Amendment to Development Agreement between Inyx Pharma Limited and Stiefel Laboratories, Inc.
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Summary
This amendment, dated November 30, 2004, updates the original Development Agreement from March 7, 2003, between Inyx Pharma Limited and Stiefel Laboratories, Inc. It adds a new product to the agreement's schedule of development activities. All other terms of the original agreement remain unchanged. The amendment outlines specific development tasks and responsibilities for both parties related to the new product, with certain confidential details redacted.
EX-10.13.6 2 inyx8kex10136113004.txt AMENDMENT TO DEVELOPMENT AGREEMENT ================================================================================ Exhibit 10.13.6 CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE COMMISSION * * * CONFIDENTIAL TREATMENT AMENDMENT TO DEVELOPMENT AGREEMENT Amendment dated November 30, 2004, to that certain Development Agreement dated March 7, 2003, between Inyx Pharma, Ltd. and Stiefel Laboratories, Inc. Exhibit B to the Development Agreement is hereby amended to add the product specified below. In all other respects the Development Agreement shall remain in effect in its original form. Dated the date first-above written. INyX PHARMA LIMITED. By: /s/ Steven J. Handley ------------------------------- Steven J. Handley, President STIEFEL LABORATORIES, INC. By: /s/ William A. Carr ------------------------------- William A. Carr, Vice President CONFIDENTIAL TREATMENT ADDENDUM TO EXHIBIT B SCHEDULE OF DEVELOPMENT ACTIVITIES IV. Task Name: *** Start Date: *** Finish Date: *** 1. Project definition and scope. 2. Acquisition, Testing, and Evaluation of drugs, excipients, and components as agreed by both parties. 3. Formulation and manufacturing process assessments to facilitate production of the product by Inyx. 4. Assessment and assistance, as necessary, in the development of mutually acceptable test methods required to secure health registrations. 5. Development and Exhibit batch preparation. 6. Development and preparation of necessary clinical supplies. 7. Assistance, as necessary, with mutually agreed testing activities to support health registrations. 8. Support in preparation and review of CMC documentation necessary to secure health registrations. TOTAL DEVELOPMENT COST ***. ---------------------------------------- *** Confidential material redacted and filed separately with the Commission.