Document:

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 $[***]

 

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

 

[***]:     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.

 

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.

 

 

ATTACHMENT A

Clinical Communications Hourly Rates

7/1/00-12/31/01

 

	
  Medical
  Writer:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Senior
  Medical Writer:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Editorial
  and Literature Search Coordinator:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Director/VP:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Hourly
  Videoconferencing Rate:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Bibliographic
  Database Access

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Copyright
  Clearance

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Document
  Procurement (External)

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Document
  Retrieval (Internal)

  	
   

  	
  $

  	
  [***]/document

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Travel:

  	
   

  	
  $

  	
  [***]

  	
   

  

 

 

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.

 

[***]:     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 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

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  PHASE II

  	
   

  	
  GROUP B

  	
   

  	
  [***] LETTERS

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  PHASE III

  	
   

  	
  GROUP C

  	
   

  	
  [***] LETTERS

  	
   

  	
  $

  	
  [***]

  	
   

  

 

•                  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 $[***] 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 $[***] 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

  	
   

  	
  $[***]/hr

  
	
  Editorial and Literature Search Coordinator

  	
   

  	
  $[***]/hr

  
	
   

  	
   

  	
   

  
	
  Management Rate:

  	
   

  	
   

  
	
  Director/Executive Director/VP

  	
   

  	
  $[***]/hr

  
	
   

  	
   

  	
   

  
	
  Internal Document 

  	
   

  	
  $[***]/document

  
	
  External Document Retrieval

  	
   

  	
  [***]

  
	
  Copyright Clearance Retrieval

  	
   

  	
  [***]

  
	
  Interlibrary Loan

  	
   

  	
  [***]

  
	
  Database Access

  	
   

  	
  [***]

  

 

[***]:                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.

 

 

	
  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

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Associate
  Director

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Director/Executive
  Director/Vice-President

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Medical
  Writing Rates:

  	
   

  	
   

  	
   

  
	
  Medical
  Writer

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Senior
  Medical Writer

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Editorial
  and Literature Search Coordinator

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ADDITIONAL
  COSTS (As Requested by CLIENT)

  	
   

  	
   

  	
   

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

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Internal
  Document Retrieval:

  	
   

  	
  [***]/document

  	
   

  
	
  Internal
  Photocopying:

  	
   

  	
  [***]/page

  	
   

  

 

[***]:                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.

 

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

  	
   

  	
  $

  	
  [***]

  
	
  Associate Director

  	
   

  	
  $

  	
  [***]

  
	
  Director/Executive Director/Vice-President

  	
   

  	
  $

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  
	
  Medical Writing Rates:

  	
   

  	
   

  
	
  Medical Writer

  	
   

  	
  $

  	
  [***]

  
	
  Senior Medical Writer

  	
   

  	
  $

  	
  [***]

  
	
  Editorial and Literature Search Coordinator

  	
   

  	
  $

  	
  [***]

  
	
   

  	
   

  	
   

  
	
  ADDITIONAL COSTS (As Requested by CLIENT)

  	
   

  	
   

  
	
   

  	
   

  	
   

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

  	
   

  	
  $

  	
  [***]

  
	
  Internal Document Retrieval:

  	
   

  	
  $

  	
  [***]/document

  
	
  Internal Photocopying:

  	
   

  	
  $

  	
  [***]/page

  

 

[***]:                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.

 

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:

•                                          [***]

•                                          [***]

•                                          [***]

•                                          [***]

•                                          [***]

•                                          [***]

 

Project
Considerations for SRLs and FAQs

 

Development of
New SRLs or FAQs

 

•                                          According
to currently available information, approximately [***] SRLs and [***] 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:

•                                          [***]

•                                          [***]

•                                          [***]

 

[***]:     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.

 

 

•                                          [***]

•                                          [***]

•                                          [***]

•                                          [***]

•                                          [***]

•                                          [***]

 

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 [***]. PPD may also consider other factors to determine whether the
selected response document topic may be targeted for update, such as [***] competitive
product information. 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.

 

•                                          [***]

 

[***]:     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.

 

 

[***]

 

2.                                       [***]

 

•                                          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 [***].
This can include [***]. 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 [***]. This dedicated approach is efficient and ensures
that style and tone remain consistent. A PPD primary

 

[***]:     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.

 

 

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 [***] 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 [***] 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

 

[***]:     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.

 

 

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 [***], 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 [***]. 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 [***], 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 [***] 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 [***].

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

•                                          There
are approximately [***] 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 [***] SRLs in the database, a review of the PCS call statistics will
determine that [***] SRLs will be slated for review/evaluation. The remainder
will be archived, combined or deleted.

•                                          Of
the [***] SRLs evaluated for a potential update, [***] 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.

 

[***]:     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.

 

 

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 [***] ad hocs per month covering all products may be
received.

•                                          The
estimated labor time for an ad hoc review is [***].

•                                          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 [***] 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 [***] 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 [***].

 

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 [***] and the [***].
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 [***] and [***]. The qualifications of the medical writing staff include
completion of specialty drug information residencies, [***] 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 [***]

 

[***]:     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
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

 

•                                          [***]

 

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:

 

•      [***]

•      [***]

•      [***]

•      [***]

•      [***]

•      [***]

 

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:

•      [***]

•              [***]

•      [***]

 

[***]:     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.

 

3

 

•      [***]

•      [***]

•      [***]

•      [***]

•      [***]

•      [***]

 

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 [***].
PPD may also consider other factors to determine whether the selected response
document topic may be targeted for update, such as [***].

 

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.

[***]

 

[***]:     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.

 

4

 

[***]

 

2.     [***]

 

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 [***]. This
can include [***]. 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 [***]. 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.

 

[***]:     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.

 

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 [***] 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 

 

[***]:     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.

 

6

 

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 [***] in length,
estimated development generally averages 6-8 hours of medical writer time and [***] each of Quality Review and
Editorial time.

•      Assuming that the FAQs are
generally [***] in length, the
estimated development time generally averages [***] of medical writer time and [***] 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 

 

[***]:     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.

 

7

 

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 [***] 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 [***] 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 [***].

 

Project Team

 

The W&ES
professional staff includes [***]. The staff receive additional certification
and skill development through the [***] and the [***]. The team also contains [***].
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 [***]. 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

•      [***]

•      [***]

 

[***]:     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.

 

 

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

 

[***]:     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.

 

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.

 

10EXHIBIT 10.46

 

RELIANT PHARMACEUTICALS-PPD MEDICAL COMMUNICATIONS

PRODUCT SAFETY/PHARMACOVIGILANCE SERVICES (PSPV) AGREEMENT

 

This AGREEMENT, executed this 25th day of February, 2003, by and between Reliant Pharmaceuticals,
LLC, a New Jersey limited liability company, having a place of business at 110 Allen Road, Liberty Corner. NJ 07938, (hereinafter referred to as “CLIENT”), and ATP, LLC, dba PPD Medical Communications, a North Carolina limited liability company
(hereinafter referred to as “PPD”).

 

W  I  T  N  E  S
S  E  T  H:

 

WHEREAS, CLIENT maintains the Company Core
Safety information and the regulatory
reporting responsibilities for
the post-marketing Pharmacovigilance functions pertaining to the products covered in this contract;

 

WHEREAS, CLIENT retains
all responsibilities associated
with Marketing Authorization Holder (MAH)
for the product/products managed by PPD;

 

WHEREAS, PPD provides a central processing facility staffed by health care professionals, research
assistants, and data entry
specialists to receive, review, process, and assess adverse events (AEs);

 

WHEREAS, CLIENT desires
to retain PPD (1) to utilize a
specified [***] for the purpose of [***],[***], and generating [***] for AEs,
(2) to perform [***] of all AEs on
a regular basis, along with [***]
review and [***] review, unless otherwise specified by mutual written agreement, and (3) to maintain dedicated toll-free
telephone numbers for CLIENT to
enable call return and to maintain
a separate toll-free telephone numbers
for CLIENT to enable call return and to maintain a separate toll-free number
for inbound/outbound faxes;

 

WHEREAS, PPD provides services to facilitate
completion of periodic reports/periodic safety update reports (PSURs) for the
product(s) indicated in this contract; and

 

WHEREAS, CLIENT retains the responsibility to approve the
final periodic report/PSUR along with submission to appropriate agencies.

 

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 PPD.

 

A.            General
Services. PPD shall provide Product
Safety/Pharmacovigilance services as herein described. PPD personnel selected for staffing the project will
receive documented training on project-specific standard operating procedures (“SOPS”), along with additional mining on CLIENTS products. CLIENT-specific toll-free telephone number(s) will be accessed by PPD exclusively to provide
services for CLIENT. The PPD telephone
access system will include queuing/auto
attendant and voice mail features
that facilitate PPD’s handling
of calls, and CLIENT will review
and approve the

 

[***]: 
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.

 

 

telephone system scripting prior to implementation by PPD. If CLIENT so requests in writing, and on reasonable advance
notice from CLIENT, PPD shall also provide backup Staff as
necessary upon mutual agreement. Services provided by PPD shall conform
to applicable local, state, and federal
laws, rules, and regulations in addition to agreed project-specific standard operating
procedures.

