DOD Revises IP Commercial Item Rules
Client Alert | less than 1 min read | 09.21.11
On September 20, 2011, DOD issued a final rule amending DFARS Part 227 and the associated clauses to eliminate the presumption of development at private expense for commercial items (other than commercially available off-the-shelf items) for major systems or subsystems. However, the implementation of this rule introduces great uncertainty as to the government’s rights to commercial item technical data and commercial computer software when there has been even a minimal government investment, particularly as it relates to the applicability of commercial licenses and marking requirements.
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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


