Sourcing and Supply Agreement – Amgen Inc.
Note: Redacted portions have been marked with [*]. The
redacted portions are subject to a request for
confidential treatment that has been filed with the Securities
and Exchange Commission.
SOURCING AND SUPPLY AGREEMENT
This Sourcing and Supply Agreement (this “Agreement”) is made by and between
Amgen USA Inc. (“Amgen”), a wholly-owned subsidiary of Amgen Inc., and DaVita
Inc. (“Dialysis Center”) to set forth the terms and conditions upon which
Dialysis Center Purchasers shall purchase EPOGEN ® (Epoetin alfa) and
Amgen shall provide discounts and pay rebates to Dialysis Center on EPOGEN. Each
of Amgen and Dialysis Center are referred to herein as a “Party” and
together as the “Parties“. Amgen Inc. is a party to this Agreement for
the purposes set forth in Sections 3.1, 8.2, 9.4, 9.5.1, and 11.14 of
this Agreement. Capitalized terms used herein and not otherwise defined herein
shall have the meaning set forth in Section 1.
RECITALS
WHEREAS, Amgen is a leading innovator in the field of ESAs
with expertise in the field of anemia management and the ability to manufacture
and supply safe and efficacious ESAs for the treatment of dialysis patients;
WHEREAS, Dialysis Center is a leading provider of dialysis
services in the Territory with expertise in establishing and delivering
state-of-the-art, quality-of-care standards, practices and procedures for the
care of patients undergoing dialysis;
WHEREAS, Dialysis Center desires to select one ESA supplier
to meet its primary ESA needs on a long term basis for patients undergoing
dialysis;
WHEREAS, Dialysis Center has evaluated the ESAs available
for commercial use and those in clinical development, including potential [*]
ESAs, and has determined that EPOGEN ® (Epoetin alfa) will be its
preferred ESA for managing anemia for patients undergoing dialysis;
WHEREAS, the Parties wish to enter into this Agreement to,
among other things, provide for Dialysis Center’s selection of Amgen as the
Dialysis Center Purchasers’ supplier of EPOGEN to meet the Dialysis Center
Purchasers’ requirements for EPOGEN for the treatment of dialysis patients
during the Term, on all of the terms provided herein;
WHEREAS, Dialysis Center seeks stable, predictable and
competitive pricing over a seven year period, which it can achieve through the
discounts, rebates and other price concessions set forth herein;
WHEREAS, in order to provide Dialysis Center with such
pricing over a seven year period, Amgen will make substantial long-term
investments and forego other potential opportunities to scale and schedule its
manufacturing capacity and supply of EPOGEN for Dialysis Center Purchasers in
accordance with Dialysis Center Purchasers’ anticipated demand for EPOGEN for
use in the Territory as provided under this Agreement;
NOW THEREFORE, in consideration of the foregoing recitals
and of the mutual promises and covenants set forth herein, and for other good
and valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, and intending to be legally bound, each Party hereby agrees as
follows:
|
1. |
DEFINITIONS |
When used with initial capitals herein, the following terms shall have the
meaning ascribed to them below:
Page 1 of 136
|
1.1. |
“Actual Supply Shortfall” has the meaning set forth in Section |
|
1.2. |
“Added Dialysis Center Purchaser” has the meaning set forth in |
|
1.3. |
“Added Dialysis Center Purchaser Effective Date” has the meaning set |
|
1.4. |
“Added Dialysis Center Purchaser Transaction Date” means with respect |
|
1.5. |
“Administrator” has the meaning set forth in Section 9.2.1. |
|
1.6. |
“Affiliate” of a given entity shall mean an entity that controls, is |
|
1.7. |
“[*]” has the meaning set forth in Section 2.5.1. |
