3
PLAYBOOK TEMPLATES

Material Transfer Agreement (MTA)

An MTA governs the transfer of tangible research materials between organizations. This playbook highlights confidentiality, permitted use, and ownership of resulting data or inventions.

Regulatory Compliance

Why This Matters: Non-compliance with regulatory frameworks can result in fines, product recalls, reputational harm, and legal liability.

Negotiation strategy

If you're the Provider:

Ensure all compliance clauses are comprehensive and cover all relevant regulations. Propose regular audits to verify adherence to standards.

If you're the Recipient:

Negotiate for reasonable audit terms and ensure indemnification clauses are balanced. Emphasize cooperation with regulatory authorities.

Essential elements

1

Compliance Representations

Obligations to follow laws.
2

Audit Rights

Rights to conduct compliance audits.
3

Indemnification

Protection against non-compliance claims.

Action framework

ACCEPT

Propose edits if specific regulations are omitted.

EDIT

Reject if compliance obligations are too vague.

ADD

Add clauses for emerging regulatory requirements.

PRO TIP

Regularly update compliance clauses to reflect changes in laws and regulations.

Example clauses

FAVORABLE

Comprehensive Compliance Clause

"Each party represents and warrants that it shall comply with all applicable healthcare and life sciences laws and regulations, including but not limited to the Federal Food, Drug, and Cosmetic Act, the Health Insurance Portability and Accountability Act (HIPAA), and any other applicable regulations enforced by the Food and Drug Administration (FDA)."
NEUTRAL

Basic Compliance Acknowledgment

"Each party acknowledges the importance of complying with applicable healthcare laws."
UNFAVORABLE

Limited Compliance Obligation

"Each party shall make reasonable efforts to comply with applicable laws."

Fallbacks

High-Risk Products

For high-risk products, ensure more stringent compliance and audit requirements are included to mitigate potential liabilities.

International Operations

Include clauses addressing compliance with international regulations and standards, especially in jurisdictions with strict healthcare laws.

New Market Entry

When entering new markets, ensure compliance clauses are tailored to local regulatory requirements and include provisions for initial audits.
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