EXHIBIT 10.19.3
AMGEN AMENDMENT NO. 1 RENAL CARE GROUP, INC. AGREEMENT
NO. 200308361
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The undersigned hereby agree to amend Agreement No. 200308361 (the "Agreement")
between Amgen USA Inc., located at Xxx Xxxxx Xxxxxx Xxxxx, Xxxxxxxx Xxxx,
Xxxxxxxxxx 00000 ("Amgen") and Renal Care Group, Inc., located at 0000 Xxxx Xxx
Xxxxxx, Xxxxx 000, Xxxxxxxxx, Xxxxxxxxx 00000 ("RCG") including any prior
amendments thereto, as stated below.
WHEREAS, Amgen and RCG entered into Agreement No. 200308361 effective January 1,
2004;
WHEREAS, the Agreement sets forth the terms and conditions for the purchase of
EPOGEN(R) (Epoetin alfa) and Aranesp(R) (darbepoetin alfa) (collectively,
"Products") by RCG, exclusively for the treatment of dialysis patients; and
WHEREAS, the parties wish to amend this Agreement to modify the term of the
Agreement, offer a Commitment Incentive for the period Amended Date through
December 31, 2004, modify rebate programs for the period January 1, 2005 through
December 31, 2005, and offer new rebates for the period January 1, 2005 through
December 31, 2005.
NOW THEREFORE, in consideration of the premises and of the mutual covenants,
representations and warranties set forth herein, the parties agree as follows:
SECTION 1. AMENDMENT AND RESTATEMENT OF THE GENERAL TERMS AND CONDITIONS - THE
GENERAL TERMS AND CONDITIONS OF THE AGREEMENT SHALL BE AMENDED AND RESTATED IN
THEIR ENTIRETY EFFECTIVE AS FOLLOWS ON DECEMBER 1, 2004 PROVIDED RCG EXECUTES
THIS AMENDED AGREEMENT ON OR BEFORE DECEMBER 1, 2004 ("AMENDED DATE"). IF RCG
EXECUTES THIS AMENDED AGREEMENT AFTER DECEMBER 1, 2004, THE AMENDED DATE SHALL
BE THE DATE ON WHICH THE PARTY LAST TO EXECUTE THIS AMENDED AGREEMENT HAS
EXECUTED THIS AMENDED AGREEMENT.
1. TERM OF AGREEMENT. The "Term" of this Agreement shall be defined as
January 1, 2004 ("Commencement Date") through December 31, 2005
("Termination Date").
2. RCG AFFILIATES. RCG must provide Amgen with a complete list of its
dialysis center affiliates ("Affiliates") on 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 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 home dialysis support facility or if Amgen determines such
Affiliate is a party to another purchase agreement for EPOGEN(R) or
Aranesp(R) with Amgen.
3. AFFILIATE ACQUISITIONS. Should RCG acquire additional Affiliates during
the Term, and such acquisitions result in an aggregate incremental
increase in total prior year base sales by more than * Million Dollars
($*), then Amgen and RCG agree to meet and in good faith review the
Agreement in light of the evolving business conditions. For purposes of
this section, base sales will be derived using the rolling twelve (12)
month period immediately
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* Omitted information is the subject of a request for confidential treatment
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has been
filed separately with the Securities and Exchange Commission.
AMENDMENT NO. 1 AGREEMENT NO. 200308361 (CONTINUED)
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preceding the Affiliate acquisition that causes RCG to meet the *
Million Dollars ($*) limitation, and using the * in effect at *.
4. OWN USE. RCG hereby certifies that Products purchased hereunder shall
be for RCG's "own use", for the exclusive treatment of dialysis
patients.
5. AUTHORIZED WHOLESALERS. Attached hereto as Appendix C is a complete
list, as of the date of execution of this Amendment, of the wholesalers
from which RCG intends to purchase Products pursuant to this Agreement.
All of the wholesalers so designated by RCG are hereby approved by
Amgen to participate in this program and are deemed "Authorized
Wholesalers". 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 Products, Amgen will work with RCG to identify other
possible Authorized Wholesalers from which RCG may purchase Products.
In the event that RCG is unable to identify another Authorized
Wholesaler from which RCG may purchase Products, 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.
