EXHIBIT 10.3
AMAGEN
FREESTANDING DIALYSIS CENTER AGREEMENT
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This Agreement ("Agreement"), between Amgen USA Inc. ("Amgen") and National
Medical Care, Inc. including all subsidiaries and affiliates that are at least
fifty and one-tenth percent (50.10%) owned by National Medical Care, Inc. and
listed on Appendix B (collectively, "NMC"), sets forth the terms and conditions
for the purchase of EPOGEN(R) (Epoetin alfa) and Aranesp(TM) (darbepoetin alfa)
(collectively, "Products") by NMC, exclusively for the treatment of dialysis
patients.
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. QUALIFIED PURCHASES. All terms contained herein apply only to purchases
made hereunder, as confirmed by Amgen ("Qualified Purchases"), by NMC and,
subject to the terms of Section 11, all Affiliates (as such term is defined
in Section 11 below) opened, acquired, or managed by NMC during the Term,
for so long as such Affiliates remain at least fifty and one-tenth percent
(50.10%) owned or managed by National Medical Care, Inc., through
wholesalers chosen by NMC and authorized by Amgen to participate in the
program ("Authorized Wholesalers") or directly from Amgen. In addition, and
also subject to the terms of Section 11, Renaissance Health Care, Inc.,
Optimal Renal Care, L.L.C., Integrated Renal Care of the Pacific, and/or
any joint venture of NMC in which NMC holds at least a fifty and one-tenth
percent (50.10%) ownership interest, will also be eligible to participate,
although not required to purchase under this Agreement. Amgen agrees to
reasonably approve Authorized Wholesalers requested by NMC. The option to
purchase on a direct basis from Amgen is subject to receipt and approval,
not to be unreasonably withheld, of an "Application for Direct Ship
Account".
3. PRICING. See Appendix A.
4. PAYMENT TERMS. The terms and conditions of this Agreement shall apply
whether NMC and/or Affiliates purchase Products through an Authorized
Wholesaler or from Amgen directly.
5. DISCOUNT. Amgen will pay discounts and incentives in accordance with the
schedule and terms set forth in Appendix A attached hereto.
6. PAYMENT OF DISCOUNTS. Any discount (hereinafter defined as including a
discount at time of purchase, rebate, incentive or other concession
impacting the total pricing of a Product) earned hereunder which is
applicable to purchases of EPOGEN(R) shall be calculated in accordance with
this Agreement, based on Qualified Purchases, using [*] as the basis for
the calculation price, and shall be paid in the form of a [*] to National
Medical Care Inc.'s corporate headquarters, except as otherwise provided
hereunder. Any discount earned hereunder which is applicable to purchases
of Aranesp(TM) used to treat dialysis patients shall be calculated in
accordance with this Agreement, based on Qualified Purchases, using [*] as
the basis for the calculation price. NMC and Affiliates shall make
available to Amgen any records concerning NMC's and Affiliates' purchase
amounts that Amgen or its auditors may reasonably request for purposes of
verifying discounts. [*]. In the event of a discrepancy between data
provided by NMC and that provided by an Authorized Wholesaler, verifiable
data submitted by NMC shall be used. Amgen will use its best efforts to
make any discount (excluding discounts at time of purchase) pursuant to
this Agreement available in accordance with the terms referenced in
Appendix A. Availability of discounts is contingent upon Amgen receiving
all relevant purchase data from all Authorized Wholesalers designated by
NMC, in a form reasonably acceptable to Amgen, detailing NMC's and
Affiliates' Qualified Purchases of Products for the relevant period, along
with any other data required by the terms of Appendix A. In the event of
any purchases directly from Amgen, all such purchase data shall be included
in the calculation of all discounts. In no event shall Amgen pay any
discount on Products distributed by NMC or Affiliates to non-Affiliates of
NMC. In the event that Amgen is notified in writing that National Medical
Care, Inc. and/or any of its subsidiaries or Affiliates (the "Acquiree") is
acquired by another entity or a change of control otherwise occurs with
respect to the Acquiree, any discount or rebate which may have been earned
and vested hereunder prior to the effective date of the acquisition shall
be paid in the form of a [*] to National Medical Care Inc.'s corporate
headquarters subject to the conditions described herein.
7. TREATMENT OF DISCOUNTS. The parties agree that they will account for any
discount or rebate earned hereunder 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, and if required by such statutes or regulations
(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
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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. NMC agrees that it
will advise all Affiliates, in writing, of any discount received by
National Medical Care's corporate headquarters hereunder with respect to
purchases made by such Affiliates and that NMC will advise said Affiliates
as to their requirement to account for any such discount in accordance with
the above stated requirements.
