Document:

Unassociated Document

    
      	 	
              g8wave,
                Inc

            
	 	
              126
                Brookline Avenue

            
	 	
              Boston,
                MA 02215

            

    

    

    July
      11,
      2007

    

    Metallica

    c/o
      Peter
      Paterno

    1900
      Avenue of the Stars

    26th
      Floor

    Los
      Angeles, CA 90067

    

    Re: 
      Music Sector Agreement - Waiver of SAR Exercise Right 

    

    Gentlemen:

    

    Reference
      is made to that certain Music Sector Agreement for the Provision of Premium
      Rate
      Telephone Services, Premium Text Services, dated May 25, 2005, between the
      band
      know as Metallica ("Artist"),
      and
      TP Corporation, a Massachusetts corporation (the "Agreement").
      Pursuant to that certain Assignment and Assumption Agreement dated May 12,
      2006,
      TP Corporation assigned its rights and obligations under the Agreement to
      G8Wave, Inc., a Delaware corporation ("g8wave").
      Capitalized terms used herein without definition shall have the respective
      meanings set forth in the Agreement.

    

    g8wave
      is
      currently attempting to effect what is commonly referred to as a "reverse merger
      transaction." Assuming this transaction is consummated, at the closing (1)
      g8wave will be merged
      with and into a wholly-owned
      subsidiary of a public company ("Pubco"),
      with
      g8wave being
      the
      surviving entity of the merger, and (2) Pubco will issue and sell shares of,
      and
      warrants to
      purchase, its common stock (the "PIPE
      Shares")
      to
      certain accredited investors in a private placement.
      Immediately following the closing of the Transaction, g8wave's former
      stockholders
      will
      continue to own a majority of the issued and outstanding shares of Pubco, and
      Pubco will file with the SEC a registration statement covering the PIPE shares.
      The transactions described above and related thereto are referred to herein
      as
      the "Transaction."

    

    Pursuant
      to Section 4.2 of the Agreement, g8wave granted to Artist an SAR, the terms
      and
conditions
      of which are set forth on Schedule C of the Agreement (the "SAR
      Terms").
      Pursuant to
      the
      SAR Terms, the SAR is exercisable on a Realization Event, and one or more
      aspects of the
      Transaction may constitute such a Realization Event.

    

    By
      signing below, Artist hereby irrevocably agrees to waive its rights, if any,
      to
      exercise the SAR in connection with the Transaction. The above waiver is given
      with respect to the Transaction
      only, and not with respect to any subsequent events that may constitute a
      Realization
      Event.

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      
Page
      2

    

    By
      signing below, Artist hereby acknowledges that it is aware, and will advise
      its
      representatives and affiliates that are or may become informed about the
      Transaction, that the United States securities laws may prohibit a person or
      entity that has material, non-public information concerning matters of the
      type
      covered by this letter from (1) purchasing or selling securities of a company
      that may be, or may be affiliated with, a party to a transaction such as the
      Transaction, or (2) from communicating such information to any other person
      or
      entity under circumstances in which it is reasonably foreseeable that such
      person or entity is likely to purchase or sell such securities. Artist further
      agrees, and shall cause its representatives and affiliates, to keep the
      existence and terms of the Transaction confidential until such time as the
      same
      are publicly disclosed by g8wave or Pubco, including by way of one or more
      filings with the Securities and Exchange Commission.

    

    Except
      as
      specifically set forth in this letter, the parties hereby confirm that the
      Agreement remains in full force and effect.

    

    [SIGNATURES
      ON NEXT PAGE]

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      
Page
      3

    Please
      confirm your agreement with the foregoing by signing in the space provided
      below
      and returning a copy of this letter to me at your earliest
      convenience.

    

    
      	 	
              Sincerely,

            
	 	 
	 	
              /s/
                Habib Khoury

            
	 	
              Habib
                Khoury

            
	 	
              President
                & CEO 

            
	 	
              G8Wave,
                Inc.

            

    

    

     

    AGREED
      AND ACCEPTED

    AS
      OF THE
      FIRST DATE 

    WRITTEN
      ABOVE BY:

     

    METALLICA

     

     

     

    By:
      /s/
      Clifford Burnstein   

    Name:
      Clifford
      Burnstein   

    Title:
      Manager[CONFIDENTIAL
      PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE
      COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THESE PORTIONS
      HAVE
      BEEN REPLACED THROUGHOUT THIS AGREEMENT AND SCHEDULES BY THE FOLLOWING SYMBOL:
      ***] 

    

    SUPPLY
      AGREEMENT

    

    This
      AGREEMENT (the "Agreement") dated as of JUNE 12, 2007 (the "Effective Date")
      between Diagnostic Chemicals Limited, doing business as, BioVectra, a Prince
      Edward Island, Canada corporation, having its principal place of business at
      16
      McCarville Street, Charlottetown, PE C1E 2A6, Canada (hereinafter referred
      to as
      "BioVectra") and SyntheMed, Inc., a Delaware corporation, with an address at
      200
      Middlesex Essex Turnpike, Suite 210, Iselin, NJ 08830 (hereinafter referred
      to
      as "SyntheMed").

    

    WHEREAS,
      BIOVECTRA is a company engaged in, among other things, synthesis of polymers
      for
      use in a wide variety of applications including medical
      applications;

    

    WHEREAS,
      SyntheMed is engaged
      in the development and commercialization of products designed to prevent or
      reduce the formation of adhesions following a broad range of surgical
      procedures, all of which are based on SyntheMed’s proprietary, bioresorbable
      polymer technology.

    

    WHEREAS,
      SyntheMed’s lead product, REPEL-CV, is classified as a medical device by the US
      Food and Drug Administration and is currently under review by the
      FDA.

    

    WHEREAS,
      BIOVECTRA has demonstrated its ability and capacity to produce polymer raw
      material in accordance with SyntheMed’s specifications for use in REPEL-CV;

    

    WHEREAS,
      SyntheMed desires BIOVECTRA to manufacture, supply and sell to SyntheMed polymer
      raw material for further processing and incorporation into SyntheMed’s REPEL-CV
      finished product, for sale by SyntheMed to its customers, and BIOVECTRA desires
      to manufacture, supply and sell to SyntheMed such polymer raw material, all
      on
      the terms and conditions set forth herein. 

    

     NOW,
      THEREFORE, in consideration of the foregoing premises and the mutual covenants
      and agreements provided herein, the parties hereto, intending to be legally
      bound hereby, agree as follows:

     

    1.
      DEFINITIONS

    

    1.1.
      "Act" shall mean the Federal Food, Drug and Cosmetic Act.

    

    1.2.
      "Approval(s)" shall mean receipt from the FDA or other applicable Regulatory
      Authority of final approval, including any applicable pricing, final labeling
      or
      reimbursement approvals, necessary to manufacture Product. 

    

    1.3.
      "BIOVECTRA Indemnified Party" shall have the meaning set forth in Section
      14.2.

    

    1.4.
      "Claim(s)" shall mean all charges, complaints, actions, suits, proceedings,
      hearings, investigations, claims and demands.

    

    1.5.
      "Commercial Product" shall mean SyntheMed’s finished product known as REPEL-CV.

