ex4_92.htm


     

    
      
         

        Exhibit 4.92

        
 

        


         

        MASTER
SERVICES AGREEMENT

         

        Between

         

        Medpace
Inc.

        an Ohio
Corporation

        4620
Wesley Avenue

        Cincinnati,
Ohio 45212

         

        (“MEDPACE”)

         

        and

         

        Amarin
Pharma Inc.

        a
Delaware Company

        Mystic
Packer Building, 12 Roosevelt Avenue

        Mystic,
Connecticut, CT 06355

         

         (“SPONSOR”)

         

        and

         

        Amarin
Pharmaceuticals Ireland Limited

        an Irish
Company

        1st
Floor, Block 3, The Oval,

        Shelbourne
Road, Ballsbridge, Dublin 4, Ireland

         

         (“APIL”)

         

        



        
          
             


          

          
             


            
              

            

          

          
             


          

        


         

        


         

        


         

        This
MASTER SERVICES AGREEMENT (the “Agreement”), dated as of the date of last
signature hereof (the “Effective Date”), is between MEDPACE, SPONSOR and
APIL.  MEDPACE, SPONSOR and APIL are sometimes referred to herein
individually as a “Party” and together as the “Parties”.

        RECITALS:

         

        WHEREAS, SPONSOR is in the
business of developing and obtaining regulatory approval of the marketing and
sale of pharmaceutical products; and

         

        WHEREAS, MEDPACE is engaged in
the business of providing services related to the design and execution of
clinical development programs involving drugs, biologics, and medical devices
through engagement by its clients, the sponsors of clinical development
programs, to perform such services; and

         

        WHEREAS, APIL is an Affiliate
of SPONSOR and is a party to this Agreement for the purpose of clarifying which
Affiliate of SPONSOR is (1) is responsible for making remittances hereunder and
(2) the owner of any Project IP and/or Project Results (as such terms are
defined hereunder); and

         

        WHEREAS, SPONSOR desires to
engage MEDPACE to perform certain services as set forth hereinafter, all in
accordance with and subject to the terms of this Agreement;

         

        NOW, THEREFORE, in
consideration of the premises and the mutual covenants and conditions
hereinafter set forth, the Parties agree as follows:

         

        
          	
                  1.  

                	
                  DEFINITIONS

                


        

         

        
          	
                  1.1.  

                	
                  “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 the subject entity,
      or owning or controlling the subject entity, at the maximum control or
      ownership right permitted in the country where such entity
      exists.

                


        

         

        
          	
                  1.2.  

                	
                  “Clinical Study” shall
      mean each human subject research study to be conducted by MEDPACE on
      behalf of SPONSOR in accordance with
the

                


        

         


        
          
             


          

          
            2

            
              

            

          

          
             


          

        


        terms of
this Agreement, the relevant Task Order and the relevant Project
Protocol.

         

        
          	
                  1.3.  

                	
                  “FDA” shall mean the
      United States Food and Drug
Administration.

                


        

         

        
          	
                  1.4.  

                	
                  “GCP” shall mean the ICH
      Harmonised 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 amendments thereof, and all local
      equivalents thereof.

                


        

         

        
          	
                  1.5.  

                	
                  “GLP” shall mean current
      Good Laboratory Practice, as detailed in Title 21 Code of Federal
      Regulations, Part 58, and the ICH Quality Guidelines, and any subsequent
      amendments thereof, and all local equivalents
  thereof.

                


        

         

        
          	
                  1.6.  

                	
                  “GMP” shall mean current
      Good Manufacturing Practice, as detailed in Title 21 Code of Federal
      Regulations, Part 210 and Part 211, and the ICH Quality Guidelines, and
      any subsequent amendments thereof, and all local equivalents
      thereof.

                


        

         

        
          	
                  1.7.  

                	
                  “Institution” shall mean
      the clinical research site at which a particular Investigator conducts a
      Clinical Study.

                


        

         

        
          	
                  1.8.  

                	
                  “Investigator” shall
      mean the individual who actually conducts a Clinical Study (i.e. under
      whose immediate direction the Study Drug(s) is administered or dispensed
      to a Study Subject).

                


        

         

        
          	
                  1.9.  

                	
                  “Payment Schedule” shall
      have the meaning given to the term in Section
  2.1.3.

                


        

         

        
          	
                  1.10.  

                	
                  “Project Schedule” shall
      have the meaning given to the term in Section
  2.1.3.

                


        

         

        
          	
                  1.11.  

                	
                  “Project” shall have the
      meaning given to the term in Section
2.1.1.

                


        

         

        
          	
                  1.12.  

                	
                  “Project Documents”
      shall mean, with respect to each Project, all documents other than
      the Project Protocol and Task Orders that are prepared by SPONSOR and/or
      MEDPACE, which instruct, provide information or otherwise explain the
      conduct of such Project.

                


        

         

        
          	
                  1.13.  

                	
                  “Project Protocol” shall
      mean the document which describes the Project objectives, design,
      methodology, statistical considerations and organization of a
      Project.

                


        

         

        
          	
                  1.14.  

                	
                  “Regulatory Agency”
      means any governmental or regulatory authority in any relevant
      jurisdictions having jurisdiction over the subject matter of the Projects,
      including without limitation the
FDA.

                


        

         


        
          
             


          

          
            3

            
              

            

          

          
             


          

        


        


         

        
          	
                  1.15.  

                	
                  “Regulatory
      Requirements” means
      those laws, regulations, codes of conduct and guidelines applicable in the
      countries in which each Project is being conducted or that are applicable
      to the class of pharmaceutical product being tested or clinical specialty
      involved, and any subsequent modifications or amendments
      thereto.

                


        

         

        
          	
                  1.16.  

                	
                  “Services” shall have
      the meaning given to the term in Section
2.1.1.

                


        

         

        
          	
                  1.17.  

                	
                  “SOPs” shall mean
      standard operating procedures.

                


        

         

        
          	
                  1.18.  

                	
                  “Study Drug(s)” shall
      mean, with respect to each Clinical Study, the active drug(s) and placebo
      that is the subject of such Clinical Study, as more particularly described
      in the Task Order applicable
thereto.

                


        

         

        
          	
                  1.19.  

                	
                  “Study Personnel” shall
      have the meaning given to the term in Section
  3.2.1.

                


        

         

        
          	
                  1.20.  

                	
                  “Study Subjects” shall
      mean an individual who participates in a Clinical Study as a recipient of
      Study Drug(s).

                


        

         

        
          	
                  1.21.  

                	
                  “Subcontractor” shall
      have the meaning given to the term in Section
  2.5.3.

                


        

         

        
          	
                  1.22.  

                	
                  Further
      Definitions:

                


        

         

        In
addition, the following definitions have the meanings in the Sections
corresponding thereto, as set forth below:

         

        


        
          	
                  Definition

                	
                  Section

                
	
                  Advance
      Payment

                	
                  7.3.1

                
	
                  Change
      Order

                	
                  6.1

                
	
                  Claims

                	
                  17.1

                
	
                  Clinical
      Study Agreement

                	
                  3.3.1

                
	
                  Damages

                	
                  17.1

                
	
                  Final
      Pass-through Costs Invoice

                	
                  7.2.10

                
	
                  Internal
      Audit

                	
                  19.1.4.1

                
	
                  Internal
      Audit Report

                	
                  19.1.4.1

                
	
                  Investigator
      Expenses

                	
                  7.2.4

                
	
                  Investigator
      Fees

                	
                  7.2.4

                
	
                  Medpace
      Confidential Information

                	
                  11.2

                
	
                  Medpace
      Expenses

                	
                  7.2.4

                
	
                  Medpace
      Fees

                	
                  7.1

                
	
                  Medpace
      SOPs

                	
                  19.2.1.1

                
	
                  Regulatory
      Inspection

                	
                  19.1.5

                
	
                  Pass-Through
      Costs

                	
                  7.2.1

                
	
                  Project
      Budget

                	
                  2.1.3

                


        


        
          
             


          

          
            4

            
              

            

          

          
             


          

        


        


        
          	
                  Project
      IP

                	
                  13.1

                
	
                  Project
      Records

                	
                  15.1

                
	
                  Project
      Results

                	
                  12.1

                
	
                  Sponsor
      Confidential Information

                	
                  11.1

                
	
                  Sponsor
      Inspection

                	
                  19.1.3

                
	
                  Subcontractor
      SOPs

                	
                  19.2.2.1

                
	
                  Term

                	
                  9.1

                
	
                  Task
      Order

                	
                  2.1.2

                
	
                  Task
      Order Change

                	
                  6.1

                
	
                  Total
      Medpace Fees

                	
                  7.1.2

                


        

        


         

         

        
          	
                  2.  

                	
                  PROJECT
      SPECIFICATIONS AND CONDUCT OF
PROJECT

                


        

         

        
          	
                  2.1.  

                	
                  Task
      Orders

                


        

         

        
          	
                  2.1.1.  

                	
                  MEDPACE
      hereby agrees to perform certain services for SPONSOR for certain
      projects, including without limitation certain Clinical Studies, (each a
      “Project”) from time to time in accordance with the terms of this
      Agreement, the relevant Task Order and the relevant Project Protocol (the
      “Services”).

                


        

         

        
          	
                  2.1.2.  

                	
                  The
      precise Services to be performed by MEDPACE shall be mutually agreed upon
      by the Parties and set forth in one or more task orders (each a “Task
      Order”), in substantially the form attached hereto as Exhibit
      A.

                


        

         

        
          	
                  2.1.3.  

                	
                  Each
      Task Order shall be signed by an authorized representative of each Party
      and shall include detailed information concerning a given Project,
      including a description of the specific services to be provided, Project
      milestones and target completion dates (“Project Schedule”), a detailed
      budget (“Project Budget”), a schedule of payments related to the Project
      Schedule and the Project Budget (“Payment Schedule”), and a copy of the
      relevant Project Protocol.

                


        

         

        
          	
                  2.1.4.  

                	
                  Each
      Task Order shall contain a transfer of obligations list in conjunction
      with the relevant Task Order and consistent with the regulations set forth
      in 21 C.F.R. Section 312, Subpart D (Responsibilities of Sponsors and
      Investigators) and all other Regulatory Requirements.  Any
      responsibilities not specifically transferred in the transfer of
      obligations list shall remain the regulatory responsibility of
      SPONSOR.

                


        

         

        
          	
                  2.2.  

                	
                  Conduct
      of the Project

                


        

         

        Each
Project shall be conducted by MEDPACE in strict accordance with:

         

        
          	
                  2.2.1  

                	
                  the
      terms of this Agreement;

                


        

         


        
          
             


          

          
            5

            
              

            

          

          
             


          

        


        


         

        
          	
                  2.2.2  

                	
                  all
      specifications, requirements and timelines established in the relevant
      Task Orders;

                


        

         

        
          	
                  2.2.3  

                	
                  the
      relevant Project Protocol, and all amendments
  thereto;

                


        

         

        
          	
                  2.2.4  

                	
                  all
      agreed SOPs;

                


        

         

        
          	
                  2.2.5  

                	
                  GMP
      and GCP; and

                


        

         

        
          	
                  2.2.6  

                	
                  all
      Regulatory Requirements

                


        

         

        
          	
                  2.3.  

