GSA Finalizes Rule Declaring Certain Commercial Supplier Agreement Terms Unenforceable
Client Alert | 1 min read | 02.26.18
On February 22, 2018, GSA published a final rule amending its acquisition regulation and declaring certain common Commercial Supplier Agreement (CSA) terms—such as indemnification and arbitration provisions, provisions that subject the U.S. Government to state law, and automatic renewal provisions—unenforceable in government contracts as inconsistent with federal procurement law. GSA published the proposed rule in June 2016 (discussed here) and related class deviation (discussed here) in August 2015.
The final rule makes several noteworthy changes to GSA’s proposed rule, including: (1) it reverts the order of precedence of contract terms to give precedence to “[a]ddenda to [the] solicitation or contract, including any commercial supplier agreements as amended by the Commercial Supplier Agreements—Unenforceable Clauses provision” over “[s]olicitation provisions” and “[o]ther paragraphs of [the] clause”; and (2) it removes the previously proposed requirement to provide full text CSA terms with the offer, paving the way for CSA terms to be incorporated by reference. As GSA maintains, this final rule will eliminate the need for negotiation on the identified unenforceable terms and could facilitate faster procurements.
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Hikma and Amici Curiae Ask Supreme Court to Revisit Induced Infringement by Generic “Skinny Labels”
In Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., C.A. No. 20-1630 (D. Del.), brand manufacturer Amarin brought an induced infringement claim against Hikma’s generic icosapent ethyl product, which lists Amarin’s Vascepa® as the reference listed drug. Vascepa was originally approved by the U.S. Food and Drug Administration (“FDA”) to treat severe hypertriglyceridemia, and later, Amarin obtained patents and approval for Vascepa as a treatment to reduce cardiovascular risk in certain patient populations. Hikma’s Abbreviated New Drug Application (“ANDA”) for generic icosapent ethyl included a Section viii statement that Hikma was not seeking approval for the patented cardiovascular indication along with a “skinny label” that included only the indication for severe hypertriglyceridemia.
Client Alert | 1 min read | 04.09.25
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