 

B.            Staff
Responses. When the Staff receives
queries not pertaining to product safety issues from consumers or health care professionals (“HCPs”), Staff will refer the consumer/HCP
to the Medical Information group handling such inquiries, or to their respective
primary health care provider. At no time
will the Staff offer therapeutic
PPD Medical Communications.

 

C.            PSPV
Services. PPD will process AEs, including
Serious Adverse Events (SAEs), for CLIENT according to
mutually agreed upon standard operating procedures and project specific protocols.
PPD will produce draft MedWatch reports
for CLIENT critique and revision.
PPD will produce a final
MedWatch form and send it to CLIENT via overnight carrier for final submission
to the agency. Similarly, PPD will
produce draft periodic reports for specified products covered under this
contract. Upon receipt of critique and revisions, PPD will return a final report to CLIENT for submission to the
agency. Depending on regulatory requirements,
a mutually agreed time line will
be developed with CLIENT for turnaround
of these reports. PPD will
assign a safety physician for this project.

 

i)              Non-Serious
AEs. PPD will handle adverse events, both expected and unexpected, in
accordance with mutually agreed project-specific protocols. PPD will send CLIENT a daily summary report
of all AEs no later than the next business day, unless
otherwise specified by CLIENT, following receipt. CLIENT will instruct PPD whether further action is necessary. Follow-up will be performed in accordance with
mutually agreed project-specific standard operating protocols. Completed case files
and source documents will be retained for a period of time determined by mutual agreement and in
accordance with applicable laws and regulations, and cases will
have been entered into the specified validated safety database.

 

ii)             SAEs. PPD will handle expected or unexpected SAEs in
accordance with mutually agreed
project-specific protocols. PPD will send to CLIENT a [***] summary report of all SAEs no later than the [***] following receipt. For
reportable events, PPD will send a draft MedWatch report to CLIENT for review and
comment within [***] of the initial notification. CLIENT will be responsible for submitting
this report to the agency within defined regulatory time frames. Follow-up will be done in accordance with
mutually negotiated project-specific protocols. PPD will provide SAE narratives
in agreed upon format, if so
requested by CLIENT. Completed case files and source documents will be
retained for a period of time determined by mutual agreement
and in accordance with applicable laws and regulations, and cases
will have been entered into the specified
validated safety database.

 

iii)            Medical
Review, AE/SAE documentation
will be reviewed upon initial receipt
and whenever substantive follow-up information is received. The safety physician will finalize the
determination of seriousness and expectedness
for each event. The
safety physician will finalize
scientific rationale and discussion

 

[***]: 
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.

 

2

 

 

(with references to the biomedical
literature) for expedited reportable unexpected
SAEs. The safety physician will also
approve the final draft of the MedWatch report and event narrative. All AEs/SAEs will be reviewed at least [***] for
trend analysis and coding
evaluation.

 

iv)           Periodic
Scientific Literature Surveillance. PPD
will process all AE/SAEs identified
as a result of regularly
scheduled systematic scientific literature surveillance. Unless otherwise
specified by CLIENT, scientific literature
surveillance will be performed
using a minimum of two databases (REACTIONS, Medline) at least monthly.
If requested, CLIENT will be provided with photocopies of scientific literature
which cite safety issues, for which CLIENT will be charged article procurement fees and copyright
clearance fees, including
translation fees for non-English language
articles, as per Attachment A.

 

v)            Periodic
report/PSUR. Upon request, and in collaboration with CLIENT, PPD will prepare periodic reports in an agreed upon format as
mandated by applicable regulatory agencies. CLIENT will provide all necessary information to enable
completion of the periodic report prior to the due date for the report. Failure
by CLIENT to provide all the
necessary information will result in a periodic report that may not meet all
regulatory requirements, and CLIENT will
assume all responsibility for such deficiencies. CLIENT will receive the draft
copy of the report for critique
and revision followed by a final
copy of the report for submission to the regulatory agency. PPD will provide
all available line listings and
tabulations, accompanying MedWatch forms, and necessary scientific literature references available to PPD.

 

D.            Project
Management. PPD shall perform Project management support which includes,
but is not limited to, oral and written communication with CLIENT, procedure and protocol development,
procedure and protocol maintenance, report
generation, training plan development, staff training. staff supervision and development,
quality assurance (including review of AE and product complaint reports),
consultative services, meeting preparation and conduction, and communication
with other third parties necessary to business
operations. Such services may be provided by Supervisor(s), Safety Coordination Specialist(s), Product Safety Manager(s), Quality Assurance
Personnel, Trainer(s), Associated Director(s), Director(s), Executive
Director(s), and/or Vice-President(s) and will be charged as stated on Attachment A.

 

E.             FDA
Issues. Immediately upon
receipt, but in no event later than one
business day after receipt thereof, PPD shall
provide CLIENT with a copy of any correspondence or notice it receives
from the FDA relating to products or services covered by this Agreement. Further,
PPD agrees to cooperate with CLIENT,
if requested, in corresponding with the FDA
or in filing any documents with respect to the products covered by this Agreement, as CLIENT deems necessary or desirable.
Such services will be charged as stated on Attachment A.

 

F.             Quality Assurance Procedures. PPD shall implement and maintain quality
assurance procedures and will provide copies of such assurance procedures to CLIENT
upon request. As mutually agreed by CLIENT
and PPD, the quality assurance processes shall incorporate any reasonable standards which CLIENT provides to PPD in writing. At

 

[***]: 
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.

 

3

 

minimum, PPD will perform quality assurance
on [***]% of the cases processed by PPD. At CLIENT’S specific request, PPD can
perform additional quality assurance measures at a mutually agreed upon fee.
The selection of cases subject to quality assurance assessment will be random
and will be determined by the supervisory staff. Additional quality assurance
may be performed as requested by CLIENT and as mutually agreed in writing.

 

G.            Hours
of Coverage. The parties agree to staffing and
hours of coverage will be from 9AM until 5PM. Monday - Friday. All
times are Eastern Time.

 

H.            Answering
Telephone Lines. Safety staff will answer
incoming telephone calls with a
mutually agreed statement, which will be provided to CLIENT prior to use, similar to: “CLIENT [Safety Department], I am a pharmacist/nurse, and my name is (consultant name).”  Simultaneous incoming calls on CLIENT lines
will be held in queue, and the Staff will answer telephone
calls in the order in which they
were received. Until such time that PPD
can answer the telephone call, if
desired by CLIENT, a
recorded message may be played. If requested
by CLIENT, PPD can establish
voice mail capability to capture inbound
call information while the Staff
is answering other telephone calls, or
to capture information after hours.
The Staff will access voice mail multiple times throughout each business day to ensure that no adverse event
reports are lost to untimely
follow-up.

 

I.              Records Kept by PPD. Information gathered shall include that which CLIENT reasonably requests or PPD deems
important. PPD shall maintain
either written or computerized records in
accordance with applicable regulatory requirements and approved CLIENT protocols.
Upon termination of this Agreement
by either party, all records shall be returned to each party, upon request by the other,
except for one copy, which may
be kept for archival purposes.

 

J.             Reports. PPD will provide CLIENT reports as requested, provided adequate advance notice is given. Requests for reports other than those
routinely produced during normal AE/SAE
processing and periodic report generation will be charged as mutually agreed in writing.

 

K.            Other Services Provided. CLIENT may request PPD’s support in performing various other
services during the term of this
Agreement. These services include
medical information inquiries, literature searches, medical letter writing.
product launch support, and contingency operations management services. Such services shall be provided under a separate agreement between PPD and
CLIENT or by Amendment to this Agreement.

 

L.             Commencement
Date. As of the date of execution of this Agreement, the commencement date
for PPD staff to perform start-up, training, and protocol development for PSPV Support Services will be on or
before September 16, 2002 (the “Commencement Date”).

 

M.           Implementation
Date. As of the date of
execution of this Agreement, the targeted implementation date for PSPV Support Services will be September 9, 2002 (the

 

[***]: 
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.

 

4

 

“Implementation Date”). The Implementation Date may be modified only upon mutual written agreement by both
CLIENT and PPD.

 

2.             Obligations of CLIENT.

 

A.            Maintenance
for Call Forwarding Capabilities.
If applicable, CLIENT is
responsible for maintaining the call forwarding
capabilities of the CLIENT toll-free number(s) and shall bear all reasonable expenses incurred for such capabilities and for the
CLIENT toll-free number(s) telephone charges used in connection with his
Agreement.

 

B.            Maintenance
for Computer Linkage Capabilities. If applicable. CLIENT is responsible for maintaining the computer linkage
capabilities and shall bear all
reasonable expenses incurred for
such capabilities used in
connection with this Agreement.

 

C.            Inform
PPD of Any Unusual Circumstances.
If a situation is anticipated that may create an
unusually high volume of adverse
events (e.g., adverse press, product recall),
CLIENT shall notify PPD
of such situation prior to its occurrence, if possible, and shall provide PPD with complete
up-to-date information necessary for processing such events.

