Life SciencesLiability
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LimitsNegotiable

Products / Completed Operations - $10M

What this clause says

Products and Completed Operations coverage with limits of not less than $10,000,000 per occurrence and in the aggregate.

What this means in plain English

Higher-tier products liability limit, typical for sponsors manufacturing oncology, biologics, injectable products, or any Schedule I-IV controlled substances.

What it means for a CDMO program

Going from $5M to $10M usually means stacking a $5M excess layer over a $5M primary tower, which is a meaningful premium step ($15K-$40K depending on revenue and product). If your sponsor is asking for $10M, they likely have higher product risk you should also be pricing into your manufacturing fee.

Carrier notes

Negotiable - many sponsors will accept $5M for non-injectable, non-Schedule oral solid dose work.

How this evaluates

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

  • products › total limit is at least $10M → Compliant: Total products limit meets $10M.
  • products › total limit is at least $5M → Borderline: Below $10M - needs additional excess layer.
  • products › total limit is not set → Gap: No products liability limit indicated.

See this in your MSA

Map this clause against your sponsor MSA.

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Related clauses

Common questions about this clause

Questions about limits

Products / Completed Operations - $10M - common questions

What kinds of sponsors typically require $10M products?

Sponsors manufacturing oncology drugs, biologics, injectables, and Schedule I-IV controlled substances. The higher requirement reflects higher product risk on their side.

How do I get from $5M to $10M most efficiently?

Stack a $5M excess layer over a $5M primary tower. Single-carrier $10M towers exist but cost more per million than the layered approach for most CDMOs in this segment.

Should I price the $10M cost into my manufacturing fee?

Yes. The $15K-$40K incremental premium for the excess layer is real cost-of-doing-business with that sponsor and should be reflected in margins.