Bluebird Bio Inc.
09/23/2024 | Press release | Distributed by Public on 09/23/2024 14:02
Material Agreement Form 8 K
|
Item 1.01
|
Entry into a Material Definitive Agreement.
|
On September 20, 2024, bluebird bio, Inc. (the "Company") and Henogen SRL, a part of Thermo Fisher Scientific ("Henogen") entered into a Master Services Agreement for Viral Vector Services, effective as of September 15, 2024 (the "Henogen Agreement"). The Henogen Agreement replaces the Company's former manufacturing agreement with Henogen, which expired on September 15, 2024.
Pursuant to the Henogen Agreement, Henogen agrees to manufacture lentiviral vector ("LVV"), currently used in the Company's gene therapy product LYFGENIA. Under the terms of the Henogen Agreement, Henogen is responsible for manufacturing LVV, conducting quality control, quality assurance, validation activities, stability testing, packaging and shipping, and providing related services for LVV for clinical or commercial use. The Henogen Agreement is structured so that individual project agreements may be entered into by the parties for the manufacture of a particular product. The Company has agreed to order LVV for commercial use based on a 12-quarter rolling forecast, subject to certain binding and semi-binding forecast periods.
The Henogen Agreement remains in effect until September 15, 2029, and will automatically renew for additional two-year periods unless either party provides advance notice of non-renewal. Either party may terminate the Henogen Agreement in the event of the other party's material uncured breach or bankruptcy proceedings, or due to certain force majeure events.
The Henogen Agreement contains certain representations, warranties, limitations of liabilities, confidentiality and indemnity obligations and other provisions customary for an agreement of its type.