ex4_87.htm


    
       

      Exhibit 4.87

      
 

      Catherine
Soldano-Noble

      Executive
Director, Marketing & Business Development

      Medpace,
Inc.

      4620
Wesley-Avenue

      Cincinnati,
OH 45212

       

      Re:
Letter Agreement for certain initial services for the Amarin Trial A
Study

       

       

      Dear
Catherine:

       

      It is
understood that this Letter Agreement is intended, subject to the terms and
conditions set out below, to precede the execution of a definitive agreement
which is expected to incorporate the terms of this Letter Agreement in addition
to additional customary terms.

       

      This
Letter Agreement is dated as of the date of last signature below (the “Effective
Date”).

       

      Medpace
Inc. (“Medpace”), Amarin Pharma Inc (“SPONSOR”) and Amarin Pharmaceuticals
Ireland Limited (“APIL”) are currently negotiating a definitive agreement to
cover Medpace’s performance of various services for the studies referenced above
(the “Studies”) (the “Master Services Agreement” or “MSA”) and are also
currently negotiating various task orders that will detail the services to be
provided under the MSA (each a “Task Order”).  This negotiation will
require more time.  SPONSOR and Medpace are in agreement, however,
that certain initial activities relating to the Amarin Trial A Study cannot wait
for finalization of the MSA, and the Task Orders, and that pending execution of
the MSA, and the Task Order that will cover the Initial Trial A Services (the
“Initial Trial A Task Order”), Medpace will provide certain initial activities
relating to the Amarin Trial A Study set forth in Schedule A in accordance with
the terms of this Letter Agreement (the “Initial Trial A Services”) and SPONSOR
will pay Medpace for these initial activities according to the terms of this
Letter Agreement as set out below.

       

      
        	
                1  

              	
                Initial
      Trial A Services

              


      

       

      
        	
                1.1  

              	
                Medpace
      shall perform the Initial Trial A Services in compliance with all
      applicable laws regulations and guidelines, including without limitation
      the Federal Food, Drug and Cosmetic Act and the regulations promulgated
      pursuant thereto, cGCP, and all future amendments thereto, and all other
      applicable laws, regulations and guidelines in all relevant jurisdictions
      the timelines and specific roles and responsibilities of Medpace and
      SPONSOR as set out in Schedule A, and the relevant standard operating
      procedures of Medpace

              


      

       

      
        	
                1.2  

              	
                Upon
      signature of this Letter Agreement, Medpace shall provide’ SPONSOR with
      copies of the standard operating procedures, of Medpace relevant to the
      performance of the Initial Trial A Services as listed in Schedule
      B.

              


      

       

      
        	
                1.3  

              	
                “cGCP”
      shall mean the ICH Harmonized Tripartite Guideline for Good Clinical
      Practice and any subsequent versions thereof, together with such other
      good clinical practice requirements as are specified in the Federal Food,
      Drug and Cosmetic Act, 21 U.S.C., applicable sections of Title 21 Code, of
      Federal Regulations, and any subsequent versions
  thereof.

              


      

       

      
        	
                2  

              	
                Confidentiality

              


      

       

      
        	
                2.1  

              	
                The
      terms and conditions of the confidentiality agreement between Medpace and
      Amarin Corporation plc (an Affiliate of SPONSOR and APIL (as such term is
      defined in Paragraph 8.2 below))

              


      

       


      
        
           


        

        
           


          
            

          

        

        
           


        

      


      dated 13
November 2008 (the “CDA”) shall apply to all Confidential Information (as such
term is defined therein) provided by SPONSOR to MEDPACE.

       

      
        	
                3  

              	
                Rights
      in Property and Patent Rights

              


      

       

      
        	
                3.1  

              	
                All
      materials documents, data, software and information of every kind and
      description and all electronic data files containing all such materials,
      documents, data, software and
information:

              


      

       

      
        	
                3.1.1  

              	
                supplied
      to Medpace by SPONSOR or any of its Affiliates;
  or

              


      

       

      
        	
                3.1.2  

              	
                prepared,
      developed, generated, derived or otherwise created by Medpace pursuant to
      this Letter Agreement, (except for the Medpace IP (as such term is defined
      below))

              


      

       

      (collectively
“Study Results”)

       

      are and
shall be the exclusive and confidential property of SPONSOR,

       

      
        	
                3.2  

              	
                SPONSOR
      and its Affiliates shall have the right to make whatever use they deem
      desirable of any Study Results.  Medpace shall, not, without the
      prior written consent of SPONSOR, publish, disseminate, or otherwise
      disclose to any third party any Study Results (except such disclosure as
      may be required by law, and in such case only to the extent required by
      law), or use any such Study Results for any purpose other than the
      performance of this Letter
Agreement.

              


      

       

      
        	
                3.3  

              	
                Any
      inventions or other intellectual property, including without limitation
      protectable copyrights and trademarks, that may evolve from, the Study
      Results or as the result of Initial Trial A Services performed by Medpace,
      under this Letter Agreement shall belong exclusively to SPONSOR, and
      Medpace agrees to assign all its rights in all such inventions and/or
      other intellectual property to SPONSOR consistent with the obligations set
      forth in Paragraph 3.6 below.

              


      

       

      
        	
                3.4  

              	
                SPONSOR
      acknowledges that all computer programs, software, applications, databases
      (excluding for the avoidance of doubt all electronic files containing all
      Study Results), proposals and other documentation generally used by
      Medpace that:

              


      

       

      
        	
                3.4.1  

              	
                have
      been independently developed without the benefit of any information
      provided by SPONSOR (including without limitation any SPONSOR data,
      information, materials or Confidential Information of SPONSOR (or
      derivatives thereof)); and

              


      

       

      
        	
                3.4.2  

              	
                have
      not been developed solely for
SPONSOR,

              


      

       

      (the
“Medpace IP”)

       

      are the
exclusive and confidential property of Medpace or the third parties from whom
Medpace has secured the right of use.  SPONSOR agrees that any
improvement, alteration or enhancement made to the Medpace IP during the course
of the Initial Trial A Services performed hereunder, without the benefit of
any information provided by SPONSOR (including without limitation any SPONSOR
data, information, materials or Confidential Information of SPONSOR (or
derivatives thereof)), shall be the property of Medpace.

