Exhibit 10.2
CONFIDENTIAL
TREATMENT
CO-PROMOTION
AGREEMENT
by and between
CUBIST
PHARMACEUTICALS, INC.
and
OPTIMER
PHARMACEUTICALS, INC.
Dated as of April 5,
2011
*Confidential Treatment Requested. Omitted
portions filed with the Securities and Exchange Commission (the
“Commission”).
Execution
Copy
TABLE OF CONTENTS
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1.
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DEFINITIONS AND CONSTRUCTION
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1
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1.1
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Definitions
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1
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1.2
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Construction
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13
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2.
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PROGRAMS GENERALLY
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13
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2.1
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Engagement of Cubist
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14
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2.2
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Program Commencement Dates
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14
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2.3
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Launch
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14
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2.4
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Launch Meeting
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14
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2.5
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Sales Force
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14
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2.6
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Medical Affairs Force
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14
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2.7
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Responsibility for Forces
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14
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3.
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SALES PROMOTION ACTIVITIES
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15
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3.1
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Sales Program Plan
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15
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3.2
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Sales Force Activities
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15
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3.3
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Promotional Medical Education
Programs
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15
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3.4
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Incentive Compensation by Cubist
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16
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3.5
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Sales Materials
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16
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3.6
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Sales Force Training
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17
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3.7
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Samples
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18
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4.
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MEDICAL AFFAIRS PROGRAM
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18
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4.1
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Medical Affairs Program Plan
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18
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4.2
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Medical Affairs Force Activities
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18
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4.3
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Performance Goals for Cubist Medical Affairs
Force
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19
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4.4
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Medical Affairs Materials
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19
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4.5
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Medical Affairs Force Training
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20
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4.6
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Information Requests
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21
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4.7
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Studies
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21
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4.8
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Expenses
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22
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4.9
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Additional Services
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22
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5.
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GOVERNANCE
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22
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5.1
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Alliance Manager
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22
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5.2
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Joint Steering Committee
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22
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5.3
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Joint Clearance Committee
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24
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6.
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OPTIMER RESPONSIBILITIES
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25
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6.1
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Manufacture and Supply
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25
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6.2
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Stockout Notice
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25
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6.3
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Other Responsibilities
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25
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6.4
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Contracting Matters
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26
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7.
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REPORTING AND AUDITS
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26
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7.1
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Reporting by Cubist
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26
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7.2
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Reporting by Optimer
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27
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7.3
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Other Information
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27
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*Confidential Treatment Requested. Omitted
portions filed with the Commission.
i
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7.4
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Information Technology
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27
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7.5
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Audit Rights
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27
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8.
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CONSIDERATION
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28
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8.1
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Service Fee
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28
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8.2
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Sales Target Bonuses
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28
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8.3
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Promotion Profit Share
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28
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8.4
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Consequences of a New Cubist Product
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29
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8.5
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Payments; Records; Audits
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29
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9.
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ADVERSE EVENT REPORTING, REGULATORY MATTERS,
PRODUCT INFORMATION AND COMPLIANCE
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29
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9.1
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Regulatory Reporting and Related
Matters
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29
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9.2
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Threatened Agency Action
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33
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9.3
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Compliance Program
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33
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9.4
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Product Information
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33
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9.5
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Compliance with Laws and Policies
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35
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10.
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RETURNED/RECALLED PRODUCT
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35
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10.1
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Returned Product
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35
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10.2
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Recalled Product
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35
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11.
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INDEPENDENT CONTRACTOR STATUS OF
CUBIST, INCLUDING THE SALES FORCES
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35
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12.
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NONCOMPETITION; NONSOLICITATION
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36
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12.1
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Noncompetition
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36
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12.2
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Non-Solicitation
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36
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13.
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CONFIDENTIALITY
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36
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13.1
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Confidential Information
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36
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13.2
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Exceptions to Confidentiality
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36
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13.3
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Residual Knowledge and Inadvertent
Disclosure
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37
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13.4
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Authorized Disclosure
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37
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13.5
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Notification
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38
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13.6
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Remedies
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38
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13.7
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Use of Names
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39
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13.8
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Confidential Treatment
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39
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14.
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TRADEMARKS AND OTHER INTELLECTUAL PROPERTY
RIGHTS
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39
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14.1
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Product Trademarks; Optimer House Marks; and
Cubist Trademarks
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39
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14.2
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Ownership
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40
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14.3
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Trademark Maintenance
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40
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14.4
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Trademark Infringement
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40
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15.
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WARRANTIES; INDEMNITIES;
INSURANCE
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40
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15.1
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Representations, Warranties and
Covenants
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40
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15.2
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Optimer Indemnification
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43
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15.3
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Cubist Indemnification
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43
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15.4
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Indemnification Procedure
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44
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15.5
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Insurance
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46
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*Confidential Treatment Requested.
Omitted portions filed with the Commission.
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ii
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16.
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TERM AND TERMINATION
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46
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16.1
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Term
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46
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16.2
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Termination
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46
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16.3
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Effect of Expiration or Termination
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48
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16.4
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Accrued Rights; Surviving Obligations
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49
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17.
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MISCELLANEOUS
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50
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17.1
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Governing Law, Jurisdiction, Venue and Service
of Process
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50
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17.2
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Force Majeure
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50
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17.3
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Waiver
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50
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17.4
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Notices
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51
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17.5
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Entire Agreement
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52
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17.6
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Successors; Assigns; Subcontracting
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52
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17.7
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Exhibits
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53
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17.8
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Counterparts
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53
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17.9
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Severability
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53
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17.10
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Affiliates
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53
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17.11
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Expenses
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53
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17.12
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Further Assurances
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53
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17.13
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Construction
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54
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17.14
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No Joint Venture
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54
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*Confidential Treatment Requested.
