EXHIBIT 10.43


 


MASTER SERVICES AGREEMENT


 


This Master
Agreement (“Agreement”) made this 11th day of December, 2001, by and between
Reliant Pharmaceutical, LLC, with its principal executive offices located at
Liberty Corner, New Jersey (“Sponsor”), and PPD Development, LLC, a Texas
limited liability company with its principal executive offices located at 3151
17th Street Extension, Wilmington, North Carolina 28412, USA (“PPD”).


 


WHEREAS,
Sponsor is engaged in the development, manufacture, distribution, and sale of
pharmaceutical products; and


 


WHEREAS, PPD
is a contract research organization engaged in the business of managing
clinical research programs; and


 


WHEREAS,
Sponsor may wish to retain the services of PPD from time to time to perform
clinical research services in connection with certain clinical research
programs Sponsor is conducting (individually, “Study”) as more fully set forth
in various project specific addenda to be attached to this Agreement and
incorporated herein by reference (“Project Addenda”); and


 


WHEREAS, PPD
is willing to provide such services to Sponsor in accordance with the terms and
conditions of this Agreement and attached Project Addenda.


 


NOW,
THEREFORE, for good and valuable consideration contained herein, the exchange,
receipt and sufficiency of which are acknowledged, the parties agree as
follows:


 


1.            Project
Addenda.


 


In the event
that the parties hereto shall reach agreement with respect to a particular Study,
a Project Addendum for said Study shall be attached to this Agreement and the
two shall collectively, independent from other Project Addenda, constitute the
entire agreement for the specific Study. No Project Addendum shall be attached
to this Agreement without first being executed by the parties hereto. 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
otherwise specifically set forth in the Project Addendum.


 


2.            Services.


 


2.1           PPD hereby agrees to provide to
Sponsor the services described in the Services section of each Project Addendum
attached to this Agreement (the “Services”). In performing the Services, PPD
shall comply with the applicable Study Protocol (“Protocol”) which shall be incorporated
therein, this Agreement, applicable Project Addendum, the written instructions
of Sponsor, standard operating procedures approved by Sponsor, relevant
professional standards, ICH Guidelines and all applicable laws, rules and
regulations, including, but not limited to, the Federal Food, Drug and Cosmetic
Act and the regulations promulgated pursuant thereto. PPD shall ensure that all
employees and agents assigned to perform Services hereunder are made aware of
the obligations contained in this Agreement and are bound by such obligations. The responsibility for the Services is being transferred to PPD in
accordance with 21 C.F.R. Section 312.52 (a copy of the transfer of obligations
is attached to each Project Addendum.)


 

















 


2.2           In the event that PPD is requested
or required to perform services beyond that which are specifically set forth m
a Project Addendum or if Sponsor desires to change the scope of services
provided under this Agreement, any such additional services and a compensation schedule
therefor must be mutually agreed upon by the parties in writing prior to the
provision of said services. Said mutually agreed upon writing shall be a CHANGE
ORDER to the pertinent Project Addendum and the services set forth therein
shall be deemed to be Services as the term is used in this Agreement, and
thereby shall be governed by the terms and conditions of this Agreement and the
Project Addendum.


 


2.3           In the event that Sponsor requests
in writing PPD to make and/or distribute copies of copyrighted materials such
as journal articles or excerpts from publications, Sponsor agrees to pay the
cost of any copyright fees incurred by PPD that are necessary for PPD to
produce such copies, unless Sponsor provides a written representation and
warranty that 1) Sponsor has paid any and all fees and costs associated with
said copying and/or distribution of the material to be copied and or
distributed; or 2) PPD is not required to pay a copyright fee to make copies or
distribute the subject material. Sponsor hereby expressly agrees to indemnify
PPD for any and all damages, losses, and costs PPD may suffer as a result of
making and/or distributing copyrighted material pursuant to Sponsor’s written
request.


 


2.4           Sponsor shall have the right, but
not the obligation, to independently visit PPD or any site where the Services
are performed to review the performance of the Services. In the event Sponsor
intends to undertake such visits, Sponsor shall provide reasonable notification
to PPD, and PPD shall provide assistance and cooperation. Sponsor’s authorized
representatives may be required to sign a confidentiality agreement, or an
access agreement for special access-controlled areas.