                	
                  Project
      Protocol

                


        

         

        
          	
                  2.3.1.  

                	
                  For
      the avoidance of doubt, MEDPACE shall not be entitled to make or implement
      any amendment to any Project Protocol without the prior written consent of
      SPONSOR.

                


        

         

        
          	
                  2.4.  

                	
                  Personnel

                


        

         

        
          	
                  2.4.1.  

                	
                  MEDPACE
      shall arrange for appropriately qualified personnel to support its
      obligations under this Agreement, the relevant Task Order and the relevant
      Project Protocol (“Medpace
Personnel”).

                


        

         

        
          	
                  2.4.2.  

                	
                  MEDPACE
      shall be responsible for ensuring that all Medpace Personnel are qualified
      by education, training and experience to perform their respective
      obligations under this Agreement, the relevant Task Order and the relevant
      Project Protocol.

                


        

         

        
          	
                  2.4.3.  

                	
                  MEDPACE
      shall provide to all relevant Medpace Personnel, subject to the
      confidentiality provisions of Section 11 of this Agreement, copies of the
      relevant Project Protocol and the Project
  Documents.

                


        

         

        
          	
                  2.4.4.  

                	
                  MEDPACE
      shall be responsible for ensuring, at the beginning of each Project, and
      on an ongoing basis during such Project, that Medpace Personnel are fully
      informed regarding the Study Drug(s), the conduct of the Project pursuant
      to the relevant Task Order and Project Protocol, and such Medpace
      Personnel’s obligations with respect to this Agreement, the relevant Task
      Order, and the relevant Project Protocol, including compliance with all
      Regulatory Requirements.

                


        

         

        
          	
                  2.4.5.  

                	
                  MEDPACE
      shall remain fully liable for its, and all Medpace Personnel’s performance
      of its, obligations hereunder.

                


        

         

        
          	
                  2.4.6.  

                	
                  Key
      personnel for both SPONSOR and MEDPACE shall be identified in the
      applicable Task Order for each Project.  Prior to their
      appointment by MEDPACE, SPONSOR shall have the right to review and approve
      the qualifications of key Medpace Personnel, which approval shall not be
      unreasonably withheld.  SPONSOR shall,
  acting

                


        

         


        
          
             


          

          
            6

            
              

            

          

          
             


          

        


        reasonably,
during the course of each Project, have the right to designate that key Medpace
Personnel working on such Project be removed and replaced.  SPONSOR
shall have the right to review and approve the qualifications of such
replacement key Medpace Personnel prior to their appointment by MEDPACE, which
approval shall not be unreasonably withheld.

         

        
          	
                  2.4.7.  

                	
                  MEDPACE
      shall maintain a consistently high skill level among all key Medpace
      Personnel (including without limitation any replacement key Medpace
      Personnel), consistent with its warranty in Section
  8.2.4.

                


        

         

        
          	
                  2.5.  

                	
                  Subcontractors

                


        

         

        
          	
                  2.5.1.  

                	
                  This
      Section 2.5 shall apply to the appointment of all subcontractors other
      than Institutions, Investigators and Study Personnel by
      MEDPACE.  Sections 3.2 and 3.3 shall apply to the appointment of
      Institutions, Investigators and Study Personnel by
  MEDPACE.

                


        

         

        
          	
                  2.5.2.  

                	
                  MEDPACE
      may not subcontract any portion of the Services hereunder without the
      prior written consent of SPONSOR.

                


        

         

        
          	
                  2.5.3.  

                	
                  Should
      MEDPACE subcontract with any third party upon such written consent of
      SPONSOR (each a “Subcontractor”), MEDPACE shall procure that such
      Subcontractors comply with all obligations of MEDPACE under this Agreement
      and any Task Order. The term Subcontractor does not include Institutions,
      Investigators and Study Personnel.

                


        

         

        
          	
                  2.5.4.  

                	
                  MEDPACE
      shall remain fully liable for its and such Subcontractor’s performance of
      the Services and the obligations of MEDPACE
  hereunder.

                


        

         

        
          	
                  2.5.5.  

                	
                  Prior
      to the appointment of any Subcontractor by MEDPACE, MEDPACE shall provide
      SPONSOR with such details as may be required by SPONSOR regarding the
      evaluation of such Subcontractor by
MEDPACE.

                


        

         

        
          	
                  2.6.  

                	
                  Progress
      Reporting

                


        

         

        
          	
                  2.6.1.  

                	
                  MEDPACE
      shall maintain appropriate systems to provide SPONSOR with regular
      information regarding the progress of the obligations transferred as
      detailed in appropriate Task
Orders.

                


        

         

        
          	
                  2.7.  

                	
                  Data
      Handling

                


        

         

        
          	
                  2.7.1.  

                	
                  MEDPACE
      shall use validated electronic data processing systems and
      maintain documentary evidence of this
  validation.

                


        

         


        
          
             


          

          
            7

            
              

            

          

          
             


          

        


        


         

        
          	
                  2.7.2.  

                	
                  MEDPACE
      shall undertake the processing of Study data in accordance with agreed
      SOPs, the relevant Task Orders, the relevant Project Protocols, and all
      Regulatory Requirements.  In particular, MEDPACE must at least
      have adequate access controls, back-up procedures, data integrity and
      validation checks, audit procedures and security training to enable
      compliance with its obligations.

                


        

         

        
          	
                  2.7.3.  

                	
                  MEDPACE
      shall make available to SPONSOR descriptions of MEDPACE’S physical and
      data security measures, standards and compliance requirements, and such
      other information as may be requested by
  SPONSOR.

                


        

         

         

        
          	
                  3.  

                	
                  CLINICAL
      STUDIES

                


        

         

        In
addition to all other provisions of this Agreement, the following provisions
shall apply specifically to the conduct of all Clinical Studies under this
Agreement:

        


        
          	
                  3.1  

                	
                  Commencement
      of Clinical Studies

                


        

         

        
          	
                  3.1.1  

                	
                  MEDPACE
      shall not commence patient recruitment for a Clinical Study until all
      appropriate regulatory approvals as detailed in the relevant Task Order
      have been obtained by SPONSOR and
MEDPACE.

                


        

         

        
          	
                  3.1.2  

                	
                  MEDPACE
      shall not commence Study Drug shipment to Investigator sites without the
      prior written approval of SPONSOR.

                


        

        


        
          	
                  3.2  

                	
                  Institutions,
      Investigators and Study Personnel

                


        

        


        
          	
                  3.2.1  

                	
                  Subject
      to the consent of SPONSOR, MEDPACE shall select appropriate Institutions
      and appropriately qualified clinical Investigators and study personnel
      (“Study Personnel”) to conduct each Study in accordance with this
      Agreement, the relevant Task Order and the relevant Project
      Protocol.

                


        

        


        
          	
                  3.2.2  

                	
                  Prior
      to conducting any Investigator meetings, MEDPACE shall agree with SPONSOR
      the extent to which SPONSOR wishes to be involved in such Investigator
      meetings.

                


        

        


        
          	
                  3.2.3  

                	
                  MEDPACE
      shall be responsible for ensuring that all Investigators and Study
      Personnel are qualified by education, training and experience to perform
      their respective obligations under this Agreement, the relevant Task Order
      and the relevant Project Protocol.

                


        

        


        
          	
                  3.2.4  

                	
                  MEDPACE
      shall provide to all Investigators and relevant Study Personnel, subject
      to the confidentiality provisions of Section 11
  of

                


        


        
          
             


          

          
            8

            
              

            

          

          
             


          

        


        this
Agreement, copies of the relevant Project Protocol and the Project
Documents.

        


        
          	
                  3.2.5  

                	
                  MEDPACE
      shall be responsible for ensuring, at the beginning of each Project, and
      on an ongoing basis during such Project, that Investigators and Study
      Personnel are fully informed regarding the Study Drug(s), the conduct of
      the Project pursuant to the relevant Task Order and Project Protocol, and
      such Study Personnel’s obligations with respect to this Agreement, the
      relevant Task Order, and the relevant Project Protocol, including
      compliance with all Regulatory
Requirements.

                


        

         
 

        
          	
                  3.3  

                	
                  Clinical
      Study Agreements

                


        

        


        
          	
                  3.3.1  

                	
                  MEDPACE
      shall ensure that, prior to the commencement of each Clinical Study, a
      clinical study agreement, in substantially the form set out in Exhibit B,
      (each a “Clinical Study Agreement”) shall be put in place with each
      Institution (and, if applicable, each
  Investigator).

                


        

        


        
          	
                  3.3.2  

                	
                  MEDPACE
      shall procure compliance by each Institution and each Investigator with
      the Clinical Study Agreement.

                


        

        


        
          	
                  3.4  

                	
                  Deviation
      from Project Protocol

                


        

        


        
          	
                  3.4.1  

                	
                  MEDPACE
      shall not deviate from the relevant Project Protocol without SPONSOR’s
      prior written consent, provided however that MEDPACE may deviate from such
      Project Protocol when necessary to protect the safety, rights or welfare
      of any Study Subjects.

                


        

        


        
          	
                  3.4.2  

                	
                  MEDPACE
      shall notify SPONSOR of any such deviations in accordance with Regulatory
      Requirements and the notification obligations set out in the relevant Task
      Order and Project Protocol.

                


        

        


        


        
          	
                  4.  

                	
                  PROJECT
      SCHEDULE

                


        

        


        
          	
                  4.1  

                	
                  Each
      Task Order shall contain a Project Schedule setting out Project timelines,
      milestones and/or target dates for completion of a Project or a portion
      thereof.   In
      all events, MEDPACE shall use its best efforts to comply with the Project
      Schedule in each Task Order.

                


        

        


        
          	
                  4.2  

                	
                  If
      at any time either Party anticipates a delay in meeting the timelines for
      a given Task Order as set forth in its Project Schedule, either due to
      changes to the Services requested by SPONSOR, or other causes, then the
      anticipating Party shall promptly notify the other Party in writing,
      specifying the reason for the delay and the anticipated effect upon the
      timelines, milestones or other

                


        


        
          
             


          

          
            9

            
              

            

          

          
             


          

        


        deliverables.  The
provisions of Section 6 (“Change Orders”) shall apply to any anticipated change
in the relevant Task Order.

        


        
          	
                  5.  

                	
                  NON-COMPLIANCE
      BY MEDPACE

                


        

        


        
          	
                  5.1  

                	
                  In
      the event that MEDPACE fails to conduct the Projects and/or perform the
      Services in accordance with the terms of this Agreement, the relevant Task
      Orders, and the relevant Project Protocols, MEDPACE shall use its best
      efforts to remedy such failure (whether by repeating the Services in
      question or some other action as approved in advance by SPONSOR) at no
      additional cost to SPONSOR, provided that such failure is not as a result
      of SPONSOR’s delay or failure to provide agreed deliverables under the
      relevant Task Order or Project
Protocol.

                


        

        


        
          	
                  5.2  

                	
                  In
      the event of a dispute as to whether or not MEDPACE has failed to
      conduct  the Projects and/or perform the Services in accordance
      with the terms of this Agreement, the relevant Task Orders, and the
      relevant Project Protocols, such dispute shall be referred to the CEO of
      MEDPACE and the Head of R&D of
SPONSOR.