Omitted portions filed with the Commission.
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iii
EXHIBITS
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Exhibit 1.1.29
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Cubist Trademarks
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Exhibit 1.1.47
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Initial Medical Affairs Program Terms
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Exhibit 1.1.48
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Initial Sales Program Terms
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Exhibit 1.1.72
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Optimer House Marks
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Exhibit 7.1
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Form of Cubist Report
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Exhibit 17.6.1
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Cubist Affiliates
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*Confidential Treatment
Requested. Omitted portions filed with the
Commission.
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iv
CO-PROMOTION
AGREEMENT
This Co-Promotion Agreement (the
“ Agreement ”) is entered into as of
April 5, 2011 (the “ Effective Date ”), by
and between Cubist Pharmaceuticals, Inc., a Delaware
corporation (“ Cubist ”) and Optimer
Pharmaceuticals, Inc., a Delaware corporation (“
Optimer ”). Cubist and Optimer are each referred to in
this Agreement as a “ Party ” and collectively
as the “ Parties .”
RECITALS
WHEREAS, Optimer intends to market
that certain pharmaceutical compound known as fidaxomicin in
prescription form;
WHEREAS, Optimer acknowledges
Cubist’s experience in commercializing and otherwise
promoting pharmaceutical products and wishes to engage the services
of Cubist to Promote (as defined herein) and provide other services
related to the Product (as defined herein) in the Territory (as
defined herein); and
WHEREAS, the Parties hereto wish to
jointly Promote (as defined herein) the Product in the Territory
(as defined herein) and perform certain other activities, all on
the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of
the respective covenants, representations, warranties and
agreements set forth herein, and intending to be legally bound
hereby, the Parties hereby agree as follows:
1.
DEFINITIONS AND
CONSTRUCTION
1.1
Definitions
.
Unless specifically set forth to the
contrary herein, the following terms shall have their indicated
meanings when used in this Agreement (including the
exhibits):
1.1.1
“ Act ” means the
Federal Food, Drug, and Cosmetic Act, as amended, and the rules,
regulations and guidelines of the FDA promulgated thereunder, as
may be in effect from time to time.
1.1.2
“ Adverse Event ”
means any adverse drug experience described in the FDA’s New
Drug Application postmarketing reporting regulations, 21 C.F.R.
314.80, as they may be amended from time to time.
1.1.3
“ Affiliate ”
means, with respect to any Person, any other Person that directly,
or indirectly through one or more intermediaries, Controls, is
Controlled by or is under Common Control with such first
Person.
1.1.4
“ Agency ” means
any governmental authority or Regulatory Authority in the
Territory.
1.1.5
“ Agreement ” is
defined in the Preamble.
*Confidential Treatment Requested. Omitted
portions filed with the Commission.
1
1.1.6
“ Alliance Manager
” is defined in Section 5.
1.1.7
“ Annual Gross Profit Share
Amount Due ” is defined in Section 8.3.
1.1.8
“ Applicable Law
” means all federal, state and local laws, and the rules,
regulations, guidelines and guidances of all Agencies, in effect
from time to time, applicable to the marketing, promotion,
distribution and sale of the Product in the Territory, including,
to the extent applicable, (i) the American Medical Association
Guidelines on Gifts to Physicians from Industry, (ii) the
PhRMA Code on Interactions with Healthcare Professionals,
(iii) the Health Insurance Portability and Accountability Act
of 1996, including the Privacy Standards (45 C.F.R. Parts 160 and
164), as amended by the American Recovery and Reinvestment Act of
2009 and any regulations promulgated thereunder, (iv) the
Social Security Act and any regulations promulgated thereunder,
(v) the Act, (vi) the PDMA, and (vii) state and
federal anti-kickback statutes, false claims statutes, statutes
that govern price reporting and reimbursement, and statutes that
govern marketing disclosure and physician payments, and all
rules and regulations promulgated thereunder, in each case in
the Territory.
1.1.9
“ Business Day ”
shall mean a day other than a Saturday or Sunday or any public
holiday in the United States. For the avoidance of doubt,
references in this Agreement to “days” shall mean
calendar days.
1.1.10
“ Business Policies
” means the Cubist Business Policies and the Optimer Business
Policies.
1.1.11
“ Call ” means an
interactive in-person visit to and discussion with a medical
professional by a pharmaceutical sales representative that consists
of one or more details of a product.
1.1.12
“ Change in Control
” means, with respect to a Party, an event or series of
related events in which:
(a)
Any Person or group (as such term is
defined in the Securities Exchange Act of 1934, as amended) (other
than one or more Affiliate(s) of such Party that were
Affiliates immediately prior to such event (any such Affiliate with
respect to such Party, an “ Existing Affiliate
”)), acquires beneficial ownership (as determined pursuant to
Rule 13d-3 promulgated under the Securities Exchange Act of
1934, as amended) of securities of such Party or any Affiliate
thereof that directly, or indirectly through one or more
intermediaries, Controls such Party (any such Affiliate with
respect to such Party, a “ Controlling Entity ”)
representing more than 50% of the voting power of the then
outstanding securities of such Party or its Controlling Entity, if
any, with respect to the election of members of the Board of
Directors or similar governing body of such Party or its
Controlling Entity, if any;
(b)
Such Party or its Controlling
Entity, if any, enters into a merger, consolidation or similar
transaction with another Person (other than an Existing Affiliate
of such Party) and (A) the members of the Board of Directors
of such Party or Controlling Entity, as applicable, immediately
prior to such transaction constitute (i) less than one half of
the members of the Board of Directors of such Party or Controlling
Entity, as applicable, following such transaction, or
(ii) less than one half of the Board of Directors of any new
Controlling Entity
*Confidential Treatment Requested. Omitted
portions filed with the Commission.