|
1.8. |
“Alternative ESA” means an ESA that is available for use in the |
|
1.9. |
“Alternative ESA Purchase Amount” has the meaning set forth in |
|
1.10. |
“Alternative ESA Purchase Event” has the meaning set forth in |
|
1.11. |
“Alternative ESA Purchase Event Share of Sales” shall be calculated as |
[*]
A = Committed Unit Purchases of Amgen ESAs during the [*] which an
Alternative ESA Purchase Event has occurred
B = Committed Unit Purchases of Amgen ESAs during the [*] which such
Alternative ESA Purchase Event has occurred
C = Committed Unit Purchases of Alternative ESAs during the [*] which an
Alternative ESA Purchase Event has occurred
D = Committed Unit Purchases of Alternative ESAs during the [*] which such
Alternative ESA Purchase Event has occurred
|
1.12. |
“Amgen Business Representative” has the meaning set forth in |
|
1.13. |
“[*]” means [*] for use with patients receiving Dialysis Services, |
|
1.14. |
“Amgen ESA Risk Evaluation Program” has the meaning set forth in |
|
1.15. |
“Amgen ESAs Share of Sales” shall mean Committed [*] Purchases of |
Page 2 of 136
Amgen ESAs Share of Sales Illustration:
Committed [*] Purchases of Amgen ESAs
–
Committed [*] Purchases of Amgen ESAs + Committed [*]
Purchases of Alternative ESAs
|
1.16. |
“Amgen Indemnitees” has the meaning set forth in Section |
|
1.17. |
“Appeal Procedures” has the meaning set forth in Section |
|
1.18. |
“Aranesp” means Amgen’s proprietary darbepoetin alfa product that is |
|
1.19. |
“Arbitrator” has the meaning set forth in Section 9.2.1. |
|
1.20. |
“Authorized Removal Occurrence” has the meaning set forth in |
|
1.21. |
“Authorized Wholesalers” shall mean those wholesalers listed on |
|
1.22. |
“Authorized Wholesaler List” has the meaning set forth in Section |
|
1.23. |
“Available EPOGEN SKUs” have the meaning set forth in Section |
|
1.24. |
“Award” has the meaning set forth in Section 9.2.3. |
|
1.25. |
“Base Invoice Discount” means the base invoice discount described in |
|
1.26. |
“Base Rate Rebate” means the base rebate described in Section |
|
1.27. |
“Baseline [*]” has the meaning set forth in Section 2.1.2. |
|
1.28. |
“[*] Rebate” means the [*] rebate described in Section 3.2 of |
|
1.29. |
“Best Price” has the meaning set forth in Section 3.6. |
|
1.30. |
“[*] Rebate” means the [*] rebate described in Section 3.3 of |
|
1.31. |
“Business Representatives” has the meaning set forth in Section |
|
1.32. |
“Certification” has the meaning set forth in Section 5.2. |
|
1.33. |
“Committed [*] Purchases of Amgen ESAs” means, for any period, the |
|
1.34. |
“Committed [*] Purchases of Alternative ESAs” means, for any period, |
|
1.35. |
“Compensation Data” has the meaning set forth in Section 6.1. |
|
1.36. |
“Confidential Information” has the meaning set forth in Section |
Page 3 of 136
|
1.37. |
“Data” means the data set forth on Schedule 1 provided by |
|
1.38. |
“Debarred Party” has the meaning set forth in Section 10.2.3. |
|
1.39. |
“Designated Affiliates” shall mean any Affiliate of Dialysis Center |
|
1.40. |
“Designated Affiliates List” has the meaning set forth in Section |
|
1.41. |
“Dialysis Center Business Representative” has the meaning set forth in |
|
1.42. |
“Dialysis Center Committed Purchasers” has the meaning set forth in |
|
1.43. |
“Dialysis Center Committed Purchasers List” has the meaning set forth |
|
1.44. |
“Dialysis Center Indemnitees” has the meaning set forth in Section |
|
1.45. |
“Dialysis Center Purchasers” shall mean Dialysis Center, the |
|
1.46. |
“Dialysis Services” means services related to the treatment of |
|
1.47. |
“Disclosing Party” has the meaning set forth in Section 11.14. |
|
1.48. |
“Discounts” means all rebates and discounts set forth on Exhibit |
