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PLAYBOOK TEMPLATES

Research Collaboration Agreement

A Research Collaboration Agreement outlines cooperative research activities between institutions or companies. This playbook discusses IP ownership, publication rights, and funding obligations.

Regulatory Compliance

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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