2
resulting from such transaction; or (B) the
Persons who beneficially owned the outstanding voting securities of
such Party or Controlling Entity, as applicable, immediately prior
to such transaction cease to beneficially own securities of such
Party or Controlling Entity, as applicable, representing more than
50% of the voting power of the then outstanding securities of such
Party or Controlling Entity, as applicable, with respect to the
election of members of the Board of Directors immediately after
such transaction in substantially the same proportions as their
ownership of securities of such Party or Controlling Entity, as
applicable, immediately prior to such transaction;
(c)
Such Party or its Controlling
Entity, if any, sells or transfers to any Person(s) (other
than a transfer by a Controlling Entity to Existing
Affiliate(s) of such Party) in one or more related
transactions, properties or assets (A) representing more than
50% of such Party’s or Controlling Entity’s, as
applicable, consolidated total assets as reflected on its most
recent Annual Report on Form 10-K or Quarterly Report on
Form 10-Q, (B) from which more than 50% of such
Party’s or Controlling Entity’s, as applicable,
consolidated operating income for its most recent fiscal year as
reflected on its most recent Annual Report on Form 10-K was
derived or (C) representing substantially all of the
properties or assets related to such Party’s obligations
under this Agreement; or
(d)
Such Party or its Controlling
Entity, if any, fails to maintain its corporate existence or
liquidates (unless, in connection with the foregoing, the assets of
such Party or Controlling Entity, as applicable, are acquired by an
Existing Affiliate of such Party and the liabilities of such Party
or Controlling Entity (including, if applicable, the Party’s
obligations under this Agreement) are assumed by such Existing
Affiliate of such Party).
1.1.13
“ Combination Promotional
Medical Education Program ” is defined in
Section 3.3.2.
1.1.14
“ Commercially Reasonable
Efforts ” of a Party mean (i) with respect to
Cubist, those efforts that are consistent with Applicable Law and
with industry standards and practices followed by a similarly
situated pharmaceutical company in the Promotion of pharmaceutical
products with a potential market comparable to the Product, and
(ii) with respect to Optimer, those efforts that are
consistent with Applicable Law and with industry standards and
practices followed by a similarly situated pharmaceutical company
in connection with the manufacture, Promotion, distribution and
sale of pharmaceutical products in a similar stage in product life
as the Product and with a potential market and profit potential
comparable to the Product (based on conditions then prevailing).
For clarity, if a Party is required hereunder to use Commercially
Reasonable Efforts with respect to a given activity and such
activity is performed by an Affiliate of such Party, rather than
such Party, such Party shall cause such Affiliate to use
Commercially Reasonable Efforts to perform such
activity.
1.1.15
“ Competing Product
” means any product, other than the Product, that has [ ]* in
the Territory, [ ]*.
1.1.16
“ Competing Program
” is defined in Section 13.3.
*Confidential Treatment Requested. Omitted
portions filed with the Commission.
3
1.1.17
“ Confidential
Information ” means (i) any and all information or
material, that, at any time before or after the Effective Date has
been or is provided or communicated to the Receiving Party by or on
behalf of the Disclosing Party, including by or on behalf of any of
its Affiliates, pursuant to this Agreement or in connection with
the transactions contemplated hereby or any discussions or
negotiations with respect thereto (including any information
disclosed pursuant to the Mutual Non-Disclosure Agreement between
the Parties effective as of July 9, 2009, as amended);
(ii) any data, ideas, concepts or techniques contained in any
of the foregoing; and (iii) any modifications of any of the
foregoing or derivations of any of the foregoing. Confidential
Information may be disclosed orally, visually, in writing, by
delivery of materials containing Confidential Information, or in
any other form now known or hereafter invented; provided, however,
that any information or material specifically relating to the
Product, including the Promotion thereof (but excluding, without
limitation, (a) the identity of and information regarding the
Target Accounts and Target Prescribers and the allocation of
Cubist’s Sales Force thereto, and (b) information
relating to the Disease State generally), shall be the Confidential
Information of Optimer regardless of which Party first disclosed
such information, and Optimer and Cubist shall be deemed the
Disclosing Party and Receiving Party, respectively, with respect
thereto. The terms of this Agreement shall be the Confidential
Information of both Parties.
1.1.18
“ Control ” and,
with correlative meanings, the terms “Controlled by”
and “under Common Control with,” means (i) the
power to direct or cause the direction of the management or
policies of a Person, whether through the ownership of voting
securities, by contract, resolution, regulation or otherwise or
(ii) the ownership, directly or indirectly, of more than 50%
of the voting securities or other ownership interest of a Person
(or, with respect to a limited partnership or other similar entity,
its general partner or controlling entity).
1.1.19
“ Controlling Entity
” is defined in Section 1.1.12(a).
1.1.20
“ Cost of Goods Sold
” means the standard cost of goods for the Product sold in
the applicable time period, which standard cost shall be determined
and allocated by Optimer in accordance with GAAP, including
Optimer’s good faith estimate of (A) Optimer’s and
its Affiliates’ [ ]*, (B) all of Optimer’s and its
Affiliates’ [ ]*, (C) [ ]*, and (D) [ ]*.
Notwithstanding the foregoing, Cost of Goods Sold for Product from
[ ]* shall be determined in accordance with clauses
(A) through (D) above whether or not [ ]*.
