Exhibit 10.1


 


AMENDED AND RESTATED LICENSE
AGREEMENT


 


This
Amended and Restated License Agreement (the “License Agreement”) is made as of
the 14th day of April 2010, by and between Corgenix Medical Corporation, a
Nevada corporation, having its principal office at 11575 Main Street, Suite 400
Broomfield CO 80020, U.S.A. (“Corgenix”) and Eiji Matsuura, Ph.D. (“Dr. Matsuura”),
an individual having his place of residence at 7-20-801 Nishino-cho, Kita-ku,
Okayama 700-0916, Japan.


 


On
or about September 29, 2002, Corgenix and Dr. Matsuura entered into a
license agreement (“Original License Agreement”).  This License Agreement amends and restates,
in its entirety, the Original License Agreement.


 


WITNESSETH:


 


WHEREAS,
Dr. Matsuura is the owner of all right, title and interest in and to
certain Technology (as hereinafter defined) relating to methods for the
determination of oxidized lipoproteins and related analytes, antibodies and
antigens, including certain Patents (as hereinafter defined); and


 


WHEREAS,
Corgenix is engaged in the business of developing, manufacturing, selling and
distributing diagnostic tests, instrumentation and related products, and
desires to obtain a license from Dr. Matsuura in order to make, use, sell
and distribute diagnostic products using the Technology on its own behalf; and


 


WHEREAS,
Dr. Matsuura is willing to grant Corgenix access to all information in the
possession of Dr. Matsuura regarding methods for the determination of
oxidized lipoproteins and access to all related analytes, antibodies and
antigens, existing as of the date of this License Agreement and any and all
improvements or future developments related thereto, including those related to
the Patents or the Japanese Patents (defined below) (hereinafter referred to as
“Technology”) to develop any human diagnostic products to be manufactured and
sold by Corgenix, including those that include the Patents or the Japanese
Patents (hereinafter referred to as “Products”).


 

















 


NOW,
THEREFORE, in consideration of the mutual covenants and agreements contained
herein, the parties hereto agree as follows:


 


ARTICLE
1 (DEFINITIONS)


In
this License Agreement, the following words and expressions have the following
meanings:


1.1  “Effective Date” means the date first above
written.


1.2  Intentionally Deleted


1.3  “Net Sales” means the total invoice price
charged by Corgenix and/or Subsidiaries to non-Subsidiary third parties for the
sale of the Products, less returns, freight charges, insurance premium and
customary trade discounts actually taken, consumption tax or other taxes levied
and customs duties.


1.4  “Party” means Corgenix or Dr. Matsuura; “Parties”
means Corgenix and Dr. Matsuura.


1.5  “Patents” means the US and
European Patents described in Exhibit A, and any subsequent patents
issued to either or both of the Parties relating to the Technology.


1.6  “Japanese Patents” means the
following patent applications: Japanese Patent Application No. 07-510213:
Method for determination of oxidized lipoproteins and use thereof”; Japanese
Patent Application No. PCT/JP02/00723: “Ligand for beta-2-glycoprotein I
and use thereof”; Japanese Patent Application No. 2002-261366: “Method for
measuring oxidized LDL-beta-2-glycoprotein I complex in living body” attached
hereto as Exhibit B; and any subsequent patents issued to either or both
of the Parties relating to the Technology.


1.7  Intentionally Deleted


1.8  “Subsidiary” means companies that are
controlled by Corgenix as of the Effective Date.  For the purpose of this definition, “control”
shall mean direct beneficial ownership of greater than fifty percent (50%) of
the voting stock or other equity ownership interest of such company.


1.9  “Territory” means worldwide except Japan.


1.10  Intentionally Deleted


 


ARTICLE
2 (GRANT OF LICENSE)


Dr. Matsuura
hereby grants to Corgenix an exclusive license, within the Territory, to
utilize the Technology to develop, manufacture, use, promote to sell, and sell
any Products during the term of this License Agreement. Corgenix shall not
sublicense such rights to any third parties without prior written consent of Dr. Matsuura
which


 

















 


consent
shall not be unreasonably withheld by Dr. Matsuura, provided, however,
that Corgenix may further sublicense such rights to Subsidiaries without prior
written consent of Dr. Matsuura.


