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Avoid Increased Damages, Ensure the Accuracy of Your Size and Status Certifications

Client Alert | 1 min read | 07.08.13

On June 28, 2013, the SBA issued a final rule, effective August 27, which (1) requires an authorized official of the company to sign representations of size or status in a bid or proposal; (2) provides that the company must update those certifications on SAM at least annually or lose those statuses until recertification; and (3) states that actions such as submission of a bid, proposal, or application for a set-aside award are deemed representations or certifications of size and/or status. The final rule also increases the risk of these representations: if a company willfully seeks and receives an award through misrepresentation of size or status, there is now a legal presumption of damages to the government equal to the total amount expended by the government under the contract, grant, or agreement.


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....