Document:

Exhibit
10.10

     

    SPONSORED
RESEARCH AGREEMENT

     

    This
Sponsored Research Agreement (the "Agreement") is made between the University of
North Texas Health Science Center at Fort Worth, ("University"), a component
institution of the University of North Texas System ("System"), and SignPath
Pharmaceuticals, Inc. a Delaware corporation with its principal place of
business at 45 Broadway, 2nd Floor New York, NY 10006 ("Sponsor").

     

    RECITALS

     

    A.
University is pursuing research in the area of cucurmin nanoparticles for drug
delivery.

     

    B.
Effective August 18, 2008 Sponsor and University entered into an exclusive
license agreement for existing intellectual property related to such research
(“License Agreement”).

     

    B.
Sponsor is willing to sponsor additional such research.

     

    C.
Sponsor desires to obtain certain rights to patents and technology resulting
from the additional research.

     

    D.
University is willing to grant certain rights to patents and technology that
result from the additional research.

     

    NOW
THEREFORE, in consideration of the mutual covenants and promises herein made,
the University and Sponsor agree as follows:

     

    
      	
              1)

            	
              EFFECTIVE
      DATE

            

    

     

    This
Agreement shall be effective as of June 1, 2009 (the "Effective
Date").

     

    
      	
              2)

            	
              RESEARCH
      PROGRAM

            

    

     

    
      	
               
      

            	
              a.

            	
              University
      will use its own facilities and its reasonable best efforts to conduct the
      research program described in Attachment A ("Research Program") under the
      direction of Dr. Jamboor Vishwanatha or his successor as mutually agreed
      to by the parties (the "Principal
  Investigator").

            

    

     

    
      	
               
      

            	
              b.

            	
              The
      Research Program shall be carried out from the Effective Date through and
      including May 31, 2010 (the "Term"). The parties may extend the Research
      Program under mutually agreeable
terms.

            

    

     

    
      	
               
      

            	
              c.

            	
              Sponsor
      understands that University's primary mission is education and advancement
      of knowledge and the Research Program will be designed to carry out that
      mission. The manner of performance of the Research Program shall be
      determined solely by the Principal Investigator. University does not
      guarantee specific results.

            

    

     

    
      	
               
      

            	
              d.

            	
              Sponsor
      understands that University may be involved in similar research through
      other researchers on behalf of itself and others. University shall be free
      to continue such research provided that it is conducted separately from
      the Research Program, and Sponsor shall not gain any rights via this
      Agreement to other research.

            

    

     

    
      
         

      

      
        1

        
          

        

      

      
         

      

    

     

    
      	
               
      

            	
              e.

            	
              University
      does not guarantee that any patent rights will result from the Research
      Program, that the scope of any patent rights will cover Sponsor's
      commercial interest, or that any patent rights will be free of dominance
      by other patents, including those based on inventions made by other
      inventors at the University or at any other System
      institution.

            

    

     

    
      	
              3)

            	
              COMPENSATION

            

    

     

    
      	
               
      

            	
              a.

            	
              As
      consideration for University's performance, Sponsor will pay the
      University a sum of one hundred fifteen thousand dollars ($115,000),
      seventy-nine thousand eight hundred sixty-one dollars and eleven cents
      ($79,861.11) in direct costs and thirty-five thousand one hundred
      thirty-eight dollars and eighty-nine cents ($35,138.89) in indirect costs
      (44%).  An initial payment of thirty thousand dollars ($30,000)
      shall be made upon execution of this Agreement, and subsequent payments
      shall be made as follows:

            

    

    

    thirty
thousand dollars ($30,000) shall be due Dec 1, 2009

     

    fifty-five
thousand dollars ($55,000) shall be due May 31, 2010

     

    
      	
               
      

            	
              b.

            	
              Sponsor
      will make payments to the University of North Texas Health Science Center
      at Fort Worth, referencing the Principal Investigator and Research Program
      title, to the following address:

            

    

     

    Office of
Grant and Contract Management

    University
of North Texas Health Science Center

    Attention:          Director

    3500 Camp
Bowie Boulevard

    Fort
Worth, TX 76107

    Telephone:
(817)735-5073

     

    
      	
               
      

            	
              c.

            	
              The
      Principal Investigator may transfer funds within the budget as needed
      without Sponsor's approval so long as the scope of work under the Research
      Program remains unchanged. Upon completion of the Research Program,
      University shall retain any uncommitted and unexpended
    funds.

            

    

     

    
      	
               
      

            	
              d.

            	
              University
      shall retain title to all equipment purchased and/or fabricated by it with
      funds provided by Sponsor under this
Agreement.

            

    

     

    
      	
              4)

            	
              COMMUNICATION,
      REPORTS, AND TRANSFERS

            

    

     

    
      	
               
      

            	
              a.

            	
              Sponsor's
      designated representative for communications with the Principal
      Investigator shall be Lawrence Helson, MD or any other person Sponsor may
      designate in writing to University and the Principal Investigator
      ("Designated Representative").

            

    

     

    
      	
               
      

            	
              b.

            	
              The
      Principal Investigator will make up to 12 oral reports and one written
      report summarizing the work completed each year of the Research Program.
      The Principal Investigator shall also submit a comprehensive final report
      within one hundred twenty (120) days after termination of the Agreement.
      The Office of Grant and Contract Management will submit a financial report
      of related Research Program expenses within one hundred twenty (120) days
      after termination.

            

    

     

    
      
         

      

      
        2

        
          

        

      

      
         

      

    

     

    
      	
               
      

            	
              c.

            	
              During
      the course of the Research Program, it is expected that the parties will
      transfer chemical materials to one another. Transfer of materials from
      University to Sponsor shall be subject to the terms and conditions of the
      material transfer agreement in Attachment B. UNTHSC shall use the
      materials provided by Sponsor solely for the purposes specified in this
      Agreement and in compliance with all applicable laws and regulations.
      UNTHSC shall not sell, transfer, disclose or otherwise provide access to
      the materials or any SPONSOR owned method or process relating thereto to
      any person or entity without the prior consent of
  SPONSOR..

            

    

     

    
      	
              5)

            	
              PUBLICITY

            

    

     

    Neither
party will reference the other in a press release or any other oral or written
statement in connection with the Research Program and its results intended for
use in the public media, except as required by the Texas Public Information Act
or other law or regulation. University, however, may acknowledge Sponsor's
support of the Research Program in scientific or academic publications or
communications without Sponsor's prior approval. In any permitted statements,
the parties shall describe the scope and nature of their participation
accurately and appropriately. Sponsor may disclose the existence of this
Agreement and the fact that UNTHSC is conducting sponsored research under this
Agreement for the purposes of raising capital, and Sponsor may use the name of
(or name employee of) University in routine business correspondence or as needed
in appropriate regulatory submissions without express written
consent.

