EXHIBIT 10.45


 


RELIANT-ATP

MEDICAL LETTER WRITING

SERVICES AGREEMENT


 


This AGREEMENT, executed this 18th day of
December, 2000, is made by and between Reliant Pharmaceuticals, LLC, a Delaware
limited liability company having a place of business at 721 Route 202/206
South, Bridgewater, New Jersey 08807 (hereafter referred to as “Reliant”), and
ATP, LLC, dba PPD ATP, LLC, a North Carolina limited liability company
(hereinafter referred to as “ATP”).


 


W  I  T  N  E  S
S  E  T  H:


 


WHEREAS, Reliant is engaged in the development,
manufacture, marketing and sale of pharmaceutical products; and


 


WHEREAS, ATP has experience and expertise in
the area of providing medical writing assistance for the pharmaceutical
industry; and


 


WHEREAS, Reliant desires to employ ATP to
prepare standard medical information letters related to Reliant products;


 


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


 


1.             Services Provided by ATP.
ATP shall provide those medical letter writing development, implementation, and
information response services which are attached hereto as an exhibit (the “Medical
Writing Services”) as requested by Reliant from time to time. ATP shall not
perform any Services without the prior written authorization of the
representative designated by Reliant.


 


2.             Obligations of Reliant.
Reliant shall provide the necessary information for ATP to develop the medical
letters for products designated by Reliant. ATP will create a draft letter and
forward such draft to Reliant for review and approval. Reliant will be solely responsible
for the final content of such letters. Reliant shall designate a representative
from time to time who is authorized to identify and request Medical Writing
Services from ATP. The initial Reliant representative is Keith S. Rotenberg,
Ph.D. Reliant has the authority to audit ATP procedures which relate to Reliant
and which materially impact ATP’s role in fulfilling services for Reliant in
accordance with established quality assurance procedures. Reliant may audit ATP
at any time during regular business hours at its discretion and agrees to give
at least seventy-two (72) hours notice to ATP. Such audits may include but are
not limited to ATP procedures, files, and records associated with any Medical
Writing Services performed by ATP hereunder.


 


3.             Term and Termination.
The term of this Agreement shall commence upon execution of this agreement by
both parties or December 18, 2000 (the “Commencement Date”), whichever is
earlier, and shall exist and continue until December 18, 2001 unless terminated
earlier as provided in this Section 3. Thereafter, this Agreement may be renewable
only under the terms and conditions that are agreed upon, in writing, by both parties.
This Agreement may be terminated as follows:


 


A.            By Reliant or ATP
without cause upon sixty (60) days written notice to the other party.


 

















 


B.            By Reliant or ATP
immediately upon notice to the other, if the other party shall fail to make any
undisputed payments within thirty (30) days of the date when due hereunder.


 


C.            By Reliant or ATP, if
the other party shall default in the performance of any term or condition of this
Agreement (other than nonpayment of moneys owed), on thirty (30) days prior
written notice to the other, specifying the nature of the default, unless such
defaulting party shall cure that default within the thirty (30) day period.


 


D.            By Reliant or ATP
immediately on notice to the other, if the other party shall make an assignment
for the benefit of creditors, shall file a petition in bankruptcy, is
adjudicated insolvent or bankrupt, or if a receiver or trustee is appointed
with respect to a substantial part of such other party’s property or a proceeding
is commenced against it which reasonably will impair substantially its ability
to perform hereunder.


 


Upon termination both parties shall be
relieved of any further obligations hereunder except those set forth in
Sections 5, 6, 7, 8, 9, and 11 and payment for Services rendered set forth in Section
4. Termination shall not affect the rights or obligations of either party
accrued as of such termination.


 


4.             Compensation.


 


Reliant shall compensate ATP for performance of services rendered pursuant
to this Agreement on the basis of time spent by ATP staff in one-fourth (1/4)
hour increments multiplied by the appropriate staff hourly rate, as set forth
in Attachment A. Notwithstanding anything to the contrary in this Section
4a, staffing fees shall not exceed $30,000 during the term of this agreement.


 


a.             during the term of
this Agreement.


 


b.             Reliant shall
reimburse ATP for specified out-of-pocket expenses incurred by ATP in biomedical
literature search and medical writing services as set forth in Attachment A.
These costs include bibliographic database access, Copyright Clearance,
external document retrieval, internal document procurement. The administrative
charge covers the cost associated with the required accounting processes.
Out-of-pocket expenses not listed above must be preapproved by Reliant.
Pre-approved travel expenses, including coach airfare, are invoiced at cost.
Meals associated with meetings as requested by Reliant are invoiced at cost. In
the event that Reliant requests ATP to make and/or distribute copies of
copyrighted materials such as journal articles or excerpts from publications,
Reliant agrees to pay the cost of any copyright fees incurred by ATP that are
necessary for ATP to produce such copies, unless ATP provides written information
indicating that ATP need not pay a copyright fee to make such copies.


 


c.             ATP shall submit
monthly invoices to Reliant setting forth the Services provided, staffing,
hours of staffing, staffing fees and additional costs. Payment for uncontested Services
shall be due within thirty (30) days of receipt of the invoice, which payment
may be credited against the monies in the Advance Account, as described below.


 


5.             Confidentiality.
Reliant and ATP hereby acknowledge that their businesses involve the
development of valuable and confidential business information. “Reliant
Confidential


 


2

















 


Information” shall mean any information
treated by Reliant as confidential, including without limitation all Reliant
Data and all information relating to ADE’s received through Reliant toll-fee
number(s) from all callers and third parties. “ATP Confidential Information”
shall mean any information rightfully treated by ATP as confidential, including
ATP’s use of telephone services to provide access to a wide variety of
information. During the term of this Agreement, and for a period of five (5)
years following the termination of this Agreement, ATP and Reliant agree that,
without the prior written consent of the other party, it shall not disclose to
any third party nor use for any purposes whatsoever, any Reliant Confidential
Information or ATP Confidential Information which has been disclosed by the
other party or by any other person or entity on behalf of the other party or
learned in the performance hereof. In addition, neither party shall disclose
the essential terms of this Agreement to any other entity or person. This obligation
of nondisclosure does not extend to Confidential Information which was in the possession
of or known by either party prior to their receipt of the information from the other
party as evidenced by written records; is or becomes available to the general
public by acts not attributable to a breach or default of an agreement by the
other party; is hereafter furnished to Reliant or ATP by a third party as a
matter of right without restriction on disclosure; or that Reliant or ATP is
obligated to produce under Court or governmental order, limited to the purpose
and extent of such order, in which case either party will notify the other as
far in advance as possible to allow the other party to challenge such
production. In addition, each party further agrees to use its reasonable
precaution to safeguard the confidentiality of all proprietary information and
trade secrets of the other party. Upon termination of this Agreement by either
party, all Confidential Information shall be returned to each party, upon
request by the other, except for one copy which may be kept for archival purposes.
Neither party shall make any press releases during the term of this Agreement with
respect to the existence of this agreement, without the prior consent of the
other party, unless such disclosure is required by Law.


 


6.             Rights to Program and
Other Property.


 


a.             All computer
programs, including any documentation relating thereto, and all trade secrets,
copyrights, and other intellectual and proprietary rights, developed by ATP in
connection with the performance of Services hereunder, are owned by and shall
remain the exclusive proprietary property of ATP. Such materials shall be
deemed confidential business information of ATP and subject to the limitations
and restrictions of Section 5 of this Agreement.


 


b.             Any data or
information generated by ATP as a result of the Medical Writing Services
performed hereunder or inquiries received through the Reliant toll-free numbers,
documents and information supplied to ATP by Reliant or any patients or healthcare
professionals purchasing, using or prescribing Reliant products, including product
package inserts, protocols, training materials and any reports or compilation
of data, inquiries, or responses prepared by ATP in performing the services for
Reliant shall be referred to as “Reliant Information.” Reliant Information shall
be owned by Reliant and, to the extent that they are reduced to written form,
Reliant shall be deemed owner of the copyright in relation to such materials.
Such materials shall be deemed confidential business information of Reliant
subject to the limitations and restrictions of Section 5 of this Agreement.
Within five (5) business days after the termination of this Agreement for any reason,
the Reliant Information shall be returned to Reliant except for one copy which
may be kept for archival purposes only. ATP shall not use Reliant Information
for any purpose other than carrying out the terms of this Agreement.


 


7.             Noninterference with
Employees. Each party acknowledges that the other’s employees have
received special training and have expertise in rendering services and are a valuable
and unique asset of such party’s business. During the period this Agreement is
in effect and for a one


 


3

















 


(1) year period following the termination of
this Agreement, each party agrees that, without the prior written consent of
the other, it shall not solicit any employee of the other (i) to terminate his
or her employment with such party or (ii) to become associated with the other
or its affiliates.


 


8.             Remedies. No
adequate remedy at law may exist or be available in the event of a breach or
threatened breach of the covenants contained in Sections 5, 6, and 7. In the
event of any breach or threatened breach by Reliant or ATP, the other party
shall be entitled to seek injunctive relief, including a temporary restraining
order and preliminary injunction, without the posting of bond or other security
restraining such breach by the other part; provided, however, that nothing
herein shall be construed as prohibiting the other party from pursuing any
other remedies available with respect to such breach or threatened breach, including
the recovery of damages.


 


9.             Indemnification.
Reliant shall indemnify and save ATP harmless from any claim, loss, liability,
or expense, including reasonable attorneys’ fees, which may be incurred by or asserted
against ATP as a result of or arising from Reliant’s breach or default of this Agreement,
the negligence or misconduct of Reliant or its employees, or on account of the Reliant
Data. ATP shall indemnify and save Reliant harmless from any claim, loss,
liability, or expense, including reasonable attorneys’ fees, which may be
incurred by or asserted against Reliant as a result of or arising from ATP’s
breach or default of this Agreement or from the negligence or misconduct of ATP
or its employees in performance of the services hereunder. The indemnifying
party, provided it properly notifies in advance and protects the interests of
the other party, shall have the sole control of the defense of any such action which
shall be exercised reasonably and of all negotiations for its settlement or
compromise, and the other party will provide, at the indemnifying party’s
expense, reasonable assistance in defending, at the indemnifying party’s
discretion, any claim, suit, or action. Neither party shall settle or admit
liability with respect to any such claims, charges, suits or other actions which
could result in liability to the other party without the prior written consent
of the other party, which consent shall not be unreasonably withheld or
delayed; provided, however, neither party may settle a claim or action related
to a liability without the consent of the other party is such settlement would
impose any monetary obligation on the other party or require the other party to
submit to an injunction or otherwise limit the other party rights under this Agreement.


 


10.           Insurance of ATP.
During the term of this Agreement, ATP shall maintain in full force and effect
comprehensive general liability insurance, including professional and contractual
liability coverages, with aggregate coverage of no less than $2,000,000 single limit.
If so requested by Reliant, ATP shall provide Reliant a certificate evidencing
such insurance. If the insurance is on a “claims made” basis, ATP shall obtain
tail coverage for at least seven (7) years after termination of this Agreement.


 


11.           Liability; Disclaimers;
Warranties


 


A.            Liability. Except
for acts constituting gross negligence or willful misconduct, neither party
shall be liable to the other under or in connection with this Agreement for
special, indirect, consequential, punitive or exemplary damages of any nature,
including lost profits or savings.


