What happens when a medical device can't get market authorization, and the distribution agreement doesn't say who was responsible for obtaining it? Björn will use a German–Hong Kong distribution dispute to show a conflict that is typical of highly regulated industries: who bears the risk that regulatory approval fails.
Björn will explain why access to the other side's regulatory filings and correspondence with authorities, together with expert-driven case management, can decide the outcome of such disputes. He will close with practical lessons on avoiding these disputes: clear clauses on license responsibility and information rights, the right mix of expertise on the tribunal, settlement windows after the expert phase, and emergency relief to secure product registrations.
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