EXHIBIT 10.63

ADDENDUM No. 4 TO

AMENDED AND RESTATED MASTER SERVICES AGREEMENT

THIS ADDENDUM No. 4 (the “Addendum”) to the AMENDED AND RESTATED MASTER SERVICES
AGREEMENT dated as of May 31, 2005, as amended (collectively, the “Agreement”),
by and between EXPRESS SCRIPTS SPECIALTY DISTRIBUTION SERVICES, INC. (“ESSDS”)
and ORPHAN MEDICAL, INC. (“Orphan Medical”) and assigned to JAZZ
PHARMACEUTICALS, INC. (“Jazz Pharmaceuticals”), is entered into as of July 16,
2007 (the “Effective Date”) by and between ESSDS and Jazz Pharmaceuticals.
Capitalized terms not otherwise defined herein shall have the same meanings as
in the Agreement.

RECITALS

WHEREAS, Jazz Pharmaceuticals desires ESSDS to provide certain Nursing Program
Services for its product, Xyrem;

WHEREAS, the parties are discussing ways to enhance the existing Xyrem Success
Program, including the possible adoption of a specialty pharmacy HUB program,
and ESSDS desires to now hire three additional full time employees in response
to these discussions;

WHEREAS, the parties desire to include and describe in more detail the provision
by ESSDS of certain Nursing Program Services;

WHEREAS, the parties desire to include and describe in more detail the
responsibilities of the three full time employees that ESSDS desires to hire and
Jazz Pharmaceuticals’ payment obligation regarding same;

WHEREAS, Section 10.10 of the Agreement provides that the Agreement may be
amended by a written instrument signed by both parties; and

WHEREAS, the parties desire to supplement the Agreement as provided herein.

NOW, THEREFORE, in consideration of the foregoing and the respective
representations, warranties, covenants and agreements set forth herein and in
the Agreement, the parties hereto agree as follows:

AGREEMENT

1. Incorporation of Recitals. The Recitals are hereby incorporated into the
Addendum.

2. Definitions. As used in this Addendum, the following term (and the plural
thereof, when appropriate) shall have the meaning set forth herein, except where
the context makes it clear that such meaning is not intended:

 

  a. “Nursing Program Services” shall mean those services set forth in Exhibit
A.

 

1

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24B-2 of the Securities Exchange Act of 1934, as
amended.

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  b. “FTE Services” shall mean those services set forth in Exhibit B.

 

  c. Capitalized terms used herein but not defined herein shall have the meaning
ascribed to them in the Agreement.

3. Performance of Nursing Program Services. ESSDS shall perform the Nursing
Program Services set forth in Exhibit A for Jazz Pharmaceuticals for its
product, Xyrem. ESSDS agrees to perform such Nursing Program Services with due
care in accordance with the standards and practices which are generally accepted
in the industry and exercised by other persons engaged in performing similar
services in the local area and in accordance with all applicable federal and
state laws and regulations.

4. Performance of FTE Services. ESSDS will hire a HUB Trainer, a Xyrem Account
Director, and a Xyrem Operations Director to perform the FTE Services set forth
in Exhibit B for Jazz Pharmaceuticals in connection with the Xyrem Success
Program. ESSDS agrees to perform such services with due care in accordance with
the standards and practices which are generally accepted in the industry and
exercised by other persons engaged in performing similar services in the local
area and in accordance with all applicable federal and state laws and
regulations.

5. Termination. Either party may terminate this Addendum on thirty (30) days’
prior written notice to the other party, provided, however, that neither party
may terminate this Addendum prior to December 31, 2007.

6. Fees. Jazz Pharmaceuticals shall pay ESSDS the monthly fees described in
Exhibit C in consideration of the performance of Nursing Program Services and
the FTE Services. The fees described on Exhibit C shall constitute full and
complete payment for performance of the Nursing Program Services and the FTE
Services under the Agreement. Payment of the fees for the FTE Services will
commence 30 days following the hire by ESSDS of individuals to perform the FTE
Services; payment for the Nursing Program Services will commence on September 1,
2007. ESSDS shall invoice Jazz Pharmaceuticals monthly. Jazz Pharmaceuticals
agrees that: (1) the fees for the Xyrem® Nursing Program Services and the FTE
Services shall constitute compensation for bona fide services; (2) the Xyrem®
Nursing Program Services and FTE Services are not intended to serve, either
directly or indirectly, as a means of marketing any Jazz Pharmaceutical product,
(3) the Xyrem® Nursing Program and FTE Services are not intended to diminish the
objectivity or professional judgment of ESSDS; (4) the Xyrem® Nursing Program
and FTE Services do not involve the counseling or promotion of any off-label use
of Jazz Pharmaceutical products; (5) the fees for the Xyrem® Nursing Program
Services and FTE Services are not intended in any way as remuneration for
referrals or for other business generated; and (6) any fees for the Xyrem®
Nursing Program Services and FTE Services represent fair market value for these
services based