1.1.21
“ Cubicin ” means
that certain pharmaceutical compound known as daptomycin in
prescription form for injection that has received Regulatory
Approval from the FDA to be marketed in the Territory under the
Cubist Trademark Cubicin.
1.1.22
“ Cubist ” is
defined in the Preamble.
1.1.23
“ Cubist Business
Policies ” means Cubist’s business policies,
standard business procedures, and coaching sheets, that in each
case, govern the Promotion and the Medical Affairs Program
activities and, in each case, to the extent such business policies,
standard business procedures, and coaching sheets are consistent
with Applicable Law and this Agreement, copies of which have been
provided by Cubist to Optimer prior to the Effective
Date
*Confidential Treatment Requested. Omitted
portions filed with the Commission.
4
(as such business policies, standard business
procedures and coaching sheets may be amended from time to time by
Cubist, provided that Cubist provides amended copies thereof to
Optimer).
1.1.24
“ Cubist Competitor
” means any Third Party that is developing or marketing [ ]*
(which, for clarification, shall not include an [ ]*) for the
treatment of [ ]*. For clarity, developing, in this definition,
refers to development of [ ]*.
1.1.25
“ Cubist Indemnified
Parties ” is defined in Section 15.2.
1.1.26
“ Cubist Medical Affairs
Force ” means the Cubist Medical Affairs Representatives
(including their direct supervisors, managers, and trainers) and
other Cubist employees performing Medical Affairs Program
activities under this Agreement.
1.1.27
“ Cubist Report ”
is defined in Section 7.1.
1.1.28
“ Cubist Sales Force
” means the Cubist Sales Representatives (including their
direct supervisors, managers, and trainers) and other Cubist
employees performing Sales Program activities under this
Agreement.
1.1.29
“ Cubist Trademarks
” means (i) the Trademarks of Cubist and its Affiliates
set forth on Exhibit 1.1.29 , and any existing, pending
or future Trademark registrations, applications and unregistered
Trademark rights, in each case relating to such Trademarks, and
(ii) any current or future modifications or variants of any of
the foregoing rights.
1.1.30
“ Detail ” means
a face-to-face (a) one-on-one discussion with a Target
Prescriber or (b) discussion with a group consisting of no
more than [ ]* Target Prescribers at the same time, in each case
during which a Sales Representative makes a presentation of certain
of the Product’s attributes, such as describing the
FDA-approved indicated uses, safety, effectiveness,
contraindications, side effects, warnings or other relevant
characteristics of the Product, consistent with the requirements of
this Agreement and Applicable Law and in a manner that is customary
in the industry for the purpose of promoting a prescription
pharmaceutical product. When used as a verb, “Detail”
means to engage in a Detail. For the avoidance of doubt, (i) a
reminder presentation or a sample drop shall not constitute a
Detail; and (ii) presentations to groups consisting of more
than [ ]* people or containing more than [ ]* Target Prescribers,
medical conventions or institutions shall not constitute
Details.
1.1.31
“ Disclosing Party
” means the Party disclosing Confidential
Information.
1.1.32
“ Disease State ”
means Clostridium difficile infection in humans.
1.1.33
“ Effective Date
” is defined in the Preamble.
1.1.34
“ Employment Law
” means all federal, state, or local statutes, laws,
ordinances, regulations or guidelines relating to
(i) employment, (ii) safety and health, and
(iii) the payment of taxes and required taxes and payments
with respect to employees.
*Confidential Treatment Requested. Omitted
portions filed with the Commission.
5
1.1.35
“ Existing Affiliate
” is defined in Section 1.1.12(a).
1.1.36
“ FDA ” means the
United States Food and Drug Administration and any successor agency
having substantially the same functions.
1.1.37
“ Field Alert ”
is defined in Section 9.1.9.
1.1.38
“ First Commercial Sale
” means the first bona fide sale of the Product in the
Territory to an end consumer (including any pharmacy, hospital,
skilled nursing facility or similar institution) following receipt
of Regulatory Approval of the Product in the Territory. For
clarity, First Commercial Sale shall not include any sale, transfer
or disposition of the Product as promotional samples or for
charitable or pre-clinical, clinical or post-approval studies
purposes.
1.1.39
“ First Sales Year
” means the 12 month period starting on the date of the First
Commercial Sale and ending on the last day of the month in which
the first anniversary of the First Commercial Sale date
occurs.
1.1.40
“ Force Majeure Event
” is defined in Section 17.2.
1.1.41
“ GAAP ” means
the United States generally accepted accounting principles, applied
on a consistent basis, or any successor accounting principles
generally accepted for public companies in the United States (such
as International Financial Reporting Standards).
1.1.42
“ Gross Profit ”
means, with respect to any period, Net Sales for such period, less
the [ ]*.
1.1.43
“ Gross Sales ”
means, for a given period, all sales of the Product during such
period ([ ]*) by or on behalf of Optimer or its Affiliates to Third
Parties in the Territory (regardless of whether Optimer or its
Affiliates have received more or less than the [ ]*). For purposes
of determining Gross Sales, (i) the Product shall be deemed to
be sold at the point of shipment, and (ii) sales, transfers or
dispositions of the Product as promotional samples or for
charitable or pre-clinical, clinical or post-approval studies
purposes shall be excluded from Gross Sales, and (iii) sales
or transfers of the Product among Optimer and its Affiliates shall
be excluded from Gross Sales, provided that any subsequent sale to
a Third Party in the Territory shall be included.
1.1.44
“ Indemnification Claim
Notice ” is defined in Section 15.4.1.
1.1.45
“ Indemnified Party
” is defined in Section 15.4.1.
