Unassociated Document


     

    
      EXHIBIT 10.14


       

      
        
          	
                  Corporation

                	
                  TERMINATION,
      PURCHASE AND LICENSE
AGREEMENT

                


        

      

       

      This
Termination, Purchase and License Agreement ("Agreement") is made as of
____________________, 2008 ("Effective Date"), by and between Boston Scientific
Corporation, One Boston Scientific Place, Natick, MA 01760 ("Seller"), and Bovie
Medical Corporation, 7100 30th
Avenue-North, St. Petersburg, FL  33710 ("Buyer") for the purpose of
purchase and sale of certain rights and assets related to the Program (as
defined in Section 1.1) and use of the rights and assets in the development,
manufacture and sale of the Product (as defined in Section 1.2); assignments and
licenses for certain intellectual property of the Parties; and termination of
that certain Distribution Agreement between the Parties dated as of October 6,
2006, as amended on August 23, 2007 (the “Distribution Agreement”), all in
accordance with this Agreement.  Buyer and Seller are herein referred
to collectively as “Parties” and individually as a “Party.”

       

      
        	
                MAILING
      ADDRESSES AND FAX NUMBERS FOR NOTICES, ETC. UNDER
  AGREEMENT

              
	 	 
	
                Buyer:

                Bovie
      Medical Corporation

                7100
      30th
      Avenue North

                St.
      Petersburg, FL 33710

                Attn:  Moshe
      Citronowicz, COO

                Fax:  (727)
      344-3876

                 

              	
                with copy
      to:

                Bovie
      Medical Corporation

                7100
      30th
      Avenue North

                St.
      Petersburg, FL 33710

                Attn:
      General Counsel

                Fax:  (727)
      344-3876

              
	
                Seller:

                Boston
      Scientific Corporation

                100
      Boston Scientific Way

                Marlborough,
      Massachusetts  01752

                Attn:  Michael
      Phalen, President Endoscopy

                Fax:  (508)
      683-5316

                 

              	
                with copy
      to:

                Boston
      Scientific Corporation

                One
      Boston Scientific Place

                Natick,
      Massachusetts  01760-1537

                Attn:  General
      Counsel

                Fax:  (508)
      650-8956

              


      

      NOW, THEREFORE, for good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the
Parties hereto agree as follows:

       

      1.           Purchase and
Sale

       

      1.1           Program.  For
purposes of this Agreement, “Program” means the SEER
Sintered Tip Resection Device, BSC Project # M0380.

       

      1.2           Product.  For
purposes of this Agreement, “Product” means any medical
device having a sintered, conductive metal tip in accordance with the Product
Specifications attached hereto as Exhibit A (Revisions
A-1 & A-2) for use in the Field.  Product specifically does not
include any generator or generator accessories.  “Field” means liver, pancreatic
and kidney tumor, orthopedic, and blood vessel sealing, therapy by delivery of
RF current and sterile saline for resection, hemostatic sealing and coagulation
of soft tissue in open surgery and/or laparoscopic surgery.

       

      1.3           Assets.  At
the closing, and upon the terms and conditions of this Agreement, Seller hereby
sells, transfers, conveys, assigns and delivers to Buyer, and Buyer purchases
from Seller, free and clear of any and all liabilities, obligations, liens and
encumbrances, all right, title and interest in and to the following Program
assets of Seller (collectively, the “Purchased Assets”), wherever
located, :

       

      (a) All
equipment, machinery, prototypes, tooling, supplies, and other personal property
of the Seller predominantly related to the Program and the design, development
and manufacture of the Product, including all records related thereto, as set
forth on Exhibit
X hereto;

      
         

        
          	
                  BUYER:
      __________ 

                	
                  Page
      1 of 8

                	
                  SELLER:
      __________

                


        

         

      

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

       

      (b) all of
Seller’s rights and interest in and under the contracts, licenses, leases and
other agreements and instruments predominantly related to the Program and the
design, development and manufacture of the Product, as set forth on Exhibit X hereto,
together with true, complete and accurate copies of the same (the “Transferred
Contracts”);

       

      (c) to the
extent assignable, approvals, clearances, authorizations, licenses and
registrations required by any governmental authority, predominantly related to
the Program and to permit the design, development, pre-clinical and clinical
testing, manufacturing, labeling, sale, distribution, and promotion of the
Product as set forth on Exhibit X hereto,
together with true, complete and accurate copies of the same (the “Transferred
Permits”);

       

      (d) all
scientific, clinical, technical, marketing, pre-sales and other data,
predominantly related to the Program and the design, development and manufacture
of the Product, including, without limitation, files, formulas, compositions,
computer discs and tapes (and reasonable use of the means to access or convert
them to a form useable by Buyer, if necessary), laboratory notebooks, design
histories, operating manuals and procedures, instructions for use, device
history records, bills of materials, and manufacturing, inspection and quality
control records and procedures, as set forth on Exhibit X
hereto;

       

      (e)           the Generated Product IP (as
defined in Section 2.1), together with true, complete and accurate copies
of the documents pertaining thereto including, without limitation, documents
used by Seller (or its counsel) in the preparation and prosecution of the
patents comprising the Generated Product IP, except as to the excluded document
categories set forth on Exhibit X
hereto;

       

      (f)           all guarantees, warranties, indemnities
and similar rights in favor of Seller with respect to any Purchased Asset;
and

       

      (g)           all rights to causes of action,
lawsuits, judgments, claims and demands of any nature available to, or being
pursued by, Seller, with respect to the Purchased Assets, whether arising by way
of counterclaim or otherwise.

       

      1.4           Delivery of Purchased
Assets.  No later than
_____ (_) business days after the closing, Seller shall package and ship (or
cause to be packaged and shipped) to Buyer all tangible personal property
elements of the Purchased Assets not in Buyer’s possession and custody as of the
closing, at Seller’s expense.

       

      2.           Assignment of Intellectual
Property; Cross-Licenses.

       

      2.1           Assignment of Generated
Product IP.  At the closing, and upon the terms and conditions
of this Agreement, Seller hereby sells, transfers, conveys and assigns to Buyer,
and Buyer purchases from Seller, free and clear of any and all liabilities,
obligations, liens and encumbrances, all right, title and interest in and to any
and all Intellectual Property Rights (as defined below) generated in the
performance of the Program and as a result of development work on the Product by
or on behalf of either Party (collectively, the “Generated Product IP”),
including but not limited to:

       

      (a)           **  **;

       

      (b)           US2007/0156134,
filed December 29, 2005, **  **;;

       

      (c)           U.S.
Patent #7,282,051, filed February 4, 2004, issued October 16, 2007, and
continuation 11/550,374 (US2007/0123848); and

       

      (d)           **  **;.

       

      For
purposes of this Agreement, “Intellectual Property Rights”
means intellectual property or proprietary rights of any description worldwide
including without limitation (i) rights in any patent, patent registration,
patent application, copyrights, industrial designs, trademarks, (ii) trade
secrets, moral rights, shop rights and publicity rights, (iii) inventions,
discoveries, know-how, techniques, methodologies, designs or data, whether or
not patented, patentable or copyrightable, (iv) rights to sue for and remedies
against past, present and future infringements or misappropriations thereof, and
rights of priority and protection of interests therein under the laws of any
jurisdiction worldwide and all tangible embodiments thereof, and (v) goodwill
related to any of the foregoing.

      
        
           

          
            	
                    BUYER:
      __________ 

                  	
                    Page 2
      of 8

                  	
                    SELLER:
      __________

                  


          

           

        

      

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

       

      2.2           License to Generated Product
IP.  At
the closing, and upon the terms and conditions of this Agreement, Buyer hereby
grants to Seller a non-exclusive, fully paid up, royalty-free, worldwide,
perpetual, irrevocable license to the Generated Product IP solely to make, have
made, use, offer for sale, sell, have sold, import and export any Seller
Products.  For purposes of this Agreement, “Seller Products” means any
product or device of Seller, provided however, such product or device shall be
for use in applications outside of a Product for the Field.  As of
January 1, 2016, the license granted to Seller under this Section 2.2 shall
cease to include the limitation in the previous sentence, i.e., “for use in
applications outside of a Product for the Field.”  The license granted
to Seller hereunder is not sublicensable, but is transferable by Seller to a
buyer only in connection with the sale of all or substantially all of the assets
relating to any Seller Product.

