PUMA BIOTECHNOLOGY, INC. (NASDAQ:PBYI) Files An 8-K Entry into a Material Definitive AgreementItem 1.01
On November20, 2017, Puma Biotechnology, Inc. (the “Company”) entered into a License Agreement (the “Agreement”) with Specialised Therapeutics Asia Pte Ltd. (“STA”).
to the Agreement, the Company granted to STA, under certain of the Company’s 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.
to the Agreement, the Company is entitled to upfront and other milestone payments of up to $4.5million, 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 Company’s Annual Report on Form 10-K for the year ended December31, 2017.
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.