XXXXX
INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT WAS GRANTED. ALL SUCH OMITTED MATERIAL WAS FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.
COPROMOTION AGREEMENT
By and between
WYETH
acting through its
WYETH PHARMACEUTICALS DIVISION
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1.
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DEFINITIONS
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1
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2.
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APPOINTMENT AND
OBLIGATIONS
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11
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2.1.
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Appointment
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11
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2.2.
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Adjustment to
Initiation Date
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11
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2.3.
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Wyeth’s
Option to Designate Substitute Products
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11
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2.4.
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Permitted
Subcontractors
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13
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2.5.
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Undertaking not
to Compete
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13
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2.6.
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Obligations of
Impax
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13
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2.7.
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Obligations of
Wyeth
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22
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2.8.
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Coordination
Meetings
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24
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2.9.
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Ownership of
Product
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25
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2.10.
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No
Distribution
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27
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3.
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PAYMENTS
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27
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3.1.
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Detail
Fee
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27
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3.2.
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Adjustments to
Detail Price
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27
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3.3.
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No Payment for
Extra Details
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28
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3.4.
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Incentive
Fee
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28
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3.5.
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Taxes and
Withholding
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28
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3.6.
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Currency
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28
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4.
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RECORD KEEPING;
REPORTING AND AUDITS
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28
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4.1.
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Impax Records
and Audits
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28
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4.2.
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Impax
Reports
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29
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4.3.
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Market
Research
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30
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4.4.
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Wyeth Records
and Audits
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30
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5.
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RELATIONSHIP
AND PUBLICITY
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31
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5.1.
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Relationship of
Parties
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31
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5.2.
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Public
Announcements
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31
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6.
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REGULATORY
COMPLIANCE
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31
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6.1.
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Marketing
Authorization
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31
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6.2.
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Recalls
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31
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6.3.
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Returns
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31
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6.4.
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Adverse Drug
Experiences
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31
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6.5.
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Product
Complaints
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33
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6.6.
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Product
Inquiries
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34
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6.7.
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Communications
with FDA
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35
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6.8.
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Additional
Responsibilities of the Parties
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35
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7.
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REPRESENTATIONS, WARRANTIES AND
COVENANTS
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35
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7.1.
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Mutual
Representations and Warranties
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35
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7.2.
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Impax
Representations and Warranties
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36
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7.3.
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Wyeth
Representations and Warranties
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36
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7.4.
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Wyeth
Covenants
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37
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7.5.
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Other
Opportunities
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37
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8.
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INDEMNIFICATION
AND INSURANCE
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37
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8.1.
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Indemnification
by Impax
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37
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8.2.
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Indemnification
by Wyeth
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38
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8.3.
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Defense of
Actions; Settlements
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38
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8.4.
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Limitation of
Liability
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38
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8.5.
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Insurance
Requirements
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39
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9.
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TERM AND
TERMINATION
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39
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9.1.
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Term
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39
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9.2.
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Termination for
Cause
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39
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9.3.
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Termination by
Wyeth
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39
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9.4.
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Termination
without Cause by Impax
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39
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9.5.
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Effect of
Termination
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39
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9.6.
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Survival of
Certain Provisions
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40
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10.
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SAMPLES
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40
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10.1.
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Provision of
Samples
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40
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10.2.
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Shipping and
Distribution of Samples
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40
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10.3.
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Compliance with
PDMA
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41
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10.4.
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Sample Carry
Program
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42
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10.5.
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Sampling
Activity System Audit
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44
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10.6.
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Investigation,
Corrective & Preventative Actions
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44
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10.7.
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Monitoring
& Auditing Programs
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44
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10.8.
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Responsibility
for Compliance
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45
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10.9.
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In-Transit
Losses
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45
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10.10.
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Improper
Handling
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45
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10.11.
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Indemnity for
Failure to Comply
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45
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10.12.
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Additional
Requirements
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45
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11.
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CONFIDENTIALITY
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46
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11.1.
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Nondisclosure
and Nonuse Obligations
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46
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11.2.
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Permitted
Disclosures
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46
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11.3.
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Return of
Confidential Information
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47
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11.4.
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Disclosure of
Agreement
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47
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11.5.
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Equitable
Relief
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47
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12.
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MISCELLANEOUS
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48
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12.1.
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Force
Majeure
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48
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12.2.
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Severability
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48
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12.3.
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Assignability
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48
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ii
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12.4.
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Notices
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49
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12.5.
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Governing Law;
Jurisdiction
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49
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12.6.
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Dispute
Resolution
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49
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12.7.
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No
Waiver
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49
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12.8.
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Headings;
Defined Terms
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50
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12.9.
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Counterparts
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50
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12.10.
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Entire
Agreement; Amendments
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50
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12.11.
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Further
Actions
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50
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iii
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-
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Sample Receipt
Forms
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-
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Wyeth Sales
Training Program for the Initial Product Exhibit A to
Schedule 1.94
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-
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Sample
Calculation of Incentive Fee
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-
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Initial Product
Patents
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-
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Wyeth
Form 1747(b)
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-
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Wyeth
Form 8202
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iv
This Copromotion
Agreement (the “Agreement”) is made and entered into as
of July 16, 2008 (the “Effective Date”), by and
between Wyeth, acting through its Wyeth Pharmaceuticals Division,
having a place of business at 500 Arcola Road, Collegeville,
Pennsylvania 19426 (“Wyeth”) and Impax Laboratories,
Inc., having a place of business at 30831 Huntwood Avenue, Hayward,
California 94544 (“Impax”). Wyeth and Impax may each be
referred to herein individually as a “Party” and
collectively as the “Parties.”
WHEREAS, Wyeth
owns and/or controls marketing and proprietary rights to the
Product (as defined below); and
WHEREAS, Impax has
a sales and marketing organization that promotes certain
pharmaceutical products to physicians and other health care
professionals;
WHEREAS, the
Parties desire that Impax participate in detailing the Product to
Neurologists (as defined below) in the United States;
WHEREAS, the
Parties have agreed to amicably settle patent litigation currently
ongoing between them, and on June 9, 2008, Wyeth and Impax
entered into a Settlement and Release Agreement (the
“Settlement Agreement”) in connection therewith;
and
WHEREAS, the
Settlement Agreement requires the Parties, upon the Settlement Date
(as such term is defined in the Settlement Agreement), to enter
into this Agreement and a License Agreement (the “License
Agreement”) for the grant by Wyeth to Impax of a
non-exclusive license under the Licensed Patents (as such term is
defined in the License Agreement) under which Impax would be
permitted to make, have made, use, sell, offer for sale, import,
market, promote and/or distribute the 37.5 mg, 75 mg and 150 mg
dosage strength extended release venlafaxine hydrochloride capsules
that are the subject of ANDA 78-057 filed by Impax on or about
December 15, 2005 with the FDA for the treatment of major
depressive disorder, social anxiety disorder and panic disorder,
subject to the terms and conditions of the License
Agreement.