 


B.            Circumstances
Beyond Control of Parties/Force Majeure. Neither party shall be liable, in any
manner, for failure to meet its obligations pursuant to this Agreement to the
extent that such failure is caused by matters which are beyond the reasonable
control of such party, including, without limitations any delay of carriers,
supplies, or telecommunication providers, severe weather or any Change of Law.
Certain members of the Staff of ATP will be pharmacists


 


4

















 


in the State of North Carolina and/or
pharmacists in other states and in the process of being licensed in North
Carolina. Any state may maintain that some licensing is required in a
particular state in order for ATP or Reliant to provide the services hereunder in
such state. In the event that a state requires licensing of the ATP employees
in that state, Reliant will nor[not?] offer
the services to be provided by ATP in Section 1 in that state, and at the
option of either party, this Agreement may terminate as stated under Section 3,
and Reliant shall pay ATP any fees earned prior to termination. As of the date
of this Agreement, ATP is unaware of any state in which ATP cannot provide services
as described in this Agreement. “Change of Law” means any change in, or binding
change in the judicial or administrative interpretation of, or adoption of, any
Law, which is implemented after the date hereof. “Law” means any federal,
state, local or other constitution, charter, act, statute, law, ordinance,
code, rule, regulations, order, specified standards or objective criteria
contained in any applicable permit or approval, or other legislative or
administrative action of the United States of America, or any state or agency,
department authority, political subdivision of other instrumentality of either
thereof, or a find decree, judgement, or order of a court. If the Force Majeure
continues for more than thirty (30) days, the party not suffering the Force
Majeure may terminate this Agreement upon five (5) days written notice to the
other party.


 


C.            Year 2000. Each
party hereto warrants to the other that as of December 31, 1999, it was Year
2000 Compliant and Ready. For purposes of this agreement, “Year 2000 Compliant
and Ready” means that (a) in all material respects the hardware and software
systems used in the operation of a party’s business and its general business
plan will (i) handle date information involving any and all dates before,
during and/or after January 1, 2006, including accepting input, providing
output and performing date calculations in whole or in part; (ii) operate
accurately without interruption-on and in respect of any and all dates before,
during and/or after January 1, 2000 and without any change in performance; and
(iii) store and provide date input information without creating any ambiguity
as to the century; and (b) the party has developed alternative plans to ensure
business continuity in the event of the failure of any or all of items (a)(i)
through (iii) above.


 


12.           Independent Contractor
Status. ATP is and at all times shall be an independent contractor in
the performance of this Agreement and is not authorized to bind Reliant to any agreement
or contract, or in any other manner, with any third party. ATP shall exercise control
over its employees and agents and shall be solely responsible for the
verification of identity and employment eligibility, for the payment of any
wages, salaries, or other remuneration of its employees and agents, and for the
payment of any payroll taxes, contributions for unemployment or workers
compensation, social security, pensions, or annuities which are imposed as a
result of the employment of ATP’s employees and/or agents.


 


13.           Assignment and Delegation
of Duties. Neither party hereto may assign any of its rights or
delegate any of its duties hereunder without the other party’s express written consent
to such assignment or delegation, except that Reliant may, without consent,
assign its rights and responsibilities hereunder to any Affiliate of Reliant or
to any corporation, firm or other business entity with or into which Reliant
may merge or consolidate or to which Reliant may sell or transfer all or
substantially all of its assets.


 


14.           Governing Law.
This Agreement shall be construed and governed under the laws of the State of
Delaware.


 


15.           Severability.
Any invalidity or unenforceability of any paragraph or part of any paragraph
herein shall not in any way affect the validity or enforceability of any other paragraph


 


5

















 


or any part of any other paragraph, and this
Agreement shall be construed in all respects as if such invalid or
unenforceable provisions were omitted.


 


16.           Entire Agreement.
This Agreement constitutes the entire Agreement among the parties pertaining to
the subject matter contained herein and supersedes any and all prior and contemporaneous
agreements, representations, and understandings. No supplement to or modification
of this Agreement shall be binding unless executed in writing by each of the parties
hereto.


 


IN WITNESS WHEREOF, each of the parties
hereto have caused this Agreement to be signed by its duly authorized officers
as of the day and year first above written.


 


	
  ATP, LLC

  	
   

  	
  RELIANT PHARMACEUTICALS, LLC

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
  Name:

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
  Title:

  	
   

  	
   

  
										



 


6

















 


EXHIBIT A


 


AXID Medical Letter Writing Project 

to

Reliant Pharmaceuticals, Inc. (Reliant) 

from PPDTM ATP (ATP)


 


December 14, 2000


 


1.             Title: RELIANT Medical Letter Writing Project


 


2.             Objective and Project Assumptions:


 


The primary objective is to support RELIANT
in the creation of standard medical letters.


 


•      The RELIANT Medical Letter Writing Project is in
addition to the Information Support Services Project (MISS). Approved medical
letters will be used in verbal and/or written responses as a part of the MISS.


•      ATP will utilize existing AXID® medical letters
as the basis for creating new, revised, and updated medical letters.


•      RELIANT will provide ATP with any currently
available information resources that it deems necessary in the development of
the medical letters (e.g., regulatory documents, product monograph,
bibliographies, abstracts, data on file, etc.).


•      ATP will conduct literature searches of
reasonable breadth and depth, acquire copies of relevant articles, and compile
draft medical letters intended to address clinician questions.


•      Literature searches, as well as compilation,
review, and approval of medical letters, will be according to processes
outlined in “Staffing and Project Management” (see below).


•      Medical letters will be completed in a time frame
that is mutually agreed upon by RELIANT and ATP.


•      As an adjunct to the primary objective, ATP may
also assist RELIANT with review and creation of other types of documents and
supportive materials including, but not limited to, review and creation of
sales training materials.


 


3.             Project Specifications:


 


A.            Start-Up
Date and Term:


 


•      Project implementation (i.e., transfer of
necessary currently available information resources) will start on or before
October 1.


•      ATP suggests that the first month of the Project
be dedicated to:


•      Deployment of resources (see Attachment A)


•      Specification of timeframes (see Attachment B)


•      Development of working processes


•      Review and agreement on topics for medical
Letters (see Attachment C)


•      Provision of necessary RELIANT documents to ATP


•      The Project may operate through December 31,
2001, although it is anticipated that the medical letters initially specified
for creation will be completed well in advance of this date.


•      Attached to this proposal is a Letter of Intent.
Execution of the Letter of Intent is necessary for ATP to proceed with Project
implementation.


•      Once the Letter of Intent is received by ATP and
the scope of services is clearly defined, ATP will prepare an Addendum to the
RELIANT MISS Service Agreement.


 

















 


B.            Hours
of Operation and Holidays:


 


•      Specification of the hours of operation and holidays
is not required for the Medical Letter Writing Project. However, should RELIANT
request accelerated turnaround of medical letters due to unforeseen events,
then, as mutually agreed upon, ATP will invoice RELIANT at time and one-half
hourly rates, or double-time where holidays apply.


 


C.            Staffing
and Project


 


•      ATP Clinical Communications will use a
cost-effective project management approach involving Medical Writers and Senior
Medical Writers to draft the medical letters. An Editorial and Literature Search
Coordinator may assist in conducting literature searches, editing documents,
and ensuring the quality of all written material. Attachment A provides hourly
rates for each type of staff.


•      The Director of Clinical Communications and/or
the Executive Director of Medical Affairs at ATP will perform final document
review.


•      Drafts will then be forwarded to individuals at
RELIANT (to be designated) for review of clinical, regulatory, legal, and other
issues.


•      RELIANT will notify ATP of any necessary changes
to the draft medical letter; ATP will make required changes, as requested, and
return the revised medical letter to RELIANT for review and final approval
(processes and individuals to be determined) prior to its use by the MISS.


•      Although all medical letter writing will be
conducted primarily by the Clinical Communications Medical Writing team, ATP
will make every effort to utilize staff from the MISS, as appropriate and where
possible, to create efficiencies and minimize costs.


 


D.            Technology


 


1.             Telecommunications:


 


•      Specification of telecommunications technology is
not required for the Project. All designated staff at RELIANT and ATP will be
available via telephone.


 


2.             Systems:


 


•      ATP will utilize Microsoft Word as its primary
word-processing software.


•      ATP and RELIANT will agree on communication
processes (e.g., transmission of drafts and review comments via e-mail).


•      ATP will conduct literature searches utilizing [***]
interfaces to biomedical databases.


 


E.             Working
Processes:


 


•      ATP and RELIANT will jointly develop working
processes.


•      Specifications of a process may include, but are
not limited to, the following:


•      Proposed topics for medical letters (see
Attachment C)


•      Sequence and timeframe for writing


•      Bibliographic databases to be used for searches


•      ATP/RELIANT collaboration process for draft
review, revision, and approval


•      Transfer of completed medical letters to the MISS


•      ATP and RELIANT contacts


•      Periodic and ad hoc revision of outdated medical
letters


 






[***]:     Certain information on this
page has been omitted and filed separately with the Commission.  Confidential treatment has been requested
with respect to the omitted portions.


 


 

















 


F.             Training:


 


•      All ATP Clinical Communications staff will
complete a comprehensive ATP training program which includes the following
courses:


•      [***]


•      [***]


•      [***]


•      [***]


•      All staff will complete project-specific training
using resources and materials agreed upon by ATP and RELIANT.


•      Staff will be trained using materials that have
been supplied to ATP by RELIANT, including those available from the MISS. Subsequent
literature research may also direct ATP Clinical Communications staff to other
sources that will assist in the creation of high-quality medical letters.


 


G.            Quality
Assurance:


 


•      All drafts will undergo quality review by the
Director of Clinical Communications or the Executive Director of Medical
Affairs at ATP.


•      ATP will administer the [***] to RELIANT at set intervals
as follows:


•      Start-up Performance Report: This report measures
ATP’s effectiveness in implementing the Project and is completed within the [***]
of the Project.


•      Annual Performance Report: This report measures
ATP’s ongoing effectiveness in managing the Project over a [***] period.


 


H.            Project
Timelines:


 


•      Project timelines and deliverables are outlined
in Attachment G.


 


I.              Budget:


 


•      ATP Clinical Communications provides medical
writing services on an hourly rate basis as indicated in Attachment A. Fees are
charged for hours dedicated to RELIANT.


 






[***]:     Certain information on this
page has been omitted and filed separately with the Commission.  Confidential treatment has been requested
with respect to the omitted portions.


 


 

















 


ATTACHMENT A


Clinical Communications Hourly Rates


7/1/00-12/31/01


 


	
  Medical
  Writer:

  	
   

  	
  $

  	
  90.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Senior
  Medical Writer:

  	
   

  	
  $

  	
  100.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Editorial
  and Literature Search Coordinator:

  	
   

  	
  $

  	
  80.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Director/VP:

  	
   

  	
  $

  	
  150.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Hourly
  Videoconferencing Rate:

  	
   

  	
  $

  	
  132.50

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Bibliographic
  Database Access

  	
   

  	
  $

  	
  Cost

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Copyright
  Clearance

  	
   

  	
  $

  	
  Cost

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Document
  Procurement (External)

  	
   

  	
  $

  	
  Cost

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Document
  Retrieval (Internal)

  	
   

  	
  $

  	
  15/document

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Travel:

  	
   

  	
  $

  	
  Cost

  	
   

  



 


 


Notes:


 


•      Fees are valid for 30 business days from the date
of this proposal.


•      ATP and RELIANT will establish timelines expected
delivery dates for completing the medical letters; should RELIANT request an
accelerated turnaround for completing medical letters, ATP may invoice RELIANT
at time and one-half of base hourly rates.


