Document:

EXHIBIT 10.43

 

MASTER SERVICES AGREEMENT

 

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

 

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

 

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

 

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

 

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

 

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

 

1.            Project
Addenda.

 

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

 

2.            Services.

 

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

 

 

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

 

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

 

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

 

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

 

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

 

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

 

3.            Compensation
and Payment.

 

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

 

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

 

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

 

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

 

3.4           Payments to PPD shall be made to:

 

PPD Development, LLC

P.O. Box 75468

Charlotte, NC 28275-5468

Tax ID# 74-2325267

 

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

 

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

 

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

 

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4.            Term
and Termination.

 

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

 

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

 

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

 

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

 

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

 

5.            Personnel.

 

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

 

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

 

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

 

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

 

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

 

6.            Confidentiality.

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

Confidentiality Disclosure
Agreement Text

 

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

 

be processed
fairly and lawfully

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

be adequate,
relevant and not excessive

be accurate
and, where necessary, kept up to date

not be kept
for longer than is necessary

be processed
in accordance with the rights of Data Subjects

be protected
by appropriate security measures

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

 

PROPOSAL AND
CONTRACT TEXT

 

Data Privacy

 

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

 

•      Patient data

•      Investigator data

 

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

 

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

 

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

 

The eight “principles”
require that data is:

 

•      Fairly and lawfully
processed

•      Processed for limited
purposes

•      Adequate, relevant and not
excessive

•      Accurate

•      Not kept any longer than
necessary

•      Processed in accordance with
the data subject’s rights

•      Secure

•      Not transferred to countries
without adequate protection

 

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

 

7.            Intellectual
Property.

 

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

 

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

 

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

 

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

 

8.            Publication.

 

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

 

9.            Indemnification.

 

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

 

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

 

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

 

10.          Insurance

 

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

 

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11.          Independent
Contractor Relationship.

 

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

 

12.          Publicity.

 

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

 

13.          Force
Majeure.

 

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

 

14.          Record
Storage.

 

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

 

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

 

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

 

15.          Regulatory
Compliance.

 

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

 

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

 

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

 

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

 

16.          Notices.

 

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

 

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If to PPD:                               PPD Development, LLC

31511 7th Street Extension

Wilmington, North Carolina 28412

Attention: CEO

Tel: (910)251-0081

Fax: (910) 762-5820

 

If to Sponsor:                        Reliant
Pharmaceutical, LLC

110 Allen Road

Liberty Corner, NJ 07938

Attn: Joseph Krivulka, President

Tel: (908) 542-4008

Fax: (980) 542-9406

 

Copy to:                                 Reliant
Pharmaceutical, LLC

110 Allen Road

Liberty Corner, NJ 07938

Attn: Michael Lerner, VP and, General Counsel

Tel: (908) 542-4008

Fax: (980) 542-9406

 

17.          Severance.

 

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

 

18.          Waiver.

 

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

 

19.          Changes
and Modification.

 

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

 

20.          Assignment.

 

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

 

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21.          No
Conflicts

 

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

 

22.          Survival

 

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

 

23.          Entire
Agreement.

 

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

 

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

 

	
  PPD
  Development, LLC

  	
  Reliant

  
	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
  Name:

  	
   

  	
   

  
	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
  Title:

  	
   

  	
   

  
	
   

  	
   

  
	
  Date:

  	
   

  	
   

  	
  Date:

  	
   

  	
   

  
											

 

12

 

AMENDMENT

 

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

 

WITNESSETH:

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

	
  Reliant
  Pharmaceuticals, LLC

  	
  PPD
  Development, LP

  
	
   

  	
   

  
	
   

  	
  By:

  	
  PPD GP, LLC

  
	
   

  	
   

  	
  Its General
  Partner

  
	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
  Name:

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
  Title:

  	
   

  	
   

  
	
  Date:

  	
   

  	
   

  	
  Date:

  	
   

  	
   

  
												

 

13

 

EXHIBIT A

 

General Consulting

 

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

 

	
  Title

  	
   

  	
  2002
  Hourly Rate

  
	
  Vice President, Regulatory and Scientific Affairs

  	
   

  	
  $

  	
  323

  
	
  Director, Regulatory Affairs (CMC, Preclinical expertise)

  	
   

  	
  $

  	
  229

  
	
  Regulatory Affairs Manager

  	
   

  	
  $

  	
  160

  
	
  Regulatory Specialist

  	
   

  	
  $

  	
  130

  
	
  Medical Writer

  	
   

  	
  $

  	
  120

  
	
  Manager Medical Writing

  	
   

  	
  $

  	
  160

  
	
  Senior Medical Writer

  	
   

  	
  $

  	
  148

  
	
  Director, Biostatistics

  	
   

  	
  $

  	
  229

  
	
  Senior Biostatistician

  	
   

  	
  $

  	
  160

  
	
  Vice President, Pharmacokinetic Services

  	
   

  	
  $

  	
  323

  

 

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

 

14

AMENDMENT NO. 1

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

	
  RELIANT
  PHARMACEUTICALS, INC.

  	
  PPD
  DEVELOPMENT, LP

  
	
   

  	
  By:  PPD GP, LLC

  Its:  General Partner

  
	
   

  	
   

  
	
   

  	
   

  
	
  By:

  	
  /s/ Steve
  Ketchum

  	
   

  	
  By:

  	
  /s/ Paul
  Covington

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
  Steve
  Ketchum, Ph.D.

  	
   

  	
  Name:

  	
  Paul S.
  Covington, MD

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  Sr. VP,
  R&D and Medical Affairs

  	
   

  	
  Title:

  	
  Executive Vice President of Development

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Date:

  	
  August 1,
  2006

  	
   

  	
  Date:

  	
  July 17,
  2006EXHIBIT 10.44

 

RELIANT PHARMACEUTICALS, INC -ATP, LLC

SERVICES AGREEMENT

 

This
AGREEMENT, effective this 12th day of February, 2001 by and between RELIANT
Pharmaceuticals, Inc., a Delaware limited liability company formed in Delaware,
having a place of business at 721 Route 202/206 South, Bridgewater, New Jersey
08807 (hereinafter referred to as “RELIANT”), and ATP, LLC, d/b/a PPD ATP, a
North Carolina limited liability company (hereinafter referred to as “ATP”).

 

WITNESS ETH:

 

WHEREAS,
RELIANT maintains toll-free number(s) through which health care professionals,
persons using RELIANT products, and other third parties may request general information
concerning RELIANT or information concerning particular RELIANT products or particular
disease conditions and effects; and

 

WHEREAS, ATP
provides a national telephone service staffed by pharmacists, nurses, customer
assistance specialists and other health care professionals available to answer inquiries
of the type received by RELIANT through its toll-free number(s); and

 

WHEREAS,
RELIANT desires to hire ATP to establish a dedicated phone line to answer
inquiries and respond to requests for information concerning specific RELIANT
products from health care professionals, persons using RELIANT products, and
other third parties who call with such requests in accordance with the terms
and conditions hereinafter set forth.

 

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.

 

A.                                   General
Services Calls received through RELIANT’s existing 1-800 number(s),
(877-926-0060), (“RELIANT toll-free number(s)”) will be directed to ATP for
handling and response in accordance with mutually agreed upon standard operating
procedures as established for this Agreement Access to the RELIANT toll-free
number(s) by ATP will be used exclusively by ATP to provide services to RELIANT
The ATP access system will include queuing and voice mail features that will
enable ATP to handle calls RELIANT will review and approve the telephone system
scripting prior to implementation by ATP According to the shall conform to all
applicable local, state and federal laws, rules, and regulations The objective
and project assumptions of the parties, as well as the performance standards
for performing the services hereunder, are more particularly set forth in Attachment
A.

 

B.                                     Staff
Responses The Staff shall respond to such questions received through the
RELIANT toll-free numbers as may be reasonably answered by the Staff using only
documents supplied or approved in writing by RELIANT to ATP, including product
package inserts, medical information letters, and other background information
and data supplied in writing from time to time by RELIANT to ATP 

 

 

(“RELIANT Data”)
The Staff shall respond to inquiries received through the RELIANT toll-free
number(s) in accordance with specifications, guidance, or directions for
response provided in writing by RELIANT to ATP If the consumers have any
inquiries about information not included in the documents that RELIANT has
provided or approved for ATP, ATP shall direct such inquiries to the consumer’s
healthcare provider All Staff responses must be presented in a non-promotional
and well-balanced manner Staff responses may include the following areas to the
extent that information that is specific to and responsive to the question(s)
asked is contained in the RELIANT Data:

 

(i)                                   A discussion of the
name and description of the product;

 

(ii)                                The dosage form, doses,
route of administration, duration of the drug therapy, and lot number of
product in question (if applicable),

 

(iii)                             Special directions and
precautions for administration, and use of a product by the health care
professional and/or consumer,

 

(iv)                            Common or severe side or
adverse effects or drug /food interactions and therapeutic contraindications,
consistent with the package insert, that may be encountered in the use of a
RELIANT product, including their avoidance and the action required if they
occur;

 

(v)                               Techniques for
self-monitoring the drug therapy;

 

(vi)                            Proper storage of a
product;

 

When the Staff
receives question(s) from consumers, only the package insert or other
references as approved by RELIANT will be used to provide answers. At no time
will the Staff provide therapy recommendations to consumers.

 

ATP and its
Staff shall not be responsible for the accuracy or adequacy of the RELIANT Data
as per agreed upon standard operating protocol ATP shall perform in accordance
and compliance with applicable drug or pharmaceutical labeling, applicable laws
and regulations, RELIANT’s instruction, and applicable standards of
professional medical care.

 

C.                                     Adverse
Event and Product Complaint Management In the event the questions raised in
a call handled by the Staff involve a potential adverse drug event (“ADE”), the
Staff shall follow RELIANT-approved written procedures Following receipt of the
ADE information, RELIANT will assume responsibility for any follow up with the
caller and for any reporting obligation to the regulatory agencies and/or other
third parties in relation to the ADE For purposes of this Agreement, it is
assumed that ATP will perform initial capture of adverse events and/or product
complaints and will forward them to Reliant via facsimile within one [***].

 

[***]:                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

 

Collectively,
the above services will hereinafter be referred to as the “Telephone Support
Services.”

 

D.                                    Quality
Assurance ATP shall maintain quality assurance processes in accordance with
mutually agreed upon procedures Such processes include, but are not limited to,
continual monitoring and supervision by the project Operations Supervisor and
random review of outgoing fulfillment materials and taped conversations, remote
call monitoring, “shadow monitoring,” review of digital recordings,
documentation review, referral review and fulfillment review An additional
component of quality assurance is the continual updating of information as
provided to ATP by RELIANT in accordance with established procedures 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 this project.

 

Adverse events
and product complaint reports will be consistently reviewed by an Operations
Supervisor prior to submission to RELIANT Time expended in performing the
review will be billed according to Attachment B ATP shall administer the PPD
ATP Performance Report Card (PRC) to RELIANT at pre- determined intervals
throughout the term of the project, as follows:

 

(i)                                   Start-Up Performance
Report, completed after initial [***], measure ATP’s effectiveness in
implementing the project.

