Document:

Unassociated Document

     

    Exhibit
10.49

    
 

    MASTER
AGREEMENT FOR CLINICAL RESEARCH SERVICES

     

    This
MASTER AGREEMENT FOR CLINICAL RESEARCH SERVICES (this “Agreement”)
is made effective January 30, 2009 (the “Effective Date”) by and between Idenix
Pharmaceuticals, Inc., a Delaware corporation having a current address of 60
Hampshire Street, Cambridge, MA 02139 USA, (“Company”), and ACLIRES International, Ltd, a
Bermudian Company, based at Milner House, 18 Parliament Street, Hamilton HM FX,
Bermuda (“CRO”). Company and CRO may be
referred to herein each, individually, as a “Party” or, collectively, as the “Parties”.

     

    BACKGROUND

     

    A.          Company
is engaged in the business of discovering and developing, pharmaceutical
products.

     

    B.          CRO
is engaged in the business of providing clinical research services, including
regulatory filing of clinical trial application, clinical and laboratory
performance of phase I/IIa studies, data management, biostatistical analysis and
medical writing.

     

    C.          Company
and CRO desire to enter into this Agreement whereby CRO will perform services
relating to certain clinical research programs Company is conducting (each, a
“Study”), all on the terms and conditions
as more fully set forth below.

     

    NOW,
THEREFORE, Company and CRO agree to the following:

    

    ARTICLE
1

    SERVICES

     

    1.1 General.  CRO agrees to perform, from time to
time, services (“Services”) in connection with a Study as will
be described in detail in one or more mutually agreed project addenda in
substantially the form set forth in Exhibit A hereto,
each of which shall be attached and incorporated into this Agreement (each, a
“Project Addendum”). The Project Addendum and this
Agreement shall constitute the entire agreement for the applicable Project. To
the extent any terms set forth in a Project Addendum shall conflict with the
terms set forth in this Agreement, the terms of this Agreement shall control,
unless the conflicting terms in this Agreement are specifically referenced in
the Project Addendum and stated to be superseded. Each Project Addendum shall be
signed by an authorized representative of each Party prior to initiation of any
work under that Project Addendum.

     

    1.2 Form of Project
Addenda.  At a minimum,
the Project Addenda for each Project shall include and describe in detail each
of the following:

     

    1.2.1   scope
of Services to be provided by CRO, including specific responsibilities and
deliverables to be provided;

     

    1.2.2   protocol
for the Study relating to such Services (“Protocol”);

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    1.2.3    milestones
for the Services (“Milestones”);

     

    1.2.4    budget
for CRO’s provision of Services (“Budget”); and

     

    1.2.5
payment schedule for the Services (“Payment Schedule”).

     

    1.3   Transferred
Responsibilities. Certain Services
to be performed by CRO under a Project Addendum may be “sponsor”
responsibilities with respect to a Study under the FDCA (as defined below) and
21 C.F.R. Part 312, Subpart D. Pursuant to 21 C.F.R. § 312.52, as part of the
Services under a Project Addendum, CRO will assume specific sponsor
responsibilities as agreed by the Parties. A list or chart of all such sponsor
responsibilities assumed by CRO in substantially the form set forth in Exhibit B hereto will
be attached as an exhibit to the Project Addendum.

     

    1.4   Performance of
Services. CRO shall perform the
Services under a Project Addendum in compliance with:

     

    1.4.1   the
terms of this Agreement, the applicable Project Addendum (including the Protocol
therein) and Company’s written instructions;

     

    1.4.2   all
laws, ordinances, rules and regulations of any governmental or regulatory
authority that apply to the Services and the activities contemplated under this
Agreement, including without limitation (i) all applicable federal, state and
local laws, rules and regulations; (ii) the U.S. Federal Food, Drug and Cosmetic
Act (“FDCA”) or similar foreign
regulations, as the case may be; (iii) regulations and guidelines of the U.S.
Food and Drug Administration (“FDA”) or
the European Medicines Agency or similar foreign regulation, as the case may be;
(iv) and ICH guidelines; (v) current Good Clinical Practices, and if applicable,
current Good Laboratory Practices, as promulgated by the FDA or the European
Medicines Agency or similar foreign regulation, as the case may be; and (vi)
applicable industry standards in the pharmaceutical industry when performing
studies used to support regulatory filings (collectively, “Applicable Laws”);

     

    1.4.3   Additionally,
CRO could outsource some services and, in that case, these services will be
detailed in Exhibit A

     

    1.5 Site Agreements. To the extent required under a Project
Addendum, CRO shall enter into agreements with participating institutions in its
own name and not as an agent of Company (each, a “Site Agreement”), provided that: (i) each Site
Agreement shall be based in all material respects on a form agreement that
Company and CRO mutually agree upon in advance, (ii) no Site Agreement shall
contain any terms inconsistent with the terms of this Agreement and the
applicable Project Addendum, (iii) the teens of each Site Agreement shall
expressly establish Company as an intended third party beneficiary of CRO’s
rights thereunder and (iv) CRO shall not agree to a material amendment to the
form agreement without Company’s consent, in each case, unless otherwise agreed
by the Parties. CRO shall exercise all reasonable efforts to ensure that the
data and results generated by the participating institutions shall be
coordinated, analyzed and reported regularly in an efficient and effective
manner and provided in a format approved by Company.

     

    
      
         

      

      
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    1.6 Changes. In the event that a change in a Study requires
a change to CRO’s Services under a Project Addendum, the Parties agree to
negotiate in good faith an amendment to the Project Addendum which reflects such
changes.

     

    1.7 Financial
Interests. CRO agrees that it will
promptly disclose to Company any direct and indirect financial interests as
described in Section 7.1.3 which are held or obtained during the term of a
Project Addendum by CRO, any of CRO’s affiliates or any CRO Personnel (as
defined below).

     

    1.8 Debarment. CRO hereby certifies that it has not been
debarred under Article 306 of the FDCA, 21 U.S.C. §335a(a) or (b) similar
foreign regulation as the case may be. In the event that CRO becomes debarred,
CRO agrees to notify Company immediately, and Company shall have the right to
immediately terminate this Agreement under Section 10.2. CRO hereby certifies
that it has not and shall not use or employ in any capacity related to the
Services any individual, corporation, partnership, or association (collectively
and individually, “CRO
Personnel”) which has been
debarred under Article 306 of the FDCA, 21 U.S.C. §335a(a) or (b) similar
foreign regulation as the case may be. In the event that CRO becomes aware of or
receives notice of the debarment of any such individual, corporation,
partnership, or association, CRO agrees to notify Company immediately, and
Company shall have the right to immediately terminate this Agreement under
Section 10.2.

    

    ARTICLE
2

    STAFFING
AND ASSIGNMENTS

     

    2.1 CRO Personnel. CRO shall use only CRO Personnel that are
adequately trained, qualified, and experienced to perform the Services assigned
them. CRO will be allowed to hire some personnel to perform activities during
either holidays or weekends. CRO shall be completely responsible for the
performance of all CRO Personnel in accordance with this Agreement.

     

    2.2 Replacement. CRO agrees that it shall not replace any
Project Team members without the prior written consent of Company. CRO agrees it
will replace any Project Team member if Company notifies CRO that the Project
Team member has failed to perform assigned Services to Company’s reasonable
satisfaction, and Company’s concerns regarding the Project Team member’s
performance are not resolved to Company’s reasonable satisfaction within seven
(7) days following Company’s notice to CRO.