    

    1.6.
      "Confidential Information" shall mean all oral or written information that
      is
      disclosed by either party (the "Disclosing Party") to the other party (the
      "Receiving Party"), or that the

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    Receiving
      Party becomes aware of as a result of its discussions and work with the
      Disclosing Party, and that is not generally known to the public, including
      but
      not limited to, information of a technical nature such as trade secrets;
      manufacturing processes or devices or know-how; techniques, data, formulas,
      inventions, discoveries or innovations (whether or not patentable),
      specifications and characteristics of current products or products under
      development; research projects, methods and results; matters of a business
      nature such as information about costs, margins, pricing policies, markets,
      sales, suppliers and customers; product, marketing or strategic plans; financial
      information; personnel records and other information of a similar nature,
      provided, however, that Confidential Information shall not include any
      information that (i) is or becomes public knowledge without breach of the
      Receiving Party's obligations hereunder; (ii) is rightfully acquired by the
      Receiving Party from a third party that legally acquired the information and
      is
      not under a confidentiality restriction on disclosure or use; (iii) was already
      known to the Receiving Party prior to receipt from the Disclosing Party as
      evidenced by written and dated records; (iv) is independently developed by
      the
      Receiving Party;(v) is required to be disclosed by law or court order, provided
      that notice of the requirement is promptly delivered to the Disclosing Party
      in
      order to provide the Disclosing Party with an opportunity to challenge or limit
      the disclosure obligations; or (vi) is disclosed or used following the Receiving
      Party's receipt of express written consent from an authorized representative
      of
      the Disclosing Party. The Receiving Party shall have the burden of proof
      respecting any of the aforementioned events on which the Receiving Party relies
      as relieving it of any confidentiality restrictions hereunder. Written
      disclosures for which protection is sought must be obviously marked as
      "Confidential" or "Proprietary" and oral disclosures for which protection is
      sought must at the outset be clearly identified by the Disclosing Party as
      Confidential Information and submitted by the Disclosing Party in summary form
      to the Receiving Party, marked as above within thirty (30) days after
      disclosure; provided, however, that protection under Article 9 shall also be
      given to information that is not so marked if a reasonable person trained in
      research, development, manufacturing and marketing within the Field would assume
      that it is Confidential Information. For written information that would not
      normally appear to constitute confidential information, for the restrictions
      on
      Confidential Information to apply, a party must mark such information
      "CONFIDENTIAL."

    

    1.7
      “Designated Facility” means the facility designated from time to time by
      SyntheMed for further processing of Product.

    

    1.8.
      "Device Master File" shall mean materials that may be used to provide detailed
      information to the FDA or other Regulatory Body about facilities, processes,
      or
      articles used in the manufacturing, processing, packaging, and storing of the
      Products.

    

    1.9.
      "Disclosing Party" shall have the meaning set forth in Section 1.6.

    

    1.10.
      "FDA" shall have the meaning set forth in Section 3.1.

    

    1.11.
      "Governmental Authority" shall mean any court, tribunal, arbitrator, agency,
      department, legislative body, commission or other instrumentality of (a) any
      government of any country, (b) any foreign, federal, state, county, city or
      other political subdivision thereof or (c) any supranational body exerting
      authority or jurisdiction over BioVectra’s manufacture of Product.

    

    1.12.
      "Initial Term" shall have the meaning set forth in Section 2.1.

    

    1.13.
      "Intellectual Property" shall mean all inventions, discoveries and innovations
      (whether patentable or unpatentable and whether or not reduced to practice),
      all
      improvements thereto, and all patents, patent rights, patent applications and
      invention disclosures, together with all reissues,

    
      
         

      

      
        2

        
          

        

      

      
         

      

    

    continuations,
      continuations-in-part, revisions, extensions, and reexaminations thereof, all
      registered or unregistered trademarks, trade names and service marks, including
      all goodwill associated therewith, and copyrights, and all applications and
      registrations for any of the foregoing owned or controlled by or issued to
      SyntheMed or BIOVECTRA, and any trade secrets and know-how, in each case
      relating to the Products or Commercial Products.

    

    1.14.
      "Losses" shall mean any and all damages, awards, deficiencies, settlement
      amounts, defaults, assessments, fines, dues, penalties, costs, fees,
      liabilities, obligations, taxes, liens, losses, and expenses (including without
      limitation court costs, interest and reasonable fees of attorneys, accountants
      and other experts) incurred by or awarded to third parties and required to
      be
      paid to third parties with respect to a Claim by reason of any judgment, order,
      decree, stipulation or injunction, or any settlement subject to the
      indemnification provisions of this Agreement, together with all documented
      out-of-pocket costs and expenses incurred in complying with any judgments,
      orders, decrees, stipulations and injunctions that arise from or relate to
      a
      Claim of a third party.

    

    1.15.
      "Post Term Supply" shall have the meaning set forth in Section 2.1.

    

    1.16.
      "Product" shall mean the polymer
      raw material
      meeting
      the Product Specifications.

    

    1.17.
      "Product Specifications" shall mean the specifications detailing the Product,
      as
      shown in Schedule 1.

    

    1.18.
      "Product Warranties" shall have the meaning set forth in Section
      11.1.

    

    1.19.
      "Purchase Orders" shall have the meaning set forth in Section 5.3.

    

    1.20.
      "Purchase Commitment" shall have the meaning set forth in Section
      4.2(b).

    

    1.21
      “Quality Agreement” shall mean the Quality Agreement executed between the
      parties on December 11, 2006.

    

    1.22.
      "QSR" shall mean the Quality System Regulation promulgated by the FDA under
      the
      Act or other applicable regulatory agencies of countries in which the Commercial
      Product will be sold as of the time of manufacture of the applicable Commercial
      Products; including ISO 13485, the European Union Council Medical Device
      Directives (the "EU Medical Device Directives"), and the Quality System
      Regulations as described in 21 CFR Part 820. 

    

    1.23.
      "Receiving Party" shall have the meaning set forth in Section 1.6.

    

    1.24.
      "Regulatory Authority" shall mean an authority or authorities designated or
      otherwise recognized by a government for regulatory purposes in connection
      with
      protection and safety of the public health (e.g., FDA, Notified Bodies, Health
      Canada, EMEA) exerting authority or jurisdiction over BIOVECTRA’s manufacture of
      Product. 

    

    1.25.
      "Renewal Term" shall have the meaning set forth in Section 2.1.

    

    1.26.
      "Rolling Forecast" shall have the meaning set forth in Section 4.2(b).Schedule
      2.

    

    1.27.
      "SyntheMed Indemnified Party" shall have the meaning set forth in Section
      14.1.

    

    1.28.
      "Term" shall have the meaning set forth in Section 2.1.

    
      
         

      

      
        3

        
          

        

      

      
         

      

    

    

    1.29.
      "Transfer Price" shall mean the price paid by SyntheMed to BIOVECTRA for the
      Product, as set forth in Section 5.1 hereof.

    

    1.30.
      "USPTO" shall mean the United States Patent and Trademark Office.

     

    2.
      TERM

    

    2.1
      Term.
      This Agreement shall commence on the Effective Date and, unless earlier
      terminated as provided herein, continue for five (5) years thereafter (the
      "Initial Term"). The Initial Term shall be automatically extended for successive
      one (1) year terms (the "Renewal Terms"), unless written notice of any party's
      intention not to extend is provided by either party at least six (6) months
      prior to the expiration of the Initial Term or a Renewal Term (the Initial
      Term
      and the Renewal Terms are collectively referred to as the "Term"); however,
      should any such notice of non-renewal be given by BIOVECTRA, BIOVECTRA shall,
      if
      so requested by SyntheMed, supply Product(s) for up to an additional twelve
      (12)
      months following the expiration of the then
      current
      Term (the "Post Term Supply") at a price to be agreed upon between the parties
      at that time. This extended term period may be extended if required in order
      to
      get all regulatory approvals.

     

    3.
      REGULATORY APPROVAL OF THE COMMERCIAL PRODUCTS 

    

    3.1
      SyntheMed shall have responsibility for obtaining all necessary U.S. and foreign
      Approvals for the Commercial Products for use, sale, marketing and distribution.
      BIOVECTRA will cooperate with SyntheMed to the extent BIOVECTRA's participation
      is reasonably necessary or appropriate in order for SyntheMed to procure such
      Approval, any required work which falls outside the scope of the work reasonably
      contemplated by the parties under this Agreement, shall be performed at a price
      to be negotiated between the parties.. Without limiting the generality of the
      foregoing, BIOVECTRA will make available to SyntheMed, without charge,
      information in BIOVECTRA's possession and control that is required to prepare
      submissions for Approval, as SyntheMed may reasonably request, and as is
      reasonably necessary to obtain Approvals. All information provided by BIOVECTRA
      hereunder shall be presented in a form which satisfies the Quality Agreement
      and
      QSR. BIOVECTRA shall consult with SyntheMed prior to engaging in any
      communication with the FDA or other Regulatory Authority in connection with
      manufacture of Product or other activities covered under this Agreement and
      shall provide SyntheMed a reasonable opportunity to review and comment upon
      any
      such proposed communication, whether written or oral. BIOVECTRA shall provide
      to
      SyntheMed copies of any and all correspondence or other communications, whether
      written, oral or otherwise, between it and the FDA or such other Regulatory
      Authorities relating to the manufacture of the Product. In the event FDA or
      other Regulatory Authority requests additional information from BIOVECTRA,
      BIOVECTRA shall fully and promptly cooperate and advise SyntheMed of the
      estimated date by which it will respond to such request. 

