# EDGAR Filing Document

**Accession Number:** 0001270073
**File Stem:** 0001104659-23-025652
**Filing Date:** 2023-2
**Character Count:** 5437
**Document Hash:** 1e84146e19e93259d87844090f64b559
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-23-025652.hdr.sgml**: 20230227

**ACCESSION NUMBER**: 0001104659-23-025652

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 12

**CONFORMED PERIOD OF REPORT**: 20230224

**ITEM INFORMATION**: Other Events

**FILED AS OF DATE**: 20230227

**DATE AS OF CHANGE**: 20230227

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** INTERCEPT PHARMACEUTICALS, INC.
- **CENTRAL INDEX KEY:** 0001270073
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 223868459
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-35668
- **FILM NUMBER:** 23670090

**BUSINESS ADDRESS:**
- **STREET 1:** 305 MADISON AVENUE
- **CITY:** MORRISTOWN
- **STATE:** NJ
- **ZIP:** 07960
- **BUSINESS PHONE:** 646-747-1000

**MAIL ADDRESS:**
- **STREET 1:** 305 MADISON AVENUE
- **CITY:** MORRISTOWN
- **STATE:** NJ
- **ZIP:** 07960

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** INTERCEPT PHARMACEUTICALS INC
- **DATE OF NAME CHANGE:** 20031113

?xml version="1.0" encoding="utf-8"?

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM 8-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): February 24, 2023

**Intercept Pharmaceuticals, Inc.**

(Exact name of registrant as specified in its charter)

<u>Delaware</u>   <u>001-35668</u>   <u>22-3868459</u> <br> (State or other jurisdiction (Commission (IRS Employer <br> of incorporation) File Number) Identification No.)

<u>305 Madison Avenue, Morristown, NJ 07960</u>

(Address of principal executive offices) (Zip Code)

Registrant's telephone number, including area code: (646) 747-1000

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:

¨ 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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| | | |
|:---|:---|:---|
| &nbsp;&nbsp;Title of each class | &nbsp;&nbsp;Trading <br> Symbol(s) | &nbsp;&nbsp;Name of each exchange on which<br> registered |
| &nbsp;&nbsp;Common Stock, par value $0.001 per share | &nbsp;&nbsp;ICPT | &nbsp;&nbsp;Nasdaq Global Select Market |

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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 February 24, 2023, Intercept Pharmaceuticals, Inc. (the "Company") and its subsidiary Intercept Pharma Europe Limited ("IPEL") (collectively, "Intercept") entered into two separate settlement agreements with (1) Apotex Inc. and Apotex Corp. (collectively, "Apotex") and (2) MSN Pharmaceuticals, Inc. and MSN Laboratories Private Limited (collectively, "MSN") resolving the previously disclosed patent litigations concerning the submissions by Apotex and MSN of Abbreviated New Drug Applications ("ANDAs") seeking approval to market generic versions of Ocaliva® (obeticholic acid) 5 mg and 10 mg tablets prior to expiration of the Company's Orange Book listed patents.

Under the terms of the agreements, Intercept granted Apotex and MSN non-exclusive, non-sublicensable, non-transferable, royalty-free licenses to commercialize their generic versions of Ocaliva in the United States commencing, respectively, on September 1, 2031, and January 1, 2032, or in each case earlier under certain circumstances. The parties will file the settlement agreements with the Federal Trade Commission and the Department of Justice pursuant to applicable law.

As a result of these settlements, and previously disclosed settlements with other generic drug manufacturers, the Company has fully resolved the patent infringement case in the United States District Court for the District of Delaware that was scheduled for trial on February 27, 2023, and the case has been terminated by the Court. Similar patent litigation previously disclosed by the Company against another ANDA filer seeking approval to market generic Ocaliva remains pending, with trial scheduled for July 22, 2024.

**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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| | | |
|:---|:---|:---|
|  | INTERCEPT PHARMACEUTICALS, INC. | INTERCEPT PHARMACEUTICALS, INC. |
|  | By: | /s/ Rocco Venezia |
|  | Name: | Rocco Venezia |
|  | Title: | Chief Accounting Officer |
| Date: February 27, 2023 |  |  |

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