                


        

        


        
          	
                  5.3  

                	
                  For
      the avoidance of doubt, nothing in this Section 5 shall affect SPONSOR’s
      right to terminate this Agreement under Section 9
  below.

                


        

        


        


        
          	
                  6.  

                	
                  CHANGE
      ORDERS

                


        

        


        
          	
                  6.1  

                	
                  Any
      change in the details of a Task Order or the assumptions upon which the
      Task Order is based (each a “Task Order Change”) may require changes in
      the Project Budget, Payment Schedule or Project Schedule.  Every
      such change shall require a written amendment to the Task Order (each a
      “Change Order”).  Each Change Order shall be in substantially
      the form set out in Exhibit C and shall detail the requested changes to
      the applicable task, responsibility, duty, budget, timeline or other
      matter.  The Change Order will become effective upon the
      execution of the Change Order by the Parties, and the Change Order will
      specify the period of time within which MEDPACE must implement the
      changes.  The Parties agree to act in good faith and promptly
      when considering a Change Order requested by another Party but no Party is
      obligated to execute a Change Order.  No Change Order shall
      become effective unless and until it is signed by the
      Parties.  Any Task Order Changes that result in additional
      charges shall be reflected in the Change Order to the affected Task Order,
      Project Budget or Payment Schedule.

                


        

        


        
          	
                  6.2  

                	
                  The
      Parties will use best efforts to ensure a Change Order has been executed
      by the Parties prior to the implementation of any Task Order
      Change.  At a minimum, Medpace will notify the Sponsor in
      advance of any additional costs

                


        


        
          
             


          

          
            10

            
              

            

          

          
             


          

        


        incurred
by MEDPACE as a result of a Task Order Change that is implemented by MEDPACE
before a Change Order is executed.

        


        
          	
                  6.3  

                	
                  The
      parties agree that:

                


        

        


        
          	
                  6.3.1  

                	
                  MEDPACE
      shall be responsible for all incremental costs which are incurred directly
      as a result of any Task Order Change requested by MEDPACE;
    and

                


        

        


        
          	
                  6.3.2  

                	
                  SPONSOR
      shall be responsible for all incremental costs which are incurred directly
      as a result of any Task Order Change requested by
  SPONSOR.

                


        

        


        
          	
                  7.  

                	
                  PROJECT
      BUDGET, PAYMENT SCHEDULE, AND TERMS

                


        

        


        
          	
                  7.1  

                	
                  MEDPACE
      Fees

                


        

        


        
          	
                  7.1.1  

                	
                  APIL
      agrees to pay MEDPACE fees for Services rendered (“MEDPACE Fees”) pursuant
      to the Project Budget and Payment Schedules included in each Task
      Order.

                


        

        


        
          	
                  7.1.2  

                	
                  The
      total Medpace Fees for each Project (the “Total MEDPACE Fees”) shall be
      set out in the relevant Task Order and in no event shall APIL be required
      to pay any amount exceeding the Total MEDPACE Fees unless otherwise agreed
      in writing by both parties by Change Order(s) in accordance with Section 6
      above.

                


        

        


        
          	
                  7.1.3  

                	
                  MEDPACE
      shall issue invoices in respect of MEDPACE Fees in accordance with the
      Payment Schedule.

                


        

        


        
          	
                  7.2  

                	
                  Pass-through
      Costs

                


        

        


        
          	
                  7.2.1  

                	
                  APIL
      agrees to reimburse MEDPACE for reasonable and necessary pass-through
      costs identified in the Task Order and incurred by MEDPACE in providing
      the Services in accordance with the relevant Task Order (“Pass-through
      Costs”).

                


        

        


        
          	
                  7.2.2  

                	
                  Pass-through
      costs incurred by MEDPACE that are (i) in addition to the total
      Pass-through Costs identified in the relevant Task Order, or (ii) that are
      not notified in accordance with Section 6.2, shall not be recoverable by
      MEDPACE without the prior written
      approval of Amarin.

                


        

        


        
          	
                  7.2.3  

                	
                  Pass-through
      Costs will be reimbursed by APIL on a direct cost basis i.e. without any
      mark up being added by MEDPACE.

                


        


        
          
             


          

          
            11

            
              

            

          

          
             


          

        


        


        


        
          	
                  7.2.4  

                	
                  Pass-through
      Costs include, but are not limited to, Investigators’ fees (“Investigator
      Fees”), reasonable and necessary expenses incurred by Investigators
      (“Investigator Expenses”), reasonable and necessary expenses incurred by
      Medpace employees (“Medpace Expenses”), CRF printing costs, courier costs,
      teleconference fees, drug packaging and labeling and pharmacy
      fees.

                


        

        


        
          	
                  7.2.5  

                	
                  MEDPACE
      shall agree Investigator Fees with each Investigator based upon industry
      standard rates in the relevant jurisdiction where such Investigator is
      located.  Upon the request of SPONSOR, MEDPACE shall provide
      such information as may be reasonably requested by SPONSOR to evidence
      that such Investigator Fees are based upon the relevant industry standard
      rates.

                


        

        


        
          	
                  7.2.6  

                	
                  All
      Medpace Expenses must comply with the MEDPACE Travel and Expenses Policy,
      as approved by SPONSOR on the Effective Date.  MEDPACE shall
      promptly notify SPONSOR of any amendments to such
      policy.  Medpace Expenses that are incurred other than in
      accordance with such policy shall not be recoverable by
      MEDPACE.

                


        

        


        
          	
                  7.2.7  

                	
                  All
      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.  Invoices in
      respect of Pass-through Costs shall be further analyzed into the following
      categories; (i) Investigator Fees, (ii) Investigator Expenses and (iii)
      other Pass-through Costs.

                


        

        


        
          	
                  7.2.8  

                	
                  In
      the case of any individual Pass-through Cost item (excluding Investigator
      Fees) exceeding US$5,000 that is not identified in the relevant Task
      Order, SPONSOR’s prior written approval must be given for such
      expense.

                


        

        


        
          	
                  7.2.9  

                	
                  MEDPACE
      shall issue invoices in respect of Pass-through Costs on a monthly
      basis.

                


        

        


        
          	
                  7.2.10  

                	
                  With
      respect to each Clinical Study, MEDPACE shall use best efforts to issue a
      final invoice in respect of all outstanding Pass-through Costs (the “Final
      Pass-through Costs Invoice”) within 90 days of the issue by MEDPACE of the
      final signed form of Clinical Study Report in accordance with the relevant
      Task Order; provided that MEDPACE agrees that it shall issue the Final
      Pass-through Costs Invoice within a maximum of 120 days of the issue by
      MEDPACE of the final signed form of Clinical Study Report in accordance
      with the relevant Task Order.  For the avoidance of doubt, once
      the Final Pass-through Costs Invoice has been issued by MEDPACE, MEDPACE
      shall not be entitled to recover any additional pass-through
      costs.

                


        


        
          
             


          

          
            12

            
              

            

          

          
             


          

        


        


        


        
          	
                  7.3  

                	
                  Advance
      Payments

                


        

         

        
          	
                  7.3.1  

                	
                  If
      SPONSOR and MEDPACE agree in writing in the relevant Task Order(s) that as
      part of the Services to be provided under such Task Order(s) that MEDPACE
      is to enter into agreements with third parties, which include but are not
      limited to third party advance payments for investigator meetings,
      vendors, Study Site payments and any payments to investigators,
      institutions, and site maintenance organizations for services performed
      that relate to a Study, and obligate itself to making payments to such
      third parties for services rendered in conducting a Study (as defined in
      the relevant Task Order(s)), then SPONSOR shall escrow in advance all
      funds necessary for MEDPACE to meet its current payment obligations under
      such agreements and those obligations for the upcoming fiscal quarter
      (including non-cancellable expenses) (an “Advance
      Payment”).  The request for an Advance Payment should be
      accompanied by appropriate documentation supporting such a
      request.

                


        

        


        


        
          	
                  7.3.2  

                	
                  APIL
      shall make such Advance Payments to MEDPACE within 5 days after receipt of
      a written invoice in respect of same. Within 5 days of each quarter end,
      Medpace will provide a statement reconciling Advance Payments made by
      Sponsor with disbursements of same by
Medpace.

                


        

        


        


        
          	
                  7.3.3  

                	
                  For
      the avoidance of doubt, this Section 7.3 is without prejudice to Section
      7.2.

                


        

        


        
          	
                  7.4  

                	
                  Subject
      to Section 7.3.2, APIL shall make payments to MEDPACE within 30 days after
      receipt of a written invoice and such supporting documentation as required
      by SPONSOR. A monthly interest rate of 1% above LIBOR will be applied to
      invoices that remain outstanding for longer than 45
  days.

                


        

         

        
          	
                  7.5  

                	
                  An
      exchange rate of 1US Dollar to 1.45 Euro will be included in each Task
      Order.  Exchange rates will be monitored on a monthly
      basis.  In the event of exchange rate fluctuations exceeding +/-
      2%, all ex-US Pass-through Costs will be adjusted
    accordingly.

                


        

         

        
          	
                  7.6  

                	
                  All
      sums referred to in each Work Order shall be exclusive of Value Added Tax
      (VAT).

                


        

         

        
          	
                  7.7  

                	
                  APIL
      shall be authorised to receive invoices and to make remittances under this
      Agreement.  All invoices should be addressed to APIL at the
      following address:

                


        

         


        
          
             


          

          
            13

            
              

            

          

          
             


          

        


        


         

        Accounts
Department

        Amarin
Pharmaceuticals Ireland Limited

        1st
Floor, Block 3

        The Oval,
Shelbourne Road

        Ballsbridge,
Dublin 4

        Ireland

        


        With an
email copy of each invoice sent to Alan Johnston at APIL at the following email
address:

        


         alan.johnston@amarincorp.com

        


        
          	
                  8.  

                	
                  WARRANTIES
      AND REPRESENTATIONS

                


        

         

        
          	
                  8.1  

                	
                  Acknowledgements:

                


        

         

        MEDPACE
acknowledges that the Services to be provided hereunder are for the benefit of,
and are subject to the oversight of SPONSOR.  MEDPACE acknowledges
that SPONSOR is the beneficiary under the terms of this Agreement and each Task
Order, and that SPONSOR is entitled to enforce the provisions
thereof.

         

        
          	
                  8.2  

                	
                  Representations,
      Warranties and Covenants of MEDPACE

                


        

         

        
          	
                  8.2.1  

                	
                  MEDPACE
      represents and warrants that it is a corporation with its principal office
      and place of business at 4620 Wesley Avenue, Cincinnati, Ohio 45212, duly
      organized, validly existing and in good standing in its place of
      organization, and is duly qualified to do
  business.

                


        

         

        
          	
                  8.2.2  

                	
                  MEDPACE
      represents and warrants that the execution and delivery of this Agreement
      has been validly authorized by all necessary corporate action and that
      this Agreement represents the valid binding agreement of MEDPACE
      enforceable in accordance with its terms.  The execution,
      delivery and performance of this Agreement will not violate any
      organizational document governing MEDPACE, any agreement to which MEDPACE
      is a party, or any law or court or governmental order, holding or writ by
      which MEDPACE is bound.

