Company: TVRD
Filing Date: 2025-05-30
Form Type: S-1
Source: 0001104659-25-054853
Chunk: 473

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-05-30
Form: S-1
Chunk 473
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 Vifor Fresenius Medical Care Renal Pharma Ltd. in May 2022, Vifor Agreement No. 1 provided full commercialization rights in dialysis clinics to CSL Vifor in the United States under a profit-sharing arrangement. Pursuant to the profit-sharing arrangement, Cara was generally entitled to 60% of the net profits (as defined in Vifor Agreement No. 1) from sales of difelikefalin injection in the United States and CSL Vifor was entitled to 40% of such net profits (excluding sales to Fresenius Medical Center dialysis clinics, compensation for which was governed by Vifor Agreement No. 2, as defined below), subject to potential temporary adjustment in future years based on certain conditions. Under Vifor Agreement No. 1, in consideration of CSL Vifor’s conduct of the marketing, promotion, selling and distribution of difelikefalin injection in the United States, Cara paid a marketing and distribution fee to CSL Vifor based on the level of annual net sales. This fee as well as CSL Vifor’s cost of goods sold (“COGS”) were deducted from net sales in calculating the net profits that are subject to the profit-sharing arrangement under Vifor Agreement No. 1.

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#### TVARDI THERAPEUTICS, INC.​(Formerly Cara Therapeutics, Inc.)NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS(amounts in thousands, except share and per share data)(unaudited)​

#### In addition, pursuant to Vifor Agreement No. 1, Cara was eligible to receive payments of up to $240,000upon the achievement of certain sales-based milestones.Cara retained the rights to make and have made difelikefalin injection (the “Licensed Product”) on a non-exclusive basis, in the United States for commercial sale of the Licensed Product for use in all therapeutic areas to prevent, inhibit or treat itch associated with pruritus in hemodialysis and peritoneal-dialysis patients (the “Field”) anywhere in the world and for supply of Licensed Product to CSL Vifor under the terms of a supply agreement (the “Vifor International Supply Agreement”) which was executed in September 2021. The supply price was Cara’s COGS, as calculated under GAAP, plus an agreed upon margin. The Vifor International Supply Agreement would co-terminate