 


2.5           All documentation related to the
Services performed hereunder shall be promptly and fully disclosed to Sponsor by
PPD upon request, or as set forth in the Protocol(s) or Project Addendum(s). PPD
shall make available all such documentation at PPD or at the investigator’s site
upon request for inspection, copying, review and audit at reasonable times by
representatives of Sponsor, the FDA or any other regulatory agencies.


 


2.6           PPD agrees to promptly take any
reasonable steps that are requested by Sponsor as a result of an audit to cure
deficiencies in all documentation related to the Services including case report
forms. PPD shall retain all documentation related to the Services, in
compliance with good clinical practice standards and applicable federal and
state laws, rules and regulations.


 


2.7           PPD shall notify Sponsor within
forty-eight (48) hours (or earlier if required by law) following PPD’s
knowledge of any event that occurs whenever an event occurs that is unexpected
or which may have an effect on the validity of any of PPD’s work hereunder. PPD
shall document the nature and cause of the event and both parties shall
document their respective actions taken as a result of such event.


 


3.            Compensation
and Payment.


 


3.1           A study budget and payment schedule
for each study shall be included in each Project Addendum. Except as otherwise
expressly provided in a payment schedule attached to an


 


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applicable Project
Addendum, PPD shall submit to Sponsor an invoice describing the Services
performed and, where applicable, costs incurred during a particular month on a
monthly basis and Sponsor shall pay said all amounts of uncontested payments of
invoices within thirty (30) days of receipt.


 


3.2           In the event any Project Addendum,
or this Agreement, is terminated pursuant to Section 4 of this Agreement, PPD
shall be compensated for all approved fees and costs incurred pursuant to a
Project Addendum up to the date of termination as demonstrated in the
applicable Project Addendum Payment Schedule. Additionally, PPD shall be
reimbursed any and all approved uncancellable obligations incurred prior to the
date of termination as regards third parties. Any funds held by PPD which shall
be shown by Sponsor to be unearned at the date of termination shall be returned
to Sponsor within forty-five (45) days of Project Addendum Termination. Certain
Services of PPD require greater utilization of resources at the outset such that
compensation based on a percentage of milestones completed prior to PPD
completing the full milestone would work to the detriment of PPD. Accordingly,
the Parties agree that in the event of early termination, compensation for
partially completed milestones shall be made on a time and materials basis.


 


3.3           Upon expiration of each Project
Addendum the parties agree to reconcile the payments made in accordance with
the associated budget for that Project Addendum. In the event that the Sponsor
owes PPD any additional compensation for approved services, Sponsor shall remit
payment to PPD within thirty (30) days of expiration for all undisputed charges.
In the event that the Sponsor has compensated PPD in excess of the charges for
the actual services performed PPD shall remit such overages to Sponsor within
thirty (30) days of expiration.


 


3.4           Payments to PPD shall be made to:


 


PPD Development, LLC

P.O. Box 75468

Charlotte, NC 28275-5468

Tax ID# 74-2325267


 


3.5           Taxes (and any penalties thereon)
imposed on any payment made by Sponsor to PPD shall be the responsibility of
PPD.


 


3.6           As used in this Agreement, the term “Pass-Through
Costs” means all investigator, Institutional Review Board or other applicable
pass-through costs actually incurred by PPD under this Agreement or the Project
Addendum in order to expedite successful completion of a Study, which costs are
normal and routine to studies similar to such Study (e.g., advancing an investigator’s
Institutional Review Board fee or reimbursing reasonable additional patient expenses).
All Pass-Through Costs not set forth on the Project Addendum must be
pre-authorized by Sponsor in writing.


 


3.7           Sponsor further agrees to reimburse
PPD, upon receiving sufficient documentation for expenses in excess of
Twenty-Five Dollars ($25.00) for all reasonable out-of-pocket costs, related
travel and hotel expenses for meetings and travel required for the Services and
set forth in the Project Addendum(s). All travel and miscellaneous expenses not
set forth on the Project Addendum(s) must be pre-authorized by Sponsor in
writing.


 


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4.            Term
and Termination.


 


4.1           The term of this Agreement shall commence
as of the Effective Date and end on the day three years from the Effective Date
unless earlier terminated in accordance with this Section 4. Project Addenda
shall commence upon the date of complete execution by the parties and shall
terminate upon the completion of Services unless earlier terminated in
accordance with this Section 4.