 

















 


ATTACHMENT B


Project Timelines (PROPOSED)


 


	
  ACTION

  	
   

  	
  TIMELINE

  
	
  Proposal review and signing of LOI

  	
   

  	
  October 2000

  
	
   

  	
   

  	
   

  
	
  Assign Medical Writer(s) at ATP and create
  an action plan that details (task, owner, timeline, status) the following:

  •      [***]

  •      [***]

  •      [***]

  •      [***]

  •      [***]

  	
   

  	
  October 2000

  
	
   

  	
   

  	
   

  
	
  Draft contract and review by RELIANT

  	
   

  	
  October 2000

  
	
   

  	
   

  	
   

  
	
  First literature searches, article obtained

  	
   

  	
  October 2000

  
	
   

  	
   

  	
   

  
	
  First medical letter(s) drafted / revised

  	
   

  	
  November 2000

  
	
   

  	
   

  	
   

  
	
  First PPDTM ATP Performance Report Card

  	
   

  	
  February 2001

  



 






[***]:     Certain information on this
page has been omitted and filed separately with the Commission.  Confidential treatment has been requested
with respect to the omitted portions.


 


 

















 


ATTACHMENT C


AXID@ Medical Letters


 


 


 


 


	
  Source
  Document

  	
   

  	
  Medical
  Letter Topic

  	
   

  	
  ATP#

  	
   

  	
  Deliverable

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  PRIORITY 1

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  AX13

  	
   

  	
  Cover Letter

  	
   

  	
  ATP-AX01

  	
   

  	
  12/31/2000

  
	
  AXLIT

  	
   

  	
  Literature Search Letter

  	
   

  	
  ATP-AX02

  	
   

  	
  12/31/2000

  
	
  AX81

  	
   

  	
  Post-marketing Spontaneous Reports

  	
   

  	
  ATP-AX03

  	
   

  	
  12/31/2000

  
	
  AX82

  	
   

  	
  No Information Available on...

  	
   

  	
  ATP-AX04

  	
   

  	
  12/31/2000

  
	
  AX – NEW

  	
   

  	
  [***]

  	
   

  	
  ATP-AX05

  	
   

  	
  12/31/2000

  
	
  AX69/78/72

  	
   

  	
  [***]

  	
   

  	
  ATP-AX06

  	
   

  	
  12/31/2000

  
	
  AX5/AX19/AX27

  	
   

  	
  Drug Interactions

  	
   

  	
  ATP-AX07

  	
   

  	
  12/31/2000

  
	
  AX7

  	
   

  	
  Long-Term Safety

  	
   

  	
  ATP-AX08

  	
   

  	
  12/31/2000

  
	
  AX25

  	
   

  	
  Acid Suppression Ability

  	
   

  	
  ATP-AX09

  	
   

  	
  12/31/2000

  
	
  AX41

  	
   

  	
  [***]

  	
   

  	
  ATP-AX10

  	
   

  	
  12/31/2000

  
	
  AX42

  	
   

  	
  [***]

  	
   

  	
  ATP-AX11

  	
   

  	
  12/31/2000

  
	
  AX 57

  	
   

  	
  [***]

  	
   

  	
  ATP-AX12

  	
   

  	
  12/31/2000

  
	
  AX 59

  	
   

  	
  [***]

  	
   

  	
  ATP-AX13

  	
   

  	
  12/31/2000

  
	
  AX68/AX70

  	
   

  	
  [***]

  	
   

  	
  ATP-AX14

  	
   

  	
  12/31/2000

  
	
  AX83

  	
   

  	
  [***]

  	
   

  	
  ATP-AX15

  	
   

  	
  12/31/2000

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  PRIORITY 2

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  AX3

  	
   

  	
  [***]

  	
   

  	
  ATP-AX16

  	
   

  	
  12/31/2000

  
	
  AX4/AX35

  	
   

  	
  Adverse Events

  	
   

  	
  ATP-AX17

  	
   

  	
  12/31/2000

  
	
  AX16/AX55

  	
   

  	
  [***]

  	
   

  	
  ATP-AX19

  	
   

  	
  12/31/2000

  
	
  AX18

  	
   

  	
  [***]

  	
   

  	
  ATP-AX20

  	
   

  	
  12/31/2000

  
	
  AX28

  	
   

  	
  [***]

  	
   

  	
  ATP-AX21

  	
   

  	
  12/31/2000

  
	
  AX47

  	
   

  	
  [***]

  	
   

  	
  ATP-AX22

  	
   

  	
  12/31/2000

  
	
  AX48

  	
   

  	
  [***]

  	
   

  	
  ATP-AX23

  	
   

  	
  12/31/2000

  
	
  AX49

  	
   

  	
  [***]

  	
   

  	
  ATP-AX24

  	
   

  	
  12/31/2000

  
	
  AX52

  	
   

  	
  [***]

  	
   

  	
  ATP-AX25

  	
   

  	
  12/31/2000

  



 


 






[***]:     Certain information on this
page has been omitted and filed separately with the Commission.  Confidential treatment has been requested
with respect to the omitted portions.


 


 

















 


	
  AX74

  	
   

  	
  [***]

  	
   

  	
  ATP-AX26

  	
   

  	
  12/31/2000

  
	
  AX38/AX66/AX67

  	
   

  	
  [***]

  	
   

  	
  ATP-AX27

  	
   

  	
  12/31/2000

  
	
  AX20

  	
   

  	
  [***]

  	
   

  	
  ATP-AX28

  	
   

  	
  12/31/2000

  
	
  AX60

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  



 


 






[***]:     Certain information on this
page has been omitted and filed separately with the Commission.  Confidential treatment has been requested
with respect to the omitted portions.


 














 


Amendment #1


 


This Amendment #1 (“Amendment”) to the
Reliant-ATP Medical Letter Writing Services Agreement dated December 18, 2000
(the “Agreement”), is entered into this 3 day of August, 2001, by and between
ATP, LLC, d/b/a PPD Medical Communications (“ATP”), a North Carolina limited
liability company with a place of business at 2655 Meridian Parkway, Durham, NC
27713, and Reliant Pharmaceuticals, LLC. a Delaware limited liability company,
with a place of business at 110 Allen Road, Liberty Comer, New Jersey 07938 (“Reliant”).


 


WHEREAS, PPD and
RELIANT desire and agree to amend the Agreement.


 


NOW THEREFORE, in
consideration of the mutual covenants set forth below and for other good and
valuable consideration, the receipt of which is hereby acknowledged, PPD and
Reliant agree as follows:


 


I.                                      Section
1 Services Provided by ATP, shall be revised by adding the following additional
language:


 


If needed and as mutually agreed, PPD will
provide product monograph development services as requested by RELIANT in writing.
Such requests for Product Monograph services shall be made by Reliant
Pharmaceuticals in writing to PPD in the form of the schedule attached hereto
as Schedule 1. The costs for such writing monographs shall not be governed by
Section 4(a) and (b).  Compensation of
the Agreement but rather as set forth in Schedule 1.


 


This Amendment may be executed in
counterparts, including facsimiles or duplicate counterparts, provided the
signatures hereto are original and genuine, each of which shall be deemed one
in the same Amendment.


 


Except as provided in this Amendment, all
other terms and conditions of the Agreement remain unchanged and continue in
full force and effect, and the parties herby ratify and confirm the Agreement
amended hereby.


 


IN WITNESS WHEREOF,
intending to be legally bound hereby, each of the parties hereto have caused
this Amendment to be signed by its duly authorized officers as of this day, of August
2001.


 


	
  Reliant Pharmaceuticals, LLC

  	
   

  	
  ATP, LLC 

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Signature

  	
   

  	
   

  	
  Signature

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Printed Name

  	
   

  	
   

  	
  Printed Name

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title

  	
   

  	
   

  	
  Title

  	
   

  	
   

  



 


PPD Medical Communications


Confidential Information


 

















 


Schedule 1

To Amendment 1 to the Reliant-ATP Medical Letter
Writing Services Agreement 

dated December 18, 2000 (the “Agreement”)


 


1.                                       Start
up date: May 31, 2001


 


2.                                       Title
of Project:             RELIANT Product
Monograph Writing Project


 


3.                                       Staffing:
                                                Clinical
Communications Staff


 


4.                                       Estimated
Termination Date of this Project:  December
31, 2001


 


5.                                       Costs:
           Monographs for [***]
will be completed as part of the existing budget for the [***] Medical Letter
writing project. In no event shall the cost for the monograph services as set
forth herein exceed the existing budget for the [***] Medical Letter writing
project.


 


6.                                       Description
of Project:                       See attached
proposal dated May 11, 2001


 


7.                                       Other
instructions:                                          NA


 


 






[***]:                Certain
information on this page has been omitted and filed separately with the
Commission.  Confidential treatment has
been requested with respect to the omitted portions.


 














 


AMENDMENT NO. 2


TO AN AGREEMENT BY AND BETWEEN


RELIANT PHARMACEUTICALS, LLC AND ATP, LLC


DATED DECEMBER 18, 2000 AND


AMENDMENT NO. 1 DATED AUGUST 3, 2001


 


THIS AMENDMENT
is made this 25th day of February 2003, by and between Reliant Pharmaceuticals,
LLC (“CLIENT”) and ATP, LLC d/b/a PPD Medical Communications (“PPD”).


 


WHEREAS, CLIENT and PPD entered into that
certain Medical Letter Writing Services Agreement (“Agreement”) dated December
18, 2000, as amended on August 3, 2001, pursuant to which PPD provides CLIENT
the preparation of standard medical information letters related to CLIENT
products (the “Agreement”); and


 


WHEREAS, CLIENT and PPD wish to amend the
Agreement to provide for PPD’s continued performance of these services.


 


NOW, THEREFORE, in consideration of the
premises and mutual covenants herein contained and other valuable
consideration, the sufficiency of which is hereby acknowledged, the parties
hereby amend the Agreement to include the following:


 


I.              Section 3, Term of
Agreement


 


II.            Budget Estimate and
Attachment A, PPD Rate Schedule


 


Revisions:


 


I.                                         Section
3, Term of Agreement. This Section shall be revised in its entirety to read
as follows.


 


3.                                       Term of Agreement. The term of this Agreement shall be
effective December 31, 2001 and shall exist and continue until December 31,
2003. Thereafter, CLIENT may renew the term for additional one-year period(s)
upon thirty (30) days written notice prior to the end of the existing term,
under the terms and conditions herein, as amended from time to time upon mutual
agreement by both parties, except that upon renewal of the Agreement, the parties
shall review and make adjustments to the hourly fee structure in Attachment A. This
Agreement may be terminated as follows:


 


A.                                   By
CLIENT or PPD without cause upon sixty (60) days written notice to the other party.


 


B.                                     By
CLIENT or PPD immediately on notice to the other, if the other party shall fail
to make any 


 

















 


undisputed payments within thirty (30) days of the date when due hereunder.


 


C.                                     By
CLIENT or PPD, if the other party shall default in the performance of any term or
condition of this Agreement (other than nonpayment of moneys owed), on thirty
(30) days prior written notice to the other, specifying the nature of the default,
unless such defaulting party shall cure that default within the thirty (30) day
period.


 


D.                                    By
CLIENT or PPD immediately on notice to the other, if the other party shall make
an assignment for the benefit of creditors, shall file a petition in
bankruptcy, is adjudicated insolvent or bankrupt, or if a receiver or trustee
is appointed with respect to a substantial part of such party’s property or a
proceeding is commenced against it which reasonably will impair substantially
its ability to perform hereunder.


 


Upon
termination, both parties shall be relieved of any further obligations
hereunder except those set forth in Sections 5, 6, 7, 8, 9 and 11 and payment
for Services rendered set forth in Section 4. Termination shall not affect the
rights or obligations of either party accrued as of such termination.


 


II.            Budget Estimate and Attachment A,
PPD Rate Schedule.


 


The Budget Estimate and Attachment A, PPD Rate Schedule are both
revised and restated in their entirety as attached hereto.


 


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 agree
as provided above.


 


	
  RELIANT
  PHARMACEUTICALS, INC.