 

(ii)                                [***] Performance
Report, conducted [***] later and regularly repeated, measures ATP’s ongoing
effectiveness in managing and maintaining the project.

 

E.                                      Staff
The parties agree that the staffing level of up to [***] full time equivalent
(FTE) pharmacist(s) be established to perform the services hereunder. For
purposes of this Agreement, one (1) FTE represents [***] ([***]) hours per week
At mutually agreed times of coverage, the Staff of ATP shall be provided to
answer the RELIANT toll-free number(s) ATP shall be solely and fully responsible
for complying with the laws and regulations applicable to the services of ATP
for RELIANT hereunder RELIANT and ATP may also modify hours of coverage and
staffing levels upon mutual agreement, in writing After the project starts and
ATP better understands the call volume dynamics (volume, length, peak hours,
completion rates, etc.), appropriate adjustments to staffing and scope of work
can be made upon approval by Reliant.

 

F.                                      Hours
of Coverage During the term of this Agreement, ATP shall provide the
General Services to RELIANT Monday through Friday between the hours of 7:00 AM
and 7:00 PM, MT All times are Mountain Time, whichever the case may

 

[***]:                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

 

be RELIANT and
ATP may also modify hours of coverage and staffing levels upon mutual
agreement, in writing.

 

G.                                     Answering
the Lines As the Staff are available to answer an incoming call, he or she
will answer the call substantially as follows: “RELIANT Medical Information
Line (or a similar greeting as mutually agreed to by the parties) I am a pharmacist/nurse
and my name is (consultant name)” If the Staff are answering another telephone
call, each incoming telephone call on the RELIANT lines will be held in a
queue, and the Staff will answer the telephone call in the order the telephone
calls were received The caller will be informed that the call may be monitored
for quality assurance purposes Until ATP can answer the telephone call, if
desired by RELIANT, a taped message will be played ATP will establish voice mail
capability to capture inbound calls while the Staff are answering another telephone
call and to capture information during after hours The Staff will access voice
mail as needed, but not less than hourly, during dedicated hours of coverage as
stated above and will manage information accordingly and in a reasonable time frame
for the nature of the inquiry.

 

H.                                    Records
Kept by ATP Information gathered shall include that which RELIANT
reasonably requests or ATP deems important ATP shall maintain either written or
computerized records in accordance with established procedures Upon termination
of this Agreement by either party, all retained records shall be returned to
each party, upon request by the other, except for one copy, which may be kept
for archival purposes Audiotape records of the calls will be retained for a
period of thirty (30) days according to ATP corporate procedures In compliance
with applicable laws and Reliant’s document retention policy, Reliant shall
accept and retain original records shipped by ATP to Reliant for retention.

 

I.                                         Reports
ATP shall forward a written report of the previous month’s activity to the
appropriate contacts at RELIANT within [***] after the end of that month These
reports may include, but are not limited to, the following:

 

(i)                                   the total number of [***]

(ii)                               [***] rates

(iii)                            nature of the inquiry and
caller type

(iv)                            number of adverse events
reported, and

(v)                               other information deemed
as reportable and mutually agreed upon, in writing, by ATP and RELIANT.

 

Upon request
from RELIANT, ATP will modify the content of the standard reports and will
invoice RELIANT according to the standard hourly rates under Attachment B of
this Agreement.

 

J.                                        Fulfillment
If needed, ATP may send (U.S. Mail, facsimile, and/or FEDEX) appropriate
literature to health care professionals, persons using RELIANT products, and
other third parties only as per agreed upon written protocol and within a
reasonable time after receipt of request While ATP expects to respond to most

 

[***]:                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

 

inquiries
within [***] of receipt of a request, for purposes of this Section and
fulfilling the terms of this Agreement, a reasonable time shall be not more
than [***] unless this time shall be extended by inadequate supply of
literature as provided by RELIANT or by other written approval of RELIANT.

 

K.                                    Project
Management ATP shall perform Project Management support which includes, but
is not limited to, oral and written communication with RELIANT, procedure and
protocol development, procedure and protocol maintenance, report generation,
staff training, staff supervision and development, training plan development,
quality assurance to include review of ADE and product complaint reports,
consultative services, meeting preparation and conduction, and communication
with other third parties necessary to business operations These services are
provided by Supervisor(s), Quality Assurance Personnel, Trainer(s), Associate
Director(s), Director(s), and/or Vice President(s) and will be charged on an
hourly rate basis according to Attachment B.

 

L.                                      Call
Tracking Application ATP shall build a customized call tracking application
for the purposes of performing the Telephone Support Services ATP will invoice
RELIANT for the actual hours dedicated building such application Should
application modifications be required, ATP will attain written approval from
RELIANT prior to making such modifications.

 

M.                                 Conformance
with Standards ATP shall devote its reasonable best efforts to perform its
duties hereunder ATP shall provide the services in accordance with the
standards and practices that are generally accepted in the industry and
exercised by other persons engaged in performing similar services ATP shall comply
with all federal and state laws, rules and regulations relating to the Services
to be performed hereunder, and shall ensure that all employees and agents
assigned to perform services hereunder are made aware of the obligations contained
in this Agreement and are bound by such obligations.

 

N.                                    Regulatory
Inquiries ATP agrees to inform RELIANT promptly of any regulatory action
taken against ATP, and to provide a copy of any written correspondence received
from a regulatory agency, that may affect ATP’s work hereunder ATP agrees to
notify RELIANT of any request received from any applicable regulatory or other
governmental agency to inspect or otherwise gain access to the information,
data or materials pertaining to the services performed by ATP under this
Agreement and the Exhibit(s) ATP shall notify RELIANT of such requests prior to
permitting any third-party access and RELIANT and ATP shall jointly agree on a
course of action in accordance with applicable law ATP agrees to permit
inspection on reasonable notice to RELIANT of such information, data and
materials by authorized representatives of such agencies as required by law ATP
shall provide RELIANT with copies of such notice(s), related correspondence and
any regulatory inspection reports and permit RELIANT representatives to attend
such visits.

 

[***]:                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

 

O.                                    No
Debarred Individuals or Entities ATP represents and warrants for itself and
its agents, that ATP has never been and is not currently, and is not using, and
shall not use, in any capacity, in connection with any of the Services performed
by ATP or its agents hereunder, the services of.

 

(i)                                  an individual who has
been debarred by the FDA pursuant to 21 U.S.C. § 335a (a) or (b) (a “Debarred
Individual”) from providing services in any capacity to a person that has an
approved or pending drug product application, or an employer, employee or
partner of a Debarred Individual; or

 

(ii)                               a corporation,
partnership, or association that has been debarred by the FDA pursuant to 21
U.S.C. § 335a (a) or (b) (a “Debarred Entity”) from submitting or assisting in
the submission of an abbreviated new drug application, or an employee, partner,
shareholder, member, subsidiary or affiliate or a Debarred Entity.

 

P.                                      No
Knowledge of Inaccuracies ATP further represents and warrants that ATP has
no knowledge of any circumstances which may affect the accuracy of the
representations and warranties set forth in the previous paragraph ATP shall notify
RELIANT promptly upon becoming aware of any such circumstances during the term
of this Agreement.

 

Q.                                    No
Conflicts ATP represents and warrants that this undertaking, including each
Project accepted by ATP, does not conflict with its duties and obligations
under any other agreement to which it is a party, including any agreement with
any other contractor or institution or any policies applicable to them.

 

2.                                      Obligations
of RELIANT.

 

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

 

B.                                     Inform
ATP of Any Unusual Circumstances If a situation is anticipated that may
create an unusually high volume of calls through the RELIANT toll-free numbers
(e.g. adverse press, product launch, product recall, etc.), RELIANT shall
notify ATP of such situation prior to the occurrence, if possible, and shall provide
ATP with any up-to-date information for ATP to give its most accurate response
to inquiries.

 

C.            Training
of ATP Employees All staff will complete a comprehensive ATP General
Training Program, which includes the following components:

Basics of Telephone and Computer Use

Phone Pro Customer Service Skills

PPD ATP Qualifying Statements

Fundamentals of Product Safety

DIA Core Curriculum for Medical Information Professionals

Staff will receive additional Project-Specific Training which includes:

Comprehensive Product Information

Clinical/Disease Background

Reliant Protocols, Processes and Procedures

Reliant may provide designated resources deemed appropriate

For incorporation into Project-Specific Training

ATP will collaborate with RELIANT in the development and implementation
of Project-Specific Training.

ATP Training team will collaborate with the Operations team to devise
comprehensive training programs, which include provisions for:

Course Syllabi

Course Curricula

Individual Training Plans

Reviews of Learning Points

Coursework Documentation Processes

RELIANT, at RELIANT’s sole expense, shall provide personnel and/or
training materials to ATP’s facilities necessary to familiarize ATP employees
with RELIANT’s products or other information required to provide the services
hereunder additional training will be conducted as needed and as mutually
agreed upon in writing by RELIANT and ATP. In cases of Staff turnover, ATP
shall be responsible for the costs associated with the first eighty (80) hours
of Staff training. Thereafter, ATP will invoice RELIANT according to the rates
outlined in Attachment B.

 

 

6

 

D.                                    Provision
of Information RELIANT shall be responsible for providing ATP with accurate
and up-to-date RELIANT Data as described in Section 1.B above.

 

E.                                      Designated
Representative RELIANT shall designate a representative from time to time
who is authorized to identify and request Services from ATP The initial RELIANT
representative is Neil Manowitz, Ph.D For the operation of the information
response service, RELIANT shall obtain a toll-free telephone number and arrange
for calls to be forwarded to ATP’s telephone response center.

 

3.                                       Term of Agreement The term of this Agreement shall commence
upon Effective Date of this Agreement and shall exist and continue until
December 31, 2001 Thereafter, this Agreement shall be automatically renewable
for successive two- year periods, under the terms and conditions herein, as
amended from time to time upon mutual agreement by both parties, except that
upon renewal of the contract, the parties shall review and make any mutually
agreed upon adjustments to the Hourly

 

7

 

Fee Schedule
in Attachment B ATP and RELIANT will negotiate in good faith and use their best
efforts to reach such mutual agreement by December 1, of each year the contract
is in force.

 

4.                                      Termination
This Agreement may be terminated as follows:

 

A.                                   By
RELIANT or ATP without cause upon one hundred twenty (120) days written notice
to the other party Under this notice of termination, the term of the Agreement
shall be one hundred twenty (120) days from the date of receipt of the written
notice by the non-terminating party.

 

B.                                     By
RELIANT or ATP 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
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 (i) cure that default within
the thirty-day period; or (ii) present the non-defaulting party a reasonable
plan to cure such default and thereafter comply with such plan as determined by
the non-defaulting party.

 

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 8, 9, 10, 11, 12, and 14 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 ATP.