 

D.            Training
of PPD Employees. While PPD employees have received
specialized training in providing services
set forth in Section 1A and 1B of
this Agreement, certain additional training will be needed on CLIENT’s
products and procedures. CLIENT, at CLIENT’s sole expense, shall provide
training personnel and/or necessary training materials to PPD for the express
purpose of familiarizing PPD employees with CLIENT’s products or other information required to provide services hereunder. Additional training after the Implementation Date will be conducted as needed and as
mutually agreed upon, in writing, by CLIENT and PPD. Fees shall be
charged according to Attachment A.

 

E.             Quality
Assurance. CLIENT has the authority to audit PPD processes and procedures
that relate to CLIENT and materially impact
PPD’s role in fulfilling services for CLIENT in accordance with
established quality assurance procedures. CLIENT may audit PPD at any time during regular business
hours and agrees to give at least three (3) business days notice to PPD. Such audits may include, but are not limited to, PPD procedures,
files, and records associated
with this project.

 

3.             Term of Agreement. The term of this Agreement shall commence upon execution of this Agreement by both parties upon Commencement
Date, whichever is earlier, and shall continue unless terminated according to
Section 4. The parties shall review and
make adjustments to Attachment A on an annual basis beginning December 31. 2003.

 

4.             Termination. 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.

 

5

 

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 or 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 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 7, 8,
9, 10, 11, and 13 and payment
for services rendered set forth in Section 5. Termination shall not affect the rights or obligations of either party
accrued as of such
termination.

 

5.             Payments for Services Rendered by PPD.

 

A.            Resource Costs. CLIENT shall
compensate PPD for performance of services
rendered by PPD pursuant to this Agreement on a monthly basis. The invoice will include cases submitted for the preceding month and billable
hours and costs applied to the project according to the rates stated in Attachment A. When off-site travel
is requested by CLIENT staff time
will be billed at rates shown in
Attachment A. On or before November 15 of each year of this Agreement, the PPD Fee Structure for the
period beginning the following
January 1 through the following December
31 shall be adjusted by mutual
agreement of CLIENT and PPD,
unless already specified in the then current Attachment A. Any such
adjustment shall be reflected in
a replacement Attachment A that shall
be signed by an authorized representative
of CLIENT and of PPD. Should the replacement Attachment A not be executed before November 15, PPD’s standard Fee Structure for the following January 1 through December 31 shall apply, pending the execution and implementation of the
replacement Attachment A.

 

B.            Start-up, Technology, Project Management, and Additional Costs. CLIENT shall compensate PPD
for Start-up, Technology, Resource Costs, Project Management, and Additional Costs as set forth in Attachment A. Technology Costs
shall only be incurred upon prior written approval by CLIENT.

 

C.            Billing
and Payment. PPD shall submit monthly invoices to CLIENT
setting forth Resource Costs in
addition to applicable Start-up, Technology,
Project Management, and Additional Costs. Payment shall be due within thirty
(30) days of receipt of the invoice. PPD’s
federal tax identification number is 56-2203444.

 

D.            Noncancelable
Obligations. If this Agreement is terminated pursuant to Section 4 hereof,
PPD shall be compensated for all fees
and costs accrued and unpaid through the
date of termination and reasonable
“wrap-up” period. Promptly upon sending or receiving notice of termination of this Agreement for any reason, PPD
shall use all reasonable efforts to minimize any further costs and to promptly cancel all cancelable
commitments. In addition, PPD shall be reimbursed for any and all noncancelable
and reasonable obligations owed to third parties and incurred by PPD in
rendering the Services.

 

6

 

6.             Independent Contractor Status. PPD is and at all times shall
be an independent contractor in the
performance of this Agreement and is not authorized to bind CLIENT to any agreement
or contract, of in any other
manner, with any third party. PPD 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 PPD’s employees and/or
agents.

 

7.             Rights to Program and Other Property. All computer programs, including any
documentation relating thereto, and all trade
secrets, copyrights, and other intellectual and proprietary rights,
developed by PPD in connection
with the performance of services hereunder, are owned by and shall remain the exclusive proprietary
property of PPD. Such materials
shall be deemed confidential business information of PPD and subject to the
limitations and restrictions of Section
8 of this Agreement. Any data
or information generated by PPD as a result of inquiries received through the CLIENT toll-free number(s),
documents and information supplied to PPD by CLIENT or any patients or health care professionals
purchasing, using, or prescribing CLIENT products, including product package inserts, protocols, training
materials, and any reports or compilation of data, inquiries, or responses prepared by PPD in performing the services for CLIENT shall be referred to as “CLIENT
Information.” CLIENT Information shall be owned by CLIENT and, to the extent that
it is reduced to written form, CLIENT shall be deemed owner of the
copyright in relation to such materials. Such materials shall be deemed confidential business information of CLIENT and
subject to the limitations and restrictions of Section 8 of this
Agreement. Within five (5) business days
after the termination of this Agreement for any reason, the
CLIENT Information shall be returned to CLIENT except for one copy which may be kept for archival purposes only. PPD shall not
use CLIENT Information for any purpose other than carrying out the terms of
this Agreement.

 

8.             Confidential Information. CLIENT and PPD hereby acknowledge that their businesses involve the development
of valuable and confidential business information. “CLIENT Confidential Information”
shall mean any information
treated by CLIENT as confidential, including without limitation CLIENT date and information relating
to AE’s received through CLIENT
toll-free number(s) treated by PPD as confidential, including PPD’s use of telephone services to
provide access to a wide variety of information on a national basis. During the
term of this Agreement, and for
a period of five (5) years following the
implementation of this Agreement, PPD and CLIENT 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, other than that set forth herein, any CLIENT Confidential Information
or PPD 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. All Confidential
Information containing personal data
shall be handled in accordance with all application law, including, but
not limited to the European Data
Protection Directive [EC/95/46]. In
addition, neither party shall disclose the
essential terms of this
Agreement to any other entity or person. This obligation of non-disclosure 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 CLIENT or PPD by a third party as a matter of right without restriction on
disclosure; or that CLIENT or PPD is obligated to produce under Court or governmental
order, limited to the purposes 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

 

7

 

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.

 

9.             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 in effect and for a one (1) year
period following the termination of this Agreement, party agrees that, without
the prior written consent of the other, it
shall neither hire any person who has been under the employment of the other during the term of
this Agreement nor shall it solicit any such person (i) to terminate his
or her
employment with such party or (ii) to become
associated with the other or its affiliates.
The following shall not be
deemed to prohibit a party from hiring an employee of the other as a result of
an unsolicited response by such employee to an open advertisement for
employment.

 

10.           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 7, 8 and 9. In the event of any breach or threatened
breach by CLIENT or PPD, 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 party;
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.

 

11.           Indemnification. CLIENT shall indemnify and save
PPD harmless from any claim, loss, liability, or expense, including
reasonable attorneys’ fees,
which may be incurred by or asserted against
PPD as a result of or arising
from CLIENT’s breach or default of this Agreement, the negligence or
misconduct of CLIENT or its employees, or on account of the CLIENT data. PPD shall indemnify
and save CLIENT harmless from any claim,
loss, liability, or expense, including
reasonable attorneys’ fees, which may be
incurred by or asserted against
CLIENT as a result of or
arising from PPD’s breach or
default of this Agreement or from the negligence or misconduct of PPD 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 injury 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 if such
settlement would impose any monetary obligation an the other party or
require the other party to submit to an
injunction or otherwise limit the other party’s rights under this Agreement.

 

12.           Insurance of PPD.
During the term of this
Agreement, PPD 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 CLIENT, PPD shall provide
CLIENT a certificate evidencing such insurance.
If the insurance is on a “claims made” basis,
if commercially available at a reasonable premium, PPD shall obtain coverage for at least seven (7)
years after termination of this Agreement,

 

13.           Liability: Disclaimers.

 

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

 

8

 

special, indirect, consequential, punitive, or exemplary damages of any nature, including lost profits or
savings.

 

B.            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, any extreme weather, any Act of God, or any Change of Law. “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 subjective
criteria contained in any applicable permit or approval, or other
legislative or administrative action of the United States of America or any
state law agency, department
authority, political subdivision of other
instrumentality of either thereof, or a final 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.

 

14.           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 CLIENT may, without consent, assign its rights and responsibilities
hereunder to any Affiliate of CLIENT or by any corporation, firm, or other business entity with or into
which CLIENT may merge or consolidate or to which CLIENT may sell or transfer all or substantially all of its assets.

 

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

 

16.           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 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.

 

17.           Entire Agreement. This Agreement, including all attachments
and schedules attached hereto, 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.