  	
   

  	
  ATP, LLC

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
  Name:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
  Title:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Date:

  	
   

  	
   

  	
  Date:

  	
   

  	
   

  
										



 

















 


BUDGET ESTIMATE:


 


Reliant Pharmaceuticals (Reliant)


from


PPD Medical Communications (PPD)


 


ESTIMATED LABOR COST FOR DEVELOPMENT OF STANDARD RESPONSE MEDICAL
LETTERS FOR [***]:


 


	
  PHASE I

  	
   

  	
  GROUP A

  	
   

  	
  [***] LETTERS

  	
   

  	
  $

  	
  33,940

  	
   

  
	
  PHASE II

  	
   

  	
  GROUP B

  	
   

  	
  [***] LETTERS

  	
   

  	
  $

  	
  29,980

  	
   

  
	
  PHASE III

  	
   

  	
  GROUP C

  	
   

  	
  [***] LETTERS

  	
   

  	
  $

  	
  18,880

  	
   

  



 


•                  PPD will not
begin work or incur any labor costs or other costs or expenses for Phase II or
Phase III Medical Letters until it has received the written authorization of a
representative designated by Reliant to begin work on Phase II or Phase III
Medical Letters.


 


•                  Notwithstanding
any provisions of Section 4 of the Agreement (as defined in Amendment No. 2 thereto),
labor costs for the Phase I, Phase II and Phase III Medical Letters shall not
exceed $83,000 in the aggregate. Pass through costs to include document
retrieval, photocopying, copyright clearance, postage, etc., will be in
addition to the labor costs above and shall not exceed $2,000 without express
permission of Reliant.


 


•                  The estimated
labor costs presented above are based upon the projected number of hours that Clinical
Communications believes would be required for completing the medical letter
developments over the course of an agreed timeline. A topic list that delineates
the letter grouping is attached to this estimate.


 


•                  This proposal is
based upon an average of [***] hours of Medical Writer’s time, [***] hours of an
Editorial and Literature Search Coordinator’s time and [***] hours for Medical
Writer peer review time for each medical letter.


 


•                  The above
estimate includes [***] revision cycles per letter. Project management fees are
included. Estimate assumes that literature search, citation analysis,
procurement, review and selection of pertinent references to be performed by
PPD.


 


•                  The development
of a product-specific and disease-specific knowledge base by the medical writer
is an integral part of a quality medical letter. PPD utilizes a team approach
that allows medical writers to be dedicated to a specific product over the cost
of the project. This dedicated approach allows for consistency of style,
content and tone as well as operational efficiencies. Since Clinical Communications
provides medical writing services on an hourly rate basis as indicated in
Attachment A, the labor cost per letter tends to decrease over the course of a
project.


 






[***]:                Certain
information on this page has been omitted and filed separately with the
Commission.  Confidential treatment has
been requested with respect to the omitted portions.


 

















 


•                  Article
procurement and database access costs are listed in Attachment A. These costs
are in addition to the Estimated Labor Costs.


 


•                  The cost ranges
listed above are reflective of the product training as well as additional
project variables which will impact the number of labor hours expended:


 


•                  [***]


•                  [***]


•                  [***]


 






[***]:                Certain
information on this page has been omitted and filed separately with the
Commission.  Confidential treatment has
been requested with respect to the omitted portions.


 

















 


ATTACHMENT A


PPD RATE SCHEDULE


 


	
  SERVICE

  	
   

  	
  COST

  
	
   

  	
   

  	
   

  
	
  Clinical Communications Staffing Rate:

  	
   

  	
   

  
	
  Medical Writer

  	
   

  	
  $96.25/hr

  
	
  Editorial and Literature Search Coordinator

  	
   

  	
  $85.50/hr

  
	
   

  	
   

  	
   

  
	
  Management Rate:

  	
   

  	
   

  
	
  Director/Executive Director/VP

  	
   

  	
  $170.25/hr

  
	
   

  	
   

  	
   

  
	
  Internal Document 

  	
   

  	
  $15/document

  
	
  External Document Retrieval

  	
   

  	
  Cost

  
	
  Copyright Clearance Retrieval

  	
   

  	
  Cost

  
	
  Interlibrary Loan

  	
   

  	
  Cost

  
	
  Database Access

  	
   

  	
  Cost + 5%

  



 


 

















 


	
  Topic List for [***]

  	
   

  
	
  Category Medical letter topic

  	
   

  



 


	
   

  	
   

  	
   

  	
   

  	
  Rank

  
	
  USE

  	
   

  	
   

  	
   

  	
   

  
	
  USE001

  	
   

  	
  Use in [***]

  	
   

  	
  A

  
	
  USE002

  	
   

  	
  Use in [***]

  	
   

  	
  A

  
	
  USE003

  	
   

  	
  Use in [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ADE

  	
   

  	
   

  	
   

  	
  A

  
	
  ADE001

  	
   

  	
  [***]

  	
   

  	
  C

  
	
  ADE002

  	
   

  	
  [***]

  	
   

  	
  B

  
	
  ADE003

  	
   

  	
  [***]

  	
   

  	
  B

  
	
  ADE004

  	
   

  	
  [***]

  	
   

  	
  C

  
	
  ADE005

  	
   

  	
  [***]

  	
   

  	
  C

  
	
  ADE006

  	
   

  	
  [***]

  	
   

  	
  C

  
	
  ADE007

  	
   

  	
  [***]

  	
   

  	
  A

  
	
  ADE008

  	
   

  	
  [***]

  	
   

  	
  C

  
	
  ADE009

  	
   

  	
  [***]

  	
   

  	
  C

  
	
  ADE010

  	
   

  	
  [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  CLN

  	
   

  	
   

  	
   

  	
   

  
	
  CLN001

  	
   

  	
  Clinical trials overview

  	
   

  	
  A

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  COM

  	
   

  	
   

  	
   

  	
   

  
	
  COM001

  	
   

  	
  [***]

  	
   

  	
  A

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  DOS

  	
   

  	
   

  	
   

  	
   

  
	
  DOS001

  	
   

  	
  Dosage and administration

  	
   

  	
  A

  
	
  DOS002

  	
   

  	
  Administration with or without food

  	
   

  	
  B

  
	
  DOS003

  	
   

  	
  [***]

  	
   

  	
  A

  
	
  DOS004

  	
   

  	
  Missed doses

  	
   

  	
  B

  
	
  DOS005

  	
   

  	
  [***]

  	
   

  	
  B

  
	
  DOS006

  	
   

  	
  [***]

  	
   

  	
  A

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  INT

  	
   

  	
   

  	
   

  	
   

  
	
  INT001

  	
   

  	
  Food-drug interactions

  	
   

  	
  C

  
	
  INT002

  	
   

  	
  [***]

  	
   

  	
  B

  
	
  INT003

  	
   

  	
  [***]

  	
   

  	
  A

  
	
  INT004

  	
   

  	
  [***]

  	
   

  	
  B

  
	
  INT005

  	
   

  	
  [***]

  	
   

  	
  B

  
	
  INT006

  	
   

  	
  [***]

  	
   

  	
  A

  
	
  INT007

  	
   

  	
  [***]

  	
   

  	
  A

  



 






[***]:                Certain
information on this page has been omitted and filed separately with the Commission.  Confidential treatment has been requested
with respect to the omitted portions.


 

















 


	
  INT008

  	
   

  	
  [***]

  	
   

  	
  B

  
	
  INT009

  	
   

  	
  [***]

  	
   

  	
  B

  
	
  INT010

  	
   

  	
  [***]

  	
   

  	
  B

  
	
  INT011

  	
   

  	
  [***]

  	
   

  	
  B

  
	
  INT012

  	
   

  	
  [***]

  	
   

  	
  B

  
	
  INT013

  	
   

  	
  [***]

  	
   

  	
  A

  
	
  INT014

  	
   

  	
  [***]

  	
   

  	
  C

  
	
  INT015

  	
   

  	
  [***]

  	
   

  	
  C

  
	
  INT016

  	
   

  	
  [***]

  	
   

  	
  C

  
	
  INT017

  	
   

  	
  [***]

  	
   

  	
  C

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  LAB

  	
   

  	
   

  	
   

  	
   

  
	
  LAB001

  	
   

  	
  Lab modifications

  	
   

  	
  B

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PHC

  	
   

  	
   

  	
   

  	
   

  
	
  PHC001

  	
   

  	
  Pharmacology

  	
   

  	
  A

  
	
  PHC002

  	
   

  	
  Chronotherapeutics

  	
   

  	
  A

  
	
  PHC003

  	
   

  	
  Delivery system/formulation

  	
   

  	
  A

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PHK

  	
   

  	
   

  	
   

  	
   

  
	
  PHK001

  	
   

  	
  Pharmacokinetics

  	
   

  	
  A

  
	
  PHK002

  	
   

  	
  Age, racial and gender variations

  	
   

  	
  B

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PRE

  	
   

  	
   

  	
   

  	
   

  
	
  PRE001

  	
   

  	
  General warnings and precautions

  	
   

  	
  A

  
	
  PRE002

  	
   

  	
  Use in [***] patients

  	
   

  	
  B

  
	
  PRE003

  	
   

  	
  Use in [***] patients

  	
   

  	
  C

  
	
  PRE004

  	
   

  	
  Use in [***] patients

  	
   

  	
  B

  
	
  PRE005

  	
   

  	
  Use [***]

  	
   

  	
  B

  
	
  PRE006

  	
   

  	
  Use in patients [***]

  	
   

  	
  B

  
	
  PRE007

  	
   

  	
  Use in patients [***]

  	
   

  	
  B

  
	
  PRE008

  	
   

  	
  Use in patients [***]

  	
   

  	
  B

  
	
  PRE009

  	
   

  	
  Use in patients [***]

  	
   

  	
  C

  
	
  PRE010

  	
   

  	
  Use in patients [***]

  	
   

  	
  A

  
	
  PRE011

  	
   

  	
  Use in patients [***]

  	
   

  	
  C

  
	
  PRE012

  	
   

  	
  Use in patients [***]

  	
   

  	
  C

  
	
  PRE013

  	
   

  	
  Use in patients [***]

  	
   

  	
  A

  
	
  PRE014

  	
   

  	
  Use in patients [***]

  	
   

  	
  B

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TOX

  	
   

  	
   

  	
   

  	
   

  
	
  TOX001

  	
   

  	
  Overdosage

  	
   

  	
  A

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TEC

  	
   

  	
   

  	
   

  	
   

  
	
  TEC001

  	
   

  	
  Storage and stability

  	
   

  	
  C

  



 






[***]:                Certain
information on this page has been omitted and filed separately with the
Commission.  Confidential treatment has
been requested with respect to the omitted portions.


 














 


AMENDMENT NO. 3


 


THIS AMENDMENT NO. 3
(“Amendment No. 3”) is made this 15th day of January, 2004 (“Effective Date”),
by and between Reliant Pharmaceuticals, LLC (“CLIENT”) and ATP, LLC d/b/a PPD
Medical Communications (“PPD”).


 


WHEREAS, CLIENT and
PPD entered into a certain Medical Letter Writing Services Agreement dated
December 18, 2000 (“Agreement”) as amended by Amendment No. 1 dated August 3,
2001 and Amendment No. 2 dated February 25, 2003 (collectively “Amendments”)
pursuant to which PPD provides CLIENT the preparation of standard medical
information letters related to CLIENT products; and


 


WHEREAS, CLIENT and
PPD wish to further 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.                                       All
references to “ATP” contained in the body of the Agreement shall be amended to
read “PPD.”


 


2.                                       The
first paragraph of Section 1, Services Provided by PPD, shall be deleted in its
entirety and replaced with the following paragraph:


 


“PPD shall provide those medical letter
writing development, implementation, and information response services (the “Medical
Writing Services”) as requested by CLIENT from time to time. PPD shall not
perform any Services without the prior written authorization of Keith S. Rotenberg,
Ph.D., or any such representative as designated by CLIENT.”


