ALAMEDA, Calif.--(BUSINESS WIRE)--Exelixis, Inc. (Nasdaq: EXEL) today announced that it has entered into a Settlement and License Agreement (Agreement) with Cipla Ltd. and Cipla USA, Inc. (collectively Cipla). This settlement resolves two patent litigations brought by Exelixis in response to Cipla’s Abbreviated New Drug Application (ANDA) seeking approval to market generic versions of CABOMETYX® (cabozantinib) tablets prior to the expiration of the applicable patents.

加利福尼亚州阿拉米达——（商业新闻短讯）——Exelixis，Inc.（纳斯达克股票代码：EXEL）今天宣布，它已与Cipla Ltd.和Cipla USA，Inc.（合称Cipla）签订和解和许可协议（协议）。该和解解决了Exelixis针对Cipla的缩写新药申请（ANDA）提起的两项专利诉讼，该申请寻求在适用专利到期之前批准CABOMETYX®（cabozantinib）片剂的仿制药上市。

The first case (Civil Action No. 23-287), filed on March 16, 2023, relates to Cipla’s ANDA for a 60 mg cabozantinib dosage strength. The second case (Civil Action No. 24-565-RGA), filed on May 9, 2024, relates to a recent amendment to Cipla’s ANDA, for the primary purpose of seeking additional approval for 20 mg and 40 mg cabozantinib dosage strengths..

2023年3月16日提交的第一起案件（第23-287号民事诉讼）涉及Cipla的ANDA，剂量为60毫克卡博替尼。第二起案件（民事诉讼号24-565-RGA）于2024年5月9日提交，涉及最近对Cipla的ANDA进行的修订，主要目的是寻求额外批准20 mg和40 mg卡博替尼的剂量强度。。

Pursuant to the terms of the Agreement, Exelixis will grant Cipla a license to market generic versions of CABOMETYX in the United States beginning on January 1, 2031, if approved by the U.S. Food and Drug Administration and subject to conditions and exceptions common to agreements of this type.

根据协议条款，Exelixis将授予Cipla自2031年1月1日起在美国销售CABOMETYX仿制药的许可证，前提是获得美国食品和药物管理局的批准，并遵守此类协议常见的条件和例外情况。

Additionally, in accordance with the Agreement, the parties will terminate all ongoing Hatch-Waxman litigation between Exelixis and Cipla regarding CABOMETYX patents pending in the U.S. District Court for the District of Delaware.

此外，根据协议，双方将终止Exelixis和Cipla之间正在进行的所有Hatch-Waxman关于CABOMETYX专利的诉讼，该专利正在特拉华州美国地方法院进行。

The Agreement is confidential and subject to review by the U.S. Federal Trade Commission (FTC) and the U.S. Department of Justice. The lawsuits will be dismissed after a period of time to allow for FTC review.

该协议是保密的，须经美国联邦贸易委员会（FTC）和美国司法部审查。一段时间后，这些诉讼将被驳回，以便联邦贸易委员会进行审查。

About Exelixis

Exelixis

Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules, antibody-drug conjugates and other biotherapeutics.

Exelixis是一家全球野心勃勃的肿瘤公司，在癌症护理的前沿创新下一代药物和方案。凭借卓越的药物发现和开发能力，我们正在迅速发展我们的产品组合，以通过我们临床上分化的小分子，抗体-药物偶联物和其他生物治疗药物的渠道，针对不断扩大的肿瘤类型和适应症。

This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product, CABOMETYX® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future.

这种全面的方法利用了数十年来对我们的科学和合作伙伴关系的强劲投资，以推进我们的研究计划，并扩大我们的旗舰商业产品CABOMETYX®（cabozantinib）的影响。Exelixis是由大胆的科学追求推动的，旨在创造变革性的治疗方法，为更多患者带来未来的希望。

For information about the company and its mission to help cancer patients recover stronger and live longer, visit www.exelixis.com, follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn..

有关该公司及其帮助癌症患者恢复健康和长寿的使命的信息，请访问www.exelixis.com，在X（Twitter）上关注@ExelixisInc，就像在Facebook上关注exelixis，Inc.一样，在LinkedIn上关注exelixis。。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ obligations under the Agreement, including Exelixis’ granting of a license to Cipla to market generic versions of CABOMETYX in the United States beginning on January 1, 2031 and termination by the parties of all ongoing Hatch-Waxman litigation regarding CABOMETYX patents; and the expectation that the lawsuits will be dismissed after a period of time following FTC review.

本新闻稿包含前瞻性声明，包括但不限于与以下相关的声明：Exelixis在本协议下的义务，包括Exelixis向Cipla授予许可，自2031年1月1日起在美国销售CABOMETYX仿制药，以及各方终止所有正在进行的Hatch-Waxman关于CABOMETYX专利的诉讼；以及在联邦贸易委员会审查一段时间后，预计这些诉讼将被驳回。

Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties.

任何涉及未来事件或情况的预期、预测或其他特征的陈述均为前瞻性陈述，并基于Exelixis当前的计划、假设、信念、期望、估计和预测。前瞻性陈述涉及风险和不确定性。

Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Exelixis’ ability to effect its obligations under the Agreement; and other factors detailed from time to time under the caption “Risk Factors” in Exelixis’ most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in Exelixis’ other future filings with the Securities and Exchange Commission.

由于这些风险和不确定性，实际结果和事件发生的时间可能与前瞻性声明中的预期有很大不同，其中包括但不限于：Exelixis履行其在本协议下义务的能力；以及Exelixis最近的10-K表年度报告和随后的10-Q表季度报告以及Exelixis未来向证券交易委员会提交的其他文件中不时在“风险因素”标题下详述的其他因素。

All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law..

本新闻稿中的所有前瞻性声明均基于截至本新闻稿发布之日Exelixis可获得的信息，Exelixis没有义务更新或修订本新闻稿中包含的任何前瞻性声明，除非法律要求。。

Exelixis, the Exelixis logo and CABOMETYX are registered U.S. trademarks of Exelixis.

Exelixis、Exelixis徽标和CABOMETYX是Exelixis的美国注册商标。