UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported):December 18, 2019
Onconova Therapeutics, Inc.
(Exact name of Registrant as specified in its charter)
| Delaware | | 001-36020 | | 22-3627252 |
(State or Other Jurisdiction
of Incorporation or Organization) | | (Commission
File Number) | | (I.R.S. Employer
Identification No.) |
375 Pheasant Run
Newtown, PA 18940
(267) 759-3680
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive
Offices)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨Written communications pursuant to Rule 425 under the Securities Act
¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act
¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act
¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.¨
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | | Trading Symbol(s) | | Name of each exchange on which registered |
| Common stock, par value $.01 per share | | ONTX | | The Nasdaq Stock Market LLC |
| Warrants to purchase common stock | | ONTXW | | The Nasdaq Stock Market LLC |
Item 1.01. Entry into a Material Definitive Agreement
Distribution, License and Supply Agreement
On December 18, 2019 (the “Effective Date”), Onconova Therapeutics, Inc. (the “Company”) entered into a Distribution, License and Supply Agreement (the “License Agreement”) with Specialised Therapeutics Asia Pte. Ltd. (“Licensee”). Under the terms of the License Agreement, the Company granted Licensee (i) a non-exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how to develop and manufacture any product (the “Licensed Product”) containing rigosertib for Australia and New Zealand (the “Territory”) and in human uses (the “Field”), and (ii) an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how to commercialize the Licensed Product in the Territory and in the Field.
Licensee has also agreed to obtain from the Company all of Licensee’s requirements of the Licensed Products for the Territory, and the Company has agreed to supply Licensee with all of its requirements of the Licensed Products. The Company may, at its discretion, use the services of a contract manufacturer to manufacture and package the Licensed Products.
The Company may be entitled to receive clinical, regulatory and sale-based milestone payments up to $30.4 million. The Company may also be entitled to receive tiered double-digit royalties based on net sales in the Territory.
The License Agreement is for a term of 15 years from the launch on a country by country basis in the Territory and contains customary provisions for termination by either party in the event of breach of the License Agreement by the other party (subject to a cure period), bankruptcy of the other party, or challenges to the patents by any sublicensee or assignee.
The foregoing description of the terms and conditions of the License Agreement does not purport to be complete and is qualified in its entirety by the full text of the License Agreement, which is attached hereto as Exhibit 10.1 and incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
* Portions of the exhibit have been omitted.
EXHIBIT INDEX
* Portions of the exhibit have been omitted.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: December 19, 2019 | Onconova Therapeutics, Inc. |
| | |
| | By: | /s/ Mark Guerin |
| | | Name: Mark Guerin |
| | | Title: Chief Financial Officer |