|
1.49. |
“Disputes” has the meaning set forth in Section 9.1. |
|
1.50. |
“[*]” has the meaning set forth in Section 2.1.2. |
|
1.51. |
“EPOGEN” means Amgen’s proprietary epoetin alfa product that is |
|
1.52. |
“EPOGEN Equivalent Quantity” has the meaning set forth in Section |
|
1.53. |
“ESAs” shall mean agents that stimulate erythropoiesis. |
|
1.54. |
“FDA” has the meaning set forth in Section 8.3. |
|
1.55. |
“FDA Website” has the meaning set forth in Section 11.18. |
|
1.56. |
“Firm” has the meaning set forth in Section 3.2. |
|
1.57. |
“Forecast Shortfall” has the meaning set forth in Section |
|
1.58. |
“Forecast Shortfall Amount” has the meaning set forth in Section |
|
1.59. |
“Force Majeure Event” has the meaning set forth in Section |
|
1.60. |
“Governmental Authority” shall mean in respect of any individual or |
|
1.61. |
“Gross Purchases of Amgen ESAs” means, for any period, the aggregate |
Page 4 of 136
|
each date of purchase, net of product returns and adjustments, which |
|
1.62. |
“Hearing” has the meaning set forth in Section 9.2.3. |
|
1.63. |
“HIPAA” shall mean the Health Insurance Portability and Accountability |
|
1.64. |
“IMS” means IMS Health Incorporated, a Delaware corporation and its |
|
1.65. |
“Indemnified Party” has the meaning set forth in Section |
|
1.66. |
“Indemnifying Party” has the meaning set forth in Section |
|
1.67. |
“Individually Identifiable Health Information” shall have the meaning |
|
1.68. |
“Initial [*]” has the meaning set forth in Section 2.1.2. |
|
1.69. |
“[*]” means an [*] for EPOGEN, Aranesp or an Alternative ESA, as |
|
1.70. |
“Joint Project” has the meaning set forth in Section 7.1. |
|
1.71. |
“Joint Project Committee” has the meaning set forth in Section |
|
1.72. |
“Law” means, individually and collectively, any and all applicable |
|
1.73. |
“Liquidated Damages” has the meaning set forth in Section |
|
1.74. |
“Managed Center” shall mean a dialysis facility that is not an |
|
1.75. |
“Managed Centers List” has the meaning set forth in Section |
|
1.76. |
“Material Label Change” means a material amendment, change, revision, |
|
1.77. |
“Minimum Forecast Commitment” has the meaning set forth in Section |
|
1.78. |
“[*] Rebate” means the [*] rebate described in Section 3.4 of |
|
1.79. |
“Non-Disclosing Party” has the meaning set forth in Section |
|
1.80. |
“Notice of Added Dialysis Center Purchaser” has the meaning set forth |
|
1.81. |
“Objection Notice” has the meaning set forth in Section 3.2. |
|
1.82. |
“Other Agreement(s)” has the meaning set forth in Section 2.2. |
|
1.83. |
“Other Agreement Early Termination Date” has the meaning set forth in |
|
1.84. |
“Party” and “Parties” have the meaning set forth in the |
|
1.85. |
“[*]” has the meaning set forth in Section 5.5. |
|
1.86. |
“Permitted Percentage Variances” has the meaning set forth in |
|
1.87. |
“Permitted Variance Period” has the meaning set forth in Section |
|
1.88. |
“Policies and Procedures” has the meaning set forth in Section |
|
1.89. |
“Project Plan” has the meaning set forth in Section 7.1. |
Page 5 of 136
|
1.90. |
“Project Proposal” has the meaning set forth in Section 7.1. |
|
1.91. |
“Purchase Commitment” has the meaning set forth in Section |
|
1.92. |
“Qualified Gross Purchases of EPOGEN” shall mean the amount of EPOGEN |
|
1.93. |
“Quarter” shall mean each calendar quarter during the Term |
|
1.94. |
“Recall” has the meaning set forth in Section 11.19. |
|
1.95. |
“Relevant Information” means the Data, all sales tracking data, |
|
1.96. |
“Research Study” has the meaning set forth in Section 5.5. |
|
1.97. |
“Rolling Forecast” has the meaning set forth in Section 2.4.1. |
|
1.98. |
