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Board Clarifies that Claim Accrual Contains Implicit "Reasonableness" Standard

Client Alert | 1 min read | 06.07.17

In Sparton DeLeon Springs, LLC (ASBCA No. 60416, May 18, 2017), the Board denied the government’s request for reconsideration of an earlier Board decision, which had rejected the government’s claim for recoupment of alleged overpayments of direct costs as time-barred by the CDA's six-year statute of limitations (previously discussed in a blog post). In support of this reconsideration decision, and in response to the government’s argument that "the Board applied the wrong legal standard for determining whether the claim had accrued," the Board explained that it saw "no conceptual difference between the 'should have been known' standard set forth in [FAR] 33.201" and "the phrase 'reasonably should have known' recited by the government" because "the one expresses only what the other implies."

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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....