     

    4.
      COMMERCIALIZATION AND SUPPLY

    

    4.1
      BIOVECTRA agrees to:

     

    a.
      manufacture, package, label, store and deliver the Product in accordance with
      the Product Specifications, Quality Agreement and QSR.

     

    b.
      supply
      SyntheMed with all of SyntheMed’s requirements of Product consistent with the
      accepted Purchase Order (pursuant to Subsection 5.3);

    
      
         

      

      
        4

        
          

        

      

      
         

      

    

     

    c.
      deliver Product hereunder to the Designated Facility or as otherwise directed
      by
      SyntheMed on the scheduled delivery dates as set forth in the relevant Purchase
      Orders described in Section 5.3;

     

    d.
      permit
      SyntheMed or its third party designee full opportunity to test the Product
      to
      ensure compliance with Product Specifications prior to delivery by BIOVECTRA,
      as
      provided in Section 6.1;

     

    e.
      obtain
      written approval from SyntheMed prior to implementing any changes to the Product
      manufacturing process, raw materials, testing, systems, equipment, procedures,
      or software, which may impact safety, quality, or effectiveness of Product,
      which approval shall not be unreasonably withheld or delayed.; 

     

    f.
      obtain
      written approval from SyntheMed prior to implementing changes to Product
      Specifications;

     

    g.
      investigate diligently, at SyntheMed’s request, complaints which relate to
      Product or to the manufacture of Product, and report back to SyntheMed within
      four (4) days of being notified by SyntheMed such complaint;

     

    h.
      provide to SyntheMed any complaints BIOVECTRA receives relating to the Product
      or the manufacture of Product within three business days of their receipt by
      BIOVECTRA;

     

    i.
      utilize in the manufacture of the Product only approved raw materials as agreed
      to by SyntheMed; and 

     

    j.
      follow
      the Quality Agreement and QSR.

    

    k.
      if an
      MDR reportable event, as described in CFR Part 803, to a patient treated with
      the Commercial Product is found to be a direct result of a change in the
      processes used by BIOVECTRA for the manufacture of the Product and the change
      was not pre-approved by SyntheMed prior to implementation, then the
      indemnification provided by SyntheMed as described in Section 15.2 (ii) to
      BIOVECTRA shall not apply to such event

    

    4.2
      SyntheMed agrees to:

    

     
      a.
      ensure that BIOVECTRA is timely provided, at no charge, a production schedule
      in
      order to enable BIOVECTRA to satisfy its manufacturing and delivery obligations
      with respect to the Products; and

    

     
      b.
      provide BIOVECTRA with rolling twelve (12) month forecasts of SyntheMed's
      requirements of Product ("Rolling Forecast"). Such forecasts shall be prepared
      in good faith and provided on a quarterly basis. The first three months of
      any
      twelve month Rolling Forecast may be accompanied by firm Purchase Orders to
      purchase Product, which Purchase Orders shall be considered a purchase
      commitment ("Purchase Commitment"). SyntheMed may at any time cancel all or
      any
      portion of any Purchase Commitment, provided that SyntheMed shall, if such
      cancellation occurs after actual commencement of Product manufacture for the
      relevant Product Order, reimburse BIOVECTRA for ***, which shall be BIOVECTRA's
      sole remedy for SyntheMed's cancellation; provided further that (i) BIOVECTRA
      will attempt to minimize any losses associated with *** and (ii) BIOVECTRA
      will
      ***.

    
      
         

      

      
        5

        
          

        

      

      
         

      

    

     
      c.
      investigate diligently all adverse events of which SyntheMed has knowledge
      or
      awareness, related to the Commercial Product, and promptly report such
      occurrences to BIOVECTRA if in the good faith reasonable determination of
      SyntheMed, the same could reasonably have been attributable to activities of
      BIOVECTRA. SyntheMed shall be responsible for the cost and execution of all
      medical device reporting ("MDR") in accordance with 21 CFR Part 803 and all
      vigilance reporting required in the markets where Commercial Products are sold;
      and 

    

     
      d.
      except as otherwise set forth herein, be solely responsible for all necessary
      Approvals to market the Commercial Products including any re-approvals required
      due to, among other things, specification changes. 

      

    5.
      ORDERING, PRICE AND PAYMENTS

    

    5.1
      Initial Transfer Price. SyntheMed shall pay the Transfer Price listed in
      Schedule 3 for the Product. 

    

    5.2
      Transfer Price Adjustment. The Transfer Price may be adjusted from time to
      time
      throughout the Term of the Agreement beginning at any time after the *** for
      factors such as, but not limited to, changes in raw material costs, labor costs,
      regulatory costs, or product liability costs. However, such adjustment shall
      not
      exceed, unless otherwise agreed, the consumer price index for Chemical Solvents
      area, as published by the U.S. Department of Labor, Bureau of Labor Statistics
      and in effect on the aforementioned date. If price adjustments are related
      to
      changes in the Product Specifications requested by SyntheMed, BIOVECTRA will
      propose new pricing which will be negotiated in good faith and, subject to
      the
      succeeding sentence, will be effective immediately upon shipment of Products
      meeting the new Product Specifications. Pricing adjustments will occur no more
      than *** and, unless otherwise agreed, shall become effective no earlier than
      three (3) months after written notice thereof is provided to SyntheMed.
      BIOVECTRA shall include in its notification a detailed justification for all
      adjustments. Such adjusted Transfer Price shall be reflected in any BIOVECTRA
      invoices issued for Product shipped after the effective date of
      adjustment.

    

    5.3
      Purchase Orders. SyntheMed shall provide BIOVECTRA with firm written purchase
      orders ("Purchase Orders") for Product in accordance with the lead-times set
      forth in Product Specifications and consistent with Purchase Commitments;
      provided, that SyntheMed shall have the right, forty five (45) days prior to
      the
      date of manufacture, to issue binding, written change orders to increase or
      decrease the quantity of such Purchase Orders. BIOVECTRA shall use its
      commercially reasonable efforts to comply with any reasonable revisions to
      Purchase Order requirements. 

    

    5.4
      Acknowledgment. Within five (5) business days after receipt of a written
      Purchase Order from SyntheMed, BIOVECTRA shall acknowledge such receipt in
      writing.

    

    5.5
      Shipping. BIOVECTRA shall ship Product to the Designated Facility or other
      SyntheMed designated location ***, in accordance with the shipment packaging
      materials and shipping method specified by SyntheMed and agreed to by BIOVECTRA.
      *** shall pay the actual documented cost of shipping Product to the shipping
      destination. *** shall be responsible for all insurance, custom's charges and
      taxes related to shipping. Title to and risk of loss for all Product supplied
      to
      SyntheMed hereunder shall pass from
      BIOVECTRA to SyntheMed upon acceptance of the shipment by the carrier at
      Designated facility. 

    

    5.6
      Invoices. BIOVECTRA shall invoice SyntheMed for the aggregate Product
      manufactured

    
      
         

      

      
        6

        
          

        

      

      
         

      

    

    per
      Purchase Order, and SyntheMed shall pay each invoice within ***; provided,
      however, that all invoices rendered pursuant to the terms of this Agreement
      during calendar year 2006 shall be paid by SyntheMed within ***. All payments
      shall be in United States currency. 

