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Agency Can't Ignore Obvious Costs In Evaluation

Client Alert | less than 1 min read | 04.18.05

While agencies are given latitude in establishing evaluation criteria, an agency cannot rationally fail to include costs it knows will be involved in the procurement. The Court of Federal Claims in Arch Chemicals, Inc. v. U.S. (Mar. 18, 2005) instructed that the agency unreasonably excluded from the evaluation plant shutdown costs it was obligated to pay the incumbent if it awarded to another company.

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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....