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You Must Ante Up To Play In The Game

Client Alert | less than 1 min read | 05.11.06

The Federal Circuit in Rex Service Corp. v. U.S. (May 8, 2006) emphasized that a company must respond to a solicitation, even if it thinks it is flawed, to be able to have standing as an "interested party" to protest. Unless the company is prevented from bidding (e.g., by a sole-source award), a company does not meet the requirements of being "an actual or prospective bidder" with a "direct economic interest" if it could have bid but didn't.

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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....