NOW, THEREFORE, in
consideration of the mutual covenants contained herein and other
good and valuable consideration, the receipt and sufficiency of
which is hereby acknowledged, the Parties hereto agree as
follows:
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1.
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DEFINITIONS.
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The
following capitalized terms shall have the following meanings for
all purposes of this Agreement:
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1.1.
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“Affiliate”
of any Party shall mean
any Person, directly or indirectly controlling, controlled by, or
under common control with such Party. For purposes of this
Section 1.1, “control” shall mean (a) in the
case of corporate entities, direct or indirect ownership of more
than fifty percent (50%) of the stock or shares having the right to
vote for the election of directors and (b) in the case of
non-corporate entities, direct or indirect ownership of at least
fifty percent (50%) of the equity
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interest with
the power to direct the management and policies of such
non-corporate entity, provided, however , for purposes of
this Agreement, the term “Affiliate” shall not include
subsidiaries in which a Party or its Affiliates owns a majority of
the ordinary voting power to elect a majority of the Board of
Directors, but is restricted from electing such majority by
contract or otherwise, until such time as such restrictions are no
longer in effect.
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1.2.
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“Agency”
shall mean any
applicable supra-national, federal, national, regional, state or
local regulatory agencies, departments, bureaus, commissions,
councils or other government entities regulating or otherwise
exercising authority with respect to the Marketing, sale,
distribution or Promotion of the Product.
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1.3.
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“Annual Change in Market
Share” shall mean, with respect to any
Product and any Contract Year, the Market Share for such Product
during such Contract Year less the Market Share for such Product
with respect to the twelve (12) calendar month period
immediately preceding such Contract Year.
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1.4.
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“Annual Change in Target
Neurologist Market Share” shall mean, with respect to any
Product and any Contract Year, the Target Neurologist Market Share
for such Product during such Contract Year less the Target
Neurologist Market Share for such Product with respect to the
twelve (12) calendar month period immediately preceding such
Contract Year.
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1.5.
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“Applicable
Laws” shall mean (a) the American
Medical Association Guidelines on Gifts to Physicians from
Industry, (b) the PhRMA Code on Interactions with Healthcare
Professionals, (c) the FD&C Act and all other federal,
state and local laws, and (d) the rules, regulations, guidance,
guidelines and requirements of all Agencies in effect from time to
time applicable to the manufacture, marketing, advertising,
promotion, distribution and sale of the Product, in each case as
applicable to a Party’s obligations hereunder.
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1.6.
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“Average Number of Tablets Per
Prescription” shall mean, with respect to any
Product and any Contract Year, the average number of retail tablets
per prescription for such Product in the Territory during such
Contract Year, as measured by IMS NPA prescription data and based
on September moving annual total for the previous calendar year and
once established shall remain constant for such Contract
Year.
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1.7.
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“Average Selling Price per
Tablet” shall mean, with respect to any
Product and any Contract Year, the total Net Sales for such Product
during such Contract Year divided by the total number of tablets of
such Product sold in such Net Sales.
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1.8.
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“Breach”
shall have the meaning
set forth in Section 9.2.
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1.9.
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“Breaching
Party” shall have the meaning set forth in
Section 9.2.
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2
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1.10.
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“Business
Day” shall mean any day other than
(a) a day which is a Saturday or a Sunday or (b) a day on
which banks in New York City, New York are authorized or obligated
by law or executive order to not open or remain closed.
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1.11.
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“Calendar
Quarter” shall mean the respective periods of
three (3) consecutive calendar months ending on March 31,
June 30, September 30, or December 31, for so long
as this Agreement is in effect.
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1.12.
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“Claims”
shall have the meaning
set forth in Section 8.1.
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1.13.
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“Commercially Reasonable
Efforts” shall mean commercially reasonable
efforts and resources.
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1.14.
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“Competing
Product” shall mean any product that is
labeled to treat one or more indications, illnesses or conditions
that the then-current Product is also labeled to treat.
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1.15.
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“Confidential
Information” shall mean any proprietary
technical, business and Marketing information of the other Party
(including, without limitation, all sales and Marketing plans)
disclosed by one Party to the other under this Agreement after the
Effective Date, and whether or not such information is identified
as confidential at the time of disclosure. This Agreement
(including the existence and terms and conditions thereof) shall be
considered Confidential Information of each Party.
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1.16.
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“Contract
Year” shall mean any of Contract Year 1,
Contract Year 2 or Contract Year 3.
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1.17.
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“Contract Year
1” shall mean the period beginning on
the Initiation Date and ending on the day prior to the first
anniversary of the Initiation Date.
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1.18.
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“Contract Year
2” shall mean the period beginning on
the first day following Contract Year 1 and ending on the day prior
to the second anniversary of the Initiation Date.
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1.19.
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“Contract Year
3” shall mean the period beginning on
the first day following Contract Year 2 and ending on the day prior
to the third anniversary of the Initiation Date.
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1.20.
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“CPI”
shall mean the Consumer
Price Index for All Urban Consumers (CPI-U): U.S. City Average,
published by the U.S. Department of Labor.
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1.21.
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“Cumulative Detail
Maximum” shall have the meaning set forth m
Section 2.6.12(a).
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1.22.
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“Cumulative
Details” shall mean, with respect to a given
period of time period, the sum of Primary Details and Secondary
Details actually performed during such period.
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3
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1.23.
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“Detail”
shall mean a
face-to-face meeting, in an individual or group practice setting,
between a Neurologist and one or more Impax PSRs during which a
complete Product presentation that is consistent with Wyeth’s
marketing and promotional strategies as communicated to Impax, is
communicated to such Neurologist, and which meeting may also
involve Sampling. When used as a verb, “Detail” shall
mean to engage in a Detail. A complete Product presentation made to
more than one neurologist shall constitute a separate Detail for
each participating Neurologist (e.g., a complete presentation made
to three Neurologists simultaneously shall constitute three
Details.)
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1.24.
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“Detailed
Product” shall mean the Product and all prior
products designated by Wyeth as the Product pursuant to this
Agreement, including, without limitation, the Initial
Product.
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1.25.
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“Disclosing
Party” shall mean the Party who is
disclosing its Confidential Information to the Receiving
Party.
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1.26.
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“Early Initiation
Notice” shall have the meaning set forth in
Section 2.2.
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1.27.
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“Extra
Detail” shall have the meaning set forth in
Section 2.6.12(b).
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1.28.
