PUMA BIOTECHNOLOGY, INC. (NASDAQ:PBYI) Files An 8-K Entry into a Material Definitive AgreementItem 1.01
On March30, 2018 (the “Effective Date”), Puma Biotechnology, Inc. (the “Company”) entered into a License Agreement (the “Agreement”) with Pint Pharma International SA (“Pint”).
to the Agreement, the Company granted to Pint, under certain of the Company’s 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 Company’s 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.
to the Agreement, the Company will receive an upfront payment of $10million and is eligible to receive regulatory milestone payments totaling up to $9.5million and sales-based milestone payments totaling up to $15million. 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 Company’s Quarterly Report on Form 10-Q for the quarter ended March31, 2018.
About PUMA BIOTECHNOLOGY, INC. (NASDAQ:PBYI)
Puma Biotechnology, Inc. is a biopharmaceutical company that focuses on the development and commercialization of products for the treatment of cancer. The Company focuses on in-licensing the global development and commercialization rights to over three drug candidates, including PB272 (neratinib (oral)), which the Company is developing for the treatment of patients with human epidermal growth factor receptor type 2 (HER2), positive breast cancer, and patients with non-small cell lung cancer, breast cancer and other solid tumors that have a HER2 mutation; PB272 (neratinib (intravenous)), which the Company is developing for the treatment of patients with advanced cancer, and PB357, which is an orally administered agent. Neratinib is a potent irreversible tyrosine kinase inhibitor (TKI) that blocks signal transduction through the epidermal growth factor receptors (EGFRs), HER1, HER2 and HER4. PUMA BIOTECHNOLOGY, INC. (NASDAQ:PBYI) Recent Trading Information
PUMA BIOTECHNOLOGY, INC. (NASDAQ:PBYI) closed its last trading session up +1.60 at 66.00 with shares trading hands.