Life SciencesLiability

Question

Which MSA clauses require additional insured status for products and completed operations?

Short answer

The additional-insured-for-products-and-completed-operations requirement appears as a discrete clause in the insurance section of most sponsor MSAs, often phrased as "Additional Insured — Products and Completed Operations." It requires an endorsement (typically ISO CG 20 37 or a manuscripted equivalent) that extends additional-insured status to claims arising from your finished products after they leave your facility.

How the clause typically appears

Sponsor MSAs in life sciences almost universally contain an insurance schedule that itemizes required coverages, limits, and endorsements. The additional-insured-for-products clause is one of those itemized requirements, typically phrased as "Sponsor shall be named as Additional Insured for Ongoing Operations AND Products / Completed Operations on Contractor's Commercial General Liability policy" or similar wording.

The clause is distinct from the more common "additional insured for ongoing operations" requirement because most CGL policies provide blanket additional-insured for ongoing operations as a default endorsement but exclude products/completed ops from that blanket. The products/completed ops AI must be added separately.

Why this matters for contract manufacturers

For a contract manufacturer (CDMO, CMO, or 503B), products and completed operations IS the operation. The vast majority of product liability claims arise from the finished product after it has left the facility, not during the manufacturing process itself. Ongoing-operations AI alone provides essentially no protection against the claims most likely to be filed.

A sponsor that accepted only ongoing-operations AI from its contract manufacturer would have no recourse to the manufacturer's CGL policy in a typical product liability claim. Sponsors know this; the products/completed ops AI requirement is non-negotiable in virtually every modern MSA.

The fix: ISO CG 20 37 or manuscripted blanket

The most common solution is the ISO CG 20 37 endorsement — "Additional Insured — Owners, Lessees Or Contractors — Completed Operations." This adds AI status for products and completed operations on a per-contract basis (the named sponsor on the endorsement is the additional insured).

For contract manufacturers serving multiple sponsors, the more efficient solution is a manuscripted blanket endorsement that automatically extends AI-for-products status to "any person or organization with whom you have agreed in writing to provide such coverage in a contract executed prior to loss." This avoids the per-sponsor endorsement administration burden.

Carriers in the dedicated life-sciences markets routinely write the manuscripted blanket. Generic CGL markets sometimes do not. This is one of the friction points where program architecture matters: a CDMO insured in a generic commercial market may discover at MSA review time that its blanket AI endorsement excludes products, and adding it as a manuscripted endorsement requires going back to the carrier.

Common variations

Some sponsor MSAs require the additional insured to be on a "primary and non-contributory" basis, meaning the contractor's policy pays first without seeking contribution from the sponsor's own policies. This is a separate endorsement (ISO CG 20 01 or manuscripted equivalent) that pairs with the AI endorsement.

Some sponsor MSAs require "severability of interests" or "cross-liability" wording, which clarifies that the policy responds to each insured as if the others did not exist. This is usually built into the policy form and rarely a separate endorsement, but worth verifying.

A small number of sponsor MSAs require the AI endorsement to extend to "subsidiaries, affiliates, directors, officers, employees, and agents" of the sponsor. ISO CG 20 37 covers the named entity only; broader wording requires a manuscripted endorsement.

What to look for at MSA review

When reviewing a sponsor MSA, isolate the insurance schedule and identify (1) whether AI-for-products is explicitly required, (2) what primary/non-contributory wording is required, (3) what severability or cross-liability wording is required, and (4) whether AI extends to sponsor affiliates. Then verify the existing CGL endorsement schedule satisfies each requirement — either via existing blanket endorsements or via per-sponsor endorsements added prior to the effective date.

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