0001104659-13-090712.txt : 20131217 0001104659-13-090712.hdr.sgml : 20131217 20131217161648 ACCESSION NUMBER: 0001104659-13-090712 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20131213 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20131217 DATE AS OF CHANGE: 20131217 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Ocera Therapeutics, Inc. CENTRAL INDEX KEY: 0001274644 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 631192270 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-35119 FILM NUMBER: 131282017 BUSINESS ADDRESS: STREET 1: 12651 HIGH BLUFF DRIVE STREET 2: SUITE 230 CITY: SAN DIEGO STATE: CA ZIP: 92130 BUSINESS PHONE: 858-436-3900 MAIL ADDRESS: STREET 1: 12651 HIGH BLUFF DRIVE STREET 2: SUITE 230 CITY: SAN DIEGO STATE: CA ZIP: 92130 FORMER COMPANY: FORMER CONFORMED NAME: TRANZYME INC DATE OF NAME CHANGE: 20031230 8-K 1 a13-26131_28k.htm 8-K

 

 

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): December 13, 2013

 

OCERA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

DELAWARE

 

001-35119

 

63-1192270

(State or other jurisdiction

 

(Commission File Number)

 

(I.R.S. Employer

of

 

 

 

Identification No.)

incorporation)

 

 

 

 

 

525 University Avenue, Suite 610

 

 

Palo Alto, CA

 

94301

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code (650) 475-0150

 

Not applicable

(Former name or former address, if changed since last report)

 

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:

 

o            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 



 

Item 1.01 Entry into a Material Definitive Agreement

 

On December 13, 2013,  Ocera Therapeutics, Inc. (the “Company”) entered into a Technology Transfer and License Agreement (the “Agreement”) with Genentech, Inc. (“Genentech”) and F. Hoffman-La Roche, Ltd. (“Roche”, and together with Genentech, the “Licensee”).   Pursuant to the Agreement, the Company shall transfer ownership of certain equipment and tangible materials, and grant a license to the Company’s  intellectual property rights, related to the Company’s  Macrocyclic Template Chemistry (MATCHTM) discovery platform to the Licensee.   As consideration for the Agreement, the Licensee will pay to the Company an upfront payment of $4,000,000, with $3,000,000 paid upon execution of the Agreement and the remaining $1,000,000 payable following the Company’s confirmation of the technology transfer.   The Licensee has the sole right, but no obligation to perform research, development, manufacturing and commercialization activities related to the compounds transferred pursuant to the Agreement.   Subject to the license set forth in the Agreement, the Company’s shall own all right, title and interest in and to the licensed intellectual property.   The Agreement shall continue in effect until the last-to-expire claim of the patents licensed exclusively to Licensee pursuant to the Agreement, unless earlier terminated by either party due to an uncured material breach by the other party, and contains customary representations and warranties, confidentiality and indemnification provisions.

 

A copy of the Company’s press release regarding the foregoing is attached hereto as Exhibit 99.1 and incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

(d)          Exhibits

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press release of Ocera Therapeutics, Inc. dated December 17, 2013

 

2



 

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.

 

December 17, 2013

Ocera Therapeutics, Inc.

 

 

 

 

By:

/s/ Linda S. Grais, M.D.

 

Name:

Linda S. Grais, M.D.

 

Title:

President and Chief Executive Officer

 

3


EX-99.1 2 a13-26131_2ex99d1.htm EX-99.1

Exhibit 99.1

 

Ocera Therapeutics and the Roche Group enter into

Technology Transfer and License Agreement

 

License of Ocera’s MATCH Discovery Platform Supports Licensee’s Drug Discovery Programs

 

Palo Alto, CA — December 17, 2013 — Ocera Therapeutics (NASDAQ: OCRX) today announced that it has entered into a Technology Transfer and License Agreement with the Roche Group, including the Research and Early Development arms of both Genentech and Roche, for rights to its Macrocyclic Template Chemistry (MATCH) discovery platform. Under the terms of the agreement, Ocera will transfer ownership of equipment and materials related to the use of the MATCH technology, and grant a license to Genentech and Roche under Ocera’s related intellectual property rights. The Roche Group will make a one-time payment to Ocera of $4 million.

 

“Both the Genentech and Roche research organizations have an interest in the application of our MATCH technology,” said Linda Grais, M.D., J.D., chief executive officer of Ocera. “We are excited that we have found a good home for this technology where it may benefit the Roche Group and ultimately patients, while we focus our efforts on clinical development of OCR-002, our product candidate for the treatment of hepatic encephalopathy, a serious liver disorder.”

 

About Ocera

 

Ocera Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of OCR-002 (ornithine phenylacetate). OCR-002 is an ammonia scavenger which has been granted Orphan Disease and Fast Track status from the FDA to treat hyperammonemia and associated hepatic encephalopathy in patients with liver cirrhosis, acute liver failure and acute liver injury. For additional information, please see www.ocerainc.com.

 

Forward Looking Statements

 

This press release contains “forward-looking” statements, including, without limitation, all statements related to Ocera’s obligations under the license agreement. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believe,” “expected,” “hope,” “plan,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Ocera’s current expectations. Forward-looking statements involve risks and uncertainties and Ocera’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, including those risks and uncertainties discussed under the heading “Risk Factors” in Ocera’s Quarterly Report on Form 10-Q for the quarter ended September 30,

 



 

2013 filed on November 14, 2013, as well as other risks detailed in Ocera’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Ocera undertakes no duty to update this information unless required by law.

 

Inquiries:

Jeri Hilleman

Ocera Therapeutics, Inc.

communications@ocerainc.com

650-475-0158