[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
U.S. CO-PROMOTION
AGREEMENT
BAYER PHARMACEUTICALS
CORPORATION
and
ONYX PHARMACEUTICALS, INC.
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Page
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ARTICLE
I
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DEFINITIONS
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1
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ARTICLE
II
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GRANTS OF
RIGHTS
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11
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Section
2.1
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Co-Promotion
Rights Relating to the Co-Promotion Collaboration
Product
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11
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Section
2.2
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Co-Promotion
Rights of other Collaboration Products, if any
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11
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ARTICLE
III
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MANAGEMENT
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11
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Section
3.1
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Overview
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11
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Section
3.2
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Joint Marketing
Committee
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12
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Section
3.3
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Committee
Decision Making
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13
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Section
3.4
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Obligations of
the Parties
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13
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ARTICLE
IV
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RESPONSIBILITIES OF ONYX
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14
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Section
4.1
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Promotion of
the Co-Promotion Collaboration Product by Onyx
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14
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Section
4.2
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CRM System and
Sales/Prescriber Data
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15
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Section
4.3
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Onyx Sales
Force
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15
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ARTICLE
V
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RESPONSIBILITIES OF BAYER
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16
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Section
5.1
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Promotion of
the Co-Promotion Collaboration Product by Bayer
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16
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Section
5.2
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CRM System and
Sales/Prescriber Data
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17
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Section
5.3
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Bayer Sales
Force
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18
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Section
5.4
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Manufacture,
Shipment, Booking, Invoicing, etc. of the Co-Promotion
Collaboration Product
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18
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ARTICLE
VI
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EMPLOYEES;
TRAINING AND MARKETING MATERIALS
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19
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Section
6.1
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Compensation of
Sales Representatives
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19
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Section
6.2
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Marketing
Materials
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20
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Section
6.3
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[ * ] of
Employees
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21
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Section
6.4
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Promotion of [
* ]
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21
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ARTICLE
VII
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REGULATORY
MATTERS
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21
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Section
7.1
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Licenses
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21
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Section
7.2
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Labeling and
Marketing Materials
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21
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Section
7.3
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Efficacy and
Safety Information
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21
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[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
-i-
Table of
Contents
(CONTINUED)
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Page
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Section
7.4
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Recalls
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22
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Section
7.5
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Pharmacovigilance Agreement
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23
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Section
7.6
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Transmittal of
Advertisements and Promotional Labeling for Drugs and Biologics for
Human Use
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23
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ARTICLE
VIII
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ECONOMICS OF
CO-PROMOTION; PROFIT SHARING
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23
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Section
8.1
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Overview
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23
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Section
8.2
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Joint Profit
and Loss Statement
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23
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Section
8.3
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Reporting
Sales
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24
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Section
8.4
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Allowable
Expenses
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24
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Section
8.5
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Determination
of Marketing Profit and Loss
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25
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Section
8.6
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Allocation of
Marketing Profit and Loss and Related Payments
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25
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Section
8.7
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[ *
]
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26
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Section
8.8
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Reimbursement
of Development Payments
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26
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Section
8.9
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Budget
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26
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Section
8.10
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Royalties
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26
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Section
8.11
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Federal and
State Tax Characterization
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26
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ARTICLE
IX
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RECORDKEEPING
AND AUDITS
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26
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Section
9.1
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Audits
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26
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Section
9.2
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Maintenance of
Books and Records
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27
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Section
9.3
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Compliance
Audits
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27
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ARTICLE
X
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TERM AND
TERMINATION
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27
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Section
10.1
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Term of
Agreement
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27
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Section
10.2
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Breaches
(General)
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27
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Section
10.3
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Allegations of
Material Breach
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28
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Section
10.4
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Termination of
Collaboration Agreement
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29
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Section
10.5
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Effects of
Termination
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29
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Section
10.6
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Survival
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29
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ARTICLE
XI
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CONFIDENTIALITY
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30
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[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
-ii-
Table of
Contents
(CONTINUED)
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Page
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ARTICLE
XII
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INDEMNIFICATION
AND INSURANCE; LIMITATION OF LIABILITY
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30
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Section
12.1
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Indemnification
by Onyx
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30
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Section
12.2
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Indemnification
by Bayer
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31
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Section
12.3
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Product
Liability Claims
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32
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Section
12.4
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Direct
Claims
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34
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Section
12.5
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Insurance
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35
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Section
12.6
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Limitation of
Liability
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35
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Section
12.7
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Disclaimer of
Warranties
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35
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Section
12.8
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Regulatory
Compliance
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36
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ARTICLE
XIII
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REPRESENTATIONS, WARRANTIES AND
COVENANTS
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37
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Section
13.1
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Representations
by Onyx
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37
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Section
13.2
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Representations
by Bayer
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38
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ARTICLE
XIV
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NOTICES
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39
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ARTICLE
XV
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DISPUTE
RESOLUTION
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40
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ARTICLE
XVI
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MISCELLANEOUS
PROVISIONS
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40
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Section
16.1
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Assignment
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40
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Section
16.2
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Governing
Law
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40
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Section
16.3
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Waiver
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40
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Section
16.4
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Entire
Agreement
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41
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Section
16.5
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Severability
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41
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Section
16.6
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Relationship of
the Parties
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41
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Section
16.7
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No Implied
Licenses
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41
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Section
16.8
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Public
Announcements
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42
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Section
16.9
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Counterparts
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42
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Section
16.10
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Force
Majeure
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42
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Section
16.11
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Interpretation
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43
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Section
16.12
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Certain
Expenses and Commissions
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43
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Section
16.13
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Headings
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43
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[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
-iii-
Table of
Contents
(CONTINUED)
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Page
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Section
16.14
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Days
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43
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[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
-iv-
U.S. CO-PROMOTION
AGREEMENT
This U.S.
CO-PROMOTION AGREEMENT (this “ Agreement ”)
is entered into as of this 6th day of March, 2006 between BAYER
PHARMACEUTICALS CORPORATION, a Delaware corporation (“
Bayer ”) and ONYX PHARMACEUTICALS, INC., a Delaware
corporation (“ Onyx ”).
