DoD Proposes Significant Amendments to the DFARS Data Rights Scheme
Client Alert | 1 min read | 06.27.16
On June 16, 2016, DoD issued a proposed rule to amend the DFARS to implement section 815 of the National Defense Authorization Act for FY 2012, which made significant changes to the data rights scheme for DoD contracts. Among other things, the proposed rule permits the release of “segregation and reintegration” technical data and computer software outside of the government (subject to restrictions), even when the item, component, or process to which that data pertains or the computer software was developed exclusively at private expense; expands DoD’s ability to order technical data and computer software post-award; doubles the time period in which DoD may challenge asserted data rights restrictions; and expressly imposes no time limit on DoD’s right to challenge fraudulently asserted restrictions.
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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.
Client Alert | 4 min read | 04.13.26
Client Alert | 4 min read | 04.10.26
CMS Finalizes Rate Notice for Medicare Parts C and D (CY 2027)
Client Alert | 2 min read | 04.10.26