       

      
        	
                3.5  

              	
                Medpace
      shall disclose promptly to sponsor any and all inventions, discoveries,
      know-how and improvements conceived or made by Medpace while providing
      Initial Trial A Services to

              


      

       


      
        
           


        

        
          -2-

          
            

          

        

        
           


        

      


      SPONSOR
pursuant to the Letter Agreement, whether or not constituting a modification or
extension of use relating to SPONSOR’s proprietary rights (“Study
IP”).

       

      
        	
                3.6  

              	
                Subject
      to Paragraph 3.4, all Study IP shall belong exclusively to SPONSOR, and
      Medpace agrees to assign all its interest therein to SPONSOR or its
      nominee whenever requested to do so by SPONSOR.  Medpace shall
      execute any and all applications, assignments, or other instruments and
      give testimony which SPONSOR shall deem necessary to apply for and obtain
      a patent in the United States of America and/or other applicable
      jurisdiction or of any foreign country or to protect otherwise SPONSOR’s
      interests and shall compensate Medpace on a reasonable basis for the time
      devoted to said activities and reimburse it for reasonable out-of-pocket
      expenses incurred.

              


      

       

      
        	
                4  

              	
                Payments

              


      

       

      
        	
                4.1  

              	
                All
      payments will be payable to Medpace Inc. (Tax ID No. 75-3033627) and
      sent to:

              


      

       

      August J.
Troendle, MD

      Medpace
Inc.

      4620
Wesley Avenue

      Cincinnati,
OH  45212

       

      
        	
                4.2  

              	
                Payments
      will be made by SPONSOR on the following
basis:

              


      

       

      
        	
                4.2.1  

              	
                SPONSOR
      shall pay Medpace fees for the provision of the Initial Trial A Services
      (the “Initial Trial a Services Fees”) up to a maximum of US$1,413,974●
      (the “Total Initial Trial A Services
Fees”).

              


      

       

      
        	
                4.2.2  

              	
                In
      no event shall SPONSOR be required to pay any amount exceeding the total
      Initial Trial A Services Fees unless otherwise agreed in writing by the
      parties.

              


      

       

      
        	
                4.2.3  

              	
                SPONSOR
      shall reimburse Medpace for reasonable and necessary expenses and
      pass-through costs incurred by Medpace in providing the Initial Trial A
      Services (“Initial Trial A Services Pass-through
  Costs”).

              


      

       

      
        	
                4.2.4  

              	
                In
      the case of any individual Initial Trial A Services Pass-through Cost
      exceeding US$5000, SPONSOR’s prior written approval must be given for such
      cost:

              


      

       

      
        	
                4.2.5  

              	
                All
      Initial Trial A Services Pass-through Costs invoiced by Medpace must be
      accompanied by appropriate documentary evidence as, required by SPONSOR,
      such as receipts or other documentation reasonably acceptable to
      SPONSOR.

              


      

       

      
        	
                4.2.6  

              	
                Upon
      execution of the relevant Task Orders, SPONSOR shall retrospectively
      determine the difference between the Initial Trial A Services Fees and
      Initial Trial A Services Pass-through Costs as agreed in the relevant Task
      Orders and all amounts paid by SPONSOR to Medpace under this Letter
      Agreement and any difference shall be credited against future amounts
      owing by SPONSOR under such Task
Orders.

              


      

       

      
        	
                4.2.7  

              	
                In
      the event that this Letter Agreement is terminated for any reason, other
      than termination by SPONSOR for breach by Medpace of its obligations
      hereunder, and the parties do not execute the MSA and the Initial Trial A
      Task Order, Medpace shall, within 30 days of the date of termination,
      provide a written account to SPONSOR of all  outstanding Initial
      Trial A Services Fees, Initial Trial A Services Pass-through Costs and all
      non-cancelable

              


      

       


      
        
           


        

        
          -3-

          
            

          

        

        
           


        

      


      expenses
incurred by Medpace (“Total Outstanding Costs”), together with appropriate
documentary evidence as required by SPONSOR.  Within 30 days of
written approval by SPONSOR of such written account, Medpace shall issue a final
invoice to SPONSOR in respect of the Total Outstanding Costs.

       

      
        	
                4.2.8  

              	
                APIL
      shall be authorized by SPONSOR to receive invoices and to make remittances
      on behalf of SPONSOR under this Agreement.  All invoices should
      be addressed to APIL at the following
address

              


      

       

      Amarin
Pharmaceuticals Ireland Limited

      1st
Floor, Block 3

      The
Oval

      Shelbourne
Road

      Ballsbridge

      Dublin
4

      Ireland

      Attn:  Accounts
Department

       

      
        	
                5  

              	
                Master
      Services Agreement and Task Orders

              


      

       

      
        	
                5.1  

              	
                When
      and if SPONSOR and Medpace execute the MSA and the Initial Trial A Task
      Order, this Letter Agreement shall be deemed terminate and superseded by
      the MSA and the Initial Trial A Task
Order.

              


      

       

      
        	
                5.2  

              	
                Upon
      execution of the MSA and the Initial Trial A Task Order, the terms and
      provisions of the MSA and the Initial Trial A Task Order shall apply to
      all Initial Trial A Services provided by Medpace
  hereunder.

              


      

       

      
        	
                5.3  

              	
                The
      MSA and all necessary Task Orders must be executed by the parties before
      any dosing of Study subjects may
commence.

              


      

       

      
        	
                5.4  

              	
                For
      the avoidance of doubt, nothing contained in this Letter Agreement shall
      be construed by implication or otherwise, as an obligation upon SPONSOR,
      APIL or Medpace to negotiate or enter into any further agreement or
      arrangement relating to the Studies or any other clinical study, including
      without limitation: the- MSA and any Task
Order.