 

A.                                   Staffing
Fee RELIANT shall compensate ATP for performance of services rendered by
ATP pursuant to this Agreement on a time of staff hourly rate basis, with that
hourly rate, based on the number of hours spent in one-fourth (1⁄4) hour
increments. The time of staff hourly rate schedule for the periods January 1,
2000, through December 31, 2001, is set forth in Attachment B and incorporated
herein by reference Terms used in Attachment B shall have the following
meanings: “Crisis” shall mean any circumstance that results or is anticipated
to cause a significant increase in call volume These circumstances include, but
are not limited to press releases, drug recall, drug tampering, professional
journal articles, and major announcements at national healthcare related
meetings In the case of a Crisis, staff will be added only upon approval from
RELIANT. “Holiday” shall mean those days

 

8

 

identified as
ATP holidays in Attachment B, that ATP provides services to RELIANT.

 

The fees
associated with Project Management as described in Section 1.K, shall be
invoiced according to the rates defined in Attachment B.

 

B.                                     Additional
Costs RELIANT shall reimburse ATP for all out-of-pocket expenses incurred
by ATP in performing the services hereunder plus a 5% administration fee. As
set forth in Attachment B, these costs include telephone usage, faxing, postage,
literature searches, and outsourced photocopying The administrative charge
covers the cost associated with the required accounting processes. Out-of-pocket
expenses not listed above must be pre-approved by RELIANT. Travel expenses,
including coach airfare, will be invoiced at cost Meals associated with
meetings as requested by RELIANT will be invoiced at cost. Customized software,
computer programming, and telephone programming will be billed according to the
rate set forth in Attachment B ATP will notify RELIANT of any unforeseen added
expenses for customized software, computer programming and will initiate such
services only with prior approval from RELIANT.

 

C.                                     Billing
and Payment ATP shall submit monthly invoices to RELIANT setting forth
staffing fees and additional costs Payment shall be due within thirty (30) days
of receipt of the invoice. Records of ATP relating to amounts invoiced may be
audited by RELIANT representatives upon receipt of reasonable notice from RELIANT
during the term of this Agreement or within four (4) years thereafter.

 

6.                                      Circumstances beyond the Control of ATP. Certain members of
the Staff of ATP will be state licensed health care professionals and/or will
be health care professionals in the process of being licensed in a particular
state. Any state may maintain that some state- specific 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 other than North Carolina
requires licensing of the ATP employees in that state, RELIANT will not offer
the services to be provided by ATP in Section 1A and lB in that state, and at
the option of either party, this Agreement may terminate as stated under
Section 4A, 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.

 

7.                                       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.

 

9

 

8.                                       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 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 9 of this agreement Any data or information generated
by ATP as a result of inquiries received through the RELIANT or any patients or
numbers, documents and information supplied to ATP by RELIANT or patients or
healthcare professionals purchasing, using the 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 and subject to the limitations and restrictions
of Section 9 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.

 

9.                                      Confidential Information RELIANT and ATP hereby acknowledge
that their businesses involve the development of valuable and confidential
business information “RELIANT Confidential Information” shall mean any
information treated by RELIANT as confidential, including without limitation
all RELIANT Data, including, but not limited to, product package inserts,
protocols, training, materials and any reports or compilation of data,
inquiries or responses prepared by ATP in performing the services hereunder for
RELIANT, 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 on a national basis 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 other than carrying out
the terms of this Agreement 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 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 purposed and extent of

 

10

 

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 notice of the other party, unless such
disclosure is required by Law.

 

10.                                Noninterference
with Employees Each party acknowledged 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 (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.

 

11.                                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 8, 9, and 10 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 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.

 

12.                                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.

 

13.                                 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

 

11

 

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.

 

14.                               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 saving.

 

B.                                     Force
Majuere 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 the following: any delay of carriers, supplies, or telecommunication providers;
extreme weather or 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 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 final decree, judgment, 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.

 

15.                                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.

 

16.                                Governing
Law This Agreement shall be construed and governed under the laws of
the State of New Jersey.

 

17.                                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.

 

18.                                Access RELIANT
shall have the right, but not the obligation, to independently visit ATP or any
site where the services are performed to review performance of services herein In
the event RELIANT intends to undertake such visits, RELIANT shall provide reasonable
notification to ATP, and ATP shall provide assistance and cooperation.

 

12

 

19.                                Construction
of Agreement The descriptive headings of the sections of this Agreement
are for convenience only and shall not affect the meaning or construction of
any of the provisions of this Agreement To the extent any provision of this
Agreement or the application thereof is found by a proper authority to be
invalid or unenforceable, it shall be considered deleted herefrom, and the
remainder of this Agreement shall continue in full force and effect.

 

20.                                Notices Any
notices, requests or other communications given under this Agreement shall be
in writing and shall be given by personal delivery, or sent by (a) facsimile
transmission (with message confirmed during normal business hours); (b) first
class mail, postage prepaid; or (c) Federal Express (or equivalent nationally
recognized overnight delivery service), delivery charges prepaid All notices
shall be given to a party at its respective address set forth below, or at such
other address as such party from time to time may specify by notice in
accordance with this Section 20 A notice shall be deemed given when actually
received; provided, that if any facsimile notice is received after 5:00 P.M.
local time at the place of receipt, it shall be deemed to have been given as of
the next following business day.

 

RELIANT:

 

Reliant
Pharmaceuticals, LLC

721 Route
202-206 South

Attn: Michael
J Lemer, Vice President

and General
Counsel

 

ATP:

PPD ATP

2655 Meridian
Parkway

Durham, North
Carolina 27713

Attn: Lori
Eberhardt, Vice President

 

21.                               Signatories This
Agreement may be executed in counterparts, each of which, when executed and
delivered, shall be deemed to be an original, and all of which, when joined,
shall together constitute one and the same agreement Any photocopy or facsimile
of this Agreement, or of any counterpart, shall be deemed the equivalent of an original.

 

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

 

23.                               Waiver. Waiver
by either party or the failure by either party to claim a breach of any
provision of this Agreement (including the Exhibit(s)) shall not be deemed to
constitute a waiver or estoppel with respect to any subsequent breach of any
provision hereof.

 

24.                               Entire
Agreement This Agreement with all attachments constitutes the entire
Agreement among the parties pertaining to the subject matter contained herein
and

 

13

 

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.

 

14

 

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.

 

	
  RELIANT
  PHARMACEUTICALS, INC.

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  Date:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Printed
  Name:

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ATP, LLC

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  By: 

  	
   

  	
   

  	
  Date:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Printed
  Name:

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
   

  	
   

  	
   

  
										

 

15

 

ATTACHMENT A

 

Objective and Project Assumptions and Performance Standards

 

1.                                       Objective
and Project Assumptions.

 

The primary
objective is to provide a centralized call unit to manage inquiries from consumers,
health care professionals, and sales representatives regarding RELIANT’s
products, which initially will include Axid®.

 

The monthly
call volume for Axid® is estimated to be two hundred (200) calls per month for
the first three (3) months and then one hundred (100) calls per month for
months 4-12.

 

ATP estimates
that the call length, including documentation, for a “standard” information request
is seven to ten (7-10) minutes per call.

 

ATP estimates
that the call length, including documentation, for adverse events and/or product
complaints are twenty to forty (20-40) minutes per call RELIANT estimates ATP
will manage approximately twenty-five (25) serious adverse events per month.

 

ATP will
coordinate fulfillment (U.S. Mail, FedEx, Fax) of medically-legally approved letters
and literature as needed.

 

Approximately fifty
to seventy-five percent (50-75%) of all inbound inquiries are followed with a
written response and/or package insert.

 

ATP will
collaborate with RELIANT in developing a process for responding to inquiries received
via e-mail.

 

RELIANT will
provide ATP with electronic copies of the standard medical letters as well as
hard copy of the current package inserts.

 

ATP provides
extensive Medical Letter writing services. Should RELIANT be interested, ATP
will provide RELIANT with a proposal to update and revise existing medical letters.

 

RELIANT will
provide ATP with letterhead, envelopes, and literature needed for fulfillment
purposes.

 

1

 

2.                                       Metric
Expectations.

 

Introduction:
Performance metrics are primarily a function of the staffing model selected RELIANT
has contracted ATP to provide [***] of coverage each day with one pharmacist
available during each hour Performance reports will be provided to RELIANT on a
monthly basis After ATP better understands the inquiry request volume,
recommendations may be made to increase efficiencies and performance metrics if
so required.

 

Crisis
conditions (media campaigns, press release, product withdrawal, etc.) may
produce spikes in inquiry volume During such unexpected conditions, all
attempts will be made to meet performance metrics although this may not be
possible and is dependent upon staffing level In order to better serve our
clients, ATP requests advance notice of such events, if possible, so that we may
provide additional qualified staff to assist during temporary crisis
conditions.

 

ATP will
proactively evaluate the below mentioned performance metrics on a monthly basis
and will recommend to RELIANT project modifications (adjust staff level, change
hours of operation, modify processes, etc.) in order to meet the below
performance metrics.

 

1.      Abandonment
Rate: ATP’s goal is to maintain an average abandonment rate of between [***],
however our experience shows that on projects with one consultant on the line
at any given time, abandonment rates range between [***]. This is attributed to
the one consultant being unavailable to answer a call while taking another
call.

2.      Average
Speed of Answer (ASA): ATP’s corporate goal is that [***] of all calls will
be answered within [***], however with one consultant on the line at a time, we
expect the following to apply:

[***] of calls will be answered within [***]. [***] of calls will be
answered within [***]. [***] of calls will be answered within [***].

If the RELIANT pharmacists is already on a call at the time when
additional calls(s) are received these subsequent callers will queue for [***]
and then be given an option to leave a voice mail message or continue to hold
Voice mail messages are considered completed (vs. abandoned) calls.

3.      FTE
Workload Each ATP health care professional is estimated to take between inquires
[***] per day depending on volume of AEs, length of the inquiry, and number of
fulfillment requests. This is based on an average of [***] per inquiry with
[***] per AE inquiry.

4.      Adverse
Event Turnaround Time: All Adverse Events and Product Complaints will be
documented and faxed to RELIANT and Innovator company within [***].

5.      Fulfillment
Turnaround Time: ATP anticipates that all standard inquiry requests for
fulfillment will be processed within [***] unless delayed by the unavailability
of fulfillment materials or supplies normally supplied by the client or due to
an extraordinarily high volume of fulfillment requests.

6.      Custom
Requests Turnaround Time: Requests for information for which no standard
response exists (e.g., off-label inquiries), hereby called Custom Requests,
will be processed as soon as possible Turnaround time on such requests may be
dependent upon information from RELIANT and/or Innovator companies Verbal
responses to such requests will be provided as soon as information is made
available to ATP Written responses to such request may or may not be fulfilled
dependent upon RELIANT and/or Innovator Company policy Written responses to custom
requests can take an undeterminable length of time due to research,
composition, and approval processes.

7.      Sales
Representative Fulfillment Requests: Sales representative’s requests will
be processed according to above specifications Those requests requiring
clarification from or follow-up with either the sales representative or initial
doctor requestor will be processed promptly Turnaround timelines may be
dependent upon the availability of either the sales representative or the
physician.

