| Item 1.01. | Entry Into a Material Definitive Agreement. |
Collaboration Agreement
On January 30, 2019, (the “Agreement Date”), MeiraGTx Holdings plc (the “Company”) and its wholly owned subsidiary, MeiraGTx UK II Limited, entered into a Collaboration, Option and License Agreement (the “Collaboration Agreement”) with Janssen Pharmaceuticals, Inc. (“Janssen”) for the research, development and commercialization of gene therapies for the treatment of inherited retinal diseases (“IRDs”).
Collaboration and Licenses
Under the Collaboration Agreement, upon the expiration or termination of applicable waiting periods and the receipt of any required approvals or clearances under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (such date, the “Effective Date” and such clearance, “Antitrust Clearance”), the Company and Janssen have agreed to collaborate on the conduct of 3 collaboration programs from the Company’s leading IRD pipeline (the “Clinical Programs”) for the following: (i) a product candidate for achromatopsia (“ACHM”) caused by mutations in CNGB3; (ii) a product candidate for ACHM caused by mutations in CNGA3; and (iii) a product candidate forX-linked retinitis pigmentosa (“XLRP”).
The Company and Janssen have agreed on a research collaboration to develop a pipeline of IRD gene therapy candidates. The parties will select and prioritize IRD targets for research. Janssen has the right toopt-in to each program coming out of the research collaboration (“Research Program”) at or before the time of clearance of an Investigational New Drug (“IND”) application by the United States Food and Drug Administration (“FDA”). The Company and Janssen have also agreed on a separate research collaboration to further develop manufacturing technology for adeno-associated virus (“AAV”)-based gene therapy products (“CMC Development Collaboration”).
Under the terms of the Collaboration Agreement, subject to the licenses granted by Janssen back to the Company, the Company has agreed to grant to Janssen, as of the Effective Date, exclusive, worldwide, royalty-bearing, transferable, sublicensable licenses to certain of the Company’s intellectual property rights, for the research, development, manufacturing and commercialization of gene therapy products (the “Products”) from: (i) the Clinical Programs; and (ii) the Research Programs for which Janssenopts-in. The Company retains all rights to a Product from the Research Program if Janssen does notopt-in to the Research Program.
Financial Terms
Under the terms of the Collaboration Agreement, Janssen has agreed to pay the Company an upfront payment of $100 million (the “Upfront Payment”) within 30 days after the Effective Date.
Janssen will fund all clinical development and commercialization costs for the Clinical Programs. Janssen will pay anopt-in fee for each Research Program that Janssen selects for further development and commercialization. Prior toopt-in to a Research Program, the parties will share the research costs for each Research Program, and a significant portion of the costs of the research collaboration will be paid by Janssen. Followingopt-in to a Research Program, Janssen will fund all clinical development and commercialization costs for the Research Program. The parties will share the costs associated with the manufacturing collaboration.
The Collaboration Agreement provides for: (i) aggregate development and commercial milestone payments from Janssen to the Company of up to $340 million for the Company’s CNGB3, CNGA3 and XLRP programs and (ii) anopt-in payment plus development milestones from Janssen to the Company for each Research Programopted-in by Janssen.
Janssen has also agreed to pay the Company royalties, based on future net sales of the Products. Such royalty percentages, for net sales globally are: (i) an untiered rate of 20 percent of annual net sales for the Clinical Programs; and (ii) an untiered high teens percentage of annual net sales for the Research Programsopted-in by Janssen. On acountry-by-country andProduct-by-Product basis, royalty payments would commence on the first commercial sale of a Product and terminate on the later of: (a) the expiration of the last valid claim covering certain aspects of the Product or its approved of use in such country; (b) 10 years from the first commercial sale of
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