Skip to main content van Berings

Insights

trade&compliance corporate

Mitigating risks in Life Sciences M&A

​In the life sciences sector, acquisitions are essential tools for driving innovation, expanding product portfolios, and entering new markets. However, the industry’s complex regulatory framework, the high failure rate of clinical trials, and the uncertainty of commercial success make these transactions particularly risky. To manage these challenges, companies increasingly rely on advanced legal strategies and sophisticated contractual structures.

Earn-Outs: linking price to performance

One of the most common mechanisms for mitigating risk is the earn-out, whereby part of the purchase price is paid only upon the achievement of specific milestones, such as regulatory approvals or future sales targets. In such agreements, it is crucial to clearly define efforts covenants, i.e., the buyer’s obligations of diligence and good faith, to prevent disputes regarding the reasonableness of the efforts made. The effectiveness of an earn-out depends heavily on the clarity and balance of these clauses, which should reflect the nature of the business and the realistic expectations of stakeholders.

Option structures: flexibility and de-risking

Another strategy to manage uncertainty is the use of option structures, allowing the buyer to defer the acquisition decision and full payment until the occurrence of certain key events, such as the successful completion of critical clinical phases or the granting of regulatory approvals. These mechanisms require careful planning to define the assets in scope and ensure shareholder support during decisive phases. The ability to “opt in” at a later stage helps minimize initial financial exposure and align investment timing with asset maturity.

Representation and Warranty Insurance (RWI): post-closing protection

For less predictable risks that may arise after closing, such as pre-existing liabilities, compliance issues, or intellectual property breaches, Representation and Warranty Insurance (RWI) is becoming an increasingly relevant tool in life sciences transactions. Despite higher premiums and a less mature insurance market compared to other industries, RWI offers effective coverage to limit financial exposure and facilitate agreement between parties.

Strategic Due Diligence

A thorough and specialized due diligence process is essential to identify potential issues and accurately assess regulatory, intellectual property, and commercial risks. This integrated approach enables the design of targeted contractual clauses and insurance protections, reducing post-closing surprises and providing a solid basis for pricing and transaction terms.

In such a complex environment, expert legal counsel is of the essence. Drafting detailed and balanced contracts that govern earn-outs, option structures, and insurance coverage, combined with careful due diligence management, creates a strong risk-mitigation framework. Experienced lawyers also play a key role in negotiation and dispute resolution, ensuring that agreements reflect both parties’ interests while preserving transaction value.

van Berings provides specialized assistance to life sciences companies in M&A processes, with a particular focus on integrated risk management. We offer proactive legal advice on strategic deal structuring and due diligence, ensuring a comprehensive, tailored, and success-oriented approach to every transaction, as well as a seasoned dispute resolution practice with particular focus on IP and product liability controversies.

DISCLAIMER: the content of this news is for informational purposes only and neither represents, nor can be construed as a legal opinion