Attention To Small Business Subcontracting Plan Is No Small Matter
Client Alert | less than 1 min read | 11.07.05
In Coastal Maritime Stevedoring, LLC (Sept. 22, 2005 http://www.gao.gov/decisions/bidpro/296627.pdf), GAO found unreasonable the Source Selection Authority's decision to change the awardee's rating from unsatisfactory to satisfactory under the socioeconomic commitment factor when the awardee's small business subcontracting plan failed to address required elements of FAR 19.704 and otherwise neglected to comply with the solicitation's required objective for subcontracting to small businesses 10% of the total contract value. GAO also determined that the agency's price/technical tradeoff was flawed because it failed to take into account advantages in the protester's proposal that translated into quantifiable cost savings to the government.
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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.
Client Alert | 4 min read | 04.13.26
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