     

    
      	
              6)

            	
              PUBLICATION

            

    

     

    University
reserves the right to publish the general scientific findings gained in the
course of the Research Program, with due regard the protection of Sponsor’s
confidential information, the protection of current and future patent filing
opportunities, regulatory and development concerns and other reasonable
considerations relating to the development of Licensed Products, as defined by
the License Agreement. University will submit the manuscript of any proposed
publication to Sponsor at least forty five (45) calendar days before such
manuscript is submitted for consideration by any publication, and Sponsor shall
have the right to review and comment upon the publication in order to protect
Sponsor’s confidential information. Upon Sponsor’s request, publication may be
delayed up to sixty (60) additional calendar days to enable Sponsor to secure
adequate intellectual property protection of Sponsor’s confidential information
that would otherwise be the publication.  In the event that the
parties reasonably determine that additional research or development work is
required or ongoing research and development needs to be completed in order to
secure appropriate intellectual property protection, and that publication will
be detrimental to obtaining adequate intellectual protection, then, at Sponsor’s
request and immediate funding of said additional research and development work,
University shall delay such publication until completion of the research or
development work and filing of appropriate patents based upon such
work.

     

    
      	
              7)

            	
              CONFIDENTIAL
      INFORMATION

            

    

     

    
      	
               
      

            	
              a.

            	
              Subject
      to Sponsor’s rights in section 7.b below, University and Sponsor each
      agree that all information contained in documents marked "confidential"
      and forwarded to by the other (i) are to be received in strict confidence,
      (ii) will be used only for the purposes of this Agreement, and (iii) will
      not be disclosed by the recipient party (except as required by law or
      court order), its agents or employees without the prior written consent of
      the disclosing party, except to the extent that the recipient party can
      establish by competent written proof that such
  information:

            

    

    
      
         

      

      
        3

        
          

        

      

      
         

      

    

     

    
      
        	 	(a) 	was
      in the public domain at the time of disclosure; or 
	 	 	 
	
                 
      

              	
                (b)

              	
                later
      became of the public domain through no act or omission of the recipient
      party, its employees, agents, successors or assigns:
  or

              

      

    

     

    
      
        	
                 
      

              	
                (c)

              	
                was
      lawfully disclosed to the recipient party by a third party having the
      right to disclose it; or

              
	 	 	 
	 	(d)	was
      already known by the recipient party at the time of disclosure;
      or 

      

    

     

    
      	
               
      

            	
              (e)

            	
              was
      independently developed by the recipient party without use of the
      disclosing party's confidential information;
or

            

    

     

    
      	
               
      

            	
              (f)

            	
              is
      required by law or regulation to be disclosed, provided that the
      disclosing party gives adequate advance notice to the other of such
      disclosure to allow that party to assert whatever exclusion or exception
      may be available to it under such law or
  regulation.

            

    

     

    
      	
               
      

            	
              b.

            	
              Each
      party's obligation of confidence hereunder will be fulfilled by using at
      least the same degree of care with the disclosing party's confidential
      information as it uses to protect its own confidential information, but
      always at least a reasonable degree of care. This obligation will exist
      while this Agreement is in force and for a period of three (3) years
      thereafter, except for confidential information which may be protected by
      law or regulation, in which case, such information shall be protected as
      long as mandated by such law or regulation requires. Sponsor shall have
      the right to disclose confidential information which is licensed as part
      of this Agreement as is reasonably required in the development and
      commercialization of Licensed Products, as defined in the License
      Agreement, so long as such disclosures do not have an adverse effect on
      the Patent Rights, as defined in the License
  Agreement.

            

    

     

    
      	
              8)

            	
              PATENTS,
      COPYRIGHTS, AND TECHNOLOGY RIGHTS

            

    

     

    
      	
               
      

            	
              a.

            	
              Title
      to all inventions and discoveries made solely by University inventors
      resulting from the Research Program shall reside in University; title to
      all inventions and discoveries made solely by Sponsor inventors resulting
      from the Research Program shall reside in Sponsor; title to all inventions
      and discoveries made jointly by University and Sponsor inventors resulting
      from the Research Program shall reside jointly in University and
      Sponsor.

            

    

     

    
      	
               
      

            	
              b.

            	
              University
      will disclose to Sponsor any inventions or discoveries resulting from the
      Research Program as soon as possible after creation and reduction to
      practice. Sponsor shall notify University within thirty (30) days of
      receipt of disclosure whether:

            

    

     

    
      	
               
      

            	
              i.

            	
              Sponsor
      desires University to file patent applications on any such invention, in
      which case Sponsor shall reimburse all University patent application
      filing costs, including those for patentability opinions;
    or

            

    

     

    
      	
               
      

            	
              ii.

            	
              Sponsor
      does not desire that a patent application be filed in which case the
      rights to such invention shall be disposed of in accordance with
      University policies with no further obligation in
  Sponsor.

            

    

     

    
      
         

      

      
        4

        
          

        

      

      
         

      

    

     

    
      	
               
      

            	
              c.

            	
              With
      respect to inventions resulting from the Research Program for which
      Sponsor has agreed to file patent application or to reimburse University's
      costs for filing patent applications and such patent applications are not
      Improvement Patents as defined in the License Agreement, University grants
      Sponsor an option to negotiate an exclusive or non-exclusive, worldwide,
      royalty-bearing license to make, use or sell under any invention or
      discovery owned wholly or partly by University and made or conceived and
      reduced to practice during the Term of this Agreement or within six (6)
      months thereafter and directly resulting from the Research Program. If
      Sponsor elects an exclusive license, it will include a right to sublicense
      with accounting to University. Sponsor shall have three (3) months from
      disclosure of any invention or discovery to notify University of its
      desire to enter into such a license agreement, and the parties shall
      negotiate in good faith for a period not to exceed six (6) months after
      that notification, or such period of time as to which the parties shall
      mutually agree. If Sponsor and University fail to enter into an agreement
      during that period of time, the rights to such invention or discovery
      shall be disposed of in accordance with University policies with no
      further obligation to Sponsor.

            

    

     

    
      	
               
      

            	
              d.

            	
              With
      respect to inventions resulting from the Research Program for which
      Sponsor has agreed to file patent application or to reimburse University's
      costs for filing patent applications and the parties have mutually
      determined that such patent applications are Improvement Patents as
      defined in the License Agreement, the parties shall amend the License
      Agreement accordingly, pursuant to section 6.2 of the License Agreement,
      and the prosecution of said patent applications shall be managed pursuant
      to section 6.1 of the License
Agreement.

            

    

     

    
      	
               
      

            	
              e.

            	
              Under
      University policy, University investigators own copyright in their
      scholarly works. Scholarly works resulting from the Research Program are
      not subject to the terms of this Section
8.

            

    

     

    
      	
              9)

            	
              LIABILITY

            

    

     

    
      	
               
      

            	
              a.

