Item 1.01 Entry into a Material Definitive Agreement.
On
Under the License Agreements, Oncoheroes will acquire exclusive, global development rights to our therapeutic candidates Dovitinib, a pan-targeted kinase inhibitor (pan-TKI), and Stenoparib, a PARP inhibitor, and assume responsibility for their further clinical development in the field of pediatric cancers. As part of the License Agreements, Oncoheroes will receive commercialization rights for pediatric cancers, subject to our first buy-back option for each program, and we will receive upfront license fees and regulatory milestones for each program. If we do not re-acquire the pediatric field rights, we will further receive certain clinical/regulatory milestone payments and royalties on sales of Stenoparib and Dovitinib in the pediatric cancer market from Oncoheroes.
Development Milestone Payments
Under the License Agreements, we would also be entitled to receive certain
milestone payments relating to the development and commercialization of
Dovitinib and Stenoparib upon the occurrence of the following events: (i) upon
the regulatory approval of a product in
Royalty Payments
In addition to the milestone payments described above, Oncoheroes has agreed to
pay us royalties based on aggregate annual net sales of all products derived
from Dovitinib and Stenoparib during the royalty term which is determined on a
country-by-country and product-by-product basis, as the period of time
commencing on the first commercial sale of any product in such country and
expiring upon the latest of (a) the expiration of the last valid claim of a
patent within (i) our intellectual property and/or (ii) the joint intellectual
property in such country (if, but only if, such joint intellectual property
arose from activities under the clinical development plan defined in the
agreement), or (b) the fifteenth (15th) anniversary of the date of first
commercial sale of such licensed drug in such country. We will be entitled to
royalty payments of between three percent (3%) and eight percent (8%) of annual
net sales of between
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The License Agreements with Oncoheroes will continue on a product-by-product and country-by-country basis until the expiration of the applicable royalty term described above. However, the License Agreements may be terminated by Oncoheroes at any time after the first anniversary of the effective date of each License Agreement for any or no reason upon (i) ninety (90) days' written notice if such notice is provided prior to first commercial sale, and (ii) one hundred eighty (180) days' written notice if such notice is provided on or after the first commercial sale. We may also terminate the License Agreements upon sixty (60) days' written notice if Oncoheroes challenges any of our licensed patents included under the License Agreements. The License Agreements may also be terminated by either party upon the material breach of the agreement by the other party if such breach is not cured within sixty (60) days, or in the event that either party files for bankruptcy.
The foregoing summary of the terms of the License Agreements and Assignment do
not purport to be complete. Copies of the License Agreements (in redacted form
subject to a confidential treatment request submitted to the
Item 7.01 Regulation FD Disclosure
On
The information reported Item 7.01 in this Current Report on Form 8-K, including Exhibit 99.1, is being "furnished" and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.
Cautionary Note Regarding Forward-Looking Statements
This Report on Form 8-K contains certain statements that are, or may be deemed to be, "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements that are purely historical are forward-looking statements. When used in this press release, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose," and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees for future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the Company's control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. All forward-looking statements in this document are qualified in their entirety by this cautionary statement.
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Item 9.01 Financial Statements and Exhibits.
(d) Exhibits Exhibit Exhibit Description 99.1 Press Release datedJanuary 3, 2022 -Allarity Therapeutics and Oncoheroes Biosciences Sign Agreements toAdvance Pediatric Cancer Development of Dovitinib and Stenoparib 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) 3
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