Esperion Therapeutics,Inc. (NASDAQ:ESPR) Files An 8-K Entry into a Material Definitive Agreement

Esperion Therapeutics,Inc. (NASDAQ:ESPR) Files An 8-K Entry into a Material Definitive Agreement
Item 9.01. Entry into a Material Definitive Agreement.

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On January2, 2019, Esperion Therapeutics,Inc. (the “Company”) entered into a License and Collaboration Agreement (the “Agreement”) with Daiichi Sankyo Europe GmbH (“DSE”). to the Agreement, the Company will grant DSE exclusive commercialization rights to bempedoic acid and the bempedoic acid / ezetimibe combination pill in the European Economic Area and Switzerland (the “Territory”). DSE will be responsible for commercialization in the Territory. The Company will be responsible for clinical development, regulatory and manufacturing activities for the licensed products globally, including the Territory.

The Company and DSE will establish a joint collaboration committee (the “JCC”) to, among other powers and responsibilities, review and guide the implementation and management of development plans of the licensed products in the Territory, review the status of licensed products, approve of DSE’s request of certain clinical activities, address certain development and manufacturing matters of the licensed products in accordance with the terms of the Agreement, and perform other activities mutually agreed by the Company and DSE from time to time.

The Company will receive an upfront cash payment of $150 million as well as $150 million upon first commercial sales in the Territory. The Company is also eligible to receive a substantial additional regulatory milestone payment upon the grant of the marketing authorization in the European Union for the cardiovascular risk reduction label, depending on the range of relative risk reduction in the Company’s CLEAR Outcomes study. In addition, the Company is eligible to receive additional sales milestone payments. Finally, the Company will receive tiered fifteen percent (15%) to twenty-five percent (25%) royalties on net Territory sales.

The Agreement will remain in effect, unless terminated earlier, until the last to expire royalty term under the Agreement. Each party has the right to terminate the Agreement for the other party’s material breach of its obligations under the Agreement, subject to cure rights. Additionally, DSE may terminate the Agreement in its sole discretion and in its entirety after a certain time period with sufficient prior written notice. The Company may also terminate the licenses of specified patent rights upon notice if DSE challenges the enforceability, validity, or scope of any patent rights belonging to the Company, unless DSE withdraws or causes the challenge to be withdrawn within a specified period. Either party to the Agreement may terminate the Agreement if the other party declares bankruptcy. Other termination rights are as specified in the Agreement. Upon termination, any license granted by the Company to DSE will terminate.

The Agreement includes customary representations and warranties on behalf of the Company and DSE as are customarily found in transactions of this nature, including representations and operative provisions as to the licensed intellectual property, regulatory matters and compliance with applicable laws. The Agreement also provides for certain mutual indemnities for breaches of representations, warranties and covenants.

The foregoing description of the material terms of the Agreement is qualified in its entirety by reference to the complete text of the Agreement, which the Company intends to file, with confidential terms redacted, with the Securities and Exchange Commission.

Item 9.01. Other Events.

On January4, 2019, the Company issued a press release announcing the entry into the Agreement. A copy of the press release is attached hereto as Exhibit99.1 and is incorporated herein by reference.

Item 9.01.Financial Statements and Exhibits.

ExhibitNo.

Description

99.1

Press Release dated January4, 2019

Esperion Therapeutics, Inc. Exhibit
EX-99.1 2 a19-1129_1ex99d1.htm EX-99.1 Exhibit 99.1       Investor Contact:   Alex Schwartz   Esperion   734-249-3386   [email protected]       Media Contact:   Elliot Fox   W2O Group   212-257-6724   [email protected]   Esperion Announces Agreement with Daiichi Sankyo Europe (DSE) to Commercialize Bempedoic Acid in Europe   —    Esperion to Receive $300 Million in Upfront and Near-term Milestones    — —    Up to $900 Million in Total Milestones     — —     Substantial Tiered Royalties     — —    Esperion Partnering with a European CV Sales Organization Exceeding 1000 and One of the Most Successful European-based Commercial Businesses    — —    Conference Call and Webcast on Friday,…
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About Esperion Therapeutics,Inc. (NASDAQ:ESPR)

Esperion Therapeutics, Inc. is a pharmaceutical company. The Company is focused on developing and commercializing oral, low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of patients with elevated LDL-C. The Company’s segment is the business of researching, developing and commercializing therapies for the treatment of patients with elevated LDL-C. The Company’s lead product candidate is ETC-1002, or bempedoic acid. The Company is engaged in conducting a global Phase III long-term safety and tolerability study of bempedoic acid in patients with hyperlipidemia whose LDL-C is not adequately controlled with low- and moderate-dose statins. Bempedoic acid is an inhibitor of ATP Citrate Lyase (ACL), a well-characterized enzyme on the cholesterol biosynthesis pathway. Bempedoic acid inhibits cholesterol synthesis in the liver, decreases intracellular cholesterol and up-regulates LDL-receptors.

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