1.1.46
“ Indemnifying Party
” is defined in Section 15.4.1.
1.1.47
“ Initial Medical Affairs
Program Terms ” means the key terms of the Medical
Affairs Program Plan set forth in Exhibit 1.1.47
attached to this Agreement as of the Effective Date.
*Confidential Treatment Requested. Omitted
portions filed with the Commission.
6
1.1.48
“ Initial Sales Program
Terms ” means the key terms of the Sales Program Plan
(including the Promotional Medical Education Program) set forth in
Exhibit 1.1.48 attached to this Agreement as of the
Effective Date.
1.1.49
“ Initial Term ”
is defined in Section 16.1.
1.1.50
“ Joint Clearance
Committee ” is defined in Section 5.3.1.
1.1.51
“ Joint Steering
Committee ” is defined in Section 5.2.1.
1.1.52
“ Key Opinion Leader
” means a medical professional recognized as a leading expert
in his or her respective field, including any person set out on a
list of such medical professionals developed jointly and agreed to
in writing by the Parties.
1.1.53
“ Know-How ”
means all technical knowledge, expertise, skill, practice, market
research data, marketing and sales data and any other
marketing-related data, proprietary rights, regulatory approvals,
discoveries, inventions, improvements, trade secrets, copyrights
and processes relating to the Product and all pre-clinical,
clinical, stability and other data relating to the
Product.
1.1.54
“ Knowledge ”
means, when referring to the knowledge of Cubist or Optimer, the
actual, unaided knowledge of the following individuals:
(a) for Cubist, Cubist’s [ ]* and (b) for Optimer,
Optimer’s [ ]*.
1.1.55
“ Losses ” is
defined in Section 15.2.
1.1.56
“ Medical Affairs Force
” means each of the Cubist Medical Affairs Force and the
Optimer Medical Affairs Force.
1.1.57
“ Medical Affairs
Materials ” is defined in Section 4.4.3.
1.1.58
“ Medical Affairs
Program ” is defined in Section 4.2.
1.1.59
“ Medical Affairs Program
Commencement Date ” means the date set forth in the
Medical Affairs Program Plan on which the Medical Affairs Program
shall commence.
1.1.60
“ Medical Affairs Program
Plan ” is defined in Section 4.1.
1.1.61
“ Medical Affairs
Representative ” means a scientific or medical
representative who (i) is primarily focused on infectious
diseases and therapeutic areas related thereto in the Territory,
(ii) has relevant clinical experience and sufficient health
care experience (including at least a four-year degree and
clinical, residency or fellowship experience or other highly
specialized training relevant to Medical Affairs Program
activities, including any such professional with a Ph.D., Pharm.D.
or M.D. degree) to engage in in-depth dialogues with physicians
regarding medical issues associated with the Product, (iii) is
employed by a Party or any of its Affiliates on a full-time basis,
and (iv) is not a Sales Representative or otherwise engaged in
direct Promotion of the Product. For clarity, (a) Cubist
Medical Affairs
*Confidential Treatment Requested. Omitted
portions filed with the Commission.
7
Representatives would include Cubist Clinical
Scientific Directors (CSDs) and (b) Optimer Medical Affairs
Representatives would include Optimer Medical Education Research
Liaisons (MERLs).
1.1.62
“ Medical Affairs Training
Materials ” is defined in
Section 4.5.2(b).
1.1.63
“ Medical Affairs Training
Plan ” means that certain plan with respect to training
the Medical Affairs Forces that shall be prepared by the Parties as
soon as practicable after the Effective Date, as such plan may be
modified from time to time by the Joint Steering Committee in
accordance with this Agreement.
1.1.64
“ National Sales
Meeting ” is defined in Section 3.6.3.
1.1.65
“ NDA ” means a
“New Drug Application,” as defined in the
Act.
1.1.66
“ Net Sales ”
means, with respect to any period, Gross Sales for such period less
deductions, to the extent recognized in accordance with GAAP, and
not for promotional purposes for: (i) [ ]*, including
(A) [ ]*, (B) [ ]*, (C) [ ]* and (D) [ ]*;
(ii) [ ]*; (iii) [ ]*; (iv) [ ]* (including [ ]*;
(v) [ ]* (but not including [ ]*; (vi) [ ]*; and
(vii) [ ]* in accordance with GAAP [ ]*. Any of the deductions
specified in this definition that involves a payment or credit
shall be taken as a deduction in the Sales Quarter in which the
payment or credit is accrued by Optimer or its applicable
Affiliate, in accordance with GAAP. If, as part of any managed care
program or arrangement, the Product is sold with other products
such that it is not possible to determine which of the deductions
set forth above are specifically attributable to the Product, then
Optimer shall apportion the deductions across the bundle of
products on a relative fair value basis. Notwithstanding anything
contained herein, in no event shall any category of expense, to the
extent included in Optimer’s determination of the Cost of
Goods Sold for a given period, be taken as a deduction in the
calculation of Net Sales for such period.
1.1.67
“ Noncompete Period
” is defined in Section 12.1.1.
1.1.68
“ Notice ” means
any notice, request, report, statement or other communication to
either Party by the other Party pursuant to, in connection with, or
relating to, this Agreement.
1.1.69
“ Off-Label Information
” means any written, printed, graphic or oral information
with respect to the Product that is inconsistent with, or outside
the scope of, the FDA-approved labeling for the Product in the
Territory.
1.1.70
“ Optimer ” is
defined in the Preamble.