WHEREAS,
Bayer’s predecessor, Miles Inc., and Onyx entered into a
Collaboration Agreement dated April 22, 1994, as amended on
April 24, 1996, February 1, 1999 and as further amended
by this Agreement (as amended, the “ Collaboration
Agreement ”), pursuant to which the parties agreed to
conduct a collaborative research program intended to discover and
develop Ras Function (as defined by the Collaboration Agreement)
modulators for all human and animal therapeutic, prophylactic, and
diagnostic indications;
WHEREAS, in
connection with the Collaboration Agreement, Bayer and Onyx have
developed BAY 43-9006 (sorafenib), now known as Nexavar, a
pharmaceutical compound which is a Co-Promotion Collaboration
Product under the Collaboration Agreement;
WHEREAS, on
December 20, 2005 (the “ Co-Promotion Effective
Date ”), the parties obtained United States Regulatory
Approvals to market and sell the Co-Promotion Collaboration
Product;
WHEREAS, under
Section 13.4 of the Collaboration Agreement, Onyx has
exercised its option to Co-Promote the Co-Promotion Collaboration
Product in the United States; and
WHEREAS, Bayer and
Onyx desire to Co-Promote the Co-Promotion Collaboration Product in
the United States, upon the terms and conditions set forth
herein.
NOW, THEREFORE, in
consideration of the mutual covenants and agreements set forth in
this Agreement, and for other good and valuable consideration, the
receipt and sufficiency of which is hereby acknowledged, the
parties hereto agree as follows, with the intent to be legally
bound:
Capitalized terms
used herein without definition shall have the meanings specified in
this Article I (such definitions to be equally applicable to
both the singular and plural forms of the terms defined). Unless
otherwise specified, all references in this Agreement to
“Sections” are to Sections of this
Agreement.
[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
1
“ ACCME
Standards ” shall mean the standards set forth by the
Accreditation Council for Continuing Medical Education relating to
educating the medical community in the United States.
“ Act
” shall mean the United States Federal Food, Drug and
Cosmetic Act, as it may be amended from time to time.
“
Advertising and Education ” shall have the meaning
specified in the Collaboration Agreement.
“
Affiliate ” shall have the meaning set forth in the
Collaboration Agreement.
“
Agreement ” shall have the meaning set forth in the
Preamble and shall include all appendices, exhibits and schedules
referenced herein or attached hereto, and as the same may be
amended or supplemented from time to time hereafter pursuant to the
provisions hereof.
“
Allowable Co-Promotion Expenses ” shall mean those
expenses incurred by the parties following the date of receipt of
United States Regulatory Approval that consist of (i) [ * ]
, (ii) [ * ] , (iii) [ * ] , (iv) [ * ] , (v)
[ * ] , (vi) [ * ] , (vii) [ * ] , (viii) [
* ] ; (ix) [ * ] , (x) [ * ] , (xi) [ * ]
, (xii) [ * ] , (xiii) [ * ] ; and (xiv) [ * ]
.
“
Allocable Co-Promotion Overhead Costs ” shall mean all
general and administrative overhead costs of the functions that
directly support the promotion of the Co-Promotion Collaboration
Product under this Agreement, including without limitation costs
reasonably attributable to compliance, account administration,
accounts payable and receivables management, interest on working
capital associated with inventory and receivables of Co-Promotion
Collaboration Product, and out-of-pocket, Third Party costs
incurred for legal and accounting functions. Unless otherwise
agreed to by the Executive Committee, all general and
administrative corporate overhead items that are included in this
definition of Allocable Co-Promotion Overhead Costs shall be [ *
] for Bayer at [ * ] at the Co-Promotion Effective Date
and shall remain at such level pending adjustment in accordance
with this definition by the Executive Committee. Unless otherwise
agreed to by the Executive Committee, Allocable Co-Promotion
Overhead Costs for Onyx shall be [ * ] .
“
Allowable Expense Report ” shall have the meaning set
forth in Section 8.4(a).
“ Annual
Sales Targets ” shall mean the aggregate level of Gross
Sales each party’s sales force is required to achieve as set
forth from time to time in the Budget.
“
Applicable Laws ” shall mean all applicable federal,
state and local laws, regulations, rules or guidelines that govern
the Co-Promotion Program and activities and services in the United
States and the other transactions contemplated by this Agreement
(including without limitation the Act, as the same may be amended
from time to time).
“
Asserting Party ” shall have the meaning set forth in
Section 12.4(a).
[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
2
“
Bayer ” shall have the meaning set forth in the
Preamble.
“ Bayer
Indemnified Party ” shall have the meaning set forth in
Section 12.1(a).
“ Bayer
Marketing Services ” shall have the meaning set forth in
Section 5.4(d).
“
Breaching Party ” shall have the meaning set forth in
Section 10.2(a).
“
Budget ” shall mean the annual budget for Allowable
Co-Promotion Expenses to be incurred by both parties during each
Contract Year of the Term in connection with the promotion and
marketing of the Co-Promotion Collaboration Product, as annually
prepared by the JMC and approved by the Executive Committee (or any
duly constituted sub-committee thereof charged with such authority
by the Executive Committee).
“ Call
Plan ” shall mean the call plan for detailing and
implementing the sale of Co-Promotion Collaboration Product in the
relevant territories by the Sales FTEs, which call plan shall be
agreed upon by the JMC not later than [ * ] days prior to
the introduction of additional products and the commencement of
detailing of such additional products by either party’s Sales
FTEs into the marketplace, and which call plan may be amended from
time to time by the JMC.
“ CIA
” shall mean the Corporate Integrity Agreement between the
Office of Inspector General of the Department of Health and Human
Services and Bayer Corporation dated January 23,
2001.
“
Claims ” shall mean any and all claims, suits,
proceedings or causes of action brought against a party.
“ Code of
Conduct ” shall mean the Healthcare Fraud and Abuse Code
of Conduct of Bayer.
“
Collaboration Agreement ” shall have the meaning set
forth in the Recitals.
“
Collaboration Revenue ” shall mean Co-Promotion Net
Sales plus US Sublicense Revenues.
“
Commercially Reasonable Efforts ” shall mean the level
of efforts and resources (including the promptness with which such
efforts and resources would be applied) commonly used [ * ]
with respect to a product of commercial potential [ * ] to
the Co-Promotion Collaboration Product at a [ * ] , taking
into consideration its [ * ] and all other relevant
factors.
