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EXHIBIT 10.1
AMENDMENT TO
LICENSE AND DISTRIBUTION AGREEMENT
This Amendment is entered into on April 30, 1998 between Sumitomo
Pharmaceuticals Co., Ltd. ("Sumitomo") and NeXstar Pharmaceuticals, Inc.
("NeXstar") regarding to the License and Distribution Agreement dated
September 26, 1996 (the "Agreement"). All terms used in this Amendment No. 1
shall have the meanings as set forth in the Agreement.
The Agreement is amended as follows:
Following paragraphs are added after Paragraph 4 of Section 3:
3-5. Product for clinical trials shall be manufactured and quality controlled
under Investigational Drug Product - GMP (Notification No. 480 of the
Pharmaceuticals Affairs Bureau in Japan dated March 31, 1997) and shall be
supplied to Sumitomo as a form of nude vial with syringe filter.
3-6. The provisions of Paragraphs 4 and 6 of Section 2 of the Agreement shall
also apply to Product for clinical trials.
3-7. NeXstar shall provide Sumitomo with the certificate of analysis for each
Product batch for clinical trials, which includes release permit based on the
manufacturing and quality control record.
All of the other terms of the Agreement shall remain the same in their entirety.
NeXstar Pharmaceuticals, Inc. Sumitomo Pharmaceuticals Co., Ltd
By: /s/ CRISPIN X.X. XXXX By: /s/ ATSUSHI MURANO
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Xxxxxxx X.X. Xxxx Xxxxxxx Murano, Ph.D.
Title: Vice President Pharmaceutical Title: Director
Operations
