Ocugen licenses OCU400 to Celairis for Australia, New Zealand and ASEAN markets
Celairis will handle regulatory filings and commercialization of the retinitis pigmentosa gene therapy across the region while Ocugen retains manufacturing rights and collects royalties and profit share.
Ocugen, Inc. announced on November 10, 2026 that it had entered into an exclusive license agreement with Celairis Therapeutics Holdings Pty Ltd, granting Celairis an exclusive, non-sublicensable, royalty-bearing license to develop, commercialize, register and otherwise exploit OCU400 in Australia, Singapore, New Zealand, Malaysia, Thailand, the Republic of the Philippines, Vietnam and Indonesia1. The agreement allows the two companies to expand the territory to other countries in Asia and Oceania by mutual agreement.1
Under the deal, Celairis will have sole control over preparing, filing and maintaining regulatory submissions and communicating with regulators in the territory, and has agreed to use commercially reasonable efforts to obtain approval and commercialize the product there.1 Ocugen will continue to own the global safety database for OCU400.1
Financially, Ocugen will receive up to $6.1 million in the aggregate consisting of a fee payable if the company gets positive topline results from its Phase 3 LiMeliGht trial plus an up-front license fee, and a separate $1.0 million milestone tied to approval by Australia's Therapeutic Goods Administration.1 Ocugen will also receive a high-single digit percentage royalty on net sales and 50% of gross profits Celairis generates from net sales in the territory.1 Ocugen retains the sole right to manufacture OCU400 in the territory, and the two companies will try to sign a separate supply agreement within 90 days of the license agreement's execution.1
The license agreement and the licenses it grants will remain in force until the latest of the 20th anniversary of first commercial sale in the territory, expiration of the last valid patent claim there, or expiration of all regulatory exclusivities, at which point it terminates automatically.1 Ocugen is running the Phase 3 "liMeliGhT" trial of OCU400, with topline data expected in the first quarter of 2027, ahead of planned U.S. and European regulatory filings.1 OCU400 has not been approved in any market in the territory.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.