6. QUALIFIED PURCHASES. Only Products purchased under this Agreement by
RCG through *.
7. COMMITMENT TO PURCHASE. RCG agrees to exclusively purchase Products for
all of its dialysis use requirements for erythropoietic stimulating
protein. RCG may purchase another brand of erythropoietic stimulating
protein 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 Products within and for the time
period reasonably required by RCG or for use by any Affiliate that has
been rejected or excluded by Amgen from participating in this Agreement
pursuant to any provision of this Agreement.
8. 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.
9. 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
prevailing * 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 no later than * after receipt by Amgen of complete
and machine readable data, in a form acceptable to Amgen, detailing all
* during the applicable period. Discount amounts, as calculated by
Amgen, must equal or exceed $* for the applicable period to qualify.
Subject to Section 12, 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
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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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AMENDMENT NO. 1 AGREEMENT NO. 200308361 (CONTINUED)
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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.
10. 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.
11. DATA COLLECTION. RCG agrees all data to be provided to Amgen pursuant
to this Agreement shall be in a form that does not disclose the
identity of any patient or any other patient-identifying information
such as name, address, telephone number, birth date, all or part of a
social security number, medical record number or prescription number.
RCG and Amgen agree to use and accept only those patient identifiers
compliant with the federal medical privacy standards codified under 45
C.F.R. parts 160 and 164 pursuant to the Health Insurance Portability
and Accountability Act ("HIPAA"). RCG acknowledges 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 Products 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 part or all of 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 it will maintain data supplied under
this Agreement in confidence and 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.
12. 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. Upon termination of this
Agreement by Amgen in accordance with this Section 12, Amgen shall have
no obligation to continue to offer the terms described herein or pay
any further discounts to RCG.
13. 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.
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. The party executing this
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AMENDMENT NO. 1 AGREEMENT NO. 200308361 (CONTINUED)
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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.
15. 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.
16. COMPLIANCE WITH HEALTH CARE PRICING AND PATIENT PRIVACY LEGISLATION AND
STATUTES; DATA USE AGREEMENT.
(a) Notwithstanding anything contained herein to the contrary, at any
time following the enactment of any federal, state, or local law,
regulation, policy, program memorandum or other interpretation,
modification or utilization guideline by any governmental payer that in
any manner reforms, modifies, alters, restricts, or otherwise affects
the pricing of or reimbursement available for Products, including but
not limited to a reimbursement or use decision, by Centers for Medicare
and Medicaid Services ("CMS") or one of its contractors (Carriers or
Fiscal Intermediaries), Amgen may, in its sole discretion, upon thirty
(30) days notice, (i) terminate this Agreement, (ii) modify any pricing
or discount terms contained herein, or (iii) exclude any Affiliates
from participating in this Agreement. Without limiting the foregoing,
any change, modification or further clarification to the Medicare
Modernization Act or any rules or regulations promulgated thereunder,
or the Hematocrit Measurement Audit Program Memorandum that occurs
subsequent to the Amended Date would specifically trigger the right to
the termination or modification referenced herein. Additionally, to
assure compliance with any existing federal, state or local statute,
regulation or ordinance, Amgen reserves the right, in its sole
discretion, to exclude any Affiliates from the pricing and discount
provisions of this Agreement and/or to reasonably modify any pricing or
discount terms contained herein. In the event there is a future change
in Medicare, Medicaid, or other federal or state statute(s) or
regulation(s) 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 or regulation. In the event Amgen chooses
to invoke the provisions contained in this Section 16(a), Amgen agrees
to enter into good faith discussions pertaining to modification of the
existing agreement or entering into a new agreement, as applicable.
(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 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 or upon such date that the law
or regulation requires, provided that, if Amgen so terminates an
incentive, RCG shall be entitled to terminate this Agreement upon
thirty (30) days notice.
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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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AMENDMENT NO. 1 AGREEMENT NO. 200308361 (CONTINUED)
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(c) Notwithstanding anything contained herein to the contrary, this
Agreement is effective only as of the date the parties hereto execute a
mutually agreeable Data Use Agreement pursuant to which RCG may
disclose a Limited Data Set of patient information to Amgen (as
specified in the Data Use Agreement and which shall include, at a
minimum, the data fields to be received by Amgen in connection with
this Agreement) for purposes of Amgen's Healthcare Operations,
Research, and Public Health analyses, and RCG's Healthcare Operations.