 


ARTICLE
3 (PATENTS AND JAPANESE PATENTS)


3.1         Patents.


3.1.1                        Corgenix is
responsible for the maintenance and prosecution of all Patents outside of
Japan.


3.1.2                        Corgenix shall
be responsible for the translation of the Japanese Patents into English and the
filing of US patents which shall be assigned to Corgenix and Dr. Matsuura.


3.1.3                        Should Corgenix
decide not to prosecute or maintain any or all of the Patents, the Patent(s) so
affected shall be reassigned by Corgenix to Dr. Matsuura.


3.2         Japanese Patents. Dr. Matsuura
is responsible for the maintenance and prosecution of all Japanese Patents.
Should Dr. Matsuura decide for any reason not to maintain any or all of
the Japanese Patents, he shall immediately notify Corgenix.


 


ARTICLE
4 (REGULATORY APPROVAL)


Corgenix shall be responsible for, and shall bear
the expenses of, filing and prosecuting any application to obtain the required
governmental approvals or consents necessary to manufacture and market any
Products in the Territory.


 


ARTICLE
5 (TECHNICAL ASSISTANCE)


Both Parties agree to
collaborate on the Technology and to provide ongoing technical support
concerning the Patents in order to obtain the governmental approvals or
consents necessary to develop, manufacture and market the Products, and
effectively promote the Products in the Territory.


 


ARTICLE
6 (ROYALTIES AND PAYMENTS)


6.1   In consideration of the grant of the rights
by Dr. Matsuura to Corgenix under this License Agreement, Corgenix shall
pay to Dr. Matsuura as follows: a royalty of four (4) percent (4 %)
of Net Sales of Products sold by Corgenix and its Subsidiaries for each
calendar half year commencing on the Effective Date and thereafter during the
term of this License Agreement shall be paid to Dr. Matsuura semi-annually
within forty-five (45) days after the ends of every June and December.


 

















 


6.2   Payment Method. All payments to Dr. Matsuura
under this License Agreement, except as otherwise agreed, shall be remitted in
United States Dollars by telegraphic transfer to the account of Dr. Matsuura,
at a bank designated by Dr. Matsuura. If a payment is delayed, overdue
interest rate will be the US Dollar London Interbank Offered Rate of
corresponding overdue period plus three percent (3%) per annum.


 


6.3   Intentionally Deleted


 


ARTICLE
7 (RECORDS)


Corgenix
shall keep complete and accurate records and books sufficiently detailed to
show the amount of the Products manufactured and sold, and the running royalty
due and payable to Dr. Matsuura for five (5) years from each calendar
year. Corgenix shall, at the request and at the expense of Dr. Matsuura,
permit Dr. Matsuura or an independent accountant designated by Dr. Matsuura
to have access to such records to examine and to copy, during ordinary business
hours, as may be necessary to verify or determine any royalties, paid or
payable, under this License Agreement.


 


ARTICLE 8 (IMPROVEMENTS)


The Parties acknowledge and agree that certain
inventions and improvements (collectively, “Improvements”) may be made by
either Party through the use of the Patents. Each Party shall inform the other
Party of any Improvements.


 


ARTICLE
9 (CONFIDENTIALITY)


Each Party acknowledges that during the course of
this License Agreement it will become privy to confidential information of the
other Party including technology, business strategy and other technical,
business and financial matters. Each Party further acknowledges that the
disclosure of such information to a third party, or the use of such information
for purposes other than the purposes of this License Agreement, would cause
irreparable injury to the other Party, which injury might not be compensated
for adequately by money damages. Each Party accordingly agrees, during the term
of this License Agreement and five (5) years thereafter, to hold all
information provided by the other Party in strict confidence and not to
disclose any such information to a third party except as required by law or as
otherwise expressly permitted by the other Party, or use such information for
any purpose other than the purposes hereof.


 

















 


As used herein, the term confidential information
shall not include information that:


(i)                                      is or becomes
generally available to the public other than as a result of disclosure by
receiving Party,


(ii)                                   was available
to receiving Party on a non-confidential basis prior to its receipt from
disclosing Party,


(iii)                                becomes
available to receiving Party lawfully from a third party that is not prohibited
from disclosing such information, or


(iv)                               is developed
independently by receiving Party as evidenced by written records other than
through knowledge of the disclosed information from disclosing Party.


