EXHIBIT 10.33
AMGEN AMENDED AND RESTATED AGREEMENT NO. 20010240
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This Amended and Restated Agreement ("Agreement") between Amgen USA Inc., Xxx
Xxxxx Xxxxxx Xxxxx, Xxxxxxxx Xxxx, Xxxxxxxxxx 00000 ("Amgen") and Renal Care
Group, 0000 Xxxx Xxx Xxxxxx, Xxxxx 000, Xxxxxxxxx XX 00000 ("RCG"), sets forth
the terms and conditions for the purchase of EPOGEN(R) (Epoetin alfa) by RCG,
exclusively for the treatment of dialysis patients.
WHEREAS, Amgen and RCG entered into Agreement #20010240 effective
January 1, 2002, and;
WHEREAS, the parties now wish to amend and restate Agreement #20010240
to extend the term for an additional year, restate the terms and
conditions to accommodate the additional year, and incorporate
additional incentive provisions covered under Agreement #20010240;
NOW, THEREFORE, in consideration of the premises and of the mutual
covenants, representations and warranties set forth herein, the parties
agree as follows:
1. TERM OF AGREEMENT. The "Term" of this Agreement shall be defined as
January 1, 2002 ("Commencement Date") through December 31, 2003
("Termination Date").
2. DIALYSIS CENTER AFFILIATES. RCG must provide Amgen with a complete list
of its dialysis center affiliates ("Affiliates") on or before the date
this Agreement is executed by RCG. Only those Affiliates approved by
Amgen and referenced in Appendix B hereto will be eligible to
participate under this Agreement. Modifications to the dialysis center
Affiliates included in Appendix B may be made pursuant to the request of
RCG's corporate headquarters and are subject to approval and
acknowledgment by Amgen in writing. Notification of proposed changes to
the list of Affiliates must be provided by RCG to Amgen in writing at
least thirty (30) days before the effective date of the proposed change.
Amgen reserves the right to accept, reject, or immediately terminate any
Affiliates with regard to participation in this Agreement, if Amgen
reasonably determines that such Affiliate is not properly classified as
a freestanding dialysis center or * or if Amgen determines such
Affiliate is a party to another * for Epogen(R) with Amgen.
3. OWN USE. RCG hereby certifies that EPOGEN(R) purchased hereunder shall
be for RCG's "own use", for the exclusive treatment of dialysis
patients.
4. AUTHORIZED WHOLESALERS. On or before the date RCG executes this
Agreement, RCG must provide Amgen with a complete list of its current
wholesalers, from which RCG intends to purchase EPOGEN(R). Wholesalers
so designated by RCG and approved by Amgen will be deemed "Authorized
Wholesalers" for the purposes of this Agreement. A current listing of
RCG's Authorized Wholesalers is included in Appendix C. Notification of
proposed changes to the list of Authorized Wholesalers must be provided
to Amgen in writing at least thirty (30) days before the effective date
of the proposed change. Amgen reserves the right to accept, reject, or
immediately terminate any wholesaler with regard to participation in
this Agreement. In the event Amgen terminates any Authorized Wholesaler
from which RCG is purchasing EPOGEN(R), Amgen will work with RCG to
identify other possible Authorized Wholesalers from which RCG may
purchase EPOGEN(R). In the event that RCG is unable to identify another
Authorized Wholesaler from which RCG may purchase EPOGEN(R), and subject
to receipt and approval of an *. RCG agrees to require all Authorized
Wholesalers to submit product sales information directly to Amgen and to
a third-party sales reporting organization designated by Amgen.
* Omitted information is the subject of a request for confidential
treatment pursuant to Rule 24b-2 under the Securities Exchange
Act of 1934 and has been filed separately with the Securities
and Exchange Commission.
AMENDED AND RESTATED AGREEMENT NO. 20010240 Ver. 7/25/02
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AGREEMENT NO. 20010240 (CONTINUED)
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5. QUALIFIED PURCHASES. Only EPOGEN(R) purchased under this Agreement by
RCG through *.
6. COMMITMENT TO PURCHASE. RCG agrees to purchase EPOGEN(R) for all of its
dialysis use requirements for recombinant human erythropoietin. RCG may
purchase another brand of recombinant human erythropoietin for its
dialysis use requirements only for the time, and only to the extent,
that Amgen has notified RCG's corporate headquarters in writing that
Amgen cannot supply EPOGEN(R) within and for the time period reasonably
required by RCG.