    

    5.7
      Tax
      Witholding. If SyntheMed in good faith concludes that tax withholdings under
      the
      laws of any country are required with respect to payments to BIOVECTRA, it
      shall
      withhold the required amount and pay it to the appropriate Governmental
      Authority, and shall promptly provide BIOVECTRA with original receipts or other
      evidence reasonably required and sufficient to allow BIOVECTRA to document
      such
      tax withholdings adequately for purposes of claiming foreign tax credits and
      similar benefits.

     

    6.
      QUALITY CONTROL AND REGULATORY COMPLIANCE

    

    6.1
      No
      Product shall be released for shipment by BIOVECTRA unless and until SyntheMed
      shall have been notified by BIOVECTRA of completion of Product manufacture
      and
      has reviewed and approved the BIOVECTRA testing results. SyntheMed will be
      afforded full opportunity to test the Product to ensure compliance with the
      Product Specifications. Notwithstanding the above, such testing shall take
      place
      within thirty (30) days of completion of Product manufacture and BIOVECTRA’s
      Certificate of Conformance and Certification to SyntheMed. Such testing may
      be
      accomplished either by SyntheMed directly or by a third party designated by
      SyntheMed, which designee may be an independent testing laboratory. Each
      delivery of Product manufactured by BIOVECTRA shall be accompanied by
      BIOVECTRA's Certificate of Conformance and Certificate of Analysis, the generic
      form of which is attached as Schedule 4.

    

    6.2
      SyntheMed or its designee shall be entitled to reject any shipment of Product
      or
      portion thereof that is not manufactured and/or delivered in accordance with
      the
      terms of this Agreement. SyntheMed shall notify BIOVECTRA of the existence
      and
      nature of any Product which does not comply with the Product Specifications
      and
      BIOVECTRA shall have a reasonable opportunity, not to exceed five (5) business
      days from receipt of notification, to inspect such non-compliant Product.
      SyntheMed shall have no obligation to pay for any Product that is subject to
      such a claim of non-compliance. If BIOVECTRA fails to timely inspect or if
      such
      inspection confirms such non-compliance, BIOVECTRA shall promptly replace such
      non-compliant Product at its own cost and expense. In the case of non-compliant
      Product previously shipped by BIOVECTRA, unless BIOVECTRA provides SyntheMed
      with detailed written instructions to return or dispose of such Product within
      5
      business days of a request by SyntheMed, SyntheMed may dispose of such Product
      as it sees fit and BIOVECTRA shall promptly reimburse SyntheMed for
      ***.

    

    6.3
      If,
      after BIOVECTRA’s inspections of such Product, the parties disagree as to the
      Product’s conformance to the Specifications either party may deliver the Product
      to an independent third-party laboratory, mutually and reasonably acceptable
      to
      both parties, for analytical testing to confirm the Product’s conformance to the
      Product Specifications. All costs associated with such third-party testing
      shall
      be at BIOVECTRA’s expense should the Product be determined by the independent
      third party laboratory to be non-compliant, and at SyntheMed’s expense should
      the Product be determined to be compliant. No inspection or testing of or
      payment for Product by SyntheMed or any third-party agent of SyntheMed shall
      constitute acceptance by SyntheMed thereof, nor shall any such inspection or
      testing be in lieu or substitution of any obligation of BIOVECTRA for testing,
      inspection and quality control as provided in the Specifications or under
      applicable local, state, or federal laws, rules, regulations, standards, codes
      or statutes.

    
      
         

      

      
        7

        
          

        

      

      
         

      

    

    6.4
      In
      the event of an audit by a Regulatory Authority at SyntheMed which involves
      any
      Product, SyntheMed shall notify BIOVECTRA of such audit promptly after receiving
      notice thereof. Pursuant to such notice of audit, BIOVECTRA shall supply
      SyntheMed with quality control documents related to the Product portion of
      the
      Commercial Product, within one business day if reasonable, from a request by
      SyntheMed.

    

    6.5
      BIOVECTRA shall promptly notify SyntheMed whenever a request for a plant
      inspection is received from the FDA or other Regulatory Authority that relates
      in any way to Product,and shall promptly advise SyntheMed of any scheduled
      or
      unscheduled Product related FDA or other Regulatory Authority inspection and
      the
      progress and results thereof. A copy of Form 483 observations or other
      applicable reports, which apply to Product shall be supplied to SyntheMed within
      one business day of receipt. BIOVECTRA, at BIOVECTRA's sole expense, shall
      promptly take steps to remedy any valid deficiencies found by the FDA or other
      Regulatory Authority inspectors relating to the manufacture of Product, and
      to
      respond promptly in writing to the Form 483 observations. BIOVECTRA shall
      provide SyntheMed with a copy of its responses to any Form 483 observations
      relating to the Products in advance of their submission to FDA, and shall notify
      SyntheMed of the date such responses are filed with the FDA.

    

    6.6
      BIOVECTRA shall not conduct a voluntary recall of Product without prior full
      consultation with SyntheMed regarding the ramifications, costs and regulatory
      strategies associated with such a recall. 

    

    6.7
      SyntheMed and BIOVECTRA shall assist and cooperate with each other in giving
      effect to any "Recall," as that term is defined in 21 CFR 810.2. BIOVECTRA
      shall
      be responsible for the cost of replacing any Product of any Recall caused by
      BIOVECTRA's shipment of Products that did not meet Product Specifications and
      the costs associated with return and reshipment of Product to a SyntheMed
      designated facility. BIOVECTRA shall have no other obligations with respect
      to
      such Recalls, except as may be provided for in Section 14.1. SyntheMed shall,
      however, bear all costs and expenses of any recall caused by Commercial Product
      design, or other acts not attributable to BIOVECTRA causing a Recall to occur,
      including, without limitation, costs of notifying customers and costs associated
      with the shipment and reshipment and replacement of such Commercial
      Products.

    

    6.8
      BIOVECTRA shall provide SyntheMed (or its third party designee) access to its
      sites and quality system records for the purpose of auditing and reviewing the
      sites for compliance with BIOVECTRA’s obligations under this Agreement (the
      "Review"). Any information obtained by SyntheMed as a result of such Review
      shall be subject to the provisions of Article 8 hereof. Such Review shall be
      made during regular business hours, upon reasonable notice and at reasonable
      intervals. BIOVECTRA shall respond to any findings under such Review in writing
      within thirty (30) days, unless otherwise agreed; additionally, SyntheMed shall
      have the right to re-Review any specific records to establish that any findings
      have been corrected.

    

    6.9
      BIOVECTRA shall cooperate with SyntheMed to provide any authorizations,
      documents, information, testing protocols and procedures relating to the
      manufacture and delivery of Product in BIOVECTRA's possession subject to Section
      3, or take such other actions, which SyntheMed may reasonably request in order
      to obtain or maintain any registration, approval, clearance, certification
      or
      other authorization with or from any federal, state, local or foreign government
      agency or any self-regulatory body notwithstanding, any required work which
      falls outside the scope of the work reasonably contemplated by the parties
      under
      this Agreement, shall be performed at a price to be negotiated between the
      parties. 

    

    6.10
      Each
      party shall keep and maintain complete and accurate records necessary for
      regulatory

    
      
         

      

      
        8

        
          

        

      

      
         

      

    

    compliance
      for a period of at least five (5) years after the expected life of the Product
      or ten (10) years from the date of creation (whichever is less), including
      all
      records that ensure the ability to perform complete lot tracing of
      Product.

    

    6.11
      The
      signed SyntheMed Quality Agreement (schedule 5) will be reviewed and updated
      as
      required per any applicable regulatory requirement changes. 

    

    6.12
      All
      documents specifically related to the manufacturing of Product (i.e. batch
      records, manufacturing procedures, FDA/ISO required documentation) will be
      the
      property of Synthemed and will be provided if and when requested. 