 

9

 

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

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  Date:

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Printed Name:

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  RELIANT PHARMACEUTICALS, LLC

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  Date:

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Printed Name:

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
   

  
									

 

10

 

ATTACHMENT A

PPD FEE STRUCTURE

 

	
   

  	
   

  	
  01/01/02

  -12/31/02

  	
   

  	
  01/01/03

  -12/31/03

  	
   

  
	
  START-UP
  COSTS (Hourly)

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Start-Up
  Costs Include: SOP Development and Approval and Project-Specific Training
  Development:

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TECHNOLOGY
  COSTS (as Indicated)

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Workstation
  Set-up (per Station  :

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Information
  Systems Support, Database and Report Programming, Videoconferencing and
  Telephone Programming Rate (per hour):

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  After-Hours
  Laptop Hardware Set-Up (per Laptop):

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  RESOURCE
  COSTS (hourly unless otherwise indicated)

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Staff Rate
  for Travel/Training Period or Specified Hourly Services:

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Product
  Safety Specialist

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Senior
  Product Safety Specialist

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Safety
  Physician

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Research
  Assistant/Data Entry

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Management
  Rate

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Safety
  Coordination specialist, Supervisor, Trainer, Quality Assurance Personnel,
  Associate Director, Product Safety Manager

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Medical
  Writer Rate:

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Senior
  Medical Writer:

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Quality
  Assurance Reviewer

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Adverse
  Event Report Management Rate (per Event)

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Non-Serious
  Adverse Event:

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Serious
  Adverse Event (SAE):

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Expedited
  AEs (Serious/Unexpected)

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Annual
  Report for [***] (per Drug):

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Annual
  Report for [***] (per Drug):

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Annual
  Report for [***] (per Drug):

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  PSUR Report
  for New Drug 1** (per Drug)

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  PSUR Report
  for New Drug 2** (per Drug)

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Monthly
  Product Safety/Pharmacovigilance (PSPV) Management Fee:

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Literature
  Searches:

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Write Search
  Strategy (One-time per Chemical Entity)

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Execute
  Monthly Search Strategy (per Chemical Entity)

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Review Citations
  for Reportability (per Hour)

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
  $

  	
   

  	
   

  	
  $

  	
   

  	
   

  
	
  ADDITIONAL
  COSTS (as Indicated)

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Telephone/Pager/Cell
  Phone Charges, Faxing, Outsourced Photocopying, Translation Services, Travel,
  Meals, Copyright Clearance, External Document Retrieval, Supplies, Postage
  and Fulfillment, Off-Site Storage:

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Document
  Storage, Medical Record Retrieval:

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Travel,
  Meals, Copyright Clearance, External Document Supplier:

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Postage and
  Fulfillment:

  	
   

  	
  $

  	
  [***]/ piece

  	
   

  	
  $

  	
  [***]/ piece

  	
   

  
	
  Internal
  Document Procurement (per Document):

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Videoconferencing
  (per Hour):

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  REACTIONS
  Database (per Year):

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  

 

[***]:  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.

 

1

 

ATTACHMENT A

PPD FEE STRUCTURE

Page 2 of 2

 

“Annual report charge is based on a base cost of $[***] per report plus
a surcharge that depends on AE/SAE volume. The surcharge is $[***] if there are no more than [***]
reported events ([***] AE’s and [***] SAE’s) per product during the reporting
interval. Should the volume of AE/SAEs exceed this threshold, additional
charges would be calculated on a prorated basis.

 

**It is recommended that RELIANT request a waiver from FDA to allow
filing of PSURs instead of quarterly reports that are required for New Drugs #1
and #2 for the 3 years following FDA approval. The costs to RELIANT would be substantially
less using the PSUR Format, as is outlined in the example below:

 

EXAMPLE: New
Drug 1 QUARTERLY REPORTS:

•                  $[***] Basic Cost for a periodic
quarterly report = $[***]/yr

•                  $[***] per drug for up to [***] AE’s =
$[***]/yr

•                  total cost per drug for quarterly
reports per year = $[***]/yr

 

New Drug 1
Semiannual PSUR Report:

•                  $[***] Basic Cost for each PSUR
Report = $[***]/yr.

•                  $[***] per drug for up to [***] AE’s
= $[***]/yr

•                  Total cost per drug for [***]
semiannual PSUR reports = $[***]/yr

 

If granted a waiver, RELIANT would not need to submit the quarterly reports
for two years but would instead file a PSUR semiannually for three years. The
waiver also provides that the NDA holder would not be required to submit the
3500A’s for non-serious AE’s; only line listings would be required.

 

The total cost savings to RELIANT if they are granted the waiver for
New Drugs #1 & #2 would be $[***]/year.

 

Last, an important point to remember is that a separate periodic report
is required for each marketed formulation of the
same drug, whereas a PSUR is prepared for each molecular entity, regardless of different
formulations. For multiple drug formulations of the same molecular entity, PSUR
charges will be billed at a higher rate as follows:

 

$[***] Basic
Cast for Each PSUR = $[***]/yr

$[***] for up
to [***] AEs including [***] SAEs = $[***]/yr

 

- NOTE: The following dates are considered as
holidays for the purpose of this Agreement. If requested by CLIENT, in writing
at least 60 working days in advance, PPD will provide services to CLIENT on
these days as mutually agreed at PPD’s Holiday rates.

 

	
  New Year’s Day (observed)

  	
   

  	
  Good Friday

  
	
  Memorial Day

  	
   

  	
  July Fourth (observed)

  
	
  Labor Day

  	
   

  	
  Thanksgiving

  
	
  Day After Thanksgiving

  	
   

  	
  Christmas Day (observed)

  
	
  Day After Christmas or Christmas Eve Day
  (observed)

  	
   

  	
  New Year’s Eve Day

  

 

Should the project operate on weekends,
holiday rates will apply to Easter Sunday and to weekend days on which the
above-observed holidays actually occur.

 

[***]:  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.

 

2

 

AMENDMENT
NO. 1

 

THIS AMENDMENT NO. 1 (“Amendment
No. 1”) 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 Product Safety/Pharmacovigilance Services Agreement
dated February 25, 2003 (“Agreement”) pursuant to which PPD provides certain
medical information services to CLIENT and

 

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

 

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

 

1.                                       The last
sentence of Section 1C(i), Services Provided by PPD, PSPV Services, Non Serious
AEs, shall be deleted in its entirety and replaced with the following two (2)
sentences:

 

“Completed case files and source documents will be
retained for a period of time determined by mutual agreement and in accordance
with applicable laws and regulations. PPD’s validated safety platform will be
implemented during the first quarter of calendar year 2004, after which time
all non-serious AEs shall be processed, archived, and analyzed within this
system.”

 

2.                                       The last
sentence of Section 1C(ii), Services Provided by PPD, PSPV Services, SAEs,
shall be deleted in its entirety and replaced with the following two (2)
sentences:

 

“Completed case files and source documents will be
retained for a period of time determined by mutual agreement and in accordance
with applicable laws and regulations. PPD’s validated safety platform will be
implemented during the first quarter of calendar year 2004, after which time
all SAEs shall be processed, archived, and analyzed within this system.”

 

3.                                       Section 1C(iv),
Services Provided by PPD, PSPV Services, Periodic Scientific Literature
Surveillance, shall be deleted in its entirety and replaced with the following:

 

“(iv) Periodic Scientific Literature Surveillance.
PPD will process all AEs/SAEs identified as a result of regularly scheduled
systematic scientific literature surveillance. Unless otherwise specified by
CLIENT, scientific literature surveillance will be performed using a minimum of
two databases [***] at least [***]. If requested, CLIENT will be provided with
photocopies of scientific literature which cite safety issues, for which CLIENT
will be charged article procurement fees and copyright clearance fees. In
addition, upon CLIENT request, PPD will make provisions for language
translation, and translation fees will be charged for non-English articles as
specified in Attachment A. Should CLIENT not request translation services, PPD
will send

 

[***]:  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.

 

 

photocopies of non-English articles to CLIENT, and
CLIENT will assume full responsibility for their further processing.”

 

4.                                       Section 1C(v)
is revised to include the title “Periodic Safety Reports” and shall be amended
to include the following:

 

“In order to be in full regulatory compliance, PPD
shall utilize a validated safety database for comprehensive management of
adverse events. This system shall comply with 21 CFR Part 11. PPD estimates
that CLIENT will require one dedicated license (user seat) for use by PPD
staff; with payment of additional setup fees, CLIENT may request secured
read-only access to CLIENT safety data from CLIENT premises. Any request for ad
hoc safety database query will be charged at time and materials by IT staff.
Such validated safety database shall be fully operational by March 31,
2004.”

 

5.                                       Section 1D,
Services Provided by PPD, Project Management, shall be deleted in its entirety
and replaced with the following:

 

“D. PSPV Project Management. PPD shall perform PSPV
Project Management support which includes, but is not limited to, oral and
written communication with CLIENT, procedure and protocol development,
procedure and protocol maintenance, report generation, training plan
development, staff training, staff supervision and development, quality
assurance (including review of AE and product complaint reports), consultative
services, meeting preparation and conduction, and communication with other third
parties necessary to business operations. Such services may be provided by
Supervisor(s), Safety Coordination Specialist(s), Product Safety Manager(s),
Quality Assurance Personnel, Trainer(s), Associate Director(s), Director(s),
Executive Director(s), and/or Vice-President(s). A monthly PSPV Project
Management fee shall be invoiced to CLIENT to cover ongoing costs for
performance of the above-listed activities in the provision of safety and
pharmacovigilance services required by regulatory agencies. Fees for the
processing of individual case safety reports (ICSRs) are invoiced on a ‘per
event’ basis according to the fee schedule presented in Attachment A of this
Amendment No. 1.”

