Life SciencesLiability

CDMO FAQ

What is the difference between additional insured and named insured for a CDMO sponsor MSA?

A named insured is a party that owns the policy: receives notice of cancellation, has rights of disclosure, and shares premium responsibility. A CDMO's named insureds are typically the operating entity, any affiliated holding company, and any related entity sharing the same risk pool. Adding a sponsor as named insured is rare and structurally inappropriate.

An additional insured (AI) is a party covered by the policy for liability arising out of the CDMO's operations, products, or completed operations - but does not own the policy and has no rights in it beyond the coverage extension. Sponsor MSAs almost universally require the sponsor (and sometimes its affiliates and parent) added as additional insured, on a primary and non-contributory basis, with respect to products and completed operations.

The most common gap on existing CDMO programs: blanket AI endorsement covers ongoing operations only, excluding products and completed operations. The Certificate of Insurance shows "additional insured" checked, but the underlying endorsement (typically CG 20 10 alone, missing CG 20 37) does not respond after the product leaves the manufacturer's control. A strict MSA read identifies this as non-compliant.

Related

CDMO sponsor MSA review

A specialist will reach out by end of business day.

Request a free coverage review