6-K 1 zlab-6k_20190611.htm 6-K zlab-6k_20190611.DOCX.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 6-K

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13A-16 OR 15D-16

OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of June 2019

 

Commission Filing Number: 001-38205

 

ZAI LAB LIMITED

(Translation of registrant’s name into English)

 

4560 Jinke Road, Bldg. 1, 4F, Pudong, Shanghai, China 201210

(Address of principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F:

Form 20-F Form 40-F

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):       

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):       



License Agreement

On June 11, 2019, Zai Lab (Shanghai) Co., Ltd., a subsidiary of Zai Lab Limited (“Zai”), entered into a License Agreement (the “Agreement”) with Deciphera Pharmaceuticals, LLC (“Deciphera”), pursuant to which Deciphera granted Zai exclusive rights to develop and commercialize Deciphera’s drug candidate, ripretinib, including certain follow-on compounds (the “Licensed Products”), in Mainland China, Hong Kong, Macau and Taiwan (each, a “region” and collectively, the “Territory”). Deciphera retains exclusive rights to, among other things, develop, manufacture and commercialize the Licensed Products outside the Territory.

Pursuant to the terms of the Agreement, Zai will pay an upfront cash payment of $20.0 million and up to $185.0 million in development and commercial milestone payments, consisting of up to $50.0 million of development milestones (including a $5.0 million near-term INTRIGUE study-related milestone) and up to $135.0 million of commercial milestones. In addition, during the term of the Agreement, Zai will pay Deciphera tiered percentage royalties ranging from low to high teens on annual net sales of the Licensed Products in the Territory, subject to adjustments in specified circumstances.

Pursuant to the terms of the Agreement, Zai will be responsible for conducting the development and commercialization activities in the Territory related to the Licensed Products, and, subject to limited exceptions pursuant to which the Company may be responsible for the cost, Zai will bear all associated expenses.  Deciphera will be solely responsible for any global clinical study of a Licensed Product, including the portions that may be conducted in the Territory, and will bear associated expenses.

Subject to specified exceptions, during the term of the Agreement, each party has agreed that neither it nor its affiliates nor, with respect to Zai, its sublicensees, will conduct any development, manufacturing and commercialization activities in the Territory that may be deemed competitive with the Licensed Products. In addition, under the Agreement, each party has granted the other party specified intellectual property licenses to enable the other party to perform its obligations and exercise its rights under the Agreement, including license grants to enable each party to conduct research, development and commercialization activities pursuant to the terms of the Agreement.  Zai will purchase the Licensed Products from Deciphera pursuant to a supply agreement and for agreed upon consideration.

The Agreement will continue on a Licensed Product-by-Licensed Product and region-by-region basis until the later of (i) the abandonment, expiry or final determination of invalidity of the last valid claim within Deciphera’s patent rights that covers the Licensed Product in such region in the Territory; (ii) the expiry of the regulatory exclusivity for such Licensed Product in such region; or (iii) the close of business of the day that is exactly ten (10) years after the date of the first commercial sale of such Licensed Product in such region. Subject to the terms of the Agreement, Zai may terminate the Agreement for convenience by providing written notice to Deciphera, which termination will be effective following a prescribed notice period. In addition, Deciphera may terminate the Agreement under specified circumstances if Zai or certain other parties challenge Deciphera’s patent rights or if Zai or its affiliates do not conduct certain development activities with respect to one or more Licensed Products for a specified period of time, subject to specified exceptions. Either party may terminate the Agreement for the other party’s uncured material breach of a material term of the Agreement, with a customary notice and cure period, or insolvency. After termination (but not natural expiration), Deciphera is entitled to retain a worldwide and perpetual license from Zai to exploit the Licensed Products.

The foregoing description of the Agreement is only a summary and is qualified in its entirety by reference to the Agreement, a copy of which will be filed as an exhibit to Zai’s next periodic report.

Zai has filed as an exhibit to this Form 6-K a press release dated June 11, 2019 announcing the entry into the Agreement.

 


EXHIBIT INDEX

 

 

 

 

Exhibit

No.

 

Description

 

 

99.1

 

Press release issued June 11, 2019.

 

 


SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

ZAI LAB LIMITED

 

 

 

By: 

/s/ Samantha Du

 

Name: 

Samantha Du

 

Title: 

Chief Executive Officer

Date: June 11, 2019