-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, RJeOc7Q+Fp/UAUCj8QrCArkp3ivvQe1s0x6OSPFz7Yyak1L9witJo/Uty11CHoNy Uoxt3BrfJd4Ast6eGM6Zow== 0001157523-08-007024.txt : 20080821 0001157523-08-007024.hdr.sgml : 20080821 20080821124606 ACCESSION NUMBER: 0001157523-08-007024 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080815 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080821 DATE AS OF CHANGE: 20080821 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOTIME INC CENTRAL INDEX KEY: 0000876343 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 943127919 STATE OF INCORPORATION: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-12830 FILM NUMBER: 081031737 BUSINESS ADDRESS: STREET 1: 1301 HARBOR BAY PARKWAY CITY: ALAMEDA STATE: CA ZIP: 94502 BUSINESS PHONE: 5105213390 MAIL ADDRESS: STREET 1: 1301 HARBOR BAY PARKWAY CITY: ALAMEDA STATE: CA ZIP: 94502 8-K 1 a5760848.htm BIOTIME, INC. 8-K

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):  August 15, 2008


BioTime, Inc.
(Exact name of registrant as specified in its charter)

California

1-12830

94-3127919

(State or other jurisdiction

of incorporation)

(Commission File Number)

 

(IRS Employer Identification

No.)

1301 Harbor Bay Parkway
Alameda, California 94502
(Address of principal executive offices)

(510) 521-3390
(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:

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))


Statements made in this Report that are not historical facts may constitute forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those discussed.  Such risks and uncertainties include but are not limited to those discussed in this report and in our other reports filed with the Securities and Exchange Commission. Words such as “expects,” “may,” “will,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” and similar expressions identify forward-looking statements.

Section 1 - Registrant’s Business and Operations

Item 1.01     Entry into a Material Definitive Agreement.

On August 15, 2008, our subsidiary Embryome Sciences, Inc. entered into a License Agreement and a Sublicense Agreement with Advanced Cell Technology, Inc. (“ACT”) under which Embryome Sciences acquired world-wide rights to use an array of ACT technology (the “ACT License”) and technology licensed by ACT from affiliates of Kirin Pharma Company, Limited (the “Kirin Sublicense”).  The ACT License and Kirin Sublicense permit the commercialization of products in human therapeutic and diagnostic product markets.

Licensed Technology

          The technology licensed by Embryome Sciences covers methods to transform cells of the human body, such as skin cells, into an embryonic state in which the cells will be pluripotent.  Pluripotent means that the cells have the potential to become any kind of cell found in the human body.  This new technology is sometimes referred to as induced pluripotent stem cell (iPS) technology.  Because iPS technology does not involve human embryos or egg cells, and classical cloning techniques are not employed, the use of iPS technology may eliminate ethical concerns that have been raised in connection with the procurement and use of human embryonic stem cells in scientific research and product development.

          The portfolio of patents and patent applications licensed by Embryome Sciences covers methods to produce iPS cells that do not carry the viral vectors or added genes. Other iPS technology currently being practiced by other researchers utilizes viruses and genes that are likely incompatible with human therapeutic uses. Embryome Sciences believes that technologies that facilitate the reprogramming of human cells to iPS cells without using viruses could be advantageous in the development of human stem cell products for use in medicine.

         Sublicensed under the Kirin Sublicense, for all human therapeutic and diagnostic applications, are patent application for methods for cloning mammals using reprogrammed donor chromatin or donor cells and methods for altering cell fate. These patent applications relate to technology to alter the state of a cell, such as a human skin cell, by exposing the cell’s DNA to the cytoplasm of another reprogramming cell with differing properties.

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In a second series of patent applications licensed nonexclusively from ACT under the ACT License, for use in commercializing the patents licensed under the Kirin Sublicense, are technologies for the use of reprogramming cells that overexpress RNAs for the genes OCT4, SOX2, Nanog, cMYC, LIN28 and other factors known to be useful in iPS technology, methods of resetting cell lifespan by extending the length of telomeres, the use of the cytoplasm of undifferentiated cells to reprogram human cells, the use of a cell bank of hemizygous O- cells, methods of screening for differentiation agents, and stem cell-derived endothelial cells modified to disrupt tumor angiogenesis.

         The ACT License also includes patent applications for other uses.  One licensed patent application covers a method of differentiation of morula or inner cell mass cells and method of making lineage-defective embryonic stem cells.  That technology can be used in producing embryonic progenitor cells without the utilization of embryonic stem cell lines.  Another licensed patent application covers novel culture systems for ex vivo development that contains technology for utilizing avian cells in the production of stem cell products free of viruses and bacteria.

ACT License Provisions

         Under the ACT License, Embryome Sciences will pay ACT a $200,000 license fee and an 5% royalty on sales of products, services, and processes that utilize the licensed ACT technology, and 20% of any fees or other payments (other than equity investments, research and development costs, loans and royalties) received by Embryome Sciences from sublicensing the ACT technology to third parties.  Once a total of $600,000 of royalties has been paid, no further royalties will be due.  