“Rolling Forecasts” has the meaning set forth in Section |
|
1.99. |
“Rules” has the meaning set forth in Section 9.2.1. |
|
1.100. |
“Self-Reported Purchase Data” means all [*] purchased of each ESA and |
|
1.101. |
“[*]” has the meaning set forth in Section 5.5. |
|
1.102. |
“Supply Commitment” has the meaning set forth in Section 2.1. |
|
1.103. |
“Supply Shortfall” has the meaning set forth in Section 2.5. |
|
1.104. |
“Supply Shortfall Notice” has the meaning set forth in Section |
|
1.105. |
“Supply Shortfall Quarter” has the meaning set forth in Section |
|
1.106. |
“Term” means the period commencing on the Term Start Date and ending |
|
1.107. |
“Term End Date” shall mean December 31, 2018. |
|
1.108. |
“Term Start Date” shall mean January 1, 2012. |
|
1.109. |
“Termination Date” means the date upon which this Agreement shall have |
|
1.110. |
“Territory” means the United States, and its territories and |
|
1.111. |
“Third Party” means any individual or entity other than a Party or an |
|
1.112. |
“Third Party Claim(s)” has the meaning set forth in Section |
|
1.113. |
“[*]” shall mean the [*] for EPOGEN to [*] as established by [*] in |
Page 6 of 136
|
2. |
PURCHASE AND SUPPLY COMMITMENTS |
|
2.1. |
Purchase and Supply Commitments. Subject to the terms and conditions |
|
2.1.1. |
Alternative ESA Purchases. If in any Quarter the Dialysis Center |
|
2.1.2. |
If a Party, in its reasonable discretion, feels that the Dialysis Center |
Page 7 of 136
|
used by the Dialysis Center Committed Purchasers patients’ during the |
|
2.2. |
Purchase Commitment Transition Period for Added Dialysis Center |
Page 8 of 136
|
Added Dialysis Center Purchaser that is a party to an Other Agreement, [*] |
|
2.3. |
Eligible Purchases. |
|
2.3.1. |
Purchases from Authorized Wholesaler. Only purchases |
|
2.3.2. |
Own Use. The Dialysis Center Purchasers shall purchase EPOGEN |
|
2.3.3. |
Maximum Quarterly Purchase Increases. Notwithstanding any |
|
2.4. |
Quantity Forecasts and Minimum Forecast Commitment. |
|
2.4.1. |
Rolling Forecast. Each Quarter during the Term, |
|
2.4.2. |
Minimum Forecast Commitment. Without reducing or |
Page 9 of 136
|
the Dialysis Center Purchasers purchase an aggregate quantity in [*] of |
|
2.4.3. |
Forecast Variance. Each Rolling Forecast provided by Dialysis |
|
Months |
[ |
*] |
[ |
*] |
[ |
*] |
[ |
*] |
[ |
*] |
||||||||||
|
Permitted Percentage Variance |
[ |
*]% |
[ |
*]% |
[ |
*]% |
[ |
*]% |
[ |
*]% |
If Dialysis Center submits a Rolling Forecast that contains a forecast for
any month therein that is not in compliance with this Section 2.4.3,
Amgen shall have the right, in its sole discretion, to either (a) accept such
forecast for any month therein that is not in compliance with this Section; or
(b) adjust such non-compliant forecasted quantity for any such month to increase
or decrease the amount forecasted for such month by up to the minimum amount
necessary to bring such forecasted quantity into compliance with this
Section 2.4.3. Dialysis Center may, at any time for any good faith
reason, request additional variances to the Permitted Percentage Variances and,
in such event, the Parties shall work in good faith to accommodate such request;
provided, however, that (i) in no event shall Amgen be liable for any resulting
Supply Shortfall or Actual Supply Shortfall and (ii) Dialysis Center shall
remain liable for any Forecast Shortfall that may occur. If in any Quarter
during the Term, the Dialysis Center Purchasers have a Forecast Shortfall and
the Parties have determined, after good faith discussions, that such Forecast
Shortfall is the necessary result of a Material Label Change, then the Dialysis
Center Purchasers shall not be liable for such Forecast Shortfall.
