Company: RGNX
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0000950170-25-038770
Chunk: 89

Company: REGENXBIO Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 89
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 in 2023, AbbVie became responsible for the majority of the ABBV-RGX-314 development expenses. 

In the United States, we will participate in commercialization of licensed products to the extent set forth in a commercialization plan to be determined in accordance with the AbbVie Collaboration and License Agreement, and the parties will equally share net profits and net losses associated with commercialization of the licensed products in the United States. Outside the United States, AbbVie will be responsible, at its sole cost, for the commercialization of licensed products. We will also be eligible to receive tiered royalties on net sales by AbbVie of licensed products outside the United States at percentages in the mid-teens to low twenties, subject to specified offsets and reductions. 

We will lead the manufacturing of ABBV-RGX-314 for clinical development and U.S. commercial supply, and AbbVie will lead manufacturing of ABBV-RGX-314 for commercial supply outside the United States. Manufacturing expenses will be allocated between the parties in accordance with the terms of the AbbVie Collaboration and License Agreement and mutually agreed supply agreements. 

Nippon Shinyaku Partnership for MPS Diseases

In January 2025, REGENXBIO and Nippon Shinyaku announced a strategic partnership to develop and commercialize RGX-121, a potential one-time gene therapy for the treatment of MPS II, and RGX-111, a potential one-time gene therapy for the treatment of MPS I, in the United States and certain countries in Asia. The Collaboration and License Agreement with Nippon Shinyaku (the Nippon Shinyaku Collaboration and License Agreement) became effective in March 2025. 

Under the terms of the Nippon Shinyaku Collaboration and License Agreement, we will receive an upfront payment of $110 million. Additionally, we are eligible to receive up to $700 million in additional milestone payments, including $40 million in development and regulatory milestone payments and $660 million in sales milestones. We are eligible to receive meaningful double-digit royalties on net sales by Nippon Shinyaku of licensed products, subject to specified offsets and reductions. We retain all rights to, and one hundred percent of any potential proceeds related to the sale of, the Priority Review Voucher for RGX-121 received upon approval.   

In accordance with the Nippon Shinyaku Collaboration and License Agreement, we will lead the development of RGX-121 and RGX-111 in the United States and