Life SciencesLiability
IndemnityAggressive — Push Back

One-Way Indemnity (Manufacturer Indemnifies Sponsor)

What this clause says

Manufacturer shall indemnify, defend, and hold harmless Sponsor and its affiliates from any and all claims, losses, damages, liabilities, costs, and expenses arising out of or related to Manufacturer's performance under this Agreement.

What this means in plain English

You alone agree to defend the sponsor and pay for any third-party claim that arises from your work — even if the sponsor was partially at fault.

What it means for a CDMO program

This is the unfavorable structure and a major redline target. At minimum, push for: (1) carve-outs for sponsor-supplied materials, sponsor specifications, sponsor regulatory submissions, and sponsor-directed manufacturing changes; (2) limit triggered only by your negligence, not strict liability; (3) cap aligned with your insurance limits so you are not exposed beyond what insurance pays.

How this evaluates

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

  • indemnity › structure equals one-way-manufacturer → Gap: One-way indemnity in favor of sponsor — major redline target.

See this in your MSA

Pre-loaded with this clause selected.

Run the Decoder

Related clauses

Questions about indemnity

One-Way Indemnity (Manufacturer Indemnifies Sponsor) — common questions

Is one-way indemnity acceptable?

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Aggressive but not unusual in startup-sponsor or single-product situations. Push for mutual or carve-outs at minimum.

How does this interact with my insurance?

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Your indemnity to the sponsor is contractual; your insurance responds to actual claims, not contract obligations directly. The two intersect when a third-party claim is brought against the sponsor and they tender it to you.

What is the negotiation move here?

+

Push to mutual, or carve out IP and regulatory matters from your indemnity, or cap at insurance limits.