bluebird bio, Inc. (NASDAQ:BLUE) Files An 8-K Entry into a Material Definitive AgreementItem 1.01Entry into a Materials Definitive Agreement
On September 22, 2017, Celgene Corporation (“Celgene”) exercised its option to exclusively license bb21217 (“bb21217”), the second anti-BCMA product candidate under the Amended and Restated Collaboration Agreement dated June 3, 2015 (as amended, the “Amended Collaboration Agreement”) between Celgene and bluebird bio, Inc. (“bluebird”). In connection with its option exercise, Celgene will pay to bluebird an option exercise payment of $15.0 million in accordance with the terms of the Amended Collaboration Agreement. On September 28, 2017, the parties entered into the Amended and Restated License Agreement (the “License Agreement”), which provides for, among other matters, Celgenes exclusive worldwide license to develop and commercialize bb21217. Under the License Agreement, subject to customary “back-up” supply rights granted to Celgene, bluebird has the sole right to manufacture or have manufactured supplies of vectors and associated payloads manufactured for incorporation into bb21217. Celgene will reimburse bluebird for its costs to manufacture and supply such vectors and associated payloads, plus a modest mark-up. bluebird will continue to be responsible for conducting the ongoing CRB-402 Phase 1 clinical study of bb21217 for the treatment of relapsed/refractory multiple myeloma. Following the completion of the CRB-402 Phase 1 clinical study, Celgene will be responsible for all costs and expenses for the development and commercialization of bb21217, subject to bluebirds co-development and co-promotion option described below.
bluebird may elect to co-develop and co-promote bb21217 in the United States. If bluebird does not exercise its option to co-develop and co-promote bb21217 in the United States, bluebird will be eligible to receive up to $10.0 million in clinical milestone payments, up to $117.0 million in regulatory milestone payments and up to $78.0 million in commercial milestone payments, in addition to the option fee. bluebird will also be eligible to receive a percentage of net sales as a royalty in a range from the mid-single digits to low-teens. The royalties payable to bluebird are subject to certain reductions, including for any royalty payments required to be made by Celgene to acquire patent rights, with an aggregate minimum floor.
If bluebird elects to co-develop and co-promote bb21217 in the United States, then bluebird and Celgene would share equally in all costs incurred relating to the development, commercialization and manufacture of bb21271 within the United States and share equally in the profits generated by bb21217 in the United States. Additionally, if bluebird elects to co-develop and co-promote bb21217, then the milestones and royalties would decrease compared to those described above. Under this scenario, bluebird would receive up to $10.0 million in clinical milestone payments and outside of the United States, up to $54.0 million in regulatory milestone payments and up to $36.0 million in commercial milestone payments, in addition to the option fee. Furthermore, to the extent any of the product candidates licensed by Celgene and co-developed and co-promoted by bluebird are commercialized, bluebird would be entitled to receive tiered royalty payments ranging from the mid-single digits to low-teens based on a percentage of net sales form sales generated outside of the United States. The royalties payable to bluebird are subject to certain reductions, including for any royalty payments required to be made by Celgene to acquire patent rights, with an aggregate minimum floor. Celgene will assume certain development obligations and must report on their progress in achieving these milestones on a quarterly basis.
Absent early termination, the License Agreement will continue on a country-by-country basis, until there are no more payments owed to bluebird on bb21217 in such country. Celgene has the right to terminate the License Agreement at its discretion upon 180-day notice, beginning with the 18-month anniversary of the effective date of the License Agreement. Each party may also terminate the License Agreement upon prior notice for an uncured material breach that fundamentally frustrates the transactions contemplated by the License Agreement. bluebird also has the right to terminate the License Agreement if Celgene or any of its affiliates challenges the validity, scope or enforceability of or otherwise opposes, any patent included within the intellectual property rights licensed to Celgene under the License Agreement.
On September 28, 2017, the parties further amended the Amended Collaboration Agreement. The amendment provides for, among other matters, updated timing for certain deliverables in connection with Celgenes option to exclusively license bb21217.
The foregoing descriptions oftheLicense Agreementand theamendment to theAmended CollaborationAgreementdo not purport to be a complete statement of the parties rights under such agreements and are qualified in their entirety by reference to the full text of such agreements, a copy of each such agreement will be filed as an exhibit to bluebirdsquarterly report on Form 10-Q for the quarter ended September 30, 2017.
Item 8.01Other Events
On September 28, 2017, bluebird bio, Inc. (“bluebird”) issued a press release announcing the treatment of the first subject in the CRB-402 Phase I clinical study of bb21217 for the treatment of relapsed/refractory multiple myeloma.The full text of the press release regarding the announcement is filed as exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01Financial Statements and Exhibits.
bluebird bio, Inc. ExhibitEX-99.1 2 blue-ex991_6.htm EX-99.1 blue-ex991_6.htm Exhibit 99.1 bluebird bio Announces First Patient Treated with Second Anti-BCMA CAR T bb21217 in CRB-402 Phase 1 Study in Patients with Relapsed/Refractory Multiple Myeloma -Celgene has exercised its option to exclusively license bb21217 under its collaboration with bluebird bio- -bluebird bio to receive $15 million option exercise payment from Celgene- Cambridge,…To view the full exhibit click
About bluebird bio, Inc. (NASDAQ:BLUE)
bluebird bio, Inc. is a biotechnology company. The Company is focused on developing transformative gene therapies for severe genetic and rare diseases and in the field of T cell-based immunotherapy. Its gene therapy clinical programs include LentiGlobin product candidate to treat transfusion-dependent B-thalassemia (TDT) and severe sickle cell disease (SCD), and Lenti-D product candidate to treat cerebral adrenoleukodystrophy (CALD), a rare hereditary neurological disorder. Its oncology programs are built using lentiviral gene delivery and T cell engineering, with a focus on developing T cell-based immunotherapies, including chimeric antigen receptor (CAR) and T cell receptor (TCR) T cell therapies. Its oncology program, bb2121, is a CAR T cell product candidate targeting B-cell maturation antigen, or BCMA, in multiple myeloma. It also offers discovery research programs utilizing megaTALs/homing endonuclease gene editing technologies for use across its pipeline.
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