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