7. CONFIDENTIALITY. Both Amgen and RCG agree that this Agreement represents
and contains confidential information which shall not be disclosed to
any third party, or otherwise made public, without prior written
authorization of the other party, except where such disclosure is
contemplated hereunder or required by law, and then only upon prior
written notification to the other party.
8. DISCOUNTS. RCG may qualify for discounts and incentives in accordance
with the schedules and terms set forth in Appendix A. Discounts in
arrears will be paid in the form of a check payable to RCG's corporate
headquarters. Discounts in arrears will be calculated in accordance with
Amgen's discount calculation policies based on * using the * in effect
as of the date of purchase as the calculation price, except as otherwise
provided hereunder. Upon vesting of all earned discounts, Amgen will use
its best efforts to make such discounts available within * after receipt
by Amgen of data, in a form reasonably acceptable to Amgen, detailing
all * during the applicable period. Discount amounts, as calculated by
Amgen, must * for the applicable period to qualify. Subject to the
section entitled "Breach of Agreement", in the event that Amgen is
notified in writing that RCG and/or any Affiliates are acquired by
another entity or a change of control otherwise occurs with respect to
RCG or an Affiliate, any discounts which may have been earned hereunder
shall be paid in the form of a check payable to RCG's or the Affiliate's
corporate headquarters subject to the conditions described herein. If
any Affiliates are added to or deleted from this Agreement during any of
the periods used for comparison, for any of the discounts paid in
arrears contained herein, Amgen reserves the right in its sole and
reasonable discretion to appropriately adjust RCG's discounts for the
relevant periods, by including or excluding any purchases made by those
Affiliates during any of those periods.
9. TREATMENT OF DISCOUNTS. RCG agrees that it will properly disclose and
account for any discount or other reduction in price earned hereunder,
in whatever form, (i.e. pricing, discount, or incentive) in a way that
complies with all applicable federal, state, and local laws and
regulations, including without limitation, Section 1128B(b) of the
Social Security Act and its implementing regulations. Section 1128B(b)
requires that a provider of services will properly disclose and
appropriately reflect the value of any discount or other reduction in
price earned in the costs claimed or charges made by the provider under
a federal health care program, as that term is defined in Section
1128B(f). RCG also agrees that it will (a) claim the benefit of such
discount received, in whatever form, in the fiscal year in which such
discount was earned or the year after, (b) fully and accurately report
the value of such discount in any cost reports filed under Title XVIII
or Title XIX of the Social Security Act, or a state health care program,
and (c) provide, upon request by the U.S. Department of Health and Human
Services or a state agency or any other federally funded state health
care program, the information furnished by Amgen concerning the amount
or value of such discount. RCG's corporate headquarters agrees that it
will advise all Affiliates, in writing, of any discount received by
RCG's corporate headquarters hereunder with respect to purchases made by
such Affiliates and that said Affiliates will account for any such
discount in accordance with the above stated requirements.
* Omitted information is the subject of a request for confidential
treatment pursuant to Rule 24b-2 under the Securities Exchange
Act of 1934 and has been filed separately with the Securities
and Exchange Commission.
AGREEMENT NO. 20010240 Ver. 7/25/02
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AGREEMENT NO. 20010240 (CONTINUED)
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10. DATA COLLECTION. RCG agrees that all data to be provided to Amgen
pursuant to this Agreement, shall be in a form that does not disclose
the identity or name of any patient or other patient-identifying
information such as address, telephone number, or social security
number. RCG acknowledges that the data to be supplied to Amgen pursuant
to this Agreement shall be used to support verification of the discounts
and incentives referenced herein, as well as for Amgen-sponsored
research concerning the role of EPOGEN(R) in improving treatment
outcomes and quality of life of dialysis patients. RCG shall
consistently use a unique alpha-numeric code (which shall not be the
same as the patient's social security number) as a "case identifier" to
track the care rendered to each individual patient over time, and such
case identifier shall be included in the data provided to Amgen. The key
or list matching patient identities to their unique case identifiers
shall not be provided to Amgen personnel. In furtherance of Amgen
research, RCG may agree from time to time to use its key to update the
patient care data by linking it with information concerning health
outcomes, quality of life, and other pertinent data that may become
available to Amgen from other sources. Any such linking of data sources
shall not provide the identity of any patient to Amgen. Amgen agrees
that it will maintain data supplied under this Agreement in confidence
and that it will not use such data to identify or contact any patient.
