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Services In Contract Don't Trump "Non-Manufacturer Rule"

Client Alert | less than 1 min read | 09.13.06

In Rotech Healthcare Inc. v. United States (July 24, 2006), a pre-award bid protest of small business set-aside procurements, the Court of Federal Claims held that the Small Business Act's "non-manufacturer rule" requires recipients of small business set-aside contracts to provide products only of domestic small business manufacturers, even if the contract is for both products and services. Finding, inter alia, that the statute is "clear and unambiguous" in its application of the rule to "any" contract for the supply of a product, Judge Bush rejected government pleas for deference to SBA's less-restrictive applications of the rule and permanently enjoined set-aside awards to offerors who failed to certify compliance.

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....