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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 Xxxxxxx
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/ Xxxxxx X. Xxxxxxx
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Xxxxxx X. Xxxxxxx, President
XXXXXXX LABORATORIES, INC.
By: /s/ Xxxxxxx X. Xxxx
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Xxxxxxx X. Xxxx, 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 ***.
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*** Confidential material redacted and filed separately with the
Commission.