 

6.                                       Section 5A of
the Agreement, Payments for Services Rendered by PPD, Resource Costs shall be
deleted in its entirety and replaced with the following:

 

“CLIENT shall compensate PPD for performance of
services rendered by PPD pursuant to this Agreement on a monthly basis. The
invoice will include cases submitted for the preceding month and billable hours
and costs applied to the project according to the rates stated in Attachment A.
When off-site travel is requested by CLIENT, staff time will be billed at rates
shown in Attachment A. The PPD Fee Structure attached to the Agreement as
Attachment A shall be revised by PPD on an annual basis during the term of the
Agreement. On or before October 15th of each year during the term of the
Agreement, PPD shall provide CLIENT with the revised PPD Fee Structure
reflecting PPD’s rates for the upcoming

 

2

 

calendar year, which revised PPD Fee Structure shall
be attached to this Agreement and incorporated by reference herein. Unless
otherwise agreed to by the parties in writing, the new PPD Fee Structure shall
be in effect for the duration of such upcoming calendar year beginning on
January 1st and ending on December 31st.”

 

7.                                       Pursuant to
Paragraph 6 above, the 2004 PPD Fee Structure attached to this Amendment No. 1
shall be effective beginning January 1, 2004 and shall remain in effect until
December 31, 2004.

 

8.                                       In the event of
any inconsistency or conflict of terms between the Agreement and this
Amendment, the terms of this Amendment No. 1 shall control.

 

9.                                       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 No. 1 to be executed as of the date first
above written.

 

	
  RELIANT PHARMACEUTICALS, INC.

  	
   

  	
  ATP, LLC

  
	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
  Name:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
  Title:

  	
   

  	
   

  
												

 

3

 

ATTACHMENT A

2004 PPD FEE STRUCTURE

01/01/2004 - 12/3l/2004

 

	
  TECHNOLOGY COSTS (as indicated)

  	
   

  	
   

  	
   

  
	
  Information Systems Support, Database and
  Report Programming, Videoconferencing and Telephone Programming Rate (per
  hour):

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Bibliographic Database Access (MedLine,
  EMBASE, REACTIONS) (per year):

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Validated Safety Database (first year)
  single seat license, Database validation, and test scripts (invoiced upon
  implementation in Q1 2004):

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  RESOURCE COSTS (hourly unless otherwise
  indicated)

  	
   

  	
   

  	
   

  
	
  Management Rate

  	
   

  	
   

  	
   

  
	
  Supervisor, Trainer, Quality Assurance
  Personnel, Product Safety Specialist:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Associate Director, Product Safety Manager:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Director, Executive Director/Vice
  President:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Periodic Safety Literature Searches*

  	
   

  	
   

  	
   

  
	
  Develop Search Strategy (One Time Fee per
  Chemical Entity):

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Execute Monthly Search Strategy (per
  Chemical Entity):

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Review Abstracted Citations/Retrieved
  Articles for Reportability:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Clinical Communications Medical Writing
  Rates

  	
   

  	
   

  	
   

  
	
  Medical Writer:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Senior Medical Writer:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Editorial & Literature Search
  Coordinator:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Adverse Event Report Management Rate (per
  event)

  	
   

  	
   

  	
   

  
	
  Non-Serious Adverse Event:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Serious Adverse Event (SAE):

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Literature Adverse Event Report :

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Annual NDA Safety Reports

  	
   

  	
   

  	
   

  
	
  Annual Report for [***]**:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Annual Report for [***]**:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Annual Report for [***]**:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Monthly Product Safety/Pharmacovigilance
  (PSPV) Management Fee:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Staff Rate for Travel or Specified Hourly
  Services

  	
   

  	
   

  	
   

  
	
  Product Safety Specialist:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Senior Product Safety Specialist:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Medical Director:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Research Assistant/Data Entry:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ADDITIONAL COSTS (as Indicated)

  	
   

  	
   

  	
   

  
	
  Telephone/Pager/Cell Phone Charges, Faxing,
  Outsourced Photocopying, Translation Services, Travel, Meals, Copyright
  Clearance, External Document Retrieval, Supplies, Postage and Fulfillment,
  Off-Site Storage:

  	
   

  	
  $

  	
  [***] 

  	
   

  
	
  Internal Photocopying:

  	
   

  	
  $

  	
  [***]/copy

  	
   

  
	
  Internal Document Procurement:

  	
   

  	
  $

  	
  [***]/document

  	
   

  

 

*Literature Search service is currently provided for Innopran XL.
Scheduled literature searches for identification of safety issues are charged
per search per month. Review and evaluation of abstracted citations and/or
retrieved articles for reportability are charged at actual time spent. If the
search results in an identifiable AE/SAE, it will be transitioned to PPD Safety
Staff for further processing at regular AE/SAE rates.

 

**Annual report charge is based on a base cost of $[***] per report
plus a surcharge that depends on AE/SAE volume. The surcharge is $[***] if
there are no more than [***] reported events ([***] AEs and [***]SAEs) per
product during the reporting interval. Should the volume of AE/SAEs exceed this
threshold, additional charges would be calculated on a prorated basis.

 

[***]:  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.

 

1

 

AMENDMENT NO. 2

 

THIS
AMENDMENT NO. 2 (“Amendment No. 2”) is made this 30th
day of March, 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 Product Safety/Pharmacovigilance Services
Agreement dated February 25, 2003 (“Agreement”) as amended by Amendment No. 1
dated January 15, 2004 (“Amendment 1”) pursuant to which PPD provides certain
medical information services to CLIENT; and

 

WHEREAS,
the Agreement together with Amendment 1 shall collectively be referred to
herein as the “Agreement”; 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
line item entitled “Annual NDA Safety Reports” on the 2004 PPD Fee Structure
pursuant to Amendment 1 of the Agreement shall be deleted in its entirety and
replaced with the following:

 

	
  “Periodic Safety Reports**

  	
   

  	
   

  	
   

  
	
  Annual NDA Report (per 21 CFR 314.81)***:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Quarterly NDA Report (per 21 CFR
  314.80)***:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Quarterly NDA Report (with 0 AE/SAE
  reports)***:

  	
   

  	
  $

  	
  [***]

  	
   

  
						

 

2.                                       Pursuant
to paragraph 1 above, the Revised 2004 PPD Fee Structure attached to this
Amendment No. 2 as Attachment A shall remain in effect until December 31, 2004.

 

3.                                       Upon
execution, this Amendment 2 shall be made a part of the Agreement and incorporated
by reference herein.

 

4.                                       In
the event of any inconsistency or conflict of terms between the Agreement and
this Amendment, the terms of this Amendment No. 2 shall control.

 

5.                                       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 No. 2 to be executed as of the date first above written.

 

	
  RELIANT PHARMACEUTICALS, INC. 

  	
  ATP, LLC

  
	
   

  	
   

  
	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
  Name:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
  Title:

  	
   

  	
   

  
								

 

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

 

ATTACHMENT A

2004 PPD FEE STRUCTURE

01/01/2004 - 12/3l/2004

 

 

	
  TECHNOLOGY COSTS (as indicated)

  	
   

  	
   

  	
   

  
	
  Information Systems Support, Database and
  Report Programming, Videoconferencing and Telephone Programming Rate (per
  hour):

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Bibliographic Database Access (MedLine,
  EMBASE, REACTIONS) (per year):

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Validated Safety Database (first year)
  single seat license, Database validation, and test scripts (invoiced upon
  implementation in Q1 2004):

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  RESOURCE COSTS (hourly unless otherwise
  indicated)

  	
   

  	
   

  	
   

  
	
  Management Rate

  	
   

  	
   

  	
   

  
	
  Supervisor, Trainer, Quality Assurance
  Personnel, Product Safety Specialist:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Associate Director, Product Safety Manager:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Director, Executive Director/Vice
  President:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Periodic Safety Literature Searches*

  	
   

  	
   

  	
   

  
	
  Develop Search Strategy (One Time Fee per
  Chemical Entity):

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Execute Monthly Search Strategy (per
  Chemical Entity):

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Review Abstracted Citations/Retrieved
  Articles for Reportability:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Clinical Communications Medical Writing
  Rates

  	
   

  	
   

  	
   

  
	
  Medical Writer:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Senior Medical Writer:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Editorial & Literature Search
  Coordinator:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Adverse Event Report Management Rate (per
  event)

  	
   

  	
   

  	
   

  
	
  Non-Serious Adverse Event:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Serious Adverse Event (SAE):

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Literature Adverse Event Report :

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Periodic Safety Reports**

  	
   

  	
   

  	
   

  
	
  Annual NDA Report (per 21 CFR 314.81)***:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Quarterly NDA Report (per 21 CFR
  314.80)***:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Quarterly NDA Report (with 0 AE/SAE
  reports)***:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Monthly Product Safety/Pharmacovigilance
  (PSPV) Management Fee:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Staff Rate for Travel or Specified Hourly
  Services

  	
   

  	
   

  	
   

  
	
  Product Safety Specialist:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Senior Product Safety Specialist:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Medical Director:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Research Assistant/Data Entry:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ADDITIONAL COSTS (as indicated)

  	
   

  	
   

  	
   

  
	
  Telephone/Pager/Cell Phone Charges, Faxing,
  Outsourced Photocopying, Translation Services, Travel, Meals, Copyright
  Clearance, External Document Retrieval, Supplies, Postage and Fulfillment,
  Off-Site Storage:

  	
   

  	
  $

  	
  [***]

  	
   

  
	
  Internal Photocopying:

  	
   

  	
  $

  	
  [***]/copy

  	
   

  
	
  Internal Document Procurement:

  	
   

  	
  $

  	
  [***]/document

  	
   

  

*Literature Search service is currently provided for [***].
Scheduled literature searches for identification of safety issues are charged
per search per month. Review and evaluation of abstracted citations and/or
retrieved articles for reportability are charged at actual time spent. If the
search results in an identifiable AE/SAE, it will be transitioned to PPD Safety
Staff for further processing at regular AE/SAE rates.