|
2.4.4. |
Good Faith Estimates. Each Rolling Forecast submitted by |
Page 10 of 136
|
Territory and reasonable inventory requirements for EPOGEN in the Territory |
|
2.4.5. |
Available EPOGEN SKUs. The Available EPOGEN SKU |
|
2.5. |
Supply Commitment Shortfalls. Dialysis Center shall promptly notify |
|
2.5.1. |
In the event of an Actual Supply Shortfall, Dialysis Center shall use good |
Page 11 of 136
|
Center shall deliver to Amgen a statement setting forth the aggregate [*] |
|
2.5.2. |
Upon the completion of an Actual Supply Shortfall, the Purchase Commitment, |
|
2.5.3. |
Provided that Amgen complies with its obligations under Section |
|
2.6. |
[*]. The Dialysis Center Purchasers shall purchase EPOGEN from an |
|
2.7. |
Authorized Wholesalers. Prior to the Term Start Date, Dialysis Center |
Page 12 of 136
|
Dialysis Center Purchasers. In the event of any removal of an Authorized |
|
2.8. |
Dialysis Center Purchasers |
|
2.8.1. |
Designated Affiliates and Managed Centers. Only the |
|
2.8.2. |
Addition of Dialysis Center Purchasers. After the Term Start |
Page 13 of 136
|
2.8.3. |
Removal of Dialysis Center Purchasers. (A) Dialysis Center |
(B) Amgen shall also have the right to remove any Designated Affiliates from
the Designated Affiliates List and any Managed Centers from the Managed Centers
List upon thirty (30) days (or such shorter /period as may be required by Law or
any Governmental Authority) written notice to Dialysis Center (a) that such
removal is required by order of a court or Governmental Authority or (b) in
instances in which Amgen determines, in its reasonable discretion, that such
removal is required (i) to comply with Law or (ii) as a result of any such
Designated Affiliate’s or Managed Center’s negligence or willful misconduct in
the use or administration of EPOGEN.
(C) The Designated Affiliates List and the Managed Centers List shall be
amended without further action required of the Parties to reflect removals made
in accordance with this Section 2.8.3.
|
2.8.4. |
Adjustments to Rolling Forecast. Following the addition or |
|
2.8.5. |
Dialysis Center Committed Purchasers List. The Dialysis |
Page 14 of 136
|
Center Committed Purchaser List as of the effective date of such removal from |
|
2.8.6. |
Access to Dialysis Center Facilities. Amgen covenants and |
|
3. |
DISCOUNTS |
|
3.1. |
Earning, Calculating, Payment and Vesting of Discounts. All Discounts |
Page 15 of 136
|
hereby guarantees Amgen’s obligations to pay all Discounts earned by Dialysis |
|
3.2. |
Verification and Audit. Discounts (including any qualification |
|
3.3. |
Adjustments for Changes. In accordance with Section 2.8.2 |
Page 16 of 136
|
Managed Center’s addition to or deletion from the Managed Centers List by |
|
3.4. |
Treatment of Discounts and Rebates. |
|
3.4.1. |
Dialysis Center agrees that Dialysis Center Purchasers shall properly |
|
3.4.2. |
In order to assist Dialysis Center’s compliance with its obligations as set |
|
3.5. |
Reports. Within ninety (90) days of the end of each Quarter, Amgen |
|
3.6. |
Best Price Limitation. At any time following the repeal, enactment or |
Page 17 of 136
|
faith that the then-existing [*] under this Agreement establishes or would |
|
4. |
GOVERNANCE |
|
4.1. |
Business Representatives. The “Business Representatives” shall |
|
4.2. |
Responsibilities of Business Representatives. The Business |
|
5. |
PATIENT AND PRODUCT DATA |
|
5.1. |
Data Submission. Dialysis Center shall deliver all Data to Amgen (or |
|
5.2. |
HIPAA Compliance. Neither Party has the intent that Dialysis Center |
Page 18 of 136
|
Amgen shall meet and in good faith mutually agree to modify this Agreement to |
|
5.3. |
Case Identifier. Dialysis Center shall consistently use a unique |
|
5.4. |
Data Use. Amgen and its Affiliates shall have the right to use Data |
|
5.5. |
Clinical Research Studies. Dialysis Center and Amgen acknowledge that |