       

      2.3           License to Existing Product
Patents.  At the closing, and upon the terms and conditions of
this Agreement, Seller hereby grants to Buyer a non-exclusive, fully paid up,
royalty-free, worldwide, perpetual, irrevocable license to Existing Product
Patents solely to make, have made, use, offer for sale, sell, have sold, import
and export the Product for use in the Field.  For purposes of this
Agreement, “Existing Product
Patents” shall include any of Seller’s invention disclosures, trade
secrets and patent applications (but not to the extent of disclosing non-public
details of such disclosures, trade secrets, or patent applications), and issued
and issuing patents existing as of the Effective Date, including continuations
and foreign counterparts thereof obtained thereafter, necessary for the
non-infringing manufacture, use and sale of the Product.  The
foregoing license is not sublicensable but is transferable by Buyer to a buyer
only in connection with the sale of all or substantially all of the assets
relating to the Product.

       

      3.           Termination of Distribution
Agreement and Releases.

       

      3.1           Termination.  The
Distribution Agreement is hereby terminated as of the Effective
Date.

       

      3.2           Releases.  Each
Party, along with its employees, officers, directors, affiliates,
subcontractors, agents, successors or assigns, hereby releases and discharges
the other Party, along with its employees, officers, directors, affiliates,
subcontractors, agents, successors or assigns, of any and all obligations,
liabilities and claims, whether known or unknown, accrued or not accrued,
contingent or otherwise, arising prior to the Effective Date, directly or
indirectly, out of or related to, the Distribution Agreement, the performance of
the Distribution Agreement or the termination of the Distribution
Agreement.

       

       

      4.           Confidential
Information

       

      4.1           Confidential
Information.

       

      (a)           "Confidential Information"
means all proprietary information disclosed by or on behalf of either Party
hereto (a “Disclosing Party”) to the other Party hereto (a “Receiving Party”),
or any of the Disclosing Party’s or Receiving Party’s employees, officers,
directors, affiliates, subcontractors, agents, successors or assigns
(collectively “Representatives” and together
with the Disclosing Party, the “Disclosing Group” or together
with the Receiving Party, the “Receiving Group”), including
information relating to the matters that are the subject of this Agreement,
including the terms, existence and nature of this Agreement, or relating to the
Disclosing Party’s other past, present or future research, technology, know-how,
ideas, concepts, designs, products, markets, customer information, computer
programs, prototypes, processes, machines, articles of manufacture, compositions
of matter, business plans and operations, technical information, drawings, or
specifications; except information which is:  (i) at the time of
disclosure, or thereafter becomes lawfully part of the public domain through no
act or omission by the Receiving Party; (ii) lawfully in the possession of
Receiving Party prior to disclosure by or on behalf of Disclosing Party, as
shown by written records; (iii) lawfully disclosed to the Receiving Party by a
third party which did not acquire the same under an obligation of
confidentiality from or through the Disclosing Group; or (iv) independently
developed by the Receiving Party without use of Confidential Information, as
shown by written records.  If a Receiving Party believes in good faith
that it is required by law to disclose any Confidential Information, it shall
provide notice to the Disclosing Party, prior to making such disclosure so as to
allow Disclosing Party time to undertake legal or other action, to prevent such
disclosure or otherwise obtain confidential treatment of such
disclosure.

      
        
           

          
            	
                    BUYER:
      __________ 

                  	
                    Page 3
      of 8

                  	
                    SELLER:
      __________

                  


          

           

        

      

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

       

      (b)           A
Receiving Party shall not, without the prior consent of the Disclosing Party,
disclose any Confidential Information to anyone for any reason at any time or
use any Confidential Information for any purpose except as requested by the
Disclosing Party.  The Receiving Party shall limit dissemination of
Confidential Information to only those of the Receiving Group having a "need to
know."  A Receiving Party shall not, except as permitted under this
Agreement:  (i) appropriate or use a Disclosing Party’s Confidential
Information in Receiving Party’s own manufacture of products for itself or for
any third party or for any other purpose; or (ii) obtain any title to, or any
interest or license in, any Confidential Information of a Disclosing
Party.

       

      (c)           Neither
Party shall issue a press release or other public announcement concerning this
Agreement (or any term sheet, bids, negotiations or other related information),
the transactions contemplated herein, or the relationship between the Parties
without the prior written approval of an authorized representative of the other
Party, which such approval the other Party shall not unreasonably withhold or
delay, provided however, a Party may issue a press release, public announcement
or disclosure of this Agreement if required by the regulations of a securities
exchange on which such Party’s securities are listed if (i) it gives the other
Party prompt notice of such requirement and (ii) it cooperates with the other
Party with respect to reasonable requests for revisions to any announcement or
reasonable requests for confidential treatment of certain sections of this
Agreement.

       

      (d)           Neither
Party shall:  (i) disclose to the other Party any confidential or
proprietary information belonging to any third party without the consent of such
third party; nor (ii) represent as being unrestricted any designs, plans,
models, samples, or other writings or products that the Disclosing Party knows
or has reason to know are covered by Intellectual Property Rights of a third
party.

       

      5.           Indemnification.  

       

      (a)           Buyer
shall indemnify, defend and hold harmless Seller and its affiliates and their
respective directors, officers, employees and agents from and against any claim,
action, suit, demand, damage, expense or losses (including reasonable attorneys’
fees) by a third party (collectively, "Claims") resulting from or to
the extent relating to: (i) Buyer’s manufacture, use, sale and marketing of the
Product, including but not limited to Claims relating to personal injury; or
(ii) infringement or alleged infringement of any third party Intellectual
Property Rights with respect to the sale of the Product.

       

      (b)           Seller shall
indemnify, defend and hold harmless Buyer and its affiliates and their
respective directors, officers, employees and agents from and against any Claims
resulting from or to the extent relating to Seller’s material breach of this
Agreement including, without limitation, any material inaccuracy of Seller’s
representations or warranties, or material breach of Seller’s covenants, under
Section 7 hereof.

       

      (c)           Either
Party’s (the “indemnifying
Party”) obligations to the other Party (the “indemnified Party”) under this
Section 5 are conditioned upon the indemnified Party:  (i) providing
written notice to the indemnifying Party of any Claims promptly, but not later
than fifteen (15) calendar days after the indemnified Party knows of such Claim;
(ii) permitting the indemnifying Party to assume full responsibility for the
defense of such Claim; (iii) assisting the indemnifying Party in defense of such
Claim at the indemnifying Party’s expense; and (iv) not compromising or settling
any such Claim without the indemnifying Party’s prior written
consent.  Indemnifying Party may not settle a Claim without the
indemnified Party’s prior written consent, which consent shall not be
unreasonably withheld or delayed, unless such settlement includes a full release
of the indemnified Party from all liability and without any condition of future
consideration.  Notwithstanding the foregoing, the indemnified Party’s
failure to give the notice specified in this Section or delay in giving such
notice, shall not affect the indemnified Party’s right to indemnification under
this Section except to the extent that indemnifying Party has been prejudiced by
such failure or delay.

       

      6.           Remedies.  Termination
of this Agreement, or the exercise of any other remedy, shall not be deemed to
be an exclusive remedy hereunder, and shall be in addition to any other remedies
available at law or in equity (including a Party’s right to obtain specific
performance and other equitable relief for other Party’s material breach
hereof).

       

      7.           Representations and
Warranties; Covenants.  Each Party hereby represents and
warrants to the other that:  (a) the execution and delivery of
and performance under this Agreement by such Party does not, and will not,
conflict with or violate any other agreement or obligations with third parties
or any restrictions of any kind or any law to which it is bound or subject; and
(b) it has the unrestricted right to disclose any information it submits to the
other Party, free of all claims of third parties, and that such disclosures do
not breach or conflict with any confidentiality provisions of any agreement to
which it is a party.