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“FDA”
shall mean the United
States Food and Drug Administration, or any successor entity
thereto.
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1.29.
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“FD&C
Act” shall mean the United States Federal
Food, Drug, and Cosmetic Act, as amended, and the rules and
regulations promulgated thereunder.
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1.30.
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“Impax Baseline PSR
Cost” shall mean the Impax PSR Cost for
the twelve (12) month period prior to the Initiation
Date.
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1.31.
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“Impax Cost
Adjustment” shall mean, with respect to any
Contract Year, the percentage equal to the lesser of (a) the
Impax Cost Increase for the previous Contract Year or (b) the
percent increase in the CPI during such previous Contract
Year.
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1.32.
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“Impax Cost
Increase” shall mean, with respect to any
Contract Year, the percentage increase (if any) in the Impax PSR
Cost for such Contract Year over the Impax PSR Cost for the prior
Contract Year or, in the case of the Impax Cost Increase for
Contract Year 1, over the Impax PSR Baseline Cost.
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1.33.
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“Impax Director of
Sales” shall mean Impax’s Vice
President of Sales and Marketing, or a position of similar
seniority occupied by a full-time employee of Impax, which position
has primary oversight responsibility for the implementation of
Impax’s obligations under this Agreement, for leading and
supervising the Impax Sales Management Team and, in conjunction
with the Impax Sales Management Team, for leading and supervising
the Impax PSRs.
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4
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1.34.
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“Impax
Personnel” shall mean the Impax PSRs, the Impax
Sales Management Team and any other employee, representative or
agent of Impax or any Permitted Subcontractor that is involved in
performing Impax’s obligations under this
Agreement.
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1.35.
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“Impax PSR”
shall mean a
professional sales representative who is an employee of either
(a) Impax or (b) a Permitted Subcontractor (in accordance
with Section 2.4 below), which professional sales
representative is responsible for Detailing the Product to
Neurologists in accordance with this Agreement.
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1.36.
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“Impax PSR
Cost” shall mean, with respect to any
Contract Year, for the Impax Baseline Cost, with respect to the
twelve (12) month period ending on the Initiation Date,
Impax’s average out of pocket cost per Impax PSR for such
Contract Year, determined (in the case of any Impax PSR who is an
employee of a Permitted Subcontractor) by dividing the amount paid
by Impax to XXXXX or any other Permitted Subcontractor for
providing such Impax PSRs during such Contract Year plus the Impax
Supervisory Costs for such Contract Year by the number of such PSRs
provided during such Contract Year. In the event that, during any
Contract Year, Impax provides Impax PSRs who are employees of Impax
rather than employees of a Permitted Subcontractor, the Parties
shall agree in good faith on a method for including the
compensation expense to Impax of providing such Impax PSRs in
Impax’s out of pocket costs on a basis that allows for a fair
and accurate determination of both Impax PSR Cost and any resulting
Impax Cost Increase.
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1.37.
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“Impax Regional
Manager” shall mean a full time employee of
Impax who is responsible for supervising Impax PSRs in a specified
collection of sales territories.
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1.38.
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“Impax Sales
Force” shall mean the Impax PSRs and the
Impax Sales Management Team.
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1.39.
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“Impax Sales Management
Team” shall mean (a) the Impax
Regional Managers; (b) Impax’s Director of Sales Operations
or equivalent thereof; and (c) the Impax Director of
Sales.
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1.40.
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“Impax Supervisory
Costs” shall mean, with respect to any
Contract Year, that portion of the compensation expense, plus any
reimbursed or directly allocated out-of-pocket expenses, incurred
during such Contract Year by Impax to provide the Impax Sales
Management Team that is allocable to management and supervision of
Impax PSRs in performance of their obligations under this Agreement
(and not to any other responsibilities), determined in accordance
with GAAP on a consistent basis.
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1.41.
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“IMS”
shall mean IMS Health
Incorporated.
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1.42.
|
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“Incentive
Fee” shall have the meaning set forth in
Section 3.4.
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5
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1.43.
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“Incremental Market
Share” shall mean, with respect to any
Product and any Contract Year, the greater of (a) the Annual
Change in Target Neurologist Market Share for such Product for such
Contract Year less the Annual Change in Market Share for such
Product for such Contract Year or (b) zero.
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1.44.
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“Incremental Net
Sales” shall mean, with respect to any
Product and any Contract Year, XXXXX for such Product in the
Territory for such Contract Year XXXXX:
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In
the case of any Product that is Detailed under this Agreement for
only a portion of a Contract Year (a “Partial Contract
Year”), Incremental Net Sales shall be determined by
reference to such Partial Contract Year by determining the
following on the basis of such Partial Contract Year rather than
the full Contract Year: XXXXX .
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1.45.
|
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“Indemnified
Party” shall have the meaning set forth in
Section 8.3.
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1.46.
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“Indemnifying
Party” shall have the meaning set forth in
Section 8.3.
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1.47.
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“Initial
Product” shall mean desvenlafaxine tablets
currently Marketed by Wyeth under the brand name PRISTIQ™ in
the Territory.
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1.48.
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“Initial
Training” shall have the meaning set forth in
Section 2.6.8(a).
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1.49.
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“Initiation
Date” shall mean July 1, 2009, or
such earlier date as may be established pursuant to
Section 2.2.
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1.50.
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“Market”
shall mean, when used as
a verb, to market, sell, distribute, Promote, or advertise a
product.
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1.51.
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“Market
Share” shall mean, with respect to any
Product and any period, the total prescriptions written for the
Product in the Territory during such period as a percentage of the
total prescriptions written for all products in the Product’s
Therapeutic Category in the Territory during such period, each as
measured by monthly Xponent prescription data published by IMS; it
being understood that the Therapeutic Category for the Initial
Product shall be the Antidepressant Category, as defined by
IMS.
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1.52.
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“Minimum Detail
Requirement” shall have the meaning set forth in
Section 2.6.12(a).
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1.53.
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“Monthly Detail
Report” shall mean, collectively, the raw
data, written report and other information that Impax is required
to deliver to Wyeth on a monthly basis pursuant to
Section 4.2.