8. COMMITMENT TO PURCHASE. NMC and Affiliates agrees to purchase EPOGEN(R) for
all of its dialysis use requirements in the United States, Puerto Rico and
Guam for recombinant human erythropoietin. Amgen agrees to make such
EPOGEN(R) available to NMC and Affiliates through its Authorized
Wholesalers or directly from Amgen. In addition to other remedies available
to NMC and Affiliates, NMC and Affiliates may purchase another brand of
recombinant human erythropoietin for its dialysis use requirements in the
United States, Puerto Rico and Guam if, and only if, NMC and/or any
Affiliates have informed Amgen, in writing, that NMC and Affiliates are
unable to acquire sufficient amounts of EPOGEN(R) to meet NMC's and
Affiliates' reasonable dialysis use requirements, and Amgen by itself, or
through its Authorized Wholesalers, is actually unable to supply NMC and
Affiliates with their reasonable dialysis use requirements of EPOGEN(R)
within the time period reasonably required by NMC and Affiliates, which, in
no event will be less than five (5) business days after Amgen's receipt of
NMC's and Affiliates' written notice. If the preceding requirements are
met, NMC and Affiliates will only be allowed to purchase another brand of
recombinant human erythropoietin for the time period, and to the extent,
that Amgen is unable to provide NMC and Affiliates with EPOGEN(R) to meet
NMC's and Affiliates' reasonable dialysis use requirements.
9. OWN USE. NMC hereby certifies that Products purchased hereunder will be for
the "own use" by NMC and the Affiliates of NMC. NMC hereby further
certifies that all of the Products purchased hereunder shall be for the
exclusive use of treating dialysis patients.
10. AUTHORIZED WHOLESALERS. A complete list of NMC's and Affiliates' current
Authorized Wholesalers, through which NMC and Affiliates may purchase
Products hereunder is attached as Appendix C. NMC and Affiliates agree to
promptly provide Amgen with any additions, deletions, or changes to the
initial list of Authorized Wholesalers. Amgen requires no less than 30 days
notice before the effective date of change for any addition or deletion of
Authorized Wholesalers hereunder. Any proposed changes to the initial list
of Authorized Wholesalers must be in writing and are subject to reasonable
approval by Amgen.
11. SUBSIDIARIES AND AFFILIATES. Within thirty (30) days of execution of this
Agreement, NMC shall provide a current listing of all affiliates, and other
entities, that will be participating in this Agreement, designating which
affiliates are owned and/or managed by NMC. Affiliates so designated by NMC
and approved by Amgen will be deemed "Affiliates" for the purposes of this
Agreement. Subsequent to approval and acceptance by Amgen, a list of
Affiliates shall be
attached to this Agreement as Appendix B and incorporated herein. Only
those Affiliates approved by Amgen and referenced in Appendix B will be
eligible to participate under this Agreement. Any NMC managed Affiliate, or
other entity with an existing contract, may participate in either their
existing agreement with Amgen, or this Agreement, but not both. Each
managed Affiliate or entity must declare under which single Amgen contract
it will participate. Only Qualified Purchases under this Agreement will be
used in the calculation of pricing, discounts or other incentives under
this Agreement. NMC will notify Amgen of changes to Appendix B, and the
effective date of change. Such effective date of change may not be earlier
than the date the notice is received by Amgen. Any proposed change to
Appendix B will be subject to the reasonable approval of Amgen based upon
Amgen's then current legal and contractual requirements, and such proposed
affiliate's classification as a freestanding dialysis center or a home
dialysis support facility.
12. TERMINATION. If either party materially breaches this Agreement, then the
other party may terminate this Agreement upon thirty (30) days advance
written notice. In the event that NMC materially breaches any provision of
this Agreement, Amgen shall have no obligation to continue to offer the
terms described herein or pay any further unvested discounts to NMC. [*].
[*].
13. CONFIDENTIALITY. Both Amgen and NMC agree that this Agreement represents
and contains confidential information which will 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 or court order. In the event NMC believes it is
obligated to disclose any such information as required by law or court
order, NMC will provide Amgen with prior written notice and an
opportunity to seek a protective order and NMC shall furnish only that
portion of the information that its counsel advises is required to be
disclosed by law.
