Document:

Unassociated Document

    
      SensiVida
Medical Technologies,
Inc.

       

      CONSULTING
AGREEMENT

       

      CONSULTING AGREEMENT dated as
of  1 June , 2010 by and between SensiVida Medical Technologies
Inc., with a principal place of business at 77 Ridgeland Road, Henrietta,
NY 14623 (the “Company”),
and  Dhurjaty
Electronics Consulting LLC,   (the “Consultant”).

       

      WHEREAS, the Consultant
desires to advise the Company and the Company desires to obtain the services of
the Consultant;

       

      WHEREAS, the Consultant and
the Company agree that certain information regarding the Company’s prototyping
and product research and development activities, its business planning and
marketing strategy, and other Company proprietary information and trade secrets
related to the Allergy Testing System, and business of the Company, that the
Consultant may obtain during the course of his services for the Company, should
be used exclusively for the benefit of the Company;

       

      NOW, THEREFORE, in
consideration of the mutual covenants and conditions herein contained, the
parties hereto agree as follows:

       

                 1.           Consultant’s
Services.  The Company hereby retains the
Consultant, and the Consultant hereby agrees to perform for the Company, certain
consulting and advisory services outlined on Exhibit A, as well as all other
consulting services and advice incidentally related thereto (the “Services”),
upon the terms and conditions set forth in this
Agreement.   

       

                 2.           Compensation
and Reimbursement of Expenses.  For the performance of the
Services to be rendered to the Company during the term of this Agreement, the
Company shall provide the Consultant the amounts as set forth on Exhibit B, as full and complete
compensation for the Services outlined above.

       

                 The
Company shall promptly pay or reimburse the Consultant for all reasonable and
necessary expenses incurred by the Consultant in connection with the performance
of the Services and related to the business of the Company, provided that such
expenses are incurred pursuant to the policy of the Company as in effect from
time to time or pursuant to the prior approval of the President of the Company,
and are itemized and accounted for in accordance with the policy of the Company
or the requirements of the Internal Revenue Service.

       

                 3.           Term.  The
term of this Agreement and the Consultant’s Services hereunder shall commence as
of the date of this Agreement and shall terminate on the earlier of the (i)
death, physical incapacity or mental incompetence of the Consultant, (ii)
12  months from date of commencement (the “Expiration
Date”) unless terminated earlier as per clause 4.

       

                 4.           Termination.  Either
party may terminate this Agreement with 30 days advance written
notice.

       

                 5.           Independent
Contractor.  It is specifically understood and agreed that
during the term of this Agreement the Consultant’s relationship to the Company
will be that of an independent contractor and that neither this Agreement nor
the Services to be rendered hereunder shall for any purpose whatsoever or in any
way or manner create any employer-employee relationship between the
parties.  Accordingly, Contractor retains the sole right to control or
direct the manner in which the Services described herein are to be
performed. The
Consultant shall have sole and exclusive responsibility for the payment of all
federal, state and local income taxes and for all employment and disability
insurance, health
insurance benefits, social security and other similar taxes or obligations with
respect to any compensation provided by the Company hereunder, whether to
Company or the Consultant.  The Consultant is not authorized to bind
the Company under any contract or to use its name except as expressly authorized
in writing by the Company.

       

      
      

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      SensiVida
Medical Technologies,
Inc.

      
      

       

      6.          Restrictions
on the Disclosure of Proprietary Information.

       

      (A)     Proprietary
Information.

       

       For
purposes of this Agreement, the term “Proprietary
Information” shall mean all knowledge and information which the
Consultant has acquired or may acquire as a result of, or related to, his
relationship with the Company concerning the Company’s business, finances, sales
and marketing plans, operations, strategic planning, current or proposed
products or services, software, methodologies, algorithms, flow charts and logic
diagrams, technical specifications and data, proprietary technology, trade
secrets, cost and pricing policies, methods of doing business, customer names
and profiles, confidential business information, know-how, techniques, and
strategies and Services related to the Allergy Testing Device as further
described in Exhibit
A.  Notwithstanding the foregoing sentence, such Proprietary
Information does not include (i) information which is or becomes publicly
available through no action or fault of the Consultant (except as may be used or
disclosed in violation of this Agreement), (ii) information acquired by the
Consultant from a source other than the Company or any of its employees or other
consultants, which source acquired such information directly from the Company
without a breach of any confidentiality obligation between such source and the
Company, (iii) information that is known to the Consultant without restriction
from his own independent sources as evidenced by the Consultant’s written
records, and which was not acquired, directly or indirectly, from the Company or
its partners, and (iv) information developed or obtained by the Consultant
unrelated to the services performed by the Consultant for the Company and
discovered from sources other than the Company.