 

[***]:                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

 

ATTACHMENT B

Rate Schedule and Budget Estimate

Page 1 of 3 

	
  Hourly Dedicated Pharmacist Staffing Rate:

  	
   

  	
   

  	
   

  
	
  7 AM - 7 PM Weekdays

  	
   

  	
  $

  	
  72.00

  	
   

  
	
  7 PM - 7 AM Weekdays & Weekends

  	
   

  	
  $

  	
  76.50

  	
   

  
	
  Crisis

  	
   

  	
  $

  	
  89.50

  	
   

  
	
  Holidays

  	
   

  	
  $

  	
  106.00

  	
   

  
	
  Hourly Dedicated Customer Assistance
  Specialist Staffing Rate:

  	
   

  	
   

  	
   

  
	
  7 AM - 7 PM Weekdays

  	
   

  	
  $

  	
  53.00

  	
   

  
	
  7 PM -7 AM Weekdays & Weekends

  	
   

  	
  $

  	
  56.25

  	
   

  
	
  Crisis

  	
   

  	
  $

  	
  66.25

  	
   

  
	
  Holidays

  	
   

  	
  $

  	
  79.50

  	
   

  
	
  Hourly Information Systems Support,
  Database Programming, and Telephone Programming Rate:

  	
   

  	
  $

  	
  132.50

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Hourly Videoconferencing Rate:

  	
   

  	
  $

  	
  132.50

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Telephone Usage, Literature searches,
  Outsourced copying:

  	
   

  	
  $

  	
  Cost + 5

  	
  %

  
	
   

  	
   

  	
   

  	
   

  
	
  Travel

  	
   

  	
  $

  	
  Cost

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Fulfillment (In-house) :

  	
   

  	
  $

  	
  Cost + $.50/piece

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Hourly Operations Supervisor, Trainer,

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Quality Assurance Coordinator Rate:

  	
   

  	
  $

  	
  95.50

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Hourly Associate Director Rate:

  	
   

  	
  $

  	
  132.50

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Hourly Director/Executive Director/VP Rate:

  	
   

  	
  $

  	
  159.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Computer workstation Set-Up

  	
   

  	
  $

  	
  500.00/station

  	
   

  

 

Note:

•      Hourly rates are applied to the time zone
which the services are performed. For purposes of this Agreement, services will
be performed in the Denver, CO facility and times listed above are in Mountain
Time.

•      Hours of operation may be modified as
approved by the parties.

 

1

 

ATTACHMENT B

(Hourly Rate Schedule and Budget Estimate)

Page 2 of 3

* The
following dates are considered as holidays for the purpose of this Agreement If
requested, Consultant will provide services to RELIANT on these days at the
rates listed above.

	
  Year 2000

  	
   

  	
   

  
	
  New Year’s Day

  	
   

  	
  Thanksgiving

  
	
  Good Friday

  	
   

  	
  Day-After Thanksgiving

  
	
  Memorial Day

  	
   

  	
  Christmas Day

  
	
  July Fourth (observed)

  	
   

  	
  Day After Christmas

  
	
  Labor Day

  	
   

  	
  December 31 (New Year’s Eve
  Day)

  
	
   

  	
   

  	
   

  
	
  Year 2001

  	
   

  	
   

  
	
  New Year’s Day

  	
   

  	
  Thanksgiving

  
	
  Good Friday

  	
   

  	
  Day-After Thanksgiving

  
	
  Memorial Day

  	
   

  	
  Christmas Eve Day

  
	
  July Fourth (observed)

  	
   

  	
  Christmas Day

  
	
  Labor Day

  	
   

  	
  December 31 (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.

 

2

 

ATTACHMENT B

Rate Schedule and Budge Estimate

Page 3 of 3

	
  Service

  	
   

  	
  Unit

  	
   

  	
  Price/Unit

  	
   

  	
  No of Units

  	
   

  	
  Total Est Cost

  	
   

  
	
  START-UP COSTS

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Protocol/SOP Development and Approvals

  	
   

  	
  hours

  	
   

  	
  $

  	
  95.50

  	
   

  	
  30

  	
   

  	
  $

  	
  2,865.00

  	
   

  
	
  Training Development

  	
   

  	
  hours

  	
   

  	
  $

  	
  95.50

  	
   

  	
  30

  	
   

  	
  $

  	
  2,865.00

  	
   

  
	
  Project Implementation Meetings

  	
   

  	
  hours

  	
   

  	
  $

  	
  95.50-132.50

  	
   

  	
  50

  	
   

  	
  $

  	
  4,775.00

  	
   

  
	
  TECHNOLOGY

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Computer Workstations, Telephone Hardware
  Set-up

  	
   

  	
  per station

  	
   

  	
  $

  	
  500.00

  	
   

  	
  1

  	
   

  	
  $

  	
  500.00

  	
   

  
	
  Telecom Set-up

  	
   

  	
  hours

  	
   

  	
  $

  	
  132.50

  	
   

  	
  4

  	
   

  	
  $

  	
  530.00

  	
   

  
	
  Voice Mail Set-up

  	
   

  	
  hours

  	
   

  	
  $

  	
  132.50

  	
   

  	
  2

  	
   

  	
  $

  	
  267.00

  	
   

  
	
  Information Resources (MicroMedex, F&C,
  etc.)

  	
   

  	
  Included

  	
   

  	
  $

  	
  0.00

  	
   

  	
  0

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Line/WAN Installation

  	
   

  	
  per line

  	
   

  	
  $

  	
  Cost

  	
   

  	
  as needed

  	
   

  	
  $

  	
  Cost

  	
   

  
	
  MS Access Call Tracking Application

  	
   

  	
  hours

  	
   

  	
  $

  	
  132.50

  	
   

  	
  30

  	
   

  	
  $

  	
  3,975.00

  	
   

  
	
  MS Access Application Test

  	
   

  	
  hours

  	
   

  	
   

  	
   

  	
  8

  	
   

  	
  $ 1,060.00

  	
   

  
	
  RESOURCE COSTS

  	
   

  	
  hours

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Pharmacist (HCP) Staff: Based on 1.5 FTE

  	
   

  	
  hours

  	
   

  	
   

  	
   

  	
  monthly

  	
   

  	
  monthly

  	
   

  
	
  Regular (7:00 A.M - 7:00 P.M., MT,
  Weekdays)

  	
   

  	
  hours

  	
   

  	
  $

  	
  72.00

  	
   

  	
  217

  	
   

  	
  $

  	
  15,624.00

  	
   

  
	
  After-hours Regular (7:00 A.M - 7:00 P.M.,
  MT, Weekdays & Weekends)

  	
   

  	
  hours

  	
   

  	
  $

  	
  76.50

  	
   

  	
  43

  	
   

  	
  $

  	
  3,289.00

  	
   

  
	
  Crisis

  	
   

  	
  hours

  	
   

  	
  $

  	
  89.50

  	
   

  	
  0

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Holiday

  	
   

  	
  hours

  	
   

  	
  $

  	
  106.00

  	
   

  	
  0

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Project Management:

  	
   

  	
  hours

  	
   

  	
  $

  	
  95.50

  	
   

  	
  as needed

  	
   

  	
  $

  	
  TBD

  	
   

  
	
  IT Support (ongoing)

  	
   

  	
  hours

  	
   

  	
  $

  	
  132.50

  	
   

  	
  as needed

  	
   

  	
  $

  	
  TBD

  	
   

  
	
  ADDITIONAL COSTS

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Phone Usage and Faxing

  	
   

  	
  per minute

  	
   

  	
  $

  	
  Cost +5

  	
  %

  	
  as needed

  	
   

  	
  $

  	
  TBD

  	
   

  
	
  Literature Search

  	
   

  	
  per search

  	
   

  	
  $

  	
  Cost +5

  	
  %

  	
  as needed

  	
   

  	
  $

  	
  TBD

  	
   

  
	
  Travel

  	
   

  	
  per trip

  	
   

  	
  $

  	
  Cost

  	
   

  	
  as needed

  	
   

  	
  $

  	
  TBD

  	
   

  
	
  Outsourced Copying

  	
   

  	
  per order

  	
   

  	
  $

  	
  Cost +5

  	
  %

  	
  as needed

  	
   

  	
  $

  	
  TBD

  	
   

  
	
  Business Related Entertainment (i.e Meals)

  	
   

  	
  per event

  	
   

  	
  $

  	
  Cost

  	
   

  	
  as needed

  	
   

  	
  $

  	
  TBD

  	
   

  
	
  Videoconferencing

  	
   

  	
  hours

  	
   

  	
  $

  	
  132.50

  	
   

  	
  as needed

  	
   

  	
  $

  	
  TBD

  	
   

  
	
  Fulfillment

  	
   

  	
  per unit

  	
   

  	
  $

  	
  Cost + $.50/piece

  	
   

  	
  as needed

  	
   

  	
  $

  	
  TBD

  	
   

  

 

 

3

 

 

AMENDMENT NO. 1

TO AN AGREEMENT BY AND BETWEEN

RELIANT PHARMACEUTICALS, LLC

AND PPD MEDICAL COMMUNICATIONS

DATED FEBRUARY 12, 2001

 

THIS AMENDMENT
is made as of December 31, 2001, by and between RELIANT PHARMACEUTICALS, LLC (“CLIENT”)
and ATP, LLC d/b/a PPD Medical Communications, successor in interest to ATP,
Inc. (“PPD”).

 

WHEREAS,
CLIENT and PPD entered into that certain services agreement dated February 12,
2001 pursuant to which PPD provides CLIENT with a communications service
staffed by health care professionals to answer inquiries relating to CLIENT’s
products (the “Agreement”); and

 

WHEREAS,
CLIENT and PPD wish to further 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:

 

1.                                       Section
3 of the Agreement is deleted in its entirety and replaced with the following
new Section 3:

 

“3.           Term
of the Agreement. The term of this Agreement shall commence upon Effective
Date of this Agreement and shall exist and continue until February 28, 2003.  Thereafter, this Agreement shall be
automatically renewable for successive one-year periods under the terms and
conditions herein, as amended from time to time upon mutual agreement by both
parties, unless a party provides the other party notice of its intention not to
renew sixty (60) days prior to the expiration of the term, except that upon
renewal of the Agreement each year, the parties shall review and make
adjustments to the hourly fee schedule in Attachment B.”

 

2.                                       Section
5A of the Agreement is amended by adding the following language as a new third
paragraph:

 

“Upon renewal of this Agreement as provided
in Section 3, on or before February 1 of each year for the term of this
Agreement, the staff hourly rate will be agreed to by the parties in the form
of a replacement Attachment B to be signed by CLIENT and PPD.  Should the replacement Attachment B not be
executed before January 15, PPD’s standard Fee Structure for the following
March 1 through December 31 shall apply, pending the execution and
implementation of the replacement Attachment B.”

