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
Negotiation strategy
Ensure all compliance clauses are comprehensive and cover all relevant regulations. Propose regular audits to verify adherence to standards.
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.
Real-world examples
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."
Alternative scenarios & positions
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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WEEK 1
CLM Readiness and Design
Our CX team works with you to understand your contracting challenges, prioritize key workflows, and identify the biggest impact areas. We build a tailored implementation plan that fits your needs.
WEEK 2
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WEEK 3
Deliver & Test
Your team builds initial playbooks, reviews existing clause libraries, and trains the DocJuris agent to align with your internal standards and negotiation positions.
WEEK 4
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