“
Committee ” shall mean any of the Executive Committee
or JMC, or any other committee operating under delegated authority
and formed with the approval of the Executive Committee or
JMC.
[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
3
“ [ * ]
Product ” shall mean any product having the [ * ]
as the Co-Promotion Collaboration Product and that is intended as a
[ * ] for, and [ * ] for, the Co-Promotion
Collaboration Product.
“
Confidential Information ” shall have the meaning set
forth in the Collaboration Agreement, as amended to include any
Information (as such term is defined in the Collaboration
Agreement) furnished by one party to another pursuant to this
Agreement.
“
Contract Year ” shall mean a 12-month period
commencing as of January 1 and ending as of December 31. For
the purposes of this Agreement, the first Contract Year shall
commence on the Co-Promotion Effective Date and end on
December 31 of the same calendar year; provided, however, that
for purposes of measuring [ * ] under Sections 4.1 and
5.1 hereof, the first Contract Year shall commence on and as of
January 1, 2006.
“
Controlling Party ” shall have the meaning set forth
in Section 12.3(e).
“
Co-Promote ” or “ Co-Promotion ”
shall mean the joint promotion of the Co-Promotion Collaboration
Product through Bayer, Onyx and their respective sales forces under
a single trademark in the United States.
“
Co-Promotion Advertising and Education Expenses ”
shall mean the costs (excluding Allocable Co-Promotion Overhead
Costs or any other overhead costs) incurred by a party or for its
account which are specifically identifiable to the Advertising and
Education of the Co-Promotion Collaboration Product in the United
States consistent with the Co-Promotion Program.
“Co-Promotion [ * ]” shall mean the [ * ]
, as determined in accordance with GAAP on a basis consistent with
Bayer’s annual audited financial statements.
“
Co-Promotion Collaboration Product ” shall mean any
pharmaceutical form or dosage of the experimental compound
designated as Bay 43-9006 (sorafenib).
“
Co-Promotion Distribution Costs ” shall mean the costs
incurred by Bayer or for its account in connection with the
freight, transportation, insurance, handling, packaging and
distribution of the Co-Promotion Collaboration Product in the
United States, which shall be [ * ] of the Co-Promotion
Collaboration Product.
“
Co-Promotion Effective Date ” shall mean the date
specified in the Recitals above.
“
Co-Promotion Marketing Expenses ” shall mean the costs
and expenses (not otherwise included in Co-Promotion Advertising
and Education Expenses or as Co-Promotion Selling and Promotion
Expenses, and excluding Allocable Co-Promotion Overhead Costs or
any other overhead costs) incurred by the parties in connection
with the marketing and support of the Co-Promotion Collaboration
Product and approved by the Executive Committee, including without
limitation [ * ] .
[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
4
“
Co-Promotion Marketing Profit or Loss ” shall have the
meaning set forth in Section 8.5.
“
Co-Promotion Net Sales ” shall mean Gross Sales less
(a) sales returns and accruals for allowances, including
trade, quantity and cash discounts and any other adjustments,
including those granted on account of price adjustments, billing
errors, rejected goods, damaged goods, returns, rebates, chargeback
rebates, fees, reimbursements or similar payments granted or given
to wholesalers or other distributors (including specialty
pharmaceutical companies who act as distributors), buying groups,
healthcare insurance carriers or other institutions, (b) any
payment in respect of sales to any Governmental or Regulatory
Authority in respect of any government subsidized program,
including and without limitation Medicare and Medicaid rebates, and
(c) any item substantially similar in character and/or
substance to the above, all as determined in accordance with GAAP
on a basis consistent with Bayer’s annual audited financial
statements. In addition, Co-Promotion Net Sales by Bayer hereunder
are subject to the following:
(1) In the case of
any sale or other disposal of a Co-Promotion Collaboration Product
by Bayer to an Affiliate, for resale, the Co-Promotion Net Sales
shall be calculated as above on the value charged or invoiced on
the first arm’s length sale to a Third Party; and
“
Co-Promotion Program ” shall mean the annual plan for
the promotion, marketing and sale of the Co-Promotion Collaboration
Product as developed by the JMC and approved by the Executive
Committee. The Co-Promotion Program shall set forth the manner in
which the Co-Promotion Collaboration Product is to be promoted and
marketed in the United States during the period to which the
Co-Promotion Program relates and shall include, at a minimum: (a)
[ * ] ; (b) [ * ] ; (c) [ * ] ; (d) [ *
] ; (e) [ * ] ; (f) [ * ] ; (g) [ * ] ;
(h) [ * ] ; (i) [ * ] ; (j) [ * ] ; and (k)
[ * ] .
“
Co-Promotion Selling and Promotion Expenses ” shall
mean all costs (excluding Allocable Co-Promotion Overhead Costs or
any other overhead costs) incurred consistent with the Budget in
the Co-Promotion Program, and specifically identifiable to the
sales and/or promotion of the Co-Promotion Collaboration Product in
the United States, including all costs associated with (a) [ *
] ; (b) [ * ] ; and (c) [ * ] . Co-Promotion
Selling and Promotion Expenses shall exclude Sales Force Expenses
and MSL Expenses.
“ CRM
System ” shall mean a customer relationship management
system utilized in connection with the tracking of sales activity
relating to the Co-Promotion Collaboration Product in the United
States.
“
Detail” or “Detailing ” shall mean each
separate face-to-face contact by a sales representative with a
Target Healthcare Professional during which time the promotional
message involving the Co-Promotion Collaboration Product is
presented and is a principal topic of discussion.
[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
5
“
Development Payments ” shall mean those payments
specified in Section 11.8 of the Collaboration
Agreement.
“ Direct
Claim ” shall have the meaning set forth in
Section 12.4(a).
“
Dispute ” shall have the meaning set forth in
Article XV.
“Equivalent Sales FTE” shall mean a Sales FTE
equivalent as determined under the standards and methods adopted by
the Executive Committee under Section 3.1(g) hereof, which
standards and methods will establish the means for measuring the
performance required of a Sales FTE deployed to market multiple
products in addition to his or her marketing and sale of
Co-Promotion Collaboration Product.
