EXHIBIT 10.33
[AMGEN LOG] AGREEMENT NO. 20010240
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This agreement ("Agreement"), together with all appendices attached hereto and
incorporated herein by this reference, between Amgen Inc. ("Amgen") and Renal
Care Group, Inc., ("RCG"), sets forth the terms and conditions for the purchase
of EPOGEN(R)(Epoetin alfa) by RCG for the exclusive 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, 2002
("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 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.
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 shall be included 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 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.
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.
* 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 - 1 - Ver. 10/8/01
AGREEMENT NO. 20010240 (CONTINUED)
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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 * 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 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.
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 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.
* 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 - 2 - Ver. 10/8/01
AGREEMENT NO. 20010240 (CONTINUED)
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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 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. 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 30 days' notice, provided that if Amgen so terminates an
incentive, RCG 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 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.
* 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 - 3 - Ver. 10/8/01
AGREEMENT NO. 20010240 (CONTINUED)
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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:
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Print Name: Print Name:
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Print Title: Print Title:
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Date: Date:
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AGREEMENT XX. 00000000 - 0 - Xxx. 10/8/01
AGREEMENT NO. 20010240 (CONTINUED)
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APPENDIX A: DISCOUNT PRICING, SCHEDULE, AND TERMS
1. PRICING. Throughout 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 the date of *. 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. *. RCG may qualify for a * provided it meets the criteria described
below in this section. * is designed to improve patient outcomes by
encouraging the * which recommends *.
A. REQUIREMENTS: In order to qualify for *, RCG'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 the
*. In addition, no more than * may have * during each *
quarter 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 *.
In order to participate in *, RCG 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 * 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
APPENDIX A: DISCOUNT PRICING, SCHEDULE, AND TERMS (CONTINUED)
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.
B. CALCULATION: Assuming RCG has fulfilled all requirements as
described in Section 2(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: The * 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 * for the *. 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
* 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 - 5 - Ver. 10/8/01
AGREEMENT NO. 20010240 (CONTINUED)
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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 the * 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 *. In addition, at the end of
the Term of this Agreement, Amgen will conduct an analysis to
determine if RCG has achieved the *. If at the end of the Term
* then Amgen *. However, if at the end of the Term, *.
APPENDIX A: DISCOUNT PRICING, SCHEDULE, AND TERMS (CONTINUED)
* ALL DIALYSIS PATIENTS *
WITH * INCENTIVE PERCENTAGE
*
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 * payment. Amgen will accept
the *. In order for such added Affiliates' * EPOGEN(R) to be
included in all subsequent * payment calculations, such
Affiliate must submit *.
3. PARTNER INFORMATION PROGRAM *. RCG shall be eligible to receive * if
certain data elements are transmitted to Amgen electronically. 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 *. Such * must be submitted, on a
*, and *. If such * is 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 * discount 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 * EPOGEN(R)from the
calculation of the * for any relevant * will vest on the last day of
the corresponding calendar *, 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.
AGREEMENT NO. 20010240 - 6 - Ver. 10/8/01
AGREEMENT NO. 20010240 (CONTINUED)
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APPENDIX A: DISCOUNT PRICING, SCHEDULE, AND TERMS (CONTINUED)
4. *. RCG may qualify for * as described below.
A. CALCULATION: RCG's * will be calculated in accordance with the
following formula. *
B. VESTING: RCG's * will vest * and the * amount earned.
* 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 - 7 - Ver. 10/8/01
AGREEMENT NO. 20010240 (CONTINUED)
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5. *.
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
* 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 - 8 - Ver. 10/8/01
AGREEMENT NO. 20010240 (CONTINUED)
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EXHIBIT #1
SAMPLE CERTIFICATION LETTER
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 *. 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:
* 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 - 9 - Ver. 10/8/01
AGREEMENT NO. 20010240 (CONTINUED)
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On behalf of FSDC Legal Name and all eligible Affiliates participating in the *
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:
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Print Name:
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Print Title:
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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.
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