      
        
           

          
            	
                    BUYER:
      __________ 

                  	
                    Page 4
      of 8

                  	
                    SELLER:
      __________

                  


          

           

          
            
              
              

            

            
              
              

              
                

              

            

            
              
              

            

          

        

      

       

      7.1           Purchased
Assets.  Seller hereby represents and warrants to Buyer that
Seller has good title to the Purchased Assets, and that the Purchased Assets
transferred or otherwise conveyed hereunder to Buyer are and shall be free and
clear of any and all liabilities, obligations, liens and
encumbrances.

       

      7.2           Further
Assurances.  Following the closing, Seller shall, from time to
time, execute and deliver such additional instruments, documents, conveyances or
assurances, and take such other actions as shall be reasonably necessary, or
otherwise reasonably requested by the Buyer, to confirm and assure the rights
and obligations provided for in this Agreement and to render effective the
consummation of the transactions contemplated hereby.

       

      7.3           Authorization. Each
Party has the corporate power and authority to execute and deliver this
Agreement, to perform fully its obligations hereunder, and to consummate the
transactions contemplated thereby. The execution and delivery by each Party of
this Agreement, and the consummation of the transactions contemplated hereby,
have been duly authorized by all requisite corporate action of each
Party.  This Agreement constitutes legal, valid and binding
obligations of each Party, enforceable against it in accordance with the terms
and conditions hereof.

       

      7.4           Litigation. There is
no action, claim, demand, suit, proceeding, arbitration, grievance, citation,
summons, subpoena, inquiry or investigation of any nature, civil, criminal,
regulatory or otherwise, in law or in equity, pending or threatened against
Seller in connection with the Purchased Assets, and Seller does not know or have
reason to be aware of any basis for the same.

       

      7.5           Brokers, Finders. All
negotiations relating to this Agreement have been carried on without the
participation of any person acting on behalf of Seller or its affiliates in such
manner as to give rise to any valid claim against the Buyer for any brokerage or
finder's commission, fee or similar compensation, or for any bonus payable to
any officer, director, employee, agent or sales representative of or consultant
to Seller or their respective affiliates upon consummation of the transactions
contemplated hereby.

       

      7.6           Liability for Transfer
Taxes. In the event any sales (including, without limitation, bulk
sales), use, value-added, documentary, stamp, registration, transfer,
conveyance, excise, recording, license and other similar taxes and fees
(collectively, "Transfer Taxes"), arising out of or in connection with or
attributable to the transactions effected pursuant to this Agreement are due,
the Parties shall agree as to which Party shall prepare any required returns or
notices and the Parties shall evenly split the cost of preparing such returns
and the amount of any Transfer Taxes due.

       

      8.           Miscellaneous

       

      8.1           Except
as specifically set forth in Sections 2.2 and 2.3 neither Party shall assign
this Agreement or its obligations hereunder, whether voluntarily or
involuntarily, without the express prior written consent of the other
Party.

       

      8.2           This
Agreement is fully binding upon the Parties’ successors and permitted
assigns.

       

      8.3           All
requests, approvals, consents and notices must be in writing and will be
effective as of the date actually received and, unless otherwise specified in
this Agreement, shall be sent as follows: (i) certified mail - return receipt
requested; (ii) a nationally recognized overnight delivery service that
guarantees overnight delivery and requires the signature of recipient; or (iii)
facsimile, transmission confirmed; to the addresses and fax numbers indicated on
the first page of this Agreement; provided, however, that in the
case of a facsimile transmission a copy is also sent one of the foregoing
methods of subsection (i) or (ii), above.

       

      8.4           This
Agreement:  (i) is governed by the laws of The State of New York,
without reference to its internal principles of conflicts of laws, any disputes
shall be brought exclusively in a federal or state court residing in New York,
and the parties agree without objection to the jurisdiction and venue of such
court; (ii) together with all Exhibits thereto (which are hereby incorporated
into this Agreement) is the entire and exclusive set of terms and conditions and
supersedes all prior agreements and understandings, both written and oral,
between the Parties with respect to the subject matter of this Agreement and
termination of the Distribution Agreement; and (iii) may only be modified by a
writing signed by both Parties.

       

      8.5           Headings
of the articles, sections and subsections of this Agreement, and the name of
this Agreement, are for reference purposes only and shall not limit or affect
the meaning or construction of the terms and conditions
hereof.  Whenever the words “include”, “includes” or “including” are
used in this Agreement, they shall be deemed in each instance to be followed by
the words “without limitation.”

      
        
           

          
            	
                    BUYER:
      __________ 

                  	
                    Page 5
      of 8

                  	
                    SELLER:
      __________

                  


          

           

          
            
              
              

            

            
              
              

              
                

              

            

            
              
              

            

             

          

        

      

      8.6           No
failure of either Party to enforce any right under this Agreement shall be
deemed a waiver thereof.

       

      8.7           All
obligations and rights which are by their nature continuing, including the
obligations contained in Sections 2.2, 2.3, 4, 5, 7, and 8 shall survive the
expiration or termination of this Agreement.

       

      
         

        
          	
                   

                  ACCEPTANCE OF AGREEMENT

                
	 


        

      

      


      By
signing below the undersigned acknowledge and accept all terms and conditions of
this Agreement.

       

      
        
          	
                  BUYER:   BOVIE MEDICAL
      CORPORATION 

                	 
      	
                  SELLER:  BOSTON SCIENTIFIC
    CORPORATION

                	 
      
	 
      	 
      	 
      	 
      	 
      	 
      
	
                  By:

                	
                  /S/
      Moshe Citronowicz

                	 
      	
                  By: 

                	/S/ Michael P.
      Phalen  	 
      
	 
      	
                  (Signature) 

                	 
      	 
      	
                  (Signature)

                	 
      
	
                  Print
      Name: 

                	
                  /S/
      Moshe Citronowicz

                	 
      	
                  Print
      Name: 

                	
                  /S/
      Michael P. Phalen 

                	 
      
	
                  Title: 

                	
                  Vice
      President / COO

                	 
      	
                  Title:

                	
                   

                	 
      
	
                  Date
      Signed: 

                	
                  4-29-08 

                	 
      	
                  Date
      Signed:

                	4-30-08 
      	 
      
	 
      	 
      	 
      	 
      	 
      	 
      


        

      

       

      
         

        
          	
                  BUYER:
      __________ 

                	
                  Page 6
      of 8

                	
                  SELLER:
      __________

                


        

         

      

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

      


      Exhibit
X: Purchased Assets

      


      Sect
1.3a)                      Equipment,
machinery, prototypes, tooling, supplies, and other personal property
predominantly related to the Program

      


      Prototypes

       

      
        
          	
                  12
      assembled prototypes in trays

                	
                  (BSC)

                
	
                  60
      porous tips w/o powder coat

                	
                  (BSC)

                
	
                  20
      short samples – blue powder coat

                	
                  (BSC)

                
	
                  20
      laser and resistance welded samples

                	
                  (BSC)

                
	
                  1
      laparoscopic prototype

                	
                  (BSC)

                
	
                  3
      bipolar prototypes

                	
                  (BSC)

                
	
                  Any
      prototype from **     **

                	
                  (Bovie)

                
	
                  Any
      prototype with **     **

                	
                  (Bovie)

                
	
                  Any
      packaging prototypes

                	
                  (Bovie)

                


        



      PDM Project
Files

      


      See 1.3d, below

      


      Equipment

      


      None

      


      Tooling and
Molds

       

      
        
          	
                  All
      of BSC’s right, title and interest in component tooling
    with

                	
                  **     **

                
	
                  Handle
      Molds    -9 tools

                	
                  **     **

                
	
                  Packaging
      Molds

                	
                  **     **

                


        

      

      


      Components and Test
Fixtures

       

      
        
          	
                  Any
      components with **     **

                	
                  (Bovie)

                
	
                  Any
      components with **     **

                	
                  (Bovie)

                


        

      

       

      Sect.
1.3b)                      Seller’s
right and interest in and under the contracts, licenses, leases and other
agreements and instruments predominantly related to the Program

      


      Contracts

       

      
        
          	
                  **     **
      letter with terms and Conditions

                	
                  (BSC)

                
	
