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New York State Debarment Risk Update

Client Alert | 1 min read | 04.05.19

Highlighting the renewed focus on debarment in state and local contracting, the state of New York recently reminded purchasing agencies of their obligations to debar non-responsible contractors and to confirm that intended awardees are otherwise eligible before awarding contracts. Executive Order (EO) 192, issued by Governor Cuomo, directs purchasing entities to consider vendor responsibility by evaluating, among other factors, financial and organizational capacity, integrity, and past performance. If buying agencies become concerned about a contractor’s responsibility, the EO instructs agencies to conduct an investigation and make a responsibility determination. Agencies are required to list nonresponsible vendors on the Office of General Services’ website. No state agency may purchase from a vendor on that list, absent a waiver, or agency leadership risks “breaching their duty as a public officer . . . ” suggesting that contract rescissions may follow, among other consequences.

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....