          Embryome Sciences may use the exclusively-licensed technology and cell lines for research purpose and for the development of therapeutic and diagnostic products for human and veterinary use, excluding (a) human and non-human animal cells for commercial research use, including small molecule and other drug testing and basic research and (b) human cells for therapeutic and diagnostic use in the treatment of human diabetes, liver diseases, retinal diseases and retinal degenerative diseases, other than applications involving the use of cells in the treatment of tumors where the primary use of the cells is the destruction or reduction of tumors and does not involve regeneration of tissue or organ function.  The exclusions from the scope of permitted uses under the ACT License will lapse if ACT’s license with a third party terminates or if the third party no longer has an exclusive license from ACT for those uses.

          Embryome Sciences’ license is non-exclusive with respect to certain uses in non-human mammals, so long as a license from ACT to Kirin remains in effect.

          Embryome Sciences’s license to use some of the ACT technology is non-exclusive, and is limited to use in conjunction with the technology sublicensed from ACT under the Kirin Sublicense, and may not be sublicensed to third parties other than subsidiaries and other affiliated

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entities.  Embryome Sciences does have the right to grant sublicenses to the other licensed ACT technology.

          Embryome Sciences will have the right to prosecute the patent applications and to enforce all patents, at its own expense, except that ACT is responsible for prosecuting patent applications for Supplemental Technology at its own expense.  Embryome Sciences will have the right to patent any new inventions arising from the use of the licensed patents and technology.

          Embryome Sciences will indemnify ACT for any products liability claims arising from products made by Embryome Sciences or its sublicensees.

          The licenses will expire in twenty years or upon the expiration of the last to expire of the licensed patents, whichever is later.

Kirin Sublicense Provisions

         Under the Kirin Sublicense, Embryome Sciences will pay ACT a $50,000 license fee and an 3.5% royalty on sales of products, services, and processes that utilize the licensed ACT technology, and 20% of any fees or other payments (other than equity investments, research and development costs, loans and royalties) received by Embryome Sciences from sublicensing the Kirin Technology to third parties.  

         Embryome Sciences will also pay to ACT or to an affiliate of Kirin Pharma Company, Limited (“Kirin”), annually, the amount, if any, by which royalties payable by ACT under its license agreement with Kirin are less than the $50,000 annual minimum royalty due.  Those payments by Embryome Sciences will be credited against other royalties payable to ACT under the Kirin Sublicense.

          Embryome Sciences may use the licensed technology for the development of therapeutic and diagnostic human cell products, including both products made, in whole or in part, of human cells, and products made from human cells.  Embryome Sciences has the right to grant sublicenses.

          Embryome Sciences will indemnify ACT for any products liability claims arising from products made by Embryome Sciences or its sublicensees.  

          The licenses will expire upon the expiration of the last to expire of the licensed patents, or May 9, 2016 if no patents are issued.

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Section 7 - Regulation FD

Item 7.01 -   Regulation FD Disclosure.

The press release filed as Exhibit 99.1 is incorporated by reference.

Section 9-Financial Statements and Exhibits

Item 9.01    Financial Statements and Exhibits.

Exhibit Number

 

Description

 

99.1

Press Release dated August 21, 2008

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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.

BIOTIME, INC.

 

 
Date:

August 21, 2008

By:

/s/ Steven A. Seinberg

Chief Financial Officer

 

6


Exhibit Number

 

Description

 

99.1

Press Release dated August 21, 2008

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EX-99.1 2 a5760848ex99_1.htm EXHIBIT 99.1

Exhibit 99.1

BioTime, Inc.s Subsidiary, Embryome Sciences, Inc., Licenses Virus-Free iPS and Embryonic Stem Cell Differentiation Technology

ALAMEDA, Calif.--(BUSINESS WIRE)--Embryome Sciences, Inc., a wholly owned subsidiary of BioTime, Inc. (OTCBB:BTIM), announced today the license of a portfolio of patents and patent applications from Advanced Cell Technology, Inc. (“ACT”) relating to induced pluripotent stem cells (“iPS”) and embryonic stem cell differentiation technology. The license is for the commercialization of products in human therapeutic and diagnostic product markets.

The technology licensed by Embryome Sciences covers methods for the transformation of cells of the human body, such as skin cells, into an embryonic and pluripotent state. Pluripotent means that the cells have the potential to become any kind of cell found in the human body. Because this iPS technology does not involve human embryos or egg cells, and classical cloning techniques are not employed, the use of iPS technology may eliminate ethical concerns that have been raised in connection with the procurement and use of human embryonic stem cells in scientific research and product development. This type of cell derivation may also prove to be more practical for the commercial production of stem cell products than previous methods.