              


      

       

      
        	
                6  

              	
                Scope
      of Letter Agreement

              


      

       

      
        	
                6.1  

              	
                Medpace
      shall perform the Initial Trial A Services described in Schedule A in
      accordance with the terms of this Letter Agreement.  For such
      initial Trial A Services, SPONSOR shall pay Medpace the amounts and on the
      terms set forth in Schedule A.  It is understood that Medpace
      shall not make any financial commitments extending beyond the amounts
      stated in Schedule A until (and to the extent permitted) the MSA and the
      relevant Task Order(s) have been executed by the parties.  If a
      financial commitment is required by Medpace beyond those stated in
      Schedule A, and prior to-the
      execution of the MSA and the relevant Task Order(s), such action will
      require written consent in advance by
SPONSOR.

              


      

       


      
        
           


        

        
          -4-

          
            

          

        

        
           


        

      


      


       

      
        	
                7  

              	
                Term
      and Termination

              


      

       

      
        	
                7.1  

              	
                The
      parties agree that this Letter Agreement shall be binding upon the parties
      with effect from the Effective Date and shall continue in full force and
      effect until terminated by the parties in accordance with the terms of
      this Letter Agreement.

              


      

       

      
        	
                7.2  

              	
                SPONSOR
      will have the right to request Medpace to immediately cease providing the
      Initial Trial A Services and to forthwith terminate this Letter Agreement
      and to forthwith terminate all negotiations regarding the MSA and any Task
      Orders at any time by advising Medpace orally and in
    writing.

              


      

       

      
        	
                7.3  

              	
                Medpace
      will have the right to stop its work and terminate this Letter Agreement
      only if SPONSOR is in default of its payment obligations under Schedule A
      and does not pay such amount in full within 10 days after written
      notice.

              


      

       

      
        	
                7.4  

              	
                This
      Letter Agreement will automatically
terminate:

              


      

       

      
        	
                7.4.1  

              	
                upon
      execution of the MSA And the Initial Trial A Task Order;
  or

              


      

       

      
        	
                7.4.2  

              	
                in
      the event that SPONSOR OR and Medpace do not execute the MSA and the
      Initial Trial A Task Order within 60 days from the Effective Date, upon
      the 60th day after the Effective
Date.

              


      

       

      
        	
                7.5  

              	
                In
      the event of termination, other than in the case of termination upon
      execution of the MSA and the Initial Trial A Task
  Order:

              


      

       

      
        	
                7.5.1  

              	
                MEDPACE
      shall use its best efforts to reduce the costs incurred by SPONSOR as a
      result, of such termination;

              


      

       

      
        	
                7.5.2  

              	
                all
      Study Results and Study IP shall either be delivered to SPONSOR, or
      disposed of, at the direction and written request of
    SPONSOR;

              


      

       

      
        	
                7.5.3  

              	
                save
      for those paragraphs that expressly deemed to survive termination of this
      Letter Agreement, the Letter Agreement shall terminate and be of no
      further force or effect and SPONSOR, APIL and Medpace shall have no
      further obligations to each other whatsoever under this Letter
      Agreement.

              


      

       

      
        	
                8  

              	
                Indemnification
      and Insurance

              


      

       

      
        	
                8.1  

              	
                SPONSOR
      shall indemnify, defend and hold harmless Medpace from and against any and
      all damages, losses, liabilities, costs or expenses (collectively
      “Damages”), resulting or arising from any third-party claims, demands,
      assessments, actions, suits, investigations or proceedings (collectively
      “Claims”), relating to or arising from or in connection with this Letter
      Agreement or the Initial Trial A Services (including but not limited to
      any Damages arising from or in connection with any study, test, device,
      product of potential product to which this Letter Agreement relates), to
      the extent such Claims or Damages have not resulted from Medpace’s
      negligent act or omission, or willful misconduct, or a breach of any
      applicable law, regulation or guideline, or breach of this Letter
      Agreement by Medpace.

              


      

       

      
        	
                8.2  

              	
                Medpace
      agrees to indemnify, defend and hold harmless SPONSOR and its Affiliates
      from and against any and all Damages resulting or arising from Claims
      relating to or arising from or in

              


      

       


      
        
           


        

        
          -5-

          
            

          

        

        
           


        

      


      connection
with this Letter Agreement or the Initial Trial A Services to the extent that
such Claims, or Damages have resulted from any negligent act or omission or
willful misconduct of Medpace or a breach of any applicable law, regulation or
guidelines, or a breach of this Letter Agreement by Medpace.

       

      “Affiliate”
shall mean a corporation or entity controlling, controlled by, or under the
common control with SPONSOR, APIL, or Medpace, as the case may
be.  For the purposes of this, Agreement, “control” shall mean the
direct or indirect ownership of more than 50% of the issued voting shares or
other voting rights of the subject entity to elect, directors, or if not meeting
the preceding criteria, any entity owned or controlled by or owning or
controlling at the maximum control or ownership right permitted in the country
where such entity exists.

       

      
        	
                8.3  

              	
                Nothing
      in this; Letter Agreement shall limit the liability of any Party for
      fraud, or limit the liability of any Party to any third party under
      applicable laws where any act, or omission of any Party results in death
      or personal injury.

              


      

       

      
        	
                8.4  

              	
                Any
      Party providing indemnification under this Letter Agreement shall have the
      right to control the defense and settlement of any Claims or
      Damages.  The indemnified party shall have’ the right to obtain
      separate legal counsel at its own expense if it so chooses.  The
      indemnifying party shall not unreasonably withhold consent for settlement
      and the indemnified party shall reasonably cooperate in the defense of any
      Claims or Damages and provide prompt notice to the indemnifying party of
      any Claims or Damages for which indemnification is sought, and shall
      reasonably and regularly consult with the indemnified party in relation to
      the progress and status of such Claim or Damages.  Save as
      aforesaid, neither the indemnifying party nor the party to be indemnified
      shall acknowledge the validity of, compromise or otherwise settle any
      Claim without the prior written consent of the other, which consent shall
      not be unreasonably withheld.  The Party seeking indemnification
      shall take all reasonable steps to mitigate any loss, or liability in
      respect of any such Claim or
Damages.

