exv10w6



 







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




     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 B-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 B. Activities of two or more Stages set forth in
Schedule B-l 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.








Page 1 of 10




 









 







5. In the event of any conflict between this Amendment #1 and the Agreement, the terms of

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.

	 	ALAMO PHARMACEUTICALS, LLC
	 
	 	 
	BY: /s/ R. K. Khankari

	 	BY:/s/ Samuel Simmons
	 
	 	 
	NAME: R. K. Khankari

	 	NAME: Samuel Simmons
	 
	 	 
	TITLE: V.P. Worldwide Drug Delivery, R&D

	 	TITLE: Chief Financial Officer
	 
	 	 
	DATE: October 14, 2005

	 	DATE: October 19, 2005






Page 2 of 10




 









 








Amended and Restated Development, License and Supply Agreement

Schedule B-l




Details of Development Activities, Costs and Timing




*** 





***




***




***






 




			
	***	 	Portions of this page have been omitted
pursuant to a request for Confidential Treatment and filed separately with the
Commission.





Page 3 of 10




 









 








Amended and Restated Development, License and Supply Agreement

Schedule B-l (Continued)




***




***




***




***





***




	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	***
	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	***
	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	***
	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	***
	 	 	*	**	 	 	*	**	 	 	*	**	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 






***






 




			
	***	 	Portions of this page
have been omitted pursuant to a request for Confidential Treatment and filed
separately with the Commission.





Page 4 of 10




 









 








Amended and Restated Development, License and Supply Agreement

Schedule B-l (Continued)




***




***




***




***




***






 




			
	***	 	Portions of this page have been omitted
pursuant to a request for Confidential Treatment and filed separately with the
Commission.





Page 5 of 10




 









 








Amended and Restated Development, License and Supply Agreement

Schedule B-l (Continued)




***




***




***




***




***






 




			
	***	 	Portions of this page have been omitted
pursuant to a request for Confidential Treatment and filed separately with the
Commission.





Page 6 of 10




 









 








Amended and Restated Development, License and Supply Agreement

Schedule B-l (Continued)




***




***




	 	 	 
	***

	 	***






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	***
	 	 	*	**	 	 	*	**	 	 	*	**	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	***
	 	 	 	 	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	***
	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**
	 






***




***




***




	 	 	 	 	 
	***

	 	***
	 	***





***




***






 




			
	***	 	Portions of this page have been omitted
pursuant to a request for Confidential Treatment and filed separately with the
Commission.





Page 7 of 10




 









 








Amended and Restated Development, License and Supply Agreement

Schedule B-l (Continued)




***



***




***




***




***




	 	 	 
	***

	 	***






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	***
	 	 	*	**	 	 	*	**	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	***
	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	***
	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**	 	 	*	**
	 






***




***






 




			
	***	 	Portions of this page have been omitted
pursuant to a request for Confidential Treatment and filed separately with the
Commission.





Page 8 of 10




 









 








Amended and Restated Development, License and Supply Agreement

Schedule B-l (Continued)




***




***



***

***

***

***

***

***

***

***

***






 




			
	***	 	Portions of this page have been omitted
pursuant to a request for Confidential Treatment and filed separately with the
Commission.





Page 9 of 10




 









 








Amended and Restated Development, License and Supply Agreement

Schedule E-l




Clozapine DuraSolv®




Anticipated Product Attributes:




***




***




***




***






 




			
	***	 	Portions of this page have been omitted
pursuant to a request for Confidential Treatment and filed separately with the
Commission.





Page 10 of 10