 


4.2           This Agreement or Project Addendum
may be terminated with or without cause by Sponsor upon thirty (30) days prior
written notice, except in the case of a debarment or threatened debarment of
PPD in which case Sponsor may terminate this Agreement immediately upon written
notice.


 


4.3           PPD may terminate this Agreement or
Project Addendum(s) with or without cause upon thirty (30) days prior written
notice to Sponsor.


 


4.4           The termination of this Agreement by
either party shall automatically terminate any and all Project Addenda, unless
otherwise agreed.


 


4.5           The obligations of the parties
contained in Sections 6, 7, 8, 9 and 15 hereof shall survive termination of
this Agreement.


 


5.            Personnel.


 


5.1           The Services with respect to each
Study shall be performed by PPD under the direction of the person identified as
the Project Manager in the applicable Project Addendum or such other person
acceptable to Sponsor as PPD may from time to time designate the Project Manager,
such Sponsor acceptance not to be unreasonably withheld.


 


5.2           PPD shall be obligated at all times
to provide a sufficient number of trained clinical research personnel on a
given Study to meet the demands of said Study.


 


5.3           PPD shall not subcontract or assign
any Services under a Project Addendum without the prior written consent of
Sponsor, such consent not to be unreasonably withheld. In the event that PPD is
given permission to subcontract or assign services PPD shall ensure that any
such subcontractor or assignee is aware of the terms of this Agreement and
Project Addendum and agrees to be bound by same. PPD shall be responsible for
any breach of the terms of this Agreement or Project Addendum by any
subcontractor or assignee. All approved subcontractors and assignees are
required to execute a Confidentiality Agreement between PPD and Sponsor.


 


5.4           During the period in which a
particular Study is being conducted, neither party shall solicit any personnel
of the other who is material to the performance of the particular Study without
the prior written consent of the other party. For purposes of this Section 5.4,
“solicit” means the initiation by
either party of a contract with any of the other party’s then current personnel
for the purposes of offering employment to such personnel, but shall not
include the circumstance where any such personnel initiate a contact with a
party for the purpose of obtaining employment with that party, whether in
response to a general advertisement of employment placed by that party or


 


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otherwise or where
such contact is initiated by a third party who was not instructed to contact
such personnel by the party.


 


6.            Confidentiality.


 


6.1           PPD agrees to treat any information
including, but not limited to, all materials, documents, information, programs
and suggestions of any kind obtained from Sponsor or generated or created by
PPD as a direct result of performing the Services under this Agreement, exclusive
of research methodologies and computer software and code developed by PPD
unless specifically included, to be referred to herein as the “Information”, as
the confidential and exclusive property of Sponsor. Notwithstanding the
foregoing, PPD research methodologies and computer software and codes shall not
include research methodologies and computer software and codes that may be
licensed to PPD from Sponsor or an agent of Sponsor as a result of a technology
transfer. In any and all such instances such information shall be the
confidential and exclusive property of Sponsor.


 


6.2           PPD agrees that it will use any
Information only to provide the Services and for no other purpose without the
prior written consent of Sponsor. PPD agrees not to disclose any of the
Information to any third party without first obtaining the written consent of
Sponsor. PPD further agrees to take all reasonable steps to ensure that the
Information shall not be used by its directors, officers, employees, agents,
representatives and advisors (PPD “Representatives”), except on like terms of
confidentiality as aforesaid, and that it shall be kept fully private and confidential
by them. PPD shall be liable for any breach of this Section 6 by PPD Representatives.
PPD shall only disclose confidential information to its PPD Representatives who
reasonably need to know some in the performance of such party’s obligations
under this Agreement.


 


6.3           The above provisions of
confidentiality shall not apply to that part of the Information which PPD is
able to demonstrate by documentary evidence:


 


(a)           was in PPD’s possession prior to receipt from Sponsor
or is developed independent from a Study; or


 


(b)           was in the public domain at the time of receipt from
Sponsor; or


 


(c)           becomes part of the public domain through no fault of
PPD, or the PPD Representative; or


 


(d)           is lawfully received by PPD from some third party
having a right of further disclosure; or


 


(e)           is required by law to be disclosed provided that PPD
has provided written notice to Sponsor of such request for disclosure prior to
any disclosure to enable Sponsor to attempt to obtain a protective order to
prevent the disclosure of the Confidential information.