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6
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1.54.
|
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“Net Sales”
shall mean the aggregate
gross amounts invoiced for the sale of Product by or on behalf of
Wyeth or any of its Affiliates (each a “Selling
Person”) in arm’s length transactions with Third
Parties for use in the Territory, less the following deductions, in
each case to the extent specifically related to Product and taken
by the Selling Person or otherwise paid for, or accrued by, the
Selling Person: (i) cash discounts; (ii) adjustments on
account of price adjustments, or billing adjustments;
(iii) returns of rejected or damaged goods;
(iv) chargebacks; (v) the cost of duties, insurance,
freight handling or other transportation costs to the extent
included in any invoiced amount used to determine gross sales; and
(vi) rebates, promotional allowances, and similar payments to
all direct customers, including wholesalers and other distributors,
buying groups, health care insurance carriers, pharmacy benefit
management companies, health maintenance organizations, Medicaid or
Medicare or similar type programs. Net Sales shall be determined
using the accrual method of accounting determined in a manner
consistent with Wyeth’s practice for its other pharmaceutical
products. Sales of Product by and between Wyeth and its Affiliates
are not sales to Third Parties and shall be excluded from Net Sales
calculations for all purposes, it being understood that the sale of
Product by Wyeth or any of its Affiliates to a Third Party shall be
utilized in calculating Net Sales under this Agreement.
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1.55.
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“Neurologist”
shall mean a medical
doctor who is (a) licensed to practice medicine in the
Territory, (b) certified in the practice of neurology by the
American Board of Psychiatry and Neurology and (c) identified
as a neurologist or as practicing any subspecialty of neurology,
other than pediatric neurology or any pediatric subspecialty, based
on the American Medical Association specialty code contained within
the monthly prescriber log delivered by IMS (or such other Third
Party vendor as Wyeth may utilize). “Neurologist” shall
also include any nurse practitioner or physician’s assistant
having prescribing authority and acting under the supervision of a
Neurologist, provided, however, that for the purpose of determining
the number of Details, (i) any nurse practitioner or
physician’s assistant together with his or her supervising
Neurologist shall be treated as a single Neurologist and
(ii) any nurse practitioner or physician’s assistant
shall be treated as being under the supervision of only one
Neurologist.
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1.56.
|
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“New Hire
Training” shall have the meaning set forth in
Section 2.6.8(b).
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1.57.
|
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“Non-Breaching
Party” shall have the meaning set forth in
Section 9.2.
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1.58.
|
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“Non-Target
Neurologist” shall mean a Neurologist practicing
in the Territory who is not a Target Neurologist.
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1.59.
|
|
“Permissible Initiation
Dates” shall mean each of the following:
July 1, 2008, October 1, 2008, January 1, 2009,
April 1, 2009 and July 1, 2009.
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1.60.
|
|
“Permitted
Subcontractor” shall have the meaning set forth in
Section 2.4.
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7
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1.61.
|
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“Person”
shall mean an
individual, a corporation, a partnership, an association, a trust
or other entity or organization, including a government or
political subdivision or an agency or instrumentality
thereof.
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1.62.
|
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“Prescribing
Information” shall mean the prescribing
information published by Wyeth in connection with the Marketing of
the Product.
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1.63.
|
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“Primary
Detail” shall mean a Detail in which Product
information is communicated by an Impax PSR to a Target Neurologist
or a Non-Target Neurologist, in each case subject to the provisions
of Section 2.6.12(b), with the specified content as defined
from time to time by Wyeth within its reasonably exercised
discretion, where (a) such information is the first such
product information communicated by such Impax PSR, (b) the
predominant portion of time and emphasis during such communication
is focused on the Product and (c) such Detail involves the
communication of information with respect to no more than three
(3) products.
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1.64.
|
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“Primary Detail
Price” shall have the meaning set forth in
Section 3.1.
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1.65.
|
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“Product”
shall mean the Initial
Product or such other product as Wyeth may designate from time to
time pursuant to Section 2.3 to have Detailed by Impax for
Wyeth under this Agreement.
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1.66.
|
|
“Product Substitution
Notice” shall have the meaning set forth in
Section 2.3.1.
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1.67.
|
|
“Promotion”
shall mean those
activities, including, without limitation, detailing and
distributing samples of a product, normally undertaken by a
pharmaceutical company’s sales force to implement marketing
plans and strategies aimed at encouraging the appropriate use of a
particular prescription pharmaceutical product. When used as a
verb, “Promote” shall mean to engage in such
activities.
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1.68.
|
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“Quarterly Detail
Minimum” shall mean XXXXX (XXXXX)
Cumulative Details (such amount to be prorated for any partial
period of three consecutive calendar months, including that portion
of such period during which there is a downward adjustment as
provided in this Section 1.68), provided that the
Quarterly Detail Minimum shall be adjusted downward by fifty
percent (50%) during the first three calendar months following the
completion of any Initial Training of the Impax Sales Force with
respect to the Initial Product or a subsequent Product pursuant to
Sections 2.6.8 and/or 2.3.3 and shall be reduced pro rata in
the case of any suspension of Product Sales due to regulatory
action or a product suspension or recall or voluntary withdrawal by
Wyeth based on the percentage which represents the number of
Business Days in the Calendar Quarter during which Detailing of the
Product is suspended or prohibited (other than as a result of any
action or omission by Impax or any Impax PSR) relative to the total
Business Days in such Calendar Quarter.
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1.69.
|
|
“Quarterly
Details” shall mean the number of Cumulative
Details performed by Impax during a given Calendar
Quarter.
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8
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1.70.
|
|
“Quarterly
Meeting” shall mean those meetings between
Impax and Wyeth as described in Section 2.8.
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1.71.
|
|
“Receiving
Party” shall mean the Party who is
receiving Confidential Information from the Disclosing
Party.
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1.72.
|
|
“Refresher
Training” shall have the meaning set forth in
Section 2.7.6(c).
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1.73.
|
|
“Retired
Neurologist” shall mean a Neurologist that is
deceased or is no longer practicing in the Territory.
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1.74.
|
|
“Sales Call
” shall mean an
interaction between an Impax PSR and a Neurologist in which the
Product is the subject of either a Primary Detail or a Secondary
Detail.
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1.75.
|
|
“Sales Call
Plan” shall mean the plan established from
time to time pursuant to Section 2.6.11, which sets forth the
Detailing reach (i.e., number of Neurologists) and frequency (i.e.,
number of Details per Neurologist and the relevant timing of such
Details) objectives for the Impax PSRs.
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1.76.
|
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“Sample”
shall mean a unit of the
Product packaged as a sample, as used by Wyeth, that is not
intended to be sold and is intended to promote the sale of the
Product. When used as a verb, “Sample” shall mean to
provide Samples to Neurologists.
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1.77.
|
|
“Sample
Audit” shall have the meaning set forth in
Section 10.5.
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1.78.
|
|
“Sample Carry
Program” shall have the meaning set forth in
Section 10.4.
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1.79.
|
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“Sample Receipt
Forms” shall mean those multi-part forms,
whether paper or electronic, supplied by Impax or Impax’s
Permitted Subcontractor for the purpose of recording Detail and
Sample activity performed by Impax PSRs during Sales Calls. These
forms shall also be used as Sample receipts on which to obtain a
Neurologist’s signature in acknowledgment of receipt of
Samples. Each Sample Receipt Form shall include, at a minimum, the
information set forth in Schedule 1.79.
