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EXHIBIT 10.33
[AMGEN LOGO] AMENDMENT #3 DATED JANUARY 30, 2001 TO AGREEMENT NO. 980202
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Agreement No. 980202, between Amgen Inc. ("Amgen") and Renal Care Group, Inc.,
including any prior amendments thereto, shall be amended and for the period
commencing April 1, 2001 shall be restated in its entirety to read as stated
below.
This agreement ("Agreement") together with all Appendices attached hereto and
incorporated herein by this reference, between Amgen Inc. ("Amgen") and Renal
Care Group, Inc., including the freestanding dialysis center affiliate(s) listed
on Appendix B (collectively, "Dialysis Center"), sets forth the terms and
conditions for the purchase of EPOGEN(R) (Epoetin alfa) by Dialysis Center for
the exclusive treatment of dialysis patients.
1. TERM OF AGREEMENT. The "Term" of this Agreement shall be defined as
April 1, 2001("Commencement Date") through December 31, 2001
("Termination Date").
2. DIALYSIS CENTER AFFILIATES. Dialysis Center must provide Amgen with a
complete list of its dialysis center affiliates ("Affiliates") on or
before the date this Agreement is executed by Dialysis Center. Only
those Affiliates approved by Amgen and referenced in Appendix B will be
eligible to participate under this Agreement. Modifications to the
dialysis center Affiliates listed on Appendix B may be made pursuant to
the request of Dialysis Center's corporate headquarters and are subject
to approval and acknowledgment by Amgen in writing. In order to allow
Amgen the appropriate time to undergo through such approval process and
to provide the Authorized Wholesalers (as defined below in Section 4)
with the appropriate lead time to set up and account for any addition
or deletion of Affiliates, Amgen requires no less than 30 days' notice
before the effective date of change for any addition or deletion of
Affiliates hereunder. Amgen reserves the right to accept, reject, or
immediately terminate any Affiliates with regard to participation in
this Agreement if Amgen determines that such Affiliate is not
classified as a freestanding dialysis center or a home dialysis support
facility.
3. OWN USE. Dialysis Center hereby certifies that EPOGEN(R)purchased
hereunder shall be for Dialysis Center's "own use", for the exclusive
treatment of dialysis patients.
4. AUTHORIZED WHOLESALERS. Dialysis Center must provide Amgen with a
complete list of its current wholesalers, from which Dialysis Center
intends to purchase EPOGEN(R), and must provide the list to Amgen on or
before the date this Agreement is executed by Dialysis Center's
corporate headquarters. The list must include the name and complete
address of each designated wholesaler. Wholesalers designated by
Dialysis Center and approved by Amgen to participate in this program
will be deemed "Authorized Wholesalers". A current listing of Dialysis
Center's Authorized Wholesalers is referenced in Appendix B.
Notification of proposed changes to the list of Authorized Wholesalers
must be provided to Amgen in writing at least 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 Dialysis Center is purchasing
EPOGEN(R), Amgen will work with Dialysis Center to identify other
possible Authorized Wholesalers from which Dialysis Center may purchase
EPOGEN(R) * Dialysis Center 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.
5. QUALIFIED PURCHASES. Only EPOGEN(R)purchased under this Agreement by
Dialysis Center through Authorized Wholesalers, at the contract prices
set forth herein, as confirmed by Amgen based on sales tracking data,
will be deemed "Qualified Purchases".
6. COMMITMENT TO PURCHASE. Dialysis Center agrees to purchase EPOGEN(R)
for all of its dialysis use requirements for recombinant human
erythropoietin. Dialysis Center 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 Dialysis
Center's corporate headquarters in writing that Amgen cannot supply
EPOGEN(R) within and for the time period reasonably required by
Dialysis Center.
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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. 980202 -1-
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AMENDMENT #3 TO AGREEMENT NO. 980202 (CONTINUED)
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7. CONFIDENTIALITY. Both Amgen and Dialysis Center 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. Dialysis Center 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
Dialysis Center's corporate headquarters. Discounts in arrears will be
calculated in accordance with Amgen's discount calculation policies
based on * using the * as the calculation price, except as otherwise
provided hereunder. Upon vesting, 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. Payment amounts, as calculated by Amgen, must equal
or exceed $100.00 for the applicable period to qualify. Subject to the
section entitled "Breach of Agreement", in the event that Amgen is
notified in writing that Dialysis Center, and/or any Affiliates (the
"Acquiree") is acquired by another entity or a change of control
otherwise occurs with respect to the Acquiree, any discounts which may
have been earned hereunder shall be paid in the form of a check payable
to the Acquiree'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 Dialysis
Center'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. Dialysis Center 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). Dialysis Center 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. Dialysis
Center's corporate headquarters agrees that it will advise all
Affiliates, in writing, of any discount received by Dialysis Center'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.
10. DATA COLLECTION. Dialysis Center 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. Dialysis Center 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. Dialysis Center 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, Dialysis
Center 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
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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. 980202 -2-
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AMENDMENT #3 TO AGREEMENT NO. 980202 (CONTINUED)
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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 30 days' advance written notice. In addition, in the event that
Dialysis Center 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 Dialysis Center.
12. GOVERNING LAW. This Agreement shall be governed by the laws of the
State of California and the parties 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 Dialysis Center
specifically warrants and represents to Amgen that he is authorized to
execute this Agreement on behalf of and has the power to bind Dialysis
Center 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 Dialysis Center 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 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 contemplated under this Agreement, either party may, in its
discretion, upon 30 days' notice, seek to modify this Agreement with
respect to the affected incentive. Dialysis Center 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 30 days' notice, provided that if Amgen so terminates an
incentive, Dialysis Center shall be entitled to terminate this
Agreement upon 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
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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. 980202 -3-
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AMENDMENT #3 TO AGREEMENT NO. 980202 (CONTINUED)
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disobedience, epidemics, 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 constitutes 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 INC. RENAL CARE GROUP, INC.
