EXHIBIT 10.33.1
AMGEN AMENDMENT #2 DATED FEBRUARY 10, 2003 TO AGREEMENT NO. 20010240
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This Amendment to Agreement No. 20010240 is being entered between Amgen USA
Inc., Xxx Xxxxx Xxxxxx Xxxxx, Xxxxxxxx Xxxx, Xxxxxxxxxx 00000 ("Amgen") and
Renal Care Group, 0000 Xxxx Xxx Xxxxxx, Xxxxx 000, Xxxxxxxxx, Xxxxxxxxx 00000
including all affiliates that are listed on Appendix B (collectively, "RCG").
WHEREAS, Amgen and RCG entered into Agreement No. 20010240 effective
January 1, 2002: and
WHEREAS, the parties now wish to amend the Agreement No. 20010240 to
incorporate the terms and conditions for the purchase of Aranesp(R)
(darbepoetin alfa) exclusively for the treatment of dialysiS patients,
and to modify certain incentive option provisions.
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. DEFINITIONS; REFERENCES. Unless otherwise specifically defined
herein, each term used in this Amendment which is defined in the Agreement
shall have the meaning assigned to such term in the Agreement. Except as
amended and supplemented hereby, all of the terms of the Agreement are
incorporated herein by reference, shall remain and continue in full force
and effect, and are hereby ratified and confirmed in all respects.
SECTION 2. AMENDMENT TO XXXXXXX 0, XXXXXXXX XXXXXX AFFILIATES. Section 2 is
hereby amended for the period April 1, 2003 through December 31, 2003, as
follows:
2. DIALYSIS CENTER AFFILIATES. Only those Affiliates approved by Amgen and
referenced in Appendix B hereto will be eligible to participate under
this Agreement. Modifications to the dialysis center Affiliates included in
Appendix B may be made pursuant to the request of RCG's corporate
headquarters and are subject to approval and acknowledgment by Amgen in
writing. Notification of proposed changes to the list of Affiliates
must be provided by RCG to Amgen in writing at least thirty (30) days
before the effective date of the proposed change. Amgen reserves the
right to accept, reject, or immediately terminate any Affiliates with
regard to participation in this Agreement, if Amgen reasonably determines
that such Affiliate is not properly classified as a freestanding dialysis
center or * or if Amgen determines such Affiliate is a party to another *
for EPOGEN(R) (Epoetin alfa)) or Aranesp(R) with Amgen.
SECTION 3. AMENDMENT TO SECTION 3, OWN USE. Section 3 is hereby amended for the
period April 1, 2003 through December 31, 2003, as follows:
3. OWN USE. RCG hereby certifies that EPOGEN(R) and Aranesp(R) (collectively,
"Products") purchased hereunder shall be for RCG's "own use", for the
exclusive treatment of dialysis patients.
SECTION 4. AMENDMENT TO SECTION 4, AUTHORIZED WHOLESALERS. Section 4 is hereby
amended for the period April 1, 2003 through December 31, 2003, as follows:
4. 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. 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 *.
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* Omitted information is the subject of a request for confidential treatment
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has been
filed separately with the Securities and Exchange Commission.
AGREEMENT NO. 20010240
AMENDMENT #2 DATED FEBRUARY 10, 2003 TO AGREEMENT NO. 20010240
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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.
SECTION 5. AMENDMENT TO SECTION 5, QUALIFIED PURCHASES. Section 5 is hereby
amended for the period April 1, 2003 through December 31, 2003, as follows:
5. QUALIFIED PURCHASES. Only Products purchased under this Agreement by RCG
through *.
SECTION 6. AMENDMENT TO SECTION 6, COMMITMENT TO PURCHASE. Section 6 is hereby
amended for the period April 1, 2003 through December 31, 2003, as follows:
6. COMMITMENT TO PURCHASE. RCG agrees to purchase Products 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
Products within and for the time period reasonably required by RCG.
SECTION 7. AMENDMENT TO SECTION 10, DATA COLLECTION. Section 10 is hereby
amended for the period April 1, 2003 through December 31, 2003, as follows:
10. 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 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 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.
SECTION 8. AMENDMENT TO SECTION 15, COMPLIANCE WITH HEALTH CARE PRICING AND
PATIENT PRIVACY LEGISLATION AND STATUTES. Section 15 is hereby amended and
restated for the period April 1, 2003 through December 31, 2003, as
follows:
15. 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 or
regulation that in any manner reforms, modifies, alters, restricts, or
otherwise affects the pricing of or
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* Omitted information is the subject of a request for confidential treatment
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has been
filed separately with the Securities and Exchange Commission.