“
Executive Committee ” or “ EC ”
shall mean that committee described and set forth in Section 3.1,
which was originally organized as the JRDC under the Collaboration
Agreement and which has been renamed the Executive
Committee.
“ FDA
” shall mean the United States Food and Drug Administration
or any successor entity thereto.
“ Force
Majeure Event ” shall have the meaning set forth in
Section 16.10.
“
GAAP ” shall mean United States generally accepted
accounting principles, as may be amended from time to
time.
“ Good
Manufacturing Practices ” shall mean the current
standards for manufacture, as set forth in the Act and applicable
regulations and guidelines promulgated thereunder or any successor
thereto, as shall be in effect from time to time during the
Term.
“
Governmental or Regulatory Authority ” shall mean any
court, tribunal, arbitrator, agency, commission, official or other
instrumentality of any government or of any federal, state, county,
city or other political subdivision thereof, including without
limitation the FDA.
“ Gross
Sales ” shall mean the amount of sales of Co-Promotion
Collaboration Product in the United States invoiced by Bayer, its
Affiliates, subcontractors and permitted sublicensees to Third
Parties, in accordance with GAAP. For timing purposes, Gross Sales
shall be recognized in accordance with the revenue recognition
policies utilized by Bayer for financial reporting
purposes.
“
Indemnifiable Losses ” shall mean liabilities, losses,
damages or other amounts payable to a Third Party claimant, as well
as any reasonable attorneys’ fees and costs of litigation
incurred by either the Bayer Indemnified Party or the Onyx
Indemnified Party, as the case may be, in connection with any
Claim.
[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
6
“ Joint
Development Committee” or “JDC ” shall mean
that joint development Sub-Committee operating under delegated
authority of the Executive Committee under Section 3.3(h) of
the Collaboration Agreement.
“ Joint
Finance Committee” or “JFC ” shall mean that
joint finance Sub-Committee operating under delegated authority of
the Executive Committee under Section 3.3(h) of the
Collaboration Agreement.
“ Joint
Marketing Committee” or “JMC” shall mean that
committee described and set forth in Section 3.2.
“ Joint
Profit and Loss Statement ” shall have the meaning set
forth in Section 8.2.
“ Limited
Recall ” shall have the meaning set forth in
Section 7.4(a).
“
Losses ” shall mean liabilities, losses, damages, as
well as any reasonable attorneys’ fees and costs of
litigation, incurred by a party.
“ LMR
” shall mean Bayer’s Legal Medical Regulatory review
team.
“
Marketing Materials ” shall have the meaning set forth
in Section 6.2(a).
“
Material Breach ” shall have the meaning set forth in
Section 10.3(a).
“
Marketing FTE Expenses ” shall mean the aggregate of
all salary and benefits expenses for a full-time equivalent (based
on a full-time equivalent year of 2,080 hours, inclusive of
vacation time and holidays) marketing personnel [ * ]
.
“ MSL
Expenses ” shall mean those costs that are identified
below and that are incurred by a party beginning [ * ] , in
each case consistent with and specifically identifiable to the
establishment and maintenance of medical affairs personnel
(including MSLs and medical affairs field directors) to the extent
such personnel are, or will be, assigned to supporting Co-Promotion
Collaboration Product in the United States: (a) [ * ] ; (b)
[ * ] ; (c) [ * ] ; (d) [ * ] ; (e) [ *
] ; and (f) [ * ] .
“ MMA
” shall have the meaning set forth in
Section 12.8(d).
“
MSLs ” shall mean the medical science liaisons to be
appointed by each party.
“ NDA
” shall mean (a) the single application or set of
applications for the Co-Promotion Collaboration Product filed by
Bayer with the FDA or any successor agency having the
administrative authority to regulate the approval for marketing of
new human pharmaceutical products, delivery systems and devices in
the United States, and (b) any related registrations with or
notifications to the FDA.
“
Non-Publishing Party ” shall have the meaning set
forth in Section 16.8.
[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
7
“
Non-Serious Adverse Event ” shall mean any adverse
drug experience associated with the use of the Co-Promotion
Collaboration Product in humans, whether or not considered
drug-related, which is not a Serious Adverse Event.
“ Notice
of Termination For Material Breach ” shall have the
meaning set forth in Section 10.3(c).
“
Notifying Party ” shall have the meaning set forth in
Section 10.2(a).
“ OIG
” shall mean the Office of the Inspector General.
“
Onyx ” shall have the meaning set forth in the
Preamble of this Agreement.
“ Onyx
Indemnified Party ” shall have the meaning set forth in
Section 12.2(a).
“
PDMA ” shall mean the Prescription Drug Marketing Act
of 1987, Title 21 of the U.S. Code of Federal Regulations, Parts
203 and 205, as amended, and any final regulations or guidances
promulgated thereunder from time-to-time.
“
Performance Qualifications ” shall mean those
qualifications for the Sales FTEs reasonably established from time
to time by the JMC.
“
Permanent Recall ” shall have the meaning set forth in
Section 7.4(a).
“
Person ” shall mean an individual, corporation,
partnership, limited liability company, trust, business trust,
association, joint stock company, joint venture, pool, syndicate,
sole proprietorship, unincorporated organization, governmental
authority, or any other form of entity not specifically listed
herein.
“
Pharmacovigilance Agreement ” shall have the meaning
set forth in Section 7.5.
“ PhRMA
Code ” shall mean the Pharmaceutical Research and
Manufacturers of America Code on Interactions with Healthcare
Professionals, as hereafter amended from time to time.
“ Product
Liability Claim ” shall have the meaning set forth in
Section 12.3(e).
“ Product
Technical Complaint ” shall mean any complaint that
questions the purity, identity, potency or quality of the
Co-Promotion Collaboration Product, its packaging or labeling or
the compliance of any batch of the Co-Promotion Collaboration
Product with Applicable Laws including current Good Manufacturing
Practices; any complaint that concerns any incident that causes the
Co-Promotion Collaboration Product or its labeling to be mistaken
for, or applied to, another article; any bacteriological
contamination or significant chemical, physical or other change or
deterioration in the Co-Promotion Collaboration Product; any
failure of one or more batches of the Co-Promotion Collaboration
Product to meet the specifications therefor in the NDA; or any
complaint or evidence of tampering with the Co-Promotion
Collaboration Product.