No reports by Amgen concerning analyses of the data or the results of
such research shall disclose the identity of any patient.
11. BREACH OF AGREEMENT. If either party materially breaches this Agreement,
then the other party may terminate this Agreement for breach upon thirty
(30) days' advance written notice. In addition, in the event that RCG
materially breaches any provision of this Agreement, Amgen shall have no
obligation to continue to offer the terms described herein or pay any
further discounts to RCG.
12. GOVERNING LAW. This Agreement shall be governed by the laws of the State
of California and the parties hereby submit to the jurisdiction of the
California courts, both state and federal.
13. WARRANTIES. Each party represents and warrants to the other that this
Agreement: (a) has been duly authorized, executed, and delivered by it,
(b) constitutes a valid, legal, and binding agreement enforceable
against it in accordance with the terms contained herein, and (c) does
not conflict with or violate any of its other contractual obligations,
expressed or implied, to which it is a party or by which it may be
bound. The party executing this Agreement on behalf of RCG specifically
warrants and represents to Amgen that he is authorized to execute this
Agreement on behalf of and has the power to bind RCG and the Affiliates
to the terms set forth in this Agreement. The party executing this
Agreement on behalf of Amgen specifically warrants and represents to RCG
that he is authorized to execute this Agreement on behalf of and has the
power to bind Amgen to the terms set forth in this Agreement.
14. NOTICES. Any notice or other communication required or permitted
hereunder shall be in writing and shall be deemed given or made when
delivered in person or when sent to the other party by first class mail,
nationally recognized overnight delivery service or other means of
written communication at the respective party's current address or at
such other address as the party shall have furnished to the other in
accordance with this provision.
15. COMPLIANCE WITH HEALTH CARE PRICING AND PATIENT PRIVACY LEGISLATION AND
STATUTES. (a) Notwithstanding anything contained herein to the contrary,
at any time following the enactment of any federal, state, or local law
or regulation that in any manner reforms, modifies, alters, restricts,
or otherwise adversely affects the pricing of or reimbursement available
for EPOGEN(R), Amgen may, in its sole discretion, upon thirty (30) days'
notice (i) terminate this Agreement, or (ii) exclude any Affiliates from
participating in this Agreement unless such Affiliate(s) certifies in
writing that they are, or will be, exempt from the provisions
thereunder. Additionally, in order to assure compliance with any
existing federal, state or local statute, regulation or ordinance, Amgen
reserves the right to exclude any Affiliates from the pricing, discount,
and incentive provisions of this Agreement if, in the opinion of Amgen's
legal counsel such exclusion is necessary to assure such compliance.
(b) Notwithstanding anything contained herein to the contrary, at
any time following the enactment of any federal, state, or local
law or regulation relating to patient privacy of medical records
that in any manner reforms, modifies, alters, restricts, or
otherwise affects any of the data received or to be received in
connection with any of the incentives
AGREEMENT NO. 20010240 Ver. 7/25/02
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AGREEMENT NO. 20010240 (CONTINUED)
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contemplated under this Agreement, either party may, in its discretion,
upon thirty (30) days' notice, seek to modify this Agreement with
respect to the affected incentive. RCG and Amgen shall meet and in good
faith seek to mutually agree to modify this Agreement to accommodate any
such change in law or regulation, with the intent to, if possible,
retain the essential * structure of the affected incentive. If the
parties, after reasonable time, are unable to agree upon a modification,
Amgen shall be entitled to terminate the affected incentive upon thirty
(30) days' notice, provided that if Amgen so terminates an incentive,
RCG shall be entitled to terminate this Agreement upon thirty (30) days'
notice.
16. FORCE MAJEURE. Neither party will be liable for delays in performance or
nonperformance of this Agreement or any covenant contained herein if
such delay or nonperformance is a result of Acts of God, civil or
military authority, civil disobedience, epidemics, terrorism, war,
failure of carriers to furnish transportation, strike, lockout or other
labor disturbances, inability to obtain material or equipment, or any
other cause of like or different nature beyond the control of such
party.
