Item 1.01 Entry into a Material Definitive Agreement
License Agreement
On September 20, 2017, Eagle Pharmaceuticals, Inc. (the Company) entered into a Product Collaboration and License Agreement, effective as of September 19, 2017, (the License Agreement) with SymBio Pharmaceuticals Limited (SymBio) for the rights to develop and commercialize the Companys bendamustine hydrochloride ready-to-dilute (RTD) injection product and rapid infusion (RI) injection product (collectively, the Products) in Japan. Under the License Agreement, SymBio will be responsible for all development of the Products in Japan and for obtaining and maintaining all regulatory approvals of the Products in Japan, with a target for regulatory approval of a Product in Japan in 2020. SymBio will bear all costs of development of the Products in Japan except that, if Japanese regulatory authorities require a certain clinical study to be conducted as a condition for approving one of the Products in Japan, Eagle will share 50% of the out-of-pocket costs of that clinical study up to a specified dollar amount. SymBio will also be responsible, at its sole cost, for all marketing, promotion, distribution and sales of the Products in Japan and is obligated to launch the Products and meet certain minimum detailing, promotion and marketing commitments in connection with commercialization of the Products in Japan.
SymBio currently markets in Japan TREAKISYM®, a lyophilized powder formulation of bendamustine hydrochloride indicated for chronic lymphocytic leukemia (CLL), relapsed or refractory low-grade Hodgkins lymphoma (NHL), mantle cell lymphoma (MCL), and as a first line treatment of low-grade NHL and MCL. Under the License Agreement, SymBio may continue to market TREAKISYM® in Japan and SymBio will be permitted to develop and market certain other bendamustine hydrochloride products in Japan for limited indications.
Pursuant to the terms of the License Agreement, the Company and SymBio will enter into a separate supply agreement, under which the Company will be responsible for manufacturing and supplying the Products to SymBio for development and commercialization in Japan. After a period of time following launch of a Product, SymBio will have the right to assume the responsibility for manufacturing of the Products in and for Japan. Under the License Agreement, the Company will retain the right to control the prosecution, maintenance and enforcement of the Companys patents covering the Products, both inside and outside of Japan.
Under the License Agreement, the Company will receive an upfront cash payment of $12.5 million, and is eligible to receive a milestone payment upon approval of a Product in Japan and a milestone payment upon achievement of certain cumulative net sales of the Products in Japan. After regulatory approval of a Product in Japan, the Company will also receive tiered, low double-digit royalties on net sales of the Products in Japan for so long as there are patents covering the Products in Japan or regulatory exclusivity for the Products in Japan.
Pursuant to the terms of the License Agreement, SymBio will have the right to terminate the License Agreement for any reason (without cause) following certain notice. The Company will have the right to terminate the License Agreement if SymBio fails to conduct material development or commercialization of the Products over a certain time period, or if SymBio challenges any of the Companys patents covering the Products. In addition, the Company and SymBio will each have the right to terminate the License Agreement in the event of the other partys material breach and failure to cure, or, under certain circumstances, in the event of the other partys bankruptcy or violation of anti-corruption laws.
The foregoing description of the material terms of the License Agreement does not purport to be complete and is subject to, and is qualified in its entirety by, reference to the full terms of the License Agreement, which the Company intends to file as an exhibit to the Companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2017. The Company intends to seek confidential treatment for certain portions of the License Agreement pursuant to a confidential treatment request to be submitted to the U.S. Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.