Exhibit 10.9
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
#2
TO AMENDED AND RESTATED
DEVELOPMENT,
LICENSE AND SUPPLY
AGREEMENT
This Amendment # 2 effective as of
the last date on the signature page hereof (“Effective
Date”), by and between CIMA LABS INC. (“CIMA”)
and Alamo Pharmaceuticals, LLC (“ALAMO”) amends and
supplements that certain Amended and Restated Development, License
and Supply Agreement between CIMA and ALAMO dated August 22,
2005, as amended by that Amendment #1 to Amended And Restated
Development, License and Supply Agreement effective
October 19, 2005 (collectively, the
“Agreement”).
WHEREAS, CIMA is currently
developing a 12.5 mg orally disintegrating tablet dose of the
Product for ALAMO, using CIMA’s DuraSolv® technology,
under the terms of the Agreement;
WHEREAS, ALAMO and CIMA agree that
such 12.5 mg orally disintegrating tablet dose should be added to
the definition of the Agreement for purposes of
commercialization;
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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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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“ Product ” shall
mean a pharmaceutical product containing (i) 12.5 mg, 25 mg,
50 mg, or 100 mg of API formulated in DuraSolv® technology for
the United States; and (ii) 25 mg, 50 mg, or 100 mg, of API
formulated in OraSolv® technology for Europe; provided that the
50 mg dose is subject to successful validation pursuant to a
mutually agreed upon development agreement. The Product definition
shall be expanded to include a 12.5 mg DuraSolv® dose for
Europe provided the Parties reasonably agree upon the terms and
conditions of a development agreement outlining the activities and
fees associated with such dose and the Parties reasonably agree to
the royalty rate and price for the such product for
Europe.
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3.
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Section 5.1(c) shall be deleted in its
entirety and replaced with the following:
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“Purchase order quantities
shall be equivalent to the validated full batch size of the
Product, Product samples, or Product placebos. The delivery
quantity of tablets for trade shall not exceed a total of
***
in any
***
, unless otherwise agreed to by the Parties. Each purchase order
shall be placed in accordance with the dosage combinations and full
batch split ratios set forth in the final approved validation
summary report and any of its approved amendments.
Alamo will compensate CIMA at the
mutually agreed amount for validation activities as set forth in
Amendment 1 Schedule B-1 under Stage V.
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4.
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Schedule B-1
added to the Agreement by Amendment #1 effective as of
October 19, 2005 shall be amended (for purposes of
clarification) by adding the phrase “at *** months” to
the phrase “***” in the section entitled
“***”.
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5.
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Schedule B-1
added to the Agreement by Amendment #1 effective as of
October 19, 2005 shall be amended by replacing
“$***” with “$***” and by replacing the
first two paragraphs regarding *** with the following:
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“***
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***
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***
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***
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***
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***
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***
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***
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***
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***
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***
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***
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***
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***
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***
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***
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***
***
***
***.”
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***
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Portions of
this page have been omitted pursuant to a request for Confidential
Treatment and filed separately with the Commission.
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6.
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Schedule B-2
attached to this Amendment #2 shall be incorporated into the
Agreement in its entirety and included for all purposes as if it
formed part of Schedule B.
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7.
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Schedule F of
the Agreement is hereby replaced by Schedule F a
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