17. MISCELLANEOUS. No modification of this Agreement will be effective
unless made in writing and executed by a duly authorized representative
of each party, except as otherwise provided hereunder. Neither party may
assign this Agreement to a third party without the prior written consent
of the other party. This Agreement may be executed in one or more
counterparts, each of which is deemed to be an original but all of which
taken together constitute one and the same agreement.
18. ENTIRE AGREEMENT. This Agreement constitutes the entire understanding
between the parties and supersedes all prior written or oral proposals,
agreements, or commitments pertaining to the subject matter herein.
Please retain one fully executed original for your records and return the other
fully executed original to Amgen.
THE PARTIES EXECUTED THIS AMENDMENT AS OF THE DATES SET FORTH BELOW.
AMGEN USA INC. RENAL CARE GROUP, INC.
Signature: Signature:
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Print Name: Print Name:
------------------------ -------------------------
Print Title: Print Title:
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Date: Date:
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* Omitted information is the subject of a request for confidential
treatment pursuant to Rule 24b-2 under the Securities Exchange
Act of 1934 and has been filed separately with the Securities
and Exchange Commission.
AGREEMENT NO. 20010240 Ver. 7/25/02
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AGREEMENT NO. 20010240 (CONTINUED)
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APPENDIX A: DISCOUNT PRICING, SCHEDULE, AND TERMS
1. PRICING. Throughout the first year of the Term of this Agreement
(January 1, 2002 - December 31, 2002), RCG may purchase
EPOGEN(R) through * at an *, which shall be equal * in effect on
*. Throughout the second year of the Term of this Agreement
(January 1, 2003 - December 31, 2003), RCG may purchase
EPOGEN(R) through * at an *, which shall be equal * in effect on
*. Amgen reserves the right to change the * at any time, which
change shall * RCG during the Term of this Agreement. Resulting
prices do not include *. All discounts earned in arrears during
the Term of the Agreement shall be calculated based *.
2. BASE SALES; SALES GROWTH CALCULATION. For purposes of * from the
*, Amgen will * by all Affiliates listed on Appendix B of this
Agreement as of the Commencement Date and, as provided for in
this Section 2, all new approved Affiliates. For new approved
Affiliates added through acquisition, * by such new approved
Affiliates shall only be * if Dialysis Center provides adequate
data to Amgen's reasonable satisfaction concerning such new
approved Affiliates' purchases of EPOGEN(R) for the same time
period from the previous year. Such new approved Affiliates' *
shall be *. For purposes of * by all Affiliates listed on
Appendix B at the beginning of CY2 and, as provided for in this
Section 2, all new approved Affiliates. For new approved
Affiliates added through acquisition, *.
3. *. RCG may qualify for * provided it meets the * defined below
and the criteria described below in this section. * is designed
to improve patient outcomes by encouraging * which recommends
*.*
APPENDIX A: DISCOUNT PRICING, SCHEDULE, AND TERMS (CONTINUED)
A. REQUIREMENTS: In order to qualify for *, RCG's aggregate * of EPOGEN(R)
during * and * by all Affiliates as listed on Appendix B on the Commencement
Date of this Agreement and those added at the beginning of * must equal or
exceed * for * and * for *, of the aggregate * of EPOGEN(R) by those same
Affiliates for *. *. In addition, no more than * may have * during each * of the
Term. If either of these criteria is not met during any given * of the Term, RCG
will not qualify for the * during that *. Failure of RCG to qualify for the *
during a particular *. If at the end of * and * the * has been met, then Amgen *
for that given * and appropriately * for those relevant * during the affected *
in which a * was not *. However, if at the end of * and * the * has not been met
for that year, * for that given *, *. *. * will be made by Amgen or RCG, as the
case may be, within * after the end of * and *, *. In order to participate *,
RCG and Affiliates must provide the following information for each dialysis
patient to Amgen or to a data collection vendor specified by Amgen *, and *
after the *:
i) all * for each dialysis patient, the date of each test, and a
consistent, unique, alpha-numeric identifier (sufficient
consistently to track an individual patient without in any way
disclosing the identity of the patient), along with the name,
address and phone number of the particular Affiliate at which
each patient received treatment (collectively the "Data"). To
the extent permitted by applicable law, Amgen may utilize the
Data for any purpose, and reserves the right to audit all Data.