 


ARTICLE 10 (PUBLIC DISCLOSURE)


When
Corgenix wants to make any public disclosure in connection with this License
Agreement, Corgenix shall propose such disclosure to Dr. Matsuura in
writing. Dr. Matsuura shall have a right to review and edit such a
proposed draft and a right to veto such a disclosure, but Dr. Matsuura
cannot unduly withhold his consent. Dr. Matsuura shall respond to Corgenix
within thirty (30) business days from the receipt of such a proposal.  Notwithstanding the foregoing, to the extent
Corgenix is required to make certain public disclosures under applicable
securities laws, Corgenix will not be required to seek any prior approval from Dr. Matsuura
or any other third party, prior to making such required public disclosure.


 


ARTICLE
11 (WARRANTY AND INFRINGEMENT)


11.1  Dr. Matsuura warrants that he
has full authority to enter into this License Agreement, and, to Dr. Matsuura’s
knowledge, the grant of the license contained herein does not infringe on any
patents, intellectual property, or other proprietary rights of any third party;
provided, however, Dr. Matsuura makes no warranties,
expressed or implied, as to the merchantability of the Technology.


 


11.2  In the event that any third party
claim is made or suit is brought against Corgenix alleging that the rights
granted in this License Agreement infringe on a third party’s patent,
intellectual property or proprietary rights, Dr. Matsuura agrees to
indemnify Corgenix for any damages, liabilities and expenses related to such
action.


 

















 


11.3  In the event that any third party infringes any of the
Patents in the Territory, then the Parties hereto shall cooperate to take
appropriate action against such third party.


 


ARTICLE
12 (INDEMNIFICATION)


Corgenix shall indemnify Dr. Matsuura from and against any
damages, liabilities, expenses to be suffered by Dr. Matsuura with regard
to product liability claim by a third party.


 


ARTICLE
13 (TERM)


This
License Agreement, unless earlier terminated pursuant to Article 14
thereof, shall continue in effect until September 29, 2022, and may be
renewed or extended for successive terms pursuant to terms and conditions
mutually agreed upon in writing.


 


ARTICLE
14 (TERMINATION)


Either
Party may, without prejudice to any other rights or remedies, terminate the
License Agreement by giving sixty (60) days written notice to the other with
immediate effect, if any of the following events should occur


(i)                                     if either Party fails to
make any payment to the other when due under this License Agreement and such
failure continues for more than thirty (30) days after receipt of a written
notice specifying the default;


(ii)                                  if either Party fails to
perform any other provision of this License Agreement which failure remains
uncorrected for more than thirty (30) days after receipt of a written notice
specifying the default;


(iii)                               if either Party files a
petition in bankruptcy, or petition in bankruptcy is filed against it, or
either Party becomes insolvent, bankrupt, or makes a general assignment for the
benefit of creditors, or goes into liquidation or receivership;


(iv)                              if either Party ceases or
threatens to cease to carry on business or disposes of the whole or any
substantial part of its undertaking or its assets.


 


ARTICLE
15 (NOTICES)


All
notices or reports required or permitted under this License Agreement shall be
in writing, and shall be given by prepaid registered airmail letter or
international courier to the addresses shown below or to such other addresses
as the parties may designate in writing.


 

















 


To Dr. Matsuura:


Eiji Matsuura, Ph.D.


7-20-801 Nishino-cho, Kita-ku


Okayama
700-0916, Japan.


 


To Corgenix:


Attention:
President


11575
Main Street, Suite 400


Broomfield,
CO 80020, U.S.A.


 


ARTICLE
16 (ENTIRE AGREEMENT)


This
License Agreement constitutes the entire agreement between Parties hereto, and
supersedes any prior written or oral agreements between Parties concerning the
subject matter hereof.


 


ARTICLE 17 (TITLES)


The
titles of the Articles of this License Agreement are for reference only, and
this License Agreement shall not be construed by reference to such titles.