“Publishing Party” shall have the meaning set
forth in Section 16.8.
[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
8
“
Recall ” shall have the meaning set forth in
Section 7.4(a).
“
Regulatory Approval Date ” shall mean the date of
receipt of United States Regulatory Approval with respect to the
Co-Promotion Collaboration Product, December 20,
2005.
“ Sales
Force Expenses ” shall mean those costs that are
identified below and that are incurred by a party beginning [ *
] , in each case consistent with and specifically identifiable
to the establishment and maintenance of sales personnel (including
a field-based sales force and regional managers) to the extent such
personnel are, or will be, assigned to selling Co-Promotion
Collaboration Product in the United States: (a) [ * ] ; (b)
[ * ] ; (c) [ * ] ; (d) [ * ] ; (e) [ *
] ; and (f) [ * ] .
“ Sales
FTE ” shall mean a full-time equivalent (based on a
full-time equivalent year of 2,080 hours, inclusive of vacation
time and holidays) field-based pharmaceutical sales representative,
district sales manager, or sales trainer who promotes a
Co-Promotion Collaboration Product in the United States during the
Term and who satisfies each of the following criteria:
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[ * ] ;
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(2)
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[ * ] ;
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(3)
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[ * ] ;
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“SEC” shall mean the United States Securities
and Exchange Commission.
“ Serious
Adverse Event ” shall mean any serious and unexpected
adverse drug experience, as defined in 21 C.F.R.
Section 314.80 or Section 312.32, associated with the use
of the Co-Promotion Collaboration Product in humans, whether or not
considered drug-related.
“
Sub-Committees ” shall mean the JDC, the JFC and the
JMC, and any other sub-committee(s) appointed by the Executive
Committee from time to time pursuant to Section 3.3(h) of the
Collaboration Agreement; any reference to a committee or
sub-committee in this Agreement shall refer to an existing
Sub-Committee.
“ Target
Healthcare Professionals ” shall mean physicians who are
cancer specialists, radiologists or other prescribers of oncology
therapeutics, including persons lawfully influencing (or in a
position to lawfully influence) the opinions of such persons, in
each case who are authorized by Applicable Laws to prescribe the
Co-Promotion Collaboration Product.
“
Term ” shall have the meaning set forth in
Section 10.1.
[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
9
“ Third
Party ” shall mean any person or entity other than Bayer
or Onyx, or an Affiliate of either of them.
“ United
States ” shall mean the United States of America, its
territories and possessions.
“ United
States Regulatory Approval ” shall mean approval by the
FDA or any successor entity of an NDA or other applicable filing
and satisfaction of any related applicable FDA registration and
notification requirements (if any), together with any pricing
approvals and labeling approvals.
“ US
COGS ” shall mean, for sales of the Co-Promotion
Collaboration Product in the United States, [ * ]
“ US
Sublicense Revenues ” shall mean all revenues received
from Third Parties as consideration for the sublicensing of the
manufacture, use and/or sale of the Co-Promotion Collaboration
Product in the United States.
“ US
Third Party Royalties ” shall mean those royalties
payable to a Third Party in respect of the import, sale, offer for
sale, use or manufacture of the Co-Promotion Collaboration Product
in the United States.
“
Weighted Average ” shall mean X where
X= [ * ] ÷ m , and where:
n1 is the number of [ * ] ;
d1 is the number of [ * ] ;
n2 is the number of [ * ] ;
d2 is the number of [ * ] ;
d1 +
d2 shall [ * ]
; and
m is the aggregate number of [ * ]
.
For
example : If the Co-Promotion Program requires that each
party [ * ] , the Weighted Average would equal:
[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
10
ARTICLE II
GRANTS OF RIGHTS
Section 2.1 Co-Promotion Rights Relating to the
Co-Promotion Collaboration Product.
(a) Pursuant to Section 13.4 of the Collaboration
Agreement, Onyx has exercised its option to Co-Promote the
Co-Promotion Collaboration Product in the United States. Subject
only to Onyx’s compliance with the terms and conditions of
the Collaboration Agreement relating to payment of one-half of the
Co-Development Costs incurred worldwide for such Co-Promotion
Collaboration Product (excluding Japan), Onyx has the right, on an
exclusive basis together with Bayer, to Co-Promote the Co-Promotion
Collaboration Product in the United States during the Term, upon
and subject to the terms and conditions set forth in this
Agreement.
(b) Subject only to Onyx’s compliance with the terms
and conditions of the Collaboration Agreement relating to payment
of one-half of the Co-Development Costs incurred worldwide for such
Co-Promotion Collaboration Product (excluding Japan), Bayer hereby
undertakes its rights to Co-Promote the Co-Promotion Collaboration
Product in the United States together with Onyx during the Term,
upon and subject to the terms and conditions set forth in this
Agreement.
Section 2.2 Co-Promotion Rights of other Collaboration
Products, if any. Notwithstanding anything to the contrary
contained herein, Onyx shall retain an option, pursuant to
Section 13.4 of the Collaboration Agreement, to co-promote in
the United States any other Collaboration Product (as such term is
defined in the Collaboration Agreement) that receives United States
Regulatory Approval, provided Onyx has paid one-half of the
Co-Development Costs incurred worldwide for such Collaboration
Product (excluding Japan). If Onyx exercises its right to
co-promote another such Collaboration Product, the parties shall
confer and enter into a separate definitive agreement substantially
similar to this Agreement pertaining to such other Collaboration
Product.
