1st Amendment to Captisol Supply Agreement



 Exhibit 10.101 
 CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. 
 1st Amendment to the 

CAPTISOL® SUPPLY AGREEMENT 
 dated as of

 December 20th, 2002 
 BY AND BETWEEN 
 CYDEX, INC. 

AND 

THE HOVIONE GROUP 
 Dated as of July 29, 2005 







 TABLE OF EXHIBITS 

 

			
	 Exhibit F
	  	Pricing
	 Exhibit G
	  	Continuous Improvement Program








 1st AMENDMENT TO THE CAPTISOL® SUPPLY AGREEMENT 
 THIS 1st
AMENDEMENT TO THE CAPTISOL SUPPLY AGREEMENT (the “AGREEMENT”) is entered into as of the 29th of July 2005, by and between: 
  

	 	(1)	CYDEX, INC., a Delaware corporation with an office at 10513 W. 84th Terr, Lenexa, Kansas, 66214 (“CYDEX”); and 


 

	 	(2)	HOVIONE LLC, a New Jersey limited liability company with an office at 40 Lake Drive, East Windsor, New Jersey 08250 (“AGENT”), acting as exclusive
sales agent for the USA for the manufacturers, HOVIONE FARMACIENCIA S.A., a Portuguese corporation (“HOVIONE SA”), and HOVIONE PHARMASCIENCE LIMITED, a Macau corporation (“HOVIONE LIMITED”), and acting as exclusive
sales agent for the project manager HOVIONE INTERNATIONAL LIMITED, a Hong Kong corporation with an office at 172 Gloucester Road, Wanchai, Hong Kong (“HOVIONE INTERNATIONAL”), jointly and severally. AGENT, HOVIONE SA, HOVIONE
LIMITED and HOVIONE INTERNATIONAL are collectively referred to herein as “HOVIONE”). 

 BACKGROUND

 Both parties declare that the original intent of the AGREEMENT entered into has been met and remains
valid. Parties feel that it is appropriate to clarify and update certain matters contained in said AGREEMENT as such this
1st Amendment has been agreed to and is amended as
follows. 
 AGREEMENTS 
 NOW, THEREFORE, in consideration of the mutual promises hereinafter made and the mutual benefits to be derived from this 1st AMENDMENT TO THE AGREEMENT, and other good and valuable consideration, the receipt and sufficiency of which is
acknowledged, the parties hereto, intending to be legally bound, hereby agree as follows: 
  

	1.	With reference to Article 1, the following definitions have been amended: 


“COMMERCIAL PRODUCTION DATE” has the meaning set forth in Section 2.2 hereof, or more specifically the
26th August 2005. 

“INITIAL TERM” means the period commencing upon the EFFECTIVE DATE and ending on March 31, 2012. 

 

	2.	With reference to clause 2.2 Timing, the parties agree that: 

 In the second sentence of clause 2.2, the clause “, which shall be on or before May 31, 2004” is hereby deleted. 








	3.	With reference to clause 4.2 Adjustments to UNIT PRICES - Parties agree that: 


1) There has been no material Variance from Engineering Information. Based on the evidence of the production campaigns performed
since 2004, the actual costs, the manufacturing efficiency set forth in Exhibit E and the information contained in Exhibit B, there is no evidence of an increase in total cost necessary to achieve the manufacturing efficiency set
forth in Exhibit E. Pricing and unit rates applicable after the COMMERCIAL PRODUCTION DATE are confirmed as per Exhibit F. 
 2) Currency Exchange Rates. The Parties acknowledge that pursuant to clause 4.2(b), the UNIT PRICES for the first CONTRACT YEAR are subject to adjustment pursuant to Exhibit D based on the
ACTUAL EXCHANGE RATE of US$[***], as reported by The Wall Street Journal, Eastern U.S. edition for the COMMERCIAL PRODUCTION DATE. 
  

	4.	With reference to Article 2, the following clause 2.9 is added: 

 2.9 Continuous Improvement Program. During the TERM, the parties may elect to pursue any one or more of the cost saving measures described in further detail in Exhibit G, subject to the
parties’ mutual agreement on division of responsibilities and costs and the potential impact on SPECIFICATION and UNIT PRICES. 
  

	5.	With reference to Clause 6.11 parties agree that: 

 The Technical Committee shall be composed of one representative of each party. Initially, such representatives shall be: 
  

			
	 •    for CYDEX:
	    	Mr. Vince Antle
		
	 •    for HOVIONE:
	    	Mr. Antonio Gomes

 The Management
Committee shall be composed of one representative of each Party. Initially, such representatives shall be: 
  

			
	 •    for CYDEX:
	    	Dr. John Siebert
		
	 •    for HOVIONE:
	    	Mr. David Hoffman

  

 

	***	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted
portions. 








 IN WITNESS WHEREOF, the parties, through their authorized representatives, have duly
executed this AGREEMENT as of the date first written above. 
  

									
	Accepted and agreed	 	 	 	 	 	 
	CYDEX, INC.	 	 	 	 	 	HOVIONE LLC
					
	By:	 	             /s/ John M.
Siebert
	 		 	By:	 	             /s/ David
Hoffman

	Name:	 	John M. Siebert	 		 	Name:	 	David Hoffman
	Title:	 	Chairman and CEO	 		 	Title:	 	President US Operations
	Date:	 	17 Jan. 2006	 		 	Date:	 	14 Jan. 2006
				
	Accepted and agreed:	 		 		 	
	HOVIONE FARMACIENCIA S.A.	 		 	HOVIONE PHARMASCIENCE LIMITED
					
	By:	 	             /s/ Noé
Carreira
	 		 	By:	 	             /s/ Carlos
Costa

	Name:	 	Noé Carreira	 		 	Name:	 	Carlos Costa
	Title:	 	Director	 		 	Title:	 	Director
	Date:	 	05 Jan. 2006	 		 	Date:	 	3 Jan. 2006
				
	HOVIONE INTERNATIONAL LIMITED	 		 		 	
					
	By:	 	             /s/ G. Villax
	 		 		 	
	Name:	 	G. Villax	 		 		 	
	Title:	 	CEO and Director	 		 		 	
	Date:	 	05 Jan. 2006	 		 		 	








 EXHIBIT F 
 PRICING 
 The following unit prices remain valid as full compensation for the
performance of HOVIONE hereunder for the manufacture and supply of CAPTISOL from its Loures site from and after the COMMERCIAL PRODUCTION DATE, unless altered based on the Agreement as a result of the issues foreseen in the AGREEMENT that have or
could occur by the [***] of the COMMERCIAL PRODUCTION DATE. CYDEX shall pay HOIVONE the following supply prices (“UNIT PRICES”) tor CAPTISOL: 
  

			
	 Quantities of CAPTISOL® Supplied in a
CONTRACT YEAR
	  	UNIT PRICES
(US$)
	 [***]
	  	[***]
	 [***]
	  	[***]
	 [***]
	  	[***]

 [***] 

 
  

	***	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted
portions. 








 EXHIBIT G 
 CONTINUOUS IMPROVEMENT PLAN 
 [***] 

 
  

	***	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted
portions.