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14. 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. NMC represents and
warrants that it has the power to bind National Medical Care, Inc. and the
subsidiaries and owned Affiliates listed on Appendix B to the terms
contained herein. NMC shall cause each managed Affiliate to be bound by the
terms and conditions of this Agreement through the execution of a joinder
agreement executed between NMC and each such managed Affiliate.
15. GOVERNING LAW. This Agreement will be governed by the laws of the State of
Delaware and the parties submit to the jurisdiction of Delaware courts,
both state and federal.
16. NOTICES. Any notice or other communication required or permitted hereunder
will be in writing and shall be deemed given or made when delivered in
person or when received by the other party sent by U.S. Mail, return
receipt requested, at the respective party's address set forth below or at
such other address as the party shall have furnished to the other in
accordance with this provision.
17. 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 materially reforms, modifies, alters, restricts, or
otherwise affects the pricing of or reimbursement available for any of the
Products, including a reimbursement or use decision by Centers for Medicare
and Medicaid Services ("CMS"), either party may initiate good faith
negotiations to modify this Agreement. If the parties, after 30 days, are
unable to agree upon such a modification (i) either party may terminate
this Agreement immediately, or (ii) Amgen may exclude any owned or managed
Affiliates from participating in this
Agreement unless such owned or managed Affiliate(s) certifies in writing
that they are, or will be, exempt from the provisions of such enacted law
or regulation. Additionally, in order to assure compliance with any
existing federal, state or local statute, regulation or ordinance, Amgen
reserves the right, in its reasonable discretion, to exclude any owned or
managed Affiliates from the pricing, discount, and incentive provisions of
this Agreement. In the event there is a future change in Medicare,
Medicaid, or other federal or state statutes or regulations or in the
interpretation thereof, which renders any of the material terms of this
Agreement unlawful or unenforceable, this Agreement shall continue only if
amended by the parties as a result of good faith negotiations as necessary
to bring the Agreement into compliance with such statute and regulation.
b) Notwithstanding anything contained herein to the contrary, in order to
assure compliance, as determined by either party in its reasonable
discretion, with any existing federal, state or local statute, regulation
or ordinance relating to patient privacy of medical records, or 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 contemplated
under this Agreement, either party may upon thirty (30) days' notice, seek
to modify this Agreement. NMC 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, [*]. If the parties in good faith determine that such
modification is not possible, the parties shall seek to modify the
Agreement in another manner acceptable to both parties. If the parties,
after a reasonable time, are unable to agree upon such a modification,
Amgen shall be entitled to terminate the affected incentive upon thirty
(30) days' notice or upon the date such change in law or regulation goes
into effect, whichever is earlier. [*].
18. INSURANCE AND INDEMNITY. During the Term of this Agreement, Amgen shall
insure coverage of its obligations hereunder consistent with Amgen
corporate policy through such programs of self-insurance and/or policies of
general liability insurance through third-party carriers as Amgen shall
determine in its sole discretion. Amgen agrees to indemnify, defend and
hold harmless NMC and its respective employees, officers and directors from
and against any and all liabilities, losses, claims, or costs, including
reasonable attorneys' fees, which result directly from Direct Product (as
such term is defined in Section 20 herein) which as of the date of shipment
by Amgen: (i) contain defects in material and workmanship, (ii) are
adulterated or misbranded within the meaning of applicable provisions of
the Federal Food, Drug and Cosmetic Act (the "FDC Act"), or (iii) are
prohibited from being introduced into interstate commerce by Section 301 of
the FDC Act or Section 351 of the Public Health Service Act; provided that
such indemnity shall not apply to claims arising out of the negligent or
willful actions or omissions of NMC or its agents, employees,
representatives, successors or assigns or due to defects in the Direct
Product caused by persons other than Amgen which
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FREESTANDING DIALYSIS CENTER AGREEMENT
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result from neglect, misuse, unauthorized adulteration or modification,
improper testing, handling or storage or any cause beyond the range of
normal usage; and further provided that (a) Amgen is promptly notified in
writing of any such claim, (b) Amgen shall have sole control of the defense
and settlement thereof, and (c) NMC cooperates fully and gives Amgen all
requested information and assistance for such defense. Notwithstanding the
foregoing, Amgen shall not be liable for loss of profit or loss of use,
incidental or consequential damages arising out of any claim asserted by
NMC under this Agreement or otherwise. The preceding paragraph sets forth
NMC's sole remedy for claims of Product defect, adulteration or
misbranding.