 

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, LLC

  	
   

  	
  ATP, LLC

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
   

  	
  Name:

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
   

  	
  Title:

  	
   

  	
   

  
											

 

 

ATTACHMENT B

PPD FEE STRUCTURE

Page 1 of 2

 

	
   

  	
   

  	
  01/01/02

  -2/28/03

  	
   

  
	
  START-UP
  COSTS (One-Time)

  	
   

  	
   

  	
   

  
	
  Start-Up
  Costs Include: Protocol/SOP Development and Approval, Training Development,
  and Project Implementation, including Associated Meetings:

  	
   

  	
  $

  	
  x,xxx.xx

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  TECHNOLOGY
  COSTS (as Indicated)

  	
   

  	
   

  	
   

  
	
  Workstation
  Set-up (per Station):

  	
   

  	
  $

  	
  500.00

  	
   

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

  	
   

  	
  $

  	
  135.00

  	
   

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

  	
   

  	
  $

  	
  1,800.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  RESOURCE
  COSTS (Hourly)

  	
   

  	
   

  	
   

  
	
  Health Care
  Professional Staffing Rate:

  	
   

  	
   

  	
   

  
	
  7 AM - 7 PM
  Weekdays*

  	
   

  	
  $

  	
  74.00

  	
   

  
	
  7 PM - 7 AM
  Weekdays & Weekends*

  	
   

  	
  $

  	
  78.00

  	
   

  
	
  Crisis

  	
   

  	
  $

  	
  91.50

  	
   

  
	
  Holidays**

  	
   

  	
  $

  	
  112.25

  	
   

  
	
  Nurse
  Staffing Rate:

  	
   

  	
   

  	
   

  
	
  7 AM - 7 PM
  Weekdays*

  	
   

  	
  $

  	
  64.00

  	
   

  
	
  7 PM - 7 AM
  Weekdays & Weekends*

  	
   

  	
  $

  	
  67.00

  	
   

  
	
  Crisis

  	
   

  	
  $

  	
  76.00

  	
   

  
	
  Holidays**

  	
   

  	
  $

  	
  92.00

  	
   

  
	
  Customer
  Assistance Specialist Staffing Rate:

  	
   

  	
   

  	
   

  
	
  7 AM - 7 PM
  Weekdays*

  	
   

  	
  $

  	
  50.00

  	
   

  
	
  7 PM - 7 AM
  Weekdays & Weekends*

  	
   

  	
  $

  	
  53.00

  	
   

  
	
  Crisis

  	
   

  	
  $

  	
  58.00

  	
   

  
	
  Holidays**

  	
   

  	
  $

  	
  68.00

  	
   

  
	
  Other
  Coverage Rate:

  	
   

  	
   

  	
   

  
	
  Pager

  	
   

  	
  $

  	
  9.50

  	
   

  
	
  Management
  Rate:

  	
   

  	
   

  	
   

  
	
  Supervisor,
  Trainer, Quality Assurance Personnel

  	
   

  	
  $

  	
  95.00

  	
   

  
	
  Associate
  Director

  	
   

  	
  $

  	
  135.00

  	
   

  
	
  Director/Executive
  Director/Vice-President

  	
   

  	
  $

  	
  159.00

  	
   

  
	
  Medical
  Writing Rate:         

  	
   

  	
   

  	
   

  
	
  Medical
  Letter Writer

  	
   

  	
  $

  	
  90.00

  	
   

  
	
  Senior
  Medical Letter Writer

  	
   

  	
  $

  	
  100.00

  	
   

  
	
  Editorial
  & Literature Search Coordinator

  	
   

  	
  $

  	
  80.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ADDITIONAL
  COSTS (as Indicated)

  	
   

  	
   

  	
   

  
	
  Telephone/Pager/Cell
  Phone Charges, Faxing, Literature Searches, Outsourced Copying, Bibliographic
  Database Access:

  	
   

  	
  $

  	
  Cost+5

  	
  %

  
	
  Travel,
  Meals, Copyright Clearance, External Document Retrieval:

  	
   

  	
  $

  	
  Cost

  	
   

  
	
  Postage and
  Fulfillment

  	
   

  	
  Cost+$.50/piece

  	
   

  

 

*All times are Mountain Time.

 

 

1

 

** 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 the listed Holidays 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.

 

2

 

AMENDMENT NO. 2

TO AN AGREEMENT BY AND BETWEEN

RELIANT PHARMACEUTICALS, LLC AND ATP, LLC 

DATED FEBRUARY 12, 2001 AND AMENDMENT NO. 1 

DATED DECEMBER 31, 2001

 

THIS AMENDMENT
is made as of this 14th day of April, 2003 (“Effective Date”), by and between Reliant
Pharmaceuticals, LLC (“RELIANT”) and ATP, LLC d/b/a PPD Medical Communications
(“PPD”).

 

WHEREAS,
RELIANT and PPD entered into that certain Services Agreement (“Agreement”) dated
February 12, 2001, as amended December 31, 2001, pursuant to which PPD provides
RELIANT a dedicated phone line to answer inquiries and respond to requests for
information concerning specific RELIANT products from healthcare professionals,
persons using RELIANT products and other third parties who call with such
requests (the “Agreement”);

 

WHEREAS,
RELIANT and PPD wish to further 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.              Attachment B, PPD Fee Structure

 

Revisions:

 

I.              Attachment
B, PPD Fee Structure.

 

Attachment B (PPD Fee Structure)
is hereby deleted and replaced in entirety with revised Attachment B (PPD Fee
Structure) for 03/01/03-12/31/03, attached hereto and incorporated herein by
reference.

 

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, LLC

  	
   

  	
  ATP, LLC

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
   

  	
  Name:

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
   

  	
  Title:

  	
   

  	
   

  
											

 

 

ATTACHMENT B

PPD FEE STRUCTURE

Page 1 of 2

 

	
   

  	
   

  	
  03/01/03

  -12/31/03

  	
   

  
	
  START-UP
  COSTS (One-Time)

  	
   

  	
   

  	
   

  
	
  Start-Up
  Costs Include: Protocol/SOP Development and Approval, Training Development,
  and Project Implementation, including Associated Meetings:

  	
   

  	
  $

  	
  N/A

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  TECHNOLOGY
  COSTS (as Indicated)

  	
   

  	
   

  	
   

  
	
  Workstation
  Set-up (per Station):

  	
   

  	
  $

  	
  750.00

  	
   

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

  	
   

  	
  $

  	
  144.50

  	
   

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

  	
   

  	
  $

  	
  1,926.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  RESOURCE
  COSTS (Hourly)

  	
   

  	
   

  	
   

  
	
  Pharmacist
  Staffing Rate:

  	
   

  	
   

  	
   

  
	
  7 AM - 7 PM
  Weekdays*

  	
   

  	
  $

  	
  79.25

  	
   

  
	
  7 PM - 7 AM
  Weekdays & Weekends*

  	
   

  	
  $

  	
  83.50

  	
   

  
	
  Crisis

  	
   

  	
  $

  	
  98.00

  	
   

  
	
  Holidays**

  	
   

  	
  $

  	
  120.00

  	
   

  
	
  Nurse
  Staffing Rate:

  	
   

  	
   

  	
   

  
	
  7 AM - 7 PM
  Weekdays*

  	
   

  	
  $

  	
  68.50

  	
   

  
	
  7 PM - 7 AM
  Weekdays & Weekends*

  	
   

  	
  $

  	
  71.75

  	
   

  
	
  Crisis

  	
   

  	
  $

  	
  81.25

  	
   

  
	
  Holidays**

  	
   

  	
  $

  	
  98.50

  	
   

  
	
  Customer
  Assistance Specialist Staffing Rate:

  	
   

  	
   

  	
   

  
	
  7 AM - 7 PM
  Weekdays*

  	
   

  	
  $

  	
  53.50

  	
   

  
	
  7 PM - 7 AM
  Weekdays & Weekends*

  	
   

  	
  $

  	
  56.75

  	
   

  
	
  Crisis

  	
   

  	
  $

  	
  62.00

  	
   

  
	
  Holidays**

  	
   

  	
  $

  	
  72.75

  	
   

  
	
  Other
  Coverage Rate:

  	
   

  	
   

  	
   

  
	
  Pager

  	
   

  	
  $

  	
  10.25

  	
   

  
	
  Management
  Rate:

  	
   

  	
   

  	
   

  
	
  Supervisor,
  Trainer, Quality Assurance Personnel

  	
   

  	
  $

  	
  101.75

  	
   

  
	
  Associate
  Director

  	
   

  	
  $

  	
  144.50

  	
   

  
	
  Director/Executive
  Director/Vice-President

  	
   

  	
  $

  	
  170.25

  	
   

  
	
  Medical
  Writing Rate:

  	
   

  	
   

  	
   

  
	
  Medical
  Letter Writer

  	
   

  	
  $

  	
  96.25

  	
   

  
	
  Senior
  Medical Letter Writer

  	
   

  	
  $

  	
  107.00

  	
   

  
	
  Editorial
  & Literature Search Coordinator

  	
   

  	
  $

  	
  85.50

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ADDITIONAL
  COSTS (as Indicated)

  	
   

  	
   

  	
   

  
	
  Telephone/Pager/Cell
  Phone Charges, Faxing, Literature Searches, Outsourced Copying, Bibliographic
  Database Access:

  	
   

  	
  $

  	
  Cost+5

  	
  %

  
	
  Travel,
  Meals, Copyright Clearance, External Document Retrieval:

  	
   

  	
  $

  	
  Cost

  	
   

  
	
  Postage and
  Fulfillment

  	
   

  	
  Cost+$.50/piece

  	
   

  

 

*All times are Mountain Time.

 

 

1

 

 

** 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 the listed Holidays 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.

 

2

 

AMENDMENT NO. 3

 

THIS
AMENDMENT NO. 3 (“Amendment No. 3) is made this 19th day of January, 2004 (“Effective
Date”), by and between Reliant Pharmaceuticals, Inc. (“CLIENT”) and ATP, LLC
d/b/a PPD Medical communications (“PPD”).

 

WHEREAS,
CLIENT and PPD entered into a certain Services Agreement dated February 12,
2001 as amended by Amendment No. 1 dated December 31,2001 and Amendment No. 2
dated April 14, 2003, (collectively, “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.               All references to “ATP” contained in the
body of the Agreement shall be amended to read “PPD .”

 

2.               The first sentence of Section 1 F,
Services Provided by PPD, Hours of Coverage, shall be deleted in its entirety and replaced with the
following sentence: “During the term of this Agreement, PPD shall provide the
General Services to CLIENT Monday through Friday between the hours of 7:00 AM and 3:00 PM, MT.”

 

3.               Section 3 of the Agreement, Term of
Agreement, shall be deleted in its entirety and replaced with the following as
of February 28, 2003:

 

“3. Term of Agreement.
The term of this Agreement shall commence upon Effective Date of this Agreement
and shall continue unless terminated in accordance with Section 4 below.”

 

4.               The last paragraph of Section 4,
Termination, shall be deleted in its entirety and replaced with the following
paragraph:

 

“Upon termination both parties shall be
relieved of any further obligations hereunder except those set for the Sections
8, 9, 10, 11, 12, 14, 17,20, 24 and 25. Termination shall not affect the rights
or obligations of either party accrued as of such termination.”

