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EXHIBIT 10.41
AMGEN
AMENDMENT #2 DATED MARCH 13, 2000 TO AGREEMENT XX. 000000
Xxxxxxxxx Xx. 000000, between Amgen Inc. ("Amgen") and Renal Care Group, Inc.,
including any prior amendments thereto, shall be amended and restated in its
entirety to read as stated below.
This agreement ("Agreement") 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, 2000 ("Commencement Date") through March 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. 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 participating in any other contract or incentive with
Amgen pertaining to the purchase of Epogen(R) or 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 whom 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), and/or arrange a temporary direct purchase relationship
between Dialysis Center and Amgen until such time as an alternative
Authorized Wholesaler can be secured by Dialysis Center. If Dialysis
Center purchases directly from Amgen as contemplated above, Amgen shall
be deemed an authorized Wholesaler for purposes of this Agreement.
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.
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5. QUALIFIED PURCHASES. Only EPOGEN(R) purchased under this Agreement by
Dialysis Center*.
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.
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 upon
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 prevailing * as the calculation price, except as
otherwise provided hereunder. Upon vesting, Amgen will use its best
efforts to make such discounts available within 30 days after receipt
by Amgen of data, in a form 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 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
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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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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 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. Either party may terminate this Agreement for
breach upon 30 days advance written notice. In addition, in the event
that Dialysis Center 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.
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15. COMPLIANCE WITH HEALTH CARE PRICING LEGISLATION AND STATUTES.
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
(a) terminate this Agreement, or (b) 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.
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.
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: /s/Xxxxxx Xxxxxxx Signature: /s/Xxxxxx Xxxxxxxxx
--------------------- ----------------------
Print Name: Xxxxxx Xxxxxxx Print Name: Xxxxxx Xxxxxxxxx
--------------------- ----------------------
Print Title: Print Title: Senior Vice President
--------------------- ----------------------
Date: March 15, 2000 Date: March 15, 2000
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APPENDIX A: DISCOUNT PRICING, SCHEDULE, AND TERMS
1. PRICING. * Contract prices do not include any wholesaler markup,
discount or rebate, service fees, or other charges or incentives.
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CONTRACT PRICE
NDC DESCRIPTION EFFECTIVE 4/1/2000
THROUGH 3/31/2001
(PER PACK)
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00000-000-00 S2 2,000 Xxxx, 0 mL (2,000 Units/mL) single-use vial *
10 vials/pack, 10 packs/case
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00000-000-00 S3 3,000 Xxxx, 0 mL (3,000 Units/mL) single-use vial *
10 vials/pack, 10 packs/case
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00000-000-00 S4 4,000 Xxxx, 0 mL (4,000 Units/mL) single-use vial *
10 vials/pack, 10 packs/case
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00000-000-00 S10 10,000 Xxxx, 0 mL (10,000 Units/mL) single-use vial *
10 vials/pack, 10 packs/case
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00000-000-00 S40 40,000 Xxxx, 0 mL (40,000 Units/mL) single-use vial *
10 vials/pack, 4 packs/case
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00000-000-00 M10 20,000 Xxxx, 0 mL (10,000 Units/mL) multi-use vial *
10 vials/pack, 4 packs/case
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00000-000-00 M20 20,000 Xxxx, 0 mL (20,000 Units/mL) multi-use vial *
10 vials/pack, 4 packs/case
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*
2. OPTIONAL HEMATOCRIT INCENTIVE. Dialysis Center may qualify for an
Optional Hematocrit/Hemoglobin Incentive ("OHI") provided the following
requirements are met:
a. REQUIREMENTS: 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 the same time period from the previous year.
In addition, at least * of Dialysis Center's patients must have Average
Patient Hematocrits (as defined in Section 2(b) below) greater than or
equal to * during each calendar quarter of the Term. If either of these
criteria is not met during any given calendar quarter of the Term,
Dialysis Center will not qualify for the OHI during that quarter.
In order to participate in the OHI, Dialysis Center must provide the
following to Amgen or to a data collection vendor specified by Amgen,
on a monthly basis, and no later than 30 days after the end of each
month:
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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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i) all hematocrit test results for each dialysis patient, the
date of each test, and a consistent, unique, alpha-numeric
identifier (sufficient to consistently 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"). 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 hematocrit test results
mustbe derived from blood samples taken immediately before
dialysis treatment using any automated red blood cell counter
testing method (e.g. Xxxxxxx-counter, Bayer-Technicon, Sysmex,
CellDyne), must be reported to the nearest tenth of one
percent, and must be submitted directly from the clinical
laboratory 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 "Annual 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.