       

      (B)           Nondisclosure
Obligation.  The Consultant agrees that he will not at any
time, either during or after the term or any termination of this Agreement,
without the prior written consent of the President or Board of Directors of the
Company, divulge or disclose to anyone outside the Company, or appropriate for
his own use or the use of any third party, any such Proprietary Information, and
will not during his engagement by the Company hereunder, or at any time
thereafter, disclose or use or attempt to use any such Proprietary Information
for his own benefit, or the benefit of any third party, or in any manner which
otherwise may injure or cause any loss to the Company. The Consultant shall
obtain from personnel, agents or other representatives employed or engaged by
him to perform any work for the Company an agreement which contains the
provisions of this Section.

       

                 The
Consultant further agrees not to make any notes, memoranda, reports, sketches,
drawings or other written information relating to any matter within the scope of
the Proprietary Information at any time otherwise than for the benefit of the
Company, and, either during or after the termination of his Services pursuant to
this Agreement, to use or permit to be used any such written information
otherwise than for the benefit of the Company.  Upon termination of
his Services, the Consultant shall deliver all such written information and all
copies thereof made during the term of this Agreement to the Company at its
principal executive office.  The terms and provisions of this Section
shall apply with equal force and effect to the work product resulting from the
Consultant’s Services hereunder and to all other property of the
Company.

       

      
        
           

        

        
          2

          
            

          

        

        
           

        

      

      SensiVida
Medical Technologies,
Inc.

       

      
        7.          Inventions.

      

       

      
        	
              	
                A.

              	
                Except
      as expressly set forth herein, nothing in this Agreement grants either
      party (Consultant or Company) any right or license to any patent,
      copyright, trademark or other intellectual property right of the
      other.

              

      

      
        	
              	
                B.

              	
                Inventorship
      for any patentable Invention (as defined below in 7c) shall be determined
      in accordance with U.S. patent law. Ownership of patents shall be
      determined based on inventorship.

              

      

      
        	
              	
                C.

              	
                It
      is expressly understood and agreed that business strategies and planning,
      designs, processes, formulae, technologies, know-how, systems, trade
      secrets, patents, copyrights, patentable inventions, discoveries,
      improvements and intellectual property rights conceived, devised,
      developed, or otherwise obtained by the Consultant during the term of this
      Agreement which directly or indirectly relate to or arise out of the
      Services rendered to the Company hereunder or the Proprietary Information
      of the Company (collectively, the “Inventions”)
      are “works for
      hire” and the Consultant agrees to transfer and assign to Company
      all of Consultant’s right, title and interest to any and all patent
      ownership interest Consultant may have throughout the world in and to such
      Inventions arising out of execution of activities specified in this
      Agreement.

              

      

      
        	
              	
                D.

              	
                The
      Consultant agrees that all Inventions, prototypes, system/subsystem
      assemblies, hardware/software, purchased and/or fabricated by Consultant
      and fully paid by Company during the Term of the agreement shall be
      provided to Company upon Termination of
  Contract.

              

      

      
        
          	
                	
                  E.

                	
                  The
      obligations of this Section 7 shall continue beyond the termination of
      this Agreement with respect to such Inventions conceived or made by the
      Consultant during the term of this Agreement, and shall be binding upon
      his affiliates, heirs, legal representatives, successors and
      assigns.

                

        

      

       

                 8.           Absence
of Conflicting Agreements.  The Company does not desire to
acquire from the Consultant any trade secret, know-how or confidential
information that he may have acquired from third
parties.  Accordingly, the Consultant represents and warrants that (i)
he is free to divulge to the Company, without any obligation to, or violation of
any right of others, any and all information, practices and techniques which the
Consultant will describe, demonstrate, divulge or make known to the Company
under this Agreement; and (ii) he is not a party to any agreement or
arrangement, whether oral or written, which would constitute a conflict of
interest with this Agreement or would prevent him from carrying out his
obligations to the Company under this Agreement.

       

                 9.           Restrictions
on Solicitation.  During any period in which the Consultant
renders Services to the Company and for a period of one (1) year thereafter, the
Consultant shall not (i) directly or indirectly, either for himself or for any
other person or entity call upon, solicit, divert or take away, any of the
customers, business or prospective customers of the Company being solicited by
the Company at the time of any termination or behalf of any entity or
organization which is a competitor of the Company or which engages in any
activity of the type described in Exhibit A.   During the
period of this Agreement and for a period of one (1) year after its termination
(for any reason), the Consultant shall not, directly or
indirectly:  (a) employ; (b) knowingly permit any company or business
organization which is directly or indirectly controlled by the Consultant to
employ; (c) recruit or attempt to recruit, solicit or attempt to solicit,
attempt to hire, interfere with or endeavor to entice away; or (d) assist any
entity, company or business organization to recruit or attempt to recruit,
solicit or attempt to solicit, attempt to hire, interfere with or endeavor to
entice away, any person who is or was employed by the Company or is or was an
agent, representative or consultant of the Company within the one (1) year prior
to the termination of this Agreement.