                


        

         

        
          	
                  8.2.3  

                	
                  MEDPACE
      further warrants that it shall render the Services requested by SPONSOR in
      accordance with high professional standards, GCP, GLP, and GMP, the agreed
      SOPs, this Agreement, the Task Orders, the Project Protocols, and, without
      prejudice to the foregoing, the standard of care customary in the contract
      research organization industry.

                


        

         


        
          
             


          

          
            14

            
              

            

          

          
             


          

        


        


         

        
          	
                  8.2.4  

                	
                  MEDPACE
      represents and warrants that the personnel assigned to perform Services
      rendered under this Agreement shall be qualified and professionally
      capable of performing the Services in accordance with this Agreement, the
      relevant Task Order, and the relevant Project Protocol, and shall devote
      such time as is necessary to perform the Services in accordance with this
      Agreement, the relevant Task Order (including the relevant Project
      Schedule), and the relevant Project
Protocol.

                


        

         

        
          	
                  8.2.5  

                	
                  MEDPACE
      further represents and warrants that it shall perform the Services in
      compliance with all Regulatory Requirements, including, without
      limitation, the Federal Food, Drug and Cosmetic Act and
      the regulations promulgated pursuant thereto, and all future amendments
      thereto, and all other applicable Regulatory Requirements in all relevant
      jurisdictions.

                


        

         

        
          	
                  8.2.6  

                	
                  MEDPACE
      represents and warrants that there is no litigation, regulatory
      investigation or proceeding, administrative hearing or any other similar
      proceeding pending or threatened against MEDPACE which could adversely
      affect MEDPACE’s ability to perform the
  Services.

                


        

         

        
          	
                  8.2.7  

                	
                  MEDPACE
      covenants that each employee, agent, developer, consultant and contractor
      who has access to, contributes to, or participates in the creation of any
      Project Results or Project IP hereunder (as such terms are defined in
      Sections 12 and 13 below) during the Term shall execute a confidentiality
      agreement in favour of MEDPACE that protects the confidentiality of such
      Project Results and Project IP and shall execute an assignment or other
      agreement to assign in favour of MEDPACE all such person’s right, title
      and interest in the Project Results and Project
  IP.

                


        

         

        
          	
                  8.3  

                	
                  Representations
      and Warranties of SPONSOR and APIL

                


        

         

        
          	
                  8.3.1  

                	
                  SPONSOR
      represents and warrants that it is a corporation with its principal office
      and place of business at Mystic Packer Building, 12 Roosevelt Avenue,
      Mystic, Connecticut, CT 06355, duly organized, validly existing and in
      good standing in its place of organization, and is duly qualified to do
      business

                


        

         

        
          	
                  8.3.2  

                	
                  APIL
      represents and warrants that it is a corporation with its principal office
      and place of business at 1st Floor, Block 3, The Oval, Shelbourne Road,
      Ballsbridge, Dublin 4, Ireland, duly incorporated and validly existing in
      its place of incorporation.

                


        

         

        
          	
                  8.3.3  

                	
                  SPONSOR
      and APIL each represents and warrants that the execution and delivery of
      this Agreement has been validly authorized by
  all

                


        

         


        
          
             


          

          
            15

            
              

            

          

          
             


          

        


        necessary
corporate action and that this Agreement represents the valid binding agreement
of SPONSOR and APIL enforceable in accordance with its terms.  The
execution, delivery and performance of this Agreement will not violate any
organizational document governing SPONSOR or APIL, any agreement to which
SPONSOR or APIL is a party, or any law or court or governmental order, holding
or writ by which SPONSOR or APIL is bound.

         

        
          	
                  8.3.4  

                	
                  SPONSOR
      and APIL each represents and warrants that there is no litigation,
      regulatory investigation or proceeding, administrative hearing or any
      other similar proceeding pending or threatened against SPONSOR or APIL
      which could adversely affect SPONSOR’s or APIL’s ability to perform its
      obligations under this Agreement or any Task
  Order.

                


        

         

        
          	
                  9.  

                	
                  TERM
      AND TERMINATION

                


        

         

        
          	
                  9.1  

                	
                  Term

                


        

         

        
          	
                  9.1.1  

                	
                  The
      Agreement shall commence on the Effective Date and shall continue in full
      force and effect until terminated by the Parties in accordance with the
      terms hereof (the “Term”).

                


        

         

        
          	
                  9.2  

                	
                  Termination by
      SPONSOR

                


        

         

        
          	
                  9.2.1  

                	
                  SPONSOR
      may forthwith terminate this Agreement or any Task Order with or without
      cause immediately upon giving MEDPACE written notice of such
      termination.

                


        

         

        
          	
                  9.3  

                	
                  Termination by
      MEDPACE

                


        

         

        
          	
                  9.3.1  

                	
                  MEDPACE
      may terminate a Task Order upon giving SPONSOR written notice of such
      termination only if SPONSOR is in material breach of its obligations
      thereunder and has not cured such default within 10 days after receipt of
      written notice if the default is the failure to pay MEDPACE any amount due
      thereunder or within 30 days after receipt of written notice in the event
      of any other default.

                


        

         

        
          	
                  9.4  

                	
                  Consequences of
      Termination

                


        

         

        
          	
                  9.4.1  

                	
                  Upon
      receipt by MEDPACE and/or SPONSOR of a termination notice, the Parties
      shall cooperate in good faith to agree on a plan to expeditiously conclude
      activities with respect to such
matter.

                


        

         

        
          	
                  9.4.2  

                	
                  As
      soon as practicable after receipt of such notice, MEDPACE shall transfer
      to SPONSOR all Project Records, Project Results, Project Documents, unused
      Study Drug, SPONSOR Confidential Information, and all other data and
      information in MEDPACE’s possession in
any

                


        

         


        
          
             


          

          
            16

            
              

            

          

          
             


          

        


        and all
formats available, including electronic format and computer files and
programs.

         

        
          	
                  9.4.3  

                	
                  In
      the event of any termination of a Task Order before completion, MEDPACE
      shall use its best efforts to reduce the costs incurred by SPONSOR as a
      result of such early termination.

                


        

         

        
          	
                  9.4.4  

                	
                  Other
      than in the event of termination by SPONSOR of this Agreement or any
      particular Task Order for breach of this Agreement by MEDPACE, as soon as
      reasonably practicable following receipt of a termination notice, MEDPACE
      shall submit an itemized accounting of Services performed, MEDPACE
      Expenses, MEDPACE Fees, Investigator Expenses, Investigator Fees and other
      non-cancelable Pass-through Costs actually incurred by MEDPACE pursuant to
      the performance of such Services, and payments received by MEDPACE from
      SPONSOR, together with any additional information required by
      SPONSOR,  in order to determine the balance to be paid by the
      Parties to each other.  Such balance shall be paid within 30
      days of approval by SPONSOR of such itemized accounting by
      MEDPACE.  For the avoidance of doubt, this Section 9.4.4 is
      without prejudice to Section
7.2.10.

                


        

         

        
          	
                  9.4.5  

                	
                  Upon
      termination for any reason of this Agreement or any Task Orders relating
      to a particular Study, MEDPACE shall immediately terminate all relevant
      Clinical Study Agreements that are in place at the date of such
      termination.

                


        

         

        
          	
                  9.4.6  

                	
                  For
      the avoidance of doubt, the provisions of Section 15.4 shall apply to all
      queries raised by SPONSOR relating to the Projects after termination of
      this Agreement or any Task Order.

                


        

         

        
          	
                  9.5  

                	
                  In
      the event that a Clinical Study is terminated by SPONSOR prior to
      completion for reasons related to the safety and welfare of the Study
      Subjects, MEDPACE shall notify the relevant regulatory authorities and
      ethics committees in accordance with the applicable Regulatory
      Requirements.

                


        

         

        
          	
                  10.  

                	
                  COMMUNICATIONS

                


        

         

        
          	
                  10.1  

                	
                  Any
      notice required or permitted under this Agreement shall be in writing and
      shall be deemed given if (i) delivered personally, (ii) mailed by prepaid,
      first class, certified mail, return receipt requested, or (iii) sent by
      express courier service, to the Party to be notified at the addresses set
      forth below (or such other address as shall be designated by written
      notice); provided that all notices shall be effective upon receipt
      thereof:

                


        

         


        
          
             


          

          
            17

            
              

            

          

          
             


          

        


        


         

        
          	
                  10.2  

                	
                  If
      to MEDPACE:

                


        

         

        Medpace,
Inc.

        4620
Wesley Avenue

        Cincinnati,
Ohio 45212

        Attn:  August
J. Troendle

        Telephone:  (513)
579-9911 x2278

         

                10.3 If
to SPONSOR:

         

        Mystic
Packer Building

        12
Roosevelt Avenue

        Mystic,
Connecticut, CT 06355

        Attn:  Rene
Brackman

        Telephone:  +1860
572-4979

        


        With a
copy (which shall not constitute notice) to:

        


        Amarin
Pharmaceuticals Ireland Limited

        1st
Floor, Block 3, The Oval,

        Shelbourne
Road, Ballsbridge,

        Dublin 4,
Ireland

        Attn:  General
Counsel

        Telephone:  +353
1 6699010

        


         

        
          11. 
CONFIDENTIALITY

        

         

        
          	
                  11.1  

                	
                  SPONSOR,
      may provide confidential information to MEDPACE during the course of this
      Agreement.  All information provided by SPONSOR, or any of its
      Affiliates on or prior to the date of this Agreement or data generated,
      derived or collected by MEDPACE for SPONSOR during the course of
      performance of the Services is deemed to be the confidential information
      of SPONSOR (“SPONSOR Confidential Information”).  SPONSOR
      Confidential Information shall include but is not limited to all
      information, data and materials, and intellectual property, and any
      non-public information pertaining to SPONSOR’s business practices or other
      proprietary information.  During the Term and for a period of 10
      (ten) years thereafter, MEDPACE undertakes to treat all SPONSOR
      Confidential Information as confidential and MEDPACE shall not disclose
      SPONSOR Confidential Information to any third party, or use SPONSOR
      Confidential Information for any purpose other than for those set forth
      under this Agreement or a Task Order, without the prior written consent of
      SPONSOR.

                


        

         

        
          	
                  11.1.1  

                	
                  MEDPACE
      shall ensure by binding written agreement that its employees, agents, and
      approved independent contractors involved in the Services (including,
      without limitation, all Investigators) and any third parties to whom
      MEDPACE intends to disclose the
SPONSOR

                


        

         


        
          
             


          

          
            18

            
              

            

          

          
             


          

        


        Confidential
Information with SPONSOR’s prior written consent shall comply with the
provisions of Article 11 of this Agreement.  MEDPACE shall disclose
SPONSOR Confidential Information only to those of its employees, agents, and
independent contractors (including, without limitation all Institutions and
Investigators) who strictly need to know SPONSOR Confidential Information for
the purpose of MEDPACE performing its obligations hereunder, who have been made
aware that the SPONSOR Confidential Information is proprietary and confidential
and who either are bound by written obligations of confidentiality to MEDPACE to
treat information such as SPONSOR Confidential Information in the strictest
confidence as such or who are provided with a copy of the provisions of this
Article 11 and agree to be bound by the terms hereof to the same extent as if
they were parties hereto.

