jw van zyl ıncTransactions and diligence
Structure the transaction around the risk that does not transfer.
In healthcare and life-sciences transactions, the things the business actually runs on do not move with the shares or the assets as a matter of course. Licences and product authorisations may be held by the wrong entity, require regulatory consent, or lapse on a change of control. Study and safety obligations survive completion. Product liability follows the product, not the transaction structure. The firm establishes which of those apply while the structure and the price can still respond to it.
Who this is for
Investors, manufacturers, strategic buyers and portfolio companies
Typically instructed by: Corporate development · investment teams · in-house legal · portfolio operations
Scope
What can be instructed
- Licences and authorisations
- Which licences and product authorisations the business operates under, which entity holds them, whether they are transferable, what consent a transfer requires, and whether they survive a change of control.
- Obligations that survive completion
- Study, sponsor, safety-reporting and post-market obligations that continue after the transaction, who carries them afterwards, and what the transaction documents have to say for that to work.
- Quality, pharmacovigilance and product liability
- Quality systems, safety-reporting history, historical recalls and open liability exposure, including exposure attaching to product already in the market.
- Regulated operations
- Diligence on clinical-research operations and site networks, and on regulated manufacturing, diagnostics and medical-device operations, including establishment and product authorisations.
- Data and intellectual property
- Ownership of study and operational data, patient-data compliance, and the ownership chain of the target's intellectual property, including anything created by contractors or funded partners.
- Deal terms and post-completion governance
- Warranties, indemnities and conditions specific to regulated risk, the separation or transition arrangements a regulated business needs, and the governance that follows completion.
Where a transaction raises merger control or tax structuring, the firm coordinates competition and tax counsel rather than advising on those questions directly.
Before you instruct
What helps the firm assess the matter
- The target and the acquiring entity, for the conflicts check.
- The stage of the transaction and the exclusivity or signing date.
- Whether a data room is open and what disciplines are already covered.
- The scope of the regulatory workstream you need covered.
Free tool
Before you instruct, work through the checklist
Use the Healthcare M&A regulatory due-diligence checklist, the exposure a standard review misses.