0000939767-24-000062.txt : 20240510 0000939767-24-000062.hdr.sgml : 20240510 20240510160543 ACCESSION NUMBER: 0000939767-24-000062 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20240509 ITEM INFORMATION: Other Events FILED AS OF DATE: 20240510 DATE AS OF CHANGE: 20240510 FILER: COMPANY DATA: COMPANY CONFORMED NAME: EXELIXIS, INC. CENTRAL INDEX KEY: 0000939767 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 043257395 STATE OF INCORPORATION: DE FISCAL YEAR END: 0103 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-30235 FILM NUMBER: 24934789 BUSINESS ADDRESS: STREET 1: 1851 HARBOR BAY PARKWAY CITY: ALAMEDA STATE: CA ZIP: 94502 BUSINESS PHONE: 6508377000 MAIL ADDRESS: STREET 1: 1851 HARBOR BAY PARKWAY CITY: ALAMEDA STATE: CA ZIP: 94502 FORMER COMPANY: FORMER CONFORMED NAME: EXELIXIS INC DATE OF NAME CHANGE: 20000207 FORMER COMPANY: FORMER CONFORMED NAME: EXELIXIS PHARMACEUTICALS INC DATE OF NAME CHANGE: 20000106 8-K 1 exel-20240509.htm 8-K exel-20240509
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM8-K

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): May 9, 2024

Exelixis_Logo_RGB_2023.jpg
EXELIXIS, INC.
(Exact name of registrant as specified in its charter)

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:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock $0.001 Par Value per ShareEXELThe 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 27, 2024, we received notice from Cipla Ltd. and Cipla USA, Inc. (individually and collectively referred to as Cipla) that it had amended its Abbreviated New Drug Application (ANDA), originally filed with the U.S. Food and Drug Administration (FDA) more than one year ago, to assert additional Paragraph IV certifications. The ANDA now requests approval to market generic versions of CABOMETYX tablets with 20 mg and 40 mg dosage strengths (in addition to the 60 mg dosage strength contemplated by Cipla’s original ANDA) prior to expiration of U.S. Patents No. 8,877,776, 9,724,342, 10,039,757, 11,091,439, 11,091,440, 11,098,015 and 11,298,349. On May 9, 2024, we filed a complaint in the United States District Court for the District of Delaware for patent infringement against 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 amended ANDA filing with the FDA. We are seeking, among other relief, an order that the effective date of any FDA approval of Cipla’s ANDA would be a date no earlier than the expiration of all of U.S. Patents No. 8,877,776, 11,091,439, 11,091,440, 11,098,015 and 11,298,349, the latest of which expires on February 10, 2032, and equitable relief enjoining Cipla from infringing these patents.



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.
EXELIXIS, INC.
May 10, 2024
/s/ Jeffrey J. Hessekiel
DateJeffrey J. Hessekiel
Executive Vice President, General Counsel
and Secretary


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Cover Page
May 09, 2024
Cover [Abstract]  
Amendment Flag false
Document Period End Date May 09, 2024
Entity Registrant Name EXELIXIS, INC.
Entity Central Index Key 0000939767
Entity Emerging Growth Company false
Title of 12(b) Security Common Stock $0.001 Par Value per Share
Trading Symbol EXEL
Security Exchange Name NASDAQ
Entity File Number 000-30235
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 04-3257395
Entity Address, Address Line One 1851 Harbor Bay Parkway
Entity Address, City or Town Alameda
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94502
City Area Code 650
Local Phone Number 837-7000
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Document Type 8-K

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