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1.80.
|
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“Secondary
Detail” shall mean a Detail in which
information about the Product is communicated by an Impax PSR to a
Target Neurologist or a Non-Target Neurologist, in each case
subject to the provisions of Section 2.6.12(b), with the
specified content as defined from time to time by Wyeth within its
reasonably exercised discretion, where (a) such information is
the second product information communicated by such Impax PSR,
(b) the amount of time and emphasis of such communication is
less than that for the communication of information of the product
that is the subject of the primary Detail during such
communication, but is more than that for the communication of
information with respect to any other product that is promoted
during such Sales Call and (c) such
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9
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Detail involves the communication of
information with respect to no more than three
(3) products.
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1.81.
|
|
“Secondary Detail
Price” shall have the meaning set forth in
Section 3.1.
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1.82.
|
|
“Substitution
Date” shall have the meaning set forth in
Section 2.3.1.
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1.83.
|
|
“Target List”
shall have the meaning
set forth in Section 2.7.3.
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1.84.
|
|
“ Target Neurologist Market Share
” shall mean, with respect to any Product and any
period, the total prescriptions written for the Product by Target
Neurologists in the Territory during such period as a percentage of
the total prescriptions written for all products in the
Product’s Therapeutic Category by Target Neurologists in the
Territory during such period, each as measured by monthly Xponent
prescription data published by IMS; it being understood that the
Therapeutic Category for the Initial Product shall be the
Antidepressant Category, as defined by IMS.
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1.85.
|
|
“Target
Neurologists” shall mean the group of Neurologists
identified by Wyeth on the then-current Target List.
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1.86.
|
|
“Tier 1 Target
Neurologists” shall mean the five hundred
(500) Target Neurologists identified by Wyeth from time to
time as Tier I Target Neurologists.
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1.87.
|
|
“Tier 2 Target
Neurologists” shall mean any Target Neurologist
other than a Tier 1 Target Neurologist.
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1.88.
|
|
“Term”
shall have the meaning
set forth in Section 9.1.
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1.89.
|
|
“Territory”
shall mean the fifty
(50) states of the United States and the District of
Columbia.
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1.90.
|
|
“Therapeutic
Category” shall mean, with respect to any
Product, the therapeutic category or categories for which IMS
reports prescriptions written for such Product and other products
included in the same category or categories.
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1.91.
|
|
“Third Party”
shall mean any Person
other than Wyeth, Impax or any of their respective
Affiliates.
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1.92.
|
|
“Trademark”
shall have the meaning
set forth in Section 2.9.2.
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1.93.
|
|
“Wyeth
Improvements” shall have the meaning set forth in
Section 2.9.6.
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|
1.94.
|
|
“Wyeth Policy on Sales and
Marketing Practices” shall mean Wyeth’s promotion
guidelines for the Product, as the same may be amended from time to
time by Wyeth, in its sole discretion.
|
10
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1.95.
|
|
“Wyeth Sales Training
Program” shall mean the sales training
program described in Schedule 1.95.
|
|
2.
|
|
APPOINTMENT AND
OBLIGATIONS
|
|
|
2.1
|
|
Appointment . Wyeth hereby appoints Impax, on a
non-exclusive basis, and Impax agrees, to Detail the Product in the
Territory to Neurologists, as of the Initiation Date and thereafter
during the Term in accordance with the terms and conditions of this
Agreement. Impax, without charge or expense to Wyeth (other than as
expressly set forth in Article 3 of this Agreement), shall
provide all facilities, personnel (including management and sales
representatives) and other resources as are reasonably necessary to
successfully perform Impax’s obligations under this
Agreement. The Parties specifically agree that, without
Wyeth’s written consent, which Wyeth may withhold in its sole
discretion, Impax shall not intentionally Detail the Product to any
physician other than a Neurologist, sell or distribute the Product,
place journal or other advertisements for the Product, issue press
releases regarding the Product, conduct opinion leader development
activity in connection with the Product, establish or participate
in advisory boards concerning the Product, participate in or
conduct peer selling activity concerning the Product, enter into or
discuss with customers or potential customers (including, without
limitation, managed care organizations) contracts for the sale of
or discounts or rebates on the sale of the Product, conduct other
general marketing activities with respect to the Product, or
initiate, conduct or participate in any studies for the Product
other than Detailing of the Product to the extent expressly
permitted by this Agreement.
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2.2
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Adjustment to Initiation
Date . Impax
shall begin Detailing the Product in accordance with this Agreement
no later than July 1, 2009. In the event that Impax procures
the necessary resources and is prepared to begin Detailing the
Product prior to July 1, 2009, Impax shall promptly notify
Wyeth in writing (such notice referred to herein as the
“Early Initiation Notice”). If Wyeth receives the Early
Initiation Notice at least sixty (60) days prior to
July 1, 2008, then the Initiation Date shall automatically be
adjusted to July 1, 2008. If Wyeth receives the Early
Initiation Notice at any other time prior to July 1, 2009,
then the Initiation Date shall automatically be adjusted to the
first of the Permissible Initiation Dates to occur no less than
ninety (90) days following Wyeth’s receipt of such Early
Initiation Notice, provided that in no event shall the
Initiation Date occur after July 1, 2009. Notwithstanding any
provision of this Section 2.2 to the contrary, in no event
shall Impax permit any member of the Impax Sales Force to begin
Detailing the Product before such individual has successfully
completed all training required pursuant to Section
2.6.8.
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2.3
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Wyeth’s Option to Designate
Substitute Products .
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2.3.1
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General . During the Term, Wyeth may, from
time to time and in its sole discretion, elect to designate an
alternate product as the Product that is to be Detailed by Impax
under this Agreement, provided that (a)
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any such
alternate product must (i) be indicated for the treatment of
one or more neurological conditions or (ii) target one or more
illnesses or conditions commonly treated by Neurologists, and
(b) Wyeth may not designate more than one (1) Product to
be Detailed under this Agreement at any given time during the Term.
