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SEC Filings

20-F
AC IMMUNE SA filed this Form 20-F on 03/21/2019
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In July 2017, AC Immune and Janssen entered into a Second Amendment to the December 2014 License, Development and Commercialization Agreement. The Amendment allows for the alignment of certain payment provisions with the new Development Plan and Research Plan activities. ACI and Janssen will jointly share R&D costs until the completion of the first Phase 2b. Under the terms of the agreement, Janssen may terminate the agreement at any time after completion of the first Phase 1b clinical study by providing 90 days’ notice to us.

 

The structure of the collaboration agreement is as follows:

 

  · A right-to-use license;

 

  · Clinical milestone payments upon completion of Phase 1b, commencement of each of Phase 2 and 3 of clinical development. For a second cohort, a milestone payment is payable to us upon commencement of Phase 2 clinical studies. In addition, for a second indication, clinical milestone payments would be payable upon commencement of Phase 3 clinical studies;

 

  · Regulatory milestone payments upon making regulatory filings in the U.S., Europe, and Japan, respectively. In addition, for a second indication, similar regulatory milestones would be payable. For a second indication, additional regulatory milestone payments are payable by Janssen to us upon receipt of each of the regulatory approvals in the U.S., Europe and Japan;

 

  · Commercialization milestones payable upon making a first commercial sale in each of the U.S., Europe and Japan, and upon achieving certain commercial milestones; and

 

  · Royalties on sales with royalty rates differing based on the level of annual sales.

 

The agreement will terminate by its terms on the date on which all royalty obligations have been paid thereunder. However, under the terms of the agreement, Janssen may terminate the agreement at any time after completion of the Phase 1b clinical study by providing 90 days’ notice to us.

 

Life Molecular Imaging SA (formerly Piramal Imaging SA)

 

In May 2014, we entered into the LCA for our first diagnostic partnership with Life Molecular Imaging. The agreement with Life Molecular is for a compound from the Morphomer chemical library that binds to pathogenic Tau for use as a PET tracer.

 

The exclusive, worldwide licensing agreement with Life Molecular Imaging includes upfront and milestone payments totaling up to EUR 157 (CHF 179) million plus royalties on sales at percentage rates ranging from mid-single digits to low double digits.

 

The structure of the collaboration agreement is as follows:

 

  · A right-to-use license;

 

  · Clinical milestone payments upon the commencement of the Phase 1 study in PSP, commencement of Phase 2 and 3 for generation of data intended to support a regulatory submission in the U.S. or EU and acceptance of Regulatory filing (NDA) and Regulatory approval for Commercialization in the US or EU. We would be entitled to further clinical milestone payments for the commencement of Phase 2 and 3 for a second indication; and

 

  · Sales milestones tied to specific annual net sales amounts.

 

The LCA agreement will terminate by its terms on the date of expiration of the last-to-expire royalty term, where each royalty term under the LCA expires on a product-by-product basis and country-by-country basis on the later of (i) ten years after the first commercial sale of the relevant product in such country or (ii) the date on which the patent covering the sale of such product in such country is no longer valid or enforceable. However, Life Molecular Imaging may terminate the LCA at any time after the first eighteen months from the effective date of this LCA on a Product-by-Product and country-by-country basis by providing three months’ notice to us.

 

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