            	
              Sponsor
      agrees to indemnify and hold harmless System, University, their Regents,
      officers, agents and employees from any liability, loss or damage they may
      suffer as a result of claims, demands, costs or judgments against them
      arising out of the activities to be carried out pursuant to the
      obligations of this Agreement, including but not limited to the use by
      Sponsor of the results obtained from the activities performed by
      University under this Agreement; provided, however, that the following is
      excluded from Sponsor's obligation to indemnify and hold
      harmless:

            

    

     

    
      	
               
      

            	
              i.

            	
              the
      negligent failure of University to substantially comply with any
      applicable governmental requirements;
or

            

    

     

    
      	
               
      

            	
              ii.

            	
              the
      negligence or willful malfeasance of any Regent, officer, agent or
      employee of University or
System.

            

    

     

    
      	
               
      

            	
              b.

            	
              Both
      parties agree that upon receipt of a notice of claim or action arising out
      of the Research Program, the party receiving such notice will notify the
      other party promptly. Sponsor agrees, at its own expense, to provide
      attorneys to defend against any actions brought or filed against
      University, System, their Regents, officers, agents and/or employees with
      respect to the subject of the indemnity contained herein, whether such
      claims or actions are rightfully brought or filed; and subject to the
      statutory duties of the Attorney General of the state of Texas, University
      agrees to cooperate with Sponsor in the defense of such claim or
      action.

            

    

     

    
      
         

      

      
        5

        
          

        

      

      
         

      

    

     

    
      	
              10)

            	
              INDEPENDENT
      CONTRACTOR

            

    

     

    It is
understood that any relationship created by this agreement between the parties
shall be that of independent contractors. Under no circumstances shall either
party be deemed an employee of the other nor shall either party act as an agent
of the other party. Any and all joint venture, joint enterprise, or partnership
status is hereby expressly denied and the parties expressly state that they have
not formed expressly or impliedly a joint venture, joint enterprise, or
partnership.

     

    
      	
              11)

            	
              TERM
      AND TERMINATION

            

    

     

    
      	
               
      

            	
              a.

            	
              This
      Agreement may be terminated by the written agreement of both
      parties.

            

    

     

    
      	
               
      

            	
              b.

            	
              In
      the event that either party shall be in default of its material
      obligations under this Agreement and shall fail to remedy such default
      within sixty (60) days after receipt of written notice thereof, this
      Agreement shall terminate upon expiration of the sixty (60) day
      period.

            

    

     

    
      	
               
      

            	
              c.

            	
              Termination
      or cancellation of this Agreement shall not affect the rights and
      obligations of the parties accrued prior to termination. Upon termination,
      Sponsor shall pay University for all reasonable expenses incurred or
      committed to be expended as of the effective termination date, including
      salaries for appointees for the remainder of their
      appointment.

            

    

     

    
      	
               
      

            	
              d.

            	
              Any
      provisions of this Agreement which by their nature extend beyond
      termination shall survive such
termination.

            

    

     

    
      	
              12)

            	
              ATTACHMENTS

            

    

     

    Attachment
A is incorporated herein and made a part of this Agreement for all
purposes.

     

    
      	
              13)

            	
              GENERAL

            

    

     

    
      	
               
      

            	
              a.

            	
              This
      Agreement may not be assigned by either party without the prior written
      consent of the other party; provided, however, that subject to the
      approval of University, which may not be unreasonably withheld, Sponsor
      may assign this Agreement to any purchaser or transferee of all or
      substantially all of Sponsor's assets or stock upon prior written notice
      to University, and University may assign its right to receive payments
      hereunder.

            

    

     

    
      	
               
      

            	
              b.

            	
              This
      Agreement constitutes the entire and only agreement between the parties
      relating to the Research Program, and all prior negotiations,
      representations, agreements and understandings are superseded hereby. No
      agreements altering or supplementing the terms hereof may be made except
      by means of a written document signed by the duly authorized
      representatives of the parties.

            

    

     

    
      	
               
      

            	
              c.

            	
              Any
      notice required by this Agreement shall be given by prepaid, first class,
      certified mail, return receipt requested, addressed in the case of
      University to:

            

    

     

    
      
         

      

      
        6

        
          

        

      

      
         

      

    

     

    Office of
Technology Transfer & Commercialization

    University
of North Texas Health Science Center

    3500 Camp
Bowie Blvd.

    Fort
Worth, Texas 76107-2699

    Attention:
Robert McClain, Ph.D.

     

    or in the
case of Sponsor to:

     

    SignPath
Pharmaceuticals, Inc.

    1375
California Road

    Quakertown,
PA 18951

    ATTENTION:
Lawrence Helson, MD

    

    AND

    

    SignPath
Pharmaceuticals, Inc.

    5377
Highlands Drive

    Longmont,
CO 80503

    ATTENTION:
Kai P. Larson

     

    or at
such other addresses as may be given from time to time in accordance with the
terms of this notice provision.

     

    
      	
               
      

            	
              d.

            	
              This
      Agreement shall be governed by, construed, and enforced in accordance with
      the internal laws of the State of
Texas.

            

    

     

    
      	
              IN
      WITNESS WHEREOF, the parties have caused this Agreement to be executed by
      their duly authorized
representatives.

            

    

     

    
      
        
          	
                  UNIVERSITY
      OF NORTH TEXAS

                	 
      	
                  SIGNPATH
      PHARMA, INC.

                
	
                  HEALTH
      SCIENCE CENTER

                	 
      	 
      
	
                  AT
      FORT WORTH

                	 
      	 
      
	 
      	 
      	 
      
	
                  /s/ Glenn Dillon

                	 
      	
                  /s/ Lawrence Helson

                
	
                  Glenn
      Dillon,
      PhD                                           
      Date

                	 
      	
                  Lawrence
      Helson,
      MD                                      Date

                
	
                  Vice
      President, Research

                	 
      	 
      
	 
      	 
      	 
      
	
                  /s/ Steve R. Russell

                	 
      	 
      
	
                  Steve
      R.
      Russell                                   
                
      Date

                	 
      	 
      
	
                  Executive
      VP for Finance & Administration

                	 
      	 
      
	 
      	 
      	 
      
	
                  Read
      and Understood by:

                	 
      	 
      
	
                  Principal
      Investigator

                	 
      	 
      
	 
      	 
      	 
      
	
                  /s/ Jamboor Vishwanatha

                	 
      	 
      
	
                  Jamboor
      Vishwanatha,
      PhD               
                   Date

                	 
      	 
      

        

      

    

     

    
      
         

      

      
        7

        
          

        

      

      
         

      

    

     

    
      Attachment
A

       

    

    
      (Research
Program)

    

     

    
      	
              1.

            	
              Upon
      receipt of curcumin and PLGA from Sign Path Pharma UNT is to make 5-6
      grams of PLGA curcumin. When this is available for
  testing,

            

    

     

    
      	
              2.