Section 3.1 Overview. The parties, by mutual consent,
have treated the JRDC (as defined in the Collaboration Agreement)
as the Executive Committee since the first two (2) calendar
quarters of 2004 (the “ Executive Committee ” or
“ EC ”). The activities of the parties under the
Collaboration Agreement and this Agreement shall also be supervised
and managed by the Executive Committee in accordance with the
procedural and governance provisions of the Collaboration Agreement
(as it may be hereafter amended from time to time). Nothing
contained in this Agreement shall be construed to expand the
authority of the Executive Committee. The Executive Committee shall
perform the specific functions set forth in the Collaboration
Agreement and in this Agreement, including the following additional
general tasks in connection with the management of the
Co-Promotion:
[ * ] =
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BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
11
(a) determine the overall strategy for the
Co-Promotion in the manner contemplated by this
Agreement;
(b) review and approve the Co-Promotion Program and
Budget and all Co-Promotion Marketing Expenses;
(c) assess and determine if any Third Party technology
should be acquired or licensed for purposes of commercialization of
the Co-Promotion Collaboration Product;
(d) establish and delegate duties and responsibilities
to other sub-committees on an “as-needed” basis to
oversee particular projects or activities, including without
limitation the Sub-Committees, by resolution without amending this
Agreement or the Collaboration Agreement, pursuant to its powers
under Section 3.3(h) of the Collaboration
Agreement;
(e) oversee and approve the activities of the
Sub-Committees;
(f) address disputes and disagreements arising in the
Sub-Committees;
(g) if either party desires to utilize its Sales FTEs
for the marketing and sale of one or more additional products with
the Co-Promotion Collaboration Product, the EC shall determine [
* ] the number of Sales FTEs such party would be required to
use to promote said multiple products so that such party’s
allocation of Sales FTE effort promoting the Co-Promotion
Collaboration Product is equivalent to the number of Sales FTEs for
that party as was set by the EC. Notwithstanding the foregoing, in
the event the Executive Committee is unable to reach agreement
within [ * ] as to such [ * ] , then [ * ]
within [ * ] , [ * ] . Such [ * ] shall [ *
] and shall [ * ] . Such party shall rely on the [ *
] to ensure that its allocation of Sales FTE effort promoting
the Co-Promotion Collaboration Product is equivalent to the number
of Sales FTEs for that party as set by the EC; and
(h) perform any other functions as appropriate to
further the purposes of this Agreement as expressly set forth
herein or as otherwise determined by the parties.
Section 3.2 Joint Marketing Committee.
(a) Formation and Membership. The Joint Marketing
Committee (the “ JMC ”) shall consist of up to
six (6) members, with up to three (3) each appointed by
Onyx and Bayer, provided that one (1) member of each party will be
a Vice-President of Sales and/or Marketing, or equivalent thereto,
for such party. In the event the Executive Committee shall decide
at any time to disband the JMC, all powers and delegated authority
of the JMC shall automatically revert, without further action, to
the Executive Committee. Notwithstanding anything to the contrary
contained herein, the authority of the JMC shall be limited to the
authority conferred upon it by the Executive Committee; nothing
contained in this Agreement shall be construed to permanently fix
or establish the powers and duties of the JMC, and the Executive
Committee shall be free to expand or contract the powers conferred
upon the JMC
[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
12
from time to
time. Members of the JMC shall be composed of senior executives of
each party authorized to make decisions with respect to the matters
within the scope of the JMC’s authority. An alternate member
designated by a party may serve temporarily in the absence of a
permanent member designated by such party. Each party shall appoint
and replace its representatives to the JMC, as appropriate during
the Co-Promotion.
(b) Functions and Powers of the Joint Marketing
Committee. The Co-Promotion activities of the parties under
this Agreement shall be supervised and managed by the JMC. The JMC
shall perform the specific functions set forth in this Agreement,
and in addition shall perform the following general tasks in
managing the Co-Promotion:
(i) prepare the Co-Promotion Program and Budget for
submission to the Executive Committee on an annual basis not later
than [ * ] ;
(ii) oversee implementation of the Co-Promotion
Program and Budget;
(iii) direct and oversee all marketing activities
concerning the Co-Promotion Collaboration Product (whether
conducted directly by the parties or through Third Party
vendors);
(iv) prepare the sales strategy for the Co-Promotion
Collaboration Product, including the development of the Call Plan
(if applicable);
(v) establish and delegate duties to other
Sub-Committees on an “as-needed” basis for purposes of
advising the JMC as to matters within its responsibilities;
and
(vi) perform any other functions as appropriate to
further the purposes of this Agreement as determined by the
provisions hereof or by the Executive Committee.
Section 3.3 Committee Decision Making. Subject to the
terms of Section 3.2 above, the JMC shall take action by
unanimous vote with each party having a single vote, irrespective
of the number of such party’s representatives actually in
attendance. The members of the JMC shall act in good faith to
cooperate with one another to reach agreement with respect to
issues to be decided by the Sub-Committee. If the JMC is unable to
reach unanimous consent on any matter over which the JMC has
authority within [ * ] of the first consideration of such
matter, the matter shall be referred to the Executive Committee for
decision.
Section 3.4 Obligations of the Parties. Onyx and Bayer
shall provide the Executive Committee and the Joint Marketing
Committee and their authorized representatives with reasonable
access during regular business hours to all records, documents and
information relating to this Co-Promotion which such Committee may
reasonably require in order to perform its obligations hereunder,
provided that if such records, documents and information are under
a bona fide obligation of confidentiality to a Third Party, then
Onyx or Bayer, as the case may be, may withhold access thereto to
the extent necessary to satisfy such obligation. In addition, the
parties agree to exercise Commercially Reasonable Efforts to
provide one another with reasonable contractual rights of access to
all such Third Party records, documents and
[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
13
information in
connection with the execution of new (or amended) Third Party
contracts entered into from time to time during the
Term.
ARTICLE IV
RESPONSIBILITIES OF ONYX
Section 4.1 Promotion of the Co-Promotion Collaboration
Product by Onyx.
(a) Throughout the Term, Onyx shall contribute fifty
percent (50%) of the overall number of Sales FTEs required by the
Co-Promotion Program as developed by the JMC and approved by the
Executive Committee. Onyx shall use its Commercially Reasonable
Efforts to market and promote the Co-Promotion Collaboration
Product to Target Healthcare Professionals in the United States in
accordance with the then-current Co-Promotion Program, and shall
perform additional services assigned to it from time to time by the
Executive Committee. Subject to Section 4.1(b), the exact
number of Sales FTEs to be provided by Onyx will be determined by
the JMC and approved by the Executive Committee and established
under and pursuant to the Co-Promotion Program.