 


3.                                       Pursuant
to Section 1 of the Agreement, Services Provided by PPD, the 2004 PPD Fee
Structure attached to this Amendment No. 3 as Attachment A shall be effective
beginning January 1, 2004 and shall remain in effect until December 31, 2004.


 


4.                                       The
first sentence of Section 3 of the Agreement, Term of Agreement, shall
be deleted in its entirety and replaced with the following sentence:


 


“The term of this Agreement shall be
effective December 31, 2001 and shall exist and continue until December 31,
2004.”


 


5.                                       The
Budget Estimate for [***] attached to the Agreement shall be deleted in its entirety.


 


6.                                       In
the event of any inconsistency or conflict of terms between the Agreement and
this Amendment No. 3, the terms of this Amendment shall control.


 


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


 






[***]:                Certain
information on this page has been omitted and filed separately with the
Commission.  Confidential treatment has
been requested with respect to the omitted portions.


 

















 


IN WITNESS WHEREOF,
the parties hereto have caused this Amendment No. 3 to be executed as of the
date first above written.


 


	
  Reliant Pharmaceuticals, LLC

  	
   

  	
  ATP, LLC

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
  Name:

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
  Title:

  	
   

  	
   

  
										



 

















 


ATTACHMENT A


2004 PPD FEE STRUCTURE


 


	
  RESOURCE
  COSTS (per Hour)

  	
   

  	
   

  	
   

  
	
  Management Rate:

  	
   

  	
   

  	
   

  
	
  Supervisor,
  Trainer, Quality Assurance Personnel

  	
   

  	
  $

  	
  109.00

  	
   

  
	
  Associate
  Director

  	
   

  	
  $

  	
  154.75

  	
   

  
	
  Director/Executive
  Director/Vice-President

  	
   

  	
  $

  	
  182.25

  	
   

  
	
  Medical
  Writing Rates:

  	
   

  	
   

  	
   

  
	
  Medical
  Writer

  	
   

  	
  $

  	
  103.00

  	
   

  
	
  Senior
  Medical Writer

  	
   

  	
  $

  	
  114.50

  	
   

  
	
  Editorial and
  Literature Search Coordinator

  	
   

  	
  $

  	
  91.50

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ADDITIONAL
  COSTS (As Requested by CLIENT)

  	
   

  	
   

  	
   

  
	
  Telephone
  Charges, Faxing, Literature Searches, Outsourced Copying, Interlibrary Loan,
  Copyright Clearance, External Document Retrieval, Postage, Database Access:

  	
   

  	
  $

  	
  Cost

  	
   

  
	
  Internal
  Document Retrieval:

  	
   

  	
  $

  	
  16.00/document

  	
   

  
	
  Internal
  Photocopying:

  	
   

  	
  $

  	
  0.08/page

  	
   

  
							



 


 


1














 


Reliant Pharmaceuticals, Inc.


110 Allen Road


Liberty Corner, NJ  07938


Tel: (908) 580-1200


Fax: (908) 542-9405


www.ReliantRx.com


 


AMENDMENT NO. 4


 


THIS
AMENDMENT NO. 4 (“Amendment”) is made this 29th day of
November, 2004 (“Effective Date”), by and between Reliant Pharmaceuticals, Inc.
(“Reliant” or “CLIENT”) and ATP, LLC d/b/a PPD Medical Communications (“PPD”).


 


WHEREAS,
CLIENT and PPD entered into a certain Medical Letter Writing Services Agreement
dated December 18, 2000, and amended by Amendment No. 1 dated August 3, 2001,
Amendment No. 2 dated February 25, 2003, and Amendment No. 3 dated January 15, 2004
(collectively, the “Agreement”) pursuant to which PPD provides CLIENT the
preparation of standard medical information letters related
to CLIENT products; and


 


WHEREAS,
CLIENT and PPD wish to further 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.                                       Pursuant
to Section 1 of the Agreement, Services Provided by PPD, the 2005 PPD
Fee Structure attached to this Amendment No. 4 as Attachment A shall be effective
beginning January 1, 2005 and shall remain in effect until December 31, 2005.


 


2.                                       The
first sentence of Section 3 of the Agreement, Term of Agreement, shall
be deleted in its entirety and replaced with the following sentence: “The term
of this Agreement shall be effective December 31, 2004 and shall exist and
continue until December 31, 2005.”


 


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.

  	
   

  	
  ATP, LLC

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
  Name:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
  Title:

  	
   

  	
   

  
										



 


 


Final 2005 Reliant MW Renewal


 

















 


ATTACHMENT A

2005 PPD FEE STRUCTURE


 


	
  RESOURCE COSTS (per Hour)

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Management Rate:

  	
   

  	
   

  
	
  Supervisor, Trainer, Quality Assurance
  Personnel

  	
   

  	
  $

  	
  123.00

  
	
  Associate Director

  	
   

  	
  $

  	
  154.75

  
	
  Director/Executive Director/Vice-President

  	
   

  	
  $

  	
  182.25

  
	
   

  	
   

  	
   

  	
   

  
	
  Medical Writing Rates:

  	
   

  	
   

  
	
  Medical Writer

  	
   

  	
  $

  	
  118.45

  
	
  Senior Medical Writer

  	
   

  	
  $

  	
  131.65

  
	
  Editorial and Literature Search Coordinator

  	
   

  	
  $

  	
  97.50

  
	
   

  	
   

  	
   

  
	
  ADDITIONAL COSTS (As Requested by CLIENT)

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Telephone Charges, Faxing, Literature
  Searches, Outsourced Copying, Interlibrary Loan, Copyright Clearance,
  External Document Retrieval, Postage, Database Access:

  	
   

  	
  $

  	
  Cost

  
	
  Internal Document Retrieval:

  	
   

  	
  $

  	
  16.00/document

  
	
  Internal Photocopying:

  	
   

  	
  $

  	
  0.09/page

  



 


 


1














 


AMENDMENT NO. 5


 


THIS AMENDMENT NO. 5 (“Amendment”) is made
this 1st day of January, 2006 (“Effective Date”) by and between Reliant
Pharmaceuticals, Inc. (“Reliant” or “CLIENT”) and ATP, LLC d/b/a PPD Medical
Communications (“PPD”).


 


WHEREAS, CLIENT and PPD entered into a certain
Medical Letter Writing Services Agreement dated December 18, 2000, and amended
by Amendment No. 1 dated August 3, 2001, Amendment No. 2 dated February 25,
2003, Amendment No. 3 dated January 15, 2004, and Amendment No. 4 dated November
29, 2004 (collectively, the “Agreement”) pursuant to which PPD provides CLIENT
the preparation of standard medical information letters related to CLIENT
products; and


 


WHEREAS, CLIENT and PPD wish to further 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.                                       Section
1 of the Agreement shall be deleted in its entirety and replaced with the
following:


 


“PPD shall
provide medical writing development, implementation, and information response
services as described in Exhibit A (“Services”). PPD shall not perform any such
Services without the prior written authorization of CLIENT or CLIENT’s
designated representative.


 


2.                                       Exhibit
A of the Agreement shall be replaced in its entirety by the revised Exhibit A,
dated January 1, 2006, attached hereto and incorporated herein.


 


3.                                       Section
4 of the agreement shall be replaced in its entirety with the 2006 PPD Fee
Structure attached as Exhibit B, dated January 1, 2006, and incorporated
herein.


 


4.                                       The
first sentence of Section 3 of the Agreement, Term of Agreement, shall be
deleted in its entirety and replaced with the following sentence:


 


“The term of
this Agreement shall be effective January 1, 2006, and shall exist and continue
until December 31, 2006.”


 


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


 


6.                                       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.

  	
   

  	
  ATP, LLC

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Steve Ketchum

  	
   

  	
  By:

  	
  /s/ Lori Eberhardt

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
  Steve Ketchum, Ph.D.

  	
   

  	
  Name:

  	
  Lori Eberhardt

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  Sr. VP, R&D and Medical Affairs

  	
   

  	
  Title:

  	
  VP, Operations

  	
   

  
										



 


1

















 


EXHIBIT A


 


WRITING AND EDITORIAL SERVICES


•              PPD, under direction from the
Medical Information contact at Reliant, will provide ongoing medical writing
support for Reliant’s library of standard response documents.  PPD’s W&ES team operates under a support
matrix with the Professional Call Center (PCC) to provide scientific writing
services, which may include the following elements:


•              Development of Standard Response
Letters (SRL) and Frequently Asked Questions (FAQ)


•              Review and evaluation of standard response
documents for the purposes of determining the need for updates


•              Updating the library of standard
response documents (SRLs or FAQs)


•              Out of Scope (or Ad Hoc) Inquiry
Management, including review and evaluation of any out of scope inquiries with
recommendations to Reliant for follow-up


•              Routine searches of the biomedical
literature to identify topics of interest to Reliant’s products


•              Project management, as needed, to
ensure the smooth operation of services on behalf of Reliant


Project Considerations for SRLs and FAQs


Development of New SRLs or FAQs


•              According to currently available
information, approximately 360 SRLs and 34 FAQs are in the library database to
support inquiries on Reliant’s products Antara, DynaCirc, DynaCirc CR, InnoPran
XL, Rythmol IR, Rythmol SR, and Omacor. 
Development of response documents for Omacor is ongoing to support the
recent launch.  Additional products and
response documents may be added at the discretion of the clinical contact at
Reliant.


•              PPD will work with Reliant to
develop collaborative processes to determine the topics for development of any
new SRLs or FAQs.  In many cases, the
decision to develop a new SRL will be made after careful consideration of a
number of factors, including such items as:


•              Call statistics


•              Out of scope inquiry data


•              Recent literature searches or new
Reliant internal data


•              New competitive products


•              Recent poster or abstract
presentations


•              Changes in the Prescribing
Information


•              PPD will utilize a methodical
approach to the development of SRLs and FAQs. Once the topic has been
identified and approved by Reliant, the medical writer assigned to Reliant will
begin development. For each topic, the general process is as follows:


•              Gather available resources


 

















 


•              Include
data on file, regulatory materials, product information (PI) and publications


•              Evaluate the resources


•              Select the pertinent, appropriate
references that answer the question, provide scientific balance and consider
the legal, regulatory guidelines.


•              Develop the response using
Reliant’s preferred style, focus, tone, degree of detail, tables, graphs, etc.


•              Provide internal editorial and
quality review


•              Submit the draft response to the
Medical Information contact at Reliant for review and approval


•              Incorporate any revisions then
provide the completed, approved response in PDF form back to the Medical
Information contact at Reliant


•              Upon final approval, the PDF will
be sent to the PPD PPC for incorporation into the database and distribution


Updating of existing SRLs or FAQs


•              PPD will work with Reliant to
develop a response document update schedule that provides for annual updating
of the responses for select products on a staggered basis.


•              PPD will utilize this update
schedule to establish a routine process for SRL and FAQ updates of Reliant’s
products.


•              In a typical process for response
document updates, PPD will perform a focused search, by response document
topic, of the biomedical literature, as well as a review of any new internal
data or information on file to determine if Reliant should consider the
response document for an update.  PPD may
also consider other factors to determine whether the selected response document
topic may be targeted for update, such as competitive product information,
changes in the focus of the response, consistency among product response
content, recent poster presentations or trends in the product inquiries.  PPD would forward the results of the
evaluation, along with any recommendations for action, to Reliant for approval.


