Item 1.01 Entry into a Material Definitive Agreement
On August 4, 2009, Marshall Edwards Pty Limited ("MEPL"), a wholly-owned
subsidiary of Marshall Edwards, Inc. (the "Company") and Novogen Research Pty
Limited ("Novogen Research"), a wholly-owned subsidiary of Novogen Limited,
entered into a license agreement pursuant to which Novogen Research granted to
MEPL an exclusive, worldwide, non-transferable license under its patents and
patent applications and in the intellectual property rights related to its know
how to conduct clinical trials, commercialize and distribute the anti-cancer
compound NV-128. The Company is a majority owned subsidiary of Novogen Limited.
The terms of the license agreement were established through arms-length
negotiations between the independent members of the board of directors of
Novogen Limited and members of the Company's Audit Committee which is composed
of independent members of the Company's board of directors. The license
agreement was unanimously approved by the board of directors of each of MEPL and
the Company. A majority of the members of the Company's board of directors are
independent in accordance with Nasdaq listing requirements.
The license agreement covers the use of NV-128 in the field of prevention,
treatment and cure of cancer in humans delivered in all forms except topical
applications. The license agreement remains in effect until (i) the expiration
or lapsing of the last relevant patents or patent applications in the world or
(ii) Novogen Research's assignment to MEPL of the last relevant patents or
patent applications in the world so that MEPL may assume the filing, prosecution
and maintenance of such patents or patent applications. Thereafter, the license
becomes a non-exclusive, perpetual and irrevocable license covering any
remaining intellectual property rights related to the know how with respect to
NV-128. MEPL may terminate the license by giving three months notice to Novogen
Research.
MEPL paid U.S. $1,500,000 to Novogen Research in August 2009, which was the
first lump sum license fee payment under the terms of the license agreement.
Future amounts payable to Novogen Research are as follows:
(i) U.S. $1,000,000 on the date an investigational new drug containing NV-128
is approved by the U.S. Food and Drug Administration (the "FDA") for use in
clinical trials or by an equivalent government agency outside the United States;
(ii) U.S. $2,000,000 on the date of enrollment of the first clinical trial
subject in a Phase II clinical trial of an investigational drug containing
NV-128;
(iii) U.S. $3,000,000 on the date of enrollment of the first clinical trial
subject in a Phase III clinical trial of an investigational drug containing
NV-128; and
(iv) U.S. $8,000,000 on the date of the first receipt of a new drug
application approval for an investigational drug containing NV-128 from the FDA
or equivalent approval from of a government agency outside the United States.
The foregoing description of the license agreement does not purport to be
complete and is qualified in its entirety by reference to the full text of the
license agreement filed as Exhibit 10.1 hereto, and is incorporated herein by
reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. Description
10.1 License Agreement dated August 4, 2009 by and between Novogen Research
Pty Limited and Marshall Edwards Pty Limited
99.1 Press Release issued by Marshall Edwards, Inc. dated August 5, 2009
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Signature
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.
MARSHALL EDWARDS, INC.
By: /s/ David R. Seaton
David R. Seaton
Chief Financial Officer
(Duly Authorized Officer and Principal
Financial Officer)
Dated: August 7, 2009