 


6.4           PPD agrees that upon termination or
expiration of this Agreement, or, at Sponsor’s request, it shall (and shall
cause its PPD Representatives to return to Sponsor all parts of the Information
provided by or generated for Sponsor in documentary form (including without
limitations, all original records and reports used in any Study and complete
and incomplete case


 


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report forms) and
return or destroy any copies thereof made by PPD, or PPD representatives and
all unused clinical supplies provided by Sponsor. Notwithstanding the
foregoing, PPD may retain one archival copy of any such Information as is
reasonably necessary for regulatory, insurance or business purposes, subject to
the ongoing obligation to maintain the confidentiality of such information.


 


6.5           PPD acknowledges that disclosure or
distribution of the Information or use of the Information contrary to the terms
of this Agreement may cause irreparable harm for which damages at law may not
be an adequate remedy, and agrees that the provisions of this Agreement prohibiting
disclosure or distribution of the Information or use contrary to the provisions
hereof may be specifically enforced by a court of competent jurisdiction in
addition to any and all other remedies available at law or in equity.


 


6.6           All Confidential Information containing
personal data shall be handled in accordance with all applicable law,
including, but not limited to the European Data Protection Directive [EC/95/46].


 


Confidentiality Disclosure
Agreement Text


 


All
Confidential Information containing personal data shall be handled in
accordance with all applicable law, including, but not limited to the European
Data Protection Directive [EC/95/46]. These state that “personal data” will.


 


be processed
fairly and lawfully


be obtained
only for specified and lawful purposes, and not be processed in any
incompatible manner


be adequate,
relevant and not excessive


be accurate
and, where necessary, kept up to date


not be kept
for longer than is necessary


be processed
in accordance with the rights of Data Subjects


be protected
by appropriate security measures


not be
transferred to third parties unless adequate level of data Protection exist


 


PROPOSAL AND
CONTRACT TEXT


 


Data Privacy


 


With the
increase in legislation regarding data privacy across many European countries
and the Safe Harbor Agreement between the United States and the European Union
implemented in November 2000, PPD has appointed a privacy officer to ensure
compliance with these guidelines. In the conduct of clinical trials, there are
two primary areas impacted by these regulations:


 


•      Patient data


•      Investigator data


 


In order to
comply with the eight “principles” (see below) relating to handling of personal
data, PPD will provide guidance to (sponsor) and/or the investigator on the
language required to obtain a


 


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compliant
Patient Informed Consent. In addition, PPD will obtain the investigator’s
consent to process their personal data.


 


In order to
comply with the applicable legislation, PPD will require (sponsor) to confirm
that they will abide by the eight “principles” in their handling of any data
transferred from PPD.


 


The eight “principles”
require that data is:


 


•      Fairly and lawfully
processed


•      Processed for limited
purposes


•      Adequate, relevant and not
excessive


•      Accurate


•      Not kept any longer than
necessary


•      Processed in accordance with
the data subject’s rights


•      Secure


•      Not transferred to countries
without adequate protection


 


A copy of the
European Data Protection Directive [EC/95/46] is available at http://europe.eu.int/eur-lex/en/lif/dat/l995/en/395/L0046.html.”


 


7.            Intellectual
Property.


 


7.1           Neither anything contained herein
nor the delivery of any information to a party shall be deemed to grant the
receiving party any right or licenses under any patents or patent applications
or to any know-how, technology or inventions of the disclosing party.


 


7.2           Sponsor Property. Subject to Section
7.3 below, all inventions, improvements in know-how, new uses, processes and
compounds or other intellectual property involving the Study Drug or Protocols
covered by this Agreement and/or Project Addendum that are conceived or reduced
to practice as a direct result of the Services (“Inventions”) shall be and
remain the sole property of Sponsor. PPD hereby assigns to Sponsor all rights
PPD or PPD Representatives may have n any Inventions involving a Study drug or
Protocol and which 1) a direct result of PPD’s provision of the Services or 2)
specifically set forth as a deliverable under a Services Addendum. PPD agrees
to assist Sponsor, at Sponsor’s expense, in obtaining or extending protection
therefor. PPD represents that it has and will continue to have agreements with
PPD Representatives to effectuate the terms of this Section. These obligations
shall continue beyond the termination of this Agreement with respect to all
Inventions conceived by PPD and PPD Representatives while providing services to
Sponsor pursuant to this Agreement and shall be binding upon PPD’s assignees,
administrators, and other legal representation.