•              Since only a portion of SRLs or
FAQs that are evaluated for updating may actually result in an updated
deliverable, PPD has provided a tiered budget for updating of the Reliant
library of standard response documents:


•              Review and evaluation of the SRL
or FAQ, including recommendations to Reliant


•              Development of an updated SRL or
FAQ


Out of Scope Inquiry Management


•              In addition to response document
development, PPD W&ES can assist with any inquiries that may fall outside
of the approved resources (also termed ad hocs).  In a post-approval environment, an evaluation
of the out of scope request may or may not result in the development of a
response.  Reliant and PPD will develop a
collaborative out of scope review process to meet Reliant’s needs for
efficiency, cost-effectiveness and customer responsiveness.  PPD has provided budget estimates for two
types of out of scope inquiry support:


1.             The out of scope
request is reviewed and evaluated but no response is developed.


 


 

















 


•              The Reliant/PPD phone consultant
would forward the out of scope request to the W&ES group.  The medical writer assigned to Reliant would
review the request, perform a literature search if indicated, consult with the
Medical Information contact and/or review the clinical information as
necessary, then forward the results of the evaluation to the Medical
Information contact at Reliant. 
Additional information from the phone consultant, such as recent
marketing initiatives or other pertinent information may also be considered, if
applicable.  The Medical Information
contact at Reliant would be informed of the nature of the request, copies of
the literature search citations and any PPD recommendations for
development.  In some cases, no
information is available to prepare a response, or the inquiry content is such
that it is unlikely to be repeated.  In
these cases, the response may be “no information is available” or Reliant may
prefer that an internal Reliant employee or field representative contact the
requestor.


2.             The out of scope is
reviewed and evaluated, and a fully integrated response is developed.  Should the feedback from Reliant indicate
that an SRL or FAQ is to be developed, then the corresponding development
charges would apply.


•              Upon approval by Reliant to
proceed, PPD will proceed to prepare the draft response.  PPD will work with Reliant to determine if
the approved out of scope response should become a part of the standard
response database.


Periodic Searches of the Biomedical Literature


•              PPD can perform periodic searches
of the biomedical literature to identify citations that are pertinent to
Reliant’s products, including citations that may refer to the class of drug or
competitive products.  In order to ensure
that all new information can be considered on a routine basis, PPD recommends
that the periodic review of published literature also include periodic review
of any new internally available Reliant Information.  This can include ongoing trials, planned
poster presentations, publications etc. PPD can work with Reliant to develop a
process to ensure continuity and routine flow of information.


•              PPD will use the citations and
information to evaluate the current library of standard responses to determine
the potential for updating, combining, revising, etc.  The results of the evaluation and
recommendations for action will be forwarded to Reliant for approval before
proceeding.


•              PPD will work with Reliant to
identify the preferred databases for the search, as well as the search
frequency.


General Project Considerations


•              PPD asks that Reliant supply
currently available information resources to be used in the preparation of the
medical information documents (e.g., regulatory documents, product monograph,
bibliographies, abstracts, data on file), and also communicate specifications
and preferences for the final product.


•              Reliant and PPD will complete the
projects in a time frame that is mutually agreed upon. Collaborative processes
will be developed for identification of the bibliographic 


 

















 


databases,
transfer of materials, assignment of responsibilities, compilation, review and
approval of documents.


•              W&ES will dedicate a team of
medical writers to Reliant for the project. 
The team will usually consist of a primary writer, a quality reviewer
and an editor.  This dedicated approach
is efficient and ensures that style and tone remain consistent.  A PPD primary point of contact for Reliant
will be designated to serve as contact person for Reliant regarding services.


•              PPD will prepare documents using
Microsoft Word.


•              PPD will prepare the standard
response documents using Reliant’s preferred style.  In the absence of style guidance from
Reliant, PPD will default to the AMA Manual of Style.


•              PPD’s internal draft-control
system allows for easy tracking of successive drafts.  Comments will report the exact location of
source text within the reference and may provide additional information about
the document.  Colored text will indicate
information taken verbatim from the PI.


•              All drafts will undergo an
internal quality review before submission to Reliant.  Completed draft documents will be forwarded
to designated individuals at Reliant for review and approval.  PPD will make requested revisions and return
the revised documents to Reliant.


•              PPD asks that Reliant assign an
internal clinical contact person to be available to PPD for questions regarding
clinical data during development.


•              PPD will conduct literature
searches and procure relevant published clinical articles.


•              PPD may utilize tertiary
references for disease-state content development and background information.


•              PPD asks that Reliant supply any
data on file or internal data to support the SRL content.  Any internal clinical data are also helpful
in determining the focus of the SRL or FAQ content.


•              Pass-through costs such as article
procurement, copyright fees, FedEx charges, telephone charges, etc., are not
included in this proposal and will be itemized separately.


•              Project management includes
routine communication with the client and internal partners, maintenance of
status sheets, filing and other duties associated with maintaining smooth
operations on behalf of Reliant.


Budget Considerations


SRL or FAQ Development


•              Under a collaborative process with
Reliant, PPD will develop new SRLs or FAQs in support of Reliant’s products.


•              The SRLs are generally two to four
pages in length, including references. 
FAQs are generally short, focused responses of one to two paragraphs in
length.


•              Since the database of standard
responses is expected to be stable over the agreement period of 12 months, we
estimate approximately 18 each of SRLs and FAQs to be needed for development in
2006.


•              Reliant has requested estimated
development times for standard response documents.  Generally speaking, it is expected that the
development time for the first group of letters for a product will be greater
than successive standard responses due to the process of obtaining familiarity
with source documents, as well as understanding the style, content 


 

















 


and messaging
expectations of Reliant.  For subsequent
letter development, the development time may be shortened as certain
efficiencies are realized, i.e., the collaborative processes for review and
approval are smooth, the topic list is well defined and PPD is knowledgeable
with source materials and Reliant’s style expectations.  Some of the letter topics in the later groups
may also be shorter in length, more focused and perhaps covering greater
amounts of PI text and/or off label topics.


•              Assuming that the SRLs will
average two to four pages in length, estimated development generally averages
6-8 hours of medical writer time and one to two hours each of Quality Review
and Editorial time.


•              Assuming that the FAQs are
generally one to two paragraphs in length, the estimated development time
generally averages one to three hours of medical writer time and one quarter
hour to one hour each of Quality Review and Editorial time.


SRL & FAQ Updating


•              PPD will work with Reliant to
develop a collaborative process for updating the response library.  The update process typically includes a
search, by response document topic, of the biomedical literature via OVID
Medline, as well as a review of any new internal data or marketing information
on file to determine if Reliant should consider the SRL for an update.  PPD will also consider other factors that may
provoke an update, such as consistency among topics, potential for combining
topics, frequency of use or Reliant’s preferred focus for the response.  PPD will forward the results of the
evaluation, along with any recommendations for action, to Reliant for
approval.  PPD will proceed with the
letter updates upon approval and direction from Reliant.


•              Since not all topics that are
evaluated for an update will actually result in an updated deliverable, PPD has
provided estimated budget for two scenarios:


•              The literature search via OVID
Medline, citation review and evaluation of each SRL or FAQ in the library
according to a pre-determined schedule. 
The estimated average review time for each topic is one quarter hour to
one hour of medical writer or literature search coordinator time depending upon
the amount of new information, call statistics or data on file included for the
review of the document.


•              The updating of the SRL or FAQ
after approval by Reliant to proceed. 
The estimated average development time for an update after the review is
completed is approximately two to four hours of medical writer time and one
quarter hour to one hour each of quality review and editorial review.


•              The following assumptions are also
used to develop the estimated budget:


•              There are approximately 334 SRLs
currently in the database to support Antara, DynaCirc (both dosage forms),
InnaPran XL and Rythmol (both dosage forms).


•              The
Omacor SRLs or FAQs are not included since they have been recently developed.


•              The
Antara FAQs are not included since the content is driven by data that is not
expected to be subject to change.


•              Of the 334 SRLs in the database, a
review of the PCS call statistics will determine that 200 SRLs will be slated
for review/evaluation.  The remainder
will be archived, combined or deleted.


 

















 


•              Of the 200 SRLs evaluated for a
potential update, 100 SRLs will require an update.


•              The update process will be to add
new data only with minor revisions to the existing content.  Current content will not be fact-checked.


Out of Scope Inquiry Management


•              Out of scope inquiry evaluation
and support are performed with routine reviews of call statistics and call
content in collaboration with the professional call center.  Since not all evaluations of an out of scope
inquiry request may result in the development of
a response, PPD has provided an estimated budget for each type of scenario:


•              Out of scope (Ad Hoc evaluation)


•              The medical writer assigned to
Reliant performs a review of the published/unpublished literature, data on file
or other clinical resource, and then consults with the Reliant contact prior to
development.  In some cases, a ‘no
information’ response or a collated literature citation list may be sent in
lieu of a fully integrated response.


•              PPD assumes approximately 10 ad
hocs per month covering all products may be received.


•              The estimated labor time for an ad
hoc review is one half hour to one hour of medical writer time.


•              If the out of scope review results
in the development of an additional SRL or FAQ, then the corresponding
development charges would apply.


Routine Searches of the Biomedical Literature


•              PPD will perform periodic searches
of the biomedical literature via OVID Medline to identify citations pertinent
to Reliant’s products.  The citations can
be evaluated for relevance to the drug class, drug product, disease state and
competitive products.  Opportunities for
development of new responses can be identified, as well as the opportunity for
pro-active updating of existing responses between the schedule update.


•              The collated citation list will be
forwarded to Reliant along with recommendations for action or follow-up.


•              The budget assumes a monthly OVID
Medline literature search and evaluation. 
The estimated time to complete the monthly review and evaluation of the
citations against Reliant’s current response document library is eight hours
per month.


Project Team


•              The W&ES professional staff
includes Pharm. D. writers with expertise in accurate, concise and timely
delivery of drug information.  The staff
receive additional certification and skill development through the American
Medical Writers Association (AMWA) and the Drug Information Association (DIA).  The team also contains an editor and
literature search coordinator who has a master’s degree in library science and
journalism as well as certification by the Board of Editors in the Life
Sciences (BELS) and AMWA.  The
qualifications of the medical writing staff include completion of specialty
drug information residencies, AMWA certification in pharmaceutical writing and
direct patient care clinical experience.


 

















 


Training


•              The PPD W&ES team carefully
selects its medical writers based upon demonstration of medical writing and
clinical skills as evaluated by PPD’s proprietary Medical Writing Sample
(MeWS), a tool to evaluate potential medical writers.  In addition to PPD general training, new
medical writers receive skill development through self-study, continuing education,
classroom training and mentoring.


PPD Medical Writing Skill Development


•              Literature Searching and
Evaluation — This self-study course enables the employee to learn literature
searching strategies and develop the skills necessary to critically evaluate
and translate the results of medical literature.


•              Introduction to Statistics — This
course allows the employee to become familiar with the biomedical use of
statistics.


•              Bibliographic database search
strategies — This interactive course provides the writer with skills to perform
targeted, focused and complete searches of bibliographic databases, e.g.
Medline and EMBASE.


•              Medical Writing Mentoring — This
mentor training process enables the developing writer to enhance their skills
and confidence in the preparation of draft medical documents under the
supervision and guidance of a Senior Medical Writer.


Quality Assurance


•              PPD will ensure that every effort
is made to adhere to accepted standards in medical information practice
including, but not limited to, clinical, ethical, regulatory and legal
standards.


•              PPD will collaborate with Reliant
to implement standard processes for transfer and review of draft
documents.  The director of W&ES will
serve as the point of contact for process and maintenance.


•              W&ES utilizes an internal peer
review process to ensure the quality of all written materials.  All documents will be prepared to client
specifications, including style, format, topic and breadth of coverage.