1.1.71
“ Optimer Business
Policies ” means Optimer’s business policies,
standard business procedures, and coaching sheets, that in each
case, relate to the Programs and the manufacture of the Product
and, in each case, to the extent consistent with Applicable Law and
this Agreement (as such business policies, standard business
procedures and coaching sheets may be amended from time to time by
Optimer).
*Confidential Treatment Requested. Omitted
portions filed with the Commission.
8
1.1.72
“ Optimer House Marks
” means (i) the Trademarks of Optimer set forth on
Exhibit 1.1.72 and any pending or future Trademark
registrations, applications and unregistered Trademark rights, in
each case relating to such Trademarks, and (ii) any current or
future modifications or variants of any of the foregoing
rights.
1.1.73
“ Optimer Indemnified
Parties ” is defined in Section 15.3.
1.1.74
“ Optimer Medical Affairs
Force ” means the Optimer Medical Affairs Representatives
(including their direct supervisors, managers, and trainers) and
other Optimer employees performing Medical Affairs Program
activities under this Agreement.
1.1.75
“ Optimer Report
” is defined in Section 7.2.
1.1.76
“ Optimer Sales Force
” means the Optimer Sales Representatives (including their
direct supervisors, managers, and trainers) and other Optimer
employees performing Sales Program activities under this
Agreement.
1.1.77
“ Other Fidaxomicin
Product ” means any form of fidaxomicin other than a
Product.
1.1.78
“ Party ” and
“ Parties ” is defined in the
Preamble.
1.1.79
“ PDMA ” means
the Prescription Drug Marketing Act of 1987, as amended, and the
rules, regulations and guidelines promulgated thereunder and in
effect from time to time.
1.1.80
“ Permitted Uses
” is defined in Section 14.1.1.
1.1.81
“ Person ” means
any individual or entity, including a government or political
subdivision, department or agency of a government.
1.1.82
“Primary Position
Detail” means a
Detail in which the Product (i) is the first product Detailed,
(ii) is emphasized [ ]* and (iii) is the primary focus of
such Detail, primary focus meaning [ ]*.
1.1.83
“ Proceeding(s) ”
is defined in Section 15.1.3(d).
1.1.84
“ Product ” means
that form of fidaxomicin in prescription form intended to be
marketed by Optimer under the Product NDA.
1.1.85
“ Product Gross Margin
Percentage ” means, with respect to any period,
(a) [ ]*, divided by (b) [ ]*.
1.1.86
“ Product Information
Request ” is defined in Section 9.4.5.
1.1.87
“ Product Labels and/or
Inserts ” means (i) all FDA-approved labels and
other written, printed or graphic matter affixed to any container,
packaging or wrapper
*Confidential Treatment Requested. Omitted
portions filed with the Commission.
9
utilized in connection with the Product, or
(ii) any written material physically accompanying the Product,
including Product package inserts.
1.1.88
“ Product NDA ”
means NDA 201,699 for Dificid™ (fidaxomicin
tablets).
1.1.89
“ Product Quality
Complaint ” means any and all manufacturing or
packaging-related complaints related to the Product, including
(i) any complaint involving the possible failure of the
Product to meet any of the specifications for the Product;
(ii) any dissatisfaction with the design, package or labeling
of the Product; or (iii) any Adverse Event that may involve
the quality of the Product.
1.1.90
“ Product Trademarks
” means (i) the Trademark Dificid™ and the
registrations thereof, (ii) any pending or future Trademark
registration applications relating to the Product, (iii) any
unregistered Trademark rights relating to the Product as may exist
through use prior to or as of the Effective Date, (iv) any
current or future modifications or variants of any of the foregoing
rights, and (v) any future Trademarks adopted by Optimer or
its Affiliates for use in connection with the Product. For the
avoidance of doubt, “Product Trademarks” shall not
include any Optimer House Marks.
1.1.91
“ Program ”
means, collectively, the Sales Program and the Medical Affairs
Program.
1.1.92
“ Program Employees
” means all members of the Cubist Sales Force, Cubist Medical
Affairs Force, Optimer Sales Force, and Optimer Medical Affairs
Force.
1.1.93
“ Promotion ”
means Detailing and those other activities normally undertaken by a
pharmaceutical company’s sales force, and its supervisors and
managers, to implement marketing plans and strategies aimed at
encouraging the appropriate use of a particular prescription
pharmaceutical product. When used as a verb, “ Promote
” means to engage in such activities.
1.1.94
“ Promotional Medical
Education Program Materials ” is defined in
Section 3.3.3.
1.1.95
“ Promotional Medical
Education Programs ” is defined in
Section 3.3.1.
1.1.96
“ Public Announcement
” means public announcements, press releases, investor calls,
or advertising, recruiting and other public documents.
1.1.97
“ Quarterly Amount Due
” is defined in Section 8.1.
1.1.98
“ Receiving Party
” means the Party receiving or having access to Confidential
Information of the other Party.
1.1.99
“ Recipients ” is
defined in Section 13.1.
*Confidential Treatment Requested. Omitted
portions filed with the Commission.
10
1.1.100
“ Regulatory Approval
” means any and all approvals (including price and
reimbursement approvals, if required), licenses, registrations, or
authorizations of Regulatory Authorities in the Territory that are
necessary for the marketing and sale of a product in the Territory
for the treatment, prevention, modulation, or diagnosis of any
disease, disorder or condition in humans.
1.1.101
“ Regulatory Authority
” shall mean any national, regional, state or local
regulatory agency, department, bureau, commission, council or other
governmental entity whose review and/or approval is necessary for
the manufacture, packaging, use, storage, import, export,
distribution, promotion, marketing, offer for sale and sale of a
product in a country for the treatment, prevention, modulation, or
diagnosis of any disease, disorder or condition in humans. For
countries where governmental approval is required for pricing or
reimbursement for a Product, “Regulatory Authority”
shall also include any national, regional, state or local
regulatory agency, department, bureau, commission, council or other
governmental entity whose review and/or approval of pricing or
reimbursement is required.
