Item 1.01. Entry into a Material Definitive Agreement.
On December 31, 2020, Inovio Pharmaceuticals, Inc. (the "Company") entered into
a Collaboration and License Agreement (the "Agreement") with Advaccine
Biopharmaceuticals Suzhou Co., Ltd. ("Advaccine"). Under the terms of the
Agreement, the Company has granted to Advaccine the exclusive right to develop,
manufacture and commercialize the Company's vaccine candidate INO-4800 within
the territories of China, Taiwan, Hong Kong and Macau (referred to collectively
as "Greater China"). Advaccine will not have the right to grant sublicenses,
other than to affiliated entities, without the Company's express prior written
consent. As part of the collaboration, Advaccine has also granted to the Company
a non-exclusive license to certain DNA vaccine manufacturing processes.
The Company and Advaccine have collaborated since January 2020 to leverage
Advaccine's clinical development expertise to conduct an early-stage clinical
trial in China in parallel with the Company's clinical development efforts in
the United States and South Korea. In December 2020, the Company and Advaccine
announced that they had dosed the first subject in a Phase 2 clinical trial of
INO-4800 in China. This trial is independent of the Company's ongoing clinical
trial of INO-4800, called INNOVATE, being conducted in the United States.
Under the Agreement, Advaccine will make an upfront payment to the Company of
$3.0 million. In addition to the upfront payment, the Company is entitled to
receive up to an aggregate of $108.0 million upon the achievement of specified
milestones related to the development, regulatory approval and commercialization
of INO-4800, including the achievement of specified net sales thresholds for
INO-4800 in Greater China, if approved. The Company will also be entitled to
receive a royalty equal to a high single-digit percentage of annual net sales in
each region within Greater China, subject to reduction in the event of
competition from biosimilar products in a particular region and in other
specified circumstances. Advaccine's obligation to pay royalties will continue,
on a licensed product-by-licensed product basis and region-by-region basis, for
ten (10) years after the first commercial sale in a particular region within
Greater China or, if later, until the expiration of the last-to-expire patent
covering a given licensed product in a given region.
Under the Agreement, Advaccine will be responsible for the development and
commercialization of the licensed products at its own cost and expense and shall
use commercially reasonable efforts to develop, obtain and maintain regulatory
approval of INO-4800, as well as the Company's CELLECTRA device and arrays for
use in connection with the administration of INO-4800, in each region in Greater
China. In the event that the Company has not initiated the planned Phase 3
segment of its ongoing clinical trial of INO-4800 in the United States within
one year after entering into the Agreement, Advaccine may elect to conduct a
Phase 3 clinical trial outside of Greater China at its own cost and expense for
the purposes of obtaining regulatory approval in China, subject to the Company's
right to review and approve the protocols and design of such a trial.
Under the Agreement, the Company will supply Advaccine's clinical requirements
of INO-4800 and devices, although Advaccine may manufacture INO-4800 for its
clinical use and may procure alternate suppliers. Advaccine is responsible for
the manufacture and supply of INO-4800 itself or through a contract manufacturer
for commercial use. Upon Advaccine's reasonable request, the parties may
negotiate a separate clinical and/or commercial supply agreement.
The Agreement will continue in force on a region-by-region basis until Advaccine
has no remaining royalty obligations in such region. Either party may terminate
the Agreement (i) in the event the other party shall have materially breached
its obligations thereunder and such default shall have continued for a specified
period after written notice thereof or (ii) upon the bankruptcy or insolvency of
the other party. In addition, the Company may terminate the agreement, upon
prior written notice, if Advaccine (i) ceases all development or
commercialization activities for at least nine months, subject to certain
exceptions, or (ii) challenges the validity, enforceability or scope of any of
the patents licensed by the Company to Advaccine under the Agreement, subject to
certain conditions. Advaccine may terminate the Agreement at any time for
convenience upon nine months' written notice to the Company, if such notice is
provided before the first commercial sale of INO-4800 in Greater China, or 18
months' written notice thereafter; provided that the Company may accelerate the
effectiveness of such termination to the extent permitted by law.
The foregoing summary of the Agreement is not complete and is qualified in its
entirety by reference to the text of the Agreement, a copy of which will be
filed as an exhibit to the Registrant's Annual Report on Form 10-K for the year
ended December 31, 2020.
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Item 7.01 Regulation FD Disclosure.
On January 4, 2021, the Company issued a press release announcing the Agreement.
A copy of this press release is furnished herewith as Exhibit 99.1 to this
report. The information contained in the press release furnished as Exhibit 99.1
shall not be deemed "filed" for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the "Exchange Act"), and is not incorporated
by reference into any of the Company's filings under the Securities Act of 1933,
as amended, or the Exchange Act, whether made before or after the date hereof,
except as shall be expressly set forth by specific reference in any such filing.
Item 9.01 Financial Statements and Exhibits.
Exhibit
No. Exhibit Description
99.1 Press Release, dated January 4, 2021.
104 Cover page interactive data file (embedded within the Inline XBRL
document).
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