-----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, CJplkcueGkvqK4HaYlKd8grdSRdqmEN3jk73ggUcZIUXCE6f0qTESsMwC1kjj2Jd krY5qOuZvd/iMKRriDV55A== 0001139020-04-000342.txt : 20041206 0001139020-04-000342.hdr.sgml : 20041206 20041206142048 ACCESSION NUMBER: 0001139020-04-000342 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20041108 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20041206 DATE AS OF CHANGE: 20041206 FILER: COMPANY DATA: COMPANY CONFORMED NAME: US BIODEFENSE INC CENTRAL INDEX KEY: 0001122130 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-BUSINESS SERVICES, NEC [7389] IRS NUMBER: 330052057 STATE OF INCORPORATION: UT FISCAL YEAR END: 1130 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-31431 FILM NUMBER: 041185968 BUSINESS ADDRESS: STREET 1: 13674 E. VALLEY BLVD. STREET 2: NA CITY: CITY OF INDUSTRY STATE: CA ZIP: 91746 BUSINESS PHONE: (626) 961-8039 MAIL ADDRESS: STREET 1: 13674 E. VALLEY BLVD. STREET 2: NA CITY: CITY OF INDUSTRY STATE: CA ZIP: 91746 FORMER COMPANY: FORMER CONFORMED NAME: PIEDMONT INC DATE OF NAME CHANGE: 20000818 8-K 1 ubdf8knihagmtnovember2320043.htm


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):  November 8,  2004


US BIODEFENSE, INC.

-------------------------------

(Exact name of registrant as specified in its charter)


                                                                                    Utah                             000-31431                 33-0052057

---------------                   --------------------            -------------------

(State or Other                 (Commission          (IRS Employer

Jurisdiction of                 File Number)           Identification

                                                                              Incorporation)                                                    No.)


13674 E. Valley Blvd.

City of Industry, CA 91746

---------------------------------------------------

(Address of principal executive offices) (Zip Code)



Registrant's telephone number, including area code:  (626) 961-0562


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))









ITEM  1.01  ENTRY  INTO  A  MATERIAL  DEFINITIVE  AGREEMENT.


On  November 8,  2004,  we entered into a Commercial Evaluation License Agreement with the United States Public Health Service within the Department of Health and Human Services.  The Agreement grants us a nonexclusive license to evaluate the suitability for commercial development of cellular and viral inactivation applied for in a Provisional Patent Application.  We paid $3,500 for the license. The term of the Agreement is six months.


The foregoing description of the terms and conditions of the Commercial Evaluation License Agreement are  qualified  in  their  entirety  by,  and made subject to, the more complete information  set  forth  in  the  Commercial Evaluation License Agreement attached to this Report as Exhibit  10.1.


ITEM  7.01  REGULATION  FD  DISCLOSURE.


On  November 8,  2004,  we  issued the press release attached to this Report as Exhibit  99.1  announcing  this  information.


The  press  release is being furnished and shall not be deemed to be "filed" for the  purposes  of Section 18 of the Securities Exchange Act of 1934, as amended, or  otherwise  subject  to  the  liabilities  of that Section. The press release attached  to this Current Report shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, except  as  shall  be  expressly set forth by specific reference in such filing.


ITEM  9.01  FINANCIAL  STATEMENTS  AND  EXHIBITS


(c)  Exhibits:


10.1  Public Health Service Commercial Evaluation License Agreement  between  the  Registrant  and  the United States Public Health Service within the Department of Health and Human Services, dated November 8,  2004.


99.1  Press  Release re: U.S. BioDefense Signs Commercial Evaluation Agreement Related To A Method For Universal Inactivation of Viruses, Parasites, and Tumor Cells with National Institute of Health, dated  November 8,  2004.





SIGNATURES


Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


                                                                                                                                            US BIODEFENSE, INC.

