Module 5 Presentations

19/07/2024

Contractual arrangements

• Issues to be aware of: – Letters of intent

– Beginning the trial before the contract is written/signed – Inconsistency with other trial documents (protocol) – Undefined terms – Incorporating other documents (cross referencing) – Gaps and ambiguities

The Organisation for Professionals in Regulatory Affairs

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Contractual arrangements

• Remedies for breach of contract

– Parties may specify remedies in the contract – Rights of the “injured” party depend upon the type of clause breached (conditions, warranties, intermediate terms) - Rescission (fundamental breaches – conditions) - Damages to place party in position would have been in if the contract had been performed), subject to mitigation and legal limits (remoteness) - Specific performance - Injunctions

The Organisation for Professionals in Regulatory Affairs

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