1.1.102
“ Residual Knowledge
” is defined in Section 13.3.
1.1.103
“ Sales Force ”
means each of the Cubist Sales Force and the Optimer Sales
Force.
1.1.104
“ Sales Materials
” is defined in Section 3.5.3.
1.1.105
“ Sales Program ”
means the program of Promoting (including Detailing) the Product,
including all supervision, management and training with respect
thereto, conducted by the Parties under Section 3.
1.1.106
“ Sales Program
Commencement Date ” means the date set forth in the Sales
Program Plan on which the Sales Program shall commence.
1.1.107
“ Sales Program Plan
” is defined in Section 3.1.
1.1.108
“ Sales Quarter ”
means each full calendar quarter during the Term, provided
that (a) the first Sales Quarter shall commence on the first
day of the first full calendar quarter immediately following the
first day of the First Sales Year (or, if the first day of the
First Sales Year is the first day of a calendar quarter, the first
Sales Quarter shall commence on the first day of the First Sales
Year), and (b) the last Sales Quarter shall end on the last
day of the last Sales Year and, provided further, that if
the first day of the First Sales Year is not the first day of a
calendar quarter, the Parties’ finance contacts shall meet
and in good faith discuss and attempt to agree upon adjustments and
reconciliations to terms of this Agreement pertaining to payments
and reporting, including adjustments to the Sales Targets, if and
as necessary to account for the discrepancy between the first and
last Sales Quarters and Sales Years. If the Parties’ finance
contacts cannot agree upon any such adjustments and
reconciliations, then “ Sales Quarter ” shall
mean each consecutive three-month period during each Sales Year,
provided that (i) the first Sales Quarter shall run
from the first day of the First Sales Year to the end of the last
day of the third full month after first day of the First Sales
Year, and (ii) each subsequent Sales Quarter shall end on the
last day of every third month thereafter.
*Confidential Treatment Requested. Omitted
portions filed with the Commission.
11
1.1.109
“ Sales
Representative ” means a sales representative
(i) who is primarily focused on infectious diseases and
therapeutic areas related thereto in the Territory, (ii) whose
skills, training and experience are consistent with
(a) industry standards applicable to the promotion, marketing
and sale of a prescription pharmaceutical product and (b) the
qualifications or requirements set forth in the Sales Program Plan,
(iii) who is responsible for Promoting the Product in the
Territory, and (iv) who is employed by a Party or any of its
Affiliates on a full-time basis. For clarity, Cubist Sales
Representatives would include Cubist Clinical Business Managers
(CBMs)).
1.1.110
“ Sales Target ”
means the target amount of Net Sales of the Product in the
Territory for each of the First Sales Year and the Second Sales
Year, as set forth on a Sales Quarterly basis in a side letter
between the Parties, dated as of the Effective Date, as such target
amount may be amended from time to time by mutual agreement of the
Parties in writing.
1.1.111
“ Sales Target Bonus
” is defined in Section 8.2.
1.1.112
“ Sales Training
Materials ” is defined in
Section 3.6.2(c).
1.1.113
“ Sales Training Plan
” means that certain plan with respect to training the Sales
Forces that shall be prepared by the Parties as soon as practicable
after the Effective Date, as such plan may be modified from time to
time by the Joint Steering Committee in accordance with this
Agreement.
1.1.114
“ Sales Year ”
means each of the First Sales Year and the Second Sales Year, as
well as any subsequent 12 month periods for which the Agreement is
extended pursuant to Section 16.1.
1.1.115
“ Second Sales Year
” means the 12 month period starting on the first day
following the end of the First Sales Year and ending on the first
anniversary of such starting date.
1.1.116
“Secondary Position
Detail” means a
Detail in which the Product is the second product discussed and the
secondary focus of such Detail, wherein “secondary
focus” means at least [ ]* and the Product is emphasized [ ]*
other than [ ]*.
1.1.117
“ Stockout ”
means:
(a)
any failure by Optimer to fulfill at
least [ ]* Optimer and, as a result of such failure, [ ]* of
(i) [ ]* or (ii) [ ]*; or
(b)
any notice or other communication by
or on behalf of Optimer or its Affiliates to Target Prescribers and
other Third Party medical professionals in the Territory that the
Product in the Territory is or will be subject to rationing,
limited availability or supply constraints.
1.1.118
“ Systems ” is
defined in Section 7.4.
*Confidential Treatment Requested. Omitted
portions filed with the Commission.
12
1.1.119
“ Target Accounts
” mean those certain institutions selected from among the
institutions that Cubist has targeted as of the Effective Date or
thereafter and that are identified in a side letter between the
Parties, dated as of the Effective Date, as such list may be
amended from time to time by amendment of the Sales Program Plan in
accordance with Section 5.2.5.
1.1.120
“ Target Prescriber
” means a physician who is licensed to prescribe drugs and is
in a position to directly influence or recommend the prescription
or purchase of the Product and who (a) is an infectious
disease physician, or (b) has already been targeted by Cubist
in connection with its other promotional activities, and in each
case, who practices, is employed by or otherwise provides services
at a Target Account.
1.1.121
“ Term ” is
defined in Section 16.1.
1.1.122
“ Territory ”
means the United States of America and its territories and
possessions, including Puerto Rico and the District of
Columbia.
1.1.123
“ Third Party ”
means any Person other than the Parties and their respective
Affiliates.