 


7.3           PPD Property. It is acknowledged
that PPD possesses certain inventions, processes, know-how, trade secrets,
improvements, other intellectual properties and other assets, including but not
limited to, data processes, technology, means or know-how developed by PPD
which relate to data collection or data management and laboratory analyses,
analytical methods, procedures and techniques, computer technical expertise and
software (including codes) which have been independently developed without the
benefit of any information provided by Sponsor (collective, “PPD Property”). Sponsor
and PPD agree that any PPD Property or improvements thereto are the


 


7

















 


sole and exclusive
property of PPD. Notwithstanding the foregoing, PPD research methodologies and
computer software and codes shall not include research methodologies and computer
software and codes that may be licensed to PPD from Sponsor or an agent of
Sponsor as a result of a technology transfer. In any and all such instances
such information shall be the confidential and exclusive property of Sponsor.


 


8.            Publication.


 


PPD may not
publish any articles or make any presentations relating to the Services or referring
to data, information or materials generated as part of the Services, in whole
or in part, without the prior written consent of Sponsor.


 


9.            Indemnification.


 


9.1           Sponsor shall indemnify PPD, its
directors, officers, employees, and internal review board for any and all
damages, costs, expenses and other liabilities, including reasonable attorney’s
fees and court costs, incurred in connection with any third-party claim, action
or proceeding arising from this Agreement or PPD’s connection to a Study,
provided however, that Sponsor shall have no obligation hereunder with respect
to any claim, action or proceeding to the extent shown by a court of competent
jurisdiction to have arisen from the negligence or intentional misconduct on
the part of PPD or any of its directors, officers, employees, agents or representatives
or breach by PPD of any of its obligations under this Agreement.


 


9.2           PPD shall indemnify Sponsor, its
directors, officers and employees for any and all damages, costs, expenses and
other liabilities, including reasonable attorney’s fees and court costs,
incurred in connection with any third-party claim, action or proceeding to the
extent shown by a court of competent jurisdiction to have arisen from the negligence
or intentional misconduct of PPD or any of its directors, officers, employees,
agents or representatives or breach of PPD of any of its obligations under this
Agreement.


 


9.3           Any party liable to provide
indemnification hereunder shall be entitled, at its option, to control the
defense settlement of any claim on which it is liable, provided that the
indemnifying party shall act reasonably and in good faith with respect to all
matters relating to the settlement or disposition of the claim as the
disposition or settlement relates to the party being indemnified. The
indemnified party shall reasonably cooperate in the investigation, defense and
settlement of any claim for which indemnification is sought hereunder and shall
provide prompt notice of any such claim or reasonably expected claim to the
indemnifying party. An Indemnified party shall have the right to retain its own
separate legal counsel at its own expense.


 


10.          Insurance


 


PPD shall
obtain any insurance coverage necessary and proper for performing the Service
contemplated hereunder and shall forward to Sponsor a certificate evidencing such
insurance prior to commencing Services hereunder.


 


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11.          Independent
Contractor Relationship.


 


The parties
hereto are independent contractors and nothing contained in this Agreement shall
be construed to place them in the relationship of partners, principal and
agent, employer/employee or joint venturer. Both parties agree that neither
shall have power or right to bind or obligate the other, nor shall either hold
itself out as having such authority.


 


12.          Publicity.


 


Except as
required by law, neither party shall use the name of the other party nor of any
employee of the other party in connection with any publicity without the prior
written approval of the other party.


 


13.          Force
Majeure.


 


In the event either
party shall be delayed or hindered in or prevented from the performance of any
act required hereunder by reasons of strike, lockouts, labor troubles, restrictive
government or judicial orders or decrees, riots, insurrection, war, Acts of
God, inclement weather or other similar reason or a cause beyond such party’s
control, then performance of such act shall be excused for the period of such
delay provided that the affected party shall use its commercially reasonable
efforts to avoid or remove such causes of non- performance and shall continue
performance with the utmost dispatch whenever such causes are removed. Any
timelines affected by such force majeure shall be extended for a period equal
to that of the delay and any affected Study Budgets shall be adjusted to
reflect costs increases resulting from force majeure. Notice of the start and
stop of any such force majeure shall be provided to the other party.