                  PO’s
      to **     **

                	
                  (BSC)

                
	
                  **     **
      quotes

                	
                  (BSC)

                


        

      

      


      


      Section
1.3c)    Approvals,
clearances, authorizations, license and registrations required by any
governmental authority, predominantly related to the Program

      


      None

      


      


      Section
1.3d)    Clinical, technical,
marketing, pre-sales and other data, predominantly related to the Program and
the design, development and manufacture of the Product

      
        
           

          
            	
                    BUYER:
      __________ 

                  	
                    Page 7
      of 8

                  	
                    SELLER:
      __________

                  


          

           

        

      

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

      
        


        Product and Marketing
Specifications

        


        
          	
                  Product
      Spec attached as part of contract

                	
                  (Bovie)

                
	
                  Drawings

                	
                  (Bovie)

                
	
                  Customer
      Input

                	
                  (BSC)

                
	
                  BSC
      PDM Files

                	
                  (BSC)

                
	
                  Design
      History File

                	
                  (Bovie)

                


        

        


        Technical Documents,
Testing, Notebook Entries, Schedules and Activities

        


        
          	
                  BSC
      PDM Files

                	
                  (BSC)

                
	
                  Personal
      Files

                	
                  (BSC)

                
	
                  Network
      Drives

                	
                  (BSC)

                
	
                  **     **

                	
                  (BSC)

                
	
                  **     **
      Documents

                	
                  (BSC)

                
	
                  **     **
      Documents

                	
                  (BSC)

                


        

        


        Meeting Minutes,
Presentations, Trip Reports, Quality Documents, Design
Control

        


        
          	
                  BSC
      PDM Files

                	
                  (BSC)

                
	
                  Personal
      Files

                	
                  (BSC)

                
	
                  Network
      Drives

                	
                  (BSC)

                
	
                  **     **
      Documents

                	
                  (BSC)

                
	
                  **     **
      Documents

                	
                  (BSC)

                


        

        


        


        Animal and Bench Testing,
Regulatory Documents, Physician Feedback

        


        
          	
                  Video
      and Photos

                	
                  (BSC)

                
	
                  Includes
      **  ** demo

                	 
      
	
                  BSC
      PDM Files

                	
                  (BSC)

                
	
                  Personal
      Files

                	
                  (BSC)

                
	
                  Network
      Drives

                	
                  (BSC)

                


        

        


        Marketing Data, Customer
Input

        


        
          	
                  Personal
      Files

                	
                  (BSC)

                
	
                  Network
      Drives

                	
                  (BSC)

                


        

        


        1.3e)           Generated
Product IP

        


        Excluded Document
Categories

        


        Only documents or portions thereof, to
the extent they incorporate attorney-client privileged legal analysis, prepared
in response to BSC’s request to its internal or external counsel, related to the
General Product IP.  Nothwithstanding the foregoing, patent search
results and drafts of unfiled patent applications shall not be
excluded.

         

        	
                BUYER:
      __________ 

              	
                Page 8
      of 8

              	
                SELLER:
      __________

              


         

        
          
            
            

          

          
            
            

            
              

            

          

          
            
            

          

           

          EXHIBIT A (ver A-1)

           

        

      

    

    
       

       

      


      BOVIE
–

      Resection
Device

      


      Product
Specifications

      


      


      


      BOVIE MEDICAL
CORPORATION

      CONFIDENTIAL

      FOR INTERNAL USE
ONLY

       

       

      
        
          


           

          BOVIE
MEDICAL CONFIDENTIAL

          THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.



        
          
            
               


            

            
               


              
                

              

            

            
               


            

          

        

        


        Table of
Contents

         

        
          
            	
                    1 
       INTRODUCTION

                  	
                    4

                  
	
                    1.1

                  	
                    Purpose

                  	
                     4

                  
	
                    1.2

                  	
                    Scope

                  	
                     4

                  
	
                    2  
      APPLICABLE
      DOCUMENTS

                  	
                     4

                  
	
                    2.1

                  	
                    Standards

                  	
                     4

                  
	
                    3.0  
      GENERAL
      DESCRIPTION

                  	
                     4

                  
	
                    3.1

                  	
                    Concept
      Drawing

                  	
                     5

                  
	
                    3.2

                  	
                    Application

                  	
                     5

                  
	
                    3.2.1

                  	
                    Intended
      Use

                  	
                     5

                  
	
                    3.2.2

                  	
                    Intended
      Users

                  	
                     6

                  
	
                    3.3

                  	
                    Quality
      System Requirements

                  	
                     6

                  
	
                    3.3.1

                  	
                    US
      Requirements

                  	
                     6

                  
	
                    3.3.2

                  	
                    Canadian
      Requirements

                  	
                     6

                  
	
                    3.3.3

                  	
                    European
      Classifications

                  	
                     7

                  
	
                    3.3.4

                  	
                    Quality
      System Requirements

                  	
                     7

                  
	
                    4  
      PRODUCT
      DOCUMENT STRUCTURE

                  	
                     7

                  
	
                    4.1

                  	
                    Project
      Documentation

                  	
                     7

                  
	
                    4.2

                  	
                    Model
      Number Format

                  	
                     7

                  
	
                    5  
      PRODUCT
      REQUIREMENTS

                  	
                     8

                  
	
                    5.1

                  	
                    Electrical
      and Mechanical

                  	
                     8

                  
	
                    5.1.1

                  	
                    Insulated
      Handle

                  	
                     8

                  
	
                    5.1.2

                  	
                    Shaft
      and Electrode Tip

                  	
                     9

                  
	
                    5.1.3

                  	
                    Shipping
      and Handling

                  	
                     10

                  
	
                    5.1.4

                  	
                    Sterilization

                  	
                     10

                  
	
                    6 
       Protection
      Against Hazards

                  	
                     10

                  
	
                    7  
      Packaging

                  	
                     10

                  
	
                    7.1

                  	
                    Labeling

                  	
                     10

                  
	
                    7.2

                  	
                    Packaging
      Configuration

                  	
                     11

                  
	
                    7.3

                  	
                    Manufacturing

                  	
                     11

                  
	 
      	 
      	 
      


          

        

         

      

       

      BOVIE
MEDICAL CONFIDENTIAL

      
        THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.

      

      


      
        
          
             


          

          
            2

            
              

            

          

          
             


          

        

      

      


      List
of Tables

       

      
        	
                Table
      One – Standards

              	
                Page
      4

              
	
                Table
      Two – Device Classifications

              	
                Page
      6

              
	
                Table
      Three – Model Number Format

              	
                Page
      7

              


      

      


      


      List
of Figures

      
        	
                Figure
      One – Concept Drawing

              	
                Page
      5

              


      

       

      

        BOVIE
MEDICAL CONFIDENTIAL

        THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.

         

      

      
        
          
             


          

          
            3

            
              

            

          

          
             


          

        

      

       

      
        
          	
                  1

                	
                  INTRODUCTION

                


        

         

      

      
        
          	
                  1.1

                	
                  Purpose

                


        

         

      

      This
Product Specification defines preliminary product requirements and constitutes a
part of the Design Inputs for the Resection Device Project for Boston Scientific
Corporation (“BSC”).

       

      
        
          	
                  1.2

                	
                  Scope

                


        

         

      

      This
Product Specification sets forth the requirements, provided by BSC, for the
Resection Device, (the “Device”).

       

      
        
          	
                  2

                	
                  APPLICABLE
      DOCUMENTS

                


        

         

      

      The
following is a list of all documents and other sources of information referenced
in this Product Specification.

       

      
        
          	
                  2.1

                	
                  Standards

                


        

         

      

       

      
        	
                Standard

              	
                Version/Date

              	
                Description

              
	
                21
      CFR Part 820

              	 
      	
                Medical
      Devices, Current Good Manufacturing Practices, Final Rule, Quality System
      Regulation.

