TURG POIN Item 1.01 Entry into a Material Definitive Agreement.
On
Pursuant to the terms of the Zai License Agreement, the Company will receive an
upfront cash payment of
Pursuant to the terms of the Zai License Agreement, Zai will be responsible for conducting the development and commercialization activities in the Territory related to the Products at Zai's own expense, subject to limited exceptions pursuant to which the Company may be responsible for the cost. The Company will be responsible for global clinical studies of the Products, including the portions that may be conducted in the Territory, at the Company's expense, except that Zai will participate in global clinical studies of the Products through clinical trial sites in the Territory as agreed as of the effective date of the Zai License Agreement and may, at Zai's election subject to specified exceptions, participate in future global clinical studies of the Products through clinical trial sites in the Territory, in each case at Zai's expense.
Subject to specified exceptions, during the term of the Zai License Agreement, Zai has agreed that neither it nor its affiliates, its licensees and its sublicensees will conduct any development, manufacturing and commercialization activities with specified products that would compete with the Products in or outside the Territory, and the Company has agreed that neither it nor its affiliates, its licensees and its sublicensees of Products will conduct any development, manufacturing and commercialization activities with such competing products in the Territory, other than manufacturing activities in support of activities outside the Territory.
Under the terms of the Zai License Agreement, the Company will have a first right to negotiate a license outside the Territory to a potential drug candidate from one of Zai pipeline programs, if Zai files an investigational new drug application for the drug candidate.
Under the terms of the Zai License Agreement, if the Company is acquired in a change of control transaction, until such time when Zai files the first regulatory approval application for the first Product in the Territory, the Company's acquirer will have a first right to negotiate with Zai the right to co-commercialize the Products in the Territory.
The Zai License Agreement will continue in effect until expiration of the last royalty term for a Product in any region in the Territory, where the royalty term for a Product in a region continues until the later of (i) the date of the last-to-expire valid claim within Company's patent rights that covers the Product in such region in the Territory; (ii) the expiry of the regulatory exclusivity for such Product in such region; or (iii) the close of business of the day that is exactly 10 years after the date of the first commercial sale of such Product in such region. Subject to the terms of the Zai License Agreement, Zai may terminate the Zai License Agreement for convenience by providing written notice to the Company, which termination will be effective following a prescribed notice period. In addition, the Company may terminate the Zai License Agreement under specified circumstances if Zai or certain other parties challenge the Company's patent rights. Either party may terminate the Zai License Agreement for the other party's uncured material breach of the Zai License Agreement, with a customary notice and cure period, for the other party's insolvency or if the other party is acquired in a change of control transaction and the acquirer is engaged in activities with a competing product that is not divested or discontinued within a specified period. After termination (but not natural expiration), other than certain terminations by Zai for cause, the Company is entitled to retain a worldwide and perpetual license from Zai to exploit the Products.
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The foregoing description of the material terms of the Zai License Agreement
does not purport to be complete and is qualified in its entirety by reference to
the complete text of the Zai License Agreement, a copy of which the Company
intends to file, with confidential terms redacted, with the
Item 2.02 Results of Operations and Financial Condition.
On
The information contained in this Current Report on Form 8-K under Item 2.02 is being furnished and shall not be deemed to be "filed" for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section and will not be incorporated by reference into any registration statement filed by the Company under the Securities Act of 1933, as amended (the "Securities Act"), unless specifically identified as being incorporated therein by reference.
Item 7.01 Regulation FD Disclosure.
On
The information contained in this Current Report on Form 8-K under Item 7.01 and Exhibit 99.1 hereto are being furnished and shall not be deemed to be "filed" for the purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section and will not be incorporated by reference into any registration statement filed by the Company under the Securities Act, unless specifically identified as being incorporated therein by reference.
Item 8.01 Other Events.
On
Repotrectinib, ROS1 and TRK Inhibitor
• Present updated data from the TRIDENT-1 study in TKI-naive patients with
ROS1-positive advanced non-small cell lung cancer ("NSCLC") in a
mini-oral presentation on January 31, 2021 at the World Conference on
Lung Cancer ;
• Provide an update on the overall Phase 2 TRIDENT-1 registrational study
timeline in the first quarter of 2021;
• Initiate the Phase 2 TRIDENT-2 combination study in patients with KRAS
mutant NSCLC mid-year 2021; and
• Provide clinical data updates from certain cohorts of the Phase 2
TRIDENT-1 study in the second half of 2021.
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TPX-0022, MET/SRC/CSF1R Inhibitor
• Initiate the Phase 2 portion of SHIELD-1, pending feedback from the U.S.
Food and Drug Administration , in the second half of 2021;
• Initiate the Phase 2 SHIELD-2 study of TPX-0022 in combination with an
epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor in the
second half of 2021; and
• Provide a clinical data update from the Phase 1 portion of the SHIELD-1
study in the second half of 2021.
TPX-0046, RET Inhibitor
• Report early interim data from initial patients enrolled in the dose
finding portion of the TPX-0046 Phase 1 study in the first half of 2021.
TPX-0131, ALK Inhibitor
• Submit the investigational new drug application for TPX-0131 in the first
quarter of 2021; and
• Initiate a Phase 1 clinical study of TPX-0131 in the first half of 2021.
Early Discovery Pipeline
• Outline research strategy, focus and milestones for future development
candidates in the second half of 2021.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits. Exhibit No. Description 99.1 Presentation Materials ofTurning Point Therapeutics, Inc. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document). Forward-Looking Statements
This report contains forward-looking statements within the meaning of the
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