b. CALCULATION: Assuming Dialysis Center has fulfilled all requirements as
described in Section 2(a) above, Dialysis Center's OHI payment will be
calculated as follows:
The "Average Patient Hematocrit" for each dialysis patient will be
based upon the average of all hematocrit test results gathered for each
patient during each calendar quarter of the Term. The Average Quarterly
Percentage of all dialysis patients with Average Patient Hematocrits
greater than or equal to * will be determined by dividing the total
number of dialysis patients with Average Patient Hematocrits greater
than or equal to * by the total number of dialysis patients treated by
Dialysis Center. The OHI will be calculated based on Dialysis Center's
overall performance in accordance with Amgen's discount calculation
policies.
c. PAYMENT: The OHI will be calculated on a quarterly basis and paid to
Dialysis Center's corporate headquarters, except as otherwise provided
hereunder. Payment is contingent upon receipt by Amgen of the "Annual
Certification Letter" and all required monthly Data for the
corresponding quarter. If Data is received more than thirty days after
the last day of any month within a given calendar quarter, the total *
of EPOGEN(R) attributable to Dialysis Center during such month will be
excluded from the calculation of the OHI for that quarter.
Notwithstanding the foregoing, if Amgen receives all required data from
a minimum of * of all entities within the definition of "Dialysis
Center" within the time frame referenced above for any month within a
given calendar quarter, the total * of EPOGEN(R) attributable to
Dialysis Center during such month, will be included in the calculation
of the OHI for that quarter. 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 OHI for any relevant quarter.
Quarterly OHI payments will be based upon the Data received from the
previous quarter, and will equal * during that quarter (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
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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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OHI schedule listed below. Notwithstanding the foregoing, payment for
any period during the Term that is not equivalent to a complete
calendar quarter, will be based on an average of the Data that is
available for that period. If the EPOGEN(R) package insert language
changes, then Amgen and Dialysis Center agree to negotiate in good
faith a reasonable amendment to the OHI provisions of this Agreement to
address any such change, if necessary. In addition, at the end of the
Term of this Agreement, Amgen will conduct an analysis to determine if
Dialysis Center has achieved the required * growth rate (contemplated
by Section 2(a) above) throughout the Term of the Agreement. If
Dialysis Center has achieved the required * growth rate, Amgen will
reconcile all previous OHI calculations and appropriately adjust the
OHI for all relevant quarters during the Term in which an OHI was not
earned.
AVERAGE QUARTERLY PERCENTAGE OF ALL DIALYSIS PATIENTS OPTIONAL HEMATOCRIT
WITH AVERAGE PATIENT HEMATOCRITS GREATER THAN OR EQUAL TO * INCENTIVE PERCENTAGE
PLEASE DIRECT YOUR ATTENTION TO THE EPOGEN(R) PACKAGE INSERT
*
d. VESTING: Dialysis Center's OHI will vest on the last day of the
corresponding quarter.
e. HEMOGLOBIN CONVERSION: Dialysis Center may choose to submit hemoglobin
test results rather than hematocrit test results as a measurement of
anemia. If during the Term, Dialysis Center elects to use hemoglobin
test results, Dialysis Center must: i) submit a "Notification Letter"
to Amgen, a sample of such Notification Letter is attached hereto as
Exhibit #2, and ii) begin submitting all hemoglobin test results for
all dialysis patients along with all other information described in
Section 2(a) above, rather than hematocrit test results for all
dialysis patients at each Affiliate for purposes of participating in
the OHI.
Amgen will accept the hemoglobin test results, multiply each test
result by *, and apply the converted results to the same schedule,
requirements, and calculations described above in place of the
hematocrit test results.
For the calendar quarter in which Dialysis Center submits its
Notification Letter ("Grace Period"), Amgen will apply Dialysis
Center's Average Quarterly Percentage from the last calendar quarter in
which complete hematocrit test results were received ("AQP-Hematocrit")
to the OHI schedule listed above in order to determine the applicable
OHI Percentage earned by Dialysis Center. If Dialysis Center's overall
performance on the OHI after the Grace Period does not equal or exceed
the overall performance by Dialysis Center prior to conversion to
hemoglobin, Amgen will continue to apply each Affiliate's
AQP-Hematocrit through the remainder of the Term, provided that during
the time period the AQP-Hematocrit is applied, *.
In the event any Affiliates still submitting Data based on hematocrit
test results are added to this Agreement after Dialysis Center has
converted to hemoglobin, such Affiliate's * of EPOGEN(R), for the
calendar quarter in which they were added, shall be included in the
calculation of the OHI payment. In order for such added Affiliates' *
of EPOGEN(R) to be included in all subsequent OHI payment calculations,
such Affiliate must submit hemoglobin test results rather than
hematocrit.
