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Court Tackles Hubzone Issues In Two Cases

Client Alert | less than 1 min read | 04.12.05

In Mark Dunning Industries, Inc. v. U.S. (Mar. 4, 2005), the Court of Federal Claims, after finding it has jurisdiction to review a SBA protest decision of a bidder's HUBZone qualification, decided that the SBA had appropriately found the bidder qualified because its "principal office" (which was in a HUBZone) was different from its headquarters (which was not). In Manson Construction Co. v. U.S. (Mar. 14, 2005), the court validated award to the second-low bidder which won because of application of the HUBZone preference, while also upholding the agency's revision of its internal estimate that brought the contractor within the "zone" of permissible cost.

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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....