     

    2.3 Training. Any replacement to the Project Team, whether
initiated by CRO or Company, shall be identified by CRO and, if acceptable to
Company, appropriately trained by CRO prior to the replacement’s performance of
any Services, at no additional cost to, or effort by, Company. If an acceptable
replacement Project Team member is not prepared to perform Services within ten
(10) days after Company’s notice for or consent to the replacement, Company may
terminate the applicable Project Addendum under Section 10.2.

     

    
      
         

      

      
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    ARTICLE
3

    PAYMENT

     

    3.1 Payments. In consideration of the Services performed by
CRO under any Project Addendum, Company will pay CRO the amounts on the
timelines specified in the Budget and Payment Schedule set forth in such Project
Addendum and in accordance with the terms thereof and this Article 3. The
aggregate fees and expenses payable by Sponsor to CRO for any Addendum shall not
exceed the total fees and expenses included in the applicable Budget and Payment
Schedule for such Addendum, unless otherwise authorized in writing in advance by
Sponsor. The Budget for each Project Addendum shall be fully transparent and
include all planned activities and all planned costs for such Project
Addendum.

     

    3.2 Invoices. CRO shall invoice Company in accordance with
the Payment Schedule set forth in each Project Addendum. Company shall pay
undisputed invoices within forty-five (45) days of receipt, provided that
Company shall notify CRO of any disputed invoices within twenty (20) days of
receiving such invoice and shall pay any undisputed amounts as set forth above.
Provided that Company pays undisputed amounts as set forth above, CRO shall
continue to conduct Services during which time the Parties shall use
commercially reasonable efforts to resolve the disputed amount.

    

    ARTICLE
4

    RECORDS
AND INSPECTIONS

     

    4.1   Financial
Records. CRO shall maintain
complete, accurate and systematic written financial and accounting records with
respect to all Services performed and costs and expenses incurred under a
Project Addendum. CRO shall preserve all such records for five (5) years
following expiration or termination of the applicable Project
Addendum.

     

    4.2   Study Records. CRO shall make available to Company (or its
designee), at Company’s request, all Study Records (as defined below) and shall
retain such Study Records in compliance with Applicable Laws, including without
limitation, 21 C.F.R. § 312.57. Upon the close of the Study, CRO shall transfer
all Study Records to Company. For purposes of this Agreement, “Study Records” shall include all
documents, records and forms supplied to CRO by or on behalf of Company, or
prepared, obtained or developed by CRO, in connection with the Services or CRO’s
performance of this Agreement, including source documents, case report forms,
laboratory data, and other similar documents.

     

    4.3   Inspection and
Audit. During the term of each
Project Addendum and for the term of any record retention period required under
this Article 4, CRO agrees that Company shall have the right, during CRO’s
regular business hours, to inspect the facilities of CRO and CRO Personnel, as
applicable, with respect to Services performed under such Project Addendum.
During the term of each Project Addendum and for the term of any record
retention period required under this Article 4 but no less than five (5) years
following expiration or termination of the applicable Project Addendum, CRO
agrees that Company shall have the right, during CRO’s regular business hours,
to audit, inspect and copy any records relating to the Services or this
Agreement (including financial records maintained pursuant to Section 4.1 and
any Study Records and records created as part of or otherwise related to an
internal audit by CRO) and such records may be used by Company for any
commercially reasonable purpose. CRO also agrees to permit the FDA or any other
appropriate regulatory agency, foreign or domestic, or body access to its
facilities and records as required by Applicable Laws.

    
      
         

      

      
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    4.4 Regulatory
Inspections. In the event CRO is
notified or otherwise becomes aware that it is to be the subject of an
inspection by, or otherwise receives any correspondence or inquiry from, the FDA
or other regulatory agency, foreign or domestic, or body in connection with a
Study or CRO’s Services under a Project Addendum CRO shall:

     

    4.4.1   immediately
notify Company thereof, and if applicable, advise Company of the occurrence of
and circumstances of the inspection;

     

    4.4.2   use
all reasonable efforts to reschedule the inspection until further instructions
are received from Company and provide Company the opportunity to be present
during such inspection;

     

    4.4.3   send
Company a copy of any inspection reports or other correspondence received or
available as a result thereof (including without limitation, Form FD-483 notices
or waning letters or similar documents); and

     

    4.5 SOPs. CRO shall review its standard operating
procedures (“SOPs) prior to a Study, and at least every
two (2) years thereafter, to ensure that such SOPs comply with Applicable Laws
and the terms of each Project Addendum. CRO agrees that, from time to time
during the term of a Project Addendum, Company may also audit CRO’s SOPs, and
CRO agrees to implement any changes to its SOPs with respect to a Project
Addendum as reasonably requested by Company.

     

    ARTICLE
5

    CONFIDENTIALITY

    

    5.1 Confidentiality. Except as expressly provided herein, CRO shall
not publish or otherwise disclose and shall not use for any purpose any data,
documents or information (including without limitation, the Protocol, Study
Records, Investigator Brochure and other clinical, technical or chemical data)
provided to or obtained or developed by CRO in connection with this Agreement,
or any documents or information furnished to CRO, or to which CRO is given
access, by or on behalf of Company in connection with a project which
potentially could be the subject of a Project Addendum, whether or not a Project
Addendum for the performance of Services is ever executed, all of which is
referred to as “Confidential
Information.” CRO agrees that it has no rights of ownership to
Confidential Information and, between CRO and Company, Confidential Information
is the sole and exclusive property of Company. CRO agrees to keep Confidential
Information confidential and not to use or disclose Confidential Information to
third parties who are not involved in the Study without prior written
authorization from Company.

     

    5.2 Exceptions. CRO’s obligations of confidentiality and
non-use shall not apply to Confidential Information which:

    
      
         

      

      
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    5.2.1 is
known to CRO, as shown by CRO’s written records, prior to its disclosure or
development under this Agreement or a Project Addendum;

     

    5.2.2 is
developed by CRO independently of this Agreement or a Project Addendum, as shown
by CRO’s contemporaneous written records;

     

    5.2.3 is
or becomes publicly available through no fault of CRO or any individual or
entity to whom the CRO or any CRO Personnel disclosed or provided access to such
Confidential Information, or of any such individual or entity); or

     

    5.2.4 is
received by CRO from a third party which has the legal right to disclose it to
CRO without confidentiality restrictions.

     

    5.3 Authorized
Disclosure. In the event CRO is
required by law to disclose Confidential Information, CRO shall notify Company
promptly of the requirement (and as far in advance of the required disclosure as
possible) and shall cooperate in any effort by Company to contest the
requirement or to seek protective orders.

     

    5.4 Return of Confidential
Information. Upon Company’s request
or any termination pursuant to Article 10, CRO shall, at the Company’s option,
immediately return to Company all materials which contain any Confidential
Information, including all copies thereof or destroy all such material and
copies thereof; if the Company requests the materials to be destroyed CRO shall
provide Company with a written declaration that such destruction occurred. The
return of Confidential Information shall not relieve CRO of its obligations
under this Article 5.

     

    5.5 Confidential
Terms. CRO shall not disclose
publicly or utilize in any advertising or promotional materials the existence of
or any terms of this Agreement or any Project Addendum, or CRO’s association
with Company, or use Company’s name or the name of any of Company’s divisions,
products or investigations without the prior written permission of
Company.

     

    5.6 No Publication by
CRO. Notwithstanding anything to the
contrary herein, CRO may not publish any articles or make any presentations
relating to the Services performed under this Agreement or referring to data,
information (including Confidential Information) or materials generated in
connection with such Services, in whole or in part, without the prior written
consent of Company.