     

    7.
      INTELLECTUAL PROPERTY RIGHTS

    

    7.1
      BIOVECTRA and SyntheMed acknowledge the exclusive right, title, interest and
      goodwill in and to each trademark, trade name or other Intellectual Property
      right owned by the other party. Neither BIOVECTRA nor SyntheMed will, at any
      time or in any way, do or cause to be done any act, or omission, or thing to
      challenge, contest or in any way impair the right, title, and interest of the
      other party. Except as otherwise provided in this Agreement, BIOVECTRA and
      SyntheMed shall not in any manner represent that either has any rights in or
      to
      any trademark, trade name or other Intellectual Property right of the other
      party and each acknowledges that the permitted use of any trademark, trade
      name
      or other Intellectual Property right of the other shall not create any ownership
      right, title, or interest in or to any trademark, trade name or other
      Intellectual Property right of the other party.

     

    8.
      CONFIDENTIAL INFORMATION

    

    8.1
      The
      parties agree:

    

     
      a. To
      receive and hold all Confidential Information in strict confidence and to
      disclose such Confidential Information only to its employees and representatives
      who have a need to know the Confidential Information. Without affecting the
      generality of the foregoing, the Receiving Party will exercise no less care
      to
      safeguard the Confidential Information than it exercises in safeguarding its
      own
      Confidential Information and will be responsible for any breach of the
      provisions of Article 8 by its employees and representatives (including its
      employees who, subsequent to the first disclosure of Confidential Information,
      become former employees);

    

     
      b. That
      the Receiving Party shall not, directly or indirectly, disclose or use the
      Confidential Information, in whole or in part, for any purposes other than
      those
      contemplated herein. Without affecting the generality of the foregoing, the
      Receiving Party shall not, directly or indirectly, disclose any such
      Confidential Information to any third party or use the Confidential Information
      for the benefit of any third party;

    

     
      c. That
      neither party shall, without the prior written consent of the other party,
      disclose to any third party Confidential Information and or any of the terms,
      conditions or other facts with respect to the business relationship of the
      parties. Any approved disclosure made shall be no more extensive than is
      necessary to meet the minimum requirement imposed on the party making such
      disclosure; it being understood that BIOVECTRA and SyntheMed consent to such
      public disclosure regarding the business relationship of the other party as
      BIOVECTRA, SyntheMed or their counsel deem necessary or appropriate to comply
      with applicable law;

    

     
      d. That
      money damages may not be a sufficient remedy for a breach of this Article 8
      and

    
      
         

      

      
        9

        
          

        

      

      
         

      

    

    that
      the
      non-breaching party may be entitled to equitable relief (including, but not
      limited to, a temporary restraining order or an injunction or specific
      performance), without posting bond or establishing monetary damages, in the
      event of any breach of the provisions of this Article 8;

    

     
      e. The
      furnishing of Confidential Information hereunder shall not constitute or be
      construed as a grant of any express or implied license or other right, or a
      covenant not to sue or forbearance from any other right of action by the
      Disclosing Party to the Receiving Party under any of the Disclosing Party's
      patents or other Intellectual Property rights;

    

     
      f. Upon
      the Disclosing Party's request at any time, or upon termination or expiration
      of
      this Agreement, the Receiving Party shall immediately return or destroy all
      written, graphic and other tangible forms of the Confidential Information (and
      all copies thereof) in the Receiving Party's possession or control except for
      one copy which may be retained by the party's legal counsel for legal archival
      purposes only; and

    

     
      g. The
      obligations of the Receiving Party regarding disclosure and use of Confidential
      Information shall survive the termination of this Agreement and shall continue
      for five (5) years after the date of termination of this Agreement.

     

    9.
      PUBLICITY

    

    9.1
      During the Term and thereafter, except as required by applicable law, neither
      party shall, without securing the prior written consent of the other party,
      release the terms of this Agreement to any third party or publicly announce
      the
      terms of this Agreement. Notwithstanding the foregoing, during the Term and
      thereafter, SyntheMed may, in addition to the disclosure permitted under Section
      8.1 above, disclose the existence and general nature of this Agreement in press
      releases, shareholder reports, quarterly and annual corporate reports,
      Securities and Exchange Commission filings and public or private equity
      offerings. In addition, both parties may provide a copy of this Agreement as
      part of a due diligence review in connection with a merger, an acquisition,
      or a
      public or private equity offering, so long as such review is under the auspices
      of an appropriate confidentiality agreement. 

     

    10.
      WARRANTIES AND REPRESENTATIONS

    

    10.1
      Subject to the provisions set forth in this Section 10.1 and Section 10.4,
      BIOVECTRA warrants: (i) that all Product delivered hereunder shall conform
      in
      all material respects to Product Specifications at the time of shipment; (ii)
      that all Product shall be manufactured substantially in accordance with (a)
      the
      Quality Agreement, (b) the pertinent rules and regulations of the QSR and ISO
      13485; (iii) that no Product delivered hereunder shall at time of shipment
      be
      adulterated or misbranded within the meaning of the Act, or within the meaning
      of any applicable state or municipal law in which the definitions of
      adulteration and misbranding are substantially the same as those contained
      in
      the Act, provided such laws are constituted and effective at the time of such
      delivery (collectively, the "Product Warranties"). These Product Warranties
      shall be null and void and shall not apply to any Product which is in any way
      altered, modified, damaged or replaced by any person other than BIOVECTRA or
      its
      agents or which is abused or misused, whether intentionally or
      accidentally.

    

    10.2
      Each
      party represents and warrants that it is and will remain in material compliance
      with all applicable federal, state and local laws, regulations and orders as
      they may apply to this Agreement.

    

    10.3
      BIOVECTRA and SyntheMed each represent and warrant for itself that (i) it is
      duly

    
      
         

      

      
        10

        
          

        

      

      
         

      

    

    incorporated
      and validly existing and in good standing under the laws of the state of its
      incorporation, (ii) it has the full right, power, and authority to execute
      and
      perform this Agreement, (iii) this Agreement does not conflict with or otherwise
      result in a breach of any agreement to which such party is a party or to which
      it is bound, and (iv) this Agreement represents a valid, legally binding
      obligation of it, enforceable against it in accordance with its
      terms.

    

    10.4
      EXCEPT AS OTHERWISE EXPRESSLY PROVIDED ELSEWHERE IN THIS AGREEMENT, NEITHER
      PARTY SHALL BE LIABLE TO THE OTHER FOR ANY INCIDENTAL, INDIRECT, CONSEQUENTIAL
      OR SPECIAL DAMAGES IN CONNECTION WITH OR ARISING OUT OF THIS
      AGREEMENT.

     

    11.
      ASSIGNMENT

    

    11.1
      Neither party may assign or transfer this Agreement, in whole or in part, to
      a
      third party without the prior written consent of the other party, which consent
      shall not be unreasonably withheld, conditioned or delayed.
      Notwithstanding the foregoing, either party may assign this Agreement to any
      of
      its affiliates, or in connection with the sale of substantially all of its
      assets which relate to this Agreement provided that in no event shall any such
      assignment release either party from its responsibilities under this Agreement
      unless the assignee has agreed in writing to assume all the obligations of
      the
      other hereunder 

    

    11.2
      This
      Agreement will bind and inure to the benefit of the respective successors and
      permitted assigns, whether so expressed or not.

     

    12.
      INSURANCE

    

    12.1
      BIOVECTRA and SyntheMed shall each obtain and maintain at all times during
      the
      Term following the first Purchase Order hereunder, product liability insurance
      in the amount of at least *** per occurrence and *** and shall deliver to the
      other party a certificate evidencing such insurance.

     

    13.
      TERMINATION 

    

    13.1
      In
      addition to any other rights of termination granted to the parties in this
      Agreement, each party shall have the right, but not the obligation, to terminate
      this Agreement upon notice to the other party under the following
      circumstances:

    

    
      	 	
              i.

            	
              for
                no reason, upon six (6) months’ prior notice to the other party;
                

            

    

    

     
      ii. if
      the other party declares bankruptcy, makes an assignment for the benefit of
      its
      creditors, if any proceedings take place for arrangement for the appointment
      of
      a receiver or trustee to take possession of such party's assets, or any other
      proceeding under law for the entry of an order for the relief of creditors
      of
      such party shall be instituted the other party which shall not have been
      vacated, discharged, stayed, satisfied or bonded pending appeal within
      forty-five (45) days from the entry thereof or if such party shall become
      insolvent; or

    

     
      iii.
      upon a material breach of this Agreement by the other party, which breach is
      not
      remedied or cured within sixty (60) days’ notice thereof by the terminating
      party.