**Refer to Appendix for listing of drug products
subject to annual or quarterly NDA periodic reports.

***Annual report charge is based on a base cost of
$[***]per report plus a surcharge that depends on AE/SAE volume. The surcharge
is $[***]if there are no more than [***] reported events ([***] AEs and [***]
SAEs) per product during the reporting interval. Should the volume of AE/SAEs
exceed this threshold, additional charges would be calculated on a prorated
basis.  Routine line listings and summary
tabulations for annual reports are provided upon client request at no
additional charge.

Quarterly report charge is based on a base cost of
$[***]per report plus a surcharge that depends on AE/SAE volume.  The surcharge is $[***] if there are no more
than [***] reported events ([***] AEs and [***] SAEs) per product during the
reporting interval.  Should the volume of
AE/SAEs exceed this threshold, additional charges would be calculated on a
prorated basis.  If there are no reported
events, AE or SAE, then the charge for the quarterly report is $[***].

[***]:  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.

 

 

 

 

APPENDIX

 

Periodic NDA Reporting
Obligations

 

Annual Report

[***]

[***]

[***]

[***]

 

Quarterly Report

[***]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[***]:  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”) 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 Product Safety/Pharmacovigliance Services
Agreement dated February 25, 2003, as amended by Amendment No. 1 dated January
15, 2004 and Amendment No. 2 dated March 30, 2004 (collectively, the
“Agreement”) pursuant to which PPD provides certain medical information
services to CLIENT; 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
last sentence of Section 1C(i) of the Agreement shall be deleted in its
entirety and replaced with the following:

 

“Completed case files and source documents will be
retained for a period of time determined by mutual agreement and in accordance
with applicable laws and regulations. All non-serious AEs shall be processed,
archived, and analyzed through utilization of a validated safety platform.”

 

2.                                    The
last sentence of Section 1C(ii) of the Agreement shall be deleted in its
entirety and replaced with the following:

 

“Completed case files and source documents will be
retained for a period of time determined by mutual agreement and in admittance
with applicable laws and regulations. All SAEs shall be processed, archived,
and analyzed through utilization of a validated safety platform.”

 

3.                                    Section
1C(iv) of the Agreement shall be deleted in its entirety and replaced with the
following:

 

“(iv) Periodic Scientific Literature Surveillance. PPD will process all
AEs/SAEs identified as a result of regularly scheduled systematic scientific
literature surveillance. Unless otherwise specified by CLIENT, scientific
literature surveillance will he performed at least [***] using [***]
bibliographic databases [***]. If requested, CLIENT will be provided with
photocopies of scientific literature which cite safety issues, for which CLIENT
will be charged article processing and/or procurement fees and applicable
copyright clearance fees. In addition, upon CLIENT request, PPD will make
provision for language translation, and translation fees for non-English
articles will be charged on a pass-through basis. Should CLIENT not request
translation service, PPD will send photocopies of non-English articles to
CLIENT and CLIENT will assume full responsibility for their further
processing.”

 

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

 

 

4.             In
Section 1D of the Agreement “Safety Coordination Specialist(s)” shall be
deleted and replaced by “Product Safety Specialist(s)”.

 

5.             Pursuant
to Section 5A of the Agreement, Services Provided by PPD the 2005 PPD Fee
Structure attached to this Amendment No. 3 as Attachment A shall be effective
beginning January 1, 2005 and shall remain in effect until December 31, 2005.

 

6.             In
Section 5C of the Agreement ‘56-2203444’ shall be deleted and replaced by
“22-2734293”.

 

7.             The
Appendix to the Agreement shall be deleted in its entirety and replaced by the
Appendix attached hereto.

 

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

 

9.             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/ Keith
  Rotenberg

  	
   

  	
  By:

  	
  /s/ Lori
  Eberhardt

  	
   

  
	
   

  	
   

  
	
  Name:

  	
  Keith S.
  Rotenberg, Ph.D.

  	
   

  	
  Name:

  	
  Lori
  Eberhardt

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  Sr. VP,
  Research & Development

  	
   

  	
  Title:

  	
  VP,
  Operations

  	
   

  
								

 

ATTACHMENT A

Revised 2005 PPD FEE STRUCTURE

01/01/2005 - 12/31/2005

 

	
  TECHNOLOGY COSTS (as indicated)

  	
   

  	
   

  	
   

  
	
  Information Systems Support, Database and
  Report Programming, Videoconferencing and Telephone Programming Rate (per
  hour):

  	
   

  	
  [***]

  	
   

  
	
  Bibliographic Database Access (MedLine,
  EMBASE, REACTIONS) (per month):

  	
   

  	
  [***]

  	
   

  
	
  Validated Safety Database
  (maintenance/year)

  	
   

  	
  [***]

  	
   

  
	
  RESOURCE COSTS (hourly unless otherwise
  indicated)

  	
   

  	
   

  	
   

  
	
  Management Rate

  	
   

  	
   

  	
   

  
	
  Supervisor, Product Safety Manager,
  Trainer, Quality Assurance:

  	
   

  	
  [***]

  	
   

  
	
  Product Safety Specialist:

  	
   

  	
  [***]

  	
   

  
	
  Associate Director:

  	
   

  	
  [***]

  	
   

  
	
  Director, Executive Director/Vice
  President:

  	
   

  	
  [***]

  	
   

  
	
  Periodic Safety Literature Searches

  	
   

  	
   

  	
   

  
	
  Execute Monthly Search Strategy (per
  Chemical Entity)(per search)

  	
   

  	
  [***]

  	
   

  
	
  Review abstract/title for reportability
  (per abstract)

  	
   

  	
  [***]

  	
   

  
	
  Article Management (per article)

  	
   

  	
  [***]

  	
   

  
	
  Full text article review & analysis
  (per article)

  	
   

  	
  [***]

  	
   

  
	
  Adverse Event Report Management Rate (per
  event)

  	
   

  	
   

  	
   

  
	
  Non-Serious Adverse Event:

  	
   

  	
  [***]

  	
   

  
	
  Serious Adverse Event (SAE):

  	
   

  	
  [***]

  	
   

  
	
  Literature Adverse Event Report:

  	
   

  	
  [***]

  	
   

  
	
  Periodic Safety Reports*

  	
   

  	
   

  	
   

  
	
  Annual NDA Report (per 21CFR 314.81)**

  	
   

  	
  [***]

  	
   

  
	
  Quarterly NDA Report (per 21CFR 314.80)**

  	
   

  	
  [***]

  	
   

  
	
  Quarterly NDA Report (with no AE/SAE
  reports)**

  	
   

  	
  [***]

  	
   

  
	
  Monthly Product Safety/Pharmacovigilance
  (PSPV) Management Fee:

  	
   

  	
  [***]

  	
   

  
	
  Staff Rate for Travel or Specified Hourly
  Services

  	
   

  	
   

  	
   

  
	
  Product Safety Specialist:

  	
   

  	
  [***]

  	
   

  
	
  Senior Product Safety Specialist:

  	
   

  	
  [***]

  	
   

  
	
  PSM:

  	
   

  	
  [***]

  	
   

  
	
  Medical Director:

  	
   

  	
  [***]

  	
   

  
	
  Research Assistant/Data Entry:

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ADDITIONAL COSTS (as indicated)

  	
   

  	
   

  	
   

  
	
  Telephone/Pager/Cell Phone Charges, Faxing,
  Outsourced Photocopying, Translation Services, Travel, Meals, Copyright
  Clearance, External Document Retrieval, Supplies, Postage and Fulfillment,
  Off-Site Storage:

  	
   

  	
  [***]

  	
   

  
	
  Internal Photocopying:

  	
   

  	
  [***]

  	
   

  

 

*Refer to Appendix for listing or drug products subject to annual or
quarterly NDA periodic reports.

 

**Annual
report charge is based on a base cost of $[***] per report plus a surcharge
that depends on AE/SAE volume. The surcharge is $[***] if there are no more
than 100 reported events (80 AEs and 20 SAEs) per product during the reporting
interval. Should the volume of AE/SAEs exceed this threshold, additional
charges would be calculated on a prorated basis.

