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| AEN > SEC Filings for AEN > Form 8-K on 26-Jun-2009 | All Recent SEC Filings |
26-Jun-2009
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.
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