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BioNTech SE
BioNTech SE
(Nasdaq: BNTX) is committed to developing breakthrough mRNA-based medicines for those in need. The announced acquisition of CureVac N.V. (Nasdaq: CVAC) (the “Acquisition”) is an investment in the future of mRNA-based cancer medicines and another strategic building block for BioNTech. Upon closing, it will bring together two highly complementary companies which have been researching and developing investigational mRNA-based products over decades with great passion and build on BioNTech’s proven track record and established position in the global mRNA industry. .
(纳斯达克:BNTX)致力于为有需要的患者开发突破性的基于mRNA的药物。宣布收购CureVac N.V.(纳斯达克:CVAC)(“收购”)是对基于mRNA的癌症药物未来的一项投资,也是BioNTech的另一个战略组成部分。收购完成后,两家高度互补的公司将强强联合,他们在过去几十年中充满热情地研究和开发基于mRNA的试验性产品,并依托BioNTech在mRNA行业的可靠业绩和稳固地位进一步发展。
Separate from the Acquisition, BioNTech SE and an affiliate (together, “BioNTech”) and Pfizer, Inc. (NYSE: PFE, “Pfizer”) entered into agreements with CureVac N.V. and an affiliate (together, “CureVac”), and an affiliate of GSK plc (LSE/NYSE: GSK, “GSK”) on August 7, 2025 (the “Settlement Arrangements”) to resolve the pending patent litigation between BioNTech, Pfizer and CureVac in the United States, and set a framework for resolving patent litigation and allegations of patent infringement between BioNTech, Pfizer and CureVac outside the U.S.
与收购无关,BioNTech SE及其关联公司(合称“BioNTech”)和辉瑞公司(纽约证券交易所:PFE,“辉瑞”)于2025年8月7日与CureVac N.V.及其关联公司(合称“CureVac”),以及GSK plc(伦敦证券交易所/纽约证券交易所:GSK,“GSK”)的一家关联公司达成了协议(“和解安排”),以解决BioNTech、辉瑞和CureVac之间在美国的未决专利诉讼,并为解决BioNTech、辉瑞和CureVac在美国以外的专利诉讼及专利侵权指控设定了框架。
(subject to closing of the Acquisition). As a consequence of entering into the Settlement Arrangements, CureVac, BioNTech and Pfizer filed a Stipulation and Order with the United States District Court for the Eastern District of Virginia dismissing with prejudice CureVac’s action for patent infringement relating to certain CureVac patents (Civil Action No 2:23-cv-222)..
(收购完成为前提)。作为达成和解协议的结果,CureVac、BioNTech 和辉瑞向美国弗吉尼亚东区地方法院提交了规定和命令,撤销了CureVac针对某些CureVac专利(民事诉讼编号2:23-cv-222)的专利侵权诉讼,且不得再次起诉。
Under the Settlement Arrangements, BioNTech and Pfizer will receive a non-exclusive license from CureVac to manufacture, use, import into the U.S. and sell mRNA-based COVID-19 and/or influenza products (“Licensed Products”). The non-exclusive license will be expanded into a worldwide license upon the closing of the Acquisition.
根据和解协议,BioNTech 和辉瑞将获得 CureVac 的非独家许可,以在美国制造、使用、进口和销售基于 mRNA 的 COVID-19 和/或流感产品(“许可产品”)。在收购完成时,该非独家许可将扩大为全球许可。
In addition, BioNTech and Pfizer will receive, among other things, a release from all claims relating to purported infringement of CureVac and GSK related to the research, development, manufacture or sale of the Pfizer-BioNTech COVID-19 vaccine in the U.S. prior to January 1, 2025 and, following closing of the Acquisition, a release from all claims by CureVac and GSK worldwide.
此外,BioNTech 和辉瑞还将获得(其中包括)一项豁免,即免除与 CureVac 和 GSK 在 2025 年 1 月 1 日之前在美国境内与辉瑞-BioNTech COVID-19 疫苗的研究、开发、制造或销售相关的所有声称侵权的索赔;在收购完成之后,CureVac 和 GSK 在全球范围内的所有索赔也将被豁免。
The Settlement Arrangements not only effectively resolve the ongoing disputes between CureVac, BioNTech and Pfizer in the U.S. and, if the Acquisition closes, the rest of the world, but it will also allow BioNTech to focus on the execution of its strategy and its priority programs, including mRNA-based product candidates..
