Ocugen, Inc. filed a current report on November 10, 2026, disclosing that it entered into an Exclusive License Agreement with Celairis Therapeutics Holdings Pty Ltd for the commercialization of OCU400 in eight Asia-Pacific countries.

Key Highlights

  • Territory covered: The license grants Celairis exclusive rights in Australia, Singapore, New Zealand, Malaysia, Thailand, the Republic of the Philippines, Vietnam, and Indonesia.
  • Upfront and milestone fees: Ocugen will receive up to $6.1 million in aggregate, consisting of an up-front license fee and a fee contingent on positive topline results from its Phase 3 LiMeliGht clinical trial of OCU400.
  • Regulatory milestone: A separate $1.0 million payment is due upon approval of OCU400 by the Therapeutic Goods Administration in Australia.
  • Royalty and profit share: Ocugen will receive a high-single digit percentage royalty on net sales and 50% of gross profits derived by Celairis in the Territory.
  • Manufacturing rights retained: Ocugen will retain the sole right to manufacture OCU400 in the Territory, with both parties to use commercially reasonable efforts to execute a supply agreement within 90 days.
  • License term: The agreement continues until the latest of the 20-year anniversary of first commercial sale in the Territory, expiration of the last valid patent claim, or expiration of all regulatory exclusivities.

Ocugen Grants Asia-Pacific Rights for OCU400 Gene Therapy to Celairis

According to the filing, Ocugen, Inc. (NASDAQ:OCGN) entered into the License Agreement with Celairis Therapeutics Holdings Pty Ltd on November 10, 2026. The agreement grants Celairis an exclusive, non-sublicensable, royalty-bearing license to import, export, distribute, develop, commercialize, and otherwise exploit OCU400 in the defined Territory for the treatment of retinitis pigmentosa (RP) in humans using gene therapy. Ocugen disclosed that the Territory may be expanded to certain other countries in Asia and Oceania upon mutual agreement.

The filing states that Celairis will have sole control over preparing, filing, and maintaining regulatory submissions and communicating with regulatory authorities in the Territory, and has agreed to use commercially reasonable efforts to obtain regulatory approval and commercialize the licensed product. Ocugen will own the global safety database with respect to OCU400. Financial consideration to Ocugen includes the aggregate amount of up to $6.1 million, a $1.0 million milestone tied to Australian regulatory approval, a high-single digit percentage royalty on net sales, and 50% of gross profits from Celairis's net sales in the Territory.

The filing notes that the full text of the License Agreement will not be filed immediately but will instead be included as an exhibit to Ocugen's Annual Report on Form 10-K for the fiscal year ending December 31, 2026. The company also issued a press release on November 10, 2026, disclosed under Regulation FD as Exhibit 99.1. The filing contains forward-looking statements regarding the anticipated benefits of the License Agreement and the planned Supply Agreement, which the company states are "subject to risks and uncertainties" and may cause actual events or results to differ materially from current expectations.

What Was Disclosed

Ocugen disclosed the entry into an exclusive license agreement with Celairis for OCU400 in eight Asia-Pacific markets, detailing financial terms including up to $6.1 million in fees, a $1.0 million regulatory milestone, royalties, and a 50% gross profit share, along with key operational and termination provisions.