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TL;DR

A 12-month review of pharmaceutical sponsor MSA insurance and indemnity provisions submitted to our MSA Decoder tool. Six findings, summarized: sponsor MSAs are now drafted to transfer risk completely to the contract manufacturer, and most operator programs cannot absorb what the MSA assigns. Methodology, raw findings, and citation guidance below.

Research · 2026

MSA Indemnity Drift Benchmark 2026.

Over the 12 months ending 31 May 2026, Life Sciences Liability reviewed sponsor MSA insurance and indemnity provisions submitted to the free MSA Decoder tool by life-sciences operators across 47 US states. Submissions span contract development and manufacturing organizations (CDMOs), contract research organizations (CROs), medical device manufacturers, and 503B outsourcing facilities.

The pattern is unambiguous: sponsor MSAs are no longer drafted to be balanced. They are drafted to transfer risk completely to the contract manufacturer, and most operator programs cannot absorb what the MSA assigns.

Findings

  1. 64%

    of sponsor MSAs reviewed contain one-way indemnity language

    The contract manufacturer indemnifies the sponsor for any claim arising out of the manufacturer's services, with no reciprocal obligation, and frequently with no cap aligned to insurance limits. A single sponsor claim that exceeds insurance limits becomes a direct claim against company equity.

  2. 78%

    of sponsor MSAs require coverages or endorsements absent from the manufacturer's current COI

    The most common gap: additional insured for products and completed operations on a primary, non-contributory basis. Approximately 41% of certificates carried only ongoing-operations AI, which does not satisfy a strict MSA read.

  3. 89%

    of certificates did not satisfy 30-day notice of cancellation language

    The "endeavor to provide notice" disclaimer most carriers issue does not constitute the carrier obligation MSAs require. A sponsor enforcing this clause can effectively call a default on any active manufacturing campaign.

  4. 71%

    of programs reviewed carried no dedicated recall coverage

    Most generalist manufacturing packages carry recall as a sublimit on the products policy, capped at a level that does not respond to a real FDA Class I recall. Sponsor MSAs increasingly require recall as a dedicated first-party policy.

  5. 47%

    of programs reviewed were under-sized on the products tower

    Sponsor MSAs in oncology, sterile injectable, biologics, and controlled-substance manufacturing increasingly require $10 million products and completed operations; many manufacturers carry $5 million as a holdover from a general manufacturing baseline.

  6. 33%

    of submissions referenced sponsor change-control or audit triggers

    Sponsor MSA language increasingly ties insurance compliance to change-control or audit gates - a non-compliant COI does not just risk first-claim exposure, it risks campaign-stop or sponsor-walk under the contract terms.

Methodology

How these numbers were derived.

Findings are drawn from anonymized aggregate data on submissions to the MSA Decoder tool over the 12 months ending 31 May 2026. Each submission includes the sponsor MSA insurance section, the operator's self-reported program structure (limits, endorsements, and dedicated lines), and the sponsor and operator categories.

Submissions with insufficient information to score against the clause library were excluded. All findings are reported as a percentage of qualifying submissions. Raw counts are available on request to research-grade publications.

Citation

For journalists and publications.

Free to cite with attribution. Suggested citation format:

Life Sciences Liability, “MSA Indemnity Drift Benchmark 2026,” lifesciencesliability.com/msa-indemnity-benchmark-2026.

Reach press@lifesciencesliability.com for raw counts, additional cuts of the data, or scheduled briefings.

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