     

    5.7 Injunctive
Relief. CRO acknowledges and agrees
that any violation of the terms of this Agreement or a Project Addendum relating
to the disclosure or use of Confidential Information may result in irreparable
injury and damage to Company that may not be adequately compensable by money
damages, and for which Company will have no adequate remedy at law. CRO
therefore consents and agrees that Company may obtain injunctions, orders or
decrees as may be necessary to protect its Confidential Information without
being required to post a bond or other security.

     

    5.8
Protection. CRO agrees to take all reasonable precautions to protect the
Confidential Information and to prevent its disclosure to and use by any
unauthorized third party. CRO further agrees to notify Company, promptly and in
writing, of any actual or suspected misappropriation or unauthorized use or
disclosure of the Confidential Information that may come to CRO’s
attention.

    
      
         

      

      
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    ARTICLE
6

    INTELLECTUAL
PROPERTY

     

    6.1 Inventions.

     

    6.1.1   For
purposes of this Agreement, “Inventions” means all
discoveries, developments, inventions (whether patentable or not), improvements,
information, materials, data, technology, works of authorship, formulas,
processes, techniques, compositions of matter, formulations, methods of use or
delivery, know-how, computer programs, databases, trade secrets, designs,
marketing plans, product plans, design plans, or business strategies which are
made by any CRO Personnel, whether alone or jointly with others: (i) in the
course of performing Services under a Project Addendum, or (ii) which contain or
are based upon Confidential Information.

     

    6.1.2   CRO
will disclose promptly to Company any Inventions. CRO agrees that, as between
CRO and Company, all Inventions shall be the sole and exclusive property of
Company, and that any Inventions which are works of authorship subject to
copyright shall be, to the greatest extent allowed, “works made for hire” of
which Company shall be deemed the author and owner of the rights comprised in
copyright. Without limiting the foregoing, CRO hereby assigns and agrees to
assign to Company all rights, title and interest CRO has in any Inventions
(including, to the extent an Invention which is a work of authorship subject to
copyright may not qualify as a “work made for hire,” all rights, title and
interest of CRO in that Invention) upon the future creation of such Inventions,
and agrees that it will obtain written agreements with all CRO Personnel to
assign all rights, title and interests in such Inventions to CRO for subsequent
assignment and transfer to Company, or directly to Company. All Inventions shall
be considered Confidential Information and shall be subject to the terms of
Article 5 above.

     

    6.2 Further
Assurances. Upon Company’s request
and as Company deems necessary or appropriate, CRO will perform, or cause its
employees and/or agents to perform any and all acts necessary to assist Company
in perfecting Company’s right, title and interest in and to all such Inventions.
Such acts will include, but not be limited to, executing all papers, including,
without limitation, all documents associated with the filing and prosecution of
patent applications, invention assignments and copyright assignments, and
providing affidavits or testimony in connection with patent interference,
validity or infringement proceedings and participating in other legal
proceedings. Reasonable costs related to such assistance, if required, will be
paid by Company. If Company is unable, after reasonable effort, to secure CRO’s
signature on any document as provided in this Section, CRO hereby designates and
appoints Company and its duly authorized officers and agents as CRO’s agent and
attorney(s) in fact to execute, verify, file and prosecute applications, and to
do all other lawfully permitted acts necessary to achieve the intent of this
Section with the same legal force and effect as if executed by CRO. CRO
represents and warrants to Company that all of its employees and agents
performing the Services hereunder are required to assign all of their right,
title and interest in and to any Inventions to CRO. Company will reimburse CRO
for reasonable and necessary expenses incurred by it as a result of such
activities.

     

    
      
         

      

      
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    ARTICLE 7

    REPRESENTATIONS
AND

    WARRANTIES;
COVENANTS

     

    7.1 Representations and
Warranties. CRO represents and
warrants that, for this Agreement and each Project Addendum:

     

    7.1.1   it
is authorized to enter into this Agreement and such Project Addendum, and that
its execution, delivery and performance of this Agreement and such Project
Addendum will not conflict with or constitute a default under any other
agreement to which it is a party or by which its assets are bound;

     

    7.1.2   it
is not a party to any agreement which would prevent it from fulfilling its
obligations under this Agreement or such Project Addendum, and that during the
term of this Agreement and such Project Addendum it will not enter into any
agreement to provide services which would in any way prevent it from providing
the Services contemplated under this Agreement or such Project
Addendum;

     

    7.1.3   CRO
has disclosed to Company any and all direct and indirect financial interests
held by CRO, any of CRO’s affiliates and any CRO Personnel, in any entity which
CRO knows is involved in the Study which is related to a Project
Addendum;

     

    7.1.4   CRO
has tested and assessed the computer software, computer hardware, and all other
devices reasonably necessary to the performance of CRO’s ongoing operations and
the conduct of all Services under a Project Addendum (collectively, the “Computing Devices”) used by CRO to determine whether
such Computing Devices will fail or will produce erroneous results (each, a
“Failure”), and there will be no
Failure(s) of CRO’s Computing Devices that will affect the Study or the
performance of any obligation of CRO under a Project Addendum or this
Agreement;

     

    7.1.5   any
electronic database and related software containing Study-related information
which is provided by CRO to Company or to which Company is given access, will
perform all expected functions and computing processes;

     

    7.2 Computing
Devices. CRO agrees:

     

    7.2.1   to
notify Company in writing immediately upon CRO’s obtaining information that any
Computing Devices used by CRO or any supplier of CRO may be the subject of a
Failure;

     

    7.2.2   to
notify Company in the event CRO determines that any Computing Devices owned,
licensed, or used by Company may be the subject of a Failure; and

     

    7.2.3   upon
Company’s written request, to participate in additional tests of the Computing
Devices used by CRO at no charge to determine whether such Computing Devices may
be the subject of Failures, and to notify Company immediately of the results of
any tests or any claim or other information that indicates the Computing Devices
of CRO or CRO’s suppliers may be the subject of a Failure.

    
      
         

      

      
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    ARTICLE
8

    INDEMNIFICATION

     

    8.1 Indemnification by Company. Company hereby agrees to defend, hold harmless
and indemnify (collectively, “Indemnify”) CRO and its officers, directors and
employees (the “CRO
Indemnitees”) from and against any and all
liabilities, expenses, damages and/or losses (including without limitation
reasonable legal expenses and reasonable attorneys’ fees) (collectively, “Losses”) resulting from suits, claims,
actions and demands, in each case brought by a Third Party (each, a “Third-Party Claim”) arising out of bodily injuries
(including death) suffered by a patient participating in a Study as a result of
Company’s drug in the course of such Study; except in each case to the extent
such Losses result from (i) the negligence, bad faith or willful misconduct of
CRO or its officers, directors, employees, agents, subcontractors or any other
CRO Personnel or (ii) any failure of CRO or its officers, directors, employees,
agents, subcontractors or any other CRO Personnel to comply with this Agreement
or a Project Addendum (including the Protocols therein) or Applicable Laws. The
foregoing obligation of Company to Indemnify the CRO Indemnitees shall be
subject to the following:

     

    8.1.1   Company
shall be promptly notified by CRO (and within no more than fifteen (15) days) of
any Third-Party Claim for which the CRO Indemnitees’ seek coverage under this
Section 8.1;

     

    8.1.2   Company
has sole control over the defense or settlement of any such Third-Party Claim;
and

     

    8.1.3   CRO
Indemnitees fully cooperate with Company in the defense or settlement of such
Third-Party Claims; provided that no CRO Indemnitee shall be required to admit
fault or responsibility in connection with any settlement.

