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bluebird bio | 8-K: Current report

bluebird bio | 8-K: Current report

bluebird bio | 8-K:重大事件
美股SEC公告 ·  2024/09/24 04:04

牛牛AI助理已提取核心訊息

On September 20, 2024, bluebird bio, Inc. entered into a Master Services Agreement with Henogen SRL, a subsidiary of Thermo Fisher Scientific, to manufacture lentiviral vector (LVV) used in bluebird bio's gene therapy product LYFGENIA. The agreement, effective as of September 15, 2024, supersedes the previous manufacturing contract with Henogen that expired on the same date. Henogen will be responsible for the production of LVV, including quality control, assurance, validation activities, stability testing, packaging, shipping, and other related services for both clinical and commercial use. The agreement allows for the creation of individual project agreements for specific products and requires bluebird bio to provide a 12-quarter rolling forecast for commercial LVV orders, with certain binding and semi-binding forecast periods. The contract is set to last until September 15, 2029, with automatic renewal for additional two-year terms unless terminated by either party due to material breach, bankruptcy proceedings, or force majeure events. It also includes standard provisions such as representations, warranties, limitations of liabilities, confidentiality, indemnity obligations, and other customary terms.
On September 20, 2024, bluebird bio, Inc. entered into a Master Services Agreement with Henogen SRL, a subsidiary of Thermo Fisher Scientific, to manufacture lentiviral vector (LVV) used in bluebird bio's gene therapy product LYFGENIA. The agreement, effective as of September 15, 2024, supersedes the previous manufacturing contract with Henogen that expired on the same date. Henogen will be responsible for the production of LVV, including quality control, assurance, validation activities, stability testing, packaging, shipping, and other related services for both clinical and commercial use. The agreement allows for the creation of individual project agreements for specific products and requires bluebird bio to provide a 12-quarter rolling forecast for commercial LVV orders, with certain binding and semi-binding forecast periods. The contract is set to last until September 15, 2029, with automatic renewal for additional two-year terms unless terminated by either party due to material breach, bankruptcy proceedings, or force majeure events. It also includes standard provisions such as representations, warranties, limitations of liabilities, confidentiality, indemnity obligations, and other customary terms.
2024年9月20日,bluebird bio與Thermo Fisher Scientific子公司Henogen SRL簽署了一項總服務協議,用於bluebird bio的基因治療產品LYFGENIA中使用的逆轉錄病毒載體(LVV)的製造。該協議自2024年9月15日起生效,取代了與Henogen簽訂的上一個製造合同,該合同於同一日期到期。Henogen將負責LVV的生產,包括質量控制、保證、驗證活動、穩定性測試、包裝、運輸和其他相關服務,用於臨床和商業用途。該協議允許爲特定產品制定單獨的項目協議,並要求bluebird bio提供爲商業LVV訂單提供爲期12個季度的滾動預測,其中包括特定的綁定和半綁定預測期。合同將持續至2029年9月15日,除非任何一方因重大違約、破產程序或不可抗力事件而終止,否則將自動續訂兩年。合同還包括諸如陳述、擔保、責任限制、保密、賠償義務和其他習慣條款等標準條款。
2024年9月20日,bluebird bio與Thermo Fisher Scientific子公司Henogen SRL簽署了一項總服務協議,用於bluebird bio的基因治療產品LYFGENIA中使用的逆轉錄病毒載體(LVV)的製造。該協議自2024年9月15日起生效,取代了與Henogen簽訂的上一個製造合同,該合同於同一日期到期。Henogen將負責LVV的生產,包括質量控制、保證、驗證活動、穩定性測試、包裝、運輸和其他相關服務,用於臨床和商業用途。該協議允許爲特定產品制定單獨的項目協議,並要求bluebird bio提供爲商業LVV訂單提供爲期12個季度的滾動預測,其中包括特定的綁定和半綁定預測期。合同將持續至2029年9月15日,除非任何一方因重大違約、破產程序或不可抗力事件而終止,否則將自動續訂兩年。合同還包括諸如陳述、擔保、責任限制、保密、賠償義務和其他習慣條款等標準條款。

譯文內容由第三人軟體翻譯。


牛牛AI助手部分由第三方人工智慧模型基於資訊內容自動產生。


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