Strategic Advocacy: Overcoming Compliance Risks in a High-Stakes Acquisition

Castle Harbour helped a U.S. healthcare buyer secure broad RWI coverage in the face of a complex regulatory compliance issue involving a European medical device target.

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Castle Harbour was engaged by a U.S.-based healthcare company pursuing the acquisition of a European medical device manufacturer with operations across Switzerland and Germany. A major diligence hurdle emerged when the target disclosed an unresolved regulatory compliance issue related to clinical trial documentation—a risk that threatened to trigger future product liability claims and regulatory sanctions.

Recognizing the sensitivity and complexity of the exposure, Castle Harbour worked hand-in-hand with the client’s regulatory counsel to frame the issue appropriately for the insurance markets. By carefully isolating the nature of the exposure and demonstrating proactive remediation efforts by the target, Castle Harbour successfully negotiated extremely limited, rather than broad, exclusions with the RWI underwriters.  The result: the buyer obtained comprehensive policy coverage for the balance of the target’s operations, mitigating the most critical regulatory risk and maintaining full acquisition momentum despite late-stage diligence concerns.

Policy type: Buyer-side RWI
Size: $250MM - $500MM
Sector: Healthcare / Life Sciences

Buyer type: Strategic / Corporate
Buyer jurisdiction: U.S.
Seller jurisdiction: Switzerland