                                                                                                                                             -----------------------------

                                                                                                                                                      Registrant



Date:  November 8, 2004                                                                                                By: /s/ David Chin

                                                                                                                                                  -------------------------

                                   

              

                                  David Chin

                                                                                                                                                  President








EX-10 2 exhibit10.htm Exhibit 10

Exhibit 10.1

PUBLIC HEALTH SERVICE


COMMERCIAL EVALUATION LICENSE AGREEMENT



This Agreement is entered into between the National Institutes of Health ("NIH"), the Centers for Disease Control and Prevention ("CDC"), or the Food and Drug Administration ("FDA"), hereinafter singly or collectively referred to as "PHS", agencies of the United States Public Health Service within the Department of Health and Human Services ("DHHS") through the Office of Technology Transfer, National Institutes of Health, having an address at 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804, U.S.A. and U.S. Biodefense, Inc. ("Licensee"), a corporation of Utah, having an office at 13674 East Valley Blvd., City of Industry, CA 91746.


1.

Definitions:


a.                                                                                                                        

"Licensed Patent Rights" means PCT or U.S. patent application(s) (including provisional patent application(s)) and/or patents and all foreign counterparts as follows: U.S. Patent Application Serial No./U.S. Provisional Patent Application Serial No. 60/555,268 filed March 22, 2004 entitled “Cellular and Viral Inactivation”.


b.                                                                                                                        

"Licensed Products" means tangible materials which, in the course of manufacture, use, sale, or importation would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.


c.                                                                                                                        

Licensed Processes” means processes which, in the course of being practiced would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.


2.

Licensee wishes to obtain a license to evaluate the commercial applications of the Licensed Products and Licensed Processes and any inventions claimed in the Licensed Patent Rights.


3.

Licensee intends to conduct laboratory experiments under this Agreement to evaluate the suitability for commercial development of inventions encompassed by the Licensed Patent Rights and the Licensed Products and Licensed Processes in the Field(s) of Use of ________________________.


4.

Licensee represents that it has the facilities, personnel, and expertise to evaluate the commercial applications of the Licensed Products, Licensed Processes, and the inventions encompassed by the Licensed Patent Rights, and that it will expend reasonable efforts and resources on research and development of potential commercial products using the Licensed Products, Licensed Processes, and the inventions encompassed by the Licensed Patent Rights.


5.

PHS hereby grants to Licensee a nonexclusive license for evaluation purposes to make and use but not to sell the Licensed Products and Licensed Processes and products and processes encompassed within the scope of a claim in the Licensed Patent Rights.  Licensee agrees that any commercial or industrial use or sale of any such products or processes, including any formalized in-house screening programs, other than for evaluation purposes, will be made only pursuant to the terms of a commercialization license to be negotiated in good faith by the parties.  The rights provided herein are provided for the evaluation of commercial applications only and not for commercial use.


6.

Licensee agrees to retain control over the Licensed Products and Licensed Processes, and not to distribute them to third parties without the prior written consent of PHS.


7.

Licensee agrees that this Agreement does not preclude PHS from distributing the Licensed Products and Licensed Processes to third parties for research or commercial purposes.


8.

In consideration of the grant in Paragraph 5, Licensee hereby agrees to pay PHS a royalty in the sum of U.S. $3,500 (Three Thousand Five Hundred Dollars).  Payment is due within thirty (30) days of Licensee's execution of this Agreement.  This royalty shall be paid in U.S. dollars.  For conversion of foreign currency to U.S. dollars, the conversion rate shall be the New York foreign exchange rate quoted in The Wall Street Journal on the day that the payment is due.  All checks and bank drafts shall be drawn on United States banks and shall be payable, as appropriate, to "NIH/Patent Licensing."  All such payments shall be sent to the following address:  NIH, P.O. Box 360120, Pittsburgh, PA 15251-6120.  Any loss of exchange, value, taxes, or other expenses incurred in the transfer or conversion to U.S. dol lars shall be paid entirely by Licensee.  Interest and penalties may be assessed by PHS on any overdue payments in accordance with the Federal Debt Collection Act.  The payment of such late charges shall not prevent PHS from exercising any other rights it may have as a consequence of the lateness of any payment.


9.

This Agreement shall become effective on the date when the last party to sign has executed this Agreement and shall expire six (6) months from its effective date.  Upon termination or expiration of this Agreement, Licensee shall return all Licensed Products to PHS or provide PHS with certification of their destruction, unless Licensee has executed a commercialization license for the Licensed Patent Rights.


10.

In the event that Licensee is in default in the performance of any material obligation under this Agreement, and if the default has not been remedied within ninety (90) days after the date of written notice of such default, PHS may terminate this Agreement by written notice.