              


      

       

      
        	
                8.5  

              	
                Notwithstanding
      the terms of this paragraph 8, in 00 event shall SPONSOR or Medpace be
      liable by reason of any representation or warranty,: condition or other
      term or any duty of common law, or under the express terms of this
      agreement, for any consequential, special or incidental or punitive loss
      or damage whether for loss of current or future profits, loss of
      enterprise value or otherwise) and whether occasioned by thenegligence of
      the respective parties, their employees or agents or otherwise, even if
      the breaching party has been advised of the possibility of such
      damages.

              


      

       

      
        	
                8.6  

              	
                Medpace
      shall at its own expense obtain and maintain insurance of a type and
      amount adequate to cover all loss,, damage, liability or costs in respect
      of which it is liable to indemnify Sponsor under the provisions of this
      Letter Agreement and shall not do or omit any act, matter or thing which
      may prejudice or render voidable any such insurance.  Such
      insurance shall be for an amount of not less than €7,500,000 per claim and
      in aggregate.  Medpace will, immediately upon the, request of
      SPONSOR, provide SPONSOR with evidence of the insurance as SPONSOR may
      reasonably require.

              


      

       

      
        	
                9  

              	
                Publicity

              


      

       

      
        	
                9.1  

              	
                Medpace
      shall not make any public announcements concerning this Letter Agreement
      or the subject matter hereof, nor use SPONSOR’s name, logo or trademark in
      any communication, release, notice or other publication, without the prior
      written consent of SPONSOR.

              


      

       


      
        
           


        

        
          -6-

          
            

          

        

        
           


        

      


      


       

      
        	
                10  

              	
                Miscellaneous

              


      

       

      
        	
                10.1  

              	
                This
      Letter Agreement and the performance hereof shall be governed, interpreted
      and construed in all respects by the internal laws of the State of New
      York.  All disputes and claims arising under this Letter
      Agreement shall be resolved exclusively in a court of applicable
      jurisdiction located in New York, New York and each Party consents to the
      venue of any such action.

              


      

       

      
        	
                10.2  

              	
                Medpace
      may not subcontract any portion of the Initial Trial A Services hereunder
      without the prior written consent of SPONSOR.  Should Medpace
      subcontract with any third party upon such written consent of SPONSOR,
      Medpace represents and warrants that such third-party subcontractor shall
      comply with all obligations of Medpace under this Letter Agreement,
      including but not limited to, obligations of confidentiality and ownership
      rights of the Study Results and Study IP, and Medpace shall remain fully
      liable for its and such third party’s performance of the Initial Trial A
      Services and the obligations of Medpace
  hereunder.

              


      

       

      
        	
                10.3  

              	
                The
      provisions of paragraphs 2, 3, 5.2, 8, 9, 10.1, 10.6 and this paragraph
      10.3 shall survive the termination of this Letter
    Agreement.

              


      

       

      
        	
                10.4  

              	
                Medpace
      shall not assign this Letter Agreement without the prior written consent
      of SPONSOR.

              


      

       

      
        	
                10.5  

              	
                This
      Letter Agreement shall not be amended, modified or supplemented in any way
      except in writing and signed by a duly authorized representative of
      SPONSOR, APIL and Medpace.

              


      

       

      
        	
                10.6  

              	
                At
      the request of any of the parties, the other parties shall (and shall use
      reasonable efforts to procure that any other necessary third parties
      shall) execute and do all such documents, acts and things as may
      reasonably be required subsequent to the signing of this Letter Agreement
      for assuring to or vesting in the requesting party the full benefit of the
      terms hereof.

              


      

       

      If the
terms of this Letter Agreement are acceptable to you, please have an appropriate
officer of Medpace sign and date both copies of this letter agreement and return
one copy to Amarin Pharma Inc, Mystic Packer Building, 12 Roosevelt Avenue,
Mystic, Connecticut, CT 06355.

       

      Sincerely,

       

      Amarin
Pharma Inc

       

      by:  /s/ Paresh
Soni                           

      Name:  Paresh
Soni

       

      Title:  SVP,
Head of Development

       

      Date:  18FEB09

       


      
        
           


        

        
          -7-

          
            

          

        

        
           


        

      


      Amarin
Pharmaceuticals Ireland Limited

       

      by:                                                    

      Name:

       

      Title:

       

      Date:

       

      AGREED
TO:  Medpace Inc.

      by:                                                    

      Name:

       

      Title:

       

      Date:

       

      
        	
                10.7  

              	
                At
      the request of any of the parties, the other parties shall (and shall use
      reasonable efforts to procure that any other necessary, third parties
      shall) execute and do all such documents, acts, and things as may
      reasonably be required
      subsequent to, the signing of this Letter
      Agreement for assuring to or vesting in the
      requesting party the full benefit of the terms
  hereof.

              


      

       

      If the
terms of this Letter Agreement are acceptable to you, please have an appropriate
officer of Medpace sign and date both copies of this letter agreement and return
one copy to Amarin Pharma Inc, Mystic Packer Building, 12 Roosevelt Avenue,
Mystic, Connecticut, CT 06355.

