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 |
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001-35119 |
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63-1192270 |
(State or other jurisdiction |
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(Commission File Number) |
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(I.R.S. Employer |
of |
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Identification No.) |
incorporation) |
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525 University Avenue, Suite 610 |
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Palo Alto, CA |
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94301 |
(Address of principal executive offices) |
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(Zip Code) |
Registrants 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 Companys intellectual property rights, related to the Companys 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 Companys 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 Companys 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 Companys 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. |
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Description |
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99.1 |
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Press release of Ocera Therapeutics, Inc. dated December 17, 2013 |
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. | |
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By: |
/s/ Linda S. Grais, M.D. |
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Name: |
Linda S. Grais, M.D. |
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Title: |
President and Chief Executive Officer |
Exhibit 99.1
Ocera Therapeutics and the Roche Group enter into
Technology Transfer and License Agreement
License of Oceras MATCH Discovery Platform Supports Licensees 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 Oceras 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 Oceras 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 Oceras current expectations. Forward-looking statements involve risks and uncertainties and Oceras 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 Oceras 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 Oceras 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