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
Map this clause against your sponsor MSA.
Run the DecoderRelated clauses
Common questions about this clause
- How does the claims process work for life sciences insurance, and what claims support do you get?
- Does EU MDR compliance extend a US device maker’s products liability to EU claims?
- Does the sponsor or the CRO pay for clinical trial insurance?
- Does a life sciences company with employees need employment practices liability (EPLI) insurance?
- Is a business owners policy (BOP) enough for a clinical-trials company or CRO?