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Item 1.01.
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Entry into a Material Definitive Agreement.
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On June 26, 2019, Savara Inc., through its wholly-owned subsidiary, Savara ApS (collectively, the “Company”), entered into a
Master Manufacturing Services Agreement (the “Master Agreement”) with Patheon UK Limited (“Patheon”). The Master Agreement governs the general terms under which Patheon, or one of its affiliates, will provide manufacturing
services to the Company for the drug products specified by the Company from time to time.
The Company expects to enter into one or more
related Product Agreements (each a “Product Agreement”) pursuant to the Master Agreement to govern the terms and conditions of Patheon’s manufacture of commercial supplies of Molgradex, the Company’s lead product candidate.
Pursuant to the Master Agreement, the Company has agreed to order from Patheon at least a certain percentage of its commercial requirements for a product under a Product Agreement. Each Product Agreement that the Company may enter into from time to
time will be governed by the terms of the Master Agreement, unless expressly modified in such Product Agreement.
The Master Agreement has
an initial term ending December 31, 2024, and will automatically renew after the initial term for successive terms of two years each if there is a Product Agreement in effect, unless the Company gives notice of its intention to terminate the
Master Agreement at least 12 months prior to the end of the then current term or Patheon give notice of its intention to terminate the Master Agreement at least 24 months prior to the end of the then current term. Unless otherwise agreed in a
Product Agreement, Product Agreements will automatically renew after its initial term for successive terms of two years each unless either party gives notice of its intention to terminate a Product Agreement at least 18 months prior to the end of
its then current term.
Either party may terminate the Master Agreement or a Product Agreement upon written notice if the other party
(i) has failed to remedy a material breach within a specified time or (ii) is declared insolvent or bankrupt, voluntarily files a petition of bankruptcy or assigns such agreement for the benefit of creditors. The Company may terminate a
Product Agreement upon 30 days’ prior written notice if any governmental agency takes any action that prevents the Company from selling the relevant product in the relevant territory or upon six months’ prior written notice if it does not
intend to order manufacturing services due to a product’s discontinuance in the market. Patheon may terminate the Master Agreement or a Product Agreement if the Company assigns such agreement to an assignee that is unacceptable to Patheon for
certain reasons, for failure of the Company to timely pay invoices, or if the Company forecasts zero volume for six months.
The Master
Agreement contains, among other provisions, customary representations and warranties by the parties, a grant to Patheon of certain limited license rights to the Company’s intellectual property in connection with Patheon’s performance of
the services under the Master Agreement, certain indemnification rights in favor of both parties, limitations of liability and customary confidentiality provisions.
The foregoing description of the Master Agreement is qualified in its entirety by reference to the text of the Master Agreement, which the
Company plans to file with its Form
10-Q
for the period ended June 30, 2019.