In the event Wyeth elects to substitute an alternate product as the
Product pursuant to this Section 2.3.1, Wyeth shall notify
Impax in writing of such substitution (each such notice referred to
herein as a “Product Substitution Notice”) no later
than sixty (60) days prior to the date specified in such
Product Substitution Notice as the date that such alternate product
is to first be Detailed pursuant to this Agreement which date shall
be the later of the date of resolution of any dispute under
Section 2.3.2 and the date of the completion of Initial
Training for the substituted Product (the “Substitution
Date”). For the avoidance of doubt, Wyeth may elect to
substitute an alternate product as the Product under this Agreement
on one or more occasions during the Term, in its sole discretion
provided that, without Impax’s consent, such substitution
shall not occur more than once in any twelve (12) month
period. Notwithstanding the foregoing limitation, in the event that
a Product undergoes a recall or voluntary withdrawal from the
market due to one or more adverse events, regulatory action,
potential or actual infringement of any patent or other
intellectual property right of any Third Party, or other reasons
outside of Wyeth’s control, Wyeth may, and shall, promptly
designate a substitute Product. In such event and subject to the
limitations set forth in Section 2.6.12(a), with respect to
the time period for which Impax is not able to Detail any Product,
Wyeth shall pay to Impax a pro-rated amount based on the monthly
average number of Details performed over the previous three
(3) months.
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2.3.2
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Designation of Competitive
Products .
Notwithstanding any provision of Section 2.3.1 to the
contrary, if at the time Wyeth delivers a Product Substitution
Notice (a) Impax owns or otherwise controls a product (i) that
Impax is detailing to Neurologists or Promoting, selling or
marketing; (ii) for which Impax or any of its Affiliates has
filed or, during the Term, expects to file, an accepted marketing
approval application with the FDA; and which Impax reasonably
expects to detail, Promote, sell or market during the Term or
(b) Impax has previously entered into an agreement with a
Third Party that obligates Impax to detail, Promote, sell or market
one or more products on behalf of such Third Party, and Impax
believes that the Product Substitution Notice can reasonably be
expected to conflict with Impax’s activities under clauses
(a) and/or (b), above then Impax shall so notify Wyeth with
five (5) business days of delivery of such Product Substitution
Notice. Within thirty (30) business days after receipt of
Impax’s notification, Wyeth will advise Impax whether it
agrees that such a conflict is reasonably likely. If Wyeth agrees,
Wyeth may elect, in its sole discretion, to either
(i) designate another substitute product as the
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Product
pursuant to Section 2.3.1 or (ii) require Impax to
continue detailing the then-current Product. If Wyeth disagrees as
to whether a conflict is reasonably likely, the matter will be
referred to the Wyeth Pharmaceuticals President, U.S.,
Pharmaceuticals and Women’s Health Care and the President of
Impax Pharmaceuticals for further review, which review shall be
completed within ten (10) Business Days after such referral.
If after such referral, either Party, in its reasonable judgment,
believes a conflict is reasonably likely, Wyeth may elect, in its
sole discretion, to either (i) designate another substitute
product as the Product pursuant to Section 2.3.1 or
(ii) require Impax to continue detailing the then-current
Product.
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2.3.3
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Alternate Product
Training .
Following Wyeth’s delivery of a Product Substitution Notice,
each Party shall use Commercially Reasonable Efforts to complete
their respective Impax PSR training obligations under
Sections 2.6.8 and 2.7.6(a) with respect to the alternate
product designated in such Product Substitution Notice prior to the
relevant Substitution Date. Impax shall ensure that no Impax PSR
engages in the Detailing of such alternate product before such
individual has successfully completed all training required
pursuant to Section 2.6.8.
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2.4
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Permitted Subcontractors
. Impax may enter into
written agreements with one or more nationally recognized contract
sales organizations, whether such organization is a Third Party or
an Affiliate of Impax, having experience in the promotion and
detailing of pharmaceutical products (each a “Permitted
Subcontractor”) whereby each such Permitted Subcontractor
provides professional sales representatives to serve as Impax PSRs
for purposes of Detailing the Product hereunder; it being
understood and agreed that XXXXX shall be a Permitted
Subcontractor. The identity of any such Permitted Subcontractor
shall be subject to Wyeth’s prior approval, not to be
unreasonably withheld. Impax shall provide Wyeth with a copy of any
such written agreement and all amendments thereto with such
Permitted Subcontractor no later than ten (10) days after
execution of such agreement or amendment thereto so that Wyeth can
confirm that such agreement or amendment complies with the terms of
this Agreement. Impax may redact the financial terms of any such
agreement to the extent that such redaction does not relate to any
obligation of Impax to Wyeth hereunder. Without limiting
Wyeth’s ability to withhold approval for other valid reason,
any such agreement or any amendment or modification thereto shall
provide for such Permitted Subcontractor to fulfill the obligations
imposed under this Agreement on Impax and/or its Permitted
Subcontractors and shall name Wyeth as a Third Party beneficiary
with direct enforcement rights against the Permitted
Subcontractor.
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2.5
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Undertaking not to
Compete .
During the Term, Impax shall not Promote to physicians, sell or
market, and Impax shall cause its Affiliates and each member of the
Impax Sales Force not to Promote to physicians, in the Territory,
any Competing Product, provided, however , that Impax shall
not be prohibited under
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this
Section 2.5 from (i) exercising its rights to sell,
market and distribute Licensed Products (as such term is defined in
the License Agreement) to the extent permitted under the License
Agreement even if a License Product would otherwise be considered
to be a Competing Product under this Agreement, provided that any
such Licensed Product is not being Promoted by any member of the
Impax Sales Force that is Detailing the Product under this
Agreement, or (ii) selling, marketing or distributing any
generic product that is AB rated to another product (other than the
XR Product, as such term is defined in the License Agreement) that,
if sold, marketed or distributed by Impax, would otherwise be a
Competing Product under this Agreement, provided such generic
product is not AB rated to the Product under this Agreement, in
each case provided that any such product is not being Promoted by
any member of the Impax Sales Force that is Detailing the Product
under this Agreement. Any breach of this provision shall constitute
a basis for termination by Wyeth pursuant to
Section 9.2.
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2.6
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Obligations of Impax
.
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2.6.1
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Impax Sales Force
. Impax shall, at its
sole expense, diligently Detail the Product in the Territory in
accordance with the terms and conditions of this Agreement. In
connection therewith, Impax shall maintain, in the Territory, a
sales force trained in accordance with this Agreement of full-time
Impax PSRs to Detail the Product using promotional materials
supplied to Impax by Wyeth. Impax shall not permit any Impax PSR to
Detail the Product until such Impax PSR has been trained in
accordance with Section 2.6.8 below and has been certified in
accordance with all certification standards established by Wyeth.
All Details provided by Impax PSRs shall be either Primary Details
or Secondary Details, subject to the limitations set forth in
Section 2.6.12. Impax shall supervise the sales force provided
by it hereunder and be responsible for its remuneration and
incentives. Impax shall be an independent contractor hereunder as
further described in Section 5.1 and the Impax PSRs shall
remain exclusively under the authority of Impax and/or
Impax’s relevant Permitted Subcontractor.
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2.6.2
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Removal of Impax
Personnel .
