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Presolicitation Statements Not Dispositive Of Whether Mod Is Beyond Scope

Client Alert | less than 1 min read | 12.28.05

An agency's presolicitation statement that it did not initially intend a contract to include certain work did not bar the agency from later adding that work, according to the Court of Federal Claims in HDM Corp. v. United States (Dec. 14, 2005). Whether a contract was amended beyond its scope depends upon the breadth of the stated objectives of the solicitation, whether bidders were told that work could be added, and the nature of the added work, so early agency statements are not dispositive, the court held in this case successfully litigated by Crowell & Moring.

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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....