              
	
                HF-18

              	
                2001

              	
                AAMI/ANSI
      Electrosurgical Devices

              
	
                10993-1

              	
                3;
      Date 8-1-03

              	
                AAMI/ANSI/ISO
      Biological evaluation of medical devices – Part 1: Evaluation and
      Testing

              
	
                EN
      980

              	
                2003

                04/16/2003

              	
                Graphical
      symbols for use in the labeling of medical devices

              
	
                EN
      ISO 14971

              	
                2000
      AMD 1 2003

                03/01/2003

              	
                Medical
      devices – Application of risk management to risk management to medical
      devices (ISO 14971:2000)

              
	
                ISTA
      2A 2006

              	
                2006

              	
                Performance
      Test for Packaged-Products Weighing 150 lbs (68 kg) or
  Less

              


      

       

      Table 1 -
Applicable Standards for Medical Devices (US)

       

      
        3.0
GENERAL DESCRIPTION 

          
            

          

        

      

      


      The
Device is a sterile, single use electrosurgical device intended to be used in
conjunction with an electrosurgical generator for the delivery of radiofrequency
(“RF”) current and sterile saline for hemostatic sealing and coagulation of soft
tissue in accordance with instructions and user procedures provided by
BSC.  The device is not intended for any other unspecified uses.

      
 

      


      
        BOVIE
MEDICAL CONFIDENTIAL

        THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.

         

      

      
        
          
             


          

          
            4

            
              

            

          

          
             


          

        

      

       

      
        3.1
Concept Drawing 

          
            

          

        

         

      

       

      Figure
1

       

      3.2
Application 

        
          

        

      

       

      
        3.2.1
Intended Use 

          
            

          

        

         

      

      The
Device is a sterile, single use electrosurgical device intended to be used in
conjunction with an electrosurgical generator for the delivery of radiofrequency
current and sterile saline for hemostatic sealing and coagulation of the soft
tissue in accordance with instructions and user procedures provided by BSC. The
device is not intended for any other unspecified uses.

      


      
         

        BOVIE
MEDICAL CONFIDENTIAL

        THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.

      

       

      
        
          
             


          

          
            5

            
              

            

          

          
             


          

        

      

       

      
        3.2.2
Intended Users 

          
            

          

        

         

      

      Users of
this Device will be healthcare professionals such as medical doctors and nurses,
who are qualified and trained in electrosurgical procedures.

       

      
        3.3
Quality System Requirements 

          
            

          

        

         

      

      The
Device has the following classifications for FDA, CMDR, and MDD
classification.

       

      
        	
                Device

              	
                US
      Classification

              	
                Canada
      Classification

              	
                MDD
      Classification

              
	
                Resection
      Device

              	
                II

              	
                III

              	
                IIb

              


      

       

      Table 2 -
Device Classifications

       

      
        3.3.1
US Requirements 

          
            

          

        

         

      

      To market
medical products, the Food and Drug Administration (FDA) must determine that a
medical device is substantially equivalent to similar marketed medical
devices.  The Bovie Regulatory department intends to use the
dissecting sealer device manufactured by TissueLink as a predicate
device.

       

      
        3.3.1.1
Classification

          
            

          

        

         

      

      The
Device’s classification is Class II.

       

      
        3.3.1.2
Safety and Effectiveness requirements 

          
            

          

        

         

      

      The
Device will meet electrical safety requirements (ANSI/AAMI
HF-18:2001).

       

      
        3.3.1.3
Quality System Requirements 

          
            

          

        

         

      

      Quality
system requirements are specified as part of 21 CFR Part 820, Quality System
Regulation.

       

      
        3.3.2
Canadian Requirements 

          
            

          

        

         

      

      To market
medical products in Canada, a license application must be presented to Health
Canada. Once the license application is approved, the medical product can be
labeled and made available for sale in the Canadian provinces.

       

      
        3.3.2.1
Classification 

          
            

          

        

         

      

      Class
III

       

       

      
        BOVIE
MEDICAL CONFIDENTIAL

        THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.

         

      

      
        
          
             


          

          
            6

            
              

            

          

          
             


          

        

      

       

      
        3.3.2.2
Safety and Effectiveness requirements 

          
            

          

        

         

      

      Safety
and effectiveness requirements closely correspond to the essential requirements
of the Medical Device Directive.  A list of Health Canada recognized
standards has been issued as of April 11, 2002 in Policy on Recognition and Use
of Standards under Medical Device Regulations.

       

      
        3.3.2.3
Quality System Requirements 

          
            

          

        

         

      

      Health
Canada requires manufacturers of Class II, III and IV device to demonstrate that
their devices are manufactured in accordance with internationally recognized
standards.  Demonstration of compliance with the quality system
requirements will be required at the time an application is made for a medical
device license.

       

      
        3.3.3
European Classifications 

          
            

          

        

         

      

      
        3.3.3.1
Classification 

          
            

          

        

         

      

      The
Device is classified IIb (Rule 9 ) in accordance with the Medical Devices
Directive Annex IX.

       

      (Reference:
Guidelines for the Classification of Medical Devices – MEDDEV 2.4/1 Rev. 8, July
2001)

       

      
        3.3.3.2
Conformance Assessment Route 

          
            

          

        

         

      

      The
Device assessment route will be via Annex II (full quality assurance
system).

       

      
        3.3.4
Quality System Requirements 

          
            

          

        

         

      

      Bovie
Medical Corporation (“Bovie”) has been certified to ISO13485

       

      
        
          	
                  4

                	
                  PRODUCT
      DOCUMENT STRUCTURE

                


        

         

      

      
        
          	
                  4.1

                	
                  Project
      Documentation

                


        

         

      

      Documents
will be in standard Bovie document format.

       

      
        
          	
                  4.2

                	
                  Model
      Number Format

                


        

         

      

      The
following table lists the Device’s model number and corresponding product /
catalog code.

       

      
        	
                Catalog
      #

              	
                Comments

              
	
                TBD

              	
                Laparoscopic  Monopolar
      Device

              
	
                TBD

              	
                Open
      Abdominal Monopolar Device

              


      

       

      Table Three

       

       

      BOVIE
MEDICAL CONFIDENTIAL

      THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.

      


      
        
          
             


          

          
            7

            
              

            

          

          
             


          

        

      

       

      
        
          	
                  5

                	
                  PRODUCT
      REQUIREMENTS

                


        

         

      

      The
following section will describe requirements for the insulated handle and shaft
with electrode tip.

       

      
        
          	
                  5.1

                	
                  Electrical
      and Mechanical

                


        

         

      

      The
Device hardware is comprised of two (2) major components: (i) an Insulated
Handle and (ii) a Shaft with Electrode Tip. RF energy is passed through the
Insulated Handle through the Shaft to the Electrode Tip by a powered lead from
an electrosurgical generator.

       

      
        
          	
                  5.1.1

                	
                  Insulated
      Handle

                


        

         

      

      The Insulated Handle encases the controlling
mechanism for the flow of saline, and activation and selection of the RF current
for the Device.

       

      5.1.1.1
Insulated Handle and Power Cord Insulation Resistance

       

      The
insulation of the Insulated Handle and Power Cord shall meet Requirements of
Section 4.2.5.4 Dielectric withstands of accessories ANSI/AAMI
HF-18:2001

       

      5.1.1.2
Insulated Handle Ergonomics

       

      The
Insulated Handle shall be designed for comfortable and efficient hand
operation.  It will incorporate an over-mold to give the body an
elegant feel and soft touch.

       

      5.1.1.3 Insulated Handle Electrical
Cord

       

      The
Insulated Handle Electrical Cord shall be approximately ten (10) feet in length
and incorporate a 3-prong electrical plug.

       

      5.1.1.4
Insulated Handle Flow Control Mechanism

       

      The
Device will have a flow control mechanism, either on the tubing or in the handle
itself so the flow can be regulated by the user within the sterile
field.

       

      5.1.1.5 Insulated Handle Tubing
Length

       

      The
tubing length should be approximately seven (7) feet in length and incorporate
an I.V. spike on the end to attach directly to a hanging IV bag.

       

      5.1.1.6
Insulated Handle Tubing Material

       

      The
tubing material should be a material that will resist kinking but should not
have so strong a memory as to pull the probe off of the sterile
field.

       

      5.1.1.7 Insulated Handle Activation
Buttons

       

       

      BOVIE
MEDICAL CONFIDENTIAL

      THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.

