Ocugen has granted Celairis Therapeutics exclusive rights to develop and commercialize its OCU400 gene therapy for retinitis pigmentosa in Australia, Singapore, New Zealand and five Southeast Asian countries. The agreement gives Celairis responsibility for local regulatory work and commercialization, while Ocugen retains the right to manufacture the therapy and will receive fees, a regulatory milestone, royalties and a share of sales-related profits.
The deal’s potential near-term payment depends in part on results from Ocugen’s Phase 3 LiMeliGht trial. The companies have not yet signed a separate manufacturing and supply agreement; they have agreed to work toward one.
Key details
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Where the license applies: The exclusive license covers Australia, Singapore, New Zealand, Malaysia, Thailand, the Philippines, Vietnam and Indonesia. The companies may add certain other countries in Asia and Oceania by mutual agreement.
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What Celairis can do: Celairis may research, develop, seek approval for, commercialize and sell OCU400 for retinitis pigmentosa in the covered countries. The license is non-sublicensable.
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Payments to Ocugen: Ocugen may receive up to $6.1 million in aggregate from an upfront license fee and a fee that is payable if Ocugen reports positive topline results from the LiMeliGht Phase 3 trial. The agreement does not specify in the announcement how much of that total is upfront versus conditional.
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Regulatory milestone and sales economics: Ocugen is also eligible for a $1 million payment if Australia’s Therapeutic Goods Administration approves OCU400. On sales in the region, Ocugen will receive a high-single-digit royalty on net sales and 50% of gross profits derived by Celairis from those sales.
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Local development and oversight: Celairis will have sole control of regulatory submissions and communications with regulators in the licensed countries, and has agreed to use commercially reasonable efforts to obtain approvals and commercialize OCU400. Ocugen will own the therapy’s global safety database.
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Manufacturing: Ocugen retains the sole right to manufacture OCU400 for the territory. Both companies will use commercially reasonable efforts to negotiate a separate supply agreement within 90 days of signing the license.
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Duration: The license is set to continue until the latest of 20 years after the first commercial sale in the territory, expiration of the last valid licensed patent claim there, or expiration of applicable regulatory exclusivities. It also includes customary termination provisions for matters such as an uncured material breach or certain insolvency events.
Plain-English implications
Celairis receives exclusive regional commercialization rights, while Ocugen keeps manufacturing control and participates in the economics of any sales. The agreement’s stated payments include a component contingent on positive Phase 3 results and a separate milestone tied to Australian approval; commercialization also depends on regulatory approval in the relevant markets.