Ocugen, Inc. has entered into an exclusive license agreement with Celairis Therapeutics Holdings Pty Ltd to commercialize its investigational gene therapy OCU400 in Australia, New Zealand, and the Association of Southeast Asian Nations (ASEAN).
Under the terms of the agreement, Celairis has been granted an exclusive, non-sublicensable license to import, export, distribute, and sell OCU400 in the specified Territory. The therapy is designed to treat retinitis pigmentosa (RP), a group of inherited retinal diseases that cause progressive vision loss and blindness.
Ocugen will retain ownership of the global safety database and the sole right to manufacture OCU400 within the Territory. Celairis is responsible for preparing, filing, and maintaining regulatory submissions, as well as obtaining regulatory approval and commercializing the product.
Financial terms of the deal include:
- Upfront and milestone payments: Ocugen will receive up to $6.1 million, consisting of an upfront license fee and a payment contingent upon the Company receiving positive topline results from its Phase 3 LiMeliGht clinical trial of OCU400.
- Regulatory milestone: An additional $1.0 million milestone payment is due upon approval of the licensed product by the Therapeutic Goods Administration in Australia.
- Royalties: Ocugen will receive a high single-digit percentage royalty on net sales generated by Celairis in the Territory.
- Profit share: The Company will receive 50% of the gross profits derived by Celairis from net sales of OCU400 in the Territory.
The agreement stipulates that the parties will enter into a manufacturing and supply agreement within 90 days. The license is valid until the last to occur of the 20-year anniversary of the first commercial sale, the expiration of relevant patents, or the expiration of regulatory exclusivities.
Ocugen is conducting the Phase 3 LiMeliGht trial, with topline data expected in the first quarter of 2027. The Company plans to submit a Biologics License Application in the U.S. and a Marketing Authorization Application in Europe following the trial results.
