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

Term & termination | Term of agreement

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

Definitions

“Agreement Term” shall mean the period of time commencing on the Effective Date and, unless this Agreement is terminated sooner as provided in Article 20, expiring on the date when no royalty or other payment obligations under this Agreement are or will become due.

20. Term and Termination

20.1 Commencement and Term. This Agreement shall be binding upon the Parties as of the Execution Date to the extent permitted by the HSR Act, including without limitation the provisions of Sections 20.3.6 and 22.1, but shall not otherwise take effect until the Effective Date, and shall thereafter continue for the Agreement Term.

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Master Alliance Provisions Guide (MAPGuide)

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

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Master Alliance Provisions Guide (MAPGuide)

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

Provision Language

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Get In Touch

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Get In Touch

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