11.

Licensee acknowledges that third parties also may be evaluating the Licensed Patent Rights, the Licensed Products, or the Licensed Processes for a variety of commercial purposes, and no guarantee can be made, should Licensee apply for a license, that such a license would be available for any particular field of use.  PHS agrees to notify Licensee promptly if it receives from another company an exclusive license application in the Field(s) of Use described in Paragraph 3.


12.

Licensee is encouraged to publish the results of its research projects using the Licensed Products or the Licensed Processes.  In all oral presentations or written publications concerning the Licensed Products or the Licensed Processes, Licensee will acknowledge the contribution by the named inventors to the Licensed Products or the Licensed Processes, unless requested otherwise by PHS or the named inventors.


13.

Licensee agrees to submit in confidence a final report to PHS within thirty (30) days of termination or expiration of this Agreement outlining in general its results of commercial evaluation of the Licensed Patent Rights, the Licensed Products, and the Licensed Processes provided by this Agreement.


14.

PHS agrees, to the extent permitted by law, to treat in confidence for a period of three (3) years from the date of disclosure any of Licensee's written information about the Licensed Patent Rights, the Licensed Products, or the Licensed Processes that is stamped "CONFIDENTIAL" except for information that was previously known to PHS, or that is or becomes publicly available, or that is disclosed to PHS by a third party without an obligation of confidentiality.


15.

NO WARRANTIES, EXPRESS OR IMPLIED, ARE OFFERED AS TO THE FITNESS FOR ANY PURPOSE OF THE LICENSED PROCESSES OR LICENSED PRODUCTS PROVIDED TO LICENSEE UNDER THIS AGREEMENT, OR THAT THE LICENSED PATENT RIGHTS MAY BE EXPLOITED WITHOUT INFRINGING OTHER PATENT RIGHTS.  LICENSEE accepts license rights to the Licensed Patent Rights, the Licensed Products, and the Licensed Processes "as is", and PHS does not offer any guarantee of any kind.


16.

Licensee agrees to indemnify and hold harmless PHS and the Government of the United States of America from any claims, costs, damages, or losses that may arise from the practice of the Licensed Patent Rights or through the use of the Licensed Products or the Licensed Processes.


17.

Neither party shall have any obligation to take any action with regard to an infringement of Licensed Patent Rights by a third party.


18.

Licensee agrees in its use of any PHS-supplied materials to comply with all applicable statutes, regulations, and guidelines, including PHS and DHHS regulations and guidelines.  Licensee agrees not to use the Licensed Processes or the Licensed Products for research involving human subjects or clinical trials in the United States without complying with 21 CFR Part 50 and 45 CFR Part 46.  Licensee agrees not to use the Licensed Processes or Licensed Products for research involving human subjects or clinical trials outside of the United States without notifying PHS, in writing, of such research or trials and complying with the applicable regulations of the appropriate national control authorities.  Written notification to PHS of research involving human subjects or clinical trials outside of the Un ited States shall be given no later than sixty (60) days prior to commencement of such research or trials.


19.

This Agreement shall be construed in accordance with U.S. Federal law, as interpreted and applied by the U.S. Federal courts in the District of Columbia.  Federal law and regulations will preempt any conflicting or inconsistent provisions in this Agreement.  Licensee agrees to be subject to the jurisdiction of U.S. courts.


20.

This Agreement constitutes the entire understanding of PHS and Licensee and supersedes all prior agreements and understandings with respect to the Licensed Patent Rights, the Licensed Products, and the Licensed Processes.


21.

The provisions of this Agreement are severable, and in the event that any provision of this Agreement shall be determined to be invalid or unenforceable under any controlling body of law, such invalidity or unenforceability shall not in any way affect the validity or enforceability of the remaining provisions of this Agreement.


22.

Paragraphs 12, 14, 15, and 16 of this Agreement shall survive termination of this Agreement.


SIGNATURES BEGIN ON NEXT PAGE


PHS COMMERCIAL EVALUATION LICENSE AGREEMENT


SIGNATURE  PAGE


In Witness Whereof, the parties have executed this Agreement on the dates set forth below.  Any communication or notice to be given shall be forwarded to the respective addresses listed below.


