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FY 2013 NDAA Shines a Spotlight on Contractor Indemnification

Client Alert | less than 1 min read | 01.04.13

Section 865 of the FY 2013 National Defense Authorization Act, signed into law on January 2, requires the Secretary of Defense to report to Congress when "entering into a contract that includes an indemnification provision relating to bodily injury caused by negligence or relating to wrongful death" or modifying an existing contract to include such language. This requirement (which excludes contracts awarded under 10 U.S.C. § 2354 and CERCLA, but not indemnification provisions authorized under Public Law 85-804) ratchets up the recent focus on contractor recovery for work performed under government contracts with its mandate that the Secretary explain to Congress the justification for including the indemnification provision.


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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....