      


      
        
          
             


          

          
            8

            
              

            

          

          
             


          

        

      

       

      The
Device should have a Cut and Coagulation Mode. “Cut”/”Coag” buttons must be easy
to operate.

       

      5.1.1.8
Insulated Handle Compatibility

       

      
        	
                 
      

              	
                ·

              	
                The
      Insulated Handle should have compatibility with standard RF generators
      used for electrocautery and standard grounding
  pad.

              


      

       

      
        	
                 
      

              	
                ·

              	
                The
      Insulated Handle should have compatibility with standard 0.9% saline I.V.
      bag.

              


      

       

       

      
        
          	
                  5.1.2

                	
                  Shaft
      and Electrode Tip

                


        

         

      

      The Shaft
and Electrode Tip provide the actual working portion of this
system.

       

      5.1.2.1
Saline Flow Rate of Device

       

      The
Saline flow rate prior to use will be
**       **

       

      5.1.2.2
Device (Shaft) Length

       

      The
Device should be straight and have two (2) lengths: one for laparoscopic
monopolar procedures (approximately thirty-two (32) cm) and one for open
monopolar procedures (approximately fourteen (14) cm).

       

      5.1.2.3
Shaft Configuration

       

      The Shaft
will be hollow to allow for fluid to flow to the sintered stainless steel tip.
The inside diameter of the Shaft should be equal to the inside diameter of the
tubing that feeds fluid to the Shaft to minimize any flow restriction in the
fluid circuit.

       

      5.1.2.4
Tip Material

       

      The Tip
shall be made of **       **

       

      .

       

      5.1.2.5
Tip Strength

       

      The
porous blade tip to shaft tensile bond strength (axial mode) must be greater
than **       **

       

       after
being subjected to a full-power simulated use duty cycle.

       

      The
porous blade tip to shaft bond strength in an flexural mode must be greater than
**       **

       

       

      
        BOVIE
MEDICAL CONFIDENTIAL

        THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.

         

      

      
        
          
             


          

          
            9

            
              

            

          

          
             


          

        

      

       

      . after
being subjected to a full-power simulated use duty cycle.

       

      5.1.2.6
Tip performance

       

      
        	
                 
      

              	
                ·

              	
                Bovie
      will exert its best efforts to meet the design goal that tip cutting
      performance be superior to competitive devices with respect to cutting
      speed. Tip will have the ability to coagulate soft tissue when performed
      in a suitable simulated use
environment.

              


      

       

      
        
          	
                  5.1.3

                	
                  Shipping
      and Handling

                


        

         

      

      4.1.3.1
Shipping Temperatures

       

      Tropical
(Wet and Dry) Conditions and Winter (Frozen) Conditions per ISTA
2A.

       

      4.1.3.2
Transportation Testing

       

      The Final
Product Packaging Configuration for the Device shall meet the finished device
requirements after being subjected to Simulated Transportation Conditioning per
ISTA 2A.

       

      
        
          	
                  5.1.4

                	
                  Sterilization

                


        

         

      

      5.1.4.1
Withstand 2x ETO Sterilization.

       

      5.1.4.2
EN 550: 1994 – Sterilization of Medical Devices – Validation and routine control
of ethylene oxide sterilization.

       

      5.1.4.3
AAMI/ANSI/ISO 11135 -1994 Medical Devices – Validation and routine control of
ethylene oxide sterilization.

       

      
        
          	
                  6

                	
                  Protection
      Against Hazards

                


        

         

      

      A
Hazard/Risk Analysis will be performed throughout the design
process.  The Hazard/Risk Analysis will be documented and filed as
part of the design history file.

       

      
        
          	
                  7

                	
                  Packaging

                


        

         

      

      
        
          	
                  7.1

                	
                    Labeling

                


        

         

      

      
        7.1.1
Package must be labeled in accordance with both BSC and Bovie Labeling
Standards.

      

      


      
        7.1.2
BSC and Bovie branding, including mutually approved trademarks, will be on
the Handle and/or the shaft.

      

      


      7.1.3 The
Device is to have a three (3) year shelf life under normal storage
conditions.

       

       

      
        BOVIE
MEDICAL CONFIDENTIAL

        THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.


      

      
        
          
             


          

          
            10

            
              

            

          

          
             


          

        

      

       

      
        
          	
                  7.2

                	
                  Packaging
      Configuration

                


        

         

      

      
        	
                 
      

              	
                ·

              	
                The
      Tip and Shaft protector shall be included into the
  Design.

              


      

      
        	
                 
      

              	
                ·

              	
                The
      Scratch Pad shall be packaged with the
Device.

              


      

      
        	
                 
      

              	
                ·

              	
                The
      Device will be packaged in a Sterile
Pouch.

              


      

      
         

        
          	
                  7.3

                	
                  Manufacturing

                


        

         

      

      Final
assembly and packaging will be performed by
Bovie.   

       

      
         

        
          BOVIE
MEDICAL CONFIDENTIAL

          THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.


        

      

      
        
          
          

        

        
          11

          
            

          

        

        
          
          

        

      

       

      APPROVALS

      


      
        	
                Author

              	    
      	 
      	 
      
	 
      	
                Thomas
      Feldhaus

              	 
      	
                Date

              
	
                Sales
      & Marketing

              	  
        	 
      	  
        
	 
      	
                Rick
      Pfahl

              	 
      	
                Date

              
	
                Regulatory

              	   
          	 
      	  
        
	 
      	
                Rick
      Kozloff

              	 
      	
                Date

              
	
                Quality

              	   
        	 
      	  
      
	 
      	
                John
      Woody

              	 
      	
                Date

              
	
                Manufacturing

              	    
      	 
      	 
       
	 
      	
                Lillian
      Eshem

              	 
      	
                Date

              
	
                Engineering

              	    
        	 
      	 
        
	 
      	
                Fred
      Baron

              	 
      	
                Date

              


      

       

      

        
          BOVIE
MEDICAL CONFIDENTIAL

          THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.

           

          
            
              
              

            

            
              12

              
                

              

            

            
              
              

            

          

           

          EXHIBIT A (ver A-2)

           

        

         

        

      

    

     

     

    BOVIE
–

    Resection
Device

    


    Product
Specifications

    


    


    


    BOVIE MEDICAL
CORPORATION

    CONFIDENTIAL

    FOR INTERNAL USE
ONLY

     

     

    BOVIE
MEDICAL CONFIDENTIAL

    THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.

    


    
      
        
           


        

        
           


          
            

          

        

        
           


        

      

    

    


    Table of
Contents

     

    
      
        	1
      INTRODUCTION	
                4

              
	
                1.1

              	
                Purpose

              	
                4

              
	
                1.2

              	
                Scope

              	
                4

              
	2
      APPLICABLE
      DOCUMENTS	
                4

              
	
                2.1

              	
                Standards

              	
                4

              
	3.0
      GENERAL
      DESCRIPTION	
                4

              
	
                3.1

              	
                Concept
      Drawing

              	
                5

              
	
                3.2

              	
                Application

              	
                5

              
	
                3.2.1

              	
                Intended
      Use

              	
                5

              
	
                3.2.2

              	
                Intended
      Users

              	
                5

              
	
                3.3

              	
                Quality
      System Requirements

              	
                6

              
	
                3.3.1

              	
                US
      Requirements

              	
                6

              
	
                3.3.2

              	
                Canadian
      Requirements

              	
                6

              
	
                3.3.3

              	
                European
      Classifications

              	
                7

              
	
                3.3.4

              	
                Quality
      System Requirements

              	
                7

              
	4
      PRODUCT
      DOCUMENT STRUCTURE	
                7

              
	
                4.1

              	
                Project
      Documentation

              	
                7

              
	
                4.2

              	
                Model
      Number Format

              	
                7

              
	5
      PRODUCT
      REQUIREMENTS	
                7

              
	
                5.1

              	
                Electrical
      and Mechanical

              	
                8

              
	
                5.1.1

              	
                Insulated
      Handle

              	
                8

              
	
                5.1.2

              	
                Shaft
      and Electrode Tip

              	
                9

              
	
                5.1.3

              	
                Shipping
      and Handling

              	
                10

              
	
                5.1.4

              	
                Sterilization

              	
                10

              
	6
      Protection
      Against Hazards	
                10

              
	7
      Packaging	
                10

              
	
                7.1

              	
                Labeling

              	
                10

              
	
                7.2

              	
                Packaging
      Configuration

              	
                10

              
	
                7.3

              	
                Manufacturing

              	
                10

              


      

    

    


    

      BOVIE
MEDICAL CONFIDENTIAL

      THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.

