BEIGENE,LTD. (NASDAQ:BGNE) Files An 8-K Entry into a Material Definitive AgreementItem 1.01 Entry into a Material Definitive Agreement.
Summary
On July5, 2017, BeiGene,Ltd. (“BeiGene” or the “Company”) announced a strategic collaboration with Celgene Corporation (“Celgene”) to which Celgene will have the exclusive right to develop and commercialize BeiGene’s investigational anti-programmed cell death protein 1 (“PD-1”) inhibitor, BGB-A317, in patients with solid tumor cancers in the United States, Europe, Japan and the rest of world outside Asia. The parties will also collaborate on up to eight registrational studies for BGB-A317 in solid tumors, including studies currently being planned by BeiGene. BeiGene will retain exclusive rights for the development and commercialization of BGB-A317 for hematological cancers globally and for solid tumors in China and the rest of Asia, other than Japan. Upon closing, BeiGene will receive $263 million in upfront license fees and a $150 million equity investment from Celgene at a 35% premium, and will be eligible to receive up to $980 million in development, regulatory and sales milestone payments and royalties in the low-double digit to mid-twenty percentages on any future sales of BGB-A317, based on specified terms.
In connection with the PD-1 collaboration, the parties also announced that BeiGene will acquire Celgene’s commercial operations and sales force in China, excluding Hong Kong, Macau and Taiwan, and gain an exclusive license in that territory to commercialize Celgene’s approved cancer therapies, ABRAXANE®, REVLIMID®, and VIDAZA®, and its investigational agent CC-122 in clinical development (the “Celgene Products”).
The transactions have been approved by the boards of directors of both companies and are expected to close in the third quarter of 2017, subject to the expiration or termination of applicable waiting periods under all applicable antitrust laws and satisfaction of other customary closing conditions.
The principal agreements for the transactions are further summarized below.
Exclusive License and Collaboration Agreement
On July5, 2017, BeiGene entered into an Exclusive License and Collaboration Agreement with Celgene and its wholly-owned subsidiary, Celgene Switzerland LLC (“Celgene Switzerland”), to which the Company has agreed to grant the Celgene parties an exclusive right to develop and commercialize BGB-A317 in all fields of treatment, other than hematology, in the United States, Europe, Japan and the rest of world other than Asia (the “PD-1 License Agreement”).
to the terms of the PD-1 License Agreement, the Celgene parties will make upfront payments to the Company of $263 million. The Company may also receive up to $980 million in potential development, regulatory and sales milestone payments and tiered royalties based on percentages of annual net sales, depending on specified terms, in the low double digit to mid-twenties, with customary reductions in specified circumstances. Royalties are payable on a licensed product-by-product and country-by-country basis until the latest of the expiration of the last valid patent claim, the expiration of regulatory exclusivity or 12 years after the first commercial sale of such licensed product in the country of sale.
Each party has the right to develop and commercialize BGB-A317 in their respective fields and territories, and have also agreed to collaborate through a joint steering committee comprised of an equal number of representatives from each party on, among other things, the conduct of up to eight global registrational clinical trials (“Basket Studies”). Each Basket Study will be conducted and funded by either the Company or Celgene in accordance with a mutually agreed development plan and study design. For any Basket Studies conducted and funded by the Company, Celgene has the right to opt into such program, at which time it will reimburse the Company for agreed upon development costs based on a multiple of such costs that varies according to the stage of development at which Celgene opts into the program. Celgene has committed to use commercially reasonable efforts to develop at least one licensed product and to seek specified regulatory approvals, and to spend at least $100 million on development for the Basket Studies led by Celgene, subject to specified conditions. In addition, BeiGene retains the right to develop BGB-A317 in combination therapies with its portfolio compounds, and Celgene has a right of first negotiation for BGB-A317 in the hematology field and in BeiGene’s territory, subject to specified conditions.