 


14.          Record
Storage.


 


14.1         During the term of this Agreement,
PPD shall maintain all materials and all other data obtained or generated by
PPD in the course of providing the Services hereunder, including all
computerized records and files. During the term of this Agreement and for a
period of two years after its expiration or termination, Sponsor may audit any
records of PPD associated with this Agreement, including, but not limited to
financial records, Study records, and patient records. Financial records may
include invoice records, invoices from third parties, contracts with third
parties and payments relating to this Agreement. PPD shall cooperate with any
audit by Sponsor and make available to Sponsor for examination and duplication,
during normal business hours and at the mutually agreeable times, all
documentation, data and information relating to a Study.


 


14.2         Upon the expiration or termination
of this Agreement all materials and all other data and information obtained or
generated by PPD in the course of providing the Services hereunder shall, at
Sponsor’s option, be (i) delivered to Sponsor at its expense and risk to its offices
in Liberty Corner, New Jersey in such form as is then currently in the
possession of PPD, (ii) retained by PPD for Sponsor for a period of two years,
or (iii) disposed of as directed by written request of Sponsor, unless such
materials are otherwise required to be stored or maintained by PPD under
applicable law. If PPD is required or requested to maintain and/or store such
material for a period beyond two years after the termination or expiration of
this Agreement, the parties shall mutually agree on PPD’s compensation
therefore. In no event shall PPD dispose of any materials or data or other
information obtained or generated by PPD in the course of providing the
Services hereunder without first giving Sponsor sixty (60) days prior written
notice of its intent to dispose same.


 


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Notwithstanding the
foregoing, PPD may retain copies of any such materials, data and information as
is reasonably necessary for regulatory purposes or to demonstrate the
satisfaction of its obligations hereunder, all subject to the confidentiality
obligations set forth herein.


 


15.          Regulatory
Compliance.


 


15.1         PPD hereby certifies that it has not
been debarred, and has not been convicted of a crime which could lead to
debarment, under the Generic Drug Enforcement Act of 1992. In the event that
PPD or any of its officers, directors, or employees under contract to perform
services under a Project Addendum with Sponsor becomes debarred or receives notice
of action or threat of action with respect to its debarment, PPD shall notify
Sponsor immediately.


 


15.2         PPD hereby certifies that it has not
utilized, and will use its reasonable best efforts not to utilize, the services
of any individual or entity in the performance of services under this Agreement
or any Project Addendum that has been debarred or that has been convicted of a crime
which could lead to debarment under the Generic Drug Enforcement Act of 1992. In
the event that PPD receives notice of the debarment or threatened debarment of
any such individual or entity, PPD shall notify Sponsor immediately.


 


15.3         PPD agrees to inform Sponsor
promptly of any regulatory action taken against PPD regarding Studies, and to
provide a copy of any written correspondence received from a regulatory agency,
that may affect PPD’s work hereunder. PPD agrees to notify Sponsor of any request
received from any applicable regulatory or other governmental agency to inspect
or otherwise gain access to the information, data or materials pertaining to
the Services performed by PPD under this Agreement and the Project Addendums. When
possible, PPD shall notify Sponsor of such requests prior to permitting and
third-party access and Sponsor and PPD shall jointly agree on a course of
action in accordance with applicable law. PPD agrees to permit inspection of
such information, data and materials by authorized representatives of such
agencies as required by law and shall notify Sponsor of such inspection promptly.
PPD shall provide Sponsor with copies of such notices(s), related
correspondence and any regulatory inspection reports and permit Sponsor
representatives to attend such visits.


 


15.4         Under certain circumstances, PPD is
required by law to report adverse unexpected events to appropriate regulatory
agencies. Should such a reporting requirement arise for the Services covered by
this Agreement, PPD shall comply with its obligations under applicable laws,
shall immediately inform Sponsor of the substance of such results and shall
provide Sponsor with a copy of any report for review and comment prior to
submission, where practicable, to an applicable regulatory agency.


