Current Report Filing (8-k)
November 22 2017 - 9:29AM
Edgar (US Regulatory)
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): November 22, 2017 (November 20, 2017)
PUMA BIOTECHNOLOGY, INC.
(Exact Name of Registrant as Specified in its Charter)
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Delaware
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001-35703
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77-0683487
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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10880 Wilshire Boulevard, Suite 2150
Los Angeles, California 90024
(Address of principal executive offices) (Zip Code)
(424)
248-6500
(Registrants telephone number, including area code)
N/A
(Former name or
former address, if changed since last report)
Check the appropriate box below
if the Form
8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule
14a-12
under the Exchange Act (17 CFR
240.14a-12)
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Pre-commencement
communications pursuant to Rule
14d-2(b)
under the Exchange Act (17 CFR
240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to Rule
13e-4(c)
under the Exchange Act (17 CFR
240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging growth company as
defined in 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. ☐
Item 1.01
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Entry into a Material Definitive Agreement.
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On November 20, 2017, Puma Biotechnology, Inc. (the
Company) entered into a License Agreement (the Agreement) with Specialised Therapeutics Asia Pte Ltd. (STA).
Pursuant
to the Agreement, the Company granted to STA, under certain of the Companys intellectual property rights relating to neratinib, an exclusive (including with respect to the Company and its affiliates), sublicensable license to commercialize any
pharmaceutical product containing neratinib in finished form (the Licensed Product) for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer and HER2-positive metastatic breast cancer in
Australia, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, New Zealand, Papua New Guinea, Philippines, Singapore, Thailand, Timor-Leste and Vietnam (the Territory).
The Agreement sets forth the parties respective obligations with respect to the development, commercialization and supply of the Licensed Product.
Within the Territory, STA will be generally responsible for regulatory and commercialization activities, and the Company will be solely responsible for the manufacturing and supply of the Licensed Product under a supply agreement that will be
entered into between the parties.
Pursuant to the Agreement, the Company is entitled to upfront and other milestone payments of up to $4.5 million,
payable upon achievement of the milestone events specified in the Agreement. Furthermore, the Company is entitled to receive significant double digit royalties calculated as a percentage of net sales of Licensed Products in the Territory.
The term of the Agreement continues, on a
country-by-country
basis, until the
later of (i) the expiration or abandonment of the last patent covering the Licensed Product or (ii) the earlier of (a) the date upon which sales of generic versions of Licensed Product reach a specified level in such country, or
(b) the tenth anniversary of the first commercial sale of the Licensed Product in such country. The Agreement may be terminated by either party if the other party commits a material breach, subject to a customary cure period, or if the other
party is insolvent. The Agreement will also terminate upon the termination of the supply agreement for Licensed Products between the parties.
The
foregoing description of the Agreement is qualified in its entirety by reference to the Agreement, a copy of which will be filed as an exhibit to the Companys Annual Report on Form
10-K
for the year
ended December 31, 2017.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
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PUMA BIOTECHNOLOGY, INC.
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Date: November 22, 2017
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By:
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/s/ Alan H. Auerbach
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Alan H. Auerbach
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Chief Executive Officer and President
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