-----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, KTAYrp6pWpPfMRno7eU36AQgtd4bvJ3LzXZKDZKKni3D1BcOkT5UuVEFkbVANOAw ZvDW4pKdSJbsKEwnJ4u8+Q== 0001132072-09-000253.txt : 20090626 0001132072-09-000253.hdr.sgml : 20090626 20090626153204 ACCESSION NUMBER: 0001132072-09-000253 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20090612 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090626 DATE AS OF CHANGE: 20090626 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ADEONA PHARMACEUTICALS, INC. CENTRAL INDEX KEY: 0000894158 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 133808303 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-12584 FILM NUMBER: 09912792 BUSINESS ADDRESS: STREET 1: 3985 RESEARCH PARK DRIVE CITY: ANN ARBOR STATE: MI ZIP: 48108 BUSINESS PHONE: 734-332-7800 MAIL ADDRESS: STREET 1: 3985 RESEARCH PARK DRIVE CITY: ANN ARBOR STATE: MI ZIP: 48108 FORMER COMPANY: FORMER CONFORMED NAME: PIPEX PHARMACEUTICALS, INC. DATE OF NAME CHANGE: 20061214 FORMER COMPANY: FORMER CONFORMED NAME: SHEFFIELD PHARMACEUTICALS INC DATE OF NAME CHANGE: 19970730 FORMER COMPANY: FORMER CONFORMED NAME: SHEFFIELD MEDICAL TECHNOLOGIES INC DATE OF NAME CHANGE: 19940606 8-K 1 s22-9240_8k.htm FORM 8-K s22-9240_8k.htm


 
 
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):  June 22, 2009
 
ADEONA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)


Delaware
 
01-12584
 
13-3808303
  (State or other jurisdiction of incorporation)
 
  (Commission File No.)
 
  (IRS Employer Identification No.)

 
3930 Varsity Drive, Ann Arbor, Michigan 48108

(Address of principal executive offices)  (Zip Code)
 
 
Registrant’s telephone number, including area code:  (734) 332-7800
 
 
(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:
 

¨
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 June 22, 2009  Adeona Pharmaceuticals, Inc. (the ‘Company”) and the Regents of the University of Michigan (the University”) amended their license agreement dated August 3, 2005 and amended on August 26, 2008 (collectively, the "License Agreement") pursuant to which the University and the Company agreed:

1.  
To limit the licensed patents to U.S. Patent 7,416,741 and corresponding foreign patents and to limit the field of use under the licensed patents to the treatment of Alzheimer’s, Huntington’s, and Parkinson’s diseases.

2.  
To replace the due diligence obligations of the Company under the License Agreement with the following:

(a)  
Initiate manufacturing under Good Manufacturing Practices (GMP) of bulk active pharmaceutical ingredient used in the licensed products within one (1) year;

(b)  
File an investigational new drug (IND) application within twelve (12) months.

(c)  
Initiate Phase I clinical trial within six months (6) of IND approval; and

(d)  
Commence first commercial sale by December 31, 2016.

3.  
The Company is to reimburse the University for patent costs in the amount of $37,562 according to the following schedule: Within five (5) days: $10,000; within six (6) months: $10,000; and within twelve (12) months: $17,562.

4.  
To reduce the annual license fees to $5,000 per year until 2015 and $50,000 per year thereafter.

The information contained in this Item 1.01 is qualified in its entirety by the Second Amendment to License Agreement attached to this Current Report on Form 8-K as Exhibit 10.1 and incorporated herein by this reference.  


 
Item 9.01.                Financial Statements and Exhibits

(d)           Exhibits.  The following exhibits are being furnished as part of this Report.

Exhibit
Number
 
Description of Exhibit
   
10.1
Second Amendment to License Agreement dated June 19, 2009 and executed June 22, 2009 between the Regents of the University of Michigan and Adeona Pharmaceuticals, Inc.
   
   


 


 
 

 


 

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.
 

 
 
 ADEONA PHARMACEUTICALS, INC.
   
 Date:  June 26, 2009 
 By:
/s/ Steve H. Kanzer
 
 
 Name:  Steve H. Kanzer
 
 Its:  Chairman and Chief Executive Officer
 

 

EX-10.1 2 s22-9240_ex101.htm EXHIBIT 10.1 s22-9240_ex101.htm
Exhibit 10.1
SECOND AMENDMENT TO LICENSE AGREEMENT


This Amendment, dated 19th June 2009 (“EFFECTIVE DATE OF AMENDMENT”), is by and between Adeona Pharmaceuticals (formerly Pipex Pharmaceuticals)  (“LICENSEE”) and the Regents of the University of Michigan ("MICHIGAN").