 

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

 

“A. Staffing Fee. CLIENT shall compensate PPD
for performance of services rendered by PPD pursuant to this Agreement on a
time of staff hourly rate basis, with that hourly rate based on the number of
hours spent in one-fourth (1/4) hour increments. The PPD Fee Structure attached
to the Agreement as Attachment B 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 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 1’ and ending on
December 31”. Terms used in Attachment 5 shall have the following meanings: “Crisis”
shall mean any circumstance that results or is anticipated to cause a
significant increase in call volume. These circumstances include, but are not
limited to press releases, drug recall, drug tampering, professional journal
articles, and major announcements at national healthcare related meetings. In
the case of a Crisis, staff will be added only upon approval from CLIENT. “Holiday”
shall mean those days identified as PPD holiday in Attachment B that PPD
provides services to CLIENT.”

 

6.               Pursuant to  Paragraph 5
above, the 2004 PPD Fee Structure attached to this Amendment as Attachment B
shall be effective beginning January 1, 2004 and shall remain in effect until
December 31,2004.

 

7.               Section 5C  of the
Agreement, Payments for Services Rendered by PPD, Billing and Payment, shall be
amended to include the following sentence:

 

“PPD’s federal tax identification number is
22-2734293.”

 

8.               The Agreement is amended to reflect a
new Section 25, Use of Copyrighted Materials, and shall read as follows:

 

“25. Use of Copyrighted Material. If, in
connection with a Project, CLIENT requests PPD to make and/or distribute copies
of copyrighted materials such as journal articles or excerpts from
publications, CLIENT agrees to pay the cost of
any copyright fees incurred by PPD that are necessary for PPD to
produce and distribute such copies. CLIENT shall indemnify PPD for any and all
damages, losses, and costs, including, without limitation, reasonable attorneys’
fees, which PPD incurs as a result of making and/or distributing copyrighted
material pursuant to CLIENT’S request.”

 

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

 

10.         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. 3 to  be executed as of the date first above written.

 

	
  Reliant
  Pharmaceuticals, Inc.

  	
   

  	
  ATP, LLC

  
	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
  Name:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
  Title:

  	
   

  	
   

  
										

 

2

 

ATTACHMENT
B

2004 PPD FEE STRUCTURE

Page 1 of 2

 

	
   

  	
   

  	
  01-01-04-

  12-31-04

  	
   

  
	
  TECHNOLOGY COSTS (as Indicated)

  	
   

  	
  $

  	
  795.00

  	
   

  
	
  Workstation Set-up (per Station):

  	
   

  	
   

  	
   

  
	
  Information Systems Support, Database and
  Report

  	
   

  	
   

  	
   

  
	
  Programming, Videoconference, and Telephone

  	
   

  	
   

  	
   

  
	
  Programming Rate (per Hour):

  	
   

  	
  $

  	
  144.50

  	
   

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

  	
   

  	
  $

  	
  2,041.50

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  RESOURCE COSTS (Hourly)

  	
   

  	
   

  	
   

  
	
  Pharmacist Staffing Rate:

  	
   

  	
   

  	
   

  
	
  7 AM - 7 PM Weekdays*

  	
   

  	
  $

  	
  86.50

  	
   

  
	
  7 PM - 7 AM Weekdays & Weekends*

  	
   

  	
  $

  	
  91.25

  	
   

  
	
  Crisis

  	
   

  	
  $

  	
  107.00

  	
   

  
	
  Holidays**

  	
   

  	
  $

  	
  131.00

  	
   

  
	
  Nurse Staffing Rate:

  	
   

  	
   

  	
   

  
	
  7 AM - 7 PM Weekdays*

  	
   

  	
  $

  	
  73.50

  	
   

  
	
  7 PM - 7 AM Weekdays & Weekends”

  	
   

  	
  $

  	
  77.00

  	
   

  
	
  Crisis

  	
   

  	
  $

  	
  87.00

  	
   

  
	
  Holidays**

  	
   

  	
  $

  	
  105.50

  	
   

  
	
  Customer Assistance Specialist Staffing
  Rate:

  	
   

  	
   

  	
   

  
	
  7 AM - 7 PM Weekdays*

  	
   

  	
  $

  	
  57.25

  	
   

  
	
  7 PM - 7 AM Weekdays & Weekends*

  	
   

  	
  $

  	
  60.75

  	
   

  
	
  Crisis

  	
   

  	
  $

  	
  66.50

  	
   

  
	
  Holidays**

  	
   

  	
  $

  	
  78.00

  	
   

  
	
  Other Coverage Rate:

  	
   

  	
   

  	
   

  
	
  Pager

  	
   

  	
  $

  	
  11.75

  	
   

  
	
  Management Rate:

  	
   

  	
   

  	
   

  
	
  Supervisor, Trainer, Quality Assurance
  Personnel

  	
   

  	
  $

  	
  109.00

  	
   

  
	
  Associate Director

  	
   

  	
  $

  	
  154.75

  	
   

  
	
  Director/Executive Director/Vice-President

  	
   

  	
  $

  	
  182.25

  	
   

  
	
  Medical Writing Rate:

  	
   

  	
   

  	
   

  
	
  Medical Letter Writer

  	
   

  	
  $

  	
  103.00

  	
   

  
	
  Senior Letter Writer

  	
   

  	
  $

  	
  114.50

  	
   

  
	
  Editorial & Literature Search Coordinator

  	
   

  	
  $

  	
  91.50

  	
   

  
	
  ADDITIONAL COSTS (as Indicated)

  	
   

  	
   

  	
   

  
	
  Telephone/Pager/Cell Phone Charges, Faxing,
  Literature Searches, Outsourced Copying, Bibliographic Database Access,
  Travel, Meals, Copyright Clearance, External Document Retrieval, Postage and
  Fulfillment, Off-Site Storage

  	
   

  	
  $

  	
  cost

  	
   

  
	
  Internal Document Retrieval

  	
   

  	
  $

  	
  16.00/document

  	
   

  
	
  Internal Photocopying

  	
   

  	
  $

  	
  0.08/page

  	
   

  
						

* All
times are Mountain Time.

 

 

3

 

Page 2 of 2

** 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 the listed
Holidays rates.

 

New Year’s Day
(observed)

Good Friday

Memorial Day

duly Fourth
(observed)

Labor Day

Thanksgiving

Day After
Thanksgiving

Christmas Day
(observed)

Day After
Christmas or Christmas Eve Day (observed)

 

 

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.

 

4

AMENDMENT NO. 4

 

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

 

WHEREAS, CLIENT and PPD entered into a certain
Services Agreement dated February 12, 2001, and amended by Amendment No. 1
dated December 31, 2001, Amendment No. 2 dated April 14, 2003 and Amendment No.
3 dated January 19, 2004 (collectively, the “Agreement”) pursuant to which PPD
provides CLIENT 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.                                       In
the preamble of the Agreement, “721 Route 202/206 South, Bridgewater, New
Jersey 08807” shall be deleted in its entirety and replace with “110 Allen
Road, Liberty Corner, New Jersey 07938”.

 

2.                                       Pursuant
to Section 5A of the Agreement, the 2005 PPD Fee Structure attached to this
Amendment No. 4 as Attachment B shall replace the existing Attachment B to the
Agreement and shall be effective beginning January 1, 2005 and shall remain in
effect until December 31, 2005.

 

3.                                       The
first sentence of Section 5B of the Agreement shall be deleted in its entirety
and replaced by the following:

 

“RELIANT shall
reimburse PPD for all out of pocket expenses incurred by PPD in performing the
services hereunder.”

 

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.

 

 

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 S. Rotenberg

  	
   

  	
  By:

  	
  /s/ Lori Eberhardt

  
	
   

  	
   

  	
   

  
	
  Name:

  	
  Keith S. Rotenberg, Ph.D.

  	
   

  	
  Name:

  	
  Lori Eberhardt

  
	
   

  	
   

  	
   

  
	
  Title:

  	
  Sr. VP, Research & Development

  	
   

  	
  Title:

  	
  VP, Operations

  
									

 

 

ATTACHMENT A

2005 PPD FEE STRUCTURE

Page 1 of 2

	
   

  	
   

  	
  01/01/05 –

  12/31/05

  	
   

  
	
  TECHNOLOGY COSTS (as indicated)

  	
   

  	
   

  	
   

  
	
  Workstation Set-up (per Station)

  	
   

  	
  $

  	
  795.00

  	
   

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

  	
   

  	
  $

  	
  144.50

  	
   

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

  	
   

  	
  $

  	
  2,041.50

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  RESOURCE COSTS (Hourly)

  	
   

  	
   

  	
   

  
	
  Pharmacist Staffing Rate

  	
   

  	
   

  	
   

  
	
  9 AM – 9 PM Weekdays*

  	
   

  	
  $

  	
  98.00

  	
   

  
	
  9 PM – 9 AM Weekdays & Weekends*

  	
   

  	
  $

  	
  98.00

  	
   

  
	
  Crisis & Holidays**

  	
   

  	
  $

  	
  125.00

  	
   

  
	
  Nurse Staffing Rate

  	
   

  	
   

  	
   

  
	
  9 AM – 9 PM Weekdays*

  	
   

  	
  $

  	
  80.00

  	
   

  
	
  9 PM – 9 AM Weekdays & Weekends*

  	
   

  	
  $

  	
  80.00

  	
   

  
	
  Crisis & Holidays**

  	
   

  	
  $

  	
  99.00

  	
   

  
	
  Customer Assistance Specialist Staffing
  Rate

  	
   

  	
   

  	
   

  
	
  9 AM – 9 PM Weekdays*

  	
   

  	
  $

  	
  58.00

  	
   

  
	
  9 PM – 9 AM Weekdays & Weekends*

  	
   

  	
  $

  	
  58.00

  	
   

  
	
  Crisis & Holidays**

  	
   

  	
  $

  	
  76.00

  	
   

  
	
  Other Coverage Rate:

  	
   

  	
   

  	
   

  
	
  Pager

  	
   

  	
  $

  	
  11.75

  	
   

  
	
  Management Rate:

  	
   

  	
   

  	
   

  
	
  Supervisor, Trainer, Quality Assurance
  Personnel

  	
   

  	
  $

  	
  123.00

  	
   

  
	
  Associate Director

  	
   

  	
  $

  	
  154.75

  	
   

  
	
  Director/Executive Director/Vice-President

  	
   

  	
  $

  	
  182.25

  	
   

  
	
  Medical Writing Rate:

  	
   

  	
   

  	
   

  
	
  Medical Letter Writer

  	
   

  	
  $

  	
  118.45

  	
   

  
	
  Senior Medical Letter Writer

  	
   

  	
  $

  	
  131.65

  	
   

  
	
  Editorial & Literature Search
  Coordinator

  	
   

  	
  $

  	
  97.50

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ADDITIONAL COSTS (as indicated)

  	
   

  	
   

  	
   

  
	
  Telephone/Pager/Cell Phone Charges, Faxing,
  Literature Searches, Outsourced Copying, Bibliographic Database Access,
  Travel, Meals, Copyright Clearance, External Document Retrieval, Postage and
  Fulfillment, Off-Site Storage:

  	
   

  	
  $

  	
  Cost

  	
   

  
	
  Internal Document Retrieval

  	
   

  	
  $

  	
  16.00/document

  	
   

  
	
  Internal Photocopying:

  	
   

  	
  $

  	
  0.09/page

  	
   

  
						

* All times are Eastern Time.

