Company: TVRD
Filing Date: 2025-02-14
Form Type: S-4/A
Source: 0001104659-25-013053
Chunk: 590

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: S-4/A
Chunk 590
---
or in exchange for the issuance of 273,533 shares of Cara’s common stock to CSL Vifor as a result of the regulatory approval of KORSUVA injection in August 2021. To date, Cara has received $50.0 million of regulatory milestones from CSL Vifor under this agreement.

Under a separate agreement with CSL Vifor, Cara is eligible to receive commercial milestone payments in the aggregate of up to $440.0 million, all of which are sales related. Cara is also eligible to receive tiered double-digit royalty payments based on annual net sales of difelikefalin injection in the licensed territories. To date, Cara has received $30.0 million of regulatory milestones from CSL Vifor. During the fourth quarter of 2023, Cara entered into the Original HCR Agreement where Cara sold its future royalties and milestone payments under this agreement to HCR (see “ — Royalty Purchase and Sale Agreement ” above).

Under the Maruishi Agreement, Cara is also potentially eligible to earn up to an aggregate of $6.0 million in clinical development milestones and $4.5 million in regulatory milestones, before any foreign exchange adjustment, as well as tiered royalties, with percentages ranging from the low double digits to the low twenties, based on net sales of products containing difelikefalin in Japan, if any, and share in any sub-license fees. In September 2023, Maruishi received manufacturing and marketing approval from Japan’s Ministry of Health, Labour and Welfare for KORSUVA IV Injection Syringe for the treatment of pruritus in hemodialysis patients. To date, Cara has received $6.5 million (before contractual foreign currency exchange adjustments) for clinical development and regulatory milestones from Maruishi. During the fourth quarter of 2023, Cara entered into the Original HCR Agreement where Cara sold its future royalties and milestone payments to HCR (see “Royalty Purchase and Sale Agreement” above).

Under the CKDP Agreement, Cara is potentially eligible to earn up to an aggregate of $2.3 million in clinical development milestones and $1.5 million in regulatory milestones, before South Korean withholding

<div align='center'>338</div>

TABLE OF CONTENTS

tax, as well as tiered royalties with percentages ranging from the high single digits to the high teens, based on net sales of products containing difelikefalin in South Korea, if any, and share in any sub-license fees. To date, $2.3