 


16.          Notices.


 


Any notice
required or permitted to be given hereunder by either party hereunder shall be in
writing and shall be deemed given on the date received if delivered personally
or by fax or five (5) days after the date postmarked if sent by registered or
certified U.S. mail, return receipt requested, postage prepaid to the following
address:


 


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If to PPD:                               PPD Development, LLC

31511 7th Street Extension

Wilmington, North Carolina 28412

Attention: CEO

Tel: (910)251-0081

Fax: (910) 762-5820


 


If to Sponsor:                        Reliant
Pharmaceutical, LLC

110 Allen Road

Liberty Corner, NJ 07938

Attn: Joseph Krivulka, President

Tel: (908) 542-4008

Fax: (980) 542-9406


 


Copy to:                                 Reliant
Pharmaceutical, LLC

110 Allen Road

Liberty Corner, NJ 07938

Attn: Michael Lerner, VP and, General Counsel

Tel: (908) 542-4008

Fax: (980) 542-9406


 


17.          Severance.


 


If any one or
more provisions of this Agreement shall be found to be illegal or unenforceable
in any respect, the validity, legality and enforceability of the remaining
provisions shall not in any way be affected or impaired thereby, provided the surviving
agreement materially comports with the parties’ original intent.


 


18.          Waiver.


 


Waiver or
forbearance by either party or the failure by either party to claim a breach of
any provision of this Agreement or exercise any right or remedy provided by this
Agreement or applicable law, shall not be deemed to constitute a waiver with
respect to any subsequent breach of any provision hereof.


 


19.          Changes
and Modification.


 


No changes or
modifications of this Agreement or any Project Addendum shall be deemed
effective unless in writing and executed by the parties hereto.


 


20.          Assignment.


 


This Agreement
and any Project Addendum may not be assigned by either party without the prior
written consent of the other party, provided, however, the parties may assign this
Agreement or a Project Addendum to a successor to the party’s business
interests and Sponsor shall have the right to assign it’s successor and
business partner upon conversion from an LLC to another legal entity.


 


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21.          No
Conflicts


 


PPD represents
and warrants that this undertaking, including each Project Addendum accepted by
PPD, does not conflict with its duties and obligations under any other
agreement to which it is a party, including any agreements with any other
contractor or institution or any policies applicable to them.


 


22.          Survival


 


Any terms of
this Agreement, which by their nature extend beyond its performance, expiration
or termination shall remain in effect indefinitely until fulfilled in accordance
with their terms.


 


23.          Entire
Agreement.


 


This Agreement
represents the complete and entire understanding between the parties regarding
the subject matter hereof and supersedes all prior negotiations,
representations or agreements, either written or oral, regarding this subject
matter.


 


IN WITNESS
THEREOF, this Agreement has been executed by the parties hereto through their
duly authorized officers as of the date set forth above.


 


	
  PPD
  Development, LLC

  	
  Reliant

  
	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
  Name:

  	
   

  	
   

  
	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
  Title:

  	
   

  	
   

  
	
   

  	
   

  
	
  Date:

  	
   

  	
   

  	
  Date:

  	
   

  	
   

  
											



 


12

















 


AMENDMENT


 


This Amendment, made this 1st day of January,
2002, by and between PPD Development, LP, successor in interest to PPD
Development, LLC (“PPD”) and Reliance Pharmaceuticals, LLC (“Institution”),
shall be an amendment to the Clinical Research Agreement dated December 11,
2001 (“Agreement”).


 


WITNESSETH:


 


WHEREAS, PPD and Institution have entered
into the Agreement which by its terms may be amended upon the mutual consent of
the parties thereto; and


 


WHEREAS, PPD and Institution hereby mutually
consent to amend the terms of the Agreement in accordance with the terms and
conditions set forth herein;


 


NOW, THEREFORE, for the valuable
consideration contained herein, and intending to be legally bound, the parties
agree as follows:


 


1.             The General Consulting rates in the
original Project Addendum reflected the 2001 rates. This amendment revises the
consulting rates to reflect the 2002 rates. These costs were revised based on a
4% inflation rate. Please see Exhibit A.


 


2.             Time and Material tasks for technical
review and/or general regulatory consulting will be based on the 2002 rates for
all labor incurred during the 2002 calendar year.