         

        
          	
                  11.1.2  

                	
                  MEDPACE
      shall exercise all due care to prevent the unauthorized disclosure and use
      of SPONSOR Confidential
Information.

                


        

         

        
          	
                  11.1.3  

                	
                  MEDPACE
      agrees that its will be responsible for any breach of this Agreement by
      any officers or employees or approved independent contractors of MEDPACE
      (including, without limitation all Institutions and Investigators) and
      agrees to take, at MEDPACE’s sole expense, all necessary measures to
      restrain officers and employees and approved independent contractors of
      MEDPACE (including, without limitation all Institutions and Investigators)
      from prohibited or unauthorized disclosure or use of SPONSOR Confidential
      Information (including, without limitation, the initiation of court
      proceedings).

                


        

         

         
 

        
          	
                  11.2  

                	
                  MEDPACE
      Confidential Information.

                


        

         

        MEDPACE
may provide confidential information to SPONSOR during the course of this
Agreement (“MEDPACE Confidential Information”).  MEDPACE Confidential
Information shall include but is not limited to standard operating procedures,
pricing, and financial information provided by MEDPACE or its Affiliates to
SPONSOR during the course of performance of the Services, and any non-public
information pertaining to MEDPACE’s business practices or other proprietary
information.  During the Term and for a period of 10 (ten) years
thereafter, SPONSOR undertakes to treat all MEDPACE Confidential Information as
confidential and SPONSOR shall not disclose MEDPACE Confidential Information to
any third party, or use MEDPACE Confidential Information for any purpose other
than for those set forth under this Agreement or a Task Order, without the prior
written consent of MEDPACE.

         

        
          	
                  11.2.1  

                	
                  SPONSOR
      shall ensure by binding written agreement that its employees, agents, and
      approved independent contractors involved
in

                


        

         


        
          
             


          

          
            19

            
              

            

          

          
             


          

        


        the
Services and any third parties to whom SPONSOR intends to disclose the MEDPACE
Confidential Information with MEDPACE’s prior written consent shall comply with
the provisions of Article 11 of this Agreement.  SPONSOR shall
disclose MEDPACE Confidential Information only to those of its employees,
agents, and independent contractors who strictly need to know MEDPACE
Confidential Information for the purpose of SPONSOR performing its obligations
hereunder, who have been made aware that the MEDPACE Confidential Information is
proprietary and confidential and who either are bound by written obligations of
confidentiality to SPONSOR to treat information such as MEDPACE Confidential
Information in the strictest confidence as such or who are provided with a copy
of the provisions of this Article 11 and agree to be bound by the terms hereof
to the same extent as if they were parties hereto.

         

        
          	
                  11.2.2  

                	
                  SPONSOR
      shall exercise all due care to prevent the unauthorized disclosure and use
      of confidential information associated with the
  Services.

                


        

         

        
          	
                  11.2.3  

                	
                  SPONSOR
      agrees that its will be responsible for any breach of this Agreement by
      any officers or employees or approved independent contractors of SPONSOR
      and agrees to take, at SPONSOR’s sole expense, all necessary measures to
      restrain officers and employees and approved independent contractors of
      SPONSOR from prohibited or unauthorized disclosure or use of MEDPACE
      Confidential Information (including, without limitation, the initiation of
      court proceedings).

                


        

         

        
          	
                  11.3  

                	
                  These
      confidentiality and nondisclosure provisions shall not apply
      to:

                


        

         

        
          	
                  11.3.1  

                	
                  information
      which has become lawfully known to the receiving Party before the date
      hereof, otherwise than in breach of any obligation of confidentiality to
      the disclosing Party, or which is independently discovered, after the date
      hereof, without the aid, application or use of the confidential
      information, as evidenced by written
records;

                


        

         

        
          	
                  11.3.2  

                	
                  information
      which is in the public domain on the date hereof or subsequently becomes
      publicly available through no fault or action of the receiving Party;
      or

                


        

         

        
          	
                  11.3.3  

                	
                  information,
      which is disclosed to the receiving Party by a third party after the date
      hererof, authorized to disclose it.

                


        

         

        
          	
                  11.4  

                	
                  Subject
      to Section 11.6, if the receiving Party is requested to disclose
      confidential information of the disclosing Party or the terms of this
      Agreement in connection with a legal or administrative proceeding or
      otherwise to comply with a requirement under applicable Regulatory
      Requirements, the

                


        

         


        
          
             


          

          
            20

            
              

            

          

          
             


          

        


        receiving
Party will give the disclosing Party prompt notice of such request so that the
disclosing Party may seek an appropriate protective order or other remedy, or
waive compliance with the relevant provisions of this Agreement.  The
disclosing Party must notify the receiving Party within 10 days that it intends
to take action in response to the request for disclosure.  If the
disclosing Party seeks a protective order or other remedy, the receiving Party,
at the disclosing Party’s expense, will cooperate with and assist the disclosing
Party in such efforts.  If any such order or other remedy does not
fully preclude disclosure, the receiving Party shall make such disclosure only
to the extent that such disclosure is legally required.  Failure of
the disclosing Party to intervene shall not relieve the obligations to maintain
confidentiality except in so far as the receiving Party must comply with the
terms of such order or proceeding compelling disclosure.

         

        
          	
                  11.5  

                	
                  SPONSOR
      shall be entitled to provide a copy of this Agreement (and any related
      agreements or documents) to a potential third party acquirer, investor or
      other commercialization partner provided that the relevant third party has
      entered into a confidentiality agreement on terms to be agreed between
      SPONSOR and such relevant third
party.

                


        

         

        
          	
                  11.6  

                	
                  Subject
      to Section 11.7, SPONSOR shall be entitled to issue any release,
      disclosure or filing relating to this Agreement required by applicable
      Regulatory Requirements or the rules or regulations of any stock exchange
      on which the securities of SPONSOR or an Affiliate of SPONSOR are
      listed.

                


        

         

        
          	
                  11.7  

                	
                  Upon
      receipt of written approval from MEDPACE, such approval not to be
      unreasonably withheld, SPONSOR shall be entitled to issue any press
      release regarding the execution of this
  Agreement.

                


        

         

        
          	
                  12.  

                	
                  RIGHTS
      IN PROPERTY

                


        

         

        
          	
                  12.1  

                	
                  All
      materials, documents, data, software and information of every kind and
      description, including without limitation all Study reports and Study
      data, and all electronic data files containing all such materials,
      documents, data, software and
information:

                


        

         

        
          	
                  12.1.1  

                	
                  supplied
      to MEDPACE by SPONSOR, APIL or any of their Affiliates;
  or

                


        

         

        
          	
                  12.1.2  

                	
                  prepared,
      developed, generated, derived or otherwise created by MEDPACE pursuant to
      this Agreement, (except for the MEDPACE procedural manuals and documented
      standard operating procedures pre-existing as of the Effective
      Date),

                


        

         

        (collectively
“Project Results”)

         

        are and
shall be the exclusive and confidential property of APIL.

         


        
          
             


          

          
            21

            
              

            

          

          
             


          

        


        


         

        
          	
                  12.2  

                	
                  APIL
      and its Affiliates shall have the right to make whatever use they deem
      desirable of any Project Results.  MEDPACE shall not, without
      the prior written consent of SPONSOR, publish, disseminate, or otherwise
      disclose to any third party any Project Results or Project IP (as such
      term is defined in Section 13.1), or use any such Project Results or
      Project IP for any purpose other than the performance of this
      Agreement.

                


        

         

        
          	
                  12.3  

                	
                  Any
      inventions or other intellectual property, including without limitation
      patents, patent applications, protectable copyrights and trademarks, that
      may evolve from the Project Results or as the result of Services performed
      by MEDPACE under this Agreement shall belong exclusively to APIL and
      MEDPACE agrees to assign all its rights in all such inventions and/or
      other intellectual property to APIL consistent with the obligations set
      forth in Article 13 below.

                


        

         

        
          	
                  12.4  

                	
                  SPONSOR
      and APIL acknowledges that all computer programs, software and
      applications, databases (excluding for the avoidance of doubt all
      electronic files containing any Project Results), and MEDPACE procedural
      manuals and documented standard operating procedures
  that:

                


        

         

        
          	
                  12.4.1  

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

                


        

         

        
          	
                  12.4.2  

                	
                  have
      not been developed 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 any Services performed hereunder, without the benefit of
any information provided by SPONSOR or APIL (including without limitation any
SPONSOR data, information, materials or SPONSOR Confidential Information (or
derivatives thereof)), shall be the property of MEDPACE.

         

         

        
          	
                  13.  

                	
                  PATENT
      RIGHTS

                


        

         

        
          	
                  13.1  

                	
                  MEDPACE
      shall disclose promptly to SPONSOR any and all inventions, discoveries,
      know-how and improvements conceived or made by MEDPACE while providing
      Services to SPONSOR pursuant to the Agreement, whether or not constituting
      an improvement, alteration, enhancement, modification, or extension of use
      of SPONSOR’s proprietary rights (“Project
IP”).

                


        

         

        
          	
                  13.2  

                	
                  Subject
      to Section 12.4, all Project IP shall belong exclusively to APIL, and
      MEDPACE agrees to assign all its interest therein to APIL or its nominee;
      whenever requested to do so by SPONSOR or APIL.  MEDPACE
      shall

                


        

         


        
          
             


          

          
            22

            
              

            

          

          
             


          

        


        execute
any and all applications, assignments, or other instruments and give testimony
which SPONSOR or APIL shall deem necessary to apply for and obtain a patent in
the United States of America and/or other country worldwide, or to protect
otherwise APIL’s interests, and APIL shall compensate MEDPACE on a reasonable
basis for the time devoted to said activities and reimburse it for reasonable
out of pocket expenses incurred.

         

         

        
          	
                  14.  

                	
                  PUBLICITY

                


        

         

        
          	
                  14.1  

                	
                  MEDPACE
      shall not make any public announcements concerning this 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.

                


        

         

        
          	
                  14.2  

                	
                  Save
      as provided in Section 11.6, SPONSOR may not use MEDPACE’s name, logo or
      trademark in any communication, release, notice or other publication
      without the express prior written consent of
  MEDPACE.

                


        

         

        
          	
                  14.3  

                	
                  Publication
      of any Project Results or Project IP from any Project or any information
      relating thereto (including that any such Project has commenced, taken
      place, or completed) shall, subject only to disclosure requirements
      imposed by applicable Regulatory Requirements, be within the sole and
      absolute discretion of the SPONSOR and MEDPACE shall not make any
      publication in relation thereto without the prior written consent of
      SPONSOR.

                


        

         

        
          	
                  14.4  

                	
                  Without
      prejudice to any other provisions of this Agreement, MEDPACE recognizes
      that Amarin Corporation plc (“Amarin”), an Affiliate of SPONSOR, is a
      publicly limited company listed on NASDAQ.  Project Results will
      likely comprise material non-public information of Amarin and the
      strictest procedures will require to be followed by MEDPACE and SPONSOR to
      safeguard the confidentiality of all such information prior to any
      disclosure by Amarin or any Affiliate of Amarin.  SPONSOR and
      MEDPACE shall agree a policy which the Parties will be required to follow
      as regards communication between SPONSOR and MEDPACE of any Project
      Results prior to Amarin’s ultimate public disclosure of
    same.