     

    8.2 Indemnification by
CRO. CRO hereby agrees to Indemnify
Company and its officers, directors, employees, contractors, consultants,
representatives and agents (“Company Indemnitees”) from and against any and all Losses
resulting from Third-Party Claims to the extent arising out of CRO’s performance
of any Project Addendum or any Services; except in each case to the extent such
Losses result from (i) the negligence, bad faith or willful misconduct of
Company or (ii) any failure of Company to comply with this Agreement or such
Project Addendum (including the Protocols therein) or Applicable
Laws.

     

    ARTICLE
9

    INSURANCE

     

    9.1 Insurance.
CRO shall, at its own expense, carry and maintain during the term of this
Agreement and each Project
Addendum the following insurance:

     

    9.1.1   Commercial
general liability insurance including premises and operations coverage with
limits of not less than [$__[1 million]_______   per occurrence and
$__[2 million]______ per annual
aggregate;]
 

    
      
         

      

      
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    9.1.2   Errors
and omissions or professional liability insurance with limits of not less than
[$__[25 million] _________ per occurrence and $__[25 million]
_________ per annual
aggregate;]

     

    9.1.3    Umbrella
Insurance with a combined single limit of [$__[25 million]________];  and

     

    9.1.4    Worker’s
compensation insurance in such amounts required by Applicable Laws.

     

    9.2 Documentation. CRO shall, at Company’s request, have its
insurance carrier(s) furnish to Company certificates of insurance or, if
self-insured, shall furnish documentation stating that all insurance required
under this Agreement is in force, such certificates or documentation to indicate
any deductible and/or self-insured retention and stipulate that the insurance
will not be canceled while this Agreement or any Project Addendum is in effect
without thirty (30) days prior written notice to Company. CRO shall on request
permit Company to examine original insurance or other protective policies issued
in compliance with the requirements of this Section. Should CRO at any time
neglect or refuse to provide the insurance required in this Section, or should
such insurance be canceled, Company shall have the right to procure insurance of
the types and in the amounts described in this Section and Company’s costs for
such insurance shall be deducted from any compensation then due or thereafter to
become due CRO. CRO shall not commence the Services under a Project Addendum
until the insurance coverage specified in this Article 9 has been
obtained.

     

    ARTICLE
10

    TERM;
TERMINATION

     

    10.1    
Term. This Agreement shall commence as of the
Effective Date, and shall continue for a period of five (5) years, or until
terminated as provided in this section 10. The Agreement will automatically
renew each year thereafter for a period of (1) One year, unless terminated as
provided in this Section 10. Each Project Addendum shall be effective upon the
date signed by the last signatory thereto and shall terminate upon the
completion of Serviced to be provided there under, unless earlier terminated in
accordance with this Section 10.

     

    10.2    
Termination for
Breach. In the event either Party
commits a material breach of its obligations under this Agreement or a Project
Addendum and fails to remedy that breach within thirty (30) days of written
notice of the breach from the other Party, the other Party may terminate the
applicable Project Addendum immediately upon written notice to the breaching
Party; provided, however, if such material breach is elsewhere
identified in this Agreement or such Project Addendum as supporting immediate
termination by the other Party, no such notice or cure period is
required.

     

    10.3     
Termination by
Company.

     

     
10.3.1   Company may terminate this Agreement or any Project
Addendum upon thirty (30) days written notice to CRO.

    
      
         

      

      
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    10.3.2   Company
may terminate this Agreement or any Project Addendum immediately by written
notice to CRO if:

     

    (i)         the
FDA, or the European Medicine Agency or similar foreign regulation, as the case
may be, withdraws authorization for the applicable Study;

     

    (ii)        safety
or ethical issues, in the opinion of Company, support termination of the
applicable Study;

    (iii)        CRO
breaches its representations and warranties or obligations under

    Article
4, 5, 6 or 7.

     

    10.4   
 Effects of
Termination. Upon receiving notice
of termination of any Project Addendum or this Agreement:

     

    10.4.1  CRO
shall use best efforts to revoke any financial obligations it has incurred and
to avoid incurring any additional costs in connection with the Project Addendum
or this Agreement, as applicable.

     

    10.4.2  CRO
shall promptly return to Company any prepaid funds which are unearned by CRO as
of the effective date of termination.

     

    10.4.3  CRO
shall: (i) terminate any agreements it has with subcontractors in connection
with the Project Addendum or this Agreement, as applicable, or assign such
agreements to Company, at Company’s option; (ii) perform such services as
reasonably requested by Company in connection with an orderly wind-down of CRO’s
Services in connection with the Project Addendum or this Agreement, as
applicable; and (iii) promptly prepare and submit to Company a final financial
report, and copies of all records, including but not limited to all financial
records, relating to the Project Addendum or this Agreement, as applicable, or
performance thereunder, and all periodic reports and other records required to
be maintained under this Agreement. In the event CRO fails to deliver to Company
any of the above-mentioned records, Company may enter CRO’s premises and collect
such records during CRO’s normal working hours.

     

    10.4.4  Company
shall pay CRO, subject to an accounting of damages due to any breach of this
Agreement or the applicable Project Addendum by CRO and to an offset of any
prepaid but unearned funds which CRO has not returned in accordance with Section
10.4.2, and to the extent the following are not duplicative, for (i) a pro-rata
amount as appropriate for Services rendered through the effective date of
termination, as calculated from the Budget; and (ii) such expenses reasonably
incurred by CRO in connection with the orderly wind-down of CRO’s Services as
requested by Company in accordance with Section 10.4.3.

     

    
      
         

      

      
        -11-

        
          

        

      

      
         

      

    

    ARTICLE
11

    MISCELLANEOUS

     

    11.1    
Governing
Law. This Agreement shall be
governed by, and construed and interpreted in accordance with, the laws of the
Commonwealth of Massachusetts, excluding its choice of law
principles.

     

    11.2    
Disputes. In the event of any dispute or claim arising
out of or in connection with this Agreement, or the performance, breach or
termination thereof, either CRO or Company may, by written notice to the other
Party, have such dispute referred to the Chief Executive Officers (or
equivalent) of CRO and Company, for attempted resolution by good faith
negotiations within thirty (30) days after such notice is received by such other
Party. If the Parties are unable to resolve such dispute within such thirty (30)
day period, such dispute shall be finally settled by binding arbitration by
Judicial Arbitration and Mediation Services, Inc. (JAMS) under its rules of
arbitration, by one (1) arbitrator appointed in accordance with said rules. The
decision and/or award rendered by the arbitrator(s) shall be written, final and
non-appealable, and judgment on such decision and/or award may be entered in any
court of competent jurisdiction. The place of arbitration shall be in the State
of Massachusetts. The costs of any arbitration, including administrative fees
and fees of the arbitrator(s), shall be shared equally by the Parties to the
dispute, unless otherwise determined by the arbitrator(s). Each Party shall bear
the cost of its own attorneys’ and expert fees. The Parties agree that, any
provision of applicable law notwithstanding, they will not request, and the
arbitrator shall have no authority to award, punitive or exemplary damages
against any Party.

