What are typical CDMO contract terms?

A typical CDMO Master Service Agreement contains the following core sections: scope of work (the manufacturing services and product specifications), regulatory responsibility allocation (which party owns FDA filings, inspection response, and reporting obligations), a quality agreement (the technical operating document for batch release, deviations, CAPAs, and change control), intellectual property ownership (who owns the manufacturing process, formulation, and improvements), indemnity (the allocation of legal liability between sponsor and manufacturer), insurance schedule (the coverages and limits the manufacturer must maintain), term and termination (typically multi-year with conditional termination rights), and dispute resolution.

Standard insurance schedules require Commercial General Liability with $1M per occurrence and $2M aggregate, products and completed operations at $5M (rising to $10M for sterile injectable, biologic, and controlled-substance work), workers compensation at statutory limits, automobile liability at $1M, umbrella or excess at $5M, professional liability for development services at $2M, and a 30-day notice of cancellation provision.

The recall extension, additional-insured provisions for the sponsor, primary and non-contributory wording, waiver of subrogation, and survival of coverage post-termination are the clauses that most often catch existing programs short of compliance.