Current Report Filing (8-k)
April 03 2018 - 9:02AM
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): April 3, 2018 (March 30, 2018)
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 March 30, 2018 (the Effective Date),
Puma Biotechnology, Inc. (the Company) entered into a License Agreement (the Agreement) with Pint Pharma International SA (Pint).
Pursuant to the Agreement, the Company granted to Pint, under certain of the Companys intellectual property rights relating to neratinib, an exclusive,
sublicensable (under certain circumstances) license to develop and commercialize any product containing neratinib and certain related compounds (the Licensed Product) in Latin America, including Argentina, Brazil, Chile, Colombia and
Mexico (the Territory).
The Agreement sets forth the parties respective obligations with respect to the development, commercialization
and supply of the Licensed Product. Pint will, at its expense, develop the Licensed Product for the purpose of obtaining regulatory approval in the Territory, subject to the Companys consent to conduct such development activities and approval
of certain aspects of clinical studies conducted by Pint. Within the Territory, Pint will also be responsible for regulatory and commercialization activities. 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, subject to certain exceptions therein.
Pursuant to the Agreement, the
Company will receive an upfront payment of $10 million and is eligible to receive regulatory milestone payments totaling up to $9.5 million and sales-based milestone payments totaling up to $15 million. In addition, the Company is
entitled to receive significant double-digit royalties calculated as a percentage of net sales of the 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 licensed patent covering the Licensed Product
in such country, or (ii) the earlier of (x) the date upon which sales of generic versions of Licensed Product reach a specified level in such country, or (y) 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. Pint may also terminate the agreement at will, for certain safety
concerns, or if Puma does not deliver certain specified documents to Pint within a certain period of time after the Effective Date.
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 Quarterly Report on Form
10-Q
for the quarter ended
March 31, 2018.
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: April 3, 2018
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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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