     

    11.3    
Assignment. CRO shall not assign this Agreement or any
Project Addendum, in whole or in part, without the prior written consent of
Company; any attempt to do so in violation of this Section 11.3 shall be void.
Company may assign this Agreement or any Project Addendum, without CRO’s
consent, to an affiliated entity or to an entity that succeeds to all or
substantially all of its business or assets relating to this Agreement, whether
by sale, merger, operation of law or otherwise, provided that such assignee
agrees in writing to be bound by the terms and conditions of this
Agreement.

     

    11.4    
Notices. All notices, requests and communications
hereunder shall be in writing and shall be personally delivered or sent by
facsimile transmission (confirmed by prepaid registered or certified mail,
return receipt requested or by international express delivery service) (e.g.,
Federal Express), mailed by registered or certified mail (return receipt
requested), postage prepaid, or sent by international express courier service,
and shall be deemed to have been properly served to the addressee upon receipt
of such written communication, to following addresses of the Parties, or such
other address as may be specified in writing to the other Party.

     

    
      
         

      

      
        -12-

        
          

        

      

      
         

      

    

     

    If to
CRO:

    1. For
Corporate Purposes:        

     

    Attention:
Robert Murphy, MD

    ACLIRES
International Ltd

    Milner
House

    18
Parliament Street

    Hamilton
HM FX

    Bermuda

    Facsimile
No.: +1-441-292-7800

    With a
copy to:

    Attention:
Jeannette Monk

    ACLIRES
International Ltd.

    Milner
House

    18
Parliament Street

    Hamilton
HM FX

    Bermuda

    Facsimile
No.: +1-441-292-7800

     

    2. For
Operational Purposes:        

     

    Juan
Carlos Chá Torea

    ACLIRES –
Argentina S.R.L.

    Avenida
del Libertador 13221

    Martínez
(B1640AOD)

    Provincia
de Buenos Aires, Argentina

    Facsímile:
+54 11 4792-9689

    With a
copy to:

    José Luis
Ippólito

    ACLIRES –
Argentina S.R.L.

    Avenida
del Libertador 13221

    Martínez
(B1640AOD)

    Provincia
de Buenos Aires, Argentina

    Facsímile:
+54 11 4792-9689

    

    
      	
              If
      to Company:    

            	 
      	
              Idenix
      Pharmaceuticals, Inc.

            
	 
      	 
      	
              One
      Kendall Square, Building 1400

            
	 
      	 
      	
              Cambridge,
      MA 02139, USA

            
	 
      	 
      	
              Attn:
      John Sullivan-Bolyai

            
	 
      	 
      	
              Fax:
      617-995-9817

            
	 
      	 
      	 
      
	
              with
      a copy to:

            	 
      	
              Idenix
      Sarl – Cap Gamma

            
	 
      	 
      	
              1682
      Rue de la Valsiere

            
	 
      	 
      	
              BP
      5001

            
	 
      	 
      	
              34189
      Montpellier Cedex 4

              France

            
	 
      	
                

            	
              Attn:
      Marie-Francoise Temam

              Fax:
      +33 (0)4 99 64 27 27

            

    

    
      
         

      

      
        -13-

        
          

        

      

      
         

      

    

    11.5    
Headings. Headings included herein are for convenience
only, do not form a part of this Agreement, and shall not be used in any way to
construe or interpret this Agreement. Any references to a particular section of
this Agreement shall be deemed to include reference to any and all subsections
thereof.

     

    11.6    
Non-Waiver. Any waiver of the terms
and conditions hereof must be explicitly in writing. The waiver by either of the
Parties of any breach of any provision hereof by the other shall not be
construed to be a waiver of any succeeding breach of such provision or a waiver
of the provision itself.

     

    11.7    
Severability. Should any section, or portion thereof, of this
Agreement be held invalid
by reason of any law, statute, or regulation existing now or in the future in
any jurisdiction by any court of competent authority or by a legally enforceable
directive of any governmental body, such section or portion thereof will be
validly reformed so as to approximate the intent of the Parties as nearly as
possible and, if unreformable, will be deemed divisible and deleted with respect
to such jurisdiction, but the Agreement will not otherwise be
affected.

     

    11.8    
Independent
Contractors. The relationship of
Company and CRO established by this Agreement is that of independent
contractors. Nothing in this Agreement shall be construed to create any other
relationship between Company and CRO. Neither Party shall have any right, power,
or authority to assume, create or incur any expense, liability, or obligation,
express or implied, on behalf of the other.

     

    11.9    
Entire
Agreement. This Agreement, together
with the Exhibits hereto, constitutes and contains the entire understanding and
agreement of the Parties respecting the subject matter hereof and cancels and
supersedes any and all prior and contemporaneous negotiations, correspondence,
understandings and agreements between the Parties, whether oral or written,
regarding such subject matter. No agreement or understanding varying or
extending this Agreement or any Project Addendum shall be binding upon either
Party, unless set forth in a writing which specifically refers to the Agreement
that is signed by duly authorized officers or representatives of the respective
Parties, and the provisions of the Agreement or such Project Addendum not
specifically amended thereby shall remain in full force and effect.

     

    11.10  
Counterparts. This Agreement may be
executed in counterparts (including facsimile counterparts), each of which shall
be deemed an original, but which together shall constitute one and the same
instrument.

    

    [The
remainder of this page intentionally left blank; the signature page
follows]

    
      
         

      

      
        -14-

        
          

        

      

      
         

      

    

    IN
WITNESS WHEREOF, the undersigned have executed this Agreement to be effective as
of the Effective Date.

    

    
      
        
          
            
              
                
                  
                    	
                            IDENIX
      PHARMACEUTICALS, INC.

                          	 
      	
                            ACLIRES
      INTERNATIONAL, LTD

                          
	 	 	 	 	 
	 
      	 
      	 
      	 
      	 
      
	
                            By:

                          	
                            

                          	 
      	
                            By:

                          	
                            

                          
	 
      	 
      	 
      	 
      	 
      
	
                            Name:
      John Sullivan-Bolyai

                          	 
      	
                            Name:
      Robert Murphy

                          
	 
      	 
      	 
      
	
                            Title:
      Vice President Clinical Research

                          	 
      	
                            Title:
      Chief Executive
Officer

                          

                  

                

              

            

          

        

      

    

    
      
         

      

      
        -15-

        
          

        

      

      
         

      

    

    EXHIBIT
A

     

    Project
Addendum

     

    To
Master Service Agreement between Idenix Pharmaceuticals Inc. (“Company”) and
Aclires International Ldt. (“CRO”), dated January 30, 2009

    

    Version #, Date

     

    1.
  SCOPE OF SERVICES

    a.   A
list of activities to be conducted could be as follows:

    
      	
               
      

            	
              i.

            	
                  Site
      identification

            

    

    
      	
               
      

            	
              ii.

            	
                  Regulatory
      activities

            

    

    
      	
               
      

            	
              iii.

            	
                  Prepare
      and maintain Trial Master File

            

    

    
      	
               
      

            	
              iv.

            	
                  Prepare
      Investigator Study File

            

    

    
      	
               
      

            	
              v.

            	
                  Monitoring

            

    

    
      	
               
      

            	
              vi.