•              At each internal review step, the
reviewers will ensure that the document meets the following standards:


•              Accurate referencing of literature


•              Appropriate literature evaluation
and selection


•              Inclusion of relevant material
from PI and article(s)


•              Absence of plagiarism


•              Organized flow of material and
concepts Accurate spelling, punctuation and grammar


•              Appropriate sentence structure


•              Clarity and focus


•              Consistency of presentation and
style


 

















 


 


Exhibit B


Effective January 1, 2006


Term of Exhibit B:  January 1,
2006 until December 31, 2006


 


PPD 2006 FEE STRUCTURE


 


	
   

  	
   

  	
  01/01/2006 — 

  	
   

  
	
  HOURLY RATES

  	
   

  	
  12/31/2006

  	
   

  
	
  WRITING AND EDITORIAL SERVICES (W&ES)

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Director

  	
   

  	
  [***]

  	
   

  
	
  Team Leader / Quality Review

  	
   

  	
  [***]

  	
   

  
	
  Medical Writer

  	
   

  	
  [***]

  	
   

  
	
  Editorial & Literature Search
  Coordinator

  	
   

  	
  [***]

  	
   

  



 


	
   

  	
   

  	
  01/01/2006 — 

  	
   

  
	
  ADDITIONAL COSTS (as indicated)

  	
   

  	
  12/31/2006

  	
   

  
	
  External Document Procurement, Language
  Translation, Copyright Clearance, Telephone, Pager & Fax Usage, Postage
  & In-house Fulfillment, Wide Area Network Access, Travel, Meals,
  Supplies, Off-site Storage and Outsourced Copying, Literature Searches,
  Bibliographic Database Access

  	
   

  	
  [***]

  	
   

  
	
  Internal
  Document Procurement (per document)

  	
   

  	
  [***]

  	
   

  
	
  Internal Copying (per page)

  	
   

  	
  [***]

  	
   

  
	
  Videoconferencing (per hour)

  	
   

  	
  [***]

  	
   

  



 


PPD and
Reliant agree that costs for Writing and Editorial Services for the calendar
year 2006 are estimated to be $[***].


 


PPD Medical Communications Estimated Expenses

2006


 


based upon
hourly rates; includes primary writing, peer review, editorial support

and project management


 


	
  Jan-06

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Medical Writing Estimate (all products) —

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  
	
  Document Procurement Estimate —

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  



 






[***]:     Certain
information on this page has been omitted and filed separately with the
Commission.  Confidential treatment has
been requested with respect to the omitted portions.


 

















 


	
  Feb-06

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Medical Writing Estimate (all products) —

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Document Procurement Estimate —

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  
	
  Mar-06

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Medical Writing Estimate (all products) —

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Document Procurement Estimate —

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  
	
  Apr-06

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Medical Writing Estimate (all products) —

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Document Procurement Estimate —

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  
	
  May — December 2006

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Medical Writing Estimate (all products) —
  ($[***]/month)

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  
	
  Document Procurement Estimate —

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2006 Total

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  



 


Reliant shall compensate PPD
for performance of services rendered by PPD pursuant to this agreement on the
basis of time spent by PPD staff in one-fourth (1/4) hour increments multiplied
by the appropriate staff hourly rate as set forth herein. Out-of-pocket costs
shall be reimbursed by Reliant at cost, pursuant to the budget set forth herein.
Reliant shall pay all undisputed invoices within thirty (30) days from receipt
of such invoices.


 


These estimates will be
reevaluated by RELIANT and PPD on a quarterly basis, with the first
reevaluation on April 1st, 2006. At this time, the number of incoming inquiries
and final costs associated with staffing, management, and fulfillment during
the first quarter of 2006 will be assessed and compared with the aforementioned
estimate. If warranted, the total estimated costs for 2006 will be revised to
more accurately reflect actual costs incurred through PPD Medical Information
services. Any revisions to the budget or the terms of this statement of work
must be agreed upon in writing by the both parties.


 


PPD will provide Reliant on a
monthly basis a copy of the monthly invoice which will outline in detail the
number of hours each employee (as indicated above) has worked on Reliant
business.


 


PPD will
provide backup receipts for out-of-pocket expenses within 90 days of invoice.


 


PPD will also
provide Reliant with weekly status reports of progress and maintenance of all
medical information letters and processing.


 


PPD shall utilize commercially
reasonable best efforts to perform the Services, to the sole satisfaction of
RELIANT, within the estimated budget set forth herein. In the event the
Services, or estimated out-of-pocket expenses, are anticipated to exceed the
estimated budget by 10% or 


 






[***]:     Certain
information on this page has been omitted and filed separately with the
Commission.  Confidential treatment has
been requested with respect to the omitted portions.


 

















 


more, PPD shall promptly notify
Reliant to obtain direction prior to exceeding the estimated budget.


 














 


AMENDMENT NO. 6


 


THIS
AMENDMENT NO. 6 (“Amendment”) is made this 14th
day of February, 2007 (“Effective Date”) by and between Reliant
Pharmaceuticals, LLC (“Reliant” or “CLIENT”) and ATP, LLC d/b/a PPD Medical
Communications (“PPD”).


 


WHEREAS,
CLIENT and PPD entered into a certain Medical Writing Services Agreement dated
December 18, 2000, and amended by Amendment No. 1 dated August 3, 2001,
Amendment No. 2 dated February 25, 2003, Amendment No. 3 dated January 15,
2004, Amendment No. 4 dated November 29, 2004 and Amendment No. 5 dated January
1, 2006 (collectively, the “Agreement”) pursuant to which PPD provides CLIENT
the preparation of medical information documents related to CLIENT products;
and


 


WHEREAS,
CLIENT and PPD wish to further 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 first sentence of Section 3 of
the Agreement, Term of Agreement, shall be deleted in its entirety and replaced
with the following sentence:


 


“The term of
this Agreement shall be effective January 1, 2007 and shall exist and continue
until December 31, 2007.”


 


2.             Exhibit A to the Agreement shall be deleted
in its entirety and replaced with the revised Exhibit A attached hereto and
incorporated herein.


 


3.             Exhibit B to the Agreement shall be
replaced in its entirety by Exhibit B attached hereto and Exhibit B shall be
effective beginning January 1, 2007 and shall remain in effect until December
31, 2007.


 


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


 


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


 


Reliant/MedComm


2007 Renewal Amdt.


 





















 


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


 


	
  RELIANT PHARMACEUTICALS, INC.

  	
  ATP, LLC

  
	
   

  	
   

  
	
  By:

  	
  /s/ Steve Ketchum

  	
   

  	
  By:

  	
  /s/ Vivian Broach

  	
   

  
	
   

  	
   

  
	
  Name:

  	
   Steve Ketchum, Ph.D

  	
   

  	
  Name:

  	
  Vivian Broach

  	
   

  
	
   

  	
   

  
	
  Title:

  	
  Sr. VP, R&D and Medical Affairs

  	
   

  	
  Title:

  	
  Executive Director, Operations

  	
   

  
	
   

  	
   

  
	
  Date:

  	
  January 27, 2007

  	
   

  	
  Date:

  	
  February 14, 2007

  	
   

  
									



 


2

















 


EXHIBIT A


WRITING AND EDITORIAL SERVICES

(“W&ES”)


PPD, under direction from the Medical Information contact at Reliant,
will provide ongoing medical writing support for Reliant’s library of standard
response documents.  PPD’s W&ES team
operates under a support matrix with the Professional Call Center (PCC) to
provide scientific writing services, which may include the following elements:


•      Development of Standard Response Letters
(SRL) and Frequently Asked Questions (FAQ)


•      Review and evaluation of standard response
documents for the purposes of determining the need for updates


•      Updating the library of standard response
documents (SRLs or FAQs)


•      Out of Scope (or Ad Hoc) Inquiry
Management, including review and evaluation of any out of scope inquiries with
recommendations to Reliant for follow-up


•      Routine searches of the biomedical
literature to identify topics of interest to Reliant’s products


•      Project management, as needed, to ensure
the smooth operation of services on behalf of Reliant


PPD’s W&ES
team has broad experience in inquiry support and maintenance of standard
response libraries.  Our goal is to
understand Reliant’s needs for medical writing support, then collaboratively
craft a solution that will provide the desired level and depth of service.


Project Considerations for SRLs and FAQs


Development of New SRLs or FAQs


PPD will work with Reliant to develop collaborative processes to
determine the topics for development of any new SRLs or FAQs.  In many cases, the decision to develop a new
SRL will be made after careful consideration of a number of factors, including
such items as:


•      Call statistics


•      Out of scope inquiry data


•      Recent literature searches or new Reliant
internal data


•      New competitive products


•      Recent poster or abstract presentations


•      Changes in the Prescribing Information


PPD will utilize a methodical approach to the development of SRLs and
FAQs.  Once the topic has been identified
and approved by Reliant, the medical writer assigned to Reliant will begin
development.  For each topic, the general
process is as follows:


•      Gather available resources


 


3

















 


•              Include
data on file, regulatory materials, product information (PI) and publications


•      Evaluate the resources


•      Select the pertinent, appropriate
references that answer the question, provide scientific balance and consider
the legal, regulatory guidelines.


•      Develop the response using Reliant’s
preferred style, focus, tone, degree of detail, tables, graphs, etc


•      Provide internal editorial and quality
review


•      Submit the draft response to the Medical
Information contact at Reliant for review and approval


•      Incorporate any revisions then provide the
completed, approved response in PDF form back to the Medical Information
contact at Reliant


•      Upon final approval, the PDF will be sent
to the PPD PCC for incorporation into the database and distribution


Updating of existing SRLs or FAQs


PPD will work
with Reliant to develop a response document update schedule that provides for
annual updating of the responses for select products on a staggered basis.  PPD will utilize this update schedule to
establish a routine process for SRL and FAQ updates of Reliant’s products.


In a typical
process for response document updates, PPD will perform a focused search, by
response document topic, of the biomedical literature, as well as a review of
any new internal data or information on file to determine if Reliant should
consider the response document for an update. 
PPD may also consider other factors to determine whether the selected
response document topic may be targeted for update, such as competitive product
information, changes in the focus of the response, consistency among product
response content, recent poster presentations or trends in the product
inquiries.


PPD would
forward the results of the evaluation, along with any recommendations for
action, to Reliant for approval.


Out of Scope Inquiry Management


In addition to
response document development, PPD’s W&ES can assist with any inquiries
that may fall outside of the approved resources (also termed ad hocs).  In a post-approval environment, an evaluation
of the out of scope request may or may not result in the development of a
response.  Reliant and PPD will develop a
collaborative out of scope review process to meet Reliant’s needs for
efficiency, cost-effectiveness and customer responsiveness.  In general, there are two types of out of
scope inquiry support:


1.     The out of scope request is reviewed and evaluated but no
response is developed.


The
Reliant/PPD phone consultant would forward the out of scope request to the
W&ES group.  The medical writer
assigned to Reliant would review the request, perform a literature search if
indicated, consult with the Medical Information contact and/or review the
clinical information as necessary, then forward the results of the evaluation
to the Medical Information contact at Reliant. 
Additional information from the phone consultant, such as recent
marketing initiatives or other pertinent information may also be considered, if
applicable.  The Medical Information
contact at Reliant would be informed 


 


4

















 


of the nature
of the request, copies of the literature search citations and any PPD
recommendations for development.  In some
cases, no information is available to prepare a response, or the inquiry
content is such that it is unlikely to be repeated.  In these cases, the response may be “no
information is available” or Reliant may prefer that an internal Reliant
employee or field representative contact the requester.


2.     The out of scope is
reviewed and evaluated, and a fully integrated response is developed.  Should the feedback from Reliant indicate
that an SRL or FAQ is to be developed, then the corresponding development
charges would apply.