该和解协议不仅有效解决了CureVac、BioNTech和辉瑞之间在美国的持续争议,并且如果收购完成,还将在全球范围内解决争议,同时也将使BioNTech能够专注于执行其战略和优先项目,包括基于mRNA的产品候选药物。
The Settlement Arrangements do not in any way constitute an admission of liability with respect to any allegation raised by CureVac or GSK, all of which BioNTech expressly denies, and nothing in the Settlement Arrangements shall be taken as or construed to be an admission by BioNTech as evidence supporting any such allegation, any matter of fact or law, any violation of law or any other liability whatsoever..
和解协议绝不构成对CureVac或GSK提出的任何指控的承认责任,所有这些指控BioNTech明确否认,并且和解协议中的任何内容均不应被视为或解释为BioNTech对支持任何此类指控、任何事实或法律问题、任何违法行为或任何其他责任的承认。
Under the terms of the Settlement Arrangements, BioNTech will, among other things, pay to the benefit of GSK $370 million to GSK and a 1% royalty on U.S. sales of Licensed Products from January 1, 2025, onward. Following the closing of the Acquisition, BioNTech will pay $130 million to GSK and a 1% royalty on rest-of-world sales of Licensed Products from January 1, 2025, onward.
根据和解协议的条款,BioNTech 将在其他事项之外,向GSK支付3.7亿美元,并从2025年1月1日起,对美国市场许可产品的销售额支付1%的特许权使用费。在收购完成后,BioNTech将向GSK支付1.3亿美元,并从2025年1月1日起,对全球其他地区许可产品的销售额支付1%的特许权使用费。
Subject to the closing of the Acquisition, Pfizer has agreed to reimburse BioNTech for $80 million and half of claimed royalties payable to GSK from January 1, 2025, onwards on sales of mRNA-based COVID-19 products in the United States..
根据收购完成的条件,辉瑞同意向BioNTech偿还8000万美元,并从2025年1月1日起,承担美国市场基于mRNA的新冠产品销售中应支付给GSK的一半专利使用费。
Pursuant to the Settlement Arrangements, BioNTech will also pay CureVac $370 million upon the closing of the Acquisition or the termination of the purchase agreement relating to the Acquisition, and a 1% royalty on U.S. sales of Licensed Products from January 1, 2025, onward. Following the closing of the Acquisition, BioNTech will pay a 1% royalty on rest-of-world sales of Licensed Products to CureVac from January 1, 2025, onward..
根据和解协议,BioNTech还将在收购完成或与收购相关的购买协议终止时向CureVac支付3.7亿美元,并从2025年1月1日起对许可产品在美国的销售额支付1%的特许权使用费。在收购完成后,BioNTech将从2025年1月1日起对许可产品在世界其他地区的销售额向CureVac支付1%的特许权使用费。
The transaction between BioNTech and CureVac announced on June 12, 2025, will, subject to regulatory approval, be implemented as planned and its terms will remain unaffected.
2025年6月12日宣布的BioNTech与CureVac之间的交易,待监管机构批准后,将按计划实施,其条款将保持不变。
About BioNTech
关于BioNTech
Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel investigative therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic modalities with the intent of rapid development of novel biopharmaceuticals.
生物制药新技术公司(BioNTech)是一家全球性的下一代免疫治疗公司,致力于开发癌症和其他严重疾病的新型研究性疗法。BioNTech 利用多种计算发现和治疗模式,旨在快速开发新型生物制药。
Its diversified portfolio of oncology product candidates aiming to address the full continuum of cancer includes mRNA cancer immunotherapies, next-generation immunomodulators and targeted therapies such as antibody-drug conjugates (ADCs) and innovative chimeric antigen receptor (CAR) T cell therapies.
其多样化的肿瘤学候选产品组合旨在应对癌症的整个连续过程,包括mRNA癌症免疫疗法、下一代免疫调节剂和靶向疗法,如抗体药物偶联物(ADC)和创新的嵌合抗原受体(CAR)T细胞疗法。
Based on its deep expertise in mRNA development and in-house manufacturing capabilities, BioNTech and its collaborators are researching and developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Bristol Myers Squibb, Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron..
基于其在mRNA开发方面的深厚专业知识和内部生产能力,BioNTech及其合作伙伴正在研究和开发多种针对不同传染病的mRNA疫苗候选产品,同时推进其多样化的肿瘤学研发管线。BioNTech已经与多家全球性和专业性制药合作伙伴建立了广泛的合作关系,其中包括百时美施贵宝、Duality Biologics、复星医药、罗氏集团成员基因泰克(Genentech)、Genevant、Genmab、MediLink、OncoC4、辉瑞(Pfizer)和再生元(Regeneron)。
For more information, please visit
更多信息,请访问
www.BioNTech.com
www.BioNTech.com
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Forward-Looking Statements
前瞻性声明
This document includes “forward-looking statements,” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “look forward,” “investigational,” “pipeline,” “to acquire,” “development,” “to include,” “commitment,” or similar terms.
