Item 1.01 Entry into a Material Definitive Agreement.
Tebipenem HBr License Agreement with GSK
On
Under the terms of the License Agreement, Spero will receive an upfront payment
of
Event Milestone payments (up to) Delivery of phase III programme$150m Total commercial milestone payments based on first sale (US/EU)$150m Sales milestone events Net sales greater than$200m $25m Net sales greater than$300m $25m Net sales greater than$400m $25m Net sales greater than$500m $50m Net sales greater than$750m $50m Net sales greater than$1,000m $50m Total sales milestone payments:$225m Royalties Low-single digit to low-double digit (if sales exceed$1bn ) tiered royalties on net product sales.
Royalties are subject to reduction in the event of third-party licenses, entry of a generic product or expiration of patent and regulatory exclusivity prior to the tenth (10th) anniversary of the first commercial sale of a GSK Licensed Product in a particular country.
Spero will be responsible for the execution and costs of the follow-up Phase III
clinical trial of tebipenem HBr. GSK will be responsible for the execution and
costs of additional further development, including Phase III regulatory filing
and commercialization activities for tebipenem HBr in the balance of the GSK
Territory outside of
Unless earlier terminated due to certain material breaches of the License Agreement or by GSK for convenience, or otherwise, the License Agreement will expire on a jurisdiction-by-jurisdiction and GSK Licensed Product-by-GSK Licensed Product basis on the latest to occur of (i) loss of patent exclusivity, (ii) loss of regulatory exclusivity or (iii) ten (10) years following the date of the first commercial sale of such licensed product in such country (the "Royalty Term"). During the Royalty Term, Spero has agreed not to develop, manufacture or commercialize any oral carbapenem for any indication or any oral antibiotic for cUTI; this restriction does not apply to any third party which acquires control of Spero after the date of the License Agreement if certain conditions are met.
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The Company has the right to terminate the License Agreement upon a material
breach by, or bankruptcy of, GSK. GSK has the right to terminate the License
Agreement at any time upon a specified number of days' notice or upon a material
breach by, or bankruptcy of, Spero. In addition, in the event that GSK has the
right to terminate the License Agreement due to a breach by Spero, GSK may elect
not to terminate the License Agreement and in lieu thereof may assume the
responsibility and expense of development of tebipenem HBr in
The License Agreement contains representations and warranties, other covenants, indemnification provisions and other terms and conditions customary for transactions of the type contemplated by the License Agreement. In support of certain of its rights to indemnification, GSK also has certain rights to suspend payments otherwise owed to Spero, as well as the right to offset payments otherwise owed to Spero against certain indemnifiable claims.
The consummation of the transactions under the License Agreement is subject to
the satisfaction of customary closing conditions, including the expiration or
termination of the applicable waiting period under the Hart-Scott-Rodino
Antitrust Improvements Act of 1976, as amended (the "HSR Act"); provided, that
either Spero or GSK may terminate the License Agreement if expiration or
termination of the applicable waiting period under the HSR Act has not occurred
by
Share Purchase Agreement
Concurrently with the execution of the License Agreement, on
Item 3.02 Unregistered Sales of
The description set forth in the section titled "Share Purchase Agreement" in
Item 1.01 of this Current Report is incorporated by reference into this Item
3.02. The Shares sold and issued in connection with the SPA have not been
registered under the Securities Act or any state securities laws and may not be
offered or sold in
Item 8.01 Other Events.
On
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1 Press Release, datedSeptember 22, 2022 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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