            	
              Set
      up s.c. Xenograft model of pancreatic cancer in nude or scid mice; when
      tumors are >2mm in diameter, 30 mice in groups of 10; Inject 35 mg/kg
      iv tiw(mon wed fri) x 3weeks.(9 doses). If iv route is difficult then use
      ip route for the whole experiment. The pancreatic cell line PAO3C (Johns
      Hopkins Source if necessary) will be
used.

            

    

     

    Group
#1—> PLGA control  10 mice

     

    Group
#2—> PLGa-curcumin 10 mice

     

    Group #
3—Untreated control 10 mice

     

    At end of
fourth week, sacrifice animals and preserve 5 tumors from each group for
histology,( and measurement of tumor tissue transketolase 1, and HSP70 if these
assays are feasible).

     

    
      	
              3.

            	
              Assuming
      no intolerable toxicity (death or wt loss>10% of baseline) in group#2;
      Then exp #2 with 50 xenografted pancreatic cancered
  mice.

            

    

     

    Group #1
PLGA control(5 mice), DMSO control (5 mice)

     

    Group #2
Curcumin in DMSO 10 mice

     

    Group #3
PLGA-curcumin @ 35mg/kg TIW x 9 doses in three weeks 10 mice)

     

    Group # 4
Gemcitibine alone(10 mice)

     

    Group #5
Gemcitabine + PLGA curcumin TIW x9 doses in three weeks(10 mice)

     

    End
fourth week preserve 3 tumors from each group for standard histology and
hisochemical assay of___(tbd).

     

    
      	
              4.

            	
              Pharmacokinetics:
      Single dose PLGA-curcumin to normal Rats; 5 female and 5 male @ 35mg/kg
      I.V. Post injection blood sampled for curcumin at 10, 15, 60 minutes, 2
      hours, 4 hours, 8 hours 16 hours & 24
hours.

            

    

     

    
      	
              5.

            	
              Non-clinical
      studies of residual drug from the 5 grams produced can be used for in
      vitro studies, stability, sizing.

            

    

     

    
      	
              6.

            	
              During
      this time another 5 grams can be made and set aside for the NCI Nanotech
      lab.

            

    

     

    
      	
              7.

            	
              Collaboration
      with Lakeshore Pharmaceutical to make 250 Grams scale-up for IND GLP lab
      studies in rats and dogs to be done at MD
  Anderson.

            

    

     

    
      	
              8.

            	
              All
      crude and collated data from the mouse and rat studies will be shared with
      SPP

            

    

     

    
      	
              9.

            	
              All
      IND lab data generated at MDACC GLP-labs will be shared by SPP with
      UNT.

            

    

     

    
      
         

      

      
        8

        
          

        

      

      
         

      

    

     

    
      Attachment
B

    

     

    
      (Material
Transfers from University to Sponsor)

    

     

    University
agrees to provide Sponsor with certain materials and know-how for the purposes
stated herein under the following conditions:

     

    
      	
              1.

            	
              The
      Material that is covered by this Material Transfer Agreement (MTA-out)
      includes: (a) PLGA nanoparticles containing curcumin developed by the
      Principal Investigator, and (b) any related material or associated
      know-how and data that will be provided by University or received by
      Sponsor from University, hereinafter "Material". The Material is
      considered proprietary to
University.

            

    

     

    
      	
              2.

            	
              The
      material shall be used by Sponsor only to support the development of
      Licensed Products, as defined in the License Agreement, pursuant to the
      terms and conditions of the License
Agreement.

            

    

     

    
      	
              3.

            	
              Pursuant
      to section 7 of the Agreement, the Material shall be considered
      confidential information belonging to
  University.

            

    

     

    
      	
              4.

            	
              Material
      is for investigational use only in laboratory animals or in-vitro
      experiments. Sponsor agrees that the Material will not be used for any
      other purpose. Neither the Material nor derivatives thereof will be used
      in human beings. Transfer of the Material to a third party by Sponsor is
      permissible provided said third party agrees to the terms contained within
      this MTA-out and that the transfer is protected by a nondisclosure
      agreement pursuant to section 3 of this MTA-out and section 7 of the
      Agreement.

            

    

     

    
      	
              5.

            	
              Sponsor
      shall have no rights in the Material other than as provided in this
      MTA-out, Agreement, or License
Agreement.

            

    

     

    
      	
              6.

            	
              The
      Material is experimental in nature and it is provided WITHOUT University
      WARRANT OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY
      OTHER WARRANTY, EXPRESS OR IMPLIED.

            

    

     

    
      	
              7.

            	
              In
      no event shall University be liable for any use by Sponsor of the Material
      for any loss, claim, damage or liability, or whatsoever kind of nature,
      which may arise form or in connection with this Agreement or the use,
      handling or storage of the Material. (Except where limited by Federal law,
      or by the constitution and laws of the state governing the recipient)
      Sponsor agrees to hold harmless University their Regents officers, agents,
      and employees, from any liability, loss or damage they may suffer as a
      result of claims, demands, costs or judgments against them arising out of
      the activities to be carried out pursuant to this Agreement and the use of
      the results obtained from Research.

            

    

     

    
      	
              8.

            	
              Sponsor
      will use the Material in compliance with all laws, governmental
      regulations and guidelines applicable to the Material, including any
      especially applicable to research with recombinant DNA, and when the
      Material is used in the United States, Sponsor will comply with current
      NIH guidelines.

            

    

     

    
      	
              9.

            	
              Sponsor
      will not export, directly or indirectly, Material to any country for which
      the U.S. Government or any agency thereof at the time of export requires
      an export license or other governmental approval, without first obtaining
      such license or approval.

            

    

     

    
      
         

      

      
        9EXHIBIT
      10.11

              
	 
      	 
      
	
                

              	
                3050
      Spruce Street

                St.
      Louis, MO 63103

                Tel
      (800) 448-0471

                Fax
      (314) 286-7817

                www.safcglobal.com

              

      

    

    

    Dr.
Lawrence Helson

    Sign Path
Pharma

    Phone
(215) 538 9996

    lhelson@comcast.net

    lhelson@signpathpharma.com

     

    
      
        
          
            
              	
                      Product
      Code:

                    	
                      CCN

                    
	
                      Project
      Number:

                    	
                      CCN06302007

                    
	
                      Rev
      #: 1

                    	 
      
	
                      Date
      of Proposal:

                    	
                      06/30/2007

                    

            

          

        

      

    

     

    
      	
              1)

            	
              Introduction

            

    

     

    

    
 

    Thank you
again for allowing SAFC to bid on cGMP manufacturing of
Curcumin.  SAFC, a division of Sigma-Aldrich Corporation, makes the
following offer from our Madison, Wisconsin facility.  SAFC has
outlined a program to manufacture CCN for the Dr. Helson.  The
following is a proposal, which will specifically define and initiate the
project.