 

2

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24B-2 of the Securities Exchange Act of 1934, as
amended.

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on arms-length negotiations. The parties acknowledge that fees paid for the
Xyrem® Nursing Program Services and FTE Services pursuant to this Agreement are
not intended in any way as a payment related to drug formulary or drug formulary
activities and have not been negotiated or discussed between the parties in
connection with any such drug formulary or formulary activities.

7. Miscellaneous.

 

  a. Except as expressly set forth in this Addendum, all of the terms and
conditions of the Agreement shall remain in full force and effect.

 

  b. To the extent there is a conflict between the terms and conditions of this
Addendum and the terms and conditions of the Agreement, this Addendum shall
control.

 

  c. This Addendum may be executed in one or more counterpart copies, each of
which shall be deemed an original, and all of which shall together be deemed to
constitute one agreement. Facsimile execution and delivery of this Addendum is
legal, valid and binding execution and delivery for all purposes.

[SIGNATURE PAGE FOLLOWS]

 

3

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24B-2 of the Securities Exchange Act of 1934, as
amended.

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IN WITNESS WHEREOF, the parties have executed or caused this Addendum to be
executed effective as of the Effective Date of this Addendum.

 

EXPRESS SCRIPTS SPECIALTY

DISTRIBUTION SERVICES, INC.

    JAZZ PHARMACEUTICALS, INC. By:   /s/ Glen H. Bogner     By:   /s/ Carol
Gamble Its:   Vice President     Its:   SVP and General Counsel

 

4

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24B-2 of the Securities Exchange Act of 1934, as
amended.

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EXHIBIT A

NURSING PROGRAM SERVICES

Population

 

  •  

Patients to whom Nursing Program Services will be offered include all newly
enrolled patients. Patients and Physicians will have the option to opt out of
the program at anytime during their course of therapy.

Staffing

 

  •  

ESSDS will staff and support the Nursing Program Services with a pool of [ * ]
to [ * ] nurses whose first priority shall be the Nursing Program Services.
These nurses will devote the majority of their time to providing Nursing Program
Services.

Contact

 

  •  

The designated nurses will contact all newly enrolled patients at designated
intervals over the course of the patient’s Xyrem therapy. There will be four
(4) scheduled calls with the patient. Outbound scripted phone calls shall be
made by a designated nurse at the following frequency:

 

  1. In the event a patient expresses concerns to the reimbursement specialist
regarding initiating therapy that could specifically be addressed by nurse
consultation, the reimbursement specialist may soft transfer the patient to a
nurse.

 

  2. The first scheduled call, however, will occur at calendar business day [ *
] after the time of therapy dispense.

 

  3. The second scheduled call between [ * ] calendar business days following
therapy initiation.

 

  4. The third scheduled call between [ * ] calendar business days following
therapy initiation.

 

  5. The fourth scheduled call between [ * ] calendar business days following
therapy initiation.

The patient may contact the nurse at other intervals throughout the program.
Additionally, it may be necessary for the nurse to contact the patient’s
physician throughout the program for clarification of orders and/or compliance
issues.

Documentation

 

  •  

ESSDS will document all contact with the enrolled patients.

 

A-1

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24B-2 of the Securities Exchange Act of 1934, as
amended.

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Reporting

 

  •  

ESSDS will provide a monthly report to Jazz Pharmaceuticals. The report
requirements, codes, format, and scripting is provided in Exhibit D. It is
intended that such information will be de-identified under HIPAA, and Jazz
Pharmaceuticals represents that it will not use such information to attempt to
identify the identity of any patient.

 

A-2

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24B-2 of the Securities Exchange Act of 1934, as
amended.