AGREEMENT NO. 20010240
AMENDMENT #2 DATED FEBRUARY 10, 2003 TO AGREEMENT NO. 20010240
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reimbursement available for Products, including but not limited to a
reimbursement or use decision by Centers for Medicare and Medicaid Services
("CMS"), Amgen may, in its sole discretion, exclude any Affiliates from
participating in this Agreement upon thirty (30) days notice, unless such
Affiliates certifies in writing that they are, or will be, exempt from the
provisions thereunder. 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.
(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, whichever is earlier.
(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 * and * analyses and RCG's Health Care Operations. Unless otherwise
specifically defined in this Agreement, each capitalized term used in this
Section 15(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.
SECTION 9. AMENDMENT TO APPENDIX A. DISCOUNT PRICING, SCHEDULE, AND TERMS.
Appendix A is hereby amended for the period April 1, 2003 through December
31, 2003, as follows:
1. PRICING - ARANESP(R). During the *, RCG may purchase Aranesp(R) through *
at a *. Amgen reserves the right to change the * at any time. Resulting
prices do not include *. *.
2. PRICING - EPOGEN(R). During the *, RCG may purchase EPOGEN(R) through * at
an *, which shall be equal * IN effect on *. Amgen reserves the right to
change the * at any time, which change shall * RCG during the Term of this
Agreement. Resulting prices do not include *. All discounts earned in
arrears during the * shall be calculated based *.
3. BASE SALES; SALES GROWTH CALCULATION. For purposes of * from *, Amgen will
* for the * by all Affiliates listed on Appendix B on the effective date of
this Amendment and, as provided for in this Section 2, all new approved
Affiliates. For new approved Affiliates added through acquisition, * by
such new approved Affiliates shall only be * if RCG provides adequate data
to Amgen's reasonable satisfaction concerning such new approved Affiliates'
*. *.
4. *. RCG may qualify for * provided it meets the * defined below and the
criteria described below in this section. * is designed to improve patient
outcomes by encouraging * which recommends *.*
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* Omitted information is the subject of a request for confidential treatment
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has been
filed separately with the Securities and Exchange Commission.
AGREEMENT NO. 20010240
AMENDMENT #2 DATED FEBRUARY 10, 2003 TO AGREEMENT NO. 20010240
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A. REQUIREMENTS: In order to qualify for *, RCG's aggregate * of EPOGEN(R)
during * and aggregate * of EPOGEN(R) and Aranesp(R) during * by all
Affiliates as listed on Appendix B on the effective date of this Amendment
must *, of the
aggregate * of EPOGEN(R) by those same Affiliates *. In addition, no more
than * may have * during each * oF the Term. If either of these criteria is
not met during any given * of the Term, RCG will not qualify for the *
during that *. Failure of RCG to qualify for the * during a particular *.
If at the end of * the * has been met, then Amgen * for * and appropriately
* for those relevant * during * in which a * was not *. However, if at the
end of * the * has not been met, * for *. * will be made by Amgen or RCG,
as the case may be, within * after the end of *, *. In order to participate
*, RCG and Affiliates must provide the following information for each
dialysis patient to Amgen or to a data collection vendor specified by Amgen
*, and * after the *:
i) all * for each dialysis patient, the date of each test, and a
consistent, unique, alphanumeric 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
(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, 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 * testing method
(*), must be reported *, and must be submitted directly from the
clinical laboratory in a format reasonably acceptable to Amgen.
Handwritten reports are not acceptable; only electronic submission
of the Data will be accepted, and
ii) upon execution of this Amendment, RCG shall simultaneously provide
to Amgen an executed "Certification Letter", a copy of which is
attached hereto as Exhibit #1. Amgen hereby acknowledges that it
has received such required Certification Letter, in a form and
substance satisfactory to Amgen. Delivery of such Certification
Letter shall serve to qualify RCG's participation in the *
throughout the * of this Agreement for the limited purpose of
certification of the accuracy of the data submitted to Amgen
hereunder.
B. CALCULATION: Assuming RCG has fulfilled all requirements as described in
Section 4(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 * of all dialysis patients with *, will be
determined by dividing the total number of dialysis patients with *. * will be
calculated based on RCG's overall performance in accordance with Amgen's
discount calculation policies.
