UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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Item 1.01. Entry into a Material Definitive Agreement.
On August 16, 2021, Novavax, Inc. and its wholly-owned subsidiary Novavax CZ (jointly, the “Company”) entered into an advance purchase agreement (the “EC Agreement”) with the European Commission (the “Commission”), acting on behalf and in the name of participating European Union member states (the “Participating Member States”) for the development, production, priority-purchasing options and supply of the Company’s COVID-19 vaccine candidate (the “Vaccine”), for the Participating Member States. Pursuant to the EC Agreement, the Company agreed to supply to the Participating Member States a minimum of 20 million and up to a maximum of 100 million initial doses of the Vaccine (the “Initial Doses”), and up to a maximum aggregate of 100 million additional doses of the Vaccine in one or more tranches, through 2023.
Pursuant to the EC Agreement, the Company agreed to use reasonable best efforts to (i) seek European marketing authorization for the Vaccine in adults as soon as possible, (ii) manufacture the Vaccine at facilities located in the European Union, and (iii) ensure continued efficacy of the Vaccine against variants of SARS-CoV-2.
If marketing authorization for the Vaccine is obtained from the European Medicines Agency, as soon as possible thereafter, the Company agreed to commence delivering shipments of the Vaccine to individual Participating Member States pursuant to Vaccine order forms to be entered into with each such Participating Member State, based on the allocation determined by the Commission and in accordance with the terms of the EC Agreement, until the aggregate amount of doses under the EC Agreement has been provided. The Company is prohibited from supplying the Vaccine to any third party if such delivery would impede or limit the fulfillment of the Company’s obligations under the EC Agreement, except with respect to the Company’s obligations under its advance purchase agreement with Gavi, the Vaccine Alliance.
The Participating Member States may donate or resell doses of the Vaccine to other European Union countries, European Economic Area members and Switzerland, subject to certain limitations set forth in the EC Agreement.
The Commission may terminate the EC Agreement if (i) the Company does not timely deliver a minimum of 20 million doses of the Vaccine, (ii) certain European statutes are breached, (iii) there is a change to the Company’s circumstances that substantially alters the reasoning under which the Commission initially entered into the EC Agreement or (iv) in the case of material breach of the Company’s obligations and other customary termination triggers. Additionally, a Participating Member State may reduce or cancel orders of the Vaccine following any delay in delivery which has not been timely cured or the Company’s anticipated failure to meet the agreed upon delivery schedule within a required time period. Unless extended pursuant to the terms of the EC Agreement, the EC Agreement will terminate upon the earlier of (a) twenty-four months from the effective date of the EC Agreement, (b) the delivery and payment of 200 million doses of the Vaccine, or (c) if the Commission has elected not to make any additional orders, the delivery of and payment for the Initial Doses of the Vaccine.
The foregoing description of the material terms of the EC Agreement does not purport to be complete and is qualified in its entirety by reference to such agreement, which will be filed with the Securities and Exchange Commission as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Novavax, Inc. | ||
| Date: August 20, 2021 | By: | /s/ John A. Herrmann III |
| Name: | John A. Herrmann III | |
| Title: | Executive Vice President, Chief Legal Officer and Corporate Secretary | |