    

    13.2
      Upon
      termination or expiration of this Agreement for any reason, including the end
      of
      the Term as defined in Section 2, nothing herein shall be construed to release
      either party from any

    
      
         

      

      
        11

        
          

        

      

      
         

      

    

    obligation,
      which matured prior to the effective date of termination, or which by their
      terms are intended to continue.

     

    14.
      INDEMNIFICATION

    

    14.1
      BIOVECTRA agrees to indemnify, defend and hold SyntheMed and any of its
      officers, directors, affiliates, employees, sales agents, successors and
      permitted assigns (each, an "SyntheMed Indemnified Party") harmless from and
      against any and all Claims of third parties for any Losses arising out of or
      resulting from: (i) the failure of BIOVECTRA to ship Product that meets the
      Product Specifications or that is not manufactured in compliance with Quality
      Agreement, and QSR; (ii) any BIOVECTRA breach of a representation, warranty,
      covenant or obligation in this Agreement; or (iii) any negligence or willful
      misconduct of BIOVECTRA or its representatives, directors, officers, employees
      and agents, in connection with the activities contemplated under this Agreement,
      in each case, only to the extent such Claims listed in Section 14.1 (i - iv)
      are
      not (a) due to the negligence or willful misconduct of a SyntheMed Indemnified
      Party, or (b) otherwise subject to indemnification under Section
      14.2.

    

    14.2
      SyntheMed agrees to indemnify, defend and hold BIOVECTRA and any of its
      officers, directors, affiliates, employees, sales agents, successors and
      permitted assigns (each, a "BIOVECTRA Indemnified Party") harmless from and
      against any and all Claims of third parties for any Losses arising out of or
      resulting from: (i) any SyntheMed breach of a representation, warranty, covenant
      or obligation in this Agreement; (ii) any personal injury or death resulting
      from use of the Commercial Product by end-users; or (iii) any negligence or
      willful misconduct of SyntheMed or its representatives, directors, officers,
      employees and agents, in connection with the activities contemplated under
      this
      Agreement.; in each case, only to the extent such Claims listed in Section
      14.2
      (i - iii) are not (a) due to the negligence or willful misconduct of a BIOVECTRA
      Indemnified Party, or (b) otherwise subject to indemnification under Section
      14.1.

    

    14.3
      To
      receive the indemnities contained in this Section 14, the party entitled to
      indemnification hereunder (the "Indemnified Party") must provide the party
      obligated to provide indemnification hereunder (the "Indemnifying Party") with
      (i) reasonably prompt notice in writing of any such Claim or action, (ii)
      information and reasonable assistance, at the Indemnifying Party's expense,
      as
      necessary or appropriate to defend or settle such Claim or action, and (iii)
      full authority to defend or settle the Claim or suit. The Indemnified Party
      shall have the right to employ separate counsel and participate in the defense
      of any Claim or action, at its own expense. Except as provided in the last
      sentence of this Section 14.3, the Indemnified Party may not settle any Claim
      or
      action under this Section 14 on behalf of the Indemnifying Party without first
      obtaining the Indemnifying Party's written permission, and so long as the
      Indemnifying Party is diligently conducting a defense as provided herein, it
      shall not be liable for the attorneys' fees or expenses of the Indemnified
      Party. If an Indemnified Party provides notice of a Claim that is subject to
      indemnification in accordance herewith and is not notified within ten (10)
      days
      that the Indemnifying Party intends to defend such Claim, the Indemnified Party
      shall be entitled to defend, settle and/or compromise such Claim, subject to
      the
      indemnification provided for herein. Nothing in this provision, however, shall
      permit either party to enter into a settlement that imposes an obligation on
      the
      other party requiring them to take any affirmative action or refrain from any
      act, unless such other party consents to such settlement.

     

    15.
      MISCELLANEOUS 

    

    15.1
      Independent Contractor. Neither party shall have the right, power or authority
      to assume or create any obligations or responsibility expressed or implied,
      on
      behalf of, or in the name of, the

    
      
         

      

      
        12

        
          

        

      

      
         

      

    

    other
      party, or to bind the other party in any manner or to any extent whatsoever,
      without the prior written approval and acceptance of the other party. Each
      of
      the parties hereto is an independent contractor for the purposes of this
      Agreement and nothing contained herein shall be deemed or construed to create
      the relationship of agency, partnership or joint venture or any other
      association except that of an independent contractor relationship.

    

    15.2
      Amendment and Waiver. This Agreement may be amended, and any provision of this
      Agreement may be waived, provided that any such amendment or waiver will be
      binding on each party only if such amendment or waiver is set forth in a writing
      executed by such parties. Waiver of a breach of the Agreement shall not
      constitute a waiver of any other subsequent breach of the Agreement. The waiver
      of any provision of this Agreement shall not constitute a continuing waiver
      of
      that provision or a waiver of any other provision of this
      Agreement.

    

    15.3
      Notices. All notices, demands and other communications to be given or delivered
      under or by reason of the provisions of this Agreement shall be in writing
      and
      shall be deemed to have been given when sent by facsimile transmission with
      acknowledged returned receipt, personally delivered or mailed by overnight
      mail,
      return receipt requested. Notices demands and communications shall, unless
      another address or individual is specified in writing, be sent to the addresses
      set forth as follows:

    

     
      If to
      SyntheMed:

    SyntheMed,
      Inc.

    200
      Middlesex-Essex Turnpike

    Suite
      210

    Iselin,
      NJ 08830

    Fax:
      732-404-1118

    

    Attention:
      President

    

     
      If to
      BIOVECTRA:

    Diagnostic
      Chemicals Limited bda BioVectra

    16
      McCarville Street

    Charlottetown,
      PEI

    C1E
      2A6,
      Canada

    Fax:
      902-566-2498

     

    Attention:
      President & CEO

      

    15.4
      Severability. Whenever possible, each provision of this Agreement will be
      interpreted in such a manner as to be effective and valid under applicable
      law,
      but if any provision of this Agreement is held to be prohibited by or invalid
      under applicable law, such provision will be ineffective only to the extent
      of
      such prohibition or invalidity, without invalidating the remainder of such
      provision or the remaining provisions of this Agreement.

    

    15.5
      Complete Agreement. This Agreement and the documents referred to herein contain
      the complete agreement between the parties and supersede all prior
      understandings, agreements and representations by or between the parties,
      written or oral, which may have related to the subject matter hereof in any
      way.

    

    

    15.6
      Counterparts. This Agreement may be executed in one or more counterparts all
      of
      which taken together will constitute one and the same instrument.

    

    15.7
      Governing Law. The law of the State of New Jersey will govern, without regard
      to
      the

    
      
         

      

      
        13

        
          

        

      

      
         

      

    

    conflicts
      of law provisions thereof, all questions concerning the construction, validity
      and interpretation of this Agreement and the performance of the obligations
      imposed by this Agreement.

    

    15.8
      Headings. Section headings used in this Agreement are for convenience only
      and
      form no part or in any way modify or define the text of meaning or any provision
      of this Agreement.

    

    15.9
      Force Majeure. In
      the
      event that any party is prevented from performing, or is unable to perform,
      any
      of its obligations under this Agreement due to any
      act
      of God,
      fire, casualty, flood, war, strike, lock out, failure of public utilities,
      injunction or any act, exercise, assertion or requirement of governmental
      authority, epidemic, destruction of production facilities, any act of declared
      or undeclared war or of a public enemy, or any riot or insurrection, any
      nuclear, biological, chemical or similar attack, any act of terrorism,
or
      any
      similar occurrence cause outside the reasonable control of that party,
and
      if
      such party shall have used its best efforts to avoid such occurrence and
      minimize its duration and has given prompt written notice to the other party,
      then the affected party's performance shall be excused and the time for
      performance shall except as otherwise provided for in this Agreement, be
      extended for the period of delay or inability to perform due to such
      occurrence.