本文件包含1934年《证券交易法》(经修订)第21E条以及1995年《私人证券诉讼改革法案》所指的“前瞻性陈述”。前瞻性陈述通常可以通过诸如“潜在”、“能够”、“将”、“计划”、“可能”、“可以”、“会”、“预期”、“期待”、“研究性”、“管线”、“收购”、“开发”、“包括”、“承诺”或类似术语来识别。
Such forward-looking statements include, but are not limited to, statements relating to the ability of BioNTech to complete the Acquisition, the impact of the Acquisition on the terms contemplated by the Settlement Agreement, Pfizer’s agreement to reimburse BioNTech with respect to royalty and upfront payments in connection with the Settlement Agreement, and the disputes among BioNTech, Pfizer, CureVac, and GSK generally.
此类前瞻性声明包括但不限于以下相关声明:BioNTech完成收购的能力、收购对和解协议条款的影响、辉瑞同意根据和解协议就特许权使用费和预付款向BioNTech进行补偿,以及BioNTech、辉瑞、CureVac和GSK之间的总体争议。
Many of these risks and uncertainties are beyond the control of BioNTech. Investors are cautioned that any such forward-looking statements are based on BioNTech’s current beliefs and expectations regarding future events and are not guarantees of future performance and involve risks and uncertainties.
许多此类风险和不确定性是 BioNTech 无法控制的。投资者应注意,任何此类前瞻性陈述均基于 BioNTech 对未来事件的当前信念和预期,并非对未来业绩的保证,且涉及风险和不确定性。
There can be no guarantees that the Acquisition will close on the expected timetable or at all. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. You should not place undue reliance on these statements..
无法保证收购将按预期时间表完成或最终完成。如果基本假设被证明不准确,或者风险或不确定性变为现实,实际结果可能与前瞻性声明中所述的结果有重大差异。您不应过度依赖这些声明。
Risks and uncertainties include, but are not limited to, uncertainties as to satisfaction of conditions to closing of the Acquisition; approval of the dismissal order contemplated by the Settlement Agreement; BioNTech and Pfizer reaching a definitive agreement with respect to the terms of Pfizer’s reimbursement; general industry conditions and competition; general political, economic and business conditions, including interest rate, inflation, tariff and currency exchange rate fluctuations, and the ongoing Russia-Ukraine and Middle East conflicts; the impact of regulatory developments and changes in the United States, Europe and countries outside of Europe, including with respect to tax matters; the impact of pharmaceutical industry regulation and health care legislation in the United States, Europe and elsewhere; the particular prescribing preferences of physicians and patients; competition from other products; challenges and uncertainties inherent in new product development; ability to obtain or maintain proprietary intellectual property protection; safety, quality, data integrity or manufacturing issues; and potential or actual data security and data privacy breaches..
风险和不确定性包括但不限于:收购完成条件的满足情况的不确定性;和解协议中预期的解雇令的批准;BioNTech和辉瑞就辉瑞的赔偿条款达成最终协议;行业总体状况与竞争;总体政治、经济和商业状况,包括利率、通胀、关税和汇率波动,以及持续的俄乌冲突和中东冲突;美国、欧洲及欧洲以外国家监管发展和变化的影响,特别是税务方面;美国、欧洲及其他地区制药行业法规和医疗立法的影响;医生和患者的特定处方偏好;来自其他产品的竞争;新产品开发固有的挑战和不确定性;获取或维持专有知识产权保护的能力;安全性、质量、数据完整性或制造问题;以及潜在或实际的数据安全和隐私泄露问题。
You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended June 30, 2025, and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at www.sec.gov. These forward-looking statements speak only as of the date hereof.
您应当查阅BioNTech截至2025年6月30日的Form 6-K报告中标题为“风险因素”下描述的风险和不确定性,以及BioNTech随后向美国证券交易委员会提交的文件,这些文件可在SEC网站www.sec.gov上查阅。这些前瞻性陈述仅截至本日期有效。
Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise..
除非法律要求,否则BioNTech拒绝承担因新信息、未来发展或其他情况而更新或修改本新闻稿中包含的任何前瞻性声明的意图或责任。