Signature: Signature:
------------------------ ------------------------
Print Name: Print Name:
------------------------ ------------------------
Print Title: Print Title:
------------------------ ------------------------
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. 980202 -4-
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AMENDMENT #3 TO AGREEMENT NO. 980202 (CONTINUED)
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APPENDIX A: DISCOUNT PRICING, SCHEDULE, AND TERMS
1. PRICING. Throughout the Term of this Agreement (April 1, 2001 -
December 31, 2001), Dialysis Center may purchase EPOGEN(R) through * at
an * which shall be equal to * . Amgen reserves the right to change the
* at any time, which change shall * Dialysis Center 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 upon the *
2. * . Dialysis Center may qualify for a * (" * ") provided it meets the
criteria described below in this section. The * is designed to improve
patient outcomes by encouraging * which recommends * .
A. REQUIREMENTS: In order to qualify for the * , Dialysis
Center's aggregate * of EPOGEN(R) by all Affiliates as listed
on Appendix B on the Commencement Date of this Agreement must
equal or exceed * of the aggregate * of EPOGEN(R) by those
same Affiliates for * . In addition, * Dialysis Center's * may
have * during * of the Term. If either of these criteria is
not met during * of the Term, Dialysis Center will not qualify
for the * during that * .
In order to participate in the * , Dialysis Center must
provide the following to Amgen or to a data collection vendor
specified by Amgen, on * , 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 * test results must be derived from * taken immediately
before dialysis treatment using any * testing method * , must
be reported to the * , and must be submitted * in a format
reasonably acceptable to Amgen. Hand written reports are not
acceptable; electronic submission of the Data is preferred,
and
ii) a properly executed "Certification Letter", a sample of which
is attached hereto as Exhibit #1, that will be provided to
Dialysis Center'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 Dialysis Center has fulfilled all
requirements as described in Section 2(a) above, Dialysis
Center's * payment 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 * by the total number of dialysis patients treated by
Dialysis Center. * will be calculated based on Dialysis
Center's overall performance in accordance with Amgen's
discount calculation policies.
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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. 980202 -5-
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AMENDMENT #3 TO AGREEMENT NO. 980202 (CONTINUED)
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C. PAYMENT: The * will be calculated on * basis and paid to
Dialysis Center's corporate headquarters, except as otherwise
provided hereunder. Payment is contingent upon receipt by
Amgen of the "Certification Letter" and all required * for the
* . If Data is received more than * after * , the total * of
EPOGEN(R)attributable to Dialysis Center during * 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 of the * for any * . *
payments will be based upon the Data received from the * , and
will equal a percentage of Dialysis Center's total * Purchases
of EPOGEN(R)during that * (exclusive of any * of EPOGEN(R)made
by Dialysis Center or any Affiliate not meeting the Data
submission requirements described above) as governed by the *
schedule listed below. *
* OF ALL DIALYSIS PATIENTS *
WITH * INCENTIVE PERCENTAGE
PLEASE DIRECT YOUR ATTENTION TO THE EPOGEN(R) PACKAGE INSERT
*
D. VESTING: Dialysis Center's * will vest on * .
APPENDIX A: DISCOUNT PRICING, SCHEDULE, AND TERMS (CONTINUED)
E. * SUBMISSION: In the event Dialysis Center 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 the * payment.
Amgen will accept the * . In order for such added Affiliates'
* of EPOGEN(R) to be included in all subsequent * payment
calculations, such Affiliate must submit * .
3. * DISCOUNT. Dialysis Center shall be eligible to receive a * if certain
data elements are transmitted to Amgen electronically. The * will be
calculated as a percentage of the * of EPOGEN(R) attributable to
Dialysis Center during* . In order to qualify for the *, the following
* must be submitted by all Affiliates * reasonably acceptable to Amgen
* . Such * must be submitted, on * , and * . If such * are received *
within * , the total * of EPOGEN(R) attributable to Dialysis Center * .
* . However, if Amgen determines that any Affiliate is consistently not
submitting the * , Amgen reserves the right in its sole discretion to
exclude such Affiliate's * of EPOGEN(R) from the calculation of the *
for * . * .
4. * . Dialysis Center may qualify for the * ("*") as described below.
A. CALCULATION: Dialysis Center's * will be calculated in
accordance with the following formula.
*
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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. 980202 -6-
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AMENDMENT #3 TO AGREEMENT NO. 980202 (CONTINUED)
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*
B. VESTING: Dialysis Center's * will vest * .
APPENDIX B: LIST OF DIALYSIS CENTER AFFILIATES
See 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
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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. 980202 -7-
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AMENDMENT #3 TO AGREEMENT NO. 980202 (CONTINUED)
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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
SAMPLE CERTIFICATION LETTER
EXHIBIT #1
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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. 980202 -8-
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AMENDMENT #3 TO AGREEMENT NO. 980202 (CONTINUED)
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Month X, 2001
FSDC Legal Name
Xxxxxx Xxxxxxx
Xxxx, XX Xxx
RE: EPOGEN(R) (Epoetin alfa) Agreement No. 9XXXXX
Dear ____________:
Thank you for your participation in the * 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 *
Program 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: _____________________________
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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. 980202 -9-
