UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01. | Other Events. |
On September 8, 2020, AVEO Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the decision by Biodesix, Inc. (“Biodesix”) to exercise its Opt-Out rights (as defined below) under the Co-Development and Collaboration Agreement (the “Co-Development Agreement”), dated April 9, 2014, as amended, by and between the Company and Biodesix. Pursuant to the Co-Development Agreement, the Company entered into a worldwide co-development and collaboration agreement with Biodesix to develop and commercialize ficlatuzumab. The Biodesix Agreement generally provides for each party to contribute 50% of all clinical, regulatory, manufacturing and other costs to develop ficlatuzumab and to share equally in any future revenue from development or commercialization, subject to opt-out rights and certain other exceptions. Under the Co-Development Agreement, the Company granted Biodesix perpetual, non-exclusive rights to certain intellectual property, including all clinical and biomarker data related to ficlatuzumab, to develop and commercialize VeriStrat®, Biodesix’s proprietary companion diagnostic test. Biodesix granted the Company perpetual, non-exclusive rights to certain intellectual property, including diagnostic data related to VeriStrat, with respect to the development and commercialization of ficlatuzumab. Each license includes the right to sublicense, subject to certain exceptions. Prior to the first commercial sale of ficlatuzumab, each party had the right to elect to discontinue its funding obligation for further development or commercialization efforts with respect to ficlatuzumab in exchange for reduced economics in the program, which is referred to as an “Opt-Out.” Pursuant to the terms of the Co-Development Agreement, as a result of Biodesix’s election to Opt-Out, Biodesix shall (i) continue to be responsible for reimbursement of development costs with respect to the ongoing Phase 2 investigator-sponsored clinical trial of ficlatuzumab in combination with ERBITUX® (cetuximab) in head and neck squamous cell cancer, (ii) cease to be entitled to 50% sharing of profits resulting from commercialization of ficlatuzumab, (iii) be entitled to a low double digit royalty on future product sales and 25% of future licensing revenue, less approximately $2.5 million Biodesix would be required to pay to the Company pursuant to the October 2016 amendment to the Co-Development Agreement and (iv) remain responsible for development obligations under the Co-Development Agreement with respect to VeriStrat (and Biodesix and the Company will be obligated to negotiate a commercialization agreement with respect to VeriStrat). As a result of Biodesix’s decision to Opt-Out, the Company will have sole decision-making authority with respect to further development and commercialization of ficlatuzumab. The Co-Development Agreement will remain in effect until the expiration of all payment obligations between the parties related to development and commercialization of ficlatuzumab, unless earlier terminated.
The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| 99.1 | Press release issued by the Company on September 8, 2020. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AVEO Pharmaceuticals, Inc. | ||||||
| Date: September 8, 2020 | ||||||
| By: | /s/ Erick Lucera | |||||
| Erick Lucera | ||||||
| Chief Financial Officer | ||||||