Impax shall promptly remove any Impax Personnel from having any
responsibilities relating to the Detailing of the Product under
this Agreement if required by any Applicable Laws. Further, Wyeth
may request Impax to promptly remove any Impax Personnel from such
responsibilities if any material events relating to the Detail of
the Product have occurred to justify such removal ( e.g. ,
failure of such Impax Personnel to comply, in connection with the
performance of such responsibilities, with any Applicable Laws or
the Wyeth Policy on Sales and Marketing Practices). Impax shall
honor any such request to the extent that Impax is permitted to do
so pursuant to applicable laws.
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2.6.3
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Sales Management
. Impax shall be
responsible for supervising the Impax PSRs, whether they are
employees of Impax or a Permitted Subcontractor. In connection
therewith, Impax shall provide a sufficient number of full time
Impax employees to serve as Impax Regional Managers, such that the
average ratio of Impax Regional Managers to Impax PSRs shall be no
greater than XXXXX . Impax may, but shall not be obligated
to appoint one or more full time Impax employees to serve as
regional directors having the responsibility for supervising a
group of Impax Regional Managers in a particular geographic region
of the Territory. Additionally, Impax shall designate a full time
Impax employee as the Impax Director of Sales who will be
responsible for (i) leading and supervising the Impax Sales
Management Team, (ii) together with the Impax Sales Management
Team, leading and supervising the Impax PSRs, (iii) the
implementation of Impax’s responsibilities hereunder and
(iv) serving as Impax’s primary point of contact for
communications between Wyeth and Impax regarding the Detailing of
the Product by Impax hereunder.
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2.6.4
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Impax Personnel
. Impax Personnel shall,
at all times during the Term, be employees of Impax or a Permitted
Subcontractor for which Impax or such Permitted Subcontractor shall
have all responsibilities as an employer, including hiring, firing,
compensation and promotions. Impax Personnel shall not be, and
shall not be considered to be, “employees” or
“joint employees” of Wyeth for any purpose as a result
of their activities under this Agreement. Wyeth shall not be
responsible for the control of any members of the Impax Personnel,
Impax and, as applicable, its Permitted Subcontractors, shall be
solely responsible for determining all conditions of employment of
all Impax Personnel. Impax shall and, as applicable, shall cause
its Permitted Subcontractors to, (i) maintain all necessary
personnel and payroll records for all Impax Personnel;
(ii) compute wages for all Impax Personnel and withhold
applicable federal, state, and local taxes and Federal FICA
payments; (iii) remit employee withholdings to the proper
governmental authorities and make employer contributions for
federal FICA and federal and state unemployment insurance payments;
(iv) pay net wages and fringe benefits, if any, directly to
the Impax Personnel; and (v) provide for liability and
Workers’ Compensation insurance coverage for all Impax
Personnel.
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2.6.5
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No Wyeth Benefits
. Impax acknowledges and
agrees that none of the Impax Personnel, nor anyone acting on its
or their behalf, shall receive any employee benefits of any kind
from Wyeth in connection with their activities under this
Agreement. In addition, Impax (on behalf of itself and the Impax
Personnel) declines any offer now or hereafter made to participate
in any of Wyeth’s benefit plans or programs. The
acknowledgment and declination set forth in this Section 2.6.5
is intended to apply even if Wyeth is determined to be a
co-employer or
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common law or
statutory law employer of any of the Impax Personnel, including the
members of the Impax Sales Force, notwithstanding the
Parties’ express agreement to the contrary. Wyeth shall not
maintain or procure any workers’ compensation or unemployment
compensation insurance for or on behalf of the Impax
Personnel.
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2.6.6
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Equal Opportunity
Employer .
Impax shall not and shall cause its Permitted Subcontractors to not
discriminate because of race, color, religion, sex, age, national
origin, disability, or status as a Vietnam veteran, as defined and
prohibited by applicable laws, in the recruitment, selection,
training, utilization, promotion, termination, or other
employment-related activities concerning the Impax Personnel. In
addition, Impax represents and warrants that both it and its
Permitted Subcontractors each are and shall continue to be during
the Term an equal opportunity employer and shall comply with all
applicable federal, state and local laws and regulations including,
to the extent required by such laws and regulations, Title VII of
the Civil Rights Act of 1964; the Equal Pay Act of 1963; the Age
Discrimination in Employment Act of 1967; the Immigration Reform
and Control Act of 1986; the Americans with Disabilities Act;
Executive Order 11246; the Rehabilitation act of 1972; the Vietnam
Era Veterans Readjustment Assistance Act of 1975; and any
applicable additions or amendments to any of the
foregoing.
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2.6.7
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Compliance with Applicable
Laws . In
connection with the Detailing of the Product in the Territory,
Impax shall comply and shall cause each of its employees,
representatives, Permitted Subcontractors and agents, including,
without limitation, all Impax Personnel, to comply with all
Applicable Laws and shall do nothing which Impax knows would
jeopardize the goodwill or reputation of Wyeth or the reputation of
the Product. Any material breach of this provision shall constitute
a basis for termination by Wyeth of this Agreement, at
Wyeth’s option, pursuant to Section 9.2.
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(a)
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Promptly following Impax’s
delivery of an Early Initiation Notice pursuant to
Section 2.2, but in no event later than the Initiation Date,
Impax shall cause all members of the Impax Sales Force to attend
and complete the Wyeth Sales Training Program (whether in person or
remotely, as determined in Wyeth’s sole discretion), as
described in Section 2.7.6, to educate the Impax Sales Force
on the Product and the Detailing thereof. At any time that Wyeth
elects to designate an alternate product as the Product pursuant to
Section 2.3, Impax shall, promptly following its receipt of
the applicable Product Substitution Notice but in no event later
than the Substitution Date specified therein, cause all members of
the
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Impax Sales
Force to attend and complete the Wyeth Sales Training Program with
respect to such alternate product (such training for the initial
Product or an alternate Product, the “Initial
Training”). Impax shall ensure, record and track that each
member of the Impax Sales Force has successfully completed the
Wyeth Sales Training Program and is certified to Detail the Product
by the Wyeth Sales Training Department before such individual is
permitted to engage in any activity relating to the Detailing of
the then-current Product. Any Initial Training described in this
Section 2.6.8(a) shall be held at a location of Wyeth’s
choosing that is reasonably acceptable to Impax (unless Wyeth
elects to hold such Initial Training remotely). Impax shall bear
the cost of all travel, lodging, meals, compensation and ancillary
expenses of all Impax Personnel who attend any Initial Training.
Wyeth shall bear the cost of delivering any Initial Training
pursuant to Section 2.7.6(a).