 

Quarterly report is based on a base cost of $[***] per report plus a
surcharge that depends on AE/SAE volume. The surcharge is $[***] if there are
no more than 50 reported events (40 AEs and 10 SAEs) per product during the
reporting interval. Should the volume of AE/SAEs exceed this threshold,
additional charges would be calculated on a prorated basis. If there are no
reported events, then the charge for the quarterly report is $[***].

 

[***]:  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.

 

1

 

APPENDIX

 

Periodic NDA Reporting Obligations

 

Annual
Reports

 

[***]

[***]

[***]

[***]

[***]

 

Quarterly Reports  

[***]

[***]

 

[***]:                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. 4

 

THIS
AMENDMENT NO. 4 (“Amendment”) is made this 7th
day of November, 2005 (“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 Product Safety/Pharmacovigilance Services
Agreement dated February 25, 2003, as amended by Amendment No. 1 dated January
15, 2004, Amendment No. 2 dated March 30, 2004 and Amendment No. 3 dated
November 29, 2004 (collectively, the “Agreement”) pursuant to which PPD
provides certain medical information services to CLIENT; 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 1C(i):  The
second sentence shall be deleted in its entirety and replaced with the
following:

 

“PPD will send to CLIENT,
via email, a [***] summary report
of all AEs received for that [***], unless otherwise specified by CLIENT.”

 

2.                                       Section 1C(ii):  The
second sentence shall be deleted in its entirety and replaced with the
following:

 

“PPD will notify CLIENT
immediately via telephone or email, but no later than [***], of all SAE reports
received by PSPV. These reports will also be included in the [***] summary report.”

 

3.                                       Attachment A to the Agreement shall be deleted in its
entirety and replaced by the revised Attachment A attached hereto.

 

4.                                       Attachment A to this Amendment shall be effective beginning
January 1, 2006 and shall remain in effect through 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.

 

[***]:  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
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, Pharm D

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  Sr. VP,
  R&D

  	
   

  	
  Title:

  	
  Executive
  Director, Ops.

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Date:

  	
  November 7,
  2005

  	
   

  	
  Date:

  	
  November 10,
  2005

  	
   

  
								

 

 

ATTACHMENT
A

2006 PPD FEE STRUCTURE

 

	
   

  	
   

  	
  01/01/2006 - 

  	
   

  
	
  HOURLY RATES (unless otherwise indicated)

  	
   

  	
  12/31/2006

  	
   

  
	
  PRODUCT SAFETY/PHARMACOVIGILANCE (PSPV)
  RATES

  	
   

  	
   

  	
   

  
	
  Monthly PSPV Management Fee

  	
   

  	
  [***]

  	
   

  
	
  Program Management

  	
   

  	
   

  	
   

  
	
  PSPV Medical Director

  	
   

  	
  [***]

  	
   

  
	
  PSPV Director

  	
   

  	
  [***]

  	
   

  
	
  PSPV Associate Director

  	
   

  	
  [***]

  	
   

  
	
  Product Safety Manager

  	
   

  	
  [***]

  	
   

  
	
  Product Safety Specialist

  	
   

  	
  [***]

  	
   

  
	
  Product Safety Assistant

  	
   

  	
  [***]

  	
   

  
	
  Adverse Event Report Management (per event)

  	
   

  	
   

  	
   

  
	
  Non-Serious Adverse Event

  	
   

  	
  [***]

  	
   

  
	
  Serious Adverse Event

  	
   

  	
  [***]

  	
   

  
	
  Literature Adverse Event Report

  	
   

  	
  [***]

  	
   

  
	
  Periodic Safety Literature Searches

  	
   

  	
   

  	
   

  
	
  Execute Monthly Search Strategy (per
  chemical entity)(per search)

  	
   

  	
  [***]

  	
   

  
	
  Review abstract/title for reportability
  (per abstract)

  	
   

  	
  [***]

  	
   

  
	
  Full text article review & analysis
  (per article)

  	
   

  	
  [***]

  	
   

  
	
  Periodic Safety Reports(1)

  	
   

  	
   

  	
   

  
	
  Annual NDA Report (per 21CFR 314.81)(2)

  	
   

  	
  [***]

  	
   

  
	
  Quarterly NDA Report (per 21CFR 314.80)(2)

  	
   

  	
  [***]

  	
   

  
	
  Quarterly NDA Report (with no AE/SAE
  reports)(2)

  	
   

  	
  [***]

  	
   

  
	
  INFORMATION TECHNOLOGY (IT) RATES

  	
   

  	
   

  	
   

  
	
  Information Systems Support, Database &
  Report Programming, Telephone Programming, and Workstation

  Set-up

  	
   

  	
  [***]

  	
   

  
	
  Bibliographic Database Access -
  MEDLINE, EMBASE, REACTIONS (per month)

  	
   

  	
  [***]

  	
   

  
	
  Validated Safety Database Access (per
  month)

  	
   

  	
  [***]

  	
   

  

 

	
   

  	
   

  	
  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

  	
   

  	
  [***]

  	
   

  
	
  Internal Document Procurement (per
  document)

  	
   

  	
  [***]

  	
   

  
	
  Internal Copying (per page)

  	
   

  	
  [***]

  	
   

  
	
  Videoconferencing (per hour)

  	
   

  	
  [***]

  	
   

  

 

	
  [***]:
  

  	
  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. 

  

 

 

Note 1:  Refer to Appendix for
listing of drug products subject to annual or quarterly NDA periodic reports.

Note 2:  The annual and quarterly
report charges are invoiced on a per report basis. If there are five or fewer
reported events for the reporting Interval, then the charge for the quarterly
report is [***] .

 

PPD invoices on a monthly basis according to the rates shown above.

 

 

	
  [***]:
  

  	
  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. 5

 

THIS
AMENDMENT NO. 5 (“Amendment”) is made this 28th
day of June, 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 Product Safety/Pharmacovigilance Services
Agreement dated February 25, 2003, as amended by Amendment No. 1 dated January
15, 2004, Amendment No. 2 dated March 30, 2004, Amendment No. 3 dated November
29, 2004 and Amendment No. 4 dated November 7, 2005 (collectively, the “Agreement”)
pursuant to which PPD provides certain medical information services to CLIENT;
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.                                       Attachment A to the Agreement shall be deleted in its
entirety and replaced by the revised Attachment A attached hereto.

 

2.                                       The Appendix attached to the Agreement shall be deleted in
its entirety and replaced by the revised Appendix attached hereto.

 

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:

  	
  /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

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Date:

  	
  June 28,
  2006

  	
   

  	
  Date:

  	
  July 13,
  2006

  	
   

  
								

 

 

ATTACHMENT
A

2006
PPD FEE STRUCTURE

 

	
   

  	
   

  	
  01/01/2006 -

  	
   

  
	
  HOURLY RATES (unless otherwise indicated)

  	
   

  	
  12/31/2006

  	
   

  
	
  PRODUCT SAFETY/PHARMACOVIGILANCE (PSPV)
  RATES

  	
   

  	
   

  	
   

  
	
  Monthly PSPV Management Fee

  	
   

  	
  [***]

  	
   

  
	
  Program Management

  	
   

  	
   

  	
   

  
	
  PSPV Medical Director

  	
   

  	
  [***]

  	
   

  
	
  PSPV Director

  	
   

  	
  [***]

  	
   

  
	
  PSPV Associate Director

  	
   

  	
  [***]

  	
   

  
	
  Product Safety Manager

  	
   

  	
  [***]

  	
   

  
	
  Product Safety Specialist

  	
   

  	
  [***]

  	
   

  
	
  Product Safety Assistant

  	
   

  	
  [***]

  	
   

  
	
  Adverse Event Report Management (per event)

  	
   

  	
   

  	
   

  
	
  Non-Serious Adverse Event

  	
   

  	
  [***]

  	
   

  
	
  Serious Adverse Event

  	
   

  	
  [***]

  	
   

  
	
  Literature Adverse Event Report

  	
   

  	
  [***]

  	
   

  
	
  Periodic Safety Literature Searches

  	
   

  	
   

  	
   

  
	
  Execute Monthly Search Strategy (per
  chemical entity)(per search)

  	
   

  	
  [***]

  	
   

  
	
  Review abstract/title for reportability
  (per abstract)

  	
   

  	
  [***]

  	
   

  
	
  Full text article review & analysis
  (per article)

  	
   

  	
  [***]

  	
   

  
	
  Periodic Safety Reports(1)

  	
   

  	
   

  	
   

  
	
  Annual NDA Report (per 21CFR 314.81)(2)

  	
   

  	
  [***]

  	
   

  
	
  Annual NDA Report (per 21CFR 314.80)(2)

  	
   

  	
  [***]

  	
   

  
	
  Quarterly NDA Report (per 21CFR 314.80)(2)

  	
   

  	
  [***]

  	
   

  
	
  Quarterly NDA Report (with no AE/SAE
  reports)(2)

  	
   

  	
  [***]

  	
   

  
	
  INFORMATION TECHNOLOGY (IT) RATES

  	
   

  	
   

  	
   

  
	
  Information Systems Support, Database &
  Report Programming, Telephone Programming, and Workstation Set-up

  	
   

  	
  [***]

  	
   

  
	
  Bibliographic Database Access -
  MEDLINE, EMBASE, REACTIONS (per month)

  	
   

  	
  [***]

  	
   

  
	
  Validated Safety Database Access (per
  month)

  	
   

  	
  [***]

  	
   

  

 

	
   

  	
   

  	
  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

  	
   

  	
  [***]

  	
   

  
	
  Internal Document Procurement (per
  document)

  	
   

  	
  [***]

  	
   

  
	
  Internal Copying (per page)

  	
   

  	
  [***]

  	
   

  
	
  Videoconferencing (per hour)

  	
   

  	
  [***]

  	
   

  

 

Note 1:  Refer to Appendix for
listing of drug products subject to annual or quarterly NDA periodic reports.

