Company: TVRD
Filing Date: 2025-05-30
Form Type: S-1
Source: 0001104659-25-054853
Chunk: 474

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-05-30
Form: S-1
Chunk 474
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 with Vifor Agreement No. 1. Cara also retained the rights to import, distribute, promote, sell and otherwise commercialize the Licensed Product on an exclusive basis outside of the Field either in or outside of the United States.The Vifor International Supply Agreement is accounted for as a customer option that is not a material right because the selling price of the Licensed Product under the Vifor International Supply Agreement is Cara’s COGS plus an agreed upon margin, which is commensurate with the “COGS plus” model that Cara would charge other parties under similar agreements (the standalone selling price) and not at a discount. Therefore, the sale of commercial supply to CSL Vifor is not a performance obligation under Vifor Agreement No. 1 but rather the Vifor International Supply Agreement is a separate agreement from Vifor Agreement No. 1. The only performance obligation under the Vifor International Supply Agreement is the delivery of the Licensed Product to CSL Vifor for commercialization. In connection with the consummation of the Asset Disposition, the Vifor International Supply Agreement was terminated (see Note 18,Subsequent Events).Vifor Fresenius Medical Care Renal Pharma Ltd.In May 2018, Cara entered into a license agreement with Vifor Fresenius Medical Care Renal Pharma Ltd. (“Vifor Agreement No. 2”) under which Cara granted Vifor Fresenius Medical Care Renal Pharma Ltd. an exclusive, royalty-bearing license, or the Vifor License, to seek regulatory approval to commercialize, import, export, use, distribute, offer for sale, promote, sell and otherwise commercialize the Licensed Product in the Field worldwide (excluding the United States, Japan and South Korea) (the “Territory”). In connection with the consummation of the Asset Disposition, Vifor Agreement No. 2 was terminated (see Note 18,Subsequent Events).Cara was eligible to receive from Vifor Fresenius Medical Care Renal Pharma Ltd. additional commercial milestone payments in the aggregate of up to $440,000, all of which are sales related. Cara was also eligible to receive tiered double-digit royalty payments based on annual net sales, as defined in Vifor Agreement No. 2, of difelikefalin injection in the licensed territories. Cara retained full commercialization rights for difelikefalin injection for the treatment of chronic kidney disease associated pruritus in the United States except