cpc_10k-ex1033.htm

Exhibit 10.33

    Product
Development Services Agreement - Second Amendment

     

    This
Second Amendment to that certain November 9, 2001 Product Development Services
Agreement as amended August 4, 2003 ("Product Development Services Agreement''),
is made as of June 2, 2006 ("Second Amendment"), by and between Biomed Research,
Inc., a Florida corporation ("Biomed”), and MedEnclosure, L.L.C., a Nevada
limited liability company ("Sponsor"). All capitalized terms used but not
otherwise defined in this Second Amendment shall have the respective meanings ascribed to
such terms in the Product Development Services Agreement, or as used
by the parties in their prior dealings.

     

    Whereas
the Product Development Services Agreement, as amended, addresses development of
the Product through various phases, through and including Phase
IV(b);

     

    Whereas
the parties desire and hereby mutually agree to continue development of Phases V
and VI on terms and conditions as set forth herein below;

     

    Whereas
the parties have entered into a separate hourly Services Agreement for services
beyond the scope of the Product Development Services Agreement, or as
contemplated by this "Second Amendment";

     

    Now
therefore, the parties hereby agree as follows:

     

    1)    To the
following budget, deliverables and milestone payment schedule for the further
development of Phases V & VI the MedClose VCS product:

     

    (a)           Services
provided beyond the scope of the Product Development Services Agreement, as
amended August 4, 2003, such as Phase IV revisions, shall be invoiced to the
Sponsor according to the Services Agreement of April 17, 2006, by and between
the parties.

     

    (b)           Budget
and deliverables for Phases V & VI as attached hereto as Exhibit
A.

     

    (c)    Milestones /
payment schedule;

     

    i.    Phase V
payments shall be made as follows:

     

    
      	
            	
              1.

            	
              Payment
      of one third $376,471 is due with the execution of this Second Amendment
      by both parties;

            


    

     

    
      	
            	
              2.

            	
              Payment
      of one third $376,471 is due 90 days after execution of this Second
      Amendment;

            


    

     

    
      	
            	
              3.

            	
              Payment
      of one third $376,471 is due 180 days after execution of this Second
      Amendment. This payment shall be offset by prepayment in the amount of
      $25,715.30 made by MedEnclosure to Biomed in connection with Phase V and
      other services ("Prepayments").

            


    

     

    
      	
            	
              4.

            	
               Effective upon the later to occur
      of the date that this Amendment is executed by both parties, and the
      receipt by MedEnclosure from Biomed of a written schedule of invoices
      containing specific charges for the Prepayments, MedEnclosure and Biomed,
      do hereby mutually release each other and their respective stockholders,
      and representatives from any known claims of any sort which either party
      now has or may ever have against the other, arising prior to the date
      hereof out of any matter, directly or indirectly related to (1) the
      Product Development Services Agreement, as amended, and (ii) the Services
      Agreement of April 17, 2006, among the
parties.

            


    

     

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    Phase VI
payments shall be made as follows:

     

    
      	
            	
              1.

            	
              Payment
      of one third [$87,446] is due upon receipt of a written notice from Biomed
      that all subjects are enrolled into the MedClose clinical trial as defined
      in CL-7000, Rev, B, which shall be incorporated as Exhibit C to this
      Agreement when it is provided.

            


    

     

    
      	
            	
              2.

            	
              Payment of one third [$87,446] is
      due when the premarket approval (PMA) application is
      submitted to the U.S. Food and Drug Administration (FDA), as evidenced by
      confirmation of delivery by Federal Express or
      similar third-party courier.

            


    

     

    
      	
            	
              3.

            	
              Payment
      of one third [$87,446] is due when the PMA application is approved by the
      FDA.

            


    

     

    (d)    On a monthly
basis, by the first of the month, Biomed shall provide brief status reports
concerning the completion of tasks under Phases V and VI, as set forth in
Exhibit A. The brief status reports shall be provided in electronic form
to:

     

    Rod
Shipman

    MedEnclosure,
LLC

    Sarasota,
FL 34243

    rshipman@insights.net

     

    e)    Clinical
trial insurance shall be paid for by MedEnclosure and shall name MedEnclosure
as the insured
party.

     

    2)          The
term "Development Plan" as defined by reference to Exhibit A of the Product
Development Services Plan in section 1.2 therein, is hereby modified as
necessary to comport with the scope of development services contemplated under
this Second Amendment.

     

    3)           Section
4.2 of the Product Development Service Agreement regarding Termination is
amended by deleting:

     

    "If this
Agreement is terminated by Sponsor during any phase of the development plan, Biomed
shall refund to Sponsor within thirty (30) days of the effective date of such
termination, a pro-rata portion of the payment with respect to such phase based
on the number days remaining in such phase (determined with reference to the total
number of days accorded to such phase on Exhibit A)."

