signpathexh106.htm


Exhibit 10.6










Amendment II


to the Agreement for the Manufacturing  of a Liposomal Formulation














between







SignPath Pharma, Inc. ("SIGNPATH")




1375 California RD,Quakertown, PA 18951, USA







and









Polymun Scientific Immunbiologische Forschung GmbH ("POLYMUN")




Donaustr. 99, 3400 Klosterneuburg, Austria







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 CESAR (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/ Lawrence Helson, MD                                                                                   /s/ Dr. Dietmar Katinger                                                    12.04.2012


Lawrence Helson, MD, CEO                                                                                   Dr. Dietmar Katinger, CEO












 




 












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