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Item 1.01 | | Entry into a Material Definitive Agreement. |
On March 29, 2019, Puma Biotechnology, Inc. (the “Company”) entered into an exclusive license agreement (the “Agreement”) with Pierre Fabre Medicament SAS (“Pierre Fabre”).
Pursuant to the Agreement, the Company granted to Pierre Fabre, under certain of the Company’s intellectual property rights relating to neratinib, an exclusive, sublicensable (under certain circumstances) license to develop, manufacture and commercialize any pharmaceutical product containing neratinib (the “Licensed Product”) for therapeutic and prophylactic indications for human or veterinary use (the “Field”) for Europe, excluding Russia and Ukraine, and North Africa and francophone countries of West Africa (the “Territory”), subject to the terms of the Agreement.
The Agreement sets forth the parties’ respective obligations with respect to the development, commercialization, manufacture and supply of the Licensed Product. In September 2018 the European Commission granted marketing authorization for NERLYNX® (neratinib) for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab-based therapy. Within the Territory, Pierre Fabre will be solely responsible, at its expense, for conducting additional clinical studies, leading regulatory activities in connection with the European Medicines Agency (EMA) and commercializing the Licensed Product. The Company will remain responsible for the funding of certain post-marketing approval studies required by the EMA and 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 will receive an upfront payment of $60 million and potentially receive regulatory and commercial milestone payments totaling up to $345 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 until, on acountry-by-country basis, the later of (i) the expiration or abandonment of the last licensed patent covering the Licensed Product in such country and (ii) the earlier of (x) the date upon which sales of generic versions of the 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 cure period, or if the other party is insolvent. Pierre Fabre may terminate the agreement at its convenience or if there is an evidence of safety issues with the Licensed Product.
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 Form10-Q for the quarter ended March 31, 2019.
