Amendment II
Exhibit 10.6
Amendment II
to the Agreement for the Manufacturing of a Liposomal Formulation
between
SignPath Pharma, Inc. ("SIGNPATH")
0000 Xxxxxxxxxx XX,Xxxxxxxxxx, XX 00000, XXX
and
Polymun Scientific Immunbiologische Forschung GmbH ("POLYMUN")
Xxxxxxxx. 00, 0000 Xxxxxxxxxxxxxx, Xxxxxxx
Pursuant to § 11.6. of the Agreement between SIGNPATH and POLYMUN from 6th of September 2007, which stipulates that "Modifications/amendments to or extensions of this Agreement are only valid if in writing and signed for and on behalf of both parties.", SIGNPATH and POLYMUN hereby acknowledge the following Amendment to the Agreement:
SIGNPATH is sponsor of a first in man study with liposomal curcumin in Vienna. Pursuant to the first Amendment to the Agreement from 10th of November 2011, POLYMUN is acting as legal representative for this study in connection with overall study management. The study will be substantially amended to include 20 additional subjects for higher doses of liposomal curcumin.
The Subject Matter of Agreement will be amended for the following additional services
Task
|
Price
|
Study Amendment Preparation
|
|
Study protocol version V04
|
€ 8.000
|
Ethic application form
|
|
EudraCT application form
|
|
Patient information
|
|
Investigator's brochure (review)
|
|
Management
|
|
Coordination activity with SIGNPATH, CRO of study, analytical laboratory (Nucro), clinical site, safety board, ethics committee, regulatory authority (AGES PharmMed)
|
€ 15.000
|
Continuation as Legal Representative
|
|
Legal representative (fee)
|
€ 7.000
|
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Payment schedule
• 25% of the costs at signing of this Amendment
• 25% of the costs at first patient in
• 50% of the costs at last patient out
Phase 1b study in cancer Patients with XXXXX (Central European Society for Anticancer
Drug Research-EWIV)
Protocol development support and project coordination by Dr. Brigitta Vcelar I € 115 per hour
Payment schedule
• Written approval by SIGNPATH of maximal amount of hours in advance for each calendar quarter
Written approval by SIGNPATH of additional amount of hours in case of previously approved amount of hours not sufficient
• Invoices per calendar quarter with tabulated form of hours spent on protocol development support by Dr. Brigitta Vcelar with summary of activities
Not included:
• Fees of regulatory authorities
• Fees of ethics committee
• Costs of patient insurance
• Print of paper CRFs
• Costs of sample shipment
The term of the Agreement defined in §4.1. of the Agreement will be extended until 31st of December 2013.
For SIGNPATH: For POLYMUN:
/s/ Xxxxxxxx Xxxxxx, MD /s/ Xx. Xxxxxxx Xxxxxxxx 12.04.2012
Xxxxxxxx Xxxxxx, MD, CEO Xx. Xxxxxxx Xxxxxxxx, CEO
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