8
PLAYBOOK TEMPLATES

Clinical Trial Agreement

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.

Term and Termination

Why This Matters: Rigid term provisions can lock parties into unfavorable arrangements or complicate exits, increasing risk.

Negotiation strategy

If you're the Sponsor:

Negotiate for flexible termination rights to allow exit in case of material breach. Ensure renewal terms align with business objectives.

If you're the Institution:

Seek to limit termination rights to protect ongoing business. Propose clear renewal terms to ensure continuity.

Essential elements

1

Contract Duration

Defines the length of the contract.
2

Renewal Options

Outlines conditions for contract renewal.
3

Termination Rights

Specifies conditions for ending the contract.

Action framework

ACCEPT

Propose edits when renewal terms are unclear or termination rights are too restrictive.

EDIT

Reject clauses that do not allow termination for cause or convenience.

ADD

Add language to define contract duration and termination rights if absent.

PRO TIP

Always ensure termination clauses include a clear definition of material breach.

Example clauses

FAVORABLE

Flexible Termination Clause

"The term of this Agreement shall be [X years], with automatic renewal for successive [Y year] periods unless either party provides written notice of non-renewal at least [Z days] prior to the end of the current term. Either party may terminate this Agreement for cause upon material breach by the other party, with [30 days] written notice."
NEUTRAL

Standard Termination Clause

"This Agreement shall continue until terminated by either party with [60 days] written notice. Termination for cause may occur upon material breach, subject to [30 days] cure period."
UNFAVORABLE

Restrictive Termination Clause

"The Agreement shall automatically renew for successive terms unless terminated by mutual consent."

Fallbacks

High-Risk Projects

In high-risk projects, ensure termination rights are robust to allow exit if project risks materialize.

Long-Term Partnerships

For long-term partnerships, focus on renewal terms that allow periodic review and adjustment.

Short-Term Contracts

In short-term contracts, prioritize clear termination rights to avoid unnecessary extensions.
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