CGL Manufacturers' Exclusion Warning
What this clause says
Vendor warrants that its Commercial General Liability policy does not contain any exclusion or limitation that would restrict coverage for Vendor's pharmaceutical, biotechnology, medical device, or compounding manufacturing operations, and shall provide policy form documentation upon Sponsor request.
What this means in plain English
A specific warning against the "manufacturers' exclusion" - a CGL endorsement (ISO CG 21 49 or similar) that excludes coverage for products manufactured by the insured. Generic CGL policies sometimes include this exclusion by default; the result is no products coverage at all under the CGL.
What it means for a CDMO program
Verify at every policy review. The manufacturers' exclusion can render an otherwise-complete CGL/products program functionally useless for a contract manufacturer. The fix is policy replacement, not endorsement - generic markets that include the exclusion typically cannot remove it. Dedicated life-sciences markets do not use this exclusion.
Carrier notes
This is the single most common hidden gap in CGL programs written by generalist commercial markets. Confirmed-clear status requires either a policy form review or a manuscripted assertion from the carrier.
How this evaluates
The Decoder applies these rules in order; the first match wins.
- cgl › manufacturers exclusion is set → Gap: CGL contains manufacturers' exclusion - products coverage may be void.
- cgl › manufacturers exclusion is not set → Compliant: No manufacturers' exclusion confirmed.
See this in your MSA
Map this clause against your sponsor MSA.
Run the DecoderRelated clauses
Common questions about this clause
- What insurance coverage does a medical device manufacturer need to supply a GPO?
- How does a typical sponsor MSA insurance schedule read?
- Who needs pharmaceutical products liability insurance?
- What products liability insurance do medical device manufacturers need?
- Which MSA clauses require additional insured status for products and completed operations?