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Offerors Beware: Exceptions to Data Rights Requirements May Prove Fatal

Client Alert | less than 1 min read | 02.03.16

In Deloitte Consulting, LLP (released Jan. 14, 2016), GAO held that, because the awardee’s proposal had taken exception to a solicitation provision that granted the government broader rights in materials (including software source code) than the rights conveyed by the FAR's standard data rights clause, it was unacceptable. This case serves as a reminder that the time for objecting to solicitation provisions, including those relating to technical data and computer software rights, is prior to proposal submission.

Insights

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....