Exhibit 10.10
CERTAIN CONFIDENTIAL PORTIONS OF
THIS EXHIBIT WERE OMITTED AND REPLACED WITH “***”. A
COMPLETE VERSION OF THE EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE
SECURITIES ACT OF 1933.
AMENDMENT#3
TO AMENDED AND RESTATED
DEVELOPMENT,
LICENSE AND SUPPLY
AGREEMENT
This Amendment # 3 effective as of
the 1 st
day of January 2008
(“Effective Date”), by and between CIMA LABS INC., a
Delaware corporation (“CIMA”), and Azur Pharma
International III Limited, a Bermuda corporation
(“AZUR”), as assignee of Alamo Pharmaceuticals, LLC,
amends and supplements that certain Amended and Restated
Development, License and Supply Agreement between CIMA and AZUR
dated August 22, 2005, as amended by that Amendment #1 to
Amended And Restated Development, License and Supply Agreement
effective October 19, 2005 and that Amendment #2 to Amended
and Restated Development, License and Supply Agreement effective
April 10, 2007 (“Amendment #2) (collectively, the
“Agreement”).
WHEREAS, AZUR has determined that it
would like to seek approval in Europe of dosage forms of the API
formulated in the DuraSolv technology in addition to the OraSolv
technology, with the intention that the DuraSolv formulations will
replace the OraSolv formulations upon regulatory
approval;
WHEREAS, AZUR would like CIMA to
conduct certain activities in connection with the validation
of three dosage forms of the API formulated in DuraSolv in blisters
and bottles for Europe and CIMA is willing to perform such work, in
accordance with the terms and conditions set forth
herein;
NOW, THEREFORE, the parties hereby
agree to amend the Agreement as follows:
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1.
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Except as
expressly defined herein, all capitalized terms shall have the
meanings set forth in the Agreement.
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2.
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Clause
(ii) in the definition of “Product” in
Section 1 of the Agreement shall be deleted in its entirety
and replaced with the following:
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“(ii) 12.5 mg, 25 mg or 100
mg, of API formulated in OraSolv® or DuraSolv® technology
for Europe subject to successful validation in accordance with this
Agreement; provided that upon applicable regulatory approval, the
DuraSolv® formulation will replace the corresponding
OraSolv® formulation”
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3.
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Schedule B-2 attached to this
Amendment #3 shall replace Exhibit B-2 attached to this Amendment
#3. The parties shall in good faith mutually agree in writing upon
any additional work, e.g., artwork for the European bottles and
blisters, necessary to launch
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EXECUTION COPY
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the Product, and compensation for
such work.
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4.
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Schedule F
shall be amended by adding the following sentence: “25mg and
100mg product for Europe will be packaged in both 100 count bottles
and six-count blisters. 12.5mg product for Europe will be packaged
in 100 count bottles only.”
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5.
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Unless
otherwise set forth in this Amendment #3, all references to
Sections or Appendices refer to Sections or Appendices of the
Agreement.
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6.
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In the event of
any conflict between this Amendment #3 and the Agreement, the terms
of this Amendment #3 shall control.
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7.
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All other terms
and conditions of the
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