AMENDMENT #1 TO AMENDED AND RESTATED DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT
Exhibit 10.6
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “***”. A COMPLETE
VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE
EXCHANGE ACT OF 1934.
AMENDMENT #1
TO AMENDED AND RESTATED DEVELOPMENT,
LICENSE AND SUPPLY AGREEMENT
TO AMENDED AND RESTATED DEVELOPMENT,
LICENSE AND SUPPLY AGREEMENT
This Amendment #1 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”) and amends
and supplements that certain Amended And Restated Development, License and Supply Agreement between
CIMA and ALAMO dated August 22, 2005 (the “Agreement”).
WHEREAS, CIMA has developed 25 mg., 50 mg. and 100 mg. orally disintegrating tablet doses of
the Product for ALAMO, using CIMA’s OraSolv® technology, under the terms of the Agreement;
WHEREAS, CIMA has performed feasibility activities on a 100 mg. orally disintegrating tablet
dose of the Product for ALAMO, using CIMA’s DuraSolv® technology, under the terms of the Agreement;
WHEREAS, ALAMO has requested that CIMA, perform feasibility and development activities to
formulate additional 12.5mg., 25 mg. and 50 mg. orally disintegrating tablet doses of the Product
for ALAMO using CIMA’s DuraSolv® technology; and development activities for the 100 mg. orally
disintegrating tablet dose of the Product for ALAMO using CIMA’s DuraSolv® technology; and
WHEREAS, the parties have agreed that in consideration for such dosage feasibility and
development activities, ALAMO shall pay to CIMA such additional sums under the Agreement as are
provided for in this Amendment #1.
NOW, THEREFORE, the parties hereby agree to amend the Agreement as follows:
1. Except as expressly defined herein, all capitalized terms shall have the meanings set forth
in the Agreement.
2. In addition to Schedule B of the Agreement, Schedule X-x attached hereto shall be
incorporated into the Agreement in its entirety and included for all purposes under the
Agreement as if it formed part of Schedule B. Activities of two or more Stages set forth in
Schedule X-x may run concurrently.
3. In addition to Schedule E of the Agreement, Schedule E-l attached hereto shall be
incorporated into the Agreement in its entirety and included for all purposes under the
Agreement as if it formed part of Schedule E.
4. Unless otherwise set forth in this Amendment, all references to Sections, Schedules or
Appendices refer to Sections, Schedules or Appendices of the Agreement.
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5. In the event of any conflict between this Amendment #1 and the Agreement, the terms of
this Amendment #1 shall control.
this Amendment #1 shall control.
6. All other terms and conditions of the Agreement shall remain in full force and effect.
IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be executed in three
originals by their duly authorized representatives.
CIMA LABS INC.
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ALAMO PHARMACEUTICALS, LLC | |
BY: /s/ X. X. Xxxxxxxx
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BY:/s/ Xxxxxx Xxxxxxx | |
NAME: X. X. Xxxxxxxx
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NAME: Xxxxxx Xxxxxxx | |
TITLE: V.P. Worldwide Drug Delivery, R&D
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TITLE: Chief Financial Officer | |
DATE: October 14, 2005
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DATE: October 19, 2005 |
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Amended and Restated Development, License and Supply Agreement
Schedule X-x
Schedule X-x
Details of Development Activities, Costs and Timing
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Amended and Restated Development, License and Supply Agreement
Schedule X-x (Continued)
Schedule X-x (Continued)
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Amended and Restated Development, License and Supply Agreement
Schedule X-x (Continued)
Schedule X-x (Continued)
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Amended and Restated Development, License and Supply Agreement
Schedule X-x (Continued)
Schedule X-x (Continued)
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Amended and Restated Development, License and Supply Agreement
Schedule X-x (Continued)
Schedule X-x (Continued)
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Amended and Restated Development, License and Supply Agreement
Schedule X-x (Continued)
Schedule X-x (Continued)
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Amended and Restated Development, License and Supply Agreement
Schedule X-x (Continued)
Schedule X-x (Continued)
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Amended and Restated Development, License and Supply Agreement
Schedule E-l
Schedule E-l
Clozapine DuraSolv®
Anticipated Product Attributes:
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