WHEREAS, LICENSEE and MICHIGAN entered into a license agreement dated August 3, 2005 and amended on August 26, 2008 (collectively, the "License Agreement"); and

WHEREAS, MICHIGAN and LICENSEE desire to modify certain provisions of the License Agreement as provided herein.

NOW THEREFORE, MICHIGAN and LICENSEE hereby agree as follows:

1.           Existing Paragraph 1.6  “PATENT RIGHTS” shall be deleted in its entirety and replaced with the following:

1.6           “PATENT RIGHTS” means MICHIGAN’S legal rights under the patent laws of the United States or relevant foreign countries for all of the following:

(a)           the following United States and foreign patents and/or patent applications, and divisionals, continuations (except continuations-in-part), and foreign counterparts of the same:

 
U.S. Issued Patent 7,416,741 entitled, “ Copper Lowering Treatment of Inflammatory and fibrotic diseases (UM 2169);

(b)           United States and foreign patents issued from the applications listed in subparagraph 1(a) above, including any reissued or reexamined patents based upon the same.

2.           Existing Paragraph 1.1 “FIELD OF USE” shall be deleted in its entirety and replaced with the following:

1.1         “FIELD OF USE” means the treatment of Alzheimer’s, Huntington’s, and Parkinson’s diseases.”

3.           Existing Paragraph 5.2  “DILIGENCE” shall be deleted in its entirety and replaced with the following:

5.2           As part of the diligence required by Paragraph 5.1, LICENSEE agrees to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following dates:

(a)  
Initiate manufacturing under Good Manufacturing Practices (GMP) of bulk active pharmaceutical ingredient used in the LICENSED PRODUCTS within one (1) year of the EFFECTIVE DATE OF AMENDMENT. Provide written proof of manufacture of bulk active pharmaceutical ingredient to MICHIGAN;
 
 


 
(b)  
File an investigational new drug (IND) application within twelve (12) months of the EFFECTIVE DATE OF AMENDMENT.

(c)  
Initiate Phase I clinical trial within six months (6) of IND approval;

(d)  
First COMMERCIAL SALE by December 31, 2016.


4.           LICENSEE shall reimburse MICHIGAN for back patent costs of $37,562.81 as follows:

 
(1)  Within five (5) days of the EFFECTIVE DATE OF AMENDMENT: $10,000;
 
(2)   Within six (6) months of the EFFECTIVE DATE OF AMENDMENT: $10,000;
 
(3)   Within twelve (12) months of EFFECTIVE DATE OF AMENDMENT: $17,562.

6.           Existing Paragraph 3.1(e) shall be deleted in its entirety and replaced with the following:
 
LICENSEE shall pay to MICHIGAN minimum annual royalties ("Annual Fee").  This Annual Fee is accrued on June 30 of the years specified below, and is payable with the semi-annual report for the ROYALTY PERIOD in which the Annual Fee accrues.  LICENSEE may credit each Annual Fee in full against all royalties under subparagraphs (b) and (c) above otherwise due MICHIGAN for the prior July 1 through the June 30 on which the Annual Fee accrues.  The Annual Fees are:

(1)           In 2010-2014: $5,000 and

(2)           In 2015 and in each year thereafter during the term of this Agreement: $50,000.  Should this Agreement terminate or expire other than on a June 30, the Annual Fee for such portion of a year shall be determined by multiplying the amount set forth above for the given year by a fraction, the numerator of which shall be the number of days since the prior June 30 during which the Agreement is in effect and the denominator of which shall be three hundred and sixty-five.

7.           Existing Paragraph 13.1 shall be deleted in its entirety and replaced with the following:

13.1           Any notice, request, report or payment required or permitted to be given or made under this Agreement by either parity is effective when mailed if sent by recognized overnight carrier or certified mail, electronic mail followed by confirmation by regular U.S. mail, or registered mail (return receipt requested) to the address set forth below or such other address as such party specifies by written notice given in conformity herewith. Any notice, request, report or payment not so given is not effective until actually received by the other party.
 
 


 
  To MICHIGAN: To LICENSEE:
     
  The University of Michigan Adeona Pharmaceuticals
  Office of Technology Transfer 3930 Varsity Drive
  1214 S. University Ave. 2nd Floor Ann Arbor, MI 48108
  Ann Arbor, MI 48104-2592  
     
  Attn: File No. 2169 Attn: Steve H. Kanzer

 
8.           Except as specifically modified and amended above, all other terms and conditions of the License Agreement remain unchanged and in effect and are hereby ratified and adopted as though fully set forth herein.

IN WITNESS WHEREOF, the parties have entered into this Amendment to the Amended Agreement as of the date and year first above-written.

 
LICENSEE
 
THE REGENTS OF THE UNIVERSITY OF MICHIGAN
 
       
By:
 
By
 
       
Title:
 
Title
 
       

 

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