19. MISCELLANEOUS. No modification of this Agreement shall be effective unless
made in writing and signed by a duly authorized representative of each
party. This Agreement constitutes the entire agreement of the parties
pertaining to the subject matter hereof and supersedes all prior written
and oral agreements and understandings pertaining hereto including without
limitation, any previous or existing contract or amendment for the purchase
of Products for use in the treatment of dialysis patients. Neither party
shall have the right to assign this Agreement to a third party without the
prior written consent of the other party provided, however, that Amgen may
assign this Agreement to any of its subsidiaries or affiliates without the
written consent of NMC. Neither party shall be liable for delays in
performance and nonperformance of this Agreement or any covenant contained
herein caused by fire, flood, storm, earthquake or other act of God, war,
terrorist acts, rebellion, riot, failure of carriers to furnish
transportation, strike, lockout or other labor disturbances, act of
government authority, inability to obtain material or equipment, or any
other cause of like or different nature beyond the control of such party.
However, during any time of nonperformance by Amgen which involves NMC's
and Affiliates' inability to obtain sufficient Products to meet NMC's and
Affiliates' reasonable dialysis use requirements, the [*] for such
nonperformance, [*] and NMC and Affiliates may purchase Products from
another supplier. The parties shall execute and deliver all documents,
provide all information, and take or refrain from taking action as may be
necessary or appropriate to achieve the purposes of this Agreement. 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 constitutes one
and the same agreement. Amgen reserves the right to rescind this offer if
the parties fail to execute this Agreement within thirty (30) days from the
date of its offering.
20. DIRECT PURCHASE OF PRODUCTS. NMC may purchase XXXXXX(X) X00, 20,000U, 1mL
vials, NDC 00000-000-00 packaged as ten (10) vials per pack and four (4)
packs per case and Aranesp(TM) 25 mcg, 1.0 mL vials, NDC 00000-000-00
packaged as four (4) vials per pack and ten (10) packs per case, 40 mcg,
1.0 mL vials, NDC 00000-000-00 packaged as four (4) vials per pack and ten
(10) packs per case, 60 mcg, 1.0 mL vials, NDC 00000-000-00 packaged as
four (4) vials per pack and ten (10) packs per case, 100 mcg, 1.0 mL vials,
NDC 00000-000-00 packaged as four (4) vials per pack and ten (10) packs per
case, and 200 mcg, 1.0 mL vials, NDC 00000-000-00 packaged as one (1) vial
per pack and four (4) packs per case, (the "Direct Product") on a direct
basis from Amgen in accordance with the terms set forth under Appendix D
which is incorporated herein by reference.
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. NATIONAL MEDICAL CARE, INC.
Signature: /s/ Xxxxxxx Xxxxxxx Signature: /s/ Xxx Xxxxx
--------------------------------- ------------------------------
Print Name: Xxxxxxx Xxxxxxx Print Name: Xxx Xxxxx
--------------------------------- ------------------------------
Print Title: Vice President and General Manager Print Title: President
---------------------------------- ------------------------------
Date: February 14, 2002 Date:
---------------------------------- ------------------------------
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APPENDIX A: DISCOUNT PRICING, SCHEDULE, AND TERMS
1. PRICING - ARANESP(TM). NMC and Affiliates may purchase Aranesp(TM)through
Authorized Wholesalers [*]. [*]. [*].
2. PRICING - EPOGEN(R). NMC and Affiliates may purchase EPOGEN(R) directly
from Amgen or through Authorized Wholesalers [*] during the period from the
Commencement Date through December 31, 2002 ("CY1"). NMC and Affiliates may
purchase EPOGEN(R) directly from Amgen or through Authorized Wholesalers
[*] during the period from January 1, 2003 through December 31, 2003
("CY2"). [*]. [*].
3. BASE SALES FOR 2001. For purposes of calculating growth in CY1, Amgen will
compare the [*]. For purposes of calculating growth in CY2, Amgen will
compare the [*]. Aggregated Qualified Purchases of EPOGEN(R) for calendar
year 2001 shall be calculated [*]. Total aggregate Qualified Purchases for
CY1 and CY2 shall be calculated using [*]. [*]
4. [*].
5. [*] For the period beginning January 1, 2002 and ending March 31, 2002 NMC
shall be eligible to receive a [*] if certain data elements are transmitted
to Amgen [*]. Beginning April 1, 2002 through the remainder of the Term of
the Agreement, the [*]. [*]
6. [*]. NMC may qualify for [*] provided it meets the criteria described
below:
a. CALCULATION: NMC's [*] will be calculated in accordance with the
following formula and with the [*] listed below:
[*].
[*]
For the purposes of calculating [*], Amgen will incorporate purchases of
any newly created facility (but not facilities added through acquisition).