       

      Sincerely,

       

      Amarin
Pharma Inc

       

      by:                                                    

      Name:

       

      Title:

       

      Date:

       

      Amarin
Pharmaceuticals Ireland Limited

      by:  /s/ Alan
Cooke                                  

      Name:  Alan
Cooke

       

      Title:  Director

       

      Date:  23/Feb./2009

       

      AGREED
TO:  Medpace Inc.

      by:                                                    

      Name:

       

      Title:

       

      Date:

       


      
        
           


        

        
          -8-

          
            

          

        

        
           


        

      


      SCHEDULE
A

       

      Initial
Service Fees

       

      
        	
                Item

              	
                Amount

              
	
                eCRF
      Development

              	
                $15,112.00

              
	
                Project
      Specific Training

              	
                $8,818.00

              
	
                Regulatory
      Agency Clinical
      Trial Submissions

              	
                $112,542.00

              
	
                IVRS
      Development

              	
                $26,830.00

              
	
                Investigator
      and Vendor Contract Negotiation

              	
                $45,686.00

              
	
                Investigator
      Files Setup

              	
                $20,198.00

              
	
                Initial
      Essential Document Collection

              	
                $146,303.00

              
	
                Project
      Management

              	
                $365,601.00

              
	
                Conference
      Calls

              	
                $31,121.00

              
	
                Pre-Study
      Visits

              	
                $44,640.00

              
	
                Monitoring
      Plan Development and Maintenance

              	
                $8,558.00

              
	
                Data
      Management Manual,

              	
                $9,735.00

              
	
                Database
      Development

              	
                $29,018.00

              
	
                Total

              	
                $864,162.00

              


      

      


      Escrow

       

      
        	
                Item

              	
                Amount

              
	
                Investigator
      Meeting Planner and Travel Fees

              	
                $264,878.00

              
	
                Central
      IRB Fees

              	
                $27,750.00

              
	
                Investigator
      Payments

              	
                $127,500.00

              
	
                Medpace
      Reference Laboratories Fees

              	
                $35,315.00

              
	
                EDC
      Vendor Fees

              	
                $77,069.00

              
	
                Total

              	
                $532,512.00

              


      

      


      Pass-Through

       

      
        	
                Item

              	
                Amount

              
	
                Monitoring
      travel

              	
                $16,000.00

              
	
                Conference
      Calls

              	
                $800.00

              
	
                Misc.
      Printing/Copying/Shipping

              	
                $500.00

              
	
                Total

              	
                $17,300.00

              


      

      


      
        	
                Note:

              	
                Pass-through
      costs listed above are not exhaustive and may include, but are nor limited
      to, CRF printing costs, courier costs, teleconference fees, drug packaging
      and labeling, pharmacy fees, travel costs, subsistence costs, and
      accommodation costs.  Escrow costs listed above may not be
      exhaustive.

              


      

       

      
        	
                Note:

              	
                Medpace
      service-fees will be billed in two payments; 50% at signing and 50% twenty
      days after signing.  Escrow costs will be billed, at
      signing.  Pass-through costs will be billed
    monthly.

              


      

       


      
        
           


        

        
           


          
            

          

        

        
           


        

      


      


      SCHEDULE
B

       

      Medpace will follow their SOPs as
listed in this Schedule B and the regulations set forth in 21 CFR, Section 312,
Subpart D (Responsibilities of Sponsors and Investigators) and appropriate EU
Directives 2001/20EC, 2005/28/EC and any other applicable international
regulatory requirements.


      
        
           


        

        
           


          
            

          

        

        
           


        

      


      
        	
                Medpace

                SOP
      Index

              
	
                SOP ID

              	
                SOP Name

              	
                Effective
      Date

              	
                Reapproval Date

              
	 
      	 
      	 
      	 
      
	
                Biometrics

              	 
      	 
      	 
      
	
                GL-BS-01-84

              	
                Data
      Analysis Plan

              	
                1/31/2008

              	
                N/A

              
	
                GL-BS-02-S4,1

              	
                Analysis
      Validation and Generation

              	
                1/31/2008

              	
                N/A

              
	
                GL-BS-03-34

              	
                Data
      Listing Validation and Generation

              	
                1/31/2008

              	
                N/A

              
	
                GL-BS-04-S4

              	
                Randomization
      Code

              	
                1/31/2008

              	
                N/A

              
	
                GL-BS-05-S4

              	
                Interim
      Analysis:

              	
                1/31/2008

              	
                N/A

              
	
                Clinical
      Operations

              	 
      	 
      	 
      
	
                BE-CO-01-S1

              	
                Clinical
      Trial Submissions in Belgium

              	
                4/4/2008

              	
                N/A

              
	
                GL-CO-01-S4.4

              	
                Trial
      Document Management

              	
                3/1/2007

              	
                11/01/2008

              
	
                GL-CO-02-S3,1

              	
                Protocol
      Review

              	
                3/26/2007

              	
                11/01/2008

              
	
                GL-CO-03-S3.2

              	
                Investigator
      Meeting

              	
                3/26/2007

              	
                11/01/2008

              
	
                GL-CO-05-S4.1

              	
                Study
      Initiation Visit

              	
                3/2/2007

              	
                N/A

              
	
                GL-GO-05-S5

              	
                Study
      Initiation Visit

              	
                2/12/2009

              	
                N/A

              
	
                GL-GO-06-S4.3

              	
                Monitoring
      Plan Development

              	
                1/12/2007

              	
                11/01/2008

              
	
                GL-GO-06-S5

              	
                Monitoring
      Plan Development

              	
                2/5/2009

              	
                N/A

              
	
                GL-CO-07-S4.2

              	
                Investigational
      Product Tracking.

              	
                5/31/2007

              	
                11/01/2008

              
	
                GL-CO-08-S9

              	
                Monitoring
      Visit

              	
                12/21/2004

              	
                N/A

              
	
                GL-CO-09-S4

              	
                Documenting
      Protocol Deviations

              	
                1/10/2009

              	
                N/A

              
	
                GL-CO-11-S4

              	
                Reporting
      and Managing Problem Issues at a Clinical Research Site

              	
                3/30/2009

              	
                N/A

              
	
                GL-CO-12-S3.1

              	
                Study
      Closeout

              	
                4/15/2007

              	
                N/A

              
	
                GL-CO-13-S4.2

              	
                Study
      Site Close-out Visit

              	
                2/15/2007

              	
                12/5/2008

              
	
                GL-CO-14-S2.2

              	
                Archiving
      of Study Material

              	
                3/1/2007

              	
                N/A

              
	
                GL-CO-15-S3

              	
                Recruitment
      and Retention Plan

              	
                6/2/2008

              	
                N/A

              
	
                GL-CO-16-S5.1

              	
                Clinical
      Research Associate Orientation and Continuing Education
      Processes