    

    15.10
      Arbitration.

    

     
      a. The
      parties will attempt in good faith to resolve through negotiation any dispute,
      claim or controversy arising out of or relating to this Agreement. Any party
      may
      initiate negotiations by providing written notice in letter form to the other
      party, setting forth the subject of the dispute and the relief requested. The
      recipient of such notice will respond in writing within five (5) business days
      with a statement of its position on and recommended solution to the dispute.
      If
      the dispute is not resolved by this exchange of correspondence, then
      representatives of each party with full settlement authority will meet at a
      mutually agreeable time and place within ten (10) business days of the date
      of
      the initial notice in order to exchange relevant information and perspectives,
      and to attempt to resolve the dispute. If the dispute is not resolved by these
      negotiations, the matter will be submitted to the American Arbitration
      Association ("AAA") for resolution.

    

     
      b. Any
      dispute, claim or controversy arising out of or relating to this Agreement
      or
      the breach, termination, enforcement, interpretation or validity thereof,
      including the determination of the scope or applicability of this Agreement
      to
      arbitrate, shall be determined by arbitration in New York, New York. The
      arbitration shall be administered by AAA pursuant to its then-current
      Comprehensive Arbitration Rules. Judgment on any arbitration award may be
      entered in any court having jurisdiction thereof and shall be final and binding
      upon the parties.

    

     
      c.
      Notwithstanding the foregoing, nothing in this Section 15.10 shall be construed
      as limiting in any way the right of a party to seek injunctive relief with
      respect to any actual or threatened breach of this Agreement from a court of
      competent jurisdiction.

    

    15.11
      Remedies. Unless otherwise expressly stated, any remedy expressly provided
      for
      herein shall not be deemed to be a limitation on any remedy for any such
      situation or occurrence.

    

    

    
      
        
           

        

        
          14

          
            

          

        

        
           

        

      

    

     

    IN
      WITNESS WHEREOF, the parties have executed this Agreement through their
duly
      authorized representatives as of the date first written above.

     

    
      
        	
                SYNTHEMED,
                  INC.

              	 	
                DIAGNOSTIC
                  CHEMICAL LIMITED dba BIOVECTRA

              
	 	 	 
	 	 	 
	
                By:  
                  /s/
                  Robert P. Hickey

              	 	
                By:  
                  /s/
                  Ron Keefe

              
	
                Name: Robert
                  Hickey

              	 	
                Name: Ron
                  Keefe

              
	 	 	 
	
                Title:
                  President
                  & CEO 

              	 	
                Title:
                  President
                  & CEO 

              
	 	 	 
	
                Date: 
                  June
                  14,2007

              	 	
                Date: 
                  June
                  12, 2007

              

      

    

    
 

    
      
         

      

      
        15

        
          

        

      

      
         

      

    

     

    LIST
      OF
      SCHEDULES

     

    Schedule
      1  Product
      Specification

    

    Schedule
      2  Rolling
      Forecast (Material Forecast)

    

    Schedule
      3  Pricing
      Schedule

    

    Schedule
      4  Certification
      of Compliance (example)

    

    Schedule
      5  Quality
      Agreement

    

    

    
      
        
           

        

        
          16

          
            

          

        

        
           

        

      

    

     

     

     

     

     

    Schedule
      1

    

    

    

    

    

    

    

      
        
           

        

        
          17

          
            

          

        

        
           

        

      

    

    

    
      	 	
              Material
                Specification

            	 

    

    

    

    1.    DESCRIPTION

    Material:
      ***

    

    2.    MATERIAL
      VENDORS 

    BioVectra
      - produces the material

    Chem
      Development Inc. (CDI) - receives material for further processing

    

    3. SPECIFICATION
      

    The
      following is the criteria used in order to demonstrate that each lot of the
      Dry
      Raw Material Polymer Powder meets its design characteristics prior to being
      released for further processing. Each criterion is tested on a lot by lot basis
      at BioVectra. The results are reviewed and approved by Synthemed and if
      acceptable, the material is released to CDI for further processing. At CDI
      receiving inspection, the product will be tested or accepted via a vendor
      certification. The methods and criteria of acceptance at receiving will be
      documented and agreed upon in advance by SyntheMed.

    

     

    3.1 ***

     

    3.2 ***

     

    3.3 ***

     

    3.4 ***

     

    3.4.1 ***

     

    3.4.2 ***

     

    3.4.3 ***

     

    3.5 ***

     

    3.6 ***

     

    3.7 ***

     

    3.8 ***

     

    
      
         

      

      
        18

        
          

        

      

      
         

      

    

     

    3.9 ***
      

     

    3.9.1 ***

     

    3.9.2 ***

     

    3.9.3 ***

     

    3.10 
      ***

     

    3.11 ***

     

    3.12 ***

    

    4.    RESPONSIBILITIES
      

    

    
      	 	
              4.1

            	
              BioVectra
                is responsible for the manufacturing of the material. BioVectra will
                be
                responsible for assuring the material meets all the specified criteria
                as
                defined in section 3.

            

    

    
      	 	
              4.2
                

            	
              CDI
                is responsible for the incoming receipt, inspection and release of
                material for further processing.

            

    

    

    

    5.    RECEIVING/STORAGE

     

    
      	 	
              5.1
                

            	
              CDI
                is responsible for the receipt and storage of material. These activities
                will be performed in accordance with documented procedures which
                are
                compliant with all applicable regulatory requirements. SyntheMed
                will
                evaluate these procedures as part of its vendor qualification and
                monitoring procedures.

            

    

    

    6.    INSPECTION
      

    

    
      	 	
              6.1

            	
              BioVectra
                is responsible for the inspection of the material prior to release
                for
                further distribution. These activities will be performed in accordance
                with documented procedures which are compliant with all applicable
                regulatory requirements. SyntheMed will evaluate these procedures
                as part
                of its vendor qualification and monitoring
                procedures.

            

    

    

    
      	 	
              6.2

            	
              CDI
                is responsible for the inspection of the incoming material. These
                activities will be performed in accordance with documented procedures
                which are compliant with all applicable regulatory requirements.
                SyntheMed
                will evaluate these procedures as part of its vendor qualification
                and
                monitoring procedures

            

    

    

    

    
      
        
           

        

        
          19

          
            

          

        

        
           

        

      

    

     

     

     

     

     

     

     

    Schedule
      2

    

    

    

    

    

    

      
        
           

        

        
          20

          
            

          

        

        
           

        

      

    

    REPEL-CV
      Raw Material Powder Forecast

    

    

    ***

    

    ***

    

    

    

    

    

    

    

    

    

    

    

    

    

    

    

    

    

    
      
        
           

        

        
          21

          
            

          

        

        
           

        

      

    

     

     

     

     

     

     

     

     

    SCHEDULE
      3

    

    

    

    

    

    

    

    

    

    
 

    
      
         

      

      
        22

        
          

        

      

      
         

      

    

    

    

    ***

     

    ***

    

    ***

    

    
      	
              ***

            	
              ***

            	
              ***

            
	
              ***

            	
              ***

            	
              ***

            
	
              ***

            	
              ***

            	
              ***

            
	
              ***

            	
              ***

            	
              ***

            

    

    

    ***

    

    ***

    ***

     

     

     

    
      
         

      

      
        23

        
          

        

      

      
         

      

    

     

     

     

     

     

     

     

     

     

     

    SCHEDULE
      4

     

     

     

     

     

     

     

     

     

     

    
      
         

      

      
        24

        
          

        

      

      
         

      

    

    

    

    

    

    

    

    ***

     

     

     

     

     

     

     

     

    
      
         

      

      
        25

        
          

        

      

      
         

      

    

     

     

     

     

     

     

     

     

     

     

    SCHEDULE
      5

     

     

     

     

     

     

     

     

     

     

    
      
         

      

      
        26

        
          

        

      

      
         

      

    

     

    SYNTHEMED
      QUALITY AGREEMENT

    

    

    This
      Quality Agreement (the "Agreement") is made as of November 10, 2006 between
      SyntheMed, Inc. and Biovectra with its principal office at 16
      McCarville St.,Charlottetown, PE C1E 2A6, Canada. 

