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Eleventh Circuit OK’s Suspension of Affiliates Beyond 18 Months

Client Alert | 1 min read | 01.08.14

In Agility Def. & Gov’t Servs. v. Dep’t of Def. (Dec. 31, 2013), the Eleventh Circuit reversed the judgment below and held that when an agency suspends a contractor it may suspend affiliates of that contractor for greater than 18 months based solely on their affiliation provided legal proceedings have been initiated during that period against the contractor. The district court had held that the regulations required affiliation-based suspensions to be lifted after 18 months unless legal proceedings had been initiated against the affiliates themselves, but the Eleventh Circuit held that affiliates are afforded sufficient due process and that no independent showing of wrongdoing by an affiliate is required for suspension or debarment.


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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....