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EXHIBIT B

FTE SERVICES

HUB Trainer

The Hub Trainer will provide all training relating to fulfillment and
distribution of Xyrem. The Hub Trainer will dedicate [ * ]% of their time to
training related to the Xyrem Success Program.

Xyrem Account Director

The Xyrem Account Director will be designed as the single point of contact for
Jazz Pharmaceuticals and will be responsible for optimizing the effectiveness of
the enhanced Xyrem Success Program. The Xyrem Account Director will dedicate
100% of their time to the Xyrem Success Program.

Xyrem Operations Director

The Xyrem Operations Director will serve as a single point of contact for the
Xyrem Account Director. The Xyrem Operations Director will dedicate 100% of
their time to the Xyrem Success Program.

All references above to the Xyrem Success Program include any enhancements
subsequently made to that program, including adoption of a specialty pharmacy
Hub program.

 

B-1

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24B-2 of the Securities Exchange Act of 1934, as
amended.

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EXHIBIT C

FEES

 

Services

   Fees  

Monthly Nursing Program Services Fee

   $ [ *]

Monthly FTE Fee

   $ [ *]*

The fee schedule listed above is subject to the following qualifications:

 

  •  

Pricing will be reviewed 6 months from the start date of the program.

 

  •  

The pricing review will take into account the necessary staffing involved and
any necessary program enhancements such as reporting, IT development and
programming, process flows, new indications, increase in sales, and any other
circumstances that are mutually agreed upon that might involve the necessary
staffing levels to change. The pricing will be reflected in a change to the FTE
rates associated with the necessary job level and skill set required to perform
the job function.

 

  •  

Any necessary changes to the data requirements post implementation and addendum
execution will be billed at a rate of $[ * ] per hour for IT development and
programming time.

 

  •  

* The monthly FTE Fee assumes that all three FTEs are hired and working at the
same time. In the event they are not, the Monthly FTE Fee will be prorated based
upon which of the three positions are actually filled, as follows:

 

  •  

Hub Trainer, $[ * ] per month;

 

  •  

Xyrem Account Director $[ * ] per month; and

 

  •  

Xyrem Operations Director $[ * ] per month.

 

C-1

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24B-2 of the Securities Exchange Act of 1934, as
amended.

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EXHIBIT D

MONTHLY REPORTS

 

Frequently Asked Questions-Monthly Patient
Questions

  

Definition

   Number Asked Monthly Pill vs Liquid    Why liquid medication? Why can’t make
it in pill form?    Dosing    Why 2 doses? Why can’t it last longer so don’t
have to take second dose?    Prescribed vs Street    What is difference between
“street” GHB and prescribed Xyrem?    Sleep Cycle/Stages    What are normal
stages of sleep?    How works    How does Xyrem help Narcolepsy w/Cataplexy,
EDS?    Withdrawal    Will I have withdrawal symptoms if I stop taking?   
Interactions - TF to RPh    Questions regarding other Xyrem interaction with
other medication? Transfer call to pharmacist.    Safety-Other Med Conditions   
Is it safe to take Xyrem when I also have heart disease, lung disease, bipolar
disease, hypertension, etc.    Awake/Emergency    Will I be able to wake up for
an emergency, children crying, alarm clock etc.    Common Side Effects    What
are the common side effects?    TF (transfer call) to Medcomm    Experiencing
common or uncommon side effects, any new symptom if associated with taking
Xyrem, death.    Central Pharmacy    Why can’t I get this at my pharmacy where I
get all my other medications?    Alcohol    Is it safe to drink alcohol when
taking Xyrem?    Travel    How do I travel with Xyrem? Any special requirements
when traveling with Xyrem?    Skipping Doses    Is it OK to skip doses (daily or
second dose)?    Ship/Delivery - TF to Pharmacy    Shipment or delivery
questions. Transfer call to Pharmacy    Cost/Bill - TF to Reimbursement   
Reimbursement questions. Transfer call to Reimbursement Specialist.   

 

D-1

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24B-2 of the Securities Exchange Act of 1934, as
amended.

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Scripting for Calls

Patient Response-Monthly

        Number Asked Monthly New Patient 1st call       Aware preparation?   
Yes/No    Aware frequency?    Yes/No    Aware titration?    Yes/No    Delay
start?    Choices: Moving, Vacation, Work/School, Talk to MD, Wean other meds,
Home Alone, Unspecified    Follow up calls post 1st call      

Taking as prescribed?