    

    Purpose
      

    The
      purpose of this Agreement is to set forth the quality arrangements for ensuring
      that the manufacture, packaging, quality control and release of the Raw Material
      Powder (the "Agreement Product") shall take place in accordance with applicable
      sections of the Quality System Regulations (Good Manufacturing Practice) as
      detailed in Title 21, Code of Federal Regulations, Part 820, US Food and Drug
      Administration, or the requirements of the European Medical Device Directives
      and ISO 13485. 

    

    Responsibilities
      

     

    1.
       Audits 

    

    Biovectra
      shall give all reasonable access to its facilities to satisfy all applicable
      regulatory audit requirements. Any such audits will determine if Biovectra
      has
      adequate premises, equipment, systems and a staff with sufficient knowledge
      and
      training to carry out satisfactorily the manufacture, assembly, packaging and
      testing of the Agreement Product destined to be further processed by SyntheMed,
      Inc. or its designee.

     

    2.
       Material
      Specifications

    

    Biovectra
      shall manufacture the Agreement Product according to the methods agreed to
      by
      SyntheMed. The information/specifications to be provided to Biovectra may
      include but may not be limited to: 

    The
      manufacturing formula 

    The
      manufacturing method

    The
      environmental conditions required 

    The
      master batch manufacturing record 

    The
      finished product specification 

    All
      analytical methods 

    
      
         

      

      
        27

        
          

        

      

      
         

      

    

     

    3.
       Change
      control 

    

    Biovectra
      shall not, except with the prior written consent of SyntheMed (which consent
      shall not be unreasonably withheld or delayed), change or cause to be changed
      any materials, equipment, or method of production or testing related to the
      Agreement Product provided however, that any such change for which SyntheMed
      has
      given its prior written consent shall also comply in all respects with all
      applicable legal requirements, and provided further, that in the event any
      change is required by any legal requirement and SyntheMed does not consent
      to
      such change within a reasonable period of time, Biovectra shall be excused
      from
      all performance hereunder. 

    

    4.
       Documentation
      

    Biovectra
      will create the documentation to produce the Agreement Product to satisfy the
      appropriate regulatory requirements. These documents will be reviewed and
      approved by SyntheMed. They will be subject to Change Control as specified
      in
      section 3 above. Biovectra will provide control of all documentation as required
      under all applicable regulations and as part of the Biovectra quality system.
      

    

    5.
       Raw
      Material Purchasing/Testing 

    Biovectra
      shall be responsible for the assessment of all ingredients to be used in the
      manufacture of the Agreement Product in order to ensure compliance with the
      agreed upon specifications. Biovectra will also be responsible for the
      qualification of all vendors that supply the ingredients for the Agreement
      Product.

    

    6.
       In-Process
      Controls 

    Biovectra
      shall be responsible for any agreed upon quality control testing required during
      the manufacture of the Agreement Product. Biovectra shall advise SyntheMed
      of
      any significant changes prior to their implementation in the in-process controls
      (ref section 3 above). 

    

    7.
       Finished
      Product Testing 

    Biovectra
      shall be responsible for testing each batch of the Agreement Product (including
      any testing requiring to be performed by a third party laboratory) to ensure
      its
      compliance with the finished product specifications agreed to by SyntheMed.
      Biovectra shall provide and/or make available a record of the test results
      for
      every batch manufactured and details of all out of specification investigations.
      SyntheMed will review the documentation and approve the release of each batch
      of
      material unless otherwise notified (see section 10). 

    

    8.
       Stability 

    Biovectra
      shall assist as needed in ensuring the generation of the stability data for
      the
      Agreement Product.

     

    9.
       Storage.
      Delivery and Transportation 

    Biovectra
      shall be responsible for the quality of the Agreement Product on its premises
      and be responsible for any subsequent deterioration of the Agreement Product
      due
      to its storage or handling. Biovectra shall utilize agreed upon means for
      transportation for delivery of the Agreement Product to SyntheMed or its
      designee.

     

    10.
       Release
      Procedure 

    Biovectra
      shall test (or have tested at a third party laboratory as agreed by SyntheMed)
      the Agreement Product to the full finished product specification in accordance
      with the requirements specified. SyntheMed shall be responsible for the final
      release of the Agreement Product according to agreed upon procedures. Biovectra
      shall provide: 

     

    
      	 	
              10.1
                

            	
              A
                Certificate of Analysis listing all test results for each batch of
                Agreement Product 

            

    

    
      	 	
              10.2
                

            	
              Certification
                that all manufacturing was completed in accordance with agreed upon
                procedures

            

    

    
      	 	
              10.3
                

            	
              Any
                other details or documents which may be agreed from time to time
                between
                the Quality Departments of Biovectra and SyntheMed.
                

            

    

    
      	 	
              10.4
                

            	
              Information
                and copies of investigation reports relating to a) critical batch
                deviations that would have an impact on the critical quality attributes
                or
                were associated with critical process parameters, b) out of specification
                results or c) non-compliances with regulatory requirements. These
                shall be
                communicated as soon as practicable to the Director, Quality Systems
                at
                SyntheMed. 

            

    

    

    11. Retention
      Samples 

    Biovectra
      shall keep adequate retention samples of the Agreement Product and raw materials
      as agreed to with SyntheMed.

     

    
      
         

      

      
        28

        
          

        

      

      
         

      

    

    

    12. Rejection
      and Reprocessing

    Prior
      to
      shipment of each batch supplied and where applicable, Biovectra shall submit
      to
      Synthemed all available information regarding major deviations, out of
      specification results and investigations, or non-compliance with GMP.

    If
      a
      batch of the Agreement Product is rejected by Biovectra for any reason,
      Biovectra must advise SyntheMed of the occurrence thereof and any other relevant
      details. 

    Rework
      or
      reprocessing of the Agreement Product is not permitted without the consent
      of
      SyntheMed. (The term 'rework/reprocessing' excludes any re-inspection activities
      that are specified in Company's approved procedures). 

     

    13. Recalls
      and Complaints 

    Biovectra
      shall conduct any reasonable investigations requested by SyntheMed pursuant
      to
      complaints received on the batches of the Agreement Product. A report of such
      investigation shall be provided in timely fashion to the Quality Department
      of
      SyntheMed. In the event of a recall of the Agreement Product, Biovectra’s
      responsibility is limited to supplying appropriate information relevant to
      any
      alleged product defect prompting such recall action. 

    

    14. Batch
      records 

    Biovectra
      shall keep original copies of all records of manufacture for at least five
      (5)
      years from the date of manufacture, and shall notify SyntheMed before disposing
      of such records. 

    Biovectra
      shall also keep records relating to the receipt, testing and use of raw
      materials and packaging components for at least five (5) years from the date
      of
      approval for use in manufacturing. 

    

    15.
       Sub-contracting 

    Biovectra
      may sub-contract the manufacture, packaging or testing of the Agreement Product
      to another site, provided that (a) SyntheMed has been notified of the site
      and
      (b) SyntheMed has approved such site.

     

    16.
       Regulatory
      Requirements 

    Biovectra
      shall provide manufacturing information as reasonably requested by SyntheMed
      in
      support of the preparation of any Regulatory submissions and/or requirements
      for
      the Agreement Product. 

    

    

    Approvals:

    

    
      	
              SyntheMed

            	
              Biovectra

            
	 	 
	
              Date:
                12-01-2006

            	
              Date:
                12-11-2006

            
	 	 
	
              Name:  
                /s/
                John Hoffer

            	
              Name: 
                /s/
                Ron Keefe

            
	
               

            	 
	
              Title: 
                Dir Quality Systems & RA

            	
              Title: 
                President
                & CEO

            

    

    

    

    
      
         

      

        29

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