            	
                  Enrollment
      and follow-up of subjects

            

    

    

    2.
  PROTOCOL

    a. The
specific protocol will be included

     

    3.
BUDGET

    a.  This
is a draft model, to be adapted to each protocol

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    PROTOCOL
NNNN-777-777

    

    SUMMARY
OF EXPENSES

    

    
      
        
          
            
              
                
                  
                    
                      
                        
                          
                            	
                                    SERVICE TO BE PROVIDED

                                  	 	
                                    TOTAL COST

                                    (USD)

                                  	 
	
                                    NON-CLINICAL
      ACTIVITIES

                                  	 	 	 
	
                                    Document
      translation and Informed Consent Form

                                  	 	 	 
	
                                    Local
      Project Management

                                  	 	 	 
	
                                    Regulatory
      activities

                                  	 	 	 
	
                                    Site
      set up

                                  	 	 	 
	
                                    IMP
      management

                                  	 	 	 
	
                                    Sample
      management

                                  	 	 	 
	
                                    ECG
      management

                                  	 	 	 
	
                                    Sub-total

                                  	 	 	0,00	 
	
                                    CLINICAL
      ACTIVITIES

                                  	 	 	 	 
	
                                    Recruitment
      activities

                                  	 	 	 	 
	
                                    Screening
      period

                                  	 	 	 	 
	
                                    Medical
      activities

                                  	 	 	 	 
	
                                    Laboratory
      activities

                                  	 	 	 	 
	
                                    Treatment
      period

                                  	 	 	 	 
	
                                    Medical
      activities

                                  	 	 	 	 
	
                                    Laboratory
      activities

                                  	 	 	 	 
	
                                    Follow-up
      period

                                  	 	 	 	 
	
                                    Medical
      activities

                                  	 	 	 	 
	
                                    Laboratory
      activities

                                  	 	 	 	 
	
                                    Safety
      management

                                  	 	 	 	 
	
                                    CRF
      completion

                                  	 	 	 	 
	
                                    Confinement

                                  	 	 	 	 
	
                                    Fees/Compensation

                                  	 	 	 	 
	
                                    Sub-total

                                  	 	 	0,00	 
	
                                    LABORATORY
      ACTIVITIES

                                  	 	 	 	 
	
                                    Laboratory
      manual

                                  	 	 	 	 
	
                                    Datamanagement

                                  	 	 	 	 
	
                                    Sample
      management

                                  	 	 	 	 
	
                                    Others

                                  	 	 	 	 
	
                                    Sub-total

                                  	 	 	0,00	 
	 
      	 	 	 	 
	
                                    GRAND
      TOTAL

                                  	 	 	0,00	 

                          

                        

                      

                    

                  

                

              

            

          

        

      

    

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      

      PROTOCOL
NNNN.777-777

      

      NON-CLINICAL
ACTIVITIES

      

      
        
          
            
              
                	
                        SERVICE TO BE PROVIDED

                      	 	
                        RESPONSIBLE

                      	 	 	
                        HOURS

                      	 	 	
                        HOURLY RATED

                        (US)

                      	 	 	
                        TOTAL COST

                        (USD)

                      	 
	
                        DOCUMENT
      TRANSLATION AND INFORMED CONSENT

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Protocol
      translation into Spanish

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        ICF
      development & adaptation to different sites

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Back
      translation of ICF

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Sub-total

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        LOCAL
      PROJECT MANAGEMENT

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Start-up

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Protocol
      review

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Project
      plan preparation

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Weekly
      teleconferences

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Investigator’s
      Meeting attendance

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Trial
      Master File preparation

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Site
      Investigator File preparation

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Preparation
      of forms, spreadsheets, guidelines

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Phone
      contact with the sites

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Sub-total

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Ongoing

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Internal
      meetings

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Monthly
      teleconferences

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Update
      study plan

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Update
      Trial Master File

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Update
      investigator Study File

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        SAE
      notification to IRB/IEC/MOH

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Budget
      administration and site payment

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Prepare
      monthly study reports

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Phone
      contact with the sites

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Sub-total

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Closure

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Complete
      document collection from the sites

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Trial
      Master File preparation for archiving

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Investigator
      Study Files preparation for archiving

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Final
      payment to the sites

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Phone
      contact with the sites

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Sub-total

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Sub-total

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        REGULATORY
      ACTIVITIES

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Package
      preparation for IRB

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        IRB
      submission

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        IRB
      fees

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Package
      preparation for IEC

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        IEC
      submission

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        IEC
      fees

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Package
      preparation for MOH

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        MOH
      submission

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        MOH
      fees

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Follow-up
      of Submissions

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Respond
      questions from IRB/IEC/MOH

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Prepare
      reports to IRB/IEC/MOH

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Sub-total

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        SITE
      SET-UP

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Prepare
      contract with investigators

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Negotiate
      contract and budget

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Initial
      protocol training

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Sub-total

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        IMP
      MANAGEMENT

                      	 	 	 	 	 	
                         

                      	 	 	 	 	 	 	 	 	 
	
                        Importation
      paperwork preparation

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Importation
      fees

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Transfer
      from customs to warehouse

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        IMP
      destruction (paperwork + destruction)

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Sub-total

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        SAMPLE
      MANAGEMENT

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Exportation
      paperwork preparation

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Exportation
      fees

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Transfer
      from the sites to central lab

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Sub-total

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        ECG
      MANAGEMENT

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Importation
      paperwork preparation

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Importation
      fees

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Return
      to eRT at the end of the trial

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Sub-total

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        SUB-TOTAL
      NON-CLINICAL ACTIVITIES

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 

              

            

          

        

      

       

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      

      PROTOCOL
NNNN-777-777

      

      CLINICAL
ACTIVITIES

      

      
        
          
            
              
                
                  	 
      	 	 	 	 	 	 	 	
                          UNIT COST

                        	 	 	
                          TOTAL COST

                        	 
	
                          SERVICE TO BE PROVIDED

                        	 	
                          # PATIENTS

                        	 	 	
                          # UNITS

                        	 	 	
                          (USD)

                        	 	 	
                          (USD)

                        	 
	
                          RECRUITMENT
      ACTIVITIES

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Call
      center organization

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Phone
      calls (average, 2 phone calls per visit)

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          SCREENING
      PERIOD

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Medical
      activities

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Informed
      consent /
      Demographics / Medical History
      /

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Complete
      Medical Examination / Height & Weight /

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Concomitant
      Medication / Incl & Excl criteria

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          ECG

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Laboratory
      activities

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Routine
      laboratory: Hematology, Chemistry, Urinalysis

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          HAV
      Ab; HBsAg; HCV Ab

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          CD4

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          HIV-RNA

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Pregnancy
      test (serum)

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Alcohol
      test

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Urine
      drug screen

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          VAT
      (24%)

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          TREATMENT
      PERIOD

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Medical
      activities

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Targeted
      physical examination

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Vital
      signs

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Adverse
      Events, Concomitant medication, Dosing, Drug
accountability

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          ECG

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Laboratory
      activities

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Routine
      laboratory Hematology, Chemistry

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Urinalysis

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Urine
      pregnancy test

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          CD4

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          HIV-RNA

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Blood
      sampling, handling and storage

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          VAT
      (24%)

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          FOLLOW-UP
      PERIOD

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Medical
      activities

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Targeted
      physical examination

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Vital
      signs

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Adverse
      Events, Concomitant medication

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          ECG

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Laboratory
      activities

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Routine
      laboratory: Hematology, Chemistry

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Urinalysis

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Urine
      pregnancy test

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          HIV-RNA

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          CD4

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Blood
      sampling, handing and storage

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          VAT
      (24%)

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          SAFETY
      MANAGEMENT

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Complete
      SAE reports (initial)

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Complete
      SAE reports (follow-up)

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          CRF
      COMPLETION

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Complete
      CRF pages

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Respond
      queries

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          CONFINEMENT

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Clinical
      bed

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Linen
      & food

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Travel
      (from and to the Unit)

