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31-Month Suspension of Affiliates Violates FAR

Client Alert | less than 1 min read | 07.06.12

In Agility Def. and Gov't Servs. (June 26), an Alabama District Court rejected the government's assertion that an agency's suspension of a government contractor is beyond judicial review and overturned the suspensions because they had exceeded 18 months, in violation of FAR 9.407-4(b). The two plaintiffs were suspended in November 2009 based on their affiliation with an indicted contractor, Public Warehousing Company, and, although the initial suspension of the affiliates was proper, the agency could not extend the suspensions of the affiliates beyond 18 months because legal proceedings had not been initiated against the affiliates themselves.


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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....