    

    This
proposal includes the quote for the GMP manufacture of one batch of curcumin at
approximately 200 g/batch.  To prepare for the manufacture of the GMP
campaign, SAFC proposes to run a non-GMP proof of concept run.  This
run will be on the gram scale and allows SAFC to develop the chemistry and gain
experience in the synthesis, as well as the analytical
methods.  During this phase, we will develop the analytical methods as
needed.  This would then be followed by a 100g non-GMP qualification
run.  Finally, the GMP portion of the work can be
performed.  We have included in this proposal the price for all phases
through GMP manufacture.  SAFC Madison has extensive experience
in  the GMP manufacturing of APIs, especially in the handling highly
potent compounds and is Safe Bridge Certified.  The FDA audited SAFC
Madison in June 2006 and there were zero 483s issued.  SAFC has
extensive experience scaling up process from the milligram and gram scale to the
kilogram scale under GMP.  We believe this project is a perfect fit
for our capabilities at our Madison, Wisconsin facility.

    
      
         

      

      
        Page 1 of
12

        
          

        

      

      
         

      

    

    

    
      
        	 
      	
                EXHIBIT
      10.11

              
	 
      	 
      
	
                

              	
                3050
      Spruce Street

                St.
      Louis, MO 63103

                Tel
      (800) 448-0471

                Fax
      (314) 286-7817

                www.safcglobal.com

              

      

    

    

    Below are
details of our current understanding of the requirements and expectations of
SAFC, based on discussions to date.  These sections would form the
basis of a formal technical proposal between Dr. Helson and SAFC.

    

    After
reading the proposal, if you have any questions, please don’t hesitate to
contact us.

    

    
      
        	
                2)

              	
                Technical
      Transfer / Process Development /
Familiarization

              

      

    

    

    
      	
            	
              a)

            	
              SAFC
      will undertake laboratory work with the key objective of performing
      process familiarization and development sufficient to enable subsequent
      manufacture of CCN solely for uses reasonably related to the development
      and submission of information under a Federal law which regulates the use
      of drugs under 35 U. S. C. §271(e)(1).  This will include
      running through the process outlined in U.S. Patent No.
      5,679,864.

            

    

    
      	
            	
              b)

            	
              Familiarization
      means transfer and running as written. Project will be performed based on
      a current patent.

            

    

    
      	
            	
              c)

            	
              SAFC
      will describe any development needed beyond the
  patent.

            

    

    
      	
            	
              d)

            	
              Dr.
      Helson will be informed of any improvements made to the
      process.

            

    

    

    
      
        	
                3)

              	
                Intellectual
      property

              

      

    

    

    
      	
            	
              a)

            	
              Any
      intellectual property discovered and recognized as such by SAFC while
      working on the CCN project will become the property of the company paying
      for the work (Dr. Helson’s
company).

            

    

     

    
      
         

      

      
        Page 2 of
12

        
          

        

      

      
         

      

    

    
      

      
        
          	 
      	
                  EXHIBIT
      10.11

                
	 
      	 
      
	
                  

                	
                  3050
      Spruce Street

                  St.
      Louis, MO 63103

                  Tel
      (800) 448-0471

                  Fax
      (314) 286-7817

                  www.safcglobal.com

                

        

      

    

    

    
      	
              4)

            	
              Project
      Details

            

    

    

    
      	
            	
              a)

            	
              Scope
      of Work: Deliverables, Timing, Resources, &
  Prices.

            

    

    

    
      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      
                                        
                                          
                                            
                                              
                                                
                                                  
                                                    
                                                      
                                                        
                                                          
                                                            
                                                              
                                                                
                                                                  
                                                                    
                                                                      
                                                                        
                                                                          
                                                                            	
                                                                                    Campaign
      1

                                                                                  	 	
                                                                                    Activity

                                                                                  	 	
                                                                                    Timing

                                                                                  	 	
                                                                                    Payment

                                                                                  	 
	
                                                                                    Phase
      1

                                                                                    Preparation

                                                                                  	 	
                                                                                    §
      Initiate kick-off meeting. 

                                                                                    §
      Order raw materials.

                                                                                  	 	
                                                                                    1
      weeks

                                                                                    (Dependent
      on 

                                                                                    availability
      of 

                                                                                    raw
      materials)

                                                                                  	 	 	 
	
                                                                                    Phase
      2

                                                                                    Proof
      of Concept 

                                                                                    and
      Analytical 

                                                                                    Method
      

                                                                                    Development

                                                                                  	 	
                                                                                     

                                                                                    §
      Perform chemistry on a gram scale with analytical
      support.

                                                                                     

                                                                                    §
      Develop an HPLC method to test final product for
      purity

                                                                                     

                                                                                  	 	
                                                                                    ~2
      weeks

                                                                                     

                                                                                    ~3
      weeks

                                                                                     

                                                                                  	 	
                                                                                    $

                                                                                     

                                                                                    $

                                                                                  	
                                                                                    21,350

                                                                                     

                                                                                    20,000

                                                                                  	 
	
                                                                                    Phase
      3

                                                                                    ~100g
      CCN

                                                                                    non-GMP

                                                                                  	 	
                                                                                    §
      SAFC manufactures ~100g CCN non-cGMP.

                                                                                    §
      CCN is analytically tested.

                                                                                    §
      SAFC drafts batch record for GMP campaign.

                                                                                  	 	
                                                                                    3-4
      weeks

                                                                                  	 	$	19,000	 
	
                                                                                    Campaign
      2

                                                                                  	 	 
      	 	 
      	 	 	 	 
	
                                                                                    Phase
      4

                                                                                    cGMP
      

                                                                                    manufacture
      of 

                                                                                    ~200g
      CCN

                                                                                  	 	
                                                                                    §
      SAFC manufactures ~200g CCN.

                                                                                    SAFC
      QC tests and releases CCN.

                                                                                  	 	
                                                                                    3-4
      weeks

                                                                                  	 	$	38,000	 

                                                                          

                                                                        

                                                                      

                                                                    

                                                                  

                                                                

                                                              

                                                            

                                                          

                                                        

                                                      

                                                    

                                                  

                                                

                                              

                                            

                                          

                                        

                                      

                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

    

     

    NOTE: The
RFP outlined a request for the synthesis of Curcumin of high
purity.  Within this request, it was asked for an evaluation of the
efficiencies of utilizing either a total synthetic route of manufacture or
purification from natural sources.  Naturally occurring Curcumin is
isolated as a mixture of similar curcuminoids, which only differ by minor
structural differences.  Therefore, the ability to separate
efficiently will be difficult and maybe impossible.  Given the
potential inefficiencies in developing a process, a total synthetic solution was
evaluated.  SAFC identified a total synthetic pathway (US 5679864)
within the patent literature that outlines a process to obtain Curcumin in
>99% purity.  It
is SAFC’s intention to utilize this route of synthesis for development with the
inherent understanding that SignPath will only utilize the material for
preclinical and clinical needs.  In the event that this
production moves forward to commercial production, either a non-infringing route
of manufacture will have to be developed, or securing of a license to practice
will have to be secured.