 

1

 

ATTACHMENT B

2004 PPD FEE STRUCTURE

 

** 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 the listed Holidays
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)

 

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.

 

2

 

AMENDMENT NO. 5

 

THIS AMENDMENT NO. 5 (“Amendment”) is made
this 1st day of January, 2006 (“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
Services Agreement dated February 12, 2001, and amended by Amendment No. 1
dated December 31, 2001, Amendment No. 2 dated April 14, 2003, Amendment No. 3
dated January 19, 2004, and Amendment No. 4 dated November 29, 2004 (collectively,
the “Agreement”) pursuant to which PPD provides CLIENT 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
first sentence of Section 1E of the Agreement shall be deleted in its entirety
and replaced with the following:

 

“The parties
agree that as of the Effective Date, the staffing level shall be [***] full
time equivalent (FTE) healthcare professionals to perform the Services
hereunder.”

 

2.                                       The
fifth sentence of Section 1E of the Agreement shall be deleted in its entirety
and replaced with the following language:

 

“RELIANT and
PPD may also modify hours of coverage, staffing level and types of staff upon
mutual agreement, in writing.”

 

3.                                       The
following shall be added to Section 1E of the Agreement:

 

“Requests for
additional temporary backup staff shall be provided in writing (e-mail is
sufficient) by RELIANT to PPD. PPD will collaborate with Reliant to
continuously evaluate workload and the ongoing need for temporary back-up
staff, and will make every effort to increase or decrease staffing levels as
quickly as possible. Notwithstanding the foregoing, PPD agrees to provide any
additional non-healthcare professional staffing within [***] business days of
receiving a written request from Reliant. The costs and fees associated with
providing such temporary backup staff shall be billed by PPD to RELIANT at the
rates listed on Attachment B to the Agreement.”

 

[***]:                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.                                       The
first sentence of Section 1F shall be deleted in its entirety and replaced with
the following:

 

“During the
term of this Agreement, PPD shall provide the General Services to RELIANT
Monday through Friday between the hours of 9:00 AM to 5:00 PM, ET.”

 

5.                                       Paragraph
4A shall be deleted in its entirety and be replaced with the following:

 

“By Reliant or
PPD without cause upon ninety (90) days written notice to the other party. The
parties agree to continue to fulfill the obligations hereunder during the
ninety (90) day notice period”

 

6.                                       Pursuant
to Section 5A of the Agreement, the 2006 PPD Fee Structure attached to this
Amendment No. 5 as Attachment B shall replace the existing Attachment B to the
Agreement and shall be effective beginning January 1, 2006 and shall remain in
effect until December 31, 2006.

 

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

 

“Additional
Costs. Reliant shall reimburse PPD for all out-of-pocket expenses incurred by
PPD in performing the services hereunder as a pass through cost in accordance
with the estimates set forth in Attachment B. Customized software, computer
programming, and telephone programming will be billed according to the rates
set for the in Attachment B. PPD will notify Reliant of any unforeseen added
expenses for customized software, computer programming, and will initiate such
services only with prior approval from Reliant.”

 

8.                                       In
Section 20 of the Agreement, “721 Route 202/206 South, Bridgewater, New Jersey
08807” shall be deleted and replaced with 110 Allen Road, Liberty Corner, New
Jersey 07938”.

 

9.                                       Attachment
A to the Agreement shall be deleted in its entirety and replaced with the
revised Attachment A attached to this Amendment No. 5.

 

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

 

11.                                 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:

  	
  March 6, 2006

  	
   

  	
  Date: 

  	
  February 19, 2006

  
									

 

 

Attachment A

Scope of Services

 

1.                                       PPD
will provide a Medical Information Support unit to manage inquiries from
healthcare professionals, consumers and sales representatives about Reliant’s
product line. Services to be provided by PPD on behalf of Reliant will be
conducted in accordance with mutually approved standard operating procedures
and include:

 

•                                          Management
of inbound telephone inquiries regarding Reliant’s product line.

 

•                                          Initial
recognition and documentation of adverse events and product complaints

 

•                                          Receipt
and processing of inquiries received via Reliant’s field sales force

 

•                                          Fulfillment
of requests for information via mail, fax or e-mail, including notification of
completion to the requesting sales representative if appropriate. Reliant will
provide letterhead and envelopes as need for fulfillment purposes. Alternatively,
PPD will gain Reliant’s approval to utilize an external printing vendor to
create necessary fulfillment supplies.

 

2.                                       Hours
of operation for the Reliant Medical Information Project will be from 9:00 am
to 5.00 pm ET, Monday through Friday. Hours may be modified as mutually agreed
upon in writing by Reliant and PPD. Hours of operation do not include PPD
holidays.

 

3.                                       PPD
will provide Project Management support which includes, but is not limited to,
oral and written communication with Reliant, procedure and protocol development,
procedure and protocol maintenance, report generation, staff training, staff
supervision and development, training plan development, quality assurance
(including review of ADE and product complaint reports), consultative services,
meeting preparation and conduction and communication with other third parties
necessary to business operations. These services are provided by Supervisor(s),
Quality Assurance and Training Personnel, Associate Director(s), Director(s)
and Executive Director(s).

 

4.                                       PPD
will collaborate with Reliant in developing and maintaining Reliant-specific
standard operating procedures (SOPs) and operating guidelines. These documents
include, but are not limited to, the following:

 

•                                          REL001:  Handling of [***] Received at PPD Medical
Communications

 

•                                          REL002:  Handling of [***] Received at PPD Medical
Communications

 

•                                          REL003:  Reliant Project Operational Procedure

 

•                                          OGREL003:  Processes Specific to Reliant-owned Products

 

5.                                       PPD
has corporate SOPs in place to support non-client-specific services which are
consistent across PPD’s contact center, the project team assigned to Reliant’s
project will follow these SOPs. Corporate SOPs include [***].

 

6.                                       PPD
will continually collaborate with Reliant to establish parameters for project
metrics and reporting requirements, and will comply with all metrics agreed to
and set forth below:

 

•                                          PPD
will meet a service level goal of [***]. If circumstances arise such that PPD
anticipates or observes a decrease in service level below this goal, PPD will
immediately contact Reliant. PPD and

 

[***]:                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.

 

 

Reliant will
mutually agree upon steps necessary to address the current situation. If
additional temporary staffing resources are recommended, PPD and Reliant will
proceed in accordance with Section 1.E. of the Agreement.

 

•                                          If
the Reliant staff is already on a call at the time when additional calls are
received, these subsequent callers will queue for [***] and then be given an
option to leave a voice mail message or continue to hold. Voice mail messages
are considered completed (versus abandoned) calls.

 

•                                          All
Adverse Events and Product Complaints will be documented and faxed to Reliant
or the appropriate recipient within [***] in accordance with mutually agreed
upon standard operating procedures.

 

•                                          PPD
will respond to all Medical Inquiry Requests within [***] of receipt at PPD. If
the response time will exceed [***], PPD will notify Reliant immediately via
e-mail. Notwithstanding, the turnaround time for information for which no
standard response exists, hereby called Custom Requests, will be processed as
soon as possible. Turnaround time on such requests may be dependent upon
information from Reliant and/or other companies. Thus, at the request of
Reliant, a customized pending letter will be sent to the requesting health care
professional until a written response can be generated. Verbal responses to
such requests will be provided as soon as information is made available to PPD.
Written responses to such requests may take an undeterminable length of time
due to research, composition, and approval processes.

 

[***]:                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

Effective January 1, 2006

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

 

2006 PPD FEE STRUCTURE

 

	
  HOURLY RATES (unless otherwise indicated)

  	
   

  	
  01/01/2006 –

  12/31/2006

  
	
  MEDICAL INFORMATION (MI) RATES

  	
   

  	
   

  
	
  Director/Executive Director/Vice President

  	
   

  	
  [***]

  
	
  Associate Director

  	
   

  	
  [***]

  
	
  Supervisor

  	
   

  	
  [***]

  
	
  Pharmacist Standard

  	
   

  	
  [***]

  
	
  Crisis & Holiday**

  	
   

  	
  [***]

  
	
  Nurse Standard

  	
   

  	
  [***]

  
	
  Crisis & Holiday**

  	
   

  	
  [***]

  
	
  CAS Standard

  	
   

  	
  [***]

  
	
  Crisis & Holiday**

  	
   

  	
  [***]

  
	
  Pager Coverage

  	
   

  	
  [***]

  
	
  INFORMATION TECHNOLOGY (IT) RATES

  	
   

  	
   

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

  	
   

  	
  [***]

  

 

	
  ADDITIONAL COSTS (as indicated)

  	
   

  	
  01/01/2006 –

  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)

  	
   

  	
  [***]

  

 

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. Such rates shall also
apply to staff time required for travel when off-site travel is requested by
Reliant. 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 invoice.

 

PPD and Reliant agree that
costs for Medical Information services for the calendar year 2006 are estimated
to be $[***]  These costs are based on an
incoming medical inquiry rate of [***] per day, and include the following:

 

[***]:                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.

 

 

	
  Staffing/Project Management, Telecom and IS Support

  	
   

  	
  [***]

  
	
  Fulfillment Handling*

  	
   

  	
  [***]

  
	
  Printing

  	
   

  	
  [***]

  
	
  TOTAL ESTIMATED COSTS

  	
   

  	
  [***]

  
	
  *Includes Postage, copyright clearance, document procurement,
  storage, etc.

  	
   

  	
   

  
					

 

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 both parties.

 

PPD will provide Reliant on a
monthly basis a financial report which will outline in detail the following
items:

 

•                                          Number
of [***] processed on a [***] basis

•                                          Number
of hours each employee (as indicated above) has worked on Reliant business

•                                          Final
monthly estimate of the number of hours charged to Reliant, organized by
product

•                                          Final
monthly estimate of costs associated with fulfillment and printing

•                                          A
dated list of invoices that have been sent to Reliant

 

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

 

For purposes of the following
estimate of expenses for the calendar year 2006, PPD’s Medical Information
support staff consists of:

 

•                                          [***]
pharmacist

•                                          [***]
nurse

 

[***]:                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.

 

 

•                                          additional
non-healthcare professional (CAS) staff as required and approved by Reliant

•                                          Project
Management including an Operations Supervisor and Associate Director of
Operations.

 

Staff will perform services as
described in Section 1 of the Agreement and Attachment A to the Agreement.