              	
                9/21/2008

              	
                N/A

              
	
                GL-CO-18-S3.2

              	
                Clinical
      Trial Manager Orientation and Evaluation Process

              	
                4/9/2007

              	
                12/5/2008

              
	
                GL-CO-19-S2.1

              	
                Projection
      Evaluation

              	
                4/15/2007

              	
                N/A

              


      


      
        
           


        

        
          Page 1 of
6

          
            

          

        

        
           


        

      


      


      
        	
                SOP ID

              	
                SOP Name

              	
                Effective
      Date

              	
                Reapproval Date

              
	 
      	 
      	 
      	 
      
	
                GL-CO-20-S5.1

              	
                General
      Study Start-up

              	
                4/10/2008

              	
                N/A

              
	
                GL-CO-21-S4

              	
                Trial
      Master File – Essential Documents

              	
                4/10/2008

              	
                N/A

              
	
                GL-CO-22-S3.2

              	
                Updated
      and Additional Essential Documents

              	
                3/12/2007

              	
                12/5/2008

              
	
                GL-CO-23-S5.2

              	
                Translation
      of Essential Documents

              	
                2/25/2008

              	
                12/5/2008

              
	
                GL-CO-24-S4

              	
                Informed
      Consent Form

              	
                4/10/2008

              	
                N/A

              
	
                GL-CO-25-S4

              	
                Pre-study
      Visit

              	
                3/1/2007

              	
                N/A

              
	
                GL-CO-26-S3.1

              	
                Selecting
      Study Principal Investigators

              	
                12/1/2007

              	
                12/5/2008

              
	
                GL-CO-27-S3.2

              	
                Quality
      Control of Essential Documents

              	
                3/12/2007

              	
                12/5/2008

              
	
                GL-CO-28-S3.2

              	
                Lead
      Clinical Research Associate

              	
                9/21/2008

              	
                N/A

              
	
                GL-CO-29-S4

              	
                Clinical
      Research Associate Oversight

              	
                9/21/2008

              	
                N/A

              
	
                GL-CO-30-S6

              	
                FDA
      Compliance Checks

              	
                10/20/2008

              	
                N/A

              
	
                GL-CO-31-S4.1

              	
                Investigational
      Product Storage

              	
                9/28/2008

              	
                N/A

              
	
                GL-CO-32-S2

              	
                Clinical
      Trial Submissions

              	
                4/10/2008

              	
                N/A

              
	
                GL-CO-33-S1.2

              	
                Project
      Training/Project and Investigative Site Hand-over Process

              	
                11/16/2007

              	
                N/A

              
	
                GL-CO-33-S2

              	
                Project
      Training/Project and Investigative Site Hand-over Process

              	
                3/1/2009

              	
                N/A

              
	
                GL-CO-34-S2.1

              	
                Internal
      Quality Check (QC) of Study Files in the Document Center

              	
                11/15/2007

              	
                12/5/2008

              
	
                GL-CO-35-S1.1

              	
                Conference
      Call and Meeting Conduct

              	
                9/10/2007

              	
                N/A

              
	
                GL-CO-36-S1.3

              	
                Site
      Feasibility

              	
                12/1/2007

              	
                N/A

              
	
                GL-CO-37-S1

              	
                Document
      Quality Control

              	
                7/11/2008

              	
                N/A

              
	
                In-Co-01S1.1

              	
                Clinical
      Trial Submissions in India

              	
                2/21/2008

              	
                N/A

              
	
                Corporate
      Affairs

              	 
      	 
      	 
      
	
                GL-CA-01-S1

              	
                Document
      Room Maintenance

              	
                1/16/2008

              	
                N/A

              
	
                GL-CA-02-S1

              	
                Authorized
      Signatory Tables

              	
                 7/3/2008

              	
                N/A

              
	
                GL-CA-03-S1

              	
                Entry
      Structure and Controls

              	
                7/9/2008

              	
                N/A

              
	
                GL-CA-04-S2.1

              	
                Corporate
      Records Retention

              	
                12/24/2008

              	
                N/A

              


      


      
        
           


        

        
          Page 2 of
6

          
            

          

        

        
           


        

      


      


      
        	
                SOP ID

              	
                SOP Name

              	
                Effective
      Date

              	
                Reapproval Date

              
	 
      	 
      	 
      	 
      
	
                GL-CA-05-S1

              	
                Non-Study
      Contracts Indexing and Tracking

              	
                7/16/2008

              	
                N/A

              
	
                US-CA-01-S1

              	
                Board
      of Directors Meetings

              	
                7/7/2008

              	
                N/A

              
	
                US-CA-02-S1

              	
                Annual
      and Special Shareholder Meetings

              	
                7/11/2008

              	
                N/A

              
	
                Data
      Management

              	 
      	 
      	 
      
	
                Gl-DM-02-S14

              	
                Data
      Entry System

              	
                1/31/2008

              	
                N/A

              
	
                Gl-DM-02-S15

              	
                Data
      Entry System

              	
                2/18/2009

              	
                N/A

              
	
                Gl-DM-03-S11

              	
                Edit
      Check Specifications

              	
                1/20/2008

              	
                N/A

              
	
                Gl-DM-04-S12

              	
                CRF
      Processing and Data Entry

              	
                1/25/2008

              	
                N/A

              
	
                Gl-DM-06-S13

              	
                Database
      Cleanup

              	
                1/25/2008

              	
                N/A

              
	
                Gl-DM-08-S10

              	
                Coding
      Process

              	
                1/20/2008

              	
                N/A

              
	
                Gl-DM-09-S10

              	
                Edit
      Check System

              	
                1/31/2008

              	
                N/A

              
	
                Gl-DM-12-S9

              	
                External
      Data Base Import System

              	
                1/31/2008

              	
                N/A

              
	
                Gl-DM-13-S7

              	
                Database
      Generation System

              	
                1/31/2008

              	
                N/A

              
	