                


        

         


        
          
             


          

          
            23

            
              

            

          

          
             


          

        


        


         

         

        
          	
                  15.  

                	
                  SECURITY
      AND DISPOSITION OF PROJECT FILES

                


        

         

        
          	
                  15.1  

                	
                  MEDPACE
      shall use best efforts, including, but not limited to, periodic backup of
      computer files, to prevent the loss or alteration of the Project Results,
      SPONSOR Confidential Information, case report forms, and all other SPONSOR
      materials, documentation and correspondence (“Project
      Records”).  MEDPACE shall comply in all respects with all
      applicable Regulatory Requirements concerning the validation, maintenance,
      creation and storage of records, including electronic
    records.

                


        

         

        
          	
                  15.2  

                	
                  At
      appropriate time points or upon completion of Services under a Task Order
      or upon the written request of SPONSOR, MEDPACE shall transfer all Project
      Records to SPONSOR.  MEDPACE shall have the right to retain one
      copy of any Project Records necessary solely to meet applicable Regulatory
      Requirements or MEDPACE’s own internal audit requirements, so long as it
      continues to maintain the confidentiality requirements of Article
      11.

                


        

         

        
          	
                  15.3  

                	
                  Project
      Records shall be retained by MEDPACE for the period required under
      applicable Regulatory Requirements.  Thereafter, MEDPACE shall,
      at the written request of SPONSOR, return or destroy such Project Records
      in accordance with the written instructions of
  SPONSOR.

                


        

         

        
          	
                  15.4  

                	
                  After
      the completion of each Project, MEDPACE shall provide all reasonable
      assistance in relation to any subsequent questions raised by SPONSOR or
      its Affiliates.   MEDPACE shall charge SPONSOR for all such
      data queries at the rate specified in the relevant Task
    Order.

                


        

         

         

        
          	
                  16.  

                	
                  SPONSOR
      OBLIGATIONS

                


        

         

        
          	
                  16.1  

                	
                  SPONSOR
      acknowledges that the performance of the Services by MEDPACE will require
      the co-operative involvement of SPONSOR and MEDPACE, and SPONSOR hereby
      agrees to provide such assistance as may be reasonably necessary to enable
      MEDPACE to perform the Services.

                


        

         

         

        
          	
                  17.  

                	
                  INDEMNIFICATION

                


        

         

        
          	
                  17.1  

                	
                  Indemnification
      by SPONSOR

                


        

        


        SPONSOR
shall indemnify, defend and hold harmless MEDPACE and its Affiliates 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 the
performance of the Services by MEDPACE under any Task Order (including but not
limited to any Damages arising from or in connection with any study, test,
device, product or potential product to which this Agreement relates), to the
extent such Claims or Damages have not resulted from MEDPACE’s


        
          
             


          

          
            24

            
              

            

          

          
             


          

        


        negligent
act or omission, or willful misconduct, or a breach of any applicable Regulatory
Requirement, or breach of this Agreement, any Task Order or Project Protocol by
MEDPACE. 

         

        
          	
                  17.2  

                	
                  Indemnification
      by MEDPACE

                


        

         

        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 connection with the performance of the Services by MEDPACE
under any Task Order 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 Regulatory Requirement, or a breach of this Agreement, any
Task Order or Project Protocol by MEDPACE.

        


        
          	
                  17.3  

                	
                  Limitation
      for fraud etc

                


        

        


        Nothing
in this 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.

        


        
          	
                  17.4  

                	
                  Process
      for Indemnification, Defense and/or Settlement of
  Claims

                


        

        


        Any Party
providing indemnification under this Agreement shall have the right to control
the defense and settlement of any Claims.  The party seeking to be
indemnified shall have the right to obtain separate legal counsel at its own
expense if it so chooses.  The party seeking to be indemnified shall
reasonably cooperate in the defense of any Claims and provide prompt notice to
the indemnifying party of any Claims for which indemnification is
sought.  The indemnifying party shall reasonably and regularly consult
with the party seeking to be indemnified in relation to the progress and status
of such Claim.  The party seeking to be indemnified shall not
acknowledge the validity of, compromise or otherwise settle any Claim without
the prior written consent of the indemnifying party, 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 Claim
or Damages.

        


        
          	
                  17.5  

                	
                  Insurance

                


        

        


        
          	
                  17.5.1  

                	
                  MEDPACE
      shall, at its own cost and expense, obtain and maintain in full force and
      effect the following insurance during the
Term:

                


        

        


        
          	
                  17.5.1.1  

                	
                  General
      Liability Insurance with a per-occurrence limit of not less than
      $1,000,000;

                


        


        
          
             


          

          
            25

            
              

            

          

          
             


          

        


        


        


        
          	
                  17.5.1.2  

                	
                  Employers
      Liability Insurance with a per-occurrence limit of not less than
      $1,000,000 per accident;

                


        

        


        
          	
                  17.5.1.3  

                	
                  Professional
      Services Errors & Omissions Liability Insurance with per-occurrence
      limit of not less than $10,000,000.

                


        

        


        
          	
                  17.5.2  

                	
                  SPONSOR
      shall, at its own cost and expense, obtain and maintain in full force and
      effect the following insurance during the
Term:

                


        

        


        
          	
                  17.5.2.1  

                	
                  General
      Liability Insurance with a per-occurrence limit of not less than an amount
      equivalent to €5,000,000;

                


        

        


        
          	
                  17.5.2.2  

                	
                  Employers
      Liability Insurance with a per-occurrence limit of not less than an amount
      equivalent to €13,000,000 per
accident;

                


        

        


        
          	
                  17.5.2.3  

                	
                  Products
      Liability Insurance (for clinical trial activity only) with a
      per-occurrence limit of not less than an amount equivalent to
      €7,500,000.

                


        

        


        
          	
                  17.5.3  

                	
                  MEDPACE
      and SPONSOR shall furnish certificates of insurance evidencing the
      required insurance policies to the other as soon as practicable after the
      Effective Date and within 30 days after renewal of such
      policies.  In the event that any of the required policies of
      insurance are written on a claims made basis, then MEDPACE and SPONSOR
      shall ensure that such policies shall be maintained during the entire Term
      and shall use reasonable endeavours to ensure that such policies shall be
      maintained for a period of not less than 3 years following the expiration
      or termination of this Agreement.  Each insurance policy that is
      required under this Agreement shall be obtained from an insurance carrier
      with an A.M. Best rating of at least A-VII.  MEDPACE and SPONSOR
      shall ensure that each of the required policies include a general
      indemnity to principal clause.

                


        

        


        
          	
                  17.5.4  

                	
                  With
      respect to each Project, MEDPACE shall, prior to the commencement of any
      Services in relation thereto, inform SPONSOR of any discrepancies between
      its insurance cover and the policy exclusions thereunder and the relevant
      Project Protocol.

                


        

         

        
          	
                  18.  

                	
                  LIMITATION
      OF LIABILITY

                


        

         

        
          	
                  18.1  

                	
                  Notwithstanding
      the terms of Article 17 above, in no 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

                


        

         


        
          
             


          

          
            26

            
              

            

          

          
             


          

        


        damage
(whether for loss of current or future profits, loss of enterprise value or
otherwise) and whether occasioned by the negligence of the respective parties,
their employees or agents or otherwise, even if the breaching party has been
advised of the possibility of such damages.

         

         

        
          	
                  19.  

                	
                  MONITORING,
      INSPECTIONS, AUDITS AND
NOTIFICATIONS

                


        

         

        
          	
                  19.1  

                	
                  Inspections/Audits

                


        

         

        
          	
                  19.1.1  

                	
                  Subject
      to Section 19.1.2, SPONSOR shall have the right, upon at least ten (10)
      business days’ prior written notice to MEDPACE, to examine the standard
      operating procedures, quality systems, facilities, books, records, papers,
      files and documentation, including computer files, data bases and records,
      at MEDPACE’s facilities and the facilities of any Subcontractors, to
      determine the adequacy of such records, to ensure the Services are being
      performed in accordance with this Agreement, the approved Task Orders and
      all applicable Regulatory Requirements, and/or to examine the financial
      records of MEDPACE as may be reasonably necessary to verify Pass-through
      Costs incurred during the performance of the Services.  Such
      inspections and audits (each a “SPONSOR Inspection”) shall be conducted
      during normal business hours.

                


        

         

        
          	
                  19.1.2  

                	
                  In
      the event that SPONSOR suspects that MEDPACE, or any Subcontractor, may be
      in breach of this Agreement, including without limitation its obligations
      to comply with GMP and/or GCP (as applicable), SPONSOR shall have the
      right, upon at least three (3) business days’ prior written notice to
      MEDPACE, to conduct a SPONSOR Inspection at MEDPACE’s facilities and the
      facilities of any Subcontractor.

                


        

         

        
          	
                  19.1.3  

                	
                  If
      any Regulatory Agency requests to inspect any books, records, data of
      MEDPACE or any Subcontractor, relating to the Services, MEDPACE shall
      immediately notify SPONSOR and shall promptly notify SPONSOR of the
      outcome of any such inspection (each a “Regulatory Inspection”) within
      five (5) business days of such outcome becoming known to
      MEDPACE.

                


        

         

        
          	
                  19.1.4  

                	
                  Internal
      Audits

                


        

         

        
          	
                  19.1.4.1  

                	
                  In
      the event that MEDPACE or any Subcontractor, conducts an internal audit
      that relates in any way to the Services (an “Internal Audit”) at the
      request and expense of SPONSOR, then MEDPACE shall, and shall procure that
      all relevant Subcontractors shall, furnish to SPONSOR a copy of the final
      report in respect of such Internal Audit (the “Internal
    Audit

                


        

         


        
          
             


          

          
            27

            
              

            

          

          
             


          

        


        Report”)
within ten (10) business days of the Internal Audit Report being
issued.

         

        
          	
                  19.1.4.2  

                	
                  In
      the event that MEDPACE or any Subcontractor conducts an Internal Audit at
      its own expense, then MEDPACE shall, and shall procure that such
      Subcontractor shall, furnish to SPONSOR a copy of the Internal Audit
      Report in a timely fashion once such report has been issued, provided that
      MEDPACE shall, and shall procure that such Subcontractor shall, notify
      SPONSOR of any critical findings in such Internal Audit Report within
      three (3) days of the Internal Audit Report being
  issued.

                


        

         

        
          	
                  19.1.5  

                	
                  MEDPACE
      shall, and shall procure that all Subcontractors shall, provide all
      necessary assistance including making available members of its staff and
      providing access to all relevant facilities and all requested records, to
      facilitate such SPONSOR Inspections, Regulatory Inspections and Internal
      Audits.

                


        

         

        
          	
                  19.1.6  

                	
                  Except
      as otherwise agreed in writing with SPONSOR, MEDPACE shall at its own cost
      and expense, and shall procure that each Subcontractor shall at its own
      cost and expense, take all reasonable steps required by SPONSOR or any
      relevant Regulatory Agency to cure any deficiencies found in any relevant
      Internal Audit, SPONSOR Inspection, Regulatory Inspection, or other
      inspection or investigation within ten (10) business days of the relevant
      report being issued or of MEDPACE or the relevant
      Subcontractor,  becoming aware of such
    deficiency.