|
6. |
OTHER DATA |
|
6.1. |
Compensation Data. Dialysis Center agrees that it shall provide the |
Page 19 of 136
|
that it shall only use the Compensation Data for sales force targeting and |
|
6.2. |
Self-Reported Purchase Data. Dialysis Center, on behalf of the |
|
7. |
JOINT PROJECTS |
|
7.1. |
Joint Projects. The Parties shall form a “Joint Project |
|
7.2. |
Joint Project Committee. |
|
7.2.1. |
Joint Project Committee Responsibilities. The Joint |
|
a) |
Reviewing and approving each new Project Proposal prior to adoption of any |
|
b) |
Reviewing and approving changes to the Project Plans for existing Joint |
|
c) |
Providing for communication and discussion between the Parties to, as |
|
d) |
Reviewing and monitoring the activities and progress of the Parties against |
|
e) |
Communicating with the Business Representatives regarding all of the |
|
f) |
Such other matters as are appropriate to make operational the terms of this |
Page 20 of 136
|
7.2.2. |
Meetings. The Joint Project Committee shall meet in person, |
|
7.2.3. |
Decision Making. The Joint Project Committee shall make |
|
8. |
WARRANTIES, REPRESENTATIONS AND COVENANTS |
|
8.1. |
Power and Authority. Each Party represents and warrants to the other |
|
8.2. |
Compliance with Law and Regulation. Amgen and Amgen Inc. shall, and |
|
8.3. |
Product. Amgen covenants and agrees that EPOGEN is not and will not be |
|
8.4. |
Data. Dialysis Center represents and warrants to Amgen that: (a) the |
Page 21 of 136
|
and/or the Self-Reported Purchase Data provided by the Dialysis Center |
|
8.5. |
Designated Affiliates List and Managed Centers List. Dialysis Center |
|
8.6. |
Adverse Claims. Each Party represents and warrants to the other Party |
|
8.7. |
NO OTHER WARRANTIES. OTHER THAN THE WARRANTIES EXPRESSLY SET FORTH IN |
|
9. |
DISPUTE RESOLUTION, INSURANCE and INDEMNITY |
|
9.1. |
Escalation of Disputes to Business Representatives. The Parties |
In the event of any Dispute, and prior to either Party (a) commencing any
action in a court of law or under any Governmental Authority, or (b) taking any
action to terminate this Agreement as provided in Section 10, the Parties
shall first undertake that the employees of each Party with relevant expertise
and authority with respect to a Dispute shall meet to discuss such Dispute
within five (5) business days of a Party receiving notice of a Dispute (except
in the case where delay in resolving any such Dispute would be materially
prejudicial to a Party, in which case the Dispute will be referred directly to
the Business Representatives). In the event the Parties are unable to resolve
any such Dispute within thirty (30) business days of the initial meeting between
the Parties, it shall be referred to the Business Representatives, who shall
negotiate with one another in good faith to reach a good faith resolution of the
Dispute; provided, that the Parties shall use commercially reasonable
best efforts to expedite the resolution of any Disputes which by their nature
need to be made quickly by the Business Representatives. In the event the
Dispute cannot be resolved by the Business Representatives within fifteen (15)
business days of the initial meeting between the Business Representatives or
such other period of time as is mutually agreed to by the Parties, then, upon
the written demand of either Party, the Dispute shall be subject to arbitration,
as provided in Section 9.2. Pending resolution of any Dispute, both
Parties will continue their performance under this Agreement of all obligations
that are not the subject of any such Dispute. If there is a Dispute relating to
any amount owed by either Party to the other Party, the undisputed
Page 22 of 136
portion of such amount shall be paid to the other Party in accordance with
the terms hereof, and the Parties shall first attempt to resolve the disputed
balance in accordance with this Section 9.1.
