Delaware
|
01-12584
|
13-3808303
|
||
(State or other jurisdiction of incorporation)
|
(Commission File No.)
|
(IRS Employer Identification No.)
|
¨
|
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
|
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.
|
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.
|
ADEONA
PHARMACEUTICALS, INC.
|
|||
Date: June
26, 2009
|
By:
|
/s/
Steve H. Kanzer
|
|
Name: Steve
H. Kanzer
|
|||
Its:
Chairman and Chief Executive
Officer
|