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Coordinator
      activities

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          FEES
      / COMPENSATION

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Physician’s
      fees

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Patient
      compensation (screening)

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Patient
      compensation (enrolled)

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          SUB-TOTAL CLINICAL
      ACTIVITIES

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 

                

              

            

          

        

      

       

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      

      PROTOCOL
NNNN-777-777

       

      LABORATORY
ACTIVITIES

      

      
        
          
            
              
                
                  	
                          SERVICE TO BE PROVIDED

                        	 	
                          RESPONSIBLE

                        	 	 	
                          HOURS /

                          UNITS

                        	 	 	
                          HOURLY RATE

                          (USD)

                        	 	 	
                          TOTAL COST

                          (USD)

                        	 
	
                          LABORATORY
      MANUAL

                        	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Development
      (including two revisions)

                        	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Translation
      into Spanish

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Distribution
      to sites

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          VAT
      (24%)

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          DATAMANAGEMENT

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Database
      development

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Phone
      calls to request database upload

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          VAT
      (24%)

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          SAMPLE
      MANAGEMENT

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Safety
      kits

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Materials
      (tubes, pipettes, boxes, LRFs)

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Kit
      preparation

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Kit
      distribution to sites

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Samples
      sent to central lab

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          PK
      kits

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Materials
      (tubes. pipettes, boxes, LRFs)

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Kit
      preparation

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Kit
      distribution to sites

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Samples
      sent to central lab

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Preparation
      of samples to XXXXXXX

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Preparation
      of samples to NNNNNNN

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          VAT
      (24%)

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          OTHERS

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Breath
      air alcohol measurement kit

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Strips
      to urine pregnancy test

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Strips
      to urine drug detection

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total
      

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          VAT
      (24%)

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          Sub-total

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                          SUB-TOTAL
      LABORATORY ACTIVITIES

                        	 	 	 	 	 	 	 	 	 	 	 	 	 	 	0,00	 

                

              

            

          

        

      

      

      4.
MILESTONES AND PAYMENT SCHEDULE

      a. This
is an example; milestones and amount of payment may vary

       

      
        
          
            
              
                
                  
                    
                      
                        	
                                PROJECT MILESTONE

                              	 
      	
                                AMOUNT DUE

                                (USD)

                              
	
                                Contract
      execution

                              	 
      	
                                GGGG,00

                              
	
                                MOH
      approval

                              	 
      	
                                GGGG,00

                              
	
                                First
      patient enrolled

                              	 
      	
                                GGGG,00

                              
	
                                Second
      cohort completed

                              	 
      	
                                GGGG,00

                              
	
                                Last
      patient completed

                              	 
      	
                                GGGG,00

                              
	
                                Last
      query responded

                              	 
      	
                                GGGG,00

                              
	
                                GRAND
      TOTAL

                              	
                                  

                              	
                                TTTTTTT,00

                              

                      

                    

                  

                

              

            

          

        

      

       

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      5.
INVOICES

      CRO shall
invoice Company based on the pre-approved payment schedule. Company will
designate a contact and address to whom invoices will be sent.

      

      6. TERMS
AND CONDITIONS

      CRO’s
work on this project addendum will be governed by the terms and conditions as
set forth in the Master Service Agreement between Idenix Pharmaceuticals Inc.
(“Company”) and Aclires International Ldt. (“CRO”), dated January 30, 2009 and
to subsequent Amendments to that Agreement.

      

      Acknowledged,
Accepted and Agreed to:

      

      
        
          
            
              
                
                  
                    
                      
                        
                          	
                                  IDENIX
      PHARMACEUTICALS, Inc

                                	 	
                                  ACLIRES
      International, Ltd.

                                
	 
      	 	 
      
	 
      	 	 
      
	
                                  Signature:

                                	
                                     

                                	 	
                                  Signature:

                                	
                                     

                                
	 
      	 	 
      
	
                                  Name:

                                	
                                     

                                	 	
                                  Name:

                                	
                                     

                                
	 
      	 	 
      
	
                                  Title:

                                	
                                     

                                	 	
                                  Title:

                                	
                                     

                                
	 
      	 	 
      
	
                                  Date:

                                	
                                     

                                	 	
                                  Date:

                                	
                                     

                                

                        

                      

                    

                  

                

              

            

          

        

      

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      EXHIBIT
B

       

      List of transferred
responsibilities

      

      An
“X” indicates the owner of the primary responsibility for the task. An “(x)
indicates subsidiary involvement

      

      
        
          
            
              
                
                  
                    
                      
                        	
                                Sponsor:

                              	 
      	 
	 
      	 
      	 
	
                                Sponsor
      Study No.:

                              	 
      	 
	 
      	 
      	 
	
                                ACLIRES
      Argentina

                              	 
      	 
	
                                Study
      No.:

                              	 
      	 

                      

                    

                  

                

              

            

          

        

      The sponsor hereby transfers to
Aclires the responsibilities as indicated
below.

       

      
        
          	 
      	 	
                  Responsibility

                	 	 	
                  Date

                	 
	
                  Tasks

                	 	
                  Sponsor

                	 	 	
                  ACLIRES

                	 	 	
                  (planned)

                	 	 	
                  (actual)

                	 
	
                  Study
      Preparation

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Study
      Synopsis or Outline

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Preparation
      of Financial Agreement

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Study
      Protocol

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  CRF
      Preparation

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  CRF
      Review

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Audit
      of the Protocol and CRFs

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Informed
      Consent Form

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Submission
      to Ethics Committees

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Subjects
      Insurance

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Submission
      to MOH (ANMAT)

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Import
      of study drug

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Packaging
      and/or Labeling of Study Drug

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Resourcing
      of registered Study Medication (if needed)

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Resourcing
      of Lab. Material

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Randomization
      Schedule

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

        

      

      

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      

      
        
          	 
      	 	
                  Responsibility

                	 	 	
                  Date

                	 
	
                  Tasks

                	 	
                  Sponsor

                	 	 	
                  ACLIRES

                	 	 	
                  (planned)

                	 	 	
                  (actual)

                	 
	
                  Study
      Conduct

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Safety
      Laboratory

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Pharmacokinetic
      Assays

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Pharmacodynamic
      Assays

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Shipment
      for PK / PD Samples

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Monitoring

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Site
      Initiation

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Site
      Close-out

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Reporting
      of SAEs to Authorities

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Preparation
      of Amendments

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  On
      Site Audit

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  Data Management / Statistical
      Analysis

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Statistical
      Analysis Plan

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Coding
      of AEs, cone. Therapies etc.

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Data
      Entry

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Database
      Validation

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Database
      review prior to lock

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Database
      Log

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Data
      Transfer

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Statistical
      Analysis

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  PK-Analysis

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Statistical
      Report

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Bioanalytical
      Report

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

        

      

       

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      

      
        
          	 
      	 	
                  Responsibility

                	 	 	
                  Date

                	 
	
                  Tasks

                	 	
                  Sponsor

                	 	 	
                  ACLIRES

                	 	 	
                  (planned)

                	 	 	
                  (actual)

                	 
	
                  Study
      Close Out

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Safety
      Summary

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Integrated
      Clinical Report

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Audit
      of Integrated Clinical Report

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Drug
      Accountability

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Return
      of Study Drug

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Archiving
      of Study Documents

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                  ·

                	
                  Shipment
      Costs for CRFs

                	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

        

      

      

      
        
          
            
              
                	 
      	 	
                        Responsibility

                      	 	 	
                        Date

                      	 
	
                        Tasks

                      	 	
                        Sponsor

                      	 	 	
                        ACLIRES

                      	 	 	
                        (planned)

                      	 	 	
                        (actual)

                      	 
	
                        Others

                      	 	 	 	 	 	 	 	 	 	 	 	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Development
      of Emergency Envelopes (patient specific) and delivery to
      site.