1.1.124
“ Third Party Claim
” is defined in Section 15.2.
1.1.125
“ Trademark ”
means any trademark, trade dress, brand mark, trade name, brand
name, corporate name, logo or business symbol.
1.1.126
“ Training Materials
” means, collectively, the Sales Training Materials and the
Medical Affairs Training Materials.
1.1.127
“ Training Plans
” means, collectively, the Sales Training Plan and the
Medical Affairs Training Plan.
1.1.128
“ Wholesale Acquisition
Cost ” means, with respect to a product, a published list
price for such product (which list price, for clarity, does not
include prompt pay or other discounts, rebates or reductions in
price) for the month in which the applicable sale of such product
occurred, as such list price is publicly reported by the selling
Person.
1.2
Construction
.
Unless the context of this Agreement
otherwise requires: (a) words of any gender include each other
gender; (b) words using the singular or plural number also
include the plural or singular number, respectively; (c) the
terms “hereof,” “herein,”
“hereby” and derivative or similar words refer to this
entire Agreement; (d) the terms “Article,”
“Section,” “Schedule” or
“Exhibit” refer to the specified Article, Section,
Schedule or Exhibit of this Agreement; (e) the term
“or” has, except where otherwise indicated, the
inclusive meaning represented by the phrase “and/or”;
and (f) the term “including” or
“includes” means “including without
limitation” or “includes without
limitation.”
*Confidential Treatment Requested. Omitted
portions filed with the Commission.
13
2.
PROGRAMS GENERALLY
2.1
Engagement of Cubist
. Subject to the terms and
conditions of this Agreement, Optimer hereby engages Cubist, and
Cubist hereby accepts such engagement, as Optimer’s exclusive
partner in Promoting the Product in the Territory, and conducting
the Sales Program and the Medical Affairs Program with respect to
the Product in the Territory.
2.2
Program Commencement
Dates . The Parties shall
mutually select and agree upon a Sales Program Commencement Date
and a Medical Affairs Program Commencement Date, which shall be set
forth in the Sales Program Plan and Medical Affairs Program Plan,
respectively.
2.3
Launch . Optimer will use Commercially Reasonable
Efforts to effect a full launch of the Product (as opposed to a
soft launch) where such launch would occur only when the
distribution network for the Product (including, for example,
Optimer’s and its wholesalers’ and distributors’
capability of receiving and fulfilling orders for the Product
throughout the Territory) is substantially established.
2.4
Launch Meeting
. If the Parties so mutually agree,
Cubist will participate in relevant portions of Optimer launch
meetings for the Product in the Territory. [ ]* will bear the cost
of [ ]* personnel attending such meetings.
2.5
Sales Force
. By the Sales Program Commencement
Date, each of Cubist and Optimer, respectively, will establish the
Cubist Sales Force and the Optimer Sales Force in accordance with
the Sales Program Plan. Without limiting the foregoing and
notwithstanding anything to the contrary herein or in the Sales
Program Plan, at all times during the Term (a) Cubist shall
maintain a Sales Force consisting of at least [ ]* Sales
Representatives and (b) Optimer shall maintain a Sales Force
consisting of at least [ ]* Sales Representatives, in each case, at
full capacity, subject to fluctuation in the ordinary course of
business for vacancies, leave, and other ordinary absences;
provided, however, that each Party shall use Commercially
Reasonable Efforts to fill vacancies within a reasonable period of
time.
2.6
Medical Affairs Force
. By the Medical Affairs Program
Commencement Date, each of Cubist and Optimer, respectively, will
establish the Cubist Medical Affairs Force and the Optimer Medical
Affairs Force in accordance with the Medical Affairs Plan. Without
limiting the foregoing and notwithstanding anything to the contrary
herein or in the Medical Affairs Program Plan, at all times during
the Term (a) Cubist shall maintain a Medical Affairs Force
consisting of at least [ ]* Medical Affairs Representatives, and
(b) Optimer shall maintain a Medical Affairs Force consisting
of at least [ ]* Medical Affairs Representatives, in each case, at
full capacity, subject to fluctuation in the ordinary course of
business for vacancies, leave, and other ordinary absences;
provided, however, that each Party shall use Commercially
Reasonable Efforts to fill vacancies within a reasonable period of
time.
2.7
Responsibility for
Forces . Except as
otherwise set forth in this Agreement, each Party shall be legally
responsible and liable for the actions, omissions and conduct of
all of the members of its Sales Force and Medical Affairs Force.
Each Party shall also be exclusively responsible for supervising
the members of its Sales Force and Medical Affairs Force in all
respects.
*Confidential Treatment Requested. Omitted
portions filed with the Commission.
14
3.
SALES PROMOTION
ACTIVITIES
3.1
Sales Program Plan
. As soon as practicable after the
Effective Date, the Parties shall prepare the Sales Program Plan
for the Product (the “ Sales Program Plan ”).
The Sales Program Plan shall be consistent with, and shall include,
at a minimum, the Initial Sales Program Terms. The Sales Program
Plan may be amended by the Joint Steering Committee in accordance
with Section 5.2.2.
3.2
Sales Force Activities
. Commencing on the Sales Program
Commencement Date and for the remainder of the Term, each Party
shall use Commercially Reasonable Efforts to ensure that its
respective Sales Force Promotes the Product in accordance with the
Sales Program Plan, including Detailing the Product to the Target
Prescribers. Optimer shall also use Commercially Reasonable Efforts
to cause its Sales Representatives to Promote (including Detailing)
the Product to institutions and physicians (other than Target
Accounts and Target Prescribers) reasonably likely to be Product
cu