    

    Total price is $98,350 for phases 1-4
that leads to 200 g of GMP CCN.

    
      
         

      

      
        Page 3 of
12

        
          

        

      

      
         

      

    

    

    
      
        	 
      	
                EXHIBIT
      10.11

              
	 
      	 
      
	
                

              	
                3050
      Spruce Street

                St.
      Louis, MO 63103

                Tel
      (800) 448-0471

                Fax
      (314) 286-7817

                www.safcglobal.com

              

      

    

    

    (Note
2:  SAFC understands that in the future, more CCN may be
required.  As the volume of product ordered goes up, the price per
gram of the product will go down.)

    

    
      	
            	
              b)

            	
              Project
      Timeline

            

    

    

    The
proposed timing for this project is shown in the Gantt chart
below.  This would include raw material
purchasing.   The current plan would be to overlap phases 3 and
4.  If the overlap of the phases is performed and a purchase order
received, then SAFC could deliver the product as early as the first week of
October.  Please see below for timing:

    

    

    

    
      	
              5)

            	
              Analytical/QC

            

    

    

    The
proposed specifications for CCN are shown in the table below and are derived
from Dr. Helson’s wishes.  The specifications will be confirmed or
modified during the qualification run and agreed upon by both Dr. Helson and
SAFC.

    

    
      
        
          
            
              
                
                  	
                          Test

                        	 	
                          Possible Limit

                        	 	
                          Sample Amount

                        
	
                          Appearance

                        	 	
                          To
      be determined

                        	 	
                          ——

                        
	
                          HPLC
      Purity

                        	 	
                          To
      be determined.  Target > 99%.

                        	 	
                          10mg

                        
	
                          FT-IR

                        	 	
                          Consistent
      with expected

                        	 	
                          5mg

                        
	
                          DSC
      Melt

                        	 	
                          To
      be determined

                        	 	
                          5mg

                        
	
                          Residual
      Solvents

                        	 	
                          To
      be determined

                        	 	
                          60mg

                        
	
                          Other
      testing to be determined with customer

                        
	 
      	 	
                          Total
      sample amount:

                        	 	
                          ~XXmg

                        
	 
      	 	
                          Retain
      Sample (2x QC sample):

                        	 	
                          ~XXmg

                        

                

              

            

          

        

      

    

     

    Method
Transfer:

    No
methods to transfer

    
      
         

      

      
        Page 4 of
12

        
          

        

      

      
         

      

    

     

    
      
        	 
      	
                EXHIBIT
      10.11

              
	 
      	 
      
	
                

              	
                3050
      Spruce Street

                St.
      Louis, MO 63103

                Tel
      (800) 448-0471

                Fax
      (314) 286-7817

                www.safcglobal.com

              

      

    

     

    Method
Development:

    Develop
an HPLC method to test final product for purity.

    Assume
that reaction can be monitored by existing in-house fast HPLC
method.

    3 weeks,
1 person

    

    Method
Validation:

    None.

    

    Qualify Reference
Standard:

    Not
included in this estimate.

     

    
      	
              6)

            	
              Work
      not included in this proposal

            

    

    

    SAFC
offers all the services required to take an API to an approval status with the
FDA.  There are several services that SAFC offers that are not
required for phase 1, but will be required for a commercial API.  SAFC
offers stability testing, stress testing, manufacture and qualification of
reference standards, impurity identification and isolation, analytical method
validation, critical parameters testing, process validation,
etc.  These are currently not included in this
proposal.  Should the project move to clinical phase 2 or onward, SAFC
would be available to provide these services.

    

    
      	
              7)

            	
              GMP
      Storage, Packaging and Dispensing

            

    

     

    Inventory
and Dispensing Services – SAFC can provide cGMP inventory and dispensing
services. SAFC will store the lot of a QC-released product, typically for a
period of two weeks at no charge. If the customer wishes to store the cGMP
material with SAFC for longer periods, the following would take
effect:

     

    
      	
            	
              a)

            	
              SAFC
      agrees to hold API’s under cGMP
conditions.

            

    

     

    
      	
            	
              b)

            	
              All
      API shipments will include a certificate of analysis and MSDS sheets and
      will comply with DOT Hazardous Materials Transportation
      Regulations.

            

    

     

    
      	
            	
              c)

            	
              SAFC
      will make periodic shipments of samples and products, by written request,
      with a minimum notice of 10 days. Sign Path agrees to allow SAFC to
      utilize their designated shipper number (FEDEX or equivalent) for each
      requested shipment of product.

            

    

     

    
      	
            	
              d)

            	
              SAFC
      agrees to provide inventory reports to Sign Path on an agreed upon
      interval.

            

    

     

    
      	
            	
              e)

            	
              Sign
      Path agrees to insure all of their inventories stored at SAFC as part of
      this agreement.  Sign Path will provide documentation showing
      insurance coverage of inventory at SAFC’s
  location.

            

    

    
      
         

      

      
        Page 5 of
12

        
          

        

      

      
         

      

    

     

    
      
        	 
      	
                EXHIBIT
      10.11

              
	 
      	 
      
	
                

              	
                3050
      Spruce Street

                St.
      Louis, MO 63103

                Tel
      (800) 448-0471

                Fax
      (314) 286-7817

                www.safcglobal.com

              

      

    

     

    
      	
               
      

            	
              f)

            	
              The
      price for storage of samples and products will be $1,000.00 USD per
      month.

            

    

     

    
      	
            	
              g)

            	
              Individual
      shipments, as requested, will be $750.00 US per
  shipment.

            

    

    

    
      	
              8)

            	
              Documentation
      / Reports

            

    

    

    Development
and/or campaign reports for each product will be provided.

    

    
      	
              9)

            	
              Terms
      and Conditions

            

    

    

    
      	
            	
              a)

            	
              In
      the absence of any separate technical agreement, this proposal and
      associated Purchase Orders could serve as a contract between the
      parties.

            

    

    
      	
            	
              b)

            	
              The
      project will be initiated by:

            

    

    
      	
               
      

            	
              i)

            	
              Receipt
      of a purchase order. The PO will cover the whole project and will be in
      the amount of  $98,350 USD for ~200 grams
      of GMP material and ~100 grams of non-GMP
  material

            

    

    
      	
               
      

            	
              ii)

            	
              SAFC
      will invoice the customer 50% of the cost of each project phase before the
      phase is started.  When each phase is completed, SAFC will
      invoice the customer for the remaining 50% of that
  phase.

            

    

    
      	
               
      

            	
              iii)

            	
              PO’s
      and checks should be sent to the attention
of:

            

    

    

    Dennis
Young, Director Operations

    SAFC

    645 Science Drive

    Madison,
WI 53711

    Phone
608-233-3115(x106)

    Fax
608-233-6873

    Email:
dyoung@sial.com

    

    
      	
               
      

            	
              iv)

            	
              Payment
      for each phase will be invoiced on phase
  completion.