    

    


    
      
        
           


        

        
          2

          
            

          

        

        
           


        

      

    

    


    List
of Tables

     

    
      	
              Table
      One – Standards

            	
              Page
      4

            
	
              Table
      Two – Device Classifications

            	
              Page
      6

            
	
              Table
      Three – Model Number Format

            	
              Page
      7

            


    

    


    


    List
of Figures

     

    
      	
              Figure
      One – Concept Drawing

            	
              Page
      5

            


    

     

    
       

    

    
      BOVIE
MEDICAL CONFIDENTIAL

      THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.

       

    

    
      
        
           


        

        
          3

          
            

          

        

        
           


        

      

    

     

    
      
        	
                1

              	
                INTRODUCTION

              


      

       

    

    
      
        	
                1.1

              	
                Purpose

              


      

       

    

    This
Product Specification defines preliminary product requirements and constitutes a
part of the Design Inputs for the Resection Device Project for Boston Scientific
Corporation (“BSC”).

     

    
      
        	
                1.2

              	
                Scope

              


      

       

    

    This
Product Specification sets forth the requirements, provided by BSC, for the
Resection Device, (the “Device”).

     

    
      
        	
                2

              	
                APPLICABLE
      DOCUMENTS

              


      

       

    

    The
following is a list of all documents and other sources of information referenced
in this Product Specification.

     

    
      
        	
                2.1

              	
                Standards

              


      

       

    

    
      	
              Standard

            	
              Version/Date

            	
              Description

            
	
              21
      CFR Part 820

            	 
      	
              Medical
      Devices, Current Good Manufacturing Practices, Final Rule, Quality System
      Regulation.

            
	
              HF-18

            	
              2001

            	
              AAMI/ANSI
      Electrosurgical Devices

            
	
              10993-1

            	
              3;
      Date 8-1-03

            	
              AAMI/ANSI/ISO
      Biological evaluation of medical devices – Part 1: Evaluation and
      Testing

            
	
              EN
      980

            	
              2003

              04/16/2003

            	
              Graphical
      symbols for use in the labeling of medical devices

            
	
              EN
      ISO 14971

            	
              2000
      AMD 1 2003

              03/01/2003

            	
              Medical
      devices – Application of risk management to risk management to medical
      devices (ISO 14971:2000)

            
	
              ISTA
      2A 2006

            	
              2006

            	
              Performance
      Test for Packaged-Products Weighing 150 lbs (68 kg) or
  Less

            


    

     

    Table 1 -
Applicable Standards for Medical Devices (US)

     

    3.0
GENERAL DESCRIPTION 

      
        

      

    

     

    The
Device is a sterile, single use electrosurgical device intended to be used in
conjunction with an electrosurgical generator for the delivery of radiofrequency
(“RF”) current and sterile saline for hemostatic sealing and coagulation of soft
tissue in accordance with instructions and user procedures provided by
BSC.  The device is not intended for any other unspecified uses.

    


     

    
      BOVIE
MEDICAL CONFIDENTIAL

      THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.


    

    
      
        
           


        

        
          4

          
            

          

        

        
           


        

      

    

     

    
      3.1
Concept Drawing 

        
          

        

      

       

    

     

    Figure
1

     

    
      3.2
Application 

        
          

        

      

       

    

    
      3.2.1
Intended Use 

        
          

        

      

       

    

    The
Device is a sterile, single use electrosurgical device intended to be used in
conjunction with an electrosurgical generator for the delivery of radiofrequency
current and sterile saline for hemostatic sealing and coagulation of the soft
tissue in accordance with instructions and user procedures provided by BSC. The
device is not intended for any other unspecified uses.

    
      


       

      3.2.2
Intended Users 

        
          

        

      

       

    

    Users of
this Device will be healthcare professionals such as medical doctors and nurses,
who are qualified and trained in electrosurgical procedures.

     

     

    
      BOVIE
MEDICAL CONFIDENTIAL

      THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.


    

    
      
        
           


        

        
          5

          
            

          

        

        
           


        

      

    

     

    
      3.3
Quality System Requirements 

        
          

        

      

       

    

    The
Device has the following classifications for FDA, CMDR, and MDD
classification.

     

    
      	
              Device

            	
              US
      Classification

            	
              Canada
      Classification

            	
              MDD
      Classification

            
	
              Resection
      Device

            	
              II

            	
              III

            	
              IIb

            


    

     

    Table 2 -
Device Classifications

     

    
      3.3.1
US Requirements 

        
          

        

      

       

    

    To market
medical products, the Food and Drug Administration (FDA) must determine that a
medical device is substantially equivalent to similar marketed medical
devices.  The Bovie Regulatory department intends to use the
dissecting sealer device manufactured by TissueLink as a predicate
device.

     

    
      3.3.1.1
Classification 

        
          

        

      

       

    

    The
Device’s classification is Class II.

     

    
      3.3.1.2
Safety and Effectiveness requirements 

        
          

        

      

       

    

    The
Device will meet electrical safety requirements (ANSI/AAMI
HF-18:2001).

     

    
      3.3.1.3
Quality System Requirements 

        
          

        

      

       

    

    Quality
system requirements are specified as part of 21 CFR Part 820, Quality System
Regulation.

     

    
      3.3.2
Canadian Requirements 

        
          

        

      

       

    

    To market
medical products in Canada, a license application must be presented to Health
Canada. Once the license application is approved, the medical product can be
labeled and made available for sale in the Canadian provinces.

     

    
      3.3.2.1
Classification 

        
          

        

      

       

    

    Class
III

     

    
      3.3.2.2
Safety and Effectiveness requirements 

        
          

        

      

       

    

    Safety
and effectiveness requirements closely correspond to the essential requirements
of the Medical Device Directive.  A list of Health Canada recognized
standards has been issued as of April 11, 2002 in Policy on Recognition and Use
of Standards under Medical Device Regulations.

     

     

    
      BOVIE
MEDICAL CONFIDENTIAL

      THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.


    

    
      
        
           


        

        
          6

          
            

          

        

        
           


        

      

    

     

    
      3.3.2.3
Quality System Requirements 

        
          

        

      

       

    

    Health
Canada requires manufacturers of Class II, III and IV device to demonstrate that
their devices are manufactured in accordance with internationally recognized
standards.  Demonstration of compliance with the quality system
requirements will be required at the time an application is made for a medical
device license.

     

    
      3.3.3
European Classifications 

        
          

        

      

       

    

    
      3.3.3.1
Classification 

        
          

        

      

       

    

    The
Device is classified IIb (Rule 9 ) in accordance with the Medical Devices
Directive Annex IX.

     

     

    (Reference:
Guidelines for the Classification of Medical Devices – MEDDEV 2.4/1 Rev. 8, July
2001)

     

    
      3.3.3.2
Conformance Assessment Route 

        
          

        

      

       

    

    The
Device assessment route will be via Annex II (full quality assurance
system).

     

    
      3.3.4
Quality System Requirements 

        
          

        

      

       

    

    Bovie
Medical Corporation (“Bovie”) has been certified to ISO13485

     

    
      
        	
                4

              	
                PRODUCT
      DOCUMENT STRUCTURE

              


      

       

    

    
      
        	
                4.1

              	
                Project
      Documentation

              


      

       

    

    Documents
will be in standard Bovie document format.

     

    
      
        	
                4.2

              	
                Model
      Number Format

              


      

       

    

    The
following table lists the Device’s model number and corresponding product /
catalog code.