|
9.2. |
Arbitration. |
|
9.2.1. |
Claims. Subject to Section 9.3 below, any Dispute that |
|
9.2.2. |
Discovery. Within forty-five (45) days after selection of the |
|
9.2.3. |
Hearing; Decision. The hearing (“Hearing“) shall |
Page 23 of 136
|
(“Appeal Procedures“) shall apply to the Arbitration, at the request |
|
9.2.4. |
Costs. Each Party shall bear its own attorney’s fees, costs, |
|
9.2.5. |
Confidentiality. Each Party acknowledges and agrees that: (a) |
|
9.3. |
Court Actions. Nothing contained in this Agreement shall deny either |
|
9.4. |
Insurance. Each Party shall secure and maintain in full force and |
|
9.5. |
Indemnity. |
|
9.5.1. |
By Amgen. Amgen agrees to indemnify, defend, and hold Dialysis |
Page 24 of 136
|
Dialysis Center Indemnitees harmless from any Third Party Claims arising out |
|
9.5.2. |
By Dialysis Center. Dialysis Center agrees to indemnify, defend, and |
|
9.6. |
Procedure for Third Party Claims. |
|
9.6.1. |
Notice. The Party receiving indemnification |
|
9.6.2. |
Control of Defense. The Indemnifying Party, at its expense, |
Page 25 of 136
|
and/or have a material adverse effect on the business and/or financial |
|
9.6.3. |
Representation. If both the Indemnifying Party and the |
|
9.6.4. |
Resolution. The Indemnifying Party shall not settle, |
|
9.6.5. |
Payment. Any final judgment entered or settlement agreed upon |
|
10. |
TERM AND TERMINATION |
|
10.1. |
Term. This Agreement shall come into effect as of the Term Start Date |
|
10.2. |
Termination for Cause. Amgen or Dialysis Center may terminate this |
|
10.2.1. |
Breach of Purchase Commitment. The Parties |
Page 26 of 136
|
Center Committed Purchasers do not meet an Amgen ESAs Share of Sales of (i) |
|
10.2.2. |
Termination for Failure to Supply. Dialysis Center may |
|
10.2.3. |
Termination for Exclusion from Federal Health Care Program. |
|
10.3. |
Liquidated Damages. The Parties acknowledge that Amgen’s actual |
For purposes of this Agreement, “Liquidated Damages” means, in
addition to any amounts owed to Amgen under this Agreement, including for breach
of the Purchase Commitment under Section 2.1, an amount in cash equal to
[*] percent ([*]%) of the [*] of Amgen’s projected [*] for each remaining
Quarter (including any fractional Quarters) in the Term, with such [*] equal to
A : B, grown Quarterly at a [*] percent ([*]%) annual rate and discounted on a
Quarterly basis, at a rate equal to the average annual increase in [*] for
EPOGEN on an [*] basis for all calendar years during the Term prior to the
related [*] calculation, where:
|
A = |
The average [*] for the [*] most recent Quarters prior to the Termination |
|||
|
B = |
The average aggregate [*] (other than the [*] Rebate, the [*] Rebate and the |
|||
Page 27 of 136
|
10.4. |
Effect of Termination. Upon any termination or expiration of this |
|
10.5. |
Survival. Any provision that, either expressly or by its nature is |
|
11. |
MISCELLANEOUS |
|
11.1. |
Amendment. Except as expressly set forth herein, no amendment of this |
|
11.2. |
Assignment. Neither Party shall have the right to assign or otherwise |
|
11.3. |
Modification of Law. If at any time following the Term Start Date, the |
Page 28 of 136
|
11.4. |
Conflicting Provisions. To the extent that any provisions of Amgen’s |
|
11.5. |
Construction. This Agreement shall be deemed to have been jointly |
|
11.6. |
Counterparts; Facsimile/PDF Signatures. This Agreement may be executed |
|
11.7. |
Currency. All amounts herein are set forth in United States Dollars. |
|
11.8. |
Force Majeure. Except as provided in Section 2.1.1 or |
|
11.9. |
Further Assurances. Each Party shall perform all further acts |