[*].
b. VESTING: Notwithstanding the foregoing, NMC's [*] will vest annually
on the [*], and will be paid in accordance with the terms and
conditions described above.
7. [*], NMC and Affiliates may qualify for a [*] provided it meets the
criteria described below in this Section. [*].
a. REQUIREMENTS: In order to qualify for [*], NMC must provide Amgen [*].
b. CALCULATION: Assuming NMC has fulfilled all requirements as described
in Section 7(a) above, the [*] for NMC will be calculated as follows:
[*].
c. PAYMENT: The [*] will be calculated on a [*] basis and paid to NMC's
corporate headquarters, except as otherwise provided hereunder. [*].
d. VESTING: Notwithstanding the foregoing, NMC's [*] will vest annually
on [*], and will be paid in accordance with the terms and conditions
described above.
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APPENDIX B: LIST OF NMC SUBSIDIARIES AND AFFILIATES
SUBSIDIARIES:
Bio-Medical Applications Management Co., Inc. and its subsidiaries
Dialysis America, Georgia, LLC.
Xxxxx, Inc.
Integrated Renal Care of the Pacific, LLC.
Infusion Care, Inc.
National Medical Care HomeCare Division, Inc.
Renal Research Institute, LLC.
SRC Holding Company, Inc. and its subsidiaries
Everest Healthcare Holdings, Inc. and its subsidiaries
Extracorporeal Alliance/CVR
Fresenius Medical Care Pharmacy Services, Inc.
AFFILIATES:
See Contract List Attached
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APPENDIX C: LIST OF NMC AUTHORIZED WHOLESALERS
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.
Bergen Xxxxxxxx Corporation
0000 Xxxxxxxxxxxx Xxxxx
Xxxxxx, XX 00000
X.X. Xxxxxx Inc.
Xxxxx X - Xxxx Xx. 00
Xxxxxxxx, XX 00000
Metro Medical Supply, Inc.
0000 Xxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Bellco Drug Corporation
000 Xxxx Xxxxxxx Xxxxxx
Xxxxxxxxxxx, XX 00000
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APPENDIX D: TERMS FOR PURCHASE OF DIRECT PRODUCT
Pursuant to Section 19 of the Agreement, the terms under which NMC may purchase
Products on a direct basis from Amgen are as follows:
1. ORDERS/INVOICES. NMC will transmit orders and receive corresponding
invoices via electronic data interchange ("EDI") in
Orders may be submitted via facsimile, mail, or telephone to the address
and telephone/fax numbers listed below. [*].
[*].
Amgen Customer Service may be reached at the following address and phone
numbers:
Amgen USA Inc.
CUSTOMER SERVICE DEPARTMENT FAX 0-000-000-0000
One Amgen Center Drive Tel: 0-000-000-0000
Xxxxxxxx Xxxx, XX 00000-0000
2. SHIPPING, TRANSPORTATION AND CHARGES. [*].
3. TITLE AND RISK OF LOSS. [*].
4. PRICING FOR DIRECT PRODUCT. NMC may purchase Direct Product from Amgen on
a direct basis in accordance with Appendix A of the Agreement.
5. TERMS OF PAYMENT. NMC agrees to pay for Direct Product ordered, at
terms of [*].
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APPENDIX E: LIST OF APPROVED DISTRIBUTION CENTERS
Fresenius USA Manufacturing, Inc.
d/b/a Nephromed and affiliates
00 Xxxxxx Xxxxxx
Xxxxxxxxx, XX 00000-0000
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EXHIBIT #1
SAMPLE CERTIFICATION LETTER
Month X, 2002
FSDC Legal Name
Xxxxxx Xxxxxxx
Xxxx, XX Xxx
RE: Agreement No. _________________
Dear ____________:
Thank you for your participation in the [*] Incentive Program. 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
incentive. If we do not receive the executed certification, we cannot provide
you with this incentive.
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 the
[*] Incentive Program under Agreement No. __________ , the undersigned hereby
certifies that the [*] data submitted for each eligible Affiliate includes the
required [*] results from all dialysis patients of such Affiliate, and does not
include [*] results from non-patients. The party executing this document also
represents and warrants that it (i) has no reason to believe that the submitted
[*] data is incorrect, and (ii) is authorized to make this certification on
behalf of all eligible Affiliates submitting [*] data.
FSDC LEGAL NAME
Signature: _____________________________
Print Name: _____________________________
Print Title: _____________________________
Date: _____________________________
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