FIRST AMENDMENT TO LICENSE, DISTRIBUTION, MANUFACTURING AND SUPPLY AGREEMENT
Exhibit 10.2
FIRST
AMENDMENT TO LICENSE, DISTRIBUTION, MANUFACTURING AND
SUPPLY AGREEMENT
SUPPLY AGREEMENT
This First Amendment to License, Distribution, Manufacturing and
Supply Agreement (this “First Amendment”) is made and
entered into as of September , 2008, by and
between LUITPOLD PHARMACEUTICALS, INC., a corporation duly
organized and existing under the applicable laws of the State of
New York, and having a principal place of business in Shirley,
New York (hereinafter referred to as “Luitpold”),
AMERICAN REGENT, INC., a corporation duly organized and existing
under the applicable laws of the State of New York, and having a
principal place of business in Shirley, New York (hereinafter
referred to as “AR”, and Luitpold and AR collectively
referred to as “Luitpold/AR”), FRESENIUS USA
MANUFACTURING, INC., a corporation duly organized and existing
under the applicable laws of the State of Delaware, and having a
principal place of business in Waltham, Massachusetts
(hereinafter referred to as “FUSA”), and VIFOR
(INTERNATIONAL), INC., a Swiss corporation having its principal
place of business at Xxxxxxxxxxxxx 00, XX-0000 Xx. Xxxxxx
(Xxxxxxxxxxx) (hereinafter referred to as “Vifor”).
WHEREAS, the parties hereto are parties to a LICENSE,
DISTRIBUTION, MANUFACTURING AND SUPPLY AGREEMENT, dated
May 30, 2008 (the “License Agreement”); and
WHEREAS, the parties hereto desire to amend the License
Agreement to correct certain provisions thereof to the intent of
the parties
NOW, THEREFORE, the parties hereto, intending to be
legally bound, agree as follows:
1. Section 1.01 of the License Agreement is amended as
follows:
A. [*]
B. [*]
C. The definition of “Effective Date” is replaced
in its entirety by the following:
“Effective Date” means (i) the first day of the
month immediately following at least thirty (30) days
following the date on which all conditions set forth in
Section 13.01 have been satisfied or waived in writing or
(ii) such earlier date on which FUSA and Luitpold/AR may
mutually agree in writing.
D. The definition of “Intellectual Property” is
amended by replacing the term “Annual Period” with the
term “Contract Year.”
E. [*]
F. [*]
G. [*]
2. [*]
3. Section 6.10 of the License Agreement is revised by
changing the term “Annual Period” to “Contract
Year.”
4. [*]
5. The numbering of Schedules/Exhibits to the License
Agreement is amended to be as follows:
Exhibit 1.01-A
|
[*] | |
Exhibit 1.01-B
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[*] | |
Exhibit 1.01-C
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[*] | |
Exhibit 1.01-D
|
[*] | |
Exhibit 1.01-E
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[*] | |
Exhibit 2.01(c)
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[*] | |
Exhibit 2.01(d-1)
|
[*] | |
Exhibit 2.01(d-2)
|
[*] |
Exhibit 3.11
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[*] | |
Exhibit 5.01(a)
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[*] | |
Exhibit 6.01
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[*] | |
Exhibit 6.03
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[*] | |
Exhibit 6.06
|
[*] | |
Exhibit 6.08
|
[*] | |
Exhibit 6.11
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[*] | |
Exhibit 6.11(h)
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[*] | |
Exhibit 7.05(a)
|
[*] |
6. [*]
7. [*]
8. Final versions of the Schedules/Exhibits are attached to
this First Amendment as follows:
Schedule 7.02(d)
|
[*] | |
Exhibit 1.01-C
|
[*] | |
Exhibit 1.01-E
|
[*] | |
Exhibit 2.01(c)
|
[*] | |
Exhibit 2.01(d-1)
|
[*] | |
Exhibit 2.01(d-2)
|
[*] | |
Exhibit 3.11
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[*] | |
Exhibit 5.01(a)
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[*] | |
Exhibit 6.01
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[*] | |
Exhibit 6.03
|
[*] | |
Exhibit 6.06
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[*] | |
Exhibit 6.08
|
[*] | |
Exhibit 6.11
|
[*] | |
Exhibit 6.11(h)
|
[*] | |
Exhibit 7.05(a)
|
[*] |
9. Except as expressly amended by this First Amendment, the
License Agreement shall remain in full force and effect. The
representations, warranties and covenants of the Parties
contained in the Agreement are true and correct in all material
respects as of and on the date hereof as if made again on the
date hereof or as of the Effective Date (as applicable) and each
Party shall have performed and complied with all of its
covenants and agreements contained in the Agreement required to
be performed and complied with by it at or prior to the
Effective Date. If requested, each Party shall provide to the
other a certificate to the matters set forth in this section
signed on behalf of such Party by an authorized officer.
10. This First Amendment may be executed in facsimile
counterparts, each of which shall have the legal binding effect
of an original signature, but all of which together shall
constitute one and the same instrument.
[Signatures
are on the following page.]
IN WITNESS WHEREOF, the parties hereto have duly executed this
First Amendment to License, Distribution, Manufacturing and
Supply Agreement as of the date first set forth above.
LUITPOLD PHARMACEUTICALS, INC.
By: |
/s/ Xxxx
Xxxx Xxxxxxx
|
Name: Xxxx Xxxx Xxxxxxx
Title: | President & CEO 9-13-08 |
AMERICAN REGENT, INC.
By: |
/s/ Xxxx
Xxxx Xxxxxxx
|
Name: Xxxx Xxxx Xxxxxxx
Title: | President & CEO |
FRESENIUS USA MANUFACTURING, INC.
By: |
/s/ Rice
Xxxxxx
|
Name:
Title: |
VIFOR (INTERNATIONAL),
INC.1
By: |
/s/ Xxxxxxx
Xxxxxx
|
Name: X. Xxxxxx
Title: | CEO Vifor Pharma |
/s/ X.
Xxxxxxxx
|
Name: X. Xxxxxxxx
Title: | Deputy CEO Vifor Pharma |
1 Executing
this Agreement to indicate its acknowledgement of and consent to
the terms and provisions hereof, and to agree to be bound to
those provisions hereof that pertain to it.
SCHEDULE 7.02 (D)
[*]
EXHIBIT 1.01-A
[*]
EXHIBIT
1.01-C
[*]
EXHIBIT 1.01-E
[*]
EXHIBIT 2.01 (C)
[*]
EXHIBIT 2.01 (D-1)
[*]
EXHIBIT 2.01 (D-2)
[*]
EXHIBIT 3.11
[*]
EXHIBIT 5.01 (A)
[*]
EXHIBIT 6.01
[*]
EXHIBIT 6.03
[*]
EXHIBIT 6.06
[*]
EXHIBIT 6.08
[*]
EXHIBIT 6.11
[*]
EXHIBIT 6.11 (H)
[*]
EXHIBIT 7.05 (a)
[*]