|
11.10. |
Governing Law. This Agreement shall be governed by the laws of the |
|
11.11. |
Merger/No Reliance. This Agreement, together with the Schedules, and |
|
11.12. |
No Partnership. The relationship between Amgen and Dialysis Center is |
|
11.13. |
Notices. Any notice or other communication required or permitted |
Page 29 of 136
|
after deposit in the United States mail with proper postage for first-class |
|
If to Amgen: |
||||
|
Amgen USA Inc. |
||||
|
One Amgen Center Drive, [*] |
||||
|
Thousand Oaks, CA 91320-1789 |
||||
|
Attn: Specialist, Contracts & Pricing : Nephrology Business Unit |
||||
|
Fax: [*] |
||||
|
with a copy to : |
||||
|
Amgen USA Inc. |
||||
|
One Amgen Center Drive, [*] |
||||
|
Thousand Oaks, CA 91320-1789 |
||||
|
Attn: General Counsel |
||||
|
Fax: [*] |
||||
|
If to Amgen Inc.: |
Amgen Inc. |
|||
|
One Amgen Center Drive, [*] |
||||
|
Thousand Oaks, CA 91320-1789 |
||||
|
Attn: General Counsel |
||||
|
Fax No.: [*] |
||||
|
If to Dialysis Center: |
||||
|
DaVita Inc. |
||||
|
1350 Old Bayshore Highway, Suite 777 |
||||
|
Burlingame, California 94010 |
||||
|
Attn: Vice-President of Purchasing |
||||
|
Fax No.: [*] |
||||
|
with a copy to: |
||||
|
DaVita Inc. |
||||
|
1551 Wewatta Street |
||||
|
Denver, CO 80202 |
||||
|
Attn: Chief Legal Officer |
||||
|
Fax No.: [*] |
||||
|
11.14. |
Confidentiality. “Confidential Information” means any and all |
Page 30 of 136
|
Amgen from using the Data, the Compensation Data, and/or the Self-Reported |
|
11.14.1. |
Confidentiality Covenants. Except to the extent expressly |
|
(a) |
was generally available to the public or otherwise part of the public domain |
|
(b) |
became generally available to the public or otherwise part of the public |
|
(c) |
was independently discovered or developed by the Non-Disclosing Party without |
|
11.14.2. |
Retention and Destruction of Confidential Information. At any |
|
11.14.3. |
Disclosures Required By Law. In the event that the |
Page 31 of 136
|
Information to) furnish only that portion of the Confidential Information |
|
11.14.4. |
Public Announcements; Authorized Disclosure. |
|
11.14.5. |
Confidential Terms. Notwithstanding the foregoing, each Party |
|
11.14.6. |
Enforcement. Each Party agrees that money damages alone would |
|
11.15. |
Severability. Subject to the provisions of Section 11.3, if any |
|
11.16. |
Waiver. No Party shall be deemed to have waived any right hereunder, |
|
11.17. |
Open Records. To the extent required by §1861(v)(1)(I) of the Social |
Page 32 of 136
|
11.18. |
Amgen’s ESA Risk Evaluation and Mitigation Strategy Program. Dialysis Center |
|
11.19. |
Recall. In the event the FDA initiates a mandatory recall or Amgen |
|
11.20. |
Assumption of Risk. Each Party expressly accepts and assumes all risks |
Page 33 of 136
The Parties have executed this Agreement by their designated representatives
set forth below.
|
AMGEN USA INC. |
||
|
By: |
/s/ Anthony C. Hooper |
|
|
Name (print): |
Anthony C. Hooper |
|
Title: |
EVP |
|
Date: |
11/15/2011 |
||
|
DIALYSIS CENTER |
|||
|
By: |
/s/ Dennis Kogod |
|
|
Name (print): |
Dennis Kogod |
|
Title: |
Chief Operating Officer |
|
Date: |
11/15/2011 |
Amgen Inc. with respect to certain provisions of this Agreement as
set forth herein.
Amgen Inc.
|
By: |
/s/ Anthony C. Hooper |
|
Name (print): |
Anthony C. Hooper |
|
Title: |
EVP |
|
Date: |
11/15/2011 |
Page 34 of 136
[Exhibits omitted by Findlaw]
Stay Up-to-Date With How the Law Affects Your Life
Enter your email address to subscribe:
Learn more about FindLaw’s newsletters, including our terms of use and privacy policy.