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SpecialtyStandard / Universal

Cyber Liability — $3M

What this clause says

Cyber Liability and Privacy insurance with a limit of not less than $3,000,000 per claim and in the aggregate, covering breach response, regulatory investigations, third-party liability, and business interruption from a network security event.

What this means in plain English

Coverage for data breaches, regulatory fines from privacy violations, and business interruption from cyber events.

What it means for a CDMO program

Increasingly required since 2023. If you handle sponsor PHI, drug master file data, or trade secrets, you need this. $3M is the new common requirement; some sponsors push to $5M. The application alone is now extensive (MFA, EDR, backup, vendor management) — start the renewal cycle 90 days before MSA execution.

How this evaluates

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

  • cyber › limit is at least $3M → Compliant: Cyber meets $3M.
  • cyber › limit is at least $1M → Borderline: Below $3M — may need limit increase.
  • cyber › limit is not set → Gap: No cyber coverage indicated.

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Pre-loaded with this clause selected.

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Related clauses

Questions about specialty

Cyber Liability — $3M — common questions

Why does a CDMO need cyber if we do not store patient data?

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Sponsor MSAs almost always require cyber because of (a) sponsor-confidential information you handle (formulations, manufacturing processes), (b) any PHI that flows through manufacturing for personalized therapies, and (c) GMP electronic records subject to 21 CFR Part 11.

Is $3M cyber enough for a mid-market CDMO?

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Usually yes for sponsors not handling significant PHI. Sponsors with large patient populations or significant biologics often require $5M-$10M.

What does pharma-grade cyber cover beyond a generic policy?

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GxP-related coverage extensions: validation event response, regulatory investigation costs, supply-chain disruption from a cyber event affecting manufacturing systems. A generic cyber policy will pay claim costs but may not cover the operational impact.