      
        
           

        

        
          3

          
            

          

        

        
           

        

      

      SensiVida
Medical Technologies,
Inc.

      

                 10.         General.  This
Agreement constitutes the entire Agreement between the parties relative to the
subject matter hereof, and supersedes all proposals or agreements, written or
oral, and all other communications between the parties relating to the subject
matter of this Agreement. No provision of this Agreement shall be waived,
amended, modified, superseded, canceled, terminated, renewed or extended except
in a written instrument signed by the party against whom any of the foregoing
actions is asserted.  Any waiver shall be limited to the particular
instance and for the particular purpose when and for which it is given. The
invalidity, illegality or unenforceability of any provision of this Agreement
shall in no way effect the validity, legality or enforceability of any other
provision of this Agreement.

       

                 This
Agreement, the Services to be performed and all rights hereunder are unique and
personal to the Consultant and may not be transferred or assigned by the
Consultant at any time.  The Company may assign its rights, together
with its obligations hereunder, to any affiliate or successor in connection with
any consolidation, merger, sale, transfer or other disposition of all or
substantially all of the Company’s business, capital stock or
assets.

       

                 This
Agreement shall be construed and enforced in accordance with, and the rights of
the parties shall be governed by, the internal laws of the State of New
York.  All notices provided for in this Agreement shall be given in
writing and shall be effective when either served by personal delivery, express
overnight courier service, facsimile transmission, or by first-class mail,
postage prepaid, addressed to the parties at their respective addresses set
forth herein, or to such other address or addresses as either party may later
specify by written notice to the other. This Agreement may be executed in
duplicate counterparts, which, when taken together, shall constitute one
instrument and each of which shall be deemed to be an original
instrument.

       

                 The
provisions of Sections 6, 7, 8 and 9 shall survive the termination or expiration
of this Agreement as a continuing agreement of the Company and the Consultant.
The Consultant acknowledges that because of the nature of the business of the
Company and the subject matter of this Agreement, a breach of this Agreement
will cause substantial injury to the Company for which money damages will not
provide an adequate remedy, and the Consultant agrees that the Company shall
have the right to obtain injunctive relief (without the necessity of posting a
bond), including the right to have the provisions of this Agreement specifically
enforced by any court having jurisdiction, in addition to, and not in limitation
of, any remedies at law that the Company may have.

       

                 Subject
to the rights of the Company and the Consultant as contained in the preceding
paragraph, any dispute, controversy or claim arising out of, in connection with,
or in relation to this Agreement or the breach of any of the provisions hereof
shall be settled by arbitration in Rochester, NY pursuant to the rules then
obtaining of the American Arbitration Association.  Any award shall be
final, binding and conclusive upon the parties and a judgment rendered thereon
may be entered in any court having competent jurisdiction thereof.

       

      ————————   signature
page follows —————————
 

      
        
           

        

        
          4

          
            

          

        

        
           

        

      

      

      SensiVida
Medical Technologies,
Inc.

       

       IN WITNESS WHEREOF, parties
have executed this Consulting Agreement as of the day and year first above
written.

      

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            	
                                    For Dhurjaty Electronics
      Consulting LLC

                                  	 	SensiVida
      Medical Technologies Inc.
	 
      	 	 	 
      	 
      
	
                                    /s/ Sreeram Dhurjaty

                                  	 	 	
                                    By:

                                  	
                                    /s/ Joes Mir

                                  
	
                                    President/Managing
      member

                                  	 	 	 
      	
                                    President/
      CEO

                                  
	 
      	 	 	 
      	 
      
	
                                    115 Sylvania Road

                                  	 	 	 
      	 
      
	
                                    Street
      Address

                                  	 	 	 
      	 
      
	 
      	 	 	 
      	 
      
	
                                    Rochester, NY,
      14618

                                  	 	 	 
      	 
      
	 
      	 	 	 
      	 
      
	
                                    City   
      State     Zip Code

                                  	 	 	 
      	 
      
	 
      	 	 	 
      	 
      
	
                                    sdhurjaty@dhurjaty.net

                                  	 	 	 
      	 
      
	 
      	 	 	 
      	 
      
	
                                    Email

                                  	 	 	 
      	 
      

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      
        
           

        

        
          5163
      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

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00184-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00184-of-00352.parquet"}]]