 


ARTICLE 18 (ARBITRATION)


Any controversy or claim arising under or in relation to this License
Agreement, except as otherwise expressly provided below, shall be settled
exclusively by arbitration in accordance with the International Arbitration Rules of
the American Arbitration Association (AAA). 
Arbitration shall take place in Denver, Colorado, U.S.A. before one
arbitrator selected by the parties jointly or failing their agreement, selected
pursuant to the rules of the AAA. The arbitration shall be conducted in
English and shall use the U.S. Federal rules of evidence and the U.S.
Federal rules of civil procedure. The substantially prevailing party shall
be entitled to recover its costs and attorneys’ fees. The decision of the
arbitrators shall be final and binding on the parties, and judgment upon the
award rendered by the arbitrators may be entered by any court having
jurisdiction thereof. Dr. Matsuura specifically consents to the
jurisdiction of the courts of the State of Colorado, U.S.A., and any other
place where it is located or can be found for purposes of enforcing an award.


 


ARTICLE
19 (ASSIGNMENT)


This
License Agreement or any part of this License Agreement may not be assigned or


 

















 


transferred
by either Party without the prior written consent of the other Party. Any
assignment or transfer without such consent shall be null and void.


 


ARTICLE
20 (NO WAIVER)


Except
where specific time limits are herein provided, no delay on the part of either
Party hereto in exercising any power or right hereunder shall operate as a
waiver thereof, nor shall any single or partial exercise of any power or right
hereunder preclude other or further exercise thereof or the exercise of any
other power or right. No waiver, modification or amendment of this License
Agreement or any provision hereof shall be enforceable against any party hereto
unless in writing, signed by the Party against whom such waiver, modification
or amendment is claimed, and with regard to any waiver, shall be limited solely
to the one event.


 


ARTICLE
21 (GOVERNING LAW)


This
License Agreement shall be governed by and construed in accordance with the
laws of Colorado.


 


[Signature Page to
Follow]


 

















 


IN CONSIDERATION OF the foregoing terms and
conditions, Corgenix and Dr. Matsuura hereto have affixed their authorized
signatures.


 


 


Corgenix
Medical Corporation


 


 


	
  s/
  Luis R. Lopez, MD

  	
   

  	
  s/
  Eiji Matsuura, Ph.D.

  
	
  Luis R. Lopez, MD

  	
   

  	
  Eiji Matsuura, Ph.D.

  
	
  Chief
  Medical Officer

  	
   

  	
   

  



 

















 


Exhibit A


 


Patents


 


US Patent # 5,900,359, effective May 4, 1999; Title: Method for Determination of Oxidized Lipoproteins and
Use Thereof. This patent covers the OxLDL/β2GPI
antigen and its use. The patent has been granted, and Corgenix must maintain
the patent. The patent was not applied for in the EU.


 


US Patent # 7,160,733 B2 effective January 9, 2007;
Title: Ligand Specific to β2-Glycoprotein
I and Use Thereof. Underlying Japanese patents
for PCT # 07-510213; 2002-261366 (per License agreement).This patent
application covers the synthesis of the OxLig-1 molecule, the use of the
OxLig-1 Ligand for β2GPI, and the method. This is considered the “key
patent” to the technology. This patent will be not be submitted to the EU.


 


US Patent # 7,422,864 B2 effective September 9, 2008;
Title: Method for Measuring Oxidized LDL-CRP
Complex and Measurement Kit Thereof. Underlying
Japanese patents for PCT # 2003-043571, 2003-333927.This patent describes the
binding of oxidized low-density lipoprotein (oxLDL) with C-reactive protein
(CRP) resulting in oxLDL/CRP (CRP-AtherOx) complex formation, and the
immunoassay method for measuring these complexes in blood.


 


US Patent # 7,455,976 B2 effective November 25, 2008;
Title: Method of Measuring Oxidized
LDL/β2-glycoprotein I Complex Occurring in Living Body. Underlying Japanese patents for PCT # 07-510213, 2002-261366.  This application describes
the binding of oxLDL/β2GPI, use of the antibody, covalent binding, MgCl2,
and the Immune complex.


 


EP# 1
548 436 B1 granted November 19, 2008; EU registration with UK, France and
Germany. Title: Method of assaying oxidized LDL-Beta
2-Glycoprotein I complex in vivo.


 


EP application # 04713170 (PCT/JP2004/001961) filed October 5,
2009; EU registration with UK, France and Germany. Title: Method for measuring oxidized
LDL-CRP complex and measuring kit thereof. Japanese Filing Date: February 21, 2002. Underlying Japanese patents
2003-043571 & 2003-333927.