                Gl-DM-15-S3

              	
                SAS
      Programming Conventions

              	
                1/31/2008

              	
                N/A

              
	
                Gl-DM-17-S2

              	
                Database
      Quality Control Review

              	
                1/25/2008

              	
                N/A

              
	
                Gl-DM-17-S3

              	
                Data
      Quality Control Review

              	
                2/15/2009

              	
                N/A

              
	
                Gl-DM-20-S2

              	
                Electronic
      Data Capture System Administration

              	
                1/31/2008

              	
                N/A

              
	
                ECG
      Core Laboratory

              	 
      	 
      	 
      
	
                GL-EL-01-S1.1

              	
                ECG
      Shipment, Tracking, and Qualification

              	
                9/19/2007

              	
                11/26/2008

              
	
                GL-EL-02-S1.1

              	
                ECG
      Electronic Receipt and Processing

              	
                9/19/2007

              	
                11/26/2008

              
	
                GL-EL-03-S1.1

              	
                ECG
      Data Review and Cleanup

              	
                9/19/2007

              	
                11/26/2008

              
	
                GL-EL-04-S1.1

              	
                ECG
      Data Format and Delivery

              	
                9/19/2007

              	
                11/26/2008

              
	
                GL-EL-05-S1

              	
                ECG
      Study Set Up

              	
                10/31/2008

              	
                N/A

              
	
                GL-EL-06-S1

              	
                Continuous
      Electrocardiogram Data Receipt and Processing

              	
                10/31/2008

              	
                N/A

              
	
                GL-EL-07-S1

              	
                H-Scribe
      Study Set Up

              	
                10/31/2008

              	
                N/A

              
	
                Finance

              	 
      	 
      	 
      
	
                GL-AA-02-S1

              	
                Payroll

              	
                4/30/2007

              	
                N/A

              


      


      
        
           


        

        
          Page 3 of
6

          
            

          

        

        
           


        

      


      


      
        	
                SOP ID

              	
                SOP Name

              	
                Effective
      Date

              	
                Reapproval Date

              
	 
      	 
      	 
      	 
      
	
                GL-AC-01-S2.1

              	
                General
      ledger System Management

              	
                3/15/2007

              	
                N/A

              
	
                GL-AC-03-S3

              	
                Procurement

              	
                3/31/2007

              	
                N/A

              
	
                GL-AC-06-S6

              	
                Accounts
      Receivable

              	
                3/31/2007

              	
                N/A

              
	
                GL-AC-11-S2.1

              	
                Revenue
      Recognition

              	
                5/4/2007

              	
                N/A

              
	
                GL-AC-15-S3

              	
                Site
      Payments

              	
                5/15/2008

              	
                N/A

              
	
                General

              	 
      	 
      	 
      
	
                GL-GN-01-S15.1

              	
                Procedures
      for Standard Operating Procedures

              	
                4/30/2008

              	
                N/A

              
	
                GL-GN-02-S3

              	
                Training
      & Development

              	
                11/30/2008

              	
                N/A

              
	
                GL-GN-03-S1.2

              	
                Office
      Security

              	
                9/19/2007

              	
                6/5/2008

              
	
                GL-GN-06-S4

              	
                Customer
      Service

              	
                12/19/2008

              	
                N/A

              
	
                GL-GN-07-S3.1

              	
                Correspondence
      Distribution

              	
                9/26/2005

              	
                11/14/2008

              
	
                HR
      & Administration

              	 
      	 
      	 
      
	
                GL-HR-01-S1.2

              	
                Employment

              	
                7/14/2008

              	
                N/A

              
	
                GL-HR-02-S1

              	
                Employee
      Compensation

              	
                7/14/2008

              	
                N/A

              
	
                Information
      Technology

              	 
      	 
      	 
      
	
                GL-IT-01-S14

              	
                Study
      Setup

              	
                5/30/2008

              	
                N/A

              
	
                GL-IT-02-S14.2

              	
                System
      Validation

              	
                1/28/2008

              	
                N/A

              
	
                GL-IT-03-S9.1

              	
                Transfer
      of Electronic Record

              	
                3/1/2008

              	
                N/A

              
	
                GL-IT-04-S13.2

              	
                System
      Maintenance

              	
                1/28/2008

              	
                N/A

              
	
                GL-IT-05-S12.1

              	
                System
      Security

              	
                1/25/2008

              	
                N/A

              
	
                GL-IT-06-S9.1

              	
                Disaster
      Recovery Plan

              	
                1/31/2008

              	
                N/A

              
	
                GL-IT-08-S6

              	
                21
      CFR Part 11 Compliance

              	
                1/28/2008

              	
                N/A

              
	
                GL-IT-09-S13

              	
                System
      Development Life Cycle

              	
                1/28/2008

              	
                N/A

              
	
                GL-IT-S14.1

              	
                Change
      Control

              	
                1/28/2008

              	
                N/A

              
	
                GL-IT-11-S10

              	
                System
      Backup, Restore, and Archive

              	
                1/28/2008

              	
                N/A

              
	
                GL-IT-12-S4.2

              	
                Request
      for Hardware, Software, and Support

              	
                1/25/2008

              	
                N/A

              
	
                GL-IT-13-S3

              	
                Directory
      Structure and Naming Conventions

              	
                3/1/2008

              	
                N/A

              


      


      
        
           


        

        
          Page 4 of
6

          
            

          

        

        
           


        

      


      


      
        	
                SOP ID

              	
                SOP Name

              	
                Effective
      Date

              	
                Reapproval Date

              
	 
      	 
      	 
      	 
      
	
                GL-IT-14-S3

              	
                Computer
      System Set Up

              	
                3/1/2008

              	
                N/A

              
	
                GL-IT-17-S2.2

              	
                Clin
      Trak IVRS Randomization Procedure

              	
                3/30/2007

              	
                10/6/2006

              
	
                GL-IT-18-S2.1

              	
                Clin
      Trak IVRS Subject Tracking Study Implementation

              	
                3/30/2007

              	
                10/6/2008

              
	
