UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): March 16, 2023
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| EXELIXIS, INC. |
| (Exact name of registrant as specified in its charter) |
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| Delaware | 000-30235 | 04-3257395 |
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
1851 Harbor Bay Parkway
Alameda, California 94502
(Address of principal executive offices) (Zip Code)
(650) 837-7000
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
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| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock $.001 Par Value per Share | EXEL | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events
On March 16, 2023, Exelixis, Inc. (Exelixis) filed a complaint in the United States District Court for the District of Delaware against Cipla, Ltd. and Cipla USA, Inc. (individually and collectively referred to as Cipla), asserting infringement of U.S. Patents No. 8,877,776, 11,091,439, 11,091,440, 11,098,015 and 11,298,349 arising from Cipla’s filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for a generic version of CABOMETYX® (cabozantinib) tablets (20 mg / 40 mg / 60 mg). Cipla requests approval to market a generic version of CABOMETYX® tablets prior to expiration of U.S. Patents No. 8,877,776, 11,091,439, 11,091,440, 11,098,015 and 11,298,349. Exelixis is seeking, among other remedies, equitable relief enjoining Cipla from infringing these patents, as well as an order that the effective date of any FDA approval of Cipla’s ANDA would be a date no earlier than the expiration of the patents identified in the complaint, the latest of which expires on February 10, 2032. Cipla has not challenged U.S. Patent No. 7,759,473, which includes claims directed to the compound cabozantinib or a pharmaceutically acceptable salt thereof, and expires on August 14, 2026.
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.
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| | | EXELIXIS, INC. |
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| March 22, 2023 | | | /s/ JEFFREY J. HESSEKIEL |
| Date | | | Jeffrey J. Hessekiel |
| | | Executive Vice President, General Counsel and Secretary |