     

    
      	
              Catalog
      #

            	
              Comments

            
	
              TBD

            	
              Laparoscopic  Monopolar
      Device

            
	
              TBD

            	
              Open
      Abdominal Monopolar Device

            


    

     

    Table Three

     

    
      
        	
                5

              	
                PRODUCT
      REQUIREMENTS

              


      

       

    

    The
following section will describe requirements for the insulated handle and shaft
with electrode tip.

     

     

    
      BOVIE
MEDICAL CONFIDENTIAL

      THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.


    

    
      
        
           


        

        
          7

          
            

          

        

        
           


        

      

    

     

    
      
        	
                5.1

              	
                Electrical
      and Mechanical

              


      

       

    

    The
Device hardware is comprised of two (2) major components: (i) an Insulated
Handle and (ii) a Shaft with Electrode Tip. RF energy is passed through the
Insulated Handle through the Shaft to the Electrode Tip by a powered lead from
an electrosurgical generator.

     

    
      
        	
              	
                5.1.1

              	
                Insulated
      Handle

              


      

       

    

    The Insulated Handle encases the controlling
mechanism for the flow of saline, and activation and selection of the RF current
for the Device.

     

    5.1.1.1
Insulated Handle and Power Cord Insulation Resistance

     

    The
insulation of the Insulated Handle and Power Cord shall meet Requirements of
Section 4.2.5.4 Dielectric withstands of accessories ANSI/AAMI
HF-18:2001

     

    5.1.1.2
Insulated Handle Ergonomics

     

    The
Insulated Handle shall be designed for comfortable and efficient hand
operation.  It will incorporate an over-mold to give the body an
elegant feel and soft touch.

     

    5.1.1.3 Insulated Handle Electrical
Cord

     

    The
Insulated Handle Electrical Cord shall be approximately ten (10) feet in length
and incorporate a 3-prong electrical plug.

     

    5.1.1.4
Insulated Handle Flow Control Mechanism

     

    The
Device will have a flow control mechanism in the handle so the flow can be
regulated by the user within the sterile field.

     

    5.1.1.5 Insulated Handle Tubing
Length

     

    The
tubing length should be approximately ten (10) feet in length and incorporate an
I.V. spike on the end to attach directly to a hanging IV bag.

     

    5.1.1.6
Insulated Handle Tubing Material

     

    The
tubing material should be a material that will resist kinking but should not
have so strong a memory as to pull the probe off of the sterile
field.

     

    5.1.1.7 Insulated Handle Activation
Buttons

     

    The
Device should have an activation button. The activation button must be easy to
operate.

     

    5.1.1.8
Insulated Handle Compatibility

     

     

    
      BOVIE
MEDICAL CONFIDENTIAL

      THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.


    

    
      
        
           


        

        
          8

          
            

          

        

        
           


        

      

    

     

    
      	
               
      

            	
              ·

            	
              The
      Insulated Handle should have compatibility with standard RF generators
      used for electrocautery and standard grounding
  pad.

            


    

     

    
      	
               
      

            	
              ·

            	
              The
      Insulated Handle should have compatibility with standard 0.9% saline I.V.
      bag.

            


    

     

    
      
        	
              	
                5.1.2

              	
                Shaft
      and Electrode Tip

              


      

       

    

    The Shaft
and Electrode Tip provide the actual working portion of this
system.

     

    5.1.2.1
Saline Flow Rate of Device

     

    The
Saline flow rate prior to use will be
**       **.

     

    5.1.2.2
Device (Shaft) Length

     

    The
Device should be straight and have two (2) lengths: one for laparoscopic
monopolar procedures (approximately thirty-two (32) cm) and one for open
monopolar procedures (approximately fourteen (14) cm).

     

    5.1.2.3
Shaft Configuration

     

    The Shaft
will be hollow to allow for fluid to flow to the sintered stainless steel tip.
The inside diameter of the Shaft should be equal to the inside diameter of the
tubing that feeds fluid to the Shaft to minimize any flow restriction in the
fluid circuit.

     

    5.1.2.4
Tip Material

     

    The Tip
shall be made of **       **.

     

    5.1.2.5
Tip Strength

     

    The
porous blade tip to shaft tensile bond strength (axial mode) must be greater
than **       ** after being subjected to a
full-power simulated use duty cycle.

     

    The
porous blade tip to shaft bond strength in an flexural mode must be greater than
**       ** after being subjected to a
full-power simulated use duty cycle.

     

    5.1.2.6
Tip performance

     

    
      	
               
      

            	
              ·

            	
              Bovie
      will exert its best efforts to meet the design goal that tip cutting
      performance be superior to competitive devices with respect to cutting
      speed. Tip will have the ability to coagulate soft tissue when performed
      in a suitable simulated use
environment.

            


    

     

     

    
      BOVIE
MEDICAL CONFIDENTIAL

      THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.


    

    
      
        
           


        

        
          9

          
            

          

        

        
           


        

      

    

     

    
      
        	
              	
                5.1.3

              	
                Shipping
      and Handling

              


      

       

    

    4.1.3.1
Shipping Temperatures

     

    Tropical
(Wet and Dry) Conditions and Winter (Frozen) Conditions per ISTA
2A.

     

    4.1.3.2
Transportation Testing

     

    The Final
Product Packaging Configuration for the Device shall meet the finished device
requirements after being subjected to Simulated Transportation Conditioning per
ISTA 2A.

     

    
      
        	
              	
                5.1.4

              	
                Sterilization

              


      

       

    

    5.1.4.1
Withstand 2x ETO Sterilization.

     

    5.1.4.2
EN 550: 1994 – Sterilization of Medical Devices – Validation and routine control
of ethylene oxide sterilization.

     

    5.1.4.3
AAMI/ANSI/ISO 11135 -1994 Medical Devices – Validation and routine control of
ethylene oxide sterilization.

     

    
      
        	
                6

              	
                Protection
      Against Hazards

              


      

       

    

    A
Hazard/Risk Analysis will be performed throughout the design
process.  The Hazard/Risk Analysis will be documented and filed as
part of the design history file.

     

    
      
        	
                7

              	
                Packaging

              


      

       

    

    
      
        	
                7.1

              	
                  Labeling

              


      

       

    

    
      7.1.1
Package must be labeled in accordance with both BSC and Bovie Labeling
Standards.

    

    


    
      7.1.2
BSC and Bovie branding, including mutually approved trademarks, will be on
the Handle and/or the shaft.

    

    


    7.1.3 The
Device is to have a three (3) year shelf life under normal storage
conditions.

    
       

      
        	
                7.2

              	
                Packaging
      Configuration

              


      

       

    

    
      	
               
      

            	
              ·

            	
              The
      Tip and Shaft protector shall be included into the
  Design.

            


    

    
      	
               
      

            	
              ·

            	
              The
      Scratch Pad shall be packaged with the
Device.

            


    

    
      	
               
      

            	
              ·

            	
              The
      Device will be packaged in a Sterile
Pouch.

            


    

    
       

      
        	
                7.3

              	
                Manufacturing

              


      

       

    

    Final
assembly and packaging will be performed by
Bovie.   

     

     

    
      BOVIE
MEDICAL CONFIDENTIAL

      THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.


    

     

    
      
        
        

      

      
        10

        
          

        

      

      
        
        

      

    

    


    APPROVALS

    


    
      	
              Author

            	 
      	 
      	 
      
	 
      	
              Thomas
      Feldhaus

            	 
      	
              Date

            
	
              Sales
      & Marketing

            	 
        	 
      	 
        
	 
      	
              Rick
      Pfahl

            	 
      	
              Date

            
	
              Regulatory

            	  
        	 
      	 
          
	 
      	
              Rick
      Kozloff

            	 
      	
              Date

            
	
              Quality

            	 
        	 
      	 
        
	 
      	
              John
      Woody

            	 
      	
              Date

            
	
              Manufacturing

            	  
      	 
      	 
      
	 
      	
              Lillian
      Eshem

            	 
      	
              Date

            
	
              Engineering

            	   
        	 
      	 
        
	 
      	
              Fred
      Baron

            	 
      	
              Date

            


    

     

    


    
      BOVIE
MEDICAL CONFIDENTIAL

      THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.

       

    

    
      
        
           


        

        
          11