            

    

    

    
      	
            	
              c)

            	
              All
      prices are in US dollars.

            

    

    
      	
            	
              d)

            	
              This
      quote is valid for 30 days from the stated date. These terms and
      conditions are valid through July 25,
2007.

            

    

    

    SAFC
embraces a partnership approach with upfront pricing for the manufacture of
CCN.  We have included in this letter an addendum, which covers our
historical approach and understanding(s) in areas typically experienced by both
parties within a contract manufacturing agreement. This addendum may generate
more questions and discussion, which we believe contributes to a healthy
understanding of the responsibilities of both parties.

    
      
         

      

      
        Page 6 of
12

        
          

        

      

      
         

      

    

    

    
      
        	 
      	
                EXHIBIT
      10.11

              
	 
      	 
      
	
                

              	
                3050
      Spruce Street

                St.
      Louis, MO 63103

                Tel
      (800) 448-0471

                Fax
      (314) 286-7817

                www.safcglobal.com

              

      

    

    

    I look
forward to your comments, discussion, and feedback on this
proposal.

    

    Sincerely,

     

    George
Rothermel, Jr

    Business
Development Manager

    SAFC
Inc.

    
      
         

      

      
        Page 7 of
12

        
          

        

      

      
         

      

    

    
      
        	 
      	
                EXHIBIT
      10.11

              
	 
      	 
      
	
                

              	
                3050
      Spruce Street

                St.
      Louis, MO 63103

                Tel
      (800) 448-0471

                Fax
      (314) 286-7817

                www.safcglobal.com

              

      

    

    

    ADDENDUM

    

     

    
      	
              1)

            	
              Quality
      Standards

            

    

     

    This
section summarizes some of the essential quality features supporting both the
laboratory development and cGMP production work. Please note that these sections
relate to the default quality standards currently applicable in Madison and
Sheboygan.   SAFC is always willing to discuss customers QA
requirements on a project-specific basis. SAFC both welcomes and actively
encourages customer audits of its facilities.

     

    
      	
            	
              a)

            	
              Development
      Laboratory Standards (non-GMP):

            

    

     

    
      	
               
      

            	
              i)

            	
              All
      activities will be undertaken in accordance with existing quality
      standards at the relevant facility.

            

    

     

    
      	
               
      

            	
              ii)

            	
              Work
      will be recorded in controlled notebooks (laboratory) or documented in
      batch records (plant).

            

    

     

    
      	
               
      

            	
              iii)

            	
              Appropriately
      trained personnel will carry out the
work.

            

    

     

    
      	
               
      

            	
              iv)

            	
              Equipment
      will be appropriately maintained to ensure
  performance.

            

    

     

    
      	
               
      

            	
              v)

            	
              Intermediates
      will be analytically tested to specifications, as
  needed.

            

    

     

    
      	
            	
              b)

            	
              cGMP
      Manufacturing Standards - cGMP manufacture will be conducted in accordance
      with FDA ICH guidelines,  as it applies to the scope of the
      project.

            

    

     

    
      	
               
      

            	
              i)

            	
              MATERIALS

            

    

     

    
      	
               
      

            	
              (1)

            	
              Materials
      will be ordered against defined
specifications.

            

    

     

    
      	
               
      

            	
              (2)

            	
              All
      raw materials will be received with a supplier’s Certificate of
      Analysis.

            

    

     

    
      	
               
      

            	
              (3)

            	
              All
      raw material batches, for use in cGMP production, will be sampled from
      their final packaging and QC released prior to
  use.

            

    

     

    
      	
               
      

            	
              (4)

            	
              All
      raw material tests and methods will be fully
  documented.

            

    

     

    
      	
               
      

            	
              (5)

            	
              The
      identity and quality status of all materials will be
      traceable.

            

    

     

    
      	
               
      

            	
              (6)

            	
              All
      materials, intermediates, and finished products will be labeled with an
      identity and test status.

            

    

    
      
         

      

      
        Page 8 of
12

        
          

        

      

      
         

      

    

    
      
        	 
      	
                EXHIBIT
      10.11

              
	 
      	 
      
	
                

              	
                3050
      Spruce Street

                St.
      Louis, MO 63103

                Tel
      (800) 448-0471

                Fax
      (314) 286-7817

                www.safcglobal.com

              

      

    

     

    
      	
               
      

            	
              ii)

            	
              EQUIPMENT

            

    

     

    
      	
               
      

            	
              (1)

            	
              All
      equipment used for cGMP manufacturing will be maintained in a qualified
      and controlled state.

            

    

     

    
      	
               
      

            	
              (2)

            	
              Equipment
      will be qualified and maintained to ensure
  performance.

            

    

     

    
      	
               
      

            	
              (3)

            	
              If
      equipment is used for measurement or inspection, it will be calibrated or
      verified to ensure operation within defined
  specifications.

            

    

     

    
      	
               
      

            	
              (4)

            	
              Multi
      purpose equipment may be utilized, following Standard Operating
      Procedures.

            

    

     

    
      	
               
      

            	
              iii)

            	
              Appropriately
      trained personnel will carry out
manufacture.

            

    

     

    
      	
              2)

            	
              QA
      / Product Release

            

    

     

    SAFC will
ensure that manufacturing has been performed in accordance with cGMP regulations
as far as it applies to the scope of this project. The following will
apply:

     

    
      	
            	
              a)

            	
              Full
      details of all cleaning, processing, and testing will be
      recorded.

            

    

     

    
      	
              
              

            	
              b)

            	
              Product
      specific Batch Records will be used in all manufacturing operations.
      Deviations will be documented and subject to Quality Assurance
      approval.

            

    

     

    
      	
            	
              c)

            	
              Process
      change control will apply. All relevant observations made during the
      processing will be documented. Any deviations from the batch record will
      be documented.

            

    

     

    
      	
            	
              d)

            	
              Full
      batch record documentation will be completed and approved by Quality
      Assurance.

            

    

     

    
      	
            	
              e)

            	
              Intermediate
      product(s) will be tested and the batch records reviewed by
      SAFC.

            

    

    
      
         

      

      
        Page 9 of
12

        
          

        

      

      
         

      

    

     

    
      
        	 
      	
                EXHIBIT
      10.11

              
	 
      	 
      
	
                

              	
                3050
      Spruce Street

                St.
      Louis, MO 63103

                Tel
      (800) 448-0471

                Fax
      (314) 286-7817

                www.safcglobal.com

              

      

    

     

    
      	
               
      

            	
              f)

            	
              SAFC
      will retain analytical samples per
SOP.

            

    

     

    
      	
            	
              g)

            	
              Copies
      of completed batch records may be provided upon
  request.