Upon approval
by Reliant to proceed, PPD will proceed to prepare the draft response.  PPD will work with Reliant to determine if
the approved out of scope response should become a part of the standard
response database.


Periodic Searches of the Biomedical Literature


PPD can
perform periodic searches of the biomedical literature to identify citations
that are pertinent to Reliant’s products, including citations that may refer to
the class of drug or competitive products. 
In order to ensure that all new information can be considered on a
routine basis, PPD recommends that the periodic review of published literature
also include periodic review of any new internally available Reliant
information.  This can include ongoing
trials, planned poster presentations, publications etc.  PPD can work with Reliant to develop a
process to ensure continuity and routine flow of information.


PPD will use
the citations and information to evaluate the current library of standard
responses to determine the potential for updating, combining, revising,
etc.  The results of the evaluation and
recommendations for action will be forwarded to Reliant for approval before
proceeding.


PPD will work
with Reliant to identify the preferred databases for the search, as well as the
search frequency.


General Project Considerations


PPD asks that
Reliant supply currently available information resources to be used in the
preparation of the medical information documents (e.g., regulatory documents,
product monograph, bibliographies, abstracts, data on file), and also
communicate specifications and preferences for the final product.


Reliant and
PPD will complete the projects in a time frame that is mutually agreed
upon.  Collaborative processes will be
developed for identification of the bibliographic databases, transfer of
materials, assignment of responsibilities, compilation, review and approval of
documents.


W&ES will
dedicate a team of medical writers to Reliant for the project.  The team will usually consist of a primary
writer, a quality reviewer and an editor. 
This dedicated approach is efficient and ensures that style and tone
remain consistent.  A PPD primary point
of contact for Reliant will be designated to serve as contact person for
Reliant regarding services.


 


5

















 


PPD will
prepare documents using Microsoft Word.


PPD will
prepare the standard response documents using Reliant’s preferred style.  In the absence of style guidance from Reliant,
PPD will default to the AMA Manual of Style.


PPD’s internal
draft-control system allows for easy tracking of successive drafts.  Comments will report the exact location of
source text within the reference and may provide additional information about the
document.  Colored text will indicate
information taken verbatim from the PI.


All drafts
will undergo an internal quality review before submission to Reliant.  Completed draft documents will be forwarded
to designated individuals at Reliant for review and approval.  PPD will make requested revisions and return
the revised documents to Reliant.


PPD asks that
Reliant assign an internal clinical contact person to be available to PPD for
questions regarding clinical data during development.


PPD will
conduct literature searches and procure relevant published clinical articles.


PPD may
utilize tertiary references for disease-state content development and
background information.


PPD asks that
Reliant supply any data on file or internal data to support the SRL content.  Any internal clinical data are also helpful
in determining the focus of the SRL or FAQ content.


Pass-through
costs such as article procurement, copyright fees, FedEx charges, telephone
charges, etc., are not included in this proposal and will be itemized
separately.


Project
management includes routine communication with the client and internal
partners, maintenance of status sheets, filing and other duties associated with
maintaining smooth operations on behalf of Reliant.


Budget Considerations


SRL or FAQ Development


Under a
collaborative process with Reliant, PPD will develop new SRLs or FAQs in
support of Reliant’s products.


The SRLs are
generally two to four pages in length, including references.  FAQs are generally short, focused responses
of one to two paragraphs in length.


Reliant has requested estimated development times for standard response
documents.  Generally speaking, it is
expected that the development time for the first group of letters for a product
will be greater than successive standard responses due to the process of
obtaining familiarity with source documents, as well as understanding the
style, content and messaging expectations of Reliant.  For subsequent letter development, the
development time may be shortened as certain efficiencies are realized, i.e.,
the collaborative processes for review and approval are smooth, the topic list
is well defined and PPD is knowledgeable with source materials and Reliant’s
style 


 


6

















 


expectations.  Some of the letter
topics in the later groups may also be shorter in length, more focused and
perhaps covering greater amounts of PI text and/or off label topics.


•      Assuming that the SRLs will average two to
four pages in length, estimated development generally averages 6-8 hours of
medical writer time and one to two hours each of Quality Review and Editorial
time.


•      Assuming that the FAQs are generally one
to two paragraphs in length, the estimated development time generally averages
one to three hours of medical writer time and one quarter hour to one hour each
of Quality Review and Editorial time.


SRL & FAQ Updating


PPD will work
with Reliant to develop a collaborative process for updating the response
library.  The update process typically
includes a search, by response document topic, of the biomedical literature via
OVID Medline, as well as a review of any new internal data or marketing
information on file to determine if Reliant should consider the SRL for an
update.  PPD will also consider other factors
that may provoke an update, such as consistency among topics, potential for
combining topics, frequency of use or Reliant’s preferred focus for the
response.  PPD will forward the results
of the evaluation, along with any recommendations for action, to Reliant for
approval.  PPD will proceed with the
letter updates upon approval and direction from Reliant.


Since not all topics that are evaluated for
an update will actually result in an updated deliverable, the following two
scenarios may occur:


•      The literature search via OVID Medline,
citation review and evaluation of each SRL or FAQ in the library according to a
pre-determined schedule.  The estimated
average review time for each topic is one quarter hour to one hour of medical
writer or literature search coordinator time depending upon the amount of new
information, call statistics or data on file included for the review of the
document.


•      The updating of the SRL or FAQ after
approval by Reliant to proceed.  The
estimated average development time for an update after the review is completed
is approximately three to four hours of medical writer time and one half hour
to one hour each of quality review and editorial review.


The update
process will be to add new data only with minor revisions to the existing
content.  Current content will not be
fact-checked.


Out of Scope Inquiry Management


Out of scope
inquiry evaluation and support are performed with routine reviews of call
statistics and call content in collaboration with the professional call
center.  Since not all evaluations of an out of scope inquiry request may result in
the development of a response, there are two
scenarios for out of scope inquiry management:


Out of scope (Ad Hoc evaluation)


•      The medical writer assigned to Reliant
performs a review of the published/unpublished literature, data on file or
other clinical resource, and then consults with the Reliant contact prior to
development.  In some cases, a ‘no
information’ response or a collated literature citation list may be sent in
lieu of a fully integrated response.


•      The estimated labor time for an ad hoc
review is one hour of medical writer time.


 


7

















 


•      If the out of scope review results in the
development of an additional SRL or FAQ, then the corresponding development
charges would apply.


Routine Searches of the Biomedical Literature


PPD will
perform periodic searches of the biomedical literature via OVID Medline to
identify citations pertinent to Reliant’s products.  The citations can be evaluated for relevance
to the drug class, drug product, disease state and competitive products.  Opportunities for development of new
responses can be identified, as well as the opportunity for pro-active updating
of existing responses between the schedule update.


The collated
citation list will be forwarded to Reliant along with recommendations for
action or follow-up.


The estimated
time to complete the monthly review and evaluation of the citations against
Reliant’s current response document library is eight hours per month.


Project Team


The W&ES
professional staff includes Pharm. D. and Ph.D. writers with expertise in
accurate, concise and timely delivery of drug information.  The staff receive additional certification
and skill development through the American Medical Writers Association (AMWA)
and the Drug Information Association (DIA). 
The team also contains an editor and literature search coordinator who
has a master’s degree in library science and journalism as well as
certification by the Board of Editors in the Life Sciences (BELS) and
AMWA.  The qualifications of the medical
writing staff include completion of specialty drug information residencies,
AMWA certification in pharmaceutical writing and direct patient care clinical
experience.


Training


The PPD
W&ES team carefully selects its medical writers based upon demonstration of
medical writing and clinical skills as evaluated by PPD’s proprietary Medical
Writing Sample (MeWS), a tool to evaluate potential medical writers.  In addition to PPD general training, new
medical writers receive skill development through self-study, continuing
education, classroom training and mentoring.


PPD Medical Writing Skill Development


•      Literature Searching and Evaluation — This
self-study course enables the employee to learn literature searching strategies
and develop the skills necessary to critically evaluate and translate the
results of medical literature.


•      Introduction to Statistics — This course
allows the employee to become familiar with the biomedical use of statistics.


•      Bibliographic database search strategies —
This interactive course provides the writer with skills to perform targeted,
focused and complete searches of bibliographic databases, e.g. Medline and
EMBASE.


•      Medical Writing Mentoring — This mentor
training process enables the developing writer to enhance their skills and
confidence in the preparation of draft medical documents under the supervision
and guidance of a Senior Medical Writer.


 


8

















 


Quality Assurance


•      PPD will ensure that every effort is made
to adhere to accepted standards in medical information practice including, but
not limited to, clinical, ethical, regulatory and legal standards.


•      PPD will collaborate with Reliant to
implement standard processes for transfer and review of draft documents.  The director of W&ES will serve as the
point of contact for process and maintenance.


•      W&ES utilizes an internal peer review
process to ensure the quality of all written materials.  All documents will be prepared to client
specifications, including style, format, topic and breadth of coverage.


•      At each internal review step, the
reviewers will ensure that the document meets the following standards:


•      Accurate referencing of literature


•      Appropriate literature evaluation and
selection


•      Inclusion of relevant material from PI and
article(s)


•      Absence of plagiarism


•      Organized flow of material and concepts
Accurate spelling, punctuation and grammar


•      Appropriate sentence structure


•      Clarity and focus


•      Consistency of presentation and style


 


9

















 


EXHIBIT B


2007 PPD FEE STRUCTURE


 


	
  WRITING AND EDITORIAL SERVICES RATES

  	
   

  	
  Unit

  	
   

  	
  2007

  	
   

  
	
  Director

  	
   

  	
  Per hour

  	
   

  	
  [***]

  	
   

  
	
  Team Leader

  	
   

  	
  Per hour

  	
   

  	
  [***]

  	
   

  
	
  Medical Writer

  	
   

  	
  Per hour

  	
   

  	
  [***]

  	
   

  
	
  Editor & Document Review Specialist

  	
   

  	
  Per hour

  	
   

  	
  [***]

  	
   

  



 


	
  ADDITIONAL COSTS

  	
   

  	
  Unit

  	
   

  	
  2007

  	
   

  
	
  External Document Procurement, Language
  Translation, Copyright Clearance, Telephone, Fax Usage, Postage, Travel,
  Meals, Supplies, Outsourced Copying

  	
   

  	
  As needed

  	
   

  	
  [***]

  	
   

  
	
  Internal Document Procurement

  	
   

  	
  Per document

  	
   

  	
  [***]

  	
   

  



 


Reliant and
PPD agree that total costs for the 2007 calendar year for Writing and Editorial
Services are estimated to be $[***], with a total monthly cost estimated at $[***].
Any revisions to the budget or the terms of this statement of work must be
agreed upon in writing by both parties.


 


PPD shall
utilize commercially reasonable best efforts to perform the Services, to the
sole satisfaction of RELIANT, within the estimated budget set forth herein. In
the event the Services, or estimated out-of-pocket expenses, are anticipated to
exceed the estimated budget by 10% or more, PPD shall promptly notify Reliant
to obtain direction prior to exceeding the estimated budget.


 


Reliant shall
compensate PPD for performance of services rendered by PPD pursuant to this
agreement on the basis of time spent by PPD staff in one-fourth (1/4) hour
increments multiplied by the appropriate staff hourly rate as set forth herein.
Out-of-pocket costs shall be reimbursed by Reliant at cost, pursuant to the
budget set forth herein. Reliant shall pay all undisputed invoices within
thirty (30) days from receipt of such invoices.


 


PPD invoices
monthly based on the fee schedule shown above. Each invoice will outline in detail
the number of hours each employee (as indicated above) has worked on behalf of
Reliant.


 






[***]:     Certain information on this page has been omitted and filed separately
with the Commission.  Confidential
treatment has been requested with respect to the omitted portions.


 


10