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COFC Reverses Another Cica Stay Override

Client Alert | less than 1 min read | 05.10.04

Although the protester’s incumbent contract (and the 6-month extension) had expired, in Keeton Corrections, Inc. v. U.S., (March 17, 2004), the Court of Federal Claims rejected as arbitrary and capricious an override decision that was premised on the purported necessity of using the awarded contract to deliver necessary correctional services to the Bureau of Prisons. The court found that the agency had not explained why sole source purchase orders could not be used to obtain the necessary services pending GAO’s protest decision, and held that such sole source orders (issued either to the protester or the awardee) would be permissible under the circumstances, and would be less harmful to competition than an override of the CICA stay.

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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....