations
Adherence to all relevant laws.
2
Audit Rights
Verification of compliance adherence.
3
Indemnification
Protection against non-compliance claims.
Action framework
ACCEPT
Propose edits when new regulations are introduced or existing ones are amended.
EDIT
Reject clauses that impose unreasonable audit demands or lack clear compliance guidelines.
ADD
Add clauses for new jurisdiction-specific regulations or emerging compliance areas.
PRO TIP
Regularly consult with legal experts to stay updated on regulatory changes and ensure contract terms reflect current laws.
Example clauses
FAVORABLE
Comprehensive Compliance Clause
"Each party shall comply with all applicable healthcare and life sciences laws, regulations, and guidelines, including but not limited to HIPAA and FDCA."
NEUTRAL
Basic Compliance Acknowledgment
"Parties agree to adhere to applicable laws and regulations."
UNFAVORABLE
Vague Compliance Terms
"Parties should try to comply with relevant laws."
Fallbacks
High-Risk Projects
In high-risk projects, ensure more stringent compliance checks and detailed audit rights to mitigate potential regulatory breaches.
Cross-Border Transactions
For cross-border deals, include clauses addressing international regulatory requirements and potential conflicts of law.
Emerging Technologies
Incorporate specific compliance measures for new technologies that may not yet be fully regulated.
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