Under no circumstances should the Data include any patient
identifiable information including, without limitation, name,
complete social security number, address or birth date. The
identity of the account submitting the Data and any association
with the Data will remain confidential. The * must be derived
from * taken immediately before dialysis treatment using any *
testing method *, must be reported *, and must be submitted
directly from the clinical laboratory in a format reasonably
acceptable to Amgen. Handwritten reports are not acceptable;
electronic submission of the Data is preferred, and
* Omitted information is the subject of a request for confidential
treatment pursuant to Rule 24b-2 under the Securities Exchange Act of
1934 and has been filed separately with the Securities and Exchange
Commission.
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* *
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AGREEMENT NO. 20010240 (CONTINUED)
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ii) a properly executed "Certification Letter", a sample of which is
attached hereto as Exhibit #1, that will be provided to RCG's
corporate headquarters, unless otherwise requested, after this
Agreement is executed by both parties.
APPENDIX A: DISCOUNT PRICING, SCHEDULE, AND TERMS (CONTINUED)
B. CALCULATION: Assuming RCG has fulfilled all requirements as
described in Section 3(a) above, RCG's * will be calculated as
follows:
The * for each dialysis patient will be based upon the average
of all * gathered for each patient during * of the Term. The *
of all dialysis patients with *, will be determined by dividing
the total number of dialysis patients with *. * will be
calculated based on RCG's overall performance in accordance with
Amgen's discount calculation policies.
C. PAYMENT: * will be calculated on a * and paid to RCG's corporate
headquarters, except as otherwise provided hereunder. Payment is
contingent upon receipt by Amgen of the "Certification Letter"
and *. If Data is received more than * after *, the total * of
EPOGEN(R) attributable to RCG during * for that *.
Notwithstanding the foregoing, if Amgen receives all required
Data from * of all Affiliates within the time frame referenced
above for *, the total * of EPOGEN(R) attributable to RCG during
*, will be included in the calculation of * for that *. However,
if Amgen determines that any Affiliate is consistently not
submitting the required Data, Amgen reserves the right in its
sole discretion to exclude such Affiliate's * of EPOGEN(R) from
the calculation * for any *. * payments will be based upon the
Data received from the *, and will equal a percentage of RCG's
total * of EPOGEN(R) during that * (exclusive of any * of
EPOGEN(R) made by RCG or any Affiliate not meeting the Data
submission requirements described above) as governed by *
schedule listed below. Notwithstanding the foregoing, payment
for any period during the Term that is not equivalent to a *,
will be based *. If the EPOGEN(R)* or the *, then Amgen and RCG
agree *. * above.
* SCHEDULE
*
PLEASE DIRECT YOUR ATTENTION TO THE EPOGEN(R) PACKAGE INSERT
*
* Omitted information is the subject of a request for confidential
treatment pursuant to Rule 24b-2 under the Securities Exchange
Act of 1934 and has been filed separately with the Securities
and Exchange Commission.
AGREEMENT NO. 20010240 Ver. 7/25/02
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AGREEMENT NO. 20010240 (CONTINUED)
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APPENDIX A: DISCOUNT PRICING, SCHEDULE, AND TERMS (CONTINUED)
*
*
PLEASE DIRECT YOUR ATTENTION TO THE EPOGEN(R) PACKAGE INSERT
*
D. VESTING: RCG's * will vest at the *.
E. * SUBMISSION: In the event RCG adds any Affiliates still
submitting Data based on * to this Agreement, such Affiliates' *
of EPOGEN(R), for the * in which they were added, shall be
included in the calculation of B *. Amgen will accept the *. In
order for such added Affiliates' * EPOGEN(R) to be included in
all subsequent * payment calculations, such Affiliate must
submit *.