(b) (i) Onyx shall provide a minimum Weighted
Average of not less than [ * ] of all [ * ] assigned
to Onyx in each [ * ] of each [ * ] of the Term. In
the event that Onyx provides less than a Weighted Average of [ *
] of all [ * ] assigned to Onyx for any given [ *
] following the first Contract Year (based on the Weighted
Average number of [ * ] for each [ * ] of the
relevant [ * ] , on an average basis), then Onyx shall incur
a [ * ] calculated as follows:
Any [ *
] due and payable under this Section will be due to Bayer no
later than thirty (30) days following the expiration of the
[ * ] that gave rise to the [ * ] . In the event that
the parties disagree whether Onyx has satisfied its obligation to
provide a Weighted Average of [ * ] of all [ * ]
assigned to Onyx in the given period, the matter shall be reviewed
by the JFC for up to [ * ] days in an attempt to resolve the
matter. In the event the JFC cannot resolve the issue within such
time period, either party shall be entitled to submit the issue to
the Executive Committee for resolution pursuant to Article 25
of the Collaboration Agreement.
(ii) Onyx
shall provide at least [ * ] of the [ * ] for each
[ * ] period beginning on each anniversary of commercial
launch of the Co-Promotion Collaboration Product. The initial [
* ] shall be equal to the [ * ] . In each case the Onyx
sales force fails to meet [ * ] of the [ * ] for a
[ * ] , Onyx shall [ * ] of the applicable Sales FTE
rate for such year. The determination of whether the [ * ]
have been met shall be measured within [ * ] days following
each anniversary of a commercial launch, and shall begin on the
second anniversary of the commercial launch. For clarity, the [
* ] provided in this Section 4.1(b)(ii) shall be additive
to the [ * ] set forth in Section 4.1(b)(i).
(c) Unless the parties otherwise agree, Onyx shall
provide fifty percent (50%) of the overall number of MSLs required
by the Co-Promotion Program to support the Co-
[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
14
Promotion
Collaboration Product, and Onyx shall be solely responsible for
100% of its own MSL Expenses, unless otherwise provided under
Section 8.4(a) below.
(d) The MSLs provided by Onyx, together with the MSLs
provided by Bayer, shall develop for approval by the JMC an
integrated medical affairs program and policies thereto approved by
the MSLs of each party that includes [ * ] from the
appropriate MSLs to any query from the field or from either
party.
(e) In performing its duties hereunder, Onyx shall,
and shall cause its employees to: (i) [ * ] ; and (ii) [
* ] . No employee of Onyx shall make any representation,
statement, warranty or guaranty with respect to the Co-Promotion
Collaboration Product that is not consistent with current labeling
of the Co-Promotion Collaboration Product or Marketing Materials
developed in conformity with Section 6.2(a) hereof, that is
deceptive or misleading or that disparages the Co-Promotion
Collaboration Products or the good name, goodwill and reputation of
Bayer. Onyx shall use Commercially Reasonable Efforts to ensure
that its services delivered pursuant to this Agreement will be
provided in a professional, ethical and competent
manner.
Section 4.2 CRM System and Sales/Prescriber Data. Bayer
shall [ * ] exercise Commercially Reasonable Efforts to [
* ] to the CRM System with [ * ] to include Onyx as a
licensee and subscriber. Such [ * ] shall provide that Bayer
and Onyx shall be [ * ] to the CRM System and to [ *
] related to the Co-Promotion Collaboration Product.
Notwithstanding the foregoing, each party’s sales
representatives shall be responsible for providing information on
an ongoing basis as requested in the CRM System, including without
limitation [ * ] information. Information contained in the
CRM System pertaining to Onyx shall be treated as Confidential
Information of Onyx and shall not be used or disclosed to Third
Parties without Onyx’s prior written approval or direction,
unless otherwise required by Applicable Laws.
Section 4.3 Onyx Sales Force.
(a) The parties agree, for purposes of this Agreement,
that each Sales FTE shall initially be assigned a Sales FTE rate of
[ * ] , which rate is based upon Bayer’s and
Onyx’s [ * ] . The Sales FTE rate shall be adjusted
annually by the Executive Committee in connection with the approval
of the Budget and shall be [ * ] ; provided ,
however , that in the event the Executive Committee is
unable to adjust the Sales FTE rate by [ * ] of the calendar
year preceding the adjustment year due to any deadlock of the
Executive Committee, the Sales FTE rate shall be adjusted to
reflect any [ * ] . Onyx shall be solely responsible for all
of its own Sales Force Expenses in promoting the Co-Promotion
Collaboration Product, unless otherwise provided under
Section 8.4(a) below. Each Sales FTE of Onyx shall be an
employee of Onyx and shall remain under the direct and exclusive
authority, supervision and control of Onyx at all times during the
Term. Onyx shall supervise and maintain such competent and
qualified sales representatives as may be required to promote the
Co-Promotion Collaboration Product as provided herein and in the
Co-Promotion Program and shall cause the sales force to meet the
Performance Qualifications. In the event that Onyx commences sales
of another product using the same sales force as used to promote
the Co-Promotion Collaboration Product, Onyx shall still
[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
15
be obligated to
satisfy its obligations hereunder, including without limitation to
provide its minimum number of Equivalent Sales FTEs required to
promote the Co-Promotion Collaboration Product. Onyx shall not [
* ] without the prior approval of the Executive Committee. For
the period commencing on the Co-Promotion Effective Date and for
[ * ] thereafter, Onyx shall [ * ] ; provided
, however , that (subject to Section 4.1(a)) Sales FTEs
may be added or removed at the discretion of Onyx.
(b) Subject to Section 6.2(a), all written,
electronic and visual communications provided to any of
Onyx’s sales representatives regarding strategy, positioning
or selling messages for the Co-Promotion Collaboration Product will
be subject to review and approval by the [ * ] to ensure
uniform messaging and execution. The costs and expenses of
providing such written, electronic and visual communications shall
be considered Allowable Co-Promotion Expenses.
ARTICLE V
RESPONSIBILITIES OF BAYER
Section 5.1 Promotion of the Co-Promotion Collaboration
Product by Bayer.
