Life SciencesLiability
SpecialtyNegotiable

Professional Liability / E&O — $2M

What this clause says

Errors and Omissions / Professional Liability insurance with a limit of not less than $2,000,000 per claim and in the aggregate, covering Manufacturer's professional services rendered under this Agreement.

What this means in plain English

Coverage for losses caused by professional errors that do not result in bodily injury or property damage.

What it means for a CDMO program

Most CDMOs do NOT need standalone E&O if they only manufacture to spec. Where you DO need it: if you provide formulation development, analytical method development, stability programs, regulatory consulting, or any service where the deliverable is intellectual rather than physical product. CROs almost always need this as a primary coverage.

Carrier notes

The dedicated life-sciences markets write monoline life sciences E&O. Many package programs include it.

How this evaluates

The Decoder applies these rules in order; the first match wins.

  • professional liability › limit is at least $2M → Compliant: E&O meets $2M.
  • professional liability › limit is not set → Gap: No professional liability indicated — required for CROs and CDMOs offering development services.

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Questions about specialty

Professional Liability / E&O — $2M — common questions

When does a CDMO need professional liability?

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When the MSA includes any service-like deliverables: consulting, formulation development, regulatory submission support, analytical services. Pure manufacturing without those deliverables typically does not require it.

How is this different from products liability?

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Products covers physical harm from the manufactured product. Professional / E&O covers errors in the service or advice provided. They are separate coverages on separate forms.

Is $2M professional enough?

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Standard for analytical-services-only deliverables. Higher tiers ($3M-$5M) when the deliverable includes regulatory submissions or formulation IP.