163
      Cabot Street

                    Beverly,
      MA 01915

                    Phone:
      (978) 927-3808

                    Fax:    
      (978) 927-1308

                  	 
      


          

        

      

    

     

    Agreement

    
    

    
      	
              Client:

            	
              SensiVida

            
	 
      	 
      
	
              Date:

            	
              May
      21, 2010

            
	 
      	 
      
	
              Project:

            	
              Regulatory
      Consulting: Assist SensiVida in developing an effective Quality System to
      ensure compliance with FDA Quality System Regulations (QSR) and current
      Good Manufacturing practices (cGMP). Conduct clinical trials and prepare
      submission for SensiVida Microneedle Allergen Array Allergy
      Test.

            


    

      

    
      

    

    Project
Scope:

     

    MDC is
prepared to assist SensiVida in developing a quality system to meet requirements
associated with FDA QSR and cGMP guideline. MDC will prepare a pre-IDE outlining
clinical study plans. FDA review of the pre-IDE will provide important guidance
on clinical study requirements. Based on FDA feedback, MDC will conduct clinical
trials, manage study data and prepare 510k submission for SensiVida Microneedle
Allergen Array Allergy Test.

     

    Project
Overview:

    MDC will
work with SensiVida on an as needed basis to accomplish the following
goals:

     

    
      
        
          	 
      	
                  
                    v

                  

                	
                  Assist
      SensiVida to develop and implement an effective design control process in
      accordance with FDA 21CFR800. MDC will be available to assist
      in assuring that all required design verification and validation data are
      generated as needed for 510k review and clearance.

                
	 
      	
                  

                    v

                  

                	
                  Assist
      in developing design verification and validation
  protocols

                
	 
      	
                  

                    v

                  

                	
                  Define
      design transfer requirements.

                
	 
      	
                  

                    v

                  

                	
                  Assist
      in selecting and auditing third party manufacturers, assuring that key
      vendors are operating in accordance with FDA QSR and cGMP
      guidelines

                
	 
      	
                  

                    v

                  

                	
                  Establish
      other quality system documents as needed during the initial phase of the
      project

                
	 
      	
                  
                    

                      v

                    

                  

                	
                  Develop
      clinical and analytical study protocols

                
	 
      	
                  

                    v

                  

                	
                  Develop
      Labeling in accordance with FDA requirements

                
	 
      	
                  

                    v

                  

                	
                  Prepare
      a pre-IDE (early in the project) and submit to the pre-IDE to the
      FDA.

                
	 
      	
                  

                    v

                  

                	
                  Following
      FDA review of the pre-IDE (usually about 60 days) schedule a meeting with
      the FDA to discuss
      requirements for the 510k submission.

                
	 
      	
                  
                    

                      v

                    

                  

                	
                  Finalize
      clinical and analytical study protocols based on FDA
    feedback

                
	 
      	
                  

                    v

                  

                	
                  Manage
      the clinical trial, including selecting sites and assisting in the IRB
      approval process

                
	 
      	
                  
                    

                      v

                    

                  

                	
                  Collect
      Study data

                
	 
      	
                  
                    
                      

                        v

                      

                    

                  

                	
                  Monitor
      study sites

                
	 
      	
                  
                    

                      v

                    

                  

                	
                  Prepare
      510k submission

                
	 
      	
                  

                    v

                  

                	
                  Monitor
      submission through the review and final clearance

                
	 
      	
                  
                    

                      v

                    

                  

                	
                  Assist
      in developing and implementing procedures for all elements of an effective
      quality system
including:

                


        

      

    

    Management
responsibility and Review

    Document
Control

    Purchasing
Controls


    
      
         


      

      
         


        
          

        

      

      
         


      

    

     

    
      	
            	 
      	 
      
	
              

            	
              

                163
      Cabot Street

                Beverly,
      MA 01915

                Phone:
      (978) 927-3808

                Fax:    
      (978) 927-1308

              

            	 
      


    

     

    Control
of Vendors

    CAPA

    Complaint
Handling

    Environmental
Controls (as needed)

    Inventory
Control (as needed)

    Calibration
(as needed)

    Process
control and validation

     

    Project
milestones and timelines will be established during the initial phase of the
study.

     

    Pre-IDE
will be a key milestone and should be able to be completed within 60- 90 days of
the start of the project.

     

    SensiVida
development schedule will impact all timelines.

     

    MDC
fee:

     

    Monthly
Retainer: $7,900 per month for 16 months

     

    SensiVida
can cancel this agreement at any time, but must provide MDC 30 days notice of
cancellation.

     

    If
for any reason, the project is delayed, SensiVida can put the project on hold
and extend the length of the project.

     

    SensiVida is responsible for all direct expenses
associated with travel and clinical study costs. 

     

    Agreed:

     

    
      
        
          
            
              	
                      By:

                    	 
      	 
      	 
	 
      	 
      	 
      	 
	
                      /s/  Fran White

                    	 
      	
                      /s/  Jose Mir

                    	 
       
	
                      Fran
      White

                      MDC
      Associates, LLC
      

                      President

                    	 
      	
                      SensiVida Medical Technologies,
      Inc.

                    	 
	 
      	 
      	 
      	 
	
                      5/21/2010

                    	 
      	
                      5/24/2010

                    	 
       
	
                      Date

                    	 
      	
                      Date