Speaking on the subject of iPS technology in his 2008 State of the Union Address, President Bush said, “This breakthrough has the potential to move us beyond the divisive debates of the past by extending the frontiers of medicine without the destruction of human life. So we are expanding funding for this type of ethical medical research.”

The portfolio of patents and patent applications licensed by Embryome Sciences covers methods to produce iPS cells that do not carry the viral vectors or added genes. Other iPS technology, currently being practiced by other researchers, utilizes viruses and genes that are likely incompatible with human therapeutic uses. Embryome Sciences believes that technologies that facilitate the reprogramming of human cells to iPS cells without using these viruses could be advantageous in the development of human stem cell products for use in medicine and are, therefore, important advancements in the field.

Sublicensed from ACT for all human therapeutic and diagnostic applications are US patent application numbers 10/032,191, titled “Methods for cloning mammals using reprogrammed donor chromatin or donor cells,” and 10/910,156, “Methods for altering cell fate.” These patent applications relate to technology to alter the state of a cell, such as a human skin cell, by exposing the cell’s DNA to the cytoplasm of another reprogramming cell with differing properties. In a second series of patent applications licensed nonexclusively from ACT for use in commercializing the previously-mentioned patents are technologies for the use of reprogramming cells that overexpress RNAs for the genes OCT4, SOX2, NANOG, cMYC, LIN28, and other factors known to be useful in iPS technology (PCT/US2006/030632), methods of resetting cell lifespan by extending the length of telomeres (10/790,640 and 11/079,930), the use of the cytoplasm of undifferentiated cells to reprogram human cells (PCT/US2000/018063), the use of hemizygous HLA O- stem cells for blood and other cell banking (PCT/US2006/040985), methods of screening for differentiation agents (PCT/US02/26945), and stem cell-derived endothelial cells modified to disrupt tumor angiogenesis (11/228,549).


“These technologies, when combined with our existing intellectual property, give us a path to create patient-specific stem cells of any kind without the difficulties of current iPS approaches,” said Michael D. West, Ph.D., CEO of BioTime and Embryome Sciences. “Our license of the iPS technology adds to our portfolio of in-licensed embryonic stem cell patent licenses that includes the core technology from the Wisconsin Alumni Research Foundation (WARF), and other technology sublicensed from Lifeline Cell Technology, LLC and Advanced Cell Technology, Inc. We plan to use the newly-acquired technologies in developing and marketing additional near-term stem cell products.”

The license package also includes US application #11/025,893, titled “Method of differentiation of morula or inner cell mass cells and method of making lineage-defective embryonic stem cells” that contains technology useful in producing embryonic progenitor cells without the utilization of embryonic stem cell lines. In addition, US application #s 11/028,345, 11/211,174 and 11/478,780, called “Novel culture systems for ex vivo development,” contains technology for utilizing avian cells in the production of stem cell products free of viruses and bacteria. These patent applications were licensed to Embryome Sciences exclusively for all applications other than drug testing, commercial research use, and use in the diagnosis or treatment of human diabetes, liver diseases, retinal diseases and retinal degenerative diseases, which are covered by a license from ACT to Lifeline Cell Technology, LLC (“Lifeline”). Embryome Sciences and Lifeline are already parties to an agreement for the production of commercial research products, which may include products using this technology.

Embryome Sciences is presently marketing cell growth media called ESpanTM in collaboration with Lifeline. These growth media are designed for the culturing of human embryonic progenitor cells. Additional new products that Embryome Sciences has targeted for development are ESpyTM cell lines, which will be derivatives of human embryonic stem cells that send beacons of light in response to the activation of particular genes. The ESpy™ cell lines will be developed in conjunction with Lifeline using ACTCellerate™ technology licensed from ACT and other technology sublicensed from Lifeline. Embryome Sciences also plans to bring to market new growth and differentiation factors that will permit researchers to manufacture specific cell types from embryonic stem cells, and purification tools useful to researchers in quality control of products for regenerative medicine.


About BioTime, Inc. (BTIM.OB):

BioTime, headquartered in Alameda, California, develops blood plasma volume expanders, blood replacement solutions for hypothermic (low temperature) surgery, organ preservation solutions, and technology for use in surgery, emergency trauma treatment and other applications. BioTime's lead product Hextend is manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corp. under exclusive licensing agreements.

BioTime has recently entered the field of regenerative medicine through its wholly owned subsidiary Embryome Sciences, Inc. where it plans to develop new medical and research products using embryonic stem cell technology. Additional information about BioTime can be found on the web at www.biotimeinc.com. Hextend®, PentaLyte®, HetaCool®, EmbryomicsTM, ESpyTM, and ESpanTM, are trademarks of BioTime, Inc.

Forward-Looking Statements

Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development and potential opportunities for the company and its subsidiary, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update these forward-looking statements.

To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list: http://www.b2i.us/irpass.asp?BzID=1152&to=ea&s=0

CONTACT:
BioTime, Inc.
Judith Segall, 510-521-3390
jsegall@biotimemail.com

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