                      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                        Certificate
      of Analysis and GMP certificateUnassociated Document

    REVOLVING PROMISSORY
NOTE

    

    

    
      	
              Up
      to $5,000,000

            	
              October
      28, 2009

              amended
      March 9, 2010

            

    

    

    FOR VALUE
RECEIVED, WORLDGATE
COMMUNICATIONS, INC., a Delaware corporation, WORLDGATE SERVICE, INC., a
Delaware corporation, WORLDGATE
FINANCE, INC., a Delaware corporation, OJO SERVICE LLC, a
Pennsylvania limited liability company, and OJO VIDEO PHONES LLC, a
Pennsylvania limited liability company (jointly and severally, the “Borrower”), hereby absolutely,
irrevocably, unconditionally and jointly and severally promises to pay to the
order of WGI INVESTOR
LLC, a Delaware limited liability company (“Lender”), in United States
dollars and in immediately available funds, the principal sum of FIVE MILLION DOLLARS
($5,000,000), or such lesser amount as may be advanced by Lender to the
Borrower from time to time in accordance with that certain Revolving Loan and
Security Agreement dated as of October 28, 2009, as amended, between the
Borrower and Lender (as it may be amended, modified, extended or restated from
time to time, the “Loan
Agreement”), together with interest thereon, as provided in the Loan
Agreement.  Notwithstanding the foregoing, the aggregate principal
amount outstanding under this Revolving Promissory Note (this “Note”) shall not exceed five
million dollars ($5,000,000).  This Note is subject to all of the
terms and conditions set forth in, and such terms and conditions are hereby
incorporated herein by reference to, the Loan Agreement.  All
capitalized terms not otherwise defined herein shall have the meanings set forth
in the Loan Agreement.  In the event of any conflict between the
provisions of this Note and the Loan Agreement, the provisions of the Loan
Agreement shall prevail.

    

    The
obligations of the Borrower evidenced by this Note are secured as set forth in
the Loan Agreement.

    

    Except as
otherwise provided in the Loan Documents, all outstanding principal and interest
with respect to Loan Advances shall be due and payable in full in cash on the
Maturity Date.  The daily unpaid principal balance outstanding under
this Note shall bear interest at the rate(s) set forth in the Loan
Agreement.  The Loan Advances may be prepaid in whole or in part at
any time without premium or penalty and amounts repaid may be re-borrowed in
accordance with the provisions of the Loan Agreement.

    

    Upon the
occurrence of an Event of Default, Lender shall have, and shall be entitled to
exercise, all of the rights and remedies set forth in the Loan
Documents.

    

    All
payments in respect of amounts outstanding under this Note shall be paid in
immediately available funds to the account(s) specified by Lender from time to
time.  Any payment due in respect of this Note which falls due on a
day other than a Business Day shall be made on the next Business
Day.

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

     

    The
Borrower hereby waives presentment and demand for payment, notice of dishonor,
protest and notice of protest of this Note.  No release of any
security for the payment of this Note or extension of time for payment of this
Note, and no alteration, amendment or waiver of any provision of this Note made
by agreement between Lender and any other Person shall release, discharge,
modify, change or affect the liability of the Borrower under this
Note.

    

    Each
right, power and remedy of Lender under this Note, the Loan Agreement, any other
Loan Document, or under applicable laws shall be cumulative and concurrent, and
the exercise of any one or more of them shall not preclude the simultaneous or
later exercise by Lender of any or all such other rights, powers or
remedies.  No failure or delay by Lender to insist upon the strict
performance of any one or more provisions of this Note, the Loan Agreement, any
other Loan Document, or to exercise any right, power or remedy consequent upon
an Event of Default shall constitute a waiver thereof, or preclude Lender from
exercising any such right, power or remedy.  No modification, change,
waiver or amendment of this Note shall be deemed to be made unless in writing
signed by the Borrower and Lender. This Note shall inure to the benefit of and
be binding upon the Borrower and Lender and their respective successors and
assigns; provided that except as set forth in the Loan Agreement, the Borrower
shall have no right to assign any of its rights or delegate any of its
obligations under this Note and provided further there shall be no restrictions
of any nature on Lender’s right to assign this Note or its rights
hereunder.  The invalidity, illegality or unenforceability of any
provision of this Note shall not affect or impair the validity, legality or
enforceability of any other provision.  This Note shall be deemed to
be made in, and shall be governed by the laws of, the State of Delaware (without
regard to its conflicts of laws principles).

    

    
    

     

    [SIGNATURE
PAGE FOLLOWS]

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    
      
         

      

      
        2

        
          

        

      

      
         

      

    

     

     

     

     

    IN WITNESS WHEREOF, this
Revolving Promissory Note has been duly executed by the undersigned as of the
day and year first above written.

    

    
      	 
      	
              BORROWER:

            
	 	 	 
	 
      	
              WORLDGATE
      COMMUNICATIONS, INC.

            
	 	 	 
	 
      	
              By:

            	
              /s/ Christopher V.
Vitale

            
	 
      	
              Name:

            	
              Christopher
      V. Vitale

            
	 
      	
              Title:

            	
              Senior
      Vice President, Legal and Regulatory,

              General
      Counsel and Secretary

            
	 
      	 
      	 
      
	 
      	
              WORLDGATE
      SERVICE, INC.

            
	 
      	 
      	 
      
	 
      	
              By:

            	
              /s/ Christopher V.
Vitale

            
	 
      	
              Name:

            	
              Christopher
      V. Vitale

            
	 
      	
              Title:

            	
              Senior
      Vice President, Legal and Regulatory,

              General
      Counsel and Secretary

            
	 
      	 
      	 
      
	 
      	
              WORLDGATE
      FINANCE, INC

            
	 
      	 
      	 
      
	 
      	
              By:

            	
              /s/ Christopher V.
Vitale

            
	 
      	
              Name:

            	
              Christopher
      V. Vitale

            
	 
      	
              Title:

            	
              Senior
      Vice President, Legal and Regulatory,

              General
      Counsel and Secretary

            
	 
      	 
      	 
      
	 
      	
              OJO
      SERVICE LLC

            
	 
      	 
      	 
      
	 
      	
              By:

            	
              WorldGate
      Communications, Inc., its sole member

            
	 
      	 
      	 
      
	 
      	
              By:

            	
              /s/ Christopher V.
Vitale

            
	 
      	
              Name:

            	
              Christopher
      V. Vitale

            
	 
      	
              Title:

            	
              Senior
      Vice President, Legal and Regulatory,

              General
      Counsel and Secretary

            
	 
      	 
      	 
      
	 
      	
              OJO
      VIDEO PHONES LLC

            
	 
      	 
      	 
      
	 
      	
              By:

            	
              WorldGate
      Communications, Inc., its sole member

            
	 
      	 
      	 
      
	 
      	
              By:

            	
              /s/ Christopher V.
Vitale

            
	 
      	
              Name:

            	
              Christopher
      V. Vitale

            
	 
      	Title:	
              Senior
      Vice President, Legal and Regulatory,

            
	 
      	 
      	
              General
      Counsel and Secretary

            

    

    
 

    
      
         

      

      
        3

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