First Amendment to Exclusive License Agreement
First
Amendment to Exclusive License Agreement
This
First Amendment to the Exclusive License Agreement ("Agreement") is made
and
entered into this 6th
day of
August 2003 by and between AltaRex Corp. (“AltaRex”) and Unither
Pharmaceuticals, Inc., a wholly-owned subsidiary of United Therapeutics
Corporation (“UP”),
together referred to as “the Parties”.
RECITALS
WHEREAS, the
Agreement was entered into by the Parties on April 17, 2002; and
WHEREAS,
the Parties desire to make certain revisions to the Agreement.
NOW,
THEREFORE, in consideration of $250,000.00 (USD) and the foregoing and the
mutual covenants herein contained, and for other good and valuable
consideration, the receipt and sufficiency of which is hereby acknowledged,
the
parties agree as follows:
I.
Paragraph
1.25 of the Agreement shall be amended in its entirety as follows:
1.25
“Territory”
means
the universe with the exception of (i) the member nations of the European
Union
as of the Effective Date but excluding Germany, and (ii) those certain countries
and rights identified in Appendix
C
to this
Agreement.
II.
Paragraph
4.2.1 of the Agreement shall be amended in its entirety as follows:
4.2.1 UP
Development Program Milestones.
UP
shall
use its best efforts to conduct the UP Development Program and, if in UP’s
opinion, the results of the UP Development Program so justify, to seek
Registration for such Product in the United States and pursue manufacturing,
commercialization and marketing of Products in the United States, and thereafter
in such additional countries within the Territory as UP determines are
commercially feasible. The UP Development Program shall include such product
development work as UP may, in its sole discretion, consider necessary for
such
Registration. UP shall commence enrollment in a pivotal OvaRex® study by April
30, 2003; and (ii) make an OvaRex® BLA submission by April 30, 2007; provided,
however, that the foregoing milestone dates shall be extended by that number
of
days as is equivalent to the duration of the Initial Assessment
Period.
III.
Paragraph
5.1 of the Agreement shall be amended in its entirety as follows:
5.1 Milestone
Payments.
In
partial consideration for the grant of the license under the Licensed Technology
to UP under Section 3.1, UP shall pay AltaRex the milestone payments in the
amount specified below for each indication for which UP seeks regulatory
approval of a Product, such payment to be made within thirty days following
the
completion of the corresponding event designated below:
|
Milestone
Payment
|
||||
|
Milestone
Event
|
Millions
of Dollars)
|
|||
|
Commencement
of first pivotal
|
$
|
0.600
|
||
|
Phase
3 enrollment
|
||||
|
Completion
of BLA filing in the U.S.
|
$
|
1.400
|
||
|
Completion
of marketing application
|
$
|
0.500
|
||
|
filing
in Germany
|
||||
|
Marketing
approval by FDA
|
$
|
3.000
|
||
|
German
Marketing approval
|
$
|
1.000
|
||
The
parties acknowledge that the first milestone payment to AltaRex in connection
with the development of OvaRex® for the treatment of ovarian cancer shall be
upon completion of a BLA filing.
IV.
UP
and
AltaRex will in good faith negotiate a supply agreement in an effort to address
AltaRex's requirements to its distributors with respect to sales of OvaRex
outside of the Territory, the price of OvaRex (FOB UP's designated warehouse
in
the United States) to be no more than that price charged by UP to its
distributors/marketing partners in the European Union.
V.
Appendix
C is amended in its entirety in the form provided at Exhibit
1
to this
First Amendment and incorporated herein.
VI.
The
terms
of this First Amendment to the Exclusive License Agreement shall supersede
and
control over all conflicting terms contained in the Exclusive License Agreement.
All other terms and conditions of the Exclusive License Agreement shall remain
in full force and effect.
IN
WITNESS WHEREOF, the parties have executed this Agreement by their authorized
officers of the date and year first above written.
| ALTAREX CORP. | UNITHER PHARMACEUTICALS, INC. |
| __________________________________ | __________________________________ |
|
Xxxx
X. Xxxxx
Senior
Vice President & General Counsel
|
|
| UNITED THERAPEUTICS CORPORATION | |
| __________________________________ | |
|
Xxxx
X. Xxxxx
Senior
Vice President & General
Counsel
|
Exhibit
1
EXCLUDED
TERRITORIES AND RIGHTS
The
following are excluded from the Territory of this Agreement:
|
Dompé(1)
|
Genesis(2)
|
Medison(2)
|
|
Italy
|
Greece
|
Israel
|
|
Switzerland
|
Turkey
|
Egypt
|
|
Austria
|
Cyprus
|
Jordan
|
|
Spain
(Faes)
|
Croatia
|
Saudi
Arabia
|
|
Portugal
(Faes)
|
Bosnia
|
Yemen
|
|
San
Marino
|
Herzegovina
|
Oman
|
|
Ukraine
|
Macedonia
|
Iraq
|
|
Belarus
|
Serbia
|
Syria
|
|
Hungary
|
Slovenia
|
Qatar
|
|
Poland
|
Albania
|
Bahrain
|
|
Czech
Republic
|
Romania
|
Kuwait
|
|
Yugoslavia
|
Bulgaria
|
UAE
|
|
Lithuania
|
Iran
|
|
|
Estonia
|
Palestine
|
|
|
Latvia
|
Lebanon
|
|
|
Vatican
City
|
(1)Dompé
has
a Right of First Offer on BrevaRex®
and
ProstaRex™ for the same countries as listed above upon the Products entering
phase II study.
(2)Genesis
and Medison have a Right of First Offer on BrevaRex®
for the
same countries as listed above upon the Product entering phase II
study.