                GL-IT-19-S2.1

              	
                Clin
      Trak IVRS Study Support and Maintenance

              	
                3/31/2007

              	
                10/6/2008

              
	
                US-IT-15-S4

              	
                Message
      Notification

              	
                3/1/2008

              	
                N/A

              
	
                IVRS

              	 
      	 
      	 
      
	
                GL-IV-01-S2

              	
                IVRS
      Study Setup Validation

              	
                12/10/2008

              	
                N/A

              
	 
      	 
      	 
      	 
      
	
                Marketing
      & BD

              	 
      	 
      	 
      
	
                GL-MK-01-S3.2

              	
                Request
      For Proposal Handling and Proposal Preparation

              	
                12/11/2006

              	
                N/A

              
	
                GL-MK-02-S3

              	
                Sponsor
      Contract Handling

              	
                4/25/2008

              	
                N/A

              
	
                GL-MK-03-S3

              	
                Change
      in Scope Process

              	
                3/1/2008

              	
                N/A

              
	
                GL-MK-04-S3

              	
                Press
      Release Process

              	
                1/31/2008

              	
                N/A

              
	
                GL-MK-05-S2

              	
                Procedures
      for Site Contracts

              	
                3/1/2008

              	
                N/A

              
	
                Medical
      Writing

              	 
      	 
      	 
      
	
                GL-MW-01-S8

              	
                Clinical
      Study Report

              	
                3/10/2008

              	
                N/A

              
	
                GL-MW-04-S4

              	
                Preparation
      of the Study Protocol

              	
                3/10/2008

              	
                N/A

              
	
                GL-MW-07-S6

              	
                Procedures
      for Compiling Appendices

              	
                3/10/2008

              	
                N/A

              
	
                GL-MW-08-S6

              	
                Document
      Quality Control

              	
                3/10/2008

              	
                N/A

              
	
                Quality
      Assurance

              	 
      	 
      	 
      
	
                BE-QA-01-S1

              	
                Disaster
      Recovery Plan - Belgium Facilities

              	
                10/25/2008

              	
                NA

              
	
                BE-QA-02-S1

              	
                Diesel
      Power Generator

              	
                10/12/2008

              	
                NA

              
	
                BE-QA-03-S1

              	
                Freezer
      CO2 Backup System

              	
                12/12/2008

              	
                NA

              
	
                GL-QA-01-S13

              	
                Investigative
      Site Audit

              	
                6/2/2008

              	
                NA

              
	
                GL-QA-04-S11

              	
                System
      Audits

              	
                5/5/2008

              	
                NA

              
	
                GL-QA-05-S9

              	
                Regulatory
      Authority Inspections

              	
                4/20/2008

              	
                NA

              


      


      
        
           


        

        
          Page 5 of
6

          
            

          

        

        
           


        

      


      


      
        	
                SOP ID

              	
                SOP Name

              	
                Effective
      Date

              	
                Reapproval Date

              
	 
      	 
      	 
      	 
      
	
                GL-QA-06-S9

              	
                Prevention
      and Detection of Fraud and Other Misconduct

              	
                10/20/2008

              	
                NA

              
	
                GL-QA-07-S3.2

              	
                Sponsor
      Audit Preparation

              	
                1/31/2008

              	
                NA

              
	
                GL-QA-08-S4

              	
                Good
      Documentation Practices

              	
                1/31/2008

              	
                NA

              
	
                GL-QA-09-S3

              	
                Quality/Assurance
      Oversight Plan

              	
                5/1/2008

              	
                NA

              
	
                GL-QA-10-S3

              	
                Vendor
      Audits

              	
                5/5/2008

              	
                N/A

              
	
                GL-QA-11-S1

              	
                Confidentiality
      of Data/HIPAA

              	
                12/15/2008

              	
                N/A

              
	
                NA-QA-01-S1

              	
                QA
      Responsibilities for GLP Compliance

              	
                10/31/2008

              	
                N/A

              
	
                NA-QA-02-S1

              	
                Quality
      Assurance Good Laboratory Practice Inspection and Audit
      Program

              	
                11/30/2008

              	
                N/A

              
	
                NA-QA-03-S1.2

              	
                QA
      Statement for GLP Study Reports

              	
                10/31/2008

              	
                N/A

              
	
                NA-QA-04-S1

              	
                Generation
      and Maintenance of the Master Schedule

              	
                10/31/2008

              	
                N/A

              
	
                Regulatory
      Affairs

              	 
      	 
      	 
      
	
                US-RA-05-S10

              	
                New
      Drug Applications

              	
                8/15/2008

              	
                N/A

              
	
                US-RA-12-S3

              	
                Investigational
      New Drug Application Submission Process

              	
                3/15/2008

              	
                N/A

              
	
                Safety

              	 
      	 
      	 
      
	
                GL-SA-01-S5

              	
                Serious
      Adverse Event Reporting

              	
                1/20/2008

              	
                N/A

              
	
                GL-SA-02-S7

              	
                Withdrawal
      due to Adverse Event and Other Event Reporting

              	
                1/20/2008

              	
                N/A

              
	
                GL-SA-03-S4

              	
                Study
      Report Narratives

              	
                1/20/2008

              	
                N/A

              
	
                GL-SA-04-S3

              	
                Safety
      Reporting to Regulatory Authorities

              	
                1/20/2008

              	
                N/A

              
	
                GA-SA-05-S3

              	
                Managing
      Adverse Events/Reactions in Blinded Clinical Trials

              	
                1/20/2008

              	
                N/A

              
	
                GL-SA-06-S3

              	
                Reconciliation
      of Serious Event Data

              	
                1/20/2008

              	
                N/A

              
	
                GL-SA-07-S1

              	
                Safety
      Event Reporting System Project Set Up

              	
                9/19/2008

              	
                N/A

              
	
                Strategic
      Development

              	 
      	 
      	 
      
	
                GL-SD-01-S2

              	
                Managing
      Strategic Transactions

              	
                1/31/2009

              	
                N/A

              
	 
      	 
      	 
      	 
      


      

      


      


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