For PHS:


_____________________________________________

_______________

Steven M. Ferguson

Date

Director, Division of Technology Development and Transfer

Office of Technology Transfer

National Institutes of Health


Mailing Address for Notices:


Office of Technology Transfer

National Institutes of Health

6011 Executive Boulevard, Suite 325

Rockville, Maryland  20852-3804  U.S.A.



For Licensee (Upon, information and belief, the undersigned expressly certifies or affirms that the contents of any statements of Licensee made or referred to in this document are truthful and accurate.):

by:


_____________________________________________

_______________

Signature of Authorized Official

Date


_____________________________________________

Printed Name


_____________________________________________

Title


Official and Mailing Address for Notices:


_____________________________________________


_____________________________________________


_____________________________________________

Any false or misleading statements made, presented, or submitted to the Government, including any relevant omissions, under this Agreement and during the course of negotiation of this Agreement are subject to all applicable civil and criminal statutes including Federal statutes 31 U.S.C. ?? 3801-3812 (civil liability) and 18 U.S.C. ? 1001 (criminal liability including fine(s) and/or imprisonment).

EX-99 3 exhibit99.htm Exhibit 99



Exhibit 99.1


U.S. BioDefense Signs Commercial Evaluation Agreement Related To A Method For Universal Inactivation of Viruses, Parasites, and Tumor Cells with National Institute of Health (NIH)


CITY OF INDUSTRY, Calif., - U.S. BioDefense (OTC Bulletin Board: UBDF - News) is pleased to announce today that it has entered into a COMMERCIAL EVALUATION LICENSE AGREEMENT Docket #E-303-2003/0 related to the patent pending pathogenic inactivation with the United States Public Health Service (“PHS”) within the Department of Health and Human Services, through the Office of Technology transfer, National Institutes of Health (NIH). The address is 6011 Executive Blvd. Suite 325 Rockville, MD 20852-3804.


According to CEO, David Chin “the invention provides new methods for inactivating viruses, bacteria, parasites and tumor cells. These inactivated agents can be used as vaccine to prevent the diseases caused by such viruses, bacteria, parasites and tumor cells. Many vaccines including the Flu vaccination Flumist are made from a live, but weakened virus.”


NIH’s bioterrorism budgets have jumped from $53 million in 2001 to $1.7 Billion in 2005.


U.S. Biodefense, Inc. intends to conduct laboratory experiments under this Agreement to evaluate the suitability for commercial development of inventions encompassed by the Licensed Patent Rights and the Licensed Products and Licensed Processes in the Field(s) of Use of Research and Development related to Biodefense Applications.  Furthermore, U.S. Biodefense, Inc. has agreed to provide the facilities, personnel, and expertise to evaluate the commercial applications of the Licensed Products, Licensed Processes, and the inventions encompassed by the Licensed Patent Rights, and that it will expend reasonable efforts and resources on research and development of potential commercial products using the Licensed Products, Licensed Processes, and the inventions encompassed by the Licensed Patent Rights.


PHS has granted to U.S. Biodefense, Inc. a nonexclusive license for evaluation purposes to make and use but not to sell the Licensed Products and Licensed Processes and products and processes encompassed within the scope of a claim in the Licensed Patent Rights.  Licensee agrees that any commercial or industrial use or sale of any such products or processes, including any formalized in-house screening programs, other than for evaluation purposes, will be made only pursuant to the terms of a commercialization license to be negotiated in good faith by the parties.  The rights provided herein are provided for the evaluation of commercial applications only and not for commercial use.


U.S. Biodefense, Inc. acknowledges that third parties also may be evaluating the Licensed Patent Rights, the Licensed Products, or the Licensed Processes for a variety of commercial purposes, and no guarantee can be made, should Licensee apply for a license, that such a license would be available for any particular field of use.  PHS agrees to notify Licensee promptly if it receives from another company an exclusive license application in the Field(s) of Use.  U.S. Biodefense, Inc.  is encouraged to publish the results of its research projects using the Licensed Products or the Licensed Processes.  In all oral presentations or written publications concerning the Licensed Products or the Licensed Processes, Licensee will acknowledge the contribution by the named inventors to the Licensed Products or the Licensed Processes, unless requested otherwise by PHS or the named invent ors.