 


3.             All other terms and conditions of the
Agreement shall remain in full force unchanged.


 


IN WITNESS WHEREOF, the undersigned have
executed this Agreement the day and year first written above.


 


	
  Reliant
  Pharmaceuticals, LLC

  	
  PPD
  Development, LP

  
	
   

  	
   

  
	
   

  	
  By:

  	
  PPD GP, LLC

  
	
   

  	
   

  	
  Its General
  Partner

  
	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
  Name:

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
  Title:

  	
   

  	
   

  
	
  Date:

  	
   

  	
   

  	
  Date:

  	
   

  	
   

  
												



 


13

















 


EXHIBIT A


 


General Consulting


 


PPD can provide a complete technical review or general regulatory
consulting at the request of Reliant. Technical reviews and consulting costs
are based on time expended on the project. The consulting rates for the
relevant department staff are as follows:


 


	
  Title

  	
   

  	
  2002
  Hourly Rate

  
	
  Vice President, Regulatory and Scientific Affairs

  	
   

  	
  $

  	
  323

  
	
  Director, Regulatory Affairs (CMC, Preclinical expertise)

  	
   

  	
  $

  	
  229

  
	
  Regulatory Affairs Manager

  	
   

  	
  $

  	
  160

  
	
  Regulatory Specialist

  	
   

  	
  $

  	
  130

  
	
  Medical Writer

  	
   

  	
  $

  	
  120

  
	
  Manager Medical Writing

  	
   

  	
  $

  	
  160

  
	
  Senior Medical Writer

  	
   

  	
  $

  	
  148

  
	
  Director, Biostatistics

  	
   

  	
  $

  	
  229

  
	
  Senior Biostatistician

  	
   

  	
  $

  	
  160

  
	
  Vice President, Pharmacokinetic Services

  	
   

  	
  $

  	
  323

  



 






*Rates for the above positions reflect the year 2002 (Based on Year
2001 rates plus 4% inflation). Rates for 2003 will be addressed if significant
amount of work flows in to that year. Other PPD personnel may assist in this
project from time-to-time and will be billed accordingly.


 


14














AMENDMENT NO. 1


 


THIS
AMENDMENT NO. 1 (“Amendment”) is made this 6th
day of July, 2006 by and between Reliant Pharmaceuticals, Inc. (“Reliant” or “CLIENT”)
and PPD Development, LP (“PPD”).


 


WHEREAS,
CLIENT and PPD entered into a certain Master Services Agreement dated December
11, 2001 (“Agreement”) pursuant to which PPD provides CLIENT certain clinical
research services; and


 


WHEREAS,
CLIENT and PPD wish to amend the Agreement as set forth herein.


 


NOW,
THEREFORE, in consideration of the premises and mutual
covenants contained herein, the receipt and sufficiency of which are hereby
acknowledged, the parties agree as follows:


 


1.                                       The term of the Agreement shall be
extended for an additional three (3) year term, to and through December 31,
2007.


 


2.                                       The parties agree that
confidentiality shall continue to be governed by the Confidentiality Agreement
between the parties dated February 1, 2006


 


3.                                       In the event of any inconsistency or
conflict of terms between the Agreement and this Amendment, the terms of this Amendment
shall control.


 


4.                                       Except as provided herein, all other
terms and conditions of the Agreement shall remain in full force and effect.


 


IN WITNESS
WHEREOF, the parties hereto have caused this Amendment
to be executed as of the date first above written.


 


	
  RELIANT
  PHARMACEUTICALS, INC.

  	
  PPD
  DEVELOPMENT, LP

  
	
   

  	
  By:  PPD GP, LLC

  Its:  General Partner

  
	
   

  	
   

  
	
   

  	
   

  
	
  By:

  	
  /s/ Steve
  Ketchum

  	
   

  	
  By:

  	
  /s/ Paul
  Covington

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
  Steve
  Ketchum, Ph.D.

  	
   

  	
  Name:

  	
  Paul S.
  Covington, MD

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  Sr. VP,
  R&D and Medical Affairs

  	
   

  	
  Title:

  	
  Executive Vice President of Development

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Date:

  	
  August 1,
  2006

  	
   

  	
  Date:

  	
  July 17,
  2006