(a) Throughout the Term, Bayer shall contribute fifty
percent (50%) of the overall number of Sales FTEs required by the
Co-Promotion Program as developed by the JMC and approved by the
Executive Committee. Bayer shall use its Commercially Reasonable
Efforts to market and promote the Co-Promotion Collaboration
Product to Target Healthcare Professionals in the United States in
accordance with the then-current Co-Promotion Program, and shall
perform additional services assigned to it from time to time by the
Executive Committee. Subject to Section 5.1(b), the exact
number of Sales FTEs to be provided by Bayer will be determined by
the JMC and approved by the Executive Committee and established
under and pursuant to the Co-Promotion Program.
(b) (i) Bayer shall provide a minimum Weighted
Average of not less than [ * ] of all [ * ] assigned
to Bayer in each [ * ] of [ * ] of the Term. In the
event that Bayer provides less than a Weighted Average of [ *
] of all [ * ] assigned to Bayer for any given [ *
] following the first Contract Year (based on the Weighted
Average number of [ * ] for each [ * ] of the
relevant [ * ] on an average basis), then Bayer shall incur
a [ * ] calculated as follows:
Any [ *
] due and payable under this Section will be due to Onyx no
later than thirty (30) days following the expiration of the
[ * ] that gave rise to the [ * ] . In the event that
the parties disagree whether Bayer has satisfied its obligation to
provide a Weighted Average of [ * ] of all [ * ]
assigned to Bayer in the given period, the matter shall be reviewed
by the JFC for up to [ * ] days in an attempt to resolve the
matter. In the event the JFC cannot resolve the issue within such
time period, either party shall be entitled to submit the issue to
the Executive Committee for resolution pursuant to Article 25
of the Collaboration Agreement.
[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
16
(ii) Bayer
shall provide at least [ * ] of the [ * ] for each
[ * ] period beginning on each anniversary of commercial
launch of the Co-Promotion Collaboration Product. The initial [
* ] shall be equal to the [ * ] . In each case the Bayer
sales force fails to meet [ * ] of the [ * ] for a
[ * ] , Bayer shall [ * ] of the applicable Sales FTE
rate for such year. The determination of whether the [ * ]
have been met shall be measured within [ * ] following each
anniversary of a commercial launch, and shall begin on the second
anniversary of the commercial launch. For clarity, the [ * ]
provided in this Section 5.1(b)(ii) shall be additive to the
[ * ] set forth in Section 5.1(b)(i).
(c) Unless the parties otherwise agree, Bayer shall
provide fifty percent (50%) of the overall number of MSLs required
by the Co-Promotion Program to support the Co-Promotion
Collaboration Product, and Bayer shall be solely responsible for
100% of its own MSL Expenses, unless otherwise provided under
Section 8.4(a) below.
(d) The MSLs provided by Bayer, together with the MSLs
provided by Onyx, shall develop for approval by the JMC an
integrated medical affairs program and policies thereto approved by
the MSLs and the Regional Sales Manager of each party that includes
[ * ] from the appropriate MSLs to any query from the field
or from either party.
(e) In performing its duties hereunder, Bayer shall,
and shall cause its employees to: (i) [ * ] ; and (ii) [
* ] . No employee of Bayer shall make any representation,
statement, warranty or guaranty with respect to the Co-Promotion
Collaboration Product that is not consistent with current labeling
of the Co-Promotion Collaboration Product or Marketing Materials
developed in conformity with Section 6.2(a) hereof, that is
deceptive or misleading or that disparages the Co-Promotion
Collaboration Products or the good name, goodwill and reputation of
Onyx. Bayer shall use Commercially Reasonable Efforts to ensure
that its services delivered pursuant to this Agreement will be
provided in a professional, ethical and competent
manner.
(f) In the event the Executive Committee decides to
promote the Co-Promotion Collaboration Product to healthcare
professionals in the [ * ] field, [ * ] shall be
included in such promotion activities. The Executive Committee
shall determine the appropriate weighting of such sales effort,
taking into consideration the [ * ] . Under such
circumstances, other promotion activities undertaken by Bayer and
Onyx related to the Co-Promotion Collaboration Product shall then
be adjusted in order to maintain equality in overall sales efforts
by each party.
Section 5.2 CRM System and Sales/Prescriber Data. As
set forth in Section 4.2 above, Bayer shall [ * ]
exercise Commercially Reasonable Efforts to [ * ] to the CRM
System with [ * ] to include Onyx as a licensee and
subscriber. Such [ * ] shall provide that Bayer and Onyx
shall be [ * ] to the CRM System and to [ * ] related
to the Co-Promotion Collaboration Product. Notwithstanding the
foregoing, each party’s sales representatives shall be
responsible for providing information on an ongoing basis as
requested in the CRM System, including without limitation [ *
] information. Information contained in the CRM System
pertaining to Bayer shall be treated as Confidential Information of
Bayer and shall not be used or disclosed to
[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
17
Third Parties
without Bayer’s prior written approval or direction, unless
otherwise required by Applicable Laws.
Section 5.3 Bayer Sales Force.
(a) The parties agree, as specified in
Section 4.3 above, each Sales FTE shall initially be assigned
a Sales FTE value of [ * ] , which rate is based upon
Bayer’s and Onyx’s [ * ] . The Sales FTE rate
shall be adjusted annually by the Executive Committee in connection
with the approval of the Budget and shall be the [ * ] ;
provided , however , that in the event the Executive
Committee is unable to adjust the Sales FTE rate by [ * ] of
the calendar year preceding the adjustment year due to any deadlock
of the Executive Committee, the Sales FTE rate shall be adjusted to
reflect any [ * ] . Bayer shall be solely responsible for
all of its own Sales Force Expenses in promoting the Co-Promotion
Collaboration Product, unless otherwise provided under
Section 8.4(a) below. Each Sales FTE of Bayer shall be an
employee of Bayer and shall remain under the direct and exclusive
authority, supervision and control of Bayer at all times during the
Term. Bayer shall supervise and maintain such competent and
qualified sales representatives as may be required to promote the
Co-Promotion Collaboration Product as provided herein and in the
Co-Promotion Program and shall cause the sales force to meet the
Performance Qualifications. In the event that Bayer commences sales
of another product using the same sales force as used to promote
the Co-Promotion Collaboration Product, Bayer shall still be
obligated to satisfy its obligations hereunder, including without
limitation to provide its minimum number of Equivalent Sales FTEs
required to promote the Co-Promotion Collaboration Product. Bayer
shall not [ * ] without the prior approval of the
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