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The Confusing World of Compensation Caps

Client Alert | less than 1 min read | 01.13.14

As a result of the confusing, inconsistent, and in some cases unenforceable changes made in the cost allowability rules setting caps on compensation costs in recent months, it is difficult to determine what rules apply to some contracts. We prepared the attached chart, which we hope will be useful, summarizing our understanding of the various sets of regulatory and statutory provisions that are likely to be applicable to currently active contracts as a tool for deciding how many alternative indirect cost submissions could be required.


Insights

Client Alert | 5 min read | 04.13.26

EU Pharma Package: Global (Orphan) Marketing Authorization Compromise Proposal

In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA). We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product....