                


        

         

        
          	
                  19.1.7  

                	
                  For
      the avoidance of doubt, the rights of SPONSOR relating to inspections and
      audits as set out in this Section 19.1 shall apply to any third party
      acting on behalf of SPONSOR, provided there is a confidentiality agreement
      in place between SPONSOR and such third party on terms to be agreed
      between SPONSOR and such third
party.

                


        

         

        
          	
                  19.2  

                	
                  Standard
      Operating Procedures

                


        

         

        
          	
                  19.2.1  

                	
                  MEDPACE
      SOPs

                


        

         

        
          	
                  19.2.1.1  

                	
                  MEDPACE
      shall, promptly following the Effective Date, provide SPONSOR with a list
      of all of SOPs of MEDPACE relating to the performance of the Services (the
      “MEDPACE SOPs”).

                


        

         

        
          	
                  19.2.1.2  

                	
                  On
      an annual basis thereafter, MEDPACE shall provide SPONSOR with an updated
      list of MEDPACE SOPs.

                


        

         


        
          
             


          

          
            28

            
              

            

          

          
             


          

        


        


         

        
          	
                  19.2.1.3  

                	
                  MEDPACE
      shall promptly notify SPONSOR of any material updates to the MEDPACE SOPs
      that are made during the period between each annual
  update.

                


        

         

        
          	
                  19.2.1.4  

                	
                  Upon
      request from SPONSOR, MEDPACE shall provide copies of the MEDPACE SOPS to
      SPONSOR.

                


        

         

        
          	
                  19.2.2  

                	
                  Subcontractor
      SOPs

                


        

         

        
          	
                  19.2.2.1  

                	
                  MEDPACE
      shall procure that, promptly following the date upon which a Subcontractor
      commences the performance of Services, each Subcontractor shall provide
      SPONSOR with a list of all SOPs of such Subcontractors relating to the
      performance of the Services (the “Subcontractor
  SOPs”).

                


        

         

        
          	
                  19.2.2.2  

                	
                  MEDPACE
      shall procure that, on an annual basis thereafter, each Subcontractor
      shall provide SPONSOR with an updated list of Subcontractor
      SOPs.

                


        

         

        
          	
                  19.2.2.3  

                	
                  MEDPACE
      shall procure that each Subcontractor shall promptly notify SPONSOR of any
      material updates to the Subcontractor SOPs that are made during the period
      between each annual update.

                


        

         

        
          	
                  19.2.2.4  

                	
                  Upon
      request from SPONSOR, MEDPACE shall procure that each Subcontractor shall
      provide copies of the Subcontractor SOPS to
  SPONSOR.

                


        

         

        
          	
                  19.2.3  

                	
                  MEDPACE
      shall not, and shall procure that each Subcontractor shall not, commence
      the performance of any Services until SPONSOR has approved the relevant
      SOPs of MEDPACE and the relevant
Subcontractors.

                


        

         

        
          	
                  19.3  

                	
                  Oversight
      of the Projects

                


        

         

        
          	
                  19.3.1  

                	
                  MEDPACE
      will actively oversee the progress of the Projects, and ensure that they
      are conducted, recorded, and reported in accordance with this Agreement,
      applicable Task Orders, the agreed SOPs, GCP, GLP, GMP, and other
      applicable Regulatory Requirements. Any deviations will be recorded and
      reported to SPONSOR as defined in the relevant Task
  Orders.

                


        

         

        
          	
                  19.3.2  

                	
                  MEDPACE
      shall, and shall procure that all Subcontractors shall, at all times make
      available to SPONSOR, or to the responsible Regulatory Agency, relevant
      records, programs and data as may reasonably be requested by SPONSOR or
      which is the subject of a Task
Order.

                


        

         


        
          
             


          

          
            29

            
              

            

          

          
             


          

        


        


         

        
          	
                  19.3.3  

                	
                  MEDPACE
      shall procure that SPONSOR shall have the right at any time to visit any
      of the facilities where MEDPACE and the Subcontractors are performing any
      of the Services in order to monitor the operations of MEDPACE and the
      Subcontractors hereunder.

                


        

         

        
          	
                  19.3.4  

                	
                  During
      such monitoring visits, SPONSOR shall have the right to inspect the work
      being done and materials used, to observe the procedures being followed,
      to examine the books, records and other data relevant to the
      Services.

                


        

         

        
          	
                  19.4  

                	
                  Notification
      of suspected fraud or misconduct

                


        

         

        
          	
                  19.4.1  

                	
                  Subject
      to Section 19.4.2, MEDPACE shall adhere to all Regulatory Requirements
      with respect to notification to SPONSOR regarding suspected fraud or
      misconduct by MEDPACE, any Institution, Investigator or Subcontractor in
      the conduct of any Project.

                


        

         

        
          	
                  19.4.2  

                	
                  MEDPACE
      shall notify SPONSOR within one (1) business day of becoming aware of any
      suspected fraud or misconduct in the conduct of any
    Project.

                


        

         

        
          	
                  19.4.3  

                	
                  Where
      any Subcontractor suspects any fraud or misconduct in the conduct of any
      Project, Medpace shall procure that such Subcontractor shall notify
      SPONSOR and MEDPACE within one (1) business day of becoming aware of any
      suspected fraud or misconduct in the conduct of any
    Project.

                


        

         

        
          	
                  19.4.4  

                	
                  If
      the initial notification is verbal, written confirmation shall be sent to
      SPONSOR by MEDPACE, and where applicable by the relevant Subcontractor,
      within one (1) working day of such initial
  notification.

                


        

         

        
          	
                  19.5  

                	
                  Institutions/Investigators

                


        

         

        
          	
                  19.5.1  

                	
                  MEDPACE
      acknowledges that, under the Clinical Study Agreement, Institution is
      obliged to make certain notifications to MEDPACE regarding the outcome of
      inspections carried out by Institution and/or by any regulatory agencies,
      that MEDPACE has certain rights to conduct certain inspections and audits
      of Institutions and/or Investigator, and that MEDPACE has certain rights
      to oversee the progress of the
Study.

                


        

         

        
          	
                  19.5.2  

                	
                  MEDPACE
      shall immediately notify SPONSOR of any notifications it receives from any
      Institution regarding such inspections by Institution and/or any
      Regulatory Agency, or the outcome of any inspection or audit conducted by
      MEDPACE of the Institution and/or Investigator, or of any observations
      MEDPACE makes while overseeing the Study, as soon as it becomes aware of
      same.

                


        

         


        
          
             


          

          
            30

            
              

            

          

          
             


          

        


        


         

         

        
          	
                  20.  

                	
                  DEBARMENT

                


        

         

        
          	
                   
      

                	
                  20.1    
      MEDPACE hereby represents, warrants, and certifies that neither it nor any
      of its officers, directors, owners, principals or employees has been or
      will be at any relevant time hereunder debarred by any Regulatory Agency
      under any applicable Regulatory Requirement, including without limitation
      by the FDA under Section 306 of the Federal Food, Drug and Cosmetic Act,
      21 U.S.C. §335a. 

                


        

        


        
          	
                  20.2  

                	
                  MEDPACE
      hereby represents, warrants, and certifies that it has not and shall not
      use in any capacity the services of any individual, corporation,
      partnership, or association (including without limitation any Institution,
      Investigator or Study Personnel)
who:

                


        

        


        
          	
                  20.2.1  

                	
                  is
      under investigation by any Regulatory Agency under any applicable
      Regulatory Requirement, including without limitation by the FDA, for a
      debarment action or is presently debarred pursuant to Section 306 (a)
      and/or Section 306 (b) of the Federal Food Drug and Cosmetic Act (21
      U.S.C. 335(a) and b) as published in the Federal Register (FR));
      or

                


        

        


        
          	
                  20.2.2  

                	
                  has
      a disqualification hearing pending or has been disqualified by any
      Regulatory Agency under any Regulatory Requirement, including without
      limitation the FDA, pursuant to US 21 CFR Section 312.70 or its successor
      provisions.

                


        

        


        
          	
                   
      

                	
                  20.3

                	
                  If,
      during the term of this Agreement, any person or entity referred to in
      Section 20.1 or Section 20.2:

                


        

         

        
          	
                   
      

                	
                  20.3.1

                	
                  comes
      under investigation by any Regulatory Agency, including without limitation
      the FDA, for debarment or disqualification;
or

                


        

         

        
          	
                   
      

                	
                  20.3.2

                	
                  is
      debarred or disqualified by any Regulatory Agency, including without
      limitation the FDA; or

                


        

         

        
          	
                   
      

                	
                  20.3.3

                	
                  engages
      in any conduct or activity which could lead to any of the above mentioned
      disqualification or debarment
actions;

                


        

         

        
          	
                   
      

                	
                  MEDPACE
      shall immediately notify SPONSOR in writing of
  same.

                


        

         

         

        
          	
                  21.  

                	
                  NON
      SOLICITATION

                


        

         

        Neither
SPONSOR nor MEDPACE nor their Affiliates shall during the Term and for a period
of twelve months following its termination, either directly or indirectly, hire
any employee of the other Party with whom it comes into contact as a result of
providing the Services, or recruit, solicit, or entice any such person to become
employed by it or any Affiliate and shall not approach any such employee for
such purpose or encourage, authorize or approve the

         


        
          
             


          

          
            31

            
              

            

          

          
             


          

        


        taking of
such action by any other person.  The Parties agree that any breach of
this provision would cause irreparable harm and that, in addition to any and all
other available remedies, injunctive relief, without the necessity of a bond or
other security, shall be appropriate and available.

         

         

        The terms
“hire” or “recruit, solicit, or entice” shall not be deemed to include general
solicitations of employment not specifically directed towards employees of a
party or any of its Affiliates, for example general press
advertisements.

         

         

        
          	
                  22.  

                	
                  ENTIRE
      AGREEMENT AND
AMENDMENTS/MODIFICATIONS

                


        

         

        This
Agreement contains the full understanding of the Parties with respect to the
subject matter hereof and supersedes all existing agreements and all other oral,
written or other communications between the Parties concerning the subject
matter hereof.  This 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.

         

         

        
          	
                  23.  

                	
                  GOVERNING
      LAW

                


        

         

        This
Agreement and the performance hereof shall be governed, interpreted and
construed in all respects by the internal laws of the State of New York and the
parties hereby submit to the non-exclusive jurisdiction of the courts of New
York, New York to resolve all disputes and claims arising under this Agreement
or any Task Order.

         

        
          	
                  24.  

                	
                  NO
      WAIVER

                


        

         

        No waiver
of any term, provision, or condition of this Agreement shall be deemed effective
unless contained in a written document signed by the Party charged with such
waiver, and no such waiver shall be deemed to be or construed as a further or
continuing waiver of any such term, provisions, or conditions, or of any other
term, provision, or condition of this Agreement.

         

         

        
          	
                  25.  

