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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

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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公司与Thermo Fisher Scientific的子公司Henogen SRL签订了一份制造业-半导体服务总协议,用于生产用于bluebird bio基因疗法产品LYFGENIA中的潜江病毒载体(LVV)。该协议自2024年9月15日起生效,取代了之前与Henogen到期的制造合同。Henogen将负责LVV的生产,包括质量控制、质量保证、验证活动、稳定性测试、包装、运输以及其他相关服务,供临床和商业用途。协议允许为特定产品创建单独的项目协议,并要求bluebird bio为商业LVV订单提供为期12个季度的滚动预测,其中部分预测期限具有约束力和半约束力。该合同计划持续至2029年9月15日,如未因重大违约、破产程序或不可抗力事件而终止,将自动续签两年。合同还包括如代表、保证、责任限制、保密、赔偿责任以及其他习惯条款等标准规定。
2024年9月20日,bluebird bio公司与Thermo Fisher Scientific的子公司Henogen SRL签订了一份制造业-半导体服务总协议,用于生产用于bluebird bio基因疗法产品LYFGENIA中的潜江病毒载体(LVV)。该协议自2024年9月15日起生效,取代了之前与Henogen到期的制造合同。Henogen将负责LVV的生产,包括质量控制、质量保证、验证活动、稳定性测试、包装、运输以及其他相关服务,供临床和商业用途。协议允许为特定产品创建单独的项目协议,并要求bluebird bio为商业LVV订单提供为期12个季度的滚动预测,其中部分预测期限具有约束力和半约束力。该合同计划持续至2029年9月15日,如未因重大违约、破产程序或不可抗力事件而终止,将自动续签两年。合同还包括如代表、保证、责任限制、保密、赔偿责任以及其他习惯条款等标准规定。
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