Unless otherwise specifically defined in this Agreement, each
capitalized term used in this Section 16(c) shall have the meaning
assigned to such term by HIPAA. If RCG terminates the Data Use
Agreement for any reason, Amgen shall be entitled to terminate this
Agreement immediately.
17. 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.
18. RIGHT OF FIRST OFFER. RCG shall promptly notify Amgen in the event it
receives a competing offer from any third party for the sale of
products in the same therapeutic class as the Products. Amgen shall
have the right in such event to have forty-five (45) days to respond to
RCG with its own pricing terms relating to products.
19. MISCELLANEOUS. No modification of this Agreement will be effective
unless mutually agreed upon, 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.
(a) Beginning *, RCG's * by all Affiliates listed on Appendix B on the
Amended Date of this Agreement during any * of this Agreement shall *
of the * by those same Affiliates for the * . RCG shall not be eligible
to receive any rebates detailed in Appendix A of this Agreement for any
* in the aggregate made during any * of this Agreement that * of the *
by those same Affiliates in the *. Any of RCG's aggregate * of the * by
those same Affiliates in the * may be approved and eligible to receive
rebates detailed in Appendix A if *. Such determination must be
approved by *. For purposes of determining the foregoing, during the
period *, Products base sales during each applicable time period shall
be derived using the *.
20. 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 and periods
of time covered herein.
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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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AMENDMENT NO. 1 AGREEMENT NO. 200308361 (CONTINUED)
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Please retain one fully executed original for your records and return the other
fully executed original to Amgen.
THE PARTIES EXECUTED THIS AMENDMENT AND RESTATEMENT OF THE AGREEMENT AS OF THE
DATES SET FORTH BELOW.
AMGEN USA INC. RENAL CARE GROUP, INC.
Signature: /s/ Xxxx Xxxxx Signature: /s/ Xxxxx X. Xxxx
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Print Name: Xxxx Xxxxx Print Name: Xxxxx X. Xxxx
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Print Title: Dir. U.S. Corporate Pricing Print Title: EVP and CFO
--------------------------- ---------------------
Date: 12/2/04 Date: 12/1/2004
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AMENDMENT NO. 1 AGREEMENT NO. 200308361 (CONTINUED)
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SECTION 2. AMENDMENT AND RESTATEMENT OF APPENDIX A: DISCOUNT PRICING,
SCHEDULE AND TERMS.
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APPENDIX A: *
APPENDIX A: DISCOUNT PRICING, SCHEDULE, AND TERMS
1. PRICING - ARANESP(R). RCG and Affiliates may purchase Aranesp(R)
(darbepoetin alfa) through * at a * off of the prevailing *. Amgen
reserves the right to change the * at any time. Resulting prices do not
include *.
2. PRICING - EPOGEN(R). RCG and Affiliates may purchase EPOGEN(R) (Epoetin
alfa) directly from Amgen or through * at a *, subject to the terms and
conditions of Section 3 below. Amgen reserves the right to change the *
at any time. Resulting prices do not include *. All discounts earned in
arrears hereunder (also known as "rebates"), through the Term of the
Agreement, shall be calculated based upon*.
3. REBATE/INCENTIVE QUALIFICATION REQUIREMENTS.
(a) *: In order for RCG to be eligible to receive any rebates or
incentives described in Section 4 and Section 7 of this Appendix A, RCG
must satisfy the following qualification requirement. No more than *
may have * during each * during the Term of this Agreement *. If this
criteria is not met during any * of the Term of the Agreement, RCG will
not qualify for any rebates described in Section 4 and Section 7 of
this Appendix A during that *. Failure of RCG to qualify under this
provision during a particular *. The * for each dialysis patient will
be based upon the average of all * for each patient during each *. RCG
and Affiliates must provide the following information for each dialysis
patient to Amgen or to a data collection vendor specified by Amgen, on
a *, and no later than * after *: all * for each dialysis patient, the
date of each *, and a consistent, unique, alpha-numeric identifier
(sufficient consistently to track an individual patient without in any
way violating the de-identification provisions of HIPAA at 45 CFR
164.514), along with the name, address and phone number of the
particular Affiliate at which each patient received treatment. To the
extent permitted by applicable law, Amgen may utilize the data detailed
in this provision for any purpose, and reserves the right to audit all
such data. Under no circumstances should such data include any patient
identifiable information including, without limitation, name, all or
part of social security number, address, medical record number, or
prescription number. 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
automated * method *, must be reported to *, and must be submitted
directly from the clinical laboratory in a format acceptable to Amgen.