            

    

     

    
      	
            	
              h)

            	
              FINAL
      PRODUCT SPECIFICATIONS

            

    

     

    
      	
               
      

            	
              i)

            	
              Typically,
      SAFC sets specifications with the customer, after a fact-finding exercise
      comprised of a development, qualification, and / or technical transfer
      exercise.

            

    

     

    
      	
               
      

            	
              ii)

            	
              If
      sufficient documented evidence exists within a technical disclosure, SAFC
      may agree to set specifications with a minimum of laboratory demonstration
      exercises.

            

    

     

    
      	
               
      

            	
              iii)

            	
              Once
      set, the product shall comply with the SAFC specification set after
      development/qualification.

            

    

     

    
      	
               
      

            	
              iv)

            	
              Additional
      test methods and/or specifications could be added, after appropriate data
      gathering, technical, and business
discussions.

            

    

     

    
      	
              3)

            	
              Project
      Management and Communication

            

    

     

    SAFC
strongly believes in the importance of timely, accurate, and open communication
during the development of technical and highly complex chemical processes. SAFC
believes project management is a highly effective tool that keeps both parties
knowledgeable and current with the project’s progress and
fluctuations

     

    
      	
            	
              a)

            	
              SAFC
      will provide project updates and requested documentation against a
      mutually agreed to schedule.

            

    

     

    
      	
            	
              b)

            	
              A
      Project Manager as the key contact for the specific project will be
      appointed. The Project Manager is typically based at the main
      manufacturing site and has overall responsibility for project coordination
      and customer communication.

            

    

     

    
      	
            	
              c)

            	
              Clarity
      of objectives is paramount at the outset of any project. SAFC recommends
      an initial project launch meeting (ideally face-to-face) to ensure
      agreement in regard to:

            

    

     

    
      	
               
      

            	
              i)

            	
              Objectives,
      milestones.

            

    

     

    
      	
               
      

            	
              ii)

            	
              Project
      liaison, project management.

            

    

     

    
      	
               
      

            	
              iii)

            	
              Specific
      outputs, deliverables.

            

    

     

    
      	
               
      

            	
              iv)

            	
              Clarification
      and sharing of additional data.

            

    

     

    
      	
               
      

            	
              v)

            	
              Communication
      frequency and channels. Routine communication is encouraged. Mode and
      frequency of communication are tailored to meet customer preferences;
      however SAFC would advocate routine communication through e-mail, with
      additional telephone conferencing and face-to-face meetings as
      appropriate.

            

    

    
      
         

      

      
        Page 10
of 12

        
          

        

      

      
         

      

    

     

    
      
        	 
      	
                EXHIBIT
      10.11

              
	 
      	 
      
	
                

              	
                3050
      Spruce Street

                St.
      Louis, MO 63103

                Tel
      (800) 448-0471

                Fax
      (314) 286-7817

                www.safcglobal.com

              

      

    

     

    
      	
            	
              d)

            	
              SAFC
      encourages a formal end of project review, and welcomes any customer
      feedback.

            

    

     

    
      	
              4)

            	
              Potential
      Additional Work

            

    

     

    SAFC
recognizes API development processes require many technical elements. SAFC has
the ability to provide many other additional services related to the specific
project. The following items are currently not included within the scope of this
evaluation / proposal:

     

    
      	
            	
              a)

            	
              Synthesis
      and characterization of relevant impurities or
  metabolites.

            

    

     

    
      	
            	
              b)

            	
              Synthesis
      and characterization of salt forms.

            

    

     

    
      	
            	
              c)

            	
              Thermal
      hazards screening, specific to the chemical
  processes.

            

    

     

    
      	
              5)

            	
              Best
      Efforts Intents

            

    

     

    
      	
            	
              a)

            	
              SAFC
      will apply best efforts using the synthetic route or process provided by
      Sign Path.  In the event that yields or purities obtained are
      contrary to those provided by Sign Path, due to but not limited to
      difficulties of scale, chemistry inconsistencies or misrepresentation,
      SAFC and Sign Path will mutually agree to discuss pathways to proceed with
      the project. These discussions may potentially require scope changes to
      the program, extension of the project timeline, and additional monetary
      funds.

            

    

     

    
      	
            	
              b)

            	
              If
      there are unforeseen complications due to the nature of the project that
      significantly hinder SAFC’s ability to proceed with the completion of this
      project; SAFC agrees to notify Sign Path of any such difficulties and
      agrees to act in good faith to resolve difficulties in an amicable manner.
      The project may require scope changes to the program, additional monetary
      funds and timeline extensions to properly proceed with the
      project.

            

    

     

    
      	
            	
              c)

            	
              SAFC
      understands that Sign Path’s quantity requirement(s) stated in the
      proposal is a nominal target output based on conversion of appropriate
      amounts of starting materials. Typically, the prices quoted in the
      proposal are on a campaign basis. The proposal is a flat charge for input
      of materials sufficient to produce the stated quantity, based on the
      yields in the technical package and supported by technical transfer. SAFC
      will be responsible for any low yield due to oversights, errors, or
      working outside the scope of the technical package in a mode not approved
      by Sign Path.

            

    

    
      
         

      

      
        Page 11
of 12

        
          

        

      

      
         

      

    

     

    
      
        	 
      	
                EXHIBIT
      10.11

              
	 
      	 
      
	
                

              	
                3050
      Spruce Street

                St.
      Louis, MO 63103

                Tel
      (800) 448-0471

                Fax
      (314) 286-7817

                www.safcglobal.com

              

      

    

     

    
      	
              6)

            	
              Cancellation
      / Termination

            

    

     

    Project
termination is regrettable, but it can and does happen. SAFC will always seek to
find a mutually agreeable position. Typically, SAFC tends to schedule its
laboratory resources four (4) weeks ahead. Additionally, SAFC tends to schedule
manufacturing time six (6) weeks ahead.

     

    Typically,
in the event of project termination, the Sign Path agrees
to pay to SAFC, as a minimum, costs associated with:

     

    
      	
            	
              a)

            	
              All
      work already completed up to the time of
  termination.

            

    

     

    
      	
            	
              b)

            	
              The
      price of all material/capital commitments already made by
      SAFC.

            

    

     

    
      	
            	
              c)

            	
              Payment
      to cover all committed development time and intended lab work for a four
      (4) week period, and all committed plant time for a six (6) week period.
      In the event that SAFC is able to re-schedule other projects for parts of
      this time, SAFC would reimburse Sign Path accordingly.

            

    

     

    
      	
              7)

            	
              Warranty
      and Liability

            

    

     

    
      	
            	
              a)

            	
              SAFC’s
      warranty would be limited to the above deliverables. No other conditions
      or warranties will be implied in relation to supply of
      material.

            

    

     

    
      	
            	
              b)

            	
              SAFC’s
      liability would be limited to supply of the end products. SAFC would not
      be liable for any consequential
loss.

            

    

    
      
         

      

      
        Page 12
of 12

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