4. *. RCG shall be eligible to receive * if certain data elements are
transmitted to Amgen *. The * will be calculated as a percentage of the
* of EPOGEN(R) attributable to RCG during *. In order to qualify for the
*, the following * must be submitted to Amgen by all Affiliates *. The *
must be submitted, on a *, and *. If the * are received * within a given
*, the total * of EPOGEN(R) attributable to RCG * from the calculation
of the * for that *. Notwithstanding the foregoing, if Amgen receives
all required * within the time frame referenced above for any *, the
total * of EPOGEN(R) attributable to RCG during such *, will be * of the
* for that *. However, if Amgen determines that any Affiliate is
consistently *, Amgen and RCG will work collaboratively in resolving
such inconsistencies. Amgen reserves the right, in its sole discretion,
to exclude any such non-reporting Affiliate's * of EPOGEN(R) from the
calculation of the * for any relevant *. The * will vest on the last day
of the corresponding *, and will be paid * thereafter.
* Omitted information is the subject of a request for confidential
treatment pursuant to Rule 24b-2 under the Securities Exchange Act of
1934 and has been filed separately with the Securities and Exchange
Commission.
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AGREEMENT NO. 20010240 (CONTINUED)
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APPENDIX A: DISCOUNT PRICING, SCHEDULE, AND TERMS (CONTINUED)
5. *. RCG may qualify for the * as described below.
A. CALCULATION: RCG's * will be calculated in accordance with the
following formula.
*
* Omitted information is the subject of a request for confidential
treatment pursuant to Rule 24b-2 under the Securities Exchange
Act of 1934 and has been filed separately with the Securities
and Exchange Commission.
AGREEMENT NO. 20010240 Ver. 7/25/02
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AGREEMENT NO. 20010240 (CONTINUED)
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APPENDIX A: DISCOUNT PRICING, SCHEDULE, AND TERMS (CONTINUED)
*
B. VESTING: RCG's * will vest *. * and the * amount earned.
6. *.
* Omitted information is the subject of a request for confidential
treatment pursuant to Rule 24b-2 under the Securities Exchange Act of
1934 and has been filed separately with the Securities and Exchange
Commission.
AGREEMENT NO. 20010240 Ver. 7/25/02
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AGREEMENT NO. 20010240 (CONTINUED)
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APPENDIX B: LIST OF RCG AFFILIATES
To be Attached
TO ENSURE YOU RECEIVE THE APPROPRIATE DISCOUNT, IT IS IMPORTANT THAT WE HAVE
YOUR CURRENT LIST OF AUTHORIZED WHOLESALERS. THE FOLLOWING LIST REPRESENTS THE
WHOLESALERS AMGEN CURRENTLY HAS ASSOCIATED WITH YOUR CONTRACT. PLEASE UPDATE THE
LIST BY ADDING OR DELETING WHOLESALERS AS NECESSARY.
Metro Medical Supply Inc.
0000 Xxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Xxxxx Xxxxxx, Inc.
000 Xxxxxx Xxxx
Xxxxxxxx, XX 00000
Priority HealthCare Corporation
000 Xxxx Xxxxxxx Xxxxxxx, Xxxxx 0000
Xxxxxxxxx Xxxxxxx, XX 00000
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EXHIBIT #1
SAMPLE CERTIFICATION LETTER
Month X, 2002
FSDC Legal Name
Xxxxxx Xxxxxxx
Xxxx, XX Xxx
RE: EPOGEN(R) (Epoetin alfa) Agreement No. 9XXXXX
Dear ____________:
Thank you for your participation in *. In order for us to enroll you, we require
that a duly authorized representative of your organization sign the
certification below.
Upon receipt of this executed document, we will calculate the value of your *.
If we do not receive the executed certification, we cannot provide you with this
*.
If you have any questions regarding this letter please contact me at *. Thank
you for your assistance in returning this certification.
Sincerely,
*
CERTIFICATION:
On behalf of FSDC Legal Name and all eligible Affiliates participating in *
under Agreement No. XXXXXX, the undersigned hereby certifies that the * required
to be submitted (herein referred to as *), for each eligible Affiliate during
the term of this Agreement includes the required * from all dialysis patients
from each such Affiliate,*. The party executing this document also represents
and warrants that it (i) has no reason to believe that the submitted * is
incorrect, and (ii) is authorized to make this certification on behalf of all
eligible Affiliates submitting *.
FSDC LEGAL NAME
Signature: _____________________________
Print Name: _____________________________
Print Title: _____________________________
Date: _____________________________
* Omitted information is the subject of a request for confidential treatment
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has
been filed separately with the Securities and Exchange Commission.
AGREEMENT NO. 20010240 Ver. 7/25/02
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