Roche – PTC Therapeutics – Spinal Muscular Atrophy Foundation, SMA Therapeutic License and Collaboration Agreement

Business model | Product supply

Summary of Approaches

What are the specific commitments made by the parties to supply and purchase the products?
- For Research supply, all Product must be supplied in accordance with the Research Plan and accompanying budget.
- For clinical supply, Roche is solely and exclusively responsible at its own expense for the manufacture and supply of clinical supplies of Product.
- For commercial supply, Roche is solely and exclusively responsible at its own expense for the commercial manufacture and supply of Product for sale in the Territory, either by itself or through Third Parties.

Annotations

This Collaboration and License Agreement (“Agreement“), effective from November 2011, is between Roche, PTC Therapeutics (“PTC“), and the SMA Foundation (“the Foundation“). The Agreement relates to activities to be carried out by Roche and PTC under a Research Plan to identify potential Development Candidates for an SMA treatment. The Research Plan builds upon prior work conducted by PTC in partnership with the SMA Foundation under a Sponsored Research Agreement (“SRA“). A number of the Agreement provisions are linked to the rights and obligations previously agreed in the SRA.

Under the Agreement, PTC grants a license under its patent rights and know-how to Roche to conduct R&D, use, market and sell Products and Compounds developed under the SRA (“SRA Product/Compound“) or under the Research Program (“New Product/Compound“) for any use (“Field“). Roche agrees to make a $30M upfront payment to PTC plus up to $460M in development and commercialization milestones as consideration for the license grants.

The parties each take responsibility for their own patent filings under the Agreement, with input from a Joint IP Team, and they agree to file for all available patent extensions. Both the Foundation and PTC retain rights to access and use relevant Roche patents, know-how and data to enable continued development and commercialization under certain circumstances.

The Agreement also provides for collaboration between the Foundation and Roche on the establishment of an expanded access program to enable patients not meeting clinical trial enrollment criteria to gain access to a Product or Development Candidate.

Per a Roche publication from December 2023, the collaboration between the Foundation, PTC and Roche resulted in the development of the first oral treatment for patients with SMA which has been made available to patients in more than 100 countries.

Provision Language

8. Supply

8.1 Research Supply of Product. All Product for use during the Research Program shall be supplied in accordance with the Research Plan and accompanying budget.

8.2 Clinical Supply of Product

8.2.1 Roche Responsibility. Roche shall be solely and exclusively responsible at its own expense for the manufacture and supply of clinical supplies of Product.

[…]

8.3 Commercial Supply of Product. Roche shall be solely and exclusively responsible at its own expense for the commercial manufacture and commercial supply of Product for sale in the Territory, either by itself or through Third Parties.

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Roche – PTC Therapeutics – Spinal Muscular Atrophy Foundation, SMA Therapeutic License and Collaboration Agreement

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Roche – PTC Therapeutics – Spinal Muscular Atrophy Foundation, SMA Therapeutic License and Collaboration Agreement

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