The invention described herein was developed with support from the National Cancer Institute. The United State Government has certain rights in the invention.  The invention is related to a method for universal inactivation of viruses, parasites and tumor cells. These inactivated agents can be used as vaccines against the diseases caused by such virtues, parasites and tumor cells. The inventive inactivation method of the agent. Hence, the immunogenic of the agent as a whole is maintained and can be safely used for vaccination without the threat of infection.


Vaccination against pathogens has been one of the major accomplishments of medicine over the past century. While effective vaccines have been developed for a large number of diseases, development if a safe and effective vaccines for a number of other diseases remain problematic. The use of inactivated or killed microbial agents as a vaccine, although generally safe, will not always be effective if the immunogenic characteristics of the agents are altered. Indeed, the preferential degradation of certain antigens on the inactivated microorganism might produce a weak or poorly targeted immune response that permits a pathological response when the host is later challenged with the live microorganism. On the other hand, while the preparation of live attenuated microbial agents as vaccines will often provide improved immunologic reactivity use of such live attenuated microbial agents have an increase s risk that the vaccine itself will be infections. Such live attenuated vaccines can be infectious, for example, as a result of reversion, or the organism may be able to propagate and provide a reservoir for future infection.  Thus, one must generally choose between improved effectiveness and greater degree of safety when selecting between the viral inactivation and viral attenuation techniques for vaccine preparation. The choice is particularly difficult when the virus is resistant to inactivation and requires highly rigorous inactivation conditions that are likely to degrade the antigenic characteristics. It is therefore desirable to provide improved methods for inactivating agents such as virus, bacteria, cancer cells and other cell types, where the methods are capable of inactivating these agents without causing substantial degradation of the antigenic structure of the agents. In particular, the inactivated agents should be useful as vaccines and free from adverse side effects at the time of adminis tration as well as upon subsequent challenge with the live agent.


 The invention provide methods for inactivating an infective or other agent of interest that involve exposing the agent to a hydrophobic photoactivatable compound, for example, 1, 5-iodonaphthylazide(INA). These compounds are non-toxic, hydrophobic compound that will penetrate into the innermost regions of biological membrane bilayers and will accumulate selectively in these regions. Upon irradiation with light, a reactive derivative of the compound is generated that binds to membrane proteins deep in the lipid bilayer. This process specifically inactivates integral and activity of the proteins that protrude from the extracellular surface of the membrane. Such inactivation is so successful that the inactivated infective agent, or other agent of interest, can be used as a vaccine.


According to the inventor, treatment of tumor cells with a photoactivable hydrophobic compound of the invention blocks cell division and colony formation with no detectable damaged to the structural integrity of cells. Moreover, when live HIV and SIV viral particles are treated with appropriate concentration of such photoactivatable hydrophobic compounds, no infectivity is observed and there were minor, generally insubstantial changes in the structural integrity of the virus particle. These modified viral particles reacted with monoclonal antibodies directed against selected viral proteins and the inactivated viruses bound to their target cells. However, viral fusion with the membrane was impaired by the inventive method for inactivation of virtues, microbes and tumor cells.


About U.S. BioDefense, Inc.


U.S. BioDefense is a Department of Defense central contractor that researches, develops, and commercializes leading-edge biodefense vaccines and related security technology.


Safe Harbor Statement Forward-Looking Statements Included in this release are certain "forward-looking" statements, involving risks and uncertainties, which are covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company's financial performance. Such statements are based on management's current expectations and are subject to certain factors, risks and uncertainties that may cause actual results, events and performance to differ materially from those referred to or implied by such statements. In addition, actual future results may differ materially from those anticipated, depending on a variety of factors, including continued maintenance of favorable license arrangements, success of market research identifying new product opportunities, successful introduction of new products, continued product innovation, t he success of enhancements to the Company's brand image, sales and earnings growth, ability to attract and retain key personnel, and general economic conditions affecting consumer spending, including uncertainties relating to global political conditions, such as terrorism. Information with respect to important factors that should be considered is contained in the Company's Annual Report on Form 10-K as filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company does not intend to update any of the forward-looking statements after the date of this release to conform these statements to actual results or to changes in its expectations, except as may be required by law.


     CONTACT:

     U.S. BioDefense, Inc.

     David Chin, 626-961-0562

     info@usbiodefense.com


  





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