Module 5 Presentations

19/07/2024

Contractual arrangements

 Content of agreement: ● Parties - which company/legal entity

● Recitals - background/objective ● Definitions - all important terms

● Rights and obligations of each party - generally the who, what, how, when and where (N.B. penalties, exclusions and indemnities) ● Termination provisions ● “Boiler plate clauses” - notices, variation, waivers, arbitration, governing law etc ● Signatures - authorised persons only ● Schedules/Annexes –detailed provisions regarding specific issues

The Organisation for Professionals in Regulatory Affairs

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Contractual arrangements

• Investigators and Sponsors – e.g. NHS/ ABPI/ BIA model Clinical Trial Agreement: – Obligations of Sponsor and Investigator with respect to obtaining regulatory approvals – Arrangements for conduct of the trial, including recruitment of trial subjects, monitoring, pharmacovigilance – Indemnities – IP rights – Confidentiality – Termination provisions

The Organisation for Professionals in Regulatory Affairs

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