                	
                  INDEPENDENT
      CONTRACTOR

                


        

         

        In
fulfilling its obligations pursuant to this Agreement, each Party shall be
acting as an independent contractor.  No Party is granted any right or
authority hereunder to assume or to create any obligation or responsibility,
express or implied, on behalf of or in the name of any other Party.

         

        26.  FORCE MAJEURE

         

        No Party
shall be liable or deemed to be in default for any delay due to causes beyond
the reasonable control of the Party, such as war, acts or threats of terrorism,
civil disorders, acts of God, or government action; provided, that

         


        
          
             


          

          
            32

            
              

            

          

          
             


          

        


        the
affected Party promptly notifies the other of the cause and its effects on the
Services to be performed hereunder and that any such delay or failure shall be
remedied by such Party as soon as practicable.  Financial difficulty
shall never be deemed a force majeure event.

         

        
          	
                  27.  

                	
                  SEVERABILITY

                


        

         

        
          	
                  27.1  

                	
                  If
      any provision in this Agreement is agreed by the Parties to be, or is
      deemed to be, or becomes invalid, illegal, void or unenforceable under any
      law that is applicable hereto:-

                


        

         

        
          	
                  27.1.1  

                	
                  such
      provision will be deleted; and

                


        

         

        
          	
                  27.1.2  

                	
                  the
      validity, legality and enforceability of the remaining provisions of this
      Agreement shall not be impaired or affected in any
  way.

                


        

         

         

        
          	
                  28.  

                	
                  ASSIGNMENT

                


        

         

        
          	
                  28.1  

                	
                  Except
      as set forth herein, no Party shall assign this Agreement or any Task
      Order except with the express prior written consent of the other
      Party.

                


        

        


        
          	
                  28.2  

                	
                  Notwithstanding
      anything contained herein, SPONSOR and APIL may assign this Agreement
      and/or any Task Order to any Affiliate or to a Successor, without the
      prior written consent of MEDPACE.

                


        

        


        
          	
                  28.3  

                	
                  As
      used herein, “Successor” means any entity which acquires all or
      substantially all of the assets or shares of a Party or any entity into
      which a Party is merged.

                


        

         

        
          	
                  29.  

                	
                  CONFLICTS
      BETWEEN AGREEMENTS

                


        

         

        In the
event that there is any conflict between the provisions of this Agreement and
any duly executed Task Order, this Agreement shall prevail, unless the Task
Order clearly states that in the event of such conflict, it shall
control.

         

        
          	
                  30.  

                	
                  FURTHER
      ASSURANCES

                


        

        


        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 Agreement for assuring to or vesting in the requesting Party
the full benefit of the terms hereof.


        
          
             


          

          
            33

            
              

            

          

          
             


          

        


        


         

        
          	
                  31.  

                	
                  SURVIVING
      PROVISIONS

                


        

         

        The
provisions of Sections 8, 9, 10, 11, 12, 13, 14, 15, 17, 18, 19, 21, 23, 30 and
this Section 31 shall survive the termination of this Agreement or any Task
Order.

         

        


         


        
          
             


          

          
            34

            
              

            

          

          
             


          

        


        IN
WITNESS WHEREOF, the Parties have executed this Agreement as of the date of last
signature below.

         

        


        


        MEDPACE,
INC.

        


        Signature:__________________________

        


        By:________________________________

        (Print
Name)

        Title:
______________________________

        


        Date:
______________________________

        


        


        


        AMARIN
PHARMA INC

        


        Signature:__________________________

        


        By:________________________________

        (Print
Name)

        Title:
______________________________

        


        Date:
______________________________

        


        


        


        AMARIN
PHARMACEUTICALS IRELAND LIMITED

        


        Signature:__________________________

        


        By:________________________________

        (Print
Name)

        Title:
______________________________

        


        Date:
______________________________

        


        


        



        
          
             


          

          
            35

            
              

            

          

          
             


          

        


        EXHIBIT
A

        


        FORM
OF TASK ORDER

        


        MEDPACE
Task Order Number: ______________

        


        MEDPACE
Project Number: ______________

         

        This Task
Order, dated as of the date of last signature below, is between Medpace Inc.
(“MEDPACE”), Amarin
Pharma Inc (“SPONSOR”)
and Amarin Pharmaceuticals Ireland Limited (“APIL”).

        


        RECITALS:

         

        WHEREAS, MEDPACE, SPONSOR and
APIL have entered into that certain Master Services Agreement
dated  __________________  (the “Master Services
Agreement”); and

         

        WHEREAS, pursuant to the
Master Services Agreement, MEDPACE has agreed to perform certain Services in
accordance with this Agreement, the relevant Task Orders, and the relevant
Project Protocol, from time to time entered into by the Parties and SPONSOR,
APIL and MEDPACE now desire to enter into such a Task Order; and

         

        WHEREAS, MEDPACE, SPONSOR and
APIL desire that MEDPACE provide certain services with respect to ______ (the
“Project”) for the study
of the product ________ (“Study Product”) as set out in
the Protocol Number: ____________, which is attached hereto as Appendix
1;

         

        NOW, THEREFORE, in
consideration of the mutual covenants contained herein, the Parties hereby agree
as follows:

        


        
          	
                  1.  

                	
                  Scope of
      Work:  MEDPACE shall perform the services described in
      the Scope of Work, attached hereto as Appendix 2, in accordance with the
      Project Schedule, attached hereto as Appendix 3 and any other documents
      attached to and specifically referenced in this Task Order
      (“Services”)

                


        

        


        
          	
                  2.  

                	
                  Compensation:  For
      performance of these Services, SPONSOR shall pay to MEDPACE an amount
      equal to the Project Budget set forth in Appendix 4, which amount shall be
      payable pursuant to the Payment Schedule set forth in Appendix
      5.  The Project Budget is provided for cost analysis
      purposes.  It is agreed that all fees are fixed prices unless
      the underlying assumptions (including without limitation trial duration,
      number of sites/patients, services provided) change and all such changes
      shall be agreed and documented in a Change Order in accordance with
      Section 6 of the MSA.  After staff are assigned, costs are
      incurred based upon allocation of staff
      capacity.  The

                


        


        
          
             


          

          
            36

            
              

            

          

          
             


          

        


        provisions
of Article 7 of the Master Services Agreement shall apply to all payments due
under this Task Order.

        


        
          	
                  3.  

                	
                  Transfer of
      Obligations:  Sponsor Obligations transferred to MEDPACE
      by SPONSOR (consistent with the regulations set forth in 21 C.F.R. Section
      312, Subpart D) and all other Regulatory Requirements are identified in
      Appendix 6.

                


        

        


        
          	
                  4.  

                	
                  Master Services
      Agreement. The provisions of the Master Services Agreement are
      hereby expressly incorporated by reference into and made a part of this
      Task Order.  Defined terms used in this Task Order shall have
      the meaning given to such terms in the Master Services Agreement unless
      defined otherwise herein.  In the event of any conflict between
      any provisions of this Task Order and the Master Services Agreement, the
      provisions of the Master Services Agreement shall
  prevail.

                


        

        


         

        IN WITNESS WHEREOF, the
Parties have hereunto signed this Task Order effective as of the day and year
first written above.

        


        MEDPACE,
INC.

        


        Signature:__________________________

        


        By:________________________________

        (Print
Name)

        Title:
______________________________

        


        Date:
______________________________

        


        


        AMARIN
PHARMA INC.

        


        Signature:__________________________

        


        By:________________________________

        (Print
Name)

        Title:
______________________________

        


        Date:
______________________________

        



        
          
             


          

          
            37

            
              

            

          

          
             


          

        


        


        AMARIN
PHARMACEUTICALS IRELAND LIMITED

        


        Signature:__________________________

        


        By:________________________________

        (Print
Name)

        Title:
______________________________

        


        Date:
______________________________

        


        


        List
of Appendices:

        


        Appendix
1:  Protocol

        Appendix
2:  Scope of Work

        Appendix
3:  Project Schedule

        Appendix
4:  Project Budget

        Appendix
5:  Payment Schedule

        Appendix
6:  Trial Master Plan


        
          
             


          

          
            38

            
              

            

          

          
             


          

        


        EXHIBIT
B

        TEMPLATE
FORM CLINICAL STUDY AGREEMENT


        
          
             


          

          
            39

            
              

            

          

          
             


          

        


        EXHIBIT
C

        


        SAMPLE
CHANGE ORDER

        


        This
CHANGE ORDER dated as of
the date of last signature below

        


        BETWEEN

        


        
          	
                  (1)  

                	
                  AMARIN PHARMA INC whose
      principal place of business is at Mystic Packer Building, 12 Roosevelt
      Avenue Mystic, Connecticut, CT 06355 (“SPONSOR”);

                


        

        


        
          	
                  (2)  

                	
                  AMARIN PHARMACEUTICALS IRELAND
      LIMITED whose registered office is at 1st
      Floor, Block 3, The Oval, Shelbourne Road, Ballsbridge, Dublin 4, Ireland
      (“APIL”);
      and

                


        

        


        
          	
                  (3)  

                	
                  MEDPACE INC., of 4620
      Wesley Avenue, Cincinnati, Ohio 45212, US (“MEDPACE”)

                


        

        


        WHEREAS

        


        
          	
                  A.  

                	
                  SPONSOR,
      APIL and MEDPACE are bound by the terms of the Master Services Agreement
      dated ________________, 200­­­9 (the “Master
      Agreement”).

                


        

        


        
          	
                  B.  

                	
                  SPONSOR,
      APIL and MEDPACE executed a task order on ________________,
      200_  (the “Task
      Order”).

                


        

        


        
          	
                  C.  

                	
                  SPONSOR,
      APIL and MEDPACE now wish to amend certain details of the Task Order on
      the terms as set out below.

                


        

        


        THE
PARTIES NOW HEREBY AGREE AS FOLLOWS:

        


        
          	
                  1  

                	
                  The
      parties agree to amend the Task Order as
  follows:

                


        

        


        


        
          	
                  Details
      of Change Required

                	
                  Change
      Value

                
	 
      	
                  [insert
      details of changes to budget, timelines, payment
  schedule]

                
	 	 
	 	 
	 	 
	
                  Date
      to Implement Change:

                	
                  DD
      MMM YYYY

                


        

        



        
          
             


          

          
            40

            
              

            

          

          
             


          

        


        


        
          	
                  2  

                	
                  Except
      as expressly set forth in this Change Order, all other terms and
      conditions of the Master Agreement and the Task Order remain the
      same.

                


        

        


        
          	
                  3  

                	
                  Unless
      otherwise defined herein, all defined terms used in this Change Order
      shall have the meaning given to such terms in the Master Agreement and the
      Task Order.

                


        

        


        
          	
                   
      

                	
                  SIGNED
      BY

                


        

        


        


        MEDPACE,
INC.

        


        Signature:__________________________

        


        By:________________________________

        (Print
Name)

        Title:
______________________________

        


        Date:
______________________________

        


        


        AMARIN
PHARMA INC.

        


        Signature:__________________________

        


        By:________________________________

        (Print
Name)

        Title:
______________________________

        


        Date:
______________________________

        


        


        AMARIN
PHARMACEUTICALS IRELAND LIMITED

        


        Signature:__________________________

        


        By:________________________________

        (Print
Name)

        Title:
______________________________

        


        Date:
______________________________

        


        


        41