Sleeping longer periods?

  

Yes/No

Yes/No

   Feel more rested?    Yes/No    Skipping doses?    Yes/No   

If patient indicates they are no longer taking Xyrem during one of the above
scheduled nurse calls, the nurse will contact the physicians’ office in a timely
manner and alert them to this finding.

Glossary of Call Type Codes:

 

Call Type Code

  

Call Type Definition

IN-MD    Inbound physician office call IN-PT    Inbound patient call Ship-1   
New Patient Call-1st attempt Ship-2    New Patient Call-2nd attempt OPT-MD   
Physician opting patient out of program OPT-PT    Patient opting out of program

DC-MD

10D-1

  

DC Xyrem-physician office notified

10-14 Days on Xyrem-1st attempt

10D-2    10-14 Days on Xyrem-2nd attempt 25D-1    25-30 Days on Xyrem-1st
attempt 25D-2    25-30 Days on Xyrem-2nd attempt 55D-1    55-60 Days on
Xyrem-1st attempt 55D-2    55-60 Days on Xyrem-2nd attempt

Monthly Number of Calls Reporting Format:

 

Call Type

   Number
of Calls

IN-MD

   0

IN-PT

   0

Ship-1

   0

Ship-2

   0

OPT-MD

   0

OPT-PT

   0

10D-1

   0

10D-2

   0

25D-1

   0

25D-2

   0

55D-1

   0

55D-2

   0

Total

   0

 

D-2

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24B-2 of the Securities Exchange Act of 1934, as
amended.

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Nurse Opt Out Data Reporting Format

 

*Patient ID

   **Physician
First Name    **Physician
Last Name   

*Physician

CHIP ID

  

*Physician

JPI ID

   Requestor    Current Case Status    Total
Fills                                                                           
                             

 

* The Patient will be de-identified

 

** Those physicians residing in NH will not be reported on

Monthly Nursing Summary Reporting Format:

Nursing Summary

 

     Patients Number of Patients Enrolled from MM/DD/YYYY through MM/DD/YYYY
(since nursing program launch date until term of program)    0 Number of
Patients Currently Participating (all newly enrolled patients from nursing
program launch date less patient and physician opt outs until term of program)
   0 Number of Patients Shipped through MM/DD/YYYY (since nursing program launch
date until term of program)    0

Percentage of Patients Shipped

   #DIV/0!

Average Number of Fills per Patient

   0.00 Number of On Hold Patients    0

Percentage of On Hold Patients

   #DIV/0! Number of Disenrolled Patients    0

Percentage of Disenrolled Patients

   #DIV/0!

 

     Count    %

Disenrolled Patients Breakout:

      Disenrolled - Cost    0    #DIV/0! Disenrolled - Refused Shipment    0   
#DIV/0! Disenrolled - MD Credential    0    #DIV/0! Disenrolled - Drug/Medical
Concern    0    #DIV/0! Disenrolled - Insurance Denial    0    #DIV/0!

 

D-3

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24B-2 of the Securities Exchange Act of 1934, as
amended.

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Disenrolled - Pt. Expired

   0    #DIV/0!

Disenrolled - Dr. not responding

   0    #DIV/0!

Disenrolled - Physician Request

   0    #DIV/0!

Disenrolled - Voluntarily

   0    #DIV/0!

Disenrolled - Unknown Reason

   0    #DIV/0!

Disenrolled - Unable to Contact

   0    #DIV/0!

Disenrolled - Prefers Alternate Therapy

   0    #DIV/0!

Total

   0    #DIV/0!

Number of Discontinued Patients

   0

Percentage of Discontinued Patients

   #DIV/0!

Discontinued Patients Breakout:

  

Discontinued - Cost

  

Discontinued - Refused Shipment

  

Discontinued - Efficacy

  

Discontinued - Drug/Medical Concern

  

Discontinued - Insurance Denial

  

Discontinued - Pt. Expired

  

Discontinued - Side Effects

  

Discontinued - Physician Request

  

Discontinued - Voluntarily

  

Discontinued - Unknown Reason

  

Discontinued - Unable to Contact

  

Discontinued - Prefers Alternate Therapy

  

Total

  

 

D-4

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24B-2 of the Securities Exchange Act of 1934, as
amended.