C. PAYMENT: * will be calculated on a * and paid to RCG's corporate
headquarters, except as otherwise provided hereunder. Payment is contingent upon
receipt by Amgen of the "Certification Letter" and *. If Data is received more
than * after *, the total * of EPOGEN(R) and Aranesp(R) attributable to RCG
during * for that *. Notwithstanding the foregoing, if Amgen receives all
required Data from * of all Affiliates within the time frame referenced above
for *, the total * of EPOGEN(R) and Aranesp(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) anD Aranesp(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) and Aranesp(R) during that * (exclusive of any * of
EPOGEN(R) AND Aranesp(R) made by RCG or any Affiliate not meeting the Data
submission requirements described above) as governeD by * schedule listed below.
Notwithstanding the foregoing, payment for any period during the * that is not
equivalent to a * will be based *. If the EPOGEN(R) or Aranesp(R) * or the *,
then Amgen and RCG agree *. * above.
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* Omitted information is the subject of a request for confidential treatment
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has been
filed separately with the Securities and Exchange Commission.
AGREEMENT NO. 20010240
AMENDMENT #2 DATED FEBRUARY 10, 2003 TO AGREEMENT NO. 20010240
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* SCHEDULE
*
PLEASE DIRECT YOUR ATTENTION TO THE EPOGEN(R) PACKAGE INSERT
*
D. VESTING: RCG's * will vest at the *.
E. * SUBMISSION: To participate in the *, RCG must * submit *, rather than
*. Such * must be submitted for all dialysis patients at each Affiliate
along with all other information described in Section 4(a) above. Amgen no
longer accepts *.
5. *. RCG shall be eligible to receive * if certain data elements are
transmitted to Amgen *. The * will be calculated as a percentage of the
* of EPOGEN(R)attributable to RCG during *. In order to qualify for the
*, the following * must be submitted to Amgen by all Affiliates pursuant to
Section 15(c) *. The * must be submitted, on a *, and *. If the * are
received * within a given *, the total * of EPOGEN(R) attributable to
RCG * from the calculation of the * for that *. Notwithstanding the
foregoing, if Amgen receives all required * within the time frame
referenced above for any *, the total * of EPOGEN(R)attributable to RCG
during such *, will be * of the * for that *. However, if Amgen determines
that any Affiliate is consistently *, Amgen and RCG will work *. Amgen
reserves the right, in its sole discretion, to exclude any such
non-reporting Affiliate's * of EPOGEN(R) from the calculation of the *
for any relevant *. The * will vest on the last day of the corresponding *,
and will be paid * thereafter.
6. *. RCG may qualify for the * as described below.
A. CALCULATION: RCG'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. 20010240
AMENDMENT #2 DATED FEBRUARY 10, 2003 TO AGREEMENT NO. 20010240
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B. VESTING: RCG's * will vest *. * and the * amount earned.
7. *
Please retain one fully executed original for your records and return the other
fully executed original to Amgen.
THE PARTIES EXECUTED THIS AMENDMENT AS OF THE DATES SET FORTH BELOW.
AMGEN USA INC. RENAL CARE GROUP, INC.
Signature: Signature:
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Print Name: Print Name:
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Print Title: Print Title:
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Date: Date:
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* Omitted information is the subject of a request for confidential treatment
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has been
filed separately with the Securities and Exchange Commission.
AGREEMENT NO. 20010240
AMENDMENT #2 DATED FEBRUARY 10, 2003 TO AGREEMENT NO. 20010240
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APPENDIX B: LIST OF RCG AFFILIATES
To be Attached
TO ENSURE YOU RECEIVE THE APPROPRIATE DISCOUNT, IT IS IMPORTANT THAT WE HAVE
YOUR CURRENT LIST OF AUTHORIZED WHOLESALERS. THE FOLLOWING LIST REPRESENTS THE
WHOLESALERS AMGEN CURRENTLY HAS ASSOCIATED WITH YOUR CONTRACT.. PLEASE UPDATE
THE LIST BY ADDING OR DELETING WHOLESALERS AS NECESSARY.
Metro Medical Supply Inc.
0000 Xxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
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AGREEMENT NO. 20010240
Exhibit #1
Sample Certification Letter
, 2003
Renal Care Group, Inc.
0000 Xxxx Xxx Xxxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
RE: Amendment #2 to Agreement No. 20010240
Dear :
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Thank you for your participation in *. In order for us to enroll you, we require
that a duly authorized representative of your organization sign the
certification below.
Upon receipt of this executed document, we will calculate the value of your *.
If we do not receive the executed certification, we cannot provide you with this
*.
If you have any questions regarding this letter please contact me at *. Thank
you for your assistance in returning this certification.
Sincerely,
*
*
CERTIFICATION:
On behalf of Renal Care Group, Inc., and all eligible Affiliates participating
in * under Agreement No. 20010240, 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.
AGREEMENT NO. 20010240
