Letter Amendment No. 1, dated as of November 9, 2000




 EXHIBIT 10.38 
 

 
 Catalytica 
 Pharmaceuticals 
 November 9, 2000 
 Mr. Randall J. Tlachac 
 Orphan Medical 
 13911 Ridgedale Drive 
 Suite 475 

Minnetonka, MN, 55305 
 Dear Randy,

 I am pleased to provide this revised commercial pricing for Xyrem Oral Solution. The new pricing includes the requested component/packaging
changes. I have also attached an amended “APPENDIX D” which includes the pricing, packaging details and related assumptions. All raw materials and packaging components are included, except the sodium oxybate bulk active. 
 Commercial Pricing 
  

							
	 Volume Breaks
	  	Conversion	  	Materials	  	Total Unit Price
	 < 300,000 units/year
	  	1.07	  	3.43	  	4.50
	 300,000—1,000,000 units/year
	  	.98	  	3.19	  	4.17
	 > 1,000,000 units/year
	  	.80	  	3.02	  	3.82

  

	 	•	 	 Volume price breaks based on annual production 


  

	 	•	 	 Pricing is based on the assumptions listed on page 2 of this letter 


  

	 	•	 	 Any change in the assumptions listed on page 2 of this letter will require that pricing be re-evaluated 


 Please indicate Orphan’s approval/acceptance of the above commercial pricing by having the appropriate individual sign and date in the space provided
below. 
 If you have any questions or need further clarification, please do not hesitate to call. 
 Sincerely, 
  

					
	 /s/ David Smithwick
	 		 	
	David Smithwick, Contract Manager	 		 	
			
	 /s/ Randall Tlachac
	 		 	 12/5/00

	Orphan Representative	 		 	Date
			
	 Director, Quality Assurance
	 		 	
	Title	 		 	

  

							
	 cc:
	  	Marie Mayo        Lori Thigpen        File (2)	  		  	

 Proposal Valid for 60 days 
 Confidential 
 Catalytica Pharmaceuticals, Inc. • P.O. Box 1887 •
Greenville, NC 27835-1887 • 252-758-3436 








 November 9, 2000 
 ASSUMPTIONS 
  

	 	•	 	 Volume price breaks based on annual production 


  

	 	•	 	 7 year Commercial Supply Agreement 


  

	 	•	 	 Subject to annual price increase specified in commercial supply agreement 


  

	 	•	 	 DEA Schedule CIII with ARCOS reporting 


  

	 	•	 	 Sodium Oxybate supplied by Orphan 


  

	 	•	 	 Orphan to supply C of C on Sodium Oxybate 


  

	 	•	 	 Manufactured four times per year or once per quarter (campaign) 


  

	 	•	 	 Minimum of three batches per campaign 


  

	 	•	 	 Each additional campaign will carry a setup charge of $15,500 


  

	 	•	 	 Manufacturing batch size of 1,000 gallon /~15,360 200ml bottles 


  

	 	•	 	 To be ordered in full batch size quantities 


  

	 	•	 	 Batches shipped within 30 days of Catalytica issuing CofC/CofA 


  

	 	•	 	 Packaging components 


  

	 	1.	Bottle, plastic 8 oz 

  

	 	2.	Screwcap, 24mm/400 C/R 

  

	 	3.	Front bottle label, 60mm width x 70mm height 

  

	 	4.	Security label—(2) top and bottom of carton 

  

	 	5.	Carton, 98.42mm length x 93.66mm width x 156.37mm depth 

  

	 	6.	Insert, one page/single sided 

  

	 	7.	Tubing, PVC, unprinted, 54mm, R/F 

  

	 	8.	Press-In bottle adapter (PIBA) 

  

	 	9.	Exacta med dispenser 

  

	 	10.	Shipper, Preprinted 

  

	 	11.	Pressure sensitive tape 

  

	 	12.	Bar code label 

  

	 	13.	Vial (2) 

  

	 	14.	Screwcap (for Vial) (2) 

 Proposal Valid for 60 days

 Confidential 
  

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