     

    and
substituting:

     

    "If this
Agreement is terminated for cause by Sponsor during any phase of the Development
Plan, Biomed shall refund to Sponsor within thirty (30) days of the effective
date of such termination, a pro-rata portion of the payment with respect to such
phase based on the number of days remaining in such phase (determined with reference to the total number of days
accorded to such phase on Exhibit A). If this Agreement is terminated
without cause by Sponsor during any phase of the Development Plan, in
addition to any other remedies available to Biomed hereunder, Sponsor shall be
obligated to pay out the balance of its obligations hereunder including payment
of all remaining installments associated with completion of the project as
defined in the Product Development Services Agreement, and as set forth at
Sections 2(b) and (a) of the Second Amendment.

     

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    This
Agreement may be terminated for cause by a party if the other party breaches any
material representation, warranty, or obligation provided hereunder. This
Agreement may be terminated for cause by Sponsor in the event that the FDA
terminates the associated investigational device exemption (IDE) or otherwise
does not permit the Study to proceed, or Sponsor terminates the Study in order
to achieve compliance with applicable FDA laws and/or regulatory
requirements."

     

    4)    In the
event that it becomes
necessary to revise, modify or change the investigational Plan, CL-7000, Rev. B,
i.e., requiring the need for a Rev. C, or the assumptions regarding Phases V and
VI change, the parties agree that such change will constitute the conditions
necessary to execute a Third Amendment to the Product Development Services
Agreement, which both parties shall negotiate in good faith.

     

    IN
WITNESS WHEREOF, the parties hereto have executed this Second Amendment to the
Product Development Services Agreement by proper persons thereunto duly
authorized:

     

     

    
      


      
        	
                MedEnclosure,
      L.L.C

                 

                By:  Rod A.
      Shipman                                       
      

                Rod
      A. Shipman, Managing Member,

                President
      and CEO

              	
                Biomed
      Research, Inc.

                 

                By:  /s/ Michael
      Dayton                  
      

                Michael
      Dayton, President

              
	 
      	 
      
	
                Date:  June
      2, 2006

              	
                Date:  6-02-06

              


      

    

    



    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      Exhibit
A

      Second
Amendment - Product Development Services Agreement

      Phase V -
Human Clinical Trial / Phase VI
- Marketing
Approval

      Phase V – Human Clinical
Trials Research

       Assumptions

      Investigational
Plan CL-7000, Rev. B

      3
clinical sites

      385-400
subjects ("run-in" + randomized)

      15 Case
Report Forms

      30 day
subject follow-up

      2 month
set-up

      8 month
subject enrollment

      3 month
data retrieval and clean-up

      12 months
for clinical phase

       

      
        INCLUDED
TASKS

        
          
            

          

        

        Clinical
trial
management               
 TOTAL CLINICAL TRIAL MANAGEMENT $ 645,870.00

        design /
print CRF's x 15

        informed
consent x 3-6

        investigator
brochure

        provide
site CRF binders

        train
sites CRF /
binders

        source
document worksheets

        identify/recruit
investigators

        negotiate
site reimbursements

        conduct
investigator meetings

        select /
obtain IRS approvals

        deliver
investigational device to sites

        manage
control of Investigational units

        train
Investigators MedClose

        train
scrub / circulating nurses Tisseel

        clinical
monitoring of sites / data 

        resolve
CRF data queries

        monitors
attend project mtgs

        weekly
subject enrollment reports

        maintain
central study files

        recruit
/ manage Medical
Monitor

        recruit /
manage Clinical Events
Committee members

        coordinate
mtgs of Medical Monitor / investigators

        coordinate
mtgs of Clinical Events Committee

        prepare /
submit required study reports to FDA

        monthly
status reports to MedEnclosure

         

          
            

          

        

        
          


          Clinical
data management TOTAL CLINICAL DATA MANAGEMENT $ 288,934.00

          design /
develop database/ entry screens

          program
allowable data rules / flagging

          test database / edit
check

          CRF
review/ query resolution

          CRF entry
validation

          QA data
audit / report

           

           

          
            
              
              

            

            
              
              

              
                

              

            

            
              
              

            

          

           

          
            EXHIBIT
A

            Second
Amendment - Product Development Services Agreement

            Phase V -
Human Clinical Trial / Phase VI - Marketing Approval

             

            
               

              INCLUDED
TASKS

              
                

              

              U.S.
Premarket Approval (PMA)
Application                   
TOTAL PMA APPLICATION $ 202,338.00

              PMA
summary:

              indications
for use.

              combination
product description; ingredients, components, modes of action.

              alternative
practices and procedures.

              marketing
history.

              summary
of non clinical laboratory studies.

              summary
of human clinical investigation.

              conclusions
drawn from studies.

              methods
and controls for manufacturing, par:treeing and storage.

              reference
to applicable performance standards; statement of conformance,

              
                detailed
analysis of non clinical studies; microbiological, toxicological,
biocompatibility, sterility, shelf life and animal studies w/statement
of compliance to GLP regulations.

