Company: TVRD
Filing Date: 2025-10-07
Form Type: S-1/A
Source: 0001104659-25-097519
Chunk: 267

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-10-07
Form: S-1/A
Chunk 267
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 associated with pruritus in hemodialysis and peritoneal-dialysis patients anywhere in the world and for supply of KORSUVA injection to Vifor Pharma. The supply price was Cara’s cost of goods sold as calculated under U.S. GAAP, plus an agreed upon margin.

CSL Vifor paid Cara $639,611 and $5,842,758 pursuant to the Vifor Pharma Supply Agreement for the fiscal years ended December 31, 2024 and 2023, respectively.

The Vifor Pharma Supply Agreement was terminated upon consummation of the Asset Disposition.

Transactions With Vifor Fresenius Medical Care Renal Pharma Ltd.

Fresenius License Agreement

In May 2018, Cara entered into a license agreement with VFMCRP (the “Fresenius Agreement”) under which Cara granted VFMCRP an exclusive, royalty-bearing license to seek regulatory approval to commercialize, import, export, use, distribute, offer for sale, promote, sell and otherwise commercialize KORSUVA (difelikefalin) injection for all therapeutic uses to prevent, inhibit or treat itch associated with pruritus in hemodialysis and peritoneal-dialysis patients worldwide (excluding the United States, Japan and South Korea). Cara retained full development and commercialization rights for KORSUVA injection for the treatment of CKD-aP in dialysis patients in the United States except in the dialysis clinics of Fresenius Medical Care North America (“FMCN”), where VFMCRP promotes KORSUVA injection under a profit-sharing arrangement.

Cara was eligible to receive from CSL Vifor commercial milestone payments in the aggregate of up to $440.0 million, all of which milestones were sales related. Cara was also eligible to receive tiered double-digit royalty payments based on annual net sales, as defined, of KORSUVA (difelikefalin) injection in the licensed territories. In the United States, CSL Vifor promoted KORSUVA (difelikefalin) injection in the dialysis clinics of FMCNA under a profit-sharing arrangement (subject to the terms and conditions of the Fresenius Agreement) based on net FMCNA clinic sales (as defined in Fresenius Agreement) and Vifor Fresenius Medical Care Renal Pharma Ltd. was entitled to 50% of such net profits, subject to potential adjustments in a calendar year based on certain conditions.

In