Note 2:  The annual and quarterly
report charges are invoiced on a per report basis. If there are five or fewer
reported events for the reporting Interval, then the charge for the quarterly
report is $[***].

 

	
  [***]:
  

  	
  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. 

  

 

 

PPD invoices on a monthly basis according to the rates shown above.

 

 

APPENDIX

 

Annual
Reports

 

[***]

[***]

[***]

[***]

[***]

 

Quarterly
Reports

 

[***]

[***]

[***]

 

	
  [***]: 

  	
  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. 6

 

THIS
AMENDMENT NO. 6 (“Amendment”) is made this 15th
day of December, 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 Product Safety/Pharmacovigilance Services
Agreement dated February 25, 2003, as amended by Amendment No. 1 dated January
15, 2004, Amendment No. 2 dated March 30, 2004, Amendment No. 3 dated November
29, 2004, Amendment No. 4 dated November 7, 2005, and Amendment No. 5 dated
June 28, 2006 (collectively, the “Agreement”) pursuant to which PPD provides
certain post-approval safety services to CLIENT; 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.C(iv) of the Agreement shall be deleted in its entirety and replaced with the
following:

 

“(iv) Periodic Scientific
Literature Surveillance. PPD will process all SAEs identified as a result of
regularly scheduled systematic scientific literature surveillance. Unless
otherwise specified by CLIENT, scientific literature surveillance will be
performed at least[***] using [***] bibliographic databases [***]. If
requested, CLIENT will be provided with photocopies of scientific literature
which cite safety issues, for which CLIENT will be charged article processing
and/or procurement fees and applicable copyright clearance fees. In addition,
upon CLIENT request, PPD will make provision for language translation, and
translation fees for non-English articles will be charged on a pass-through
basis.”

 

2              A
new Section 1.N. shall be added to the Agreement, to read:

 

“N. “MedDRA and WHODrug Dictionary License. The parties
acknowledge that MedDRA and Uppsala Monitoring Centre product licenses are
required by all parties who wish to distribute or receive MedDRA or WHODrug
dictionary terminology. Each party represents and warrants that it possesses a
current MedDRA and/or Uppsala Monitoring Centre product license. In the event
CLIENT requests that PPD perform services which require PPD to distribute
MedDRA terminology or WHODrug dictionary to third parties, CLIENT shall be
responsible for ensuring that all such third parties possess the necessary
MedDRA and/or Uppsala Monitoring Centre product licenses.”

 

[***]:  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.

 

 

3              Section
5.B. of the Agreement shall be deleted in its entirety and replaced with the
following:

 

“CLIENT shall compensate PPD
for Start-up, Technology, Resource Costs, Project Management, and Additional
Costs as set forth in Attachment A. PPD’s Fee Schedule will include a Monthly
IT Support Fee which has been calculated based on program-specific technology
requirements and which covers the scope of services outlined below. Should IT
support outside of this scope be requested, PPD will provide a budget estimate
to cover the required services. Out of scope IT support services will not be
performed unless mutually agreed upon in writing.

 

The Monthly IT Support Fee
includes support and management of the following, based upon CLIENT
program-specific requirements:

 

a.                                       PPD-provided hardware, operating systems and applications

b.                                      PPD shared network resources

c.                                       PPD telephony and call-recording systems

i.                                          Quarterly updates to telephone message scripting and/or
programming

ii.                                       Ten (10) pre-defined holiday script changes per year

 

d.                                      General troubleshooting of client-provided hardware and/or
applications

e.                                       PPD-Company network connectivity

i.                                          Support/Configuration of inter-company VPN over the internet

ii.                                       Support assistance of client-owned or-managed WAN

iii.                                    Administration of PPD firewall for either connection type

 

4              The Appendix attached to the
Agreement shall be deleted in its entirety and replaced by the revised Appendix
attached hereto.

 

5              Attachment A to the Agreement
shall be deleted in its entirety and replaced by the revised Attachment A
attached hereto.

 

6              Attachment A to the Agreement
shall be effective beginning January 1, 2007, and shall remain in effect
through December 31, 2007.

 

7              Capitalized terms used herein and
not otherwise defined herein shall have the meaning ascribed to them in the
Agreement.

 

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

 

9              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/ Vivian
  Broach

  	
   

  
	
   

  	
   

  
	
  Name:

  	
  Steve
  Ketchum, Ph.D.

  	
   

  	
  Name:

  	
  Vivian
  Broach

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  Sr. VP,
  R&D and Medical Affairs

  	
   

  	
  Title:

  	
  Executive
  Director, Operations

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Date:

  	
  December 15,
  2006

  	
   

  	
  Date:

  	
  January 2,
  2007

  	
   

  
								

 

 

APPENDIX

 

	
  Annual
  Reports

  
	
   

  
	
  [***]

  
	
   

  
	
  Quarterly
  Reports

  
	
   

  
	
  [***]

  

 

 

[***]:  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

2007 PPD FEE STRUCTURE

 

	
  PRODUCT SAFETY/PHARMACOVIGILANCE (PSPV) RATES

  	
   

  	
  Unit

  	
   

  	
  2007

  	
   

  
	
  PSPV Management Fee

  	
   

  	
  Per month

  	
   

  	
  [***]

  	
   

  
	
  Program Management

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PSPV Medical Director

  	
   

  	
  Per hour

  	
   

  	
  [***]

  	
   

  
	
  PSPV Director

  	
   

  	
  Per hour

  	
   

  	
  [***]

  	
   

  
	
  PSPV Associate Director

  	
   

  	
  Per hour

  	
   

  	
  [***]

  	
   

  
	
  Product Safety Manager

  	
   

  	
  Per hour

  	
   

  	
  [***]

  	
   

  
	
  Product Safety Specialist

  	
   

  	
  Per hour

  	
   

  	
  [***]

  	
   

  
	
  Product Safety Assistant

  	
   

  	
  Per hour

  	
   

  	
  [***]

  	
   

  
	
  Adverse Event Report Management

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Non-Serious Adverse Event

  	
   

  	
  Per report

  	
   

  	
  [***]

  	
   

  
	
  Serious Event

  	
   

  	
  Per report

  	
   

  	
  [***]

  	
   

  
	
  Literature Adverse Event Report

  	
   

  	
  Per report

  	
   

  	
  [***]

  	
   

  
	
  Periodic Safety Literature Searches

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Execute Monthly Search Strategy (per
  chemical entity)

  	
   

  	
  Per search

  	
   

  	
  [***]

  	
   

  
	
  Review abstract/title for reportability

  	
   

  	
  Per abstract

  	
   

  	
  [***]

  	
   

  
	
  Full text article review & analysis

  	
   

  	
  Per article

  	
   

  	
  [***]

  	
   

  
	
  Periodic Safety Reports(1)

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Annual NDA Report (per 21CFR 314.81)

  	
   

  	
  Per report

  	
   

  	
  [***]

  	
   

  
	
  Annual NDA ADE Report (per 21CFR 314.80)

  	
   

  	
  Per report

  	
   

  	
  [***]

  	
   

  
	
  Quarterly NDA ADE Report (per 21CFR 314.80)

  	
   

  	
  Per report

  	
   

  	
  [***]

  	
   

  
	
  Quarterly NDA ADE Report (per 21CFR 314.80
  with 5 or fewer AE/SAE reports)

  	
   

  	
  Per report

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  IT Support Fee

  	
   

  	
  Per month

  	
   

  	
  [***]

  	
   

  

 

	
  ADDITIONAL COSTS

  	
   

  	
  Unit

  	
   

  	
  2007

  	
   

  
	
  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

  	
   

  	
  As needed

  	
   

  	
  [***]

  	
   

  
	
  Bibliographic Database Access

  	
   

  	
  Per month

  	
   

  	
  [***]

  	
   

  
	
  Validated Safety Database Access

  	
   

  	
  Per month

  	
   

  	
  [***]

  	
   

  
	
  Internal Document Procurement

  	
   

  	
  Per document

  	
   

  	
  [***]

  	
   

  

 

Note 1:  Refer to Appendix for listing of drug
products subject to annual or quarterly NDA periodic reports.

 

[***]:  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.

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