 

PPD Medical Communication Estimated Expenses

2006

 

	
  Item

  	
   

  	
  Monthly Estimate:

  January 2006

  
	
  Med Info Support: staff*, telecom**,

  	
  IS/IT support

  	
   

  	
  [***]

  
	
  •     CAS:

  	
  [***] hours

  	
   

  	
   

  
	
  •     RN:

  	
  [***] hours

  	
   

  	
   

  
	
  •     RPh:

  	
  [***] hours

  	
   

  	
   

  
	
  •     Supervisor

  	
  [***] hours

  	
   

  	
   

  
	
  •     A.D.:

  	
  [***] hours

  	
   

  	
   

  
	
  •     IS Support:

  	
  [***] hours

  	
   

  	
   

  
	
  Med Info Support: fulfillment handling***

  	
   

  	
  [***]

  
	
  Med Info Support: printing

  	
   

  	
  [***]

  
	
  Med Info Support: TOTAL January Monthly Estimate

  	
   

  	
  [***]

  

 

	
   

  	
   

  	
  Monthly Estimate:

  February 2006

  
	
  Med Info Support: staff*, telecom**,

  	
  IS/IT support

  	
   

  	
  [***]

  
	
  •     CAS:

  	
  [***] hours

  	
   

  	
   

  
	
  •     RN:

  	
  [***] hours

  	
   

  	
   

  
	
  •     RPh:

  	
  [***] hours

  	
   

  	
   

  
	
  •     Supervisor:

  	
  [***] hours

  	
   

  	
   

  
	
  •     A.D.:

  	
  [***] hours

  	
   

  	
   

  
	
  •     IS Support:

  	
  [***] hours

  	
   

  	
   

  
	
  Med Info Support: fulfillment handling***

  	
   

  	
  [***]

  
	
  Med Info Support: printing

  	
   

  	
  [***]

  
	
  Med Info Support: TOTAL February Monthly Estimate

  	
   

  	
  [***]

  

 

	
   

  	
   

  	
  Monthly Estimate:

  March 2006

  
	
  Med Info Support: staff*, telecom**,

  	
  IS/IT support

  	
   

  	
  [***]

  
	
  •     CAS:

  	
  [***] hours

  	
   

  	
   

  
	
  •     RN:

  	
  [***] hours

  	
   

  	
   

  
	
  •     RPh:

  	
  [***] hours

  	
   

  	
   

  

 

[***]:                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.

 

 

	
  •     Supervisor:

  	
  [***] hours

  	
   

  	
   

  
	
  •     A.D.:

  	
  [***] hours

  	
   

  	
   

  
	
  •     IS Support:

  	
  [***] hours

  	
   

  	
   

  
	
  Med Info Support: fulfillment handling***

  	
   

  	
  [***]

  
	
  Med Info Support: printing

  	
   

  	
  [***]

  
	
  Med Info Support: TOTAL February Monthly Estimate

  	
   

  	
  [***]

  

 

	
   

  	
   

  	
  Monthly Estimate:

  April – December 2006

  
	
  Med Info Support: staff*, telecom**,

  	
  IS/IT support

  	
   

  	
  [***]

  
	
  •     CAS:

  	
  [***] hours

  	
   

  	
   

  
	
  •     RN:

  	
  [***] hours

  	
   

  	
   

  
	
  •     RPh:

  	
  [***] hours

  	
   

  	
   

  
	
  •     Supervisor:

  	
  [***] hours

  	
   

  	
   

  
	
  •     A.D.:

  	
  [***] hours

  	
   

  	
   

  
	
  •     IS Support:

  	
  [***] hour

  	
   

  	
   

  
	
  Med Info Support: fulfillment handling***

  	
   

  	
  [***]

  
	
  Med Info Support: printing

  	
   

  	
  [***]

  
	
  Med Info Support: TOTAL February Monthly Estimate

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  
	
  Med Info Support:  2006 ANNUAL
  ESTIMATE

  	
   

  	
  [***]

  

 

* inc. Project Management

** Telecom cost estimate is based on an average expense of
approximately $[***] per month

*** inc. postage, copyright clearance, document procurement, storage,
etc.

 

The following dates are
considered as holidays for the purpose of this Agreement. If requested by
RELIANT, in writing at least 60 working days in advance, PPD will provide
services to RELIANT on these days as mutually agreed at he listed holiday
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.

 

 

	
  New Year’s Day (observed)

  	
   

  	
  July Fourth (observed)

  	
   

  	
  Christmas Day (observed)

  
	
  Good Friday

  	
   

  	
  Labor Day

  	
   

  	
  Day After Thanksgiving

  
	
  Memorial Day

  	
   

  	
  Thanksgiving

  	
   

  	
  Day After Christmas or Christmas Eve Day (observed)

  

 

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.

 

 

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
Services Agreement dated February 12, 2001, and amended by Amendment No. 1
dated December 31, 2001, Amendment No. 2 dated April 14, 2003, Amendment No. 3
dated January 19, 2004, Amendment No. 4 dated November 29, 2004 and Amendment
No. 5 dated January 1, 2006 (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
1.A. of the Agreement: The fifth (5th) sentence shall be deleted in
its entirety and replaced with the following:

 

“According to
the mutual agreement of Reliant and PPD, PPD shall make available a sufficient
number of highly qualified pharmacists and/or nurses, and customer assistance
specialists (“Staff’) as approved by Reliant, to handle the volume of calls
directed to PPD through the Reliant toll-free number(s).”

 

2.                                       Section
1.E. of the Agreement: The first (1st) sentence shall be deleted in
its entirety and replaced with the following:

 

“The parties
agree that the staffing level of up to [***] full time equivalent (FTE)
healthcare professionals and [***] FTE customer assistance specialist be
established to perform the services hereunder.”

 

3.                                       Section
1.F. of the Agreement: The first (1st) sentence shall be deleted in
its entirety and replaced with the following:

 

“During the
term of this Agreement, PPD shall provide the General Services to CLIENT Monday
through Friday between the hours of 9:00 AM and 5:00 PM, ET.”

 

4.                                       Pursuant
to Section 5A of the Agreement, the 2007 PPD Fee Schedule attached to this
Amendment No. 6 as Attachment B shall replace the existing Attachment B to the
Agreement and shall be effective beginning January 1, 2007 and shall remain in
effect until December 31, 2007.

 

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

 

[***]:                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.                                       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:

  	
  January 27, 2007

  	
   

  	
  Date:

  	
  February 14, 2007

  
											

 

 

ATTACHMENT B

2007 PPD FEE SCHEDULE

 

	
  MEDICAL INFORMATION SUPPORT RATES

  	
   

  	
  Unit

  	
   

  	
  2007

  
	
  Director

  	
   

  	
  Per hour

  	
   

  	
  [***]

  
	
  Associate Director

  	
   

  	
  Per hour

  	
   

  	
  [***]

  
	
  Supervisor

  	
   

  	
  Per hour

  	
   

  	
  [***]

  
	
  Pharmacist Standard – Weekday (Mon – Fri)

  	
   

  	
  Per hour

  	
   

  	
  [***]

  
	
  Pharmacist Crisis & Holiday**

  	
   

  	
  Per hour

  	
   

  	
  [***]

  
	
  Nurse Standard – Weekday (Mon – Fri)

  	
   

  	
  Per hour

  	
   

  	
  [***]

  
	
  Nurse Crisis & Holiday**

  	
   

  	
  Per hour

  	
   

  	
  [***]

  
	
  CAS Standard – Weekday (Mon – Fri)

  	
   

  	
  Per hour

  	
   

  	
  [***]

  
	
  CAS Crisis & Holiday**

  	
   

  	
  Per hour

  	
   

  	
  [***]

  
	
  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, Literature Searches

  	
   

  	
  As needed

  	
   

  	
  [***]

  
	
  Internal Document Procurement

  	
   

  	
  Per document

  	
   

  	
  [***]

  

 

Reliant and
PPD agree that total costs for the 2007 calendar year for Medical Information
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.

 

 

**The
following dates are considered as holidays for the purpose of this Agreement. If
requested in writing at least 60 working days in advance, PPD will provide
services on these days as mutually agreed at the listed holiday rates.

 

	
  New Year’s Day (observed)

  	
   

  	
  Thanksgiving

  
	
  Good Friday

  	
   

  	
  Day after Thanksgiving

  
	
  Memorial Day

  	
   

  	
  Christmas Day (observed)

  
	
  July Fourth (observed)

  	
   

  	
  Day after Christmas or Christmas Eve Day (observed)

  
	
  Labor 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.

 

 

Reliant Pharmaceuticals, INC.

DEPARTMENTS Medical Affairs (502)

PRODUCTS All Products and Projects

VERSION Budget rev A – 2007

 

	
   

  	
   

  	
   

  	
   

  	
  January

  	
   

  	
  February

  	
   

  	
  March

  	
   

  	
  April

  	
   

  	
  May

  	
   

  	
  June

  	
   

  	
  July

  	
   

  	
  August

  	
   

  	
  September

  	
   

  	
  October

  	
   

  	
  November

  	
   

  	
  December

  	
   

  	
  Total

  Year

  	
   

  
	
   

  	
   

  	
  Headcount

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  60000

  	
   

  	
  Salaries & Wages

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  60200

  	
   

  	
  Employee Benefits Expense

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  60010

  	
   

  	
  Performance Bonuses

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  60100

  	
   

  	
  Payroll Taxes Expense

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  60300

  	
   

  	
  Recruiting Agency Fees

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Total Compensation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  71000

  	
   

  	
  Office Supplies

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  71200

  	
   

  	
  Office Postage

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  72000

  	
   

  	
  Consulting Fees

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  72050

  	
   

  	
  Consultant Honorarium

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  71500

  	
   

  	
  Membership & Dues

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  71550

  	
   

  	
  Publications & Subscriptions

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  65005

  	
   

  	
  Literature – Non Brand

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  72230

  	
   

  	
  Software Expense

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  69010

  	
   

  	
  Medical Letters

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  69100

  	
   

  	
  Med Information Support Line

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  71210

  	
   

  	
  Common Telephone & Comm - IT

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  61300

  	
   

  	
  Business Travel & Lodging

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  61320

  	
   

  	
  Business Meals

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  61500

  	
   

  	
  Entertainment & Meals

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  61520

  	
   

  	
  Business / Holiday Gifts

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  61530

  	
   

  	
  Telephone & Comm

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  72100

  	
   

  	
  Temporary Help

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Total Operating Expenses

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Total Departmental Expenses

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  66340

  	
   

  	
  Educational Grants

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  65350

  	
   

  	
  Journal Supplement

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  65355

  	
   

  	
  Advisory / Scientific Meetings

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  65358

  	
   

  	
  Other Medical Education Costs

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Other Cost Responsibilities

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
  Sub Total Expenses

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Allocation Out – Brand Spend

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
  Allocation Out – COGS

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
  Allocation Out – Comm Ops

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
  Allocation Out – Depr & Amort

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
  Allocation Out – Interest Expense

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
  Allocation Out – Other Exp & Inc

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
  Allocation Out – Regulatory Filings

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  

 

[***]:                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.

 

 

 

	
   

  	
   

  	
  Allocation Out – R&D Projects

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
  Allocation Out – Income Taxes

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
  Allocation Out – Direct Mfg OH

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
  Allocation Out – Regulatory S&M

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
  Total &L Reclassifications

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
  Net Allocations In/Out

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  

 

[***]:                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.

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00131-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00131-of-00352.parquet"}]]