Handwritten reports are not acceptable; only machine readable
submission of the data will be accepted; and
(b) *: In order for RCG to be eligible to receive any rebates or
incentives described in Section 7 of this Appendix A, RCG must satisfy
the following qualification requirement. RCG's * of EPOGEN(R) and
Aranesp(R) during * and during * by all Affiliates listed on Appendix B
on the Commencement Date of this Agreement and those added at the
beginning of * must equal or exceed * and * respectively *, of the * of
EPOGEN(R) and Aranesp(R) by those same Affiliates for the time period
from *, for *, and from * for *. For purposes of calculating the *,
EPOGEN(R) and Aranesp(R) base sales during each applicable time period
shall be derived using the * in effect at the Commencement Date. All
estimated payments for discounts in arrears that contain growth
requirements will be measured by using a *. If RCG has not satisfied
the * for any particular *, then *. The determination as to RCG's
attainment or failure to attain the * shall be based upon the * in
effect on the Commencement Date.
4. *. RCG may qualify for the * during each * (as defined in the schedule
below) as described in this Section 4 of Appendix A.
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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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AMENDMENT NO. 1 AGREEMENT NO. 200308361 (CONTINUED)
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(a) REQUIREMENT: In order to qualify for the * RCG must meet the *
contained in Section 3(a) of this Appendix A. If this criteria is not
met during any * during the period *, RCG will not qualify for *
described below in this Section 4 during that *.
(b) CALCULATION: RCG's * will be calculated in accordance with the
following formula and the * listed below. * will be calculated on a *.
(c) * . The * schedule is as follows:
(d) PAYMENT. Estimated payments will be made * using *.
(e) VESTING. RCG's * will vest at *.
5. PARTNER INFORMATION PROGRAM *. For the Term of the Agreement RCG shall
be eligible to receive a * provided certain data elements are
transmitted to Amgen electronically. The * will be calculated as * of
EPOGEN(R) attributable to RCG during each *. To qualify for the *, the
following * must be submitted to Amgen by RCG and all Affiliates * :
*
(a) For the period *, the following * shall be added as requirements of
the *:
*
(b) For the period *, the following * shall be removed a
requirement of the *: *
Such * must be submitted, on a *, and no later than * after *. If such
* is received more than * after *, the * of EPOGEN(R) attributable to
RCG during such * will be excluded from the calculation of the * for
that * . Notwithstanding the foregoing, if Amgen receives all required
* from * within the time frame referenced above for any * within a
given *, the * of EPOGEN(R) attributable to RCG and all Affiliates
during such *, will be included in the calculation of the * for that *.
6. *. The purpose of the * is to improve the transmission, quality and
validation of all data sent from RCG and its Affiliates and received by
Amgen, such that the processes used by both companies are more
efficient and timely. For the period * RCG shall be eligible to receive
a * provided the following requirements below are met. The * will be
calculated as * of EPOGEN(R) attributable to RCG during each *.
(a) To qualify for * for the period *, the following requirements must
be met:
i) RCG must *;
ii) RCG must *.
(b) To qualify for the * for the period * , the following additional
requirements must be met:
i) RCG must *;
ii) RCG and Amgen must mutually agree upon *:
o *;
o *;
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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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AMENDMENT NO. 1 AGREEMENT NO. 200308361 (CONTINUED)
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o *;
o *;
o *;
o *;
o *.
o *.
(c) To qualify for * for the period *, RCG must additionally achieve
the * goals as set forth in *.