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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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3. ELECTRONIC DATA 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 each quarter. In order to
qualify for the *, the following EPOGEN(R) Related Patient Data must be
submitted by all Affiliates in an electronic format reasonably
acceptable to Amgen (such as: Excel; Lotus 123.wk1; or text file that
is tab delimited, comma delimited, or space delimited): Facility ID,
Patient ID (sufficient to consistently track an individual patient
without in any way disclosing the identity of the patient), Draw Date,
Hematocrit, Hemoglobin, Transferrin Saturation, and Ferritin. Such
EPOGEN(R) Related Patient Data must be submitted, on a monthly basis,
and no later than 30 days after the end of each month. If such
EPOGEN(R) Related Patient Data is received more than thirty days after
the last day of any month within a given calendar quarter, the total *
of EPOGEN(R) attributable to Dialysis Center during such month will be
excluded from the calculation of the * for that quarter.
Notwithstanding the foregoing, if Amgen receives all required data from
a minimum of * of all entities within the definition of "Dialysis
Center" within the time frame referenced above for any month within a
given calendar quarter, the total * of EPOGEN(R) attributable to
Dialysis Center during such month, will be included in the calculation
of the * for that quarter. 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 relevant quarter.
The Electronic Data Discount will vest on the last day of the
corresponding quarter, and will be paid 30 days thereafter.
4. VOLUME PERFORMANCE INCENTIVE. Dialysis Center may qualify for the
Volume Performance Incentive ("VPI") as described below.
a. CALCULATION: Dialysis Center's VPI will be calculated in accordance
with the following formula.
*
Estimated payments will be made quarterly using Amgen's discount
calculation policies, and the VPI will be reconciled at the end of the
Term.
b. VESTING: Dialysis Center's VPI will vest quarterly.
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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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APPENDIX B: LIST OF DIALYSIS CENTER AFFILIATES
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
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EXHIBIT #1
SAMPLE ANNUAL CERTIFICATION LETTER
Month X, 199X
FSDC Legal Name
Xxxxxx Xxxxxxx
Xxxx, XX Xxx
RE: EPOGEN(R) (Epoetin alfa) Agreement No. 9XXXXX
Dear ____________:
Thank you for your participation in the Optional Hematocrit/Hemoglobin Incentive
Program. In order for us to enroll you, we require that a duly authorized
representative of your organization sign the certification below.
Upon receipt of this executed document, we will calculate the value of your
incentive. If we do not receive the executed certification, we cannot provide
you with this incentive.
If you have any questions regarding this letter please contact me at
(000) 000-0000. Thank you for your assistance in returning this certification.
Sincerely,
Xxx Xxxxx
Outcomes Incentive Analyst
CERTIFICATION:
On behalf of FSDC Legal Name and all eligible Affiliates participating in the
Optional Hematocrit/Hemoglobin Incentive Program under Agreement No. XXXXXX, the
undersigned hereby certifies that the hematocrit/hemoglobin data and any other
data required to be submitted (herein referred to as "Data"), for each eligible
Affiliate during the term of this Agreement includes the required Data from all
dialysis patients from each such Affiliate, and does not include Data from
non-patients. The party executing this document also represents and warrants
that it (i) has no reason to believe that the submitted Data is incorrect, and
(ii) is authorized to make this certification on behalf of all eligible
Affiliates submitting Data.
FSDC LEGAL NAME
Signature: _____________________________
Print Name: _____________________________
Print Title: _____________________________
Date: _____________________________
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EXHIBIT #2
SAMPLE NOTIFICATION LETTER
Month X, 199X
Xx. Xxx Xxxxx
Outcomes Incentive Analyst
Amgen Inc./Contract Sales Department
One Amgen Center Drive/Mail Stop 37-2-A
Xxxxxxxx Xxxx, XX 00000
RE: Amgen Agreement No. XXXXXX
Dear Xx. Xxxxx:
This letter serves as notification that FSDC Legal Name and all eligible
Affiliates participating in the Optional Hematocrit/Hemoglobin Incentive Program
under Agreement No. XXXXXX, will begin using hemoglobin test results as a
measurement of anemia as of Month X, 199X, and will begin submitting hemoglobin
test results rather than hematocrit test results for purposes of participating
in the Optional Hematocrit/Hemoglobin Incentive Program.
We understand that any discount under the Optional Hematocrit/Hemoglobin
Incentive Program will now be based solely on hemoglobin test results and that
hematocrit test results will no longer be accepted. We also understand that such
hemoglobin test results will be converted and applied to the same schedule,
requirements, and calculations described in the Optional Hematocrit/Hemoglobin
Incentive Program outlined in the Agreement.
Sincerely,
Name of Administrator
Title