              

              
                detailed
analysis of human clinical studies; protocol, investigators, subjects. AE's,
device failures, complaints, results of statistical analyses, contraindications,
precautions, etc.

              

              bibliography,
copies of pertinent published reports.

              proposed
packaging and labeling.

              environmental
assessment.

              anancial
disclosure and certification,

              reference
to applicable master files, i.a., Tisseel biologics application
(BLA).

              update of
pending application w/ new safety and effectiveness information, where
applicable,

              negotiate
final labeing; Instructions for use, patient information booklet, products
labels.

              prepare
summary of safety and effectiveness (SS&E) document for public release by
FDA. monthly status reports to MedEnclosure

               

               

                
                  

                

              

              
                PMA
Application Amendments

                amendments to pending PMA
application w/revised and/or additional Information, where necessary,
assumptions are
the same as those above, i.e.. human data derived from CL-7000, Rev. 13
trial.

                 

                  
                    

                  

                

                 

                TOTAL
PROJECT • PHASE VI  $262, 338.00

                Direct
pass through of actual expenses:

                 

                
                  	
                          1.

                        	
                          Any
      governmental fees, such as user fees, required for the submission of
      marketing approval applications, and any amendments or supplements
      thereto, shall be expenses passed through directly to
      MedEnclosure

                        


                

                
                  	
                          2.

                        	
                          Any
      changes to the assumptions or task list above will require a Change
      Order approved by both Biomed MedEnclosure subject to Section 4
      of the foregoing Second Amendment.

                        


                

                 

                Marketing
approval outside the United States:

                
                  
                    	
                            1.

                          	
                            By
      contracting the U.S. PMA
      application through Biomed, MedEnclosure is entitled to significant
      discounts for additional marketing approval applications in Canada and
      European
      Union countries.

                          


                  

                

                
                  
                    	
                            2.

                          	
                            Marketing
      applications in Canada and EU countries shall be negotiated independent of
      this agreement.

                          


                  

                

                 

                 

                
                  
                    
                    

                  

                  
                    
                    

                    
                      

                    

                  

                  
                    
                    

                  

                

              

            

          

        

      

    

     

    
      EXHIBIT
A

       

      Second
Amendment - Product Development Services Agreement

       

      Phase V -
Human Clinical Trial / Phase VI - Marketing Approval

       

       

      Biostatistical     
TOTAL BIOSTATISTICAL MANAGEMENT     $214,809.00

      develop
randornization scheme

      implement
randomization

      create
statistical analysis table shells

      create statistical listing
shells

      SAS programming

      statistical
reports

      data
transfer

      statistics
QC review & OA report

      statistics teleconferences
/ consults

       

      
        
          

        

      

       

      TOTAL
PROJECT - PHASE V $1,129,493.00

       

      Direct
pass-through of actual expense:

       

      
        
          	
                  1.

                	
                  AR expenses incurred for travel
      and other expenses incurred in performance of services by
      Biomed, BioStat,
      Medical Monitor, and Clinical Events Cornrnittee, as approved by
      Biomed.

                


        

      

       

      
        	
                2.

              	
                Any
      expenses approved by Biomed incurred for copying, printing and delivery of
      project documents, i.e., case report
forms.

              


      

       

      
        	
                3.

              	
                Investigational
      site per patient fees, femoral ultrasound, ABA,
  etc

              


      

       

      
        	
                4.

              	
                Institutional
      Review Board (RIB) fees

              


      

       

      
        
          	
                  5.

                	
                  Honorarium
      and fees for services performed by Medical Monitor and Clinical Events
      Committee (CEO)

                


        

      

       

      
        	
                6.

              	
                Any
      governmental fees approved by Biomed associated with submission of
      human study applications shall be passed through directly to
      MedEnclosure

              


      

       

      
        	
                7.

              	
                Billing
      to MedEnclosure will occur monthly for pass through expenses pre-paid by
      Biomed, along with receipts of actual expenses. Payment will be
      made within 30 days of the receipt of the invoice in electronic form by
      MedEnclosure, or a finance charge will be issued for all outstanding
      balances (annualized rate of 12%).

              


      

       

      
        	
                8.

              	
                Any
      changes to the assumptions or task list above
      will require a Change Order approved by both Biomed and MedEnclosure
      subject to Section 4 of the foregoing Second
      Amendment.