The * referenced in this Section 6(a)(i) must be submitted, on *, and
no later than * after *. If such * is received more than * after *, the
* of EPOGEN(R) attributable to RCG during such * will be excluded from
the calculation of the * for that *.
The * will vest * on the * and be paid * in accordance with the terms
and conditions described above.
7. *. For the Term of the Agreement, RCG may qualify for the * provided it
meets the criteria described below in this Section 7. The * is designed
to improve patient outcomes by encouraging an increase in the number of
patients managed within both the * set forth in the * which recommends
a target * and a *.
(a) Requirements: In order to qualify for the * , RCG must meet the
Rebate/Incentive Qualification Requirements contained in Section 3 of
this Appendix A, and RCG and its Affiliates must provide Amgen the
following data items, on a * , and no later than * after *, in a * . In
the event * is submitted, instead of *, Amgen will convert such * to *
by *. Amgen will convert all * for each patient by RCG and its
Affiliates, AND all the * for each patient by RCG and its Affiliates
into the * for each patient by RCG and its Affiliates, AND the * for
each patient by RCG and its Affiliates for each of the * (as defined in
the schedule immediately below). RCG hereby certifies that the *
submitted for each eligible Affiliate includes the required results
from all dialysis patients of such Affiliate, and does not include
results from non-patients. RCG 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 *.
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(b) Calculation: Assuming RCG and Affiliates have fulfilled all
requirements as described in Section 7(a) above, to qualify for the *,
RCG must achieve an increase in the *, as that term is defined below,
from the *, as that term is defined below, during each *, and such
increase shall be defined as *.
For purposes of this Section 7, * shall mean * for each patient by RCG
and its Affiliates AND the * for each patient by RCG and its Affiliates
during the period *; and * shall mean * for each patient by RCG and its
Affiliates AND * for each patient by RCG and its Affiliates for each of
the above referenced *.
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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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AMENDMENT NO. 1 AGREEMENT NO. 200308361 (CONTINUED)
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Using the * described above, the * will be calculated as the *, as
shown below:
*
*
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*
Using the * described above, which shall be calculated on a *, the *
for each * will be calculated as the *, as shown below:
*
*
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*
The * shall then be calculated by *, as shown below:
*
The * will be calculated on a * in accordance with *. Following
determination of the *, Amgen shall then calculate RCG's * in
accordance with the following formula and the * listed below:
*
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*
*
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* * *
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* * *
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* * *
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* * *
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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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AMENDMENT NO. 1 AGREEMENT NO. 200308361 (CONTINUED)
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* * *
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* * *
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(c) Payment: The * will be calculated and paid to RCG on a *. Payment
is contingent upon *. Such * must be submitted, on a *, and no later
than * after *. If such * is received more than * after * within a
given *, the * of EPOGEN(R) attributable to RCG during such * will be
excluded from the calculation of the *. Notwithstanding the foregoing,
if Amgen receives all required * from * within the time frame
referenced above for any * within a *, the * of EPOGEN(R) attributable
to RCG and all Affiliates during such *, will be included in the
calculation of the *. However, if Amgen determines that any Affiliate
is consistently not submitting the required *
The * will vest * on the * and * respectively, and be paid * in
accordance with the terms and conditions described above.
8. * . For the period *, RCG may qualify for * as outlined below.
(a) Calculation: *
(b) Payment and Vesting: The * will vest on the * and will be paid
within * after *.
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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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AMENDMENT NO. 1 AGREEMENT NO. 200308361 (CONTINUED)
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APPENDIX B: LIST OF RCG AFFILIATES
(To be provided by RCG)
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AMENDMENT NO. 1 AGREEMENT NO. 200308361 (CONTINUED)
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APPENDIX C: LIST OF WHOLESALERS
TO ENSURE RCG RECEIVES THE APPROPRIATE DISCOUNT, IT IS IMPORTANT AMGEN RECEIVES
RCG'S CURRENT LIST OF AUTHORIZED WHOLESALERS. THE FOLLOWING LIST REPRESENTS THE
WHOLESALERS AMGEN CURRENTLY HAS ASSOCIATED WITH RCG'S CONTRACT. PLEASE UPDATE
THE LIST BY ADDING OR DELETING WHOLESALERS AS NECESSARY.
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