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(b)
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After the Initial Training has
occurred. Impax shall ensure, record and track that each new member
of the Impax Sales Force has successfully completed the Wyeth Sales
Training Program (“New Hire Training”) and is certified
to Detail the Product by the Wyeth Sales Training Department before
such individual is permitted to engage in any activity relating to
the Detailing of the then-current Product. All New Hire Training
shall be conducted by experienced Impax sales training personnel
who have themselves been trained by Wyeth’s sales training
personnel with respect to the Product and the Detailing thereof.
Impax shall offer New Hire Training three (3) times per
Contract Year, or more frequently as reasonably necessary based on
turnover of the Impax Sales Force. Impax shall be responsible for
all expenses incurred in connection with New Hire
Training.
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(c)
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On
an ongoing basis during the Term, Impax shall ensure, record and
track that each member of the Impax Sales Force successfully
completes at least four (4) hours of Refresher Training every
six (6) months. All Refresher Training shall be conducted by
experienced Impax sales training personnel who have themselves been
trained by Wyeth’s sales training personnel with respect to
the Product and the Detailing thereof. Impax shall be responsible
for all expenses incurred in connection with Refresher
Training.
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(d)
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In
the event Impax conducts any sales training meetings related to the
Product, Impax shall provide Wyeth with reasonable notice and shall
allow Wyeth to have one or more Wyeth representatives attend such
training at Wyeth’s expense.
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2.6.9
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Adverse Event or Experience
Reporting Procedures . Impax shall maintain standard
operating procedures consistent with and comparable to
Wyeth’s standard operating procedures for handling AEs and
shall conduct periodic training of the Impax Sales Force in all
aspects of AE reporting and maintain training records of such
trainings. At Impax’s request, Wyeth will provide training to
the Impax Sales Force on standard operating procedures for handling
AEs.
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2.6.10
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Meetings . At Wyeth’s request, Impax
shall cause (i) the members of the Impax Sales Management
Team, other than the Impax Regional Managers, to attend, at
Impax’s expense, that portion of Wyeth’s senior sales
management meetings during which the Product is discussed and
(ii) the Impax Regional Managers to attend that portion of the
semi-annual Wyeth district managers plan of action
(“POA”) meetings during which the Product is discussed.
After attending each such meeting, each Impax Regional Manager
shall meet with the Impax PSRs under his or her supervision to
discuss the Product POA content. Impax shall provide reasonable
notice to Wyeth of similar meetings conducted by Impax during which
the Product is discussed and shall permit Wyeth representatives to
attend any such meeting at Wyeth’s expense.
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2.6.11
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Sales Call Plan
. No later than thirty
(30) days prior to the Initiation Date, Impax shall provide
Wyeth with a copy of the proposed initial Sales Call Plan. Such
Sales Call Plan shall govern the Detailing efforts of the Impax
PSRs and the Impax Regional Managers. Thereafter, Impax shall
propose modifications to the Sales Call Plan from time to time, but
not later than sixty (60) days prior to the effective date of
such modified Sales Call Plan, to reflect Wyeth’s changes to
the Target List and as otherwise necessary to enable Impax to
satisfy its obligations pursuant to Section 2.6.12.
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2.6.12
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Performance of Details
.
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(a)
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General . During the Term, Impax shall
complete no less than XXXXX Cumulative Details (the
“Minimum Detail Requirement”) and no more than
XXXXX Cumulative Details (the “Cumulative Detail
Maximum”) of the Product to Neurologists in accordance with
the terms of this Agreement and the then current Sales Call Plan.
Without limiting the foregoing, in no event shall Impax deliver
less than XXXXX or more than XXXXX Cumulative Details
pursuant to this Agreement during any Calendar Quarter without
Wyeth’s prior written consent. For the avoidance of doubt,
Details completed with respect to more than one Product in the
event Wyeth elects to substitute an alternate Product pursuant to
Section 2.3 shall be aggregated for the purposes of
determining the foregoing amounts of Cumulative Details.
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(b)
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Detail Allocation
. Impax shall ensure
that at least XXXXX percent ( XXXXX %) of the
Quarterly Details delivered by Impax in each Calendar Quarter are
delivered to Target Neurologists. Impax shall Detail each
accessible Target Neurologist at least XXXXX every Calendar
Quarter, but in no event XXXXX and (ii) with respect to
Tier 2 Target Neurologists, no more than XXXXX . In the
event that Impax elects to Detail any Non-Target Neurologist, Impax
shall not Detail such Non-Target Neurologist more than XXXXX
per Calendar Quarter. Any Details performed in excess of the
limitations set forth in this Section 2.6.12 or otherwise in
contravention of any provision of this Agreement (each, an
“Extra Detail”) shall not be considered a Detail
performed by Impax under this Agreement for any purpose, including,
without limitation, for purposes of determining whether Impax has
delivered the minimum number of Details that it is required to
deliver during a given period. Further, notwithstanding any
provision of this Agreement to the contrary, Wyeth shall have no
obligation to pay Impax any amount with respect to the performance
of any Extra Detail.
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(c)
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Detail Standards
. Impax shall ensure
that each Detail performed hereunder is conducted in strict
accordance with the then-current Wyeth Policy on Sales and
Marketing Practices and the terms of this Agreement. Impax shall
cause each Impax PSR when conducting each Detail to leave a
business card with each Neurologist Detailed by such Impax PSR,
which business card shall identify the Impax PSR as an employee or
representative of Impax. In no event shall any member of the Impax
Sales Force or any other Impax Personnel at any time identify,
either expressly or through implication, themselves as a an
employee or agent of Wyeth.
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2.6.13
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Data Collection and Reporting
Systems .
Impax shall, at no expense to Wyeth, establish and, during the Term
and the three (3) year period following the expiration or
earlier termination of this Agreement, maintain data collection and
reporting systems, for all Details performed and all Samples
distributed by any member of the Impax Sales Force, which systems
and the corresponding data collection and reporting procedures
shall be in compliance with Wyeth’s accountability
requirements, as the same may be communicated to Impax by Wyeth in
writing from time to time. In connection therewith, Impax, at its
own expense, shall provide each Impax Regional Manager and each
Impax PSR with a laptop computer and the necessary software to
enable recording, reporting and regular transmission of data over a
secured line consistent with Wyeth standards. Additionally, Impax,
at its own expense, shall provide each member of the Impax Sales
Force with email and voicemail access for use by Impax, each of its
Permitted
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Subcontractors
and Wyeth in communicating with the Impax Sales Force, as the same
may be communicated to Impax by Wyeth in writing from time to time.
Wyeth and Impax shall agree on a data format to provide for
transfer of Detail and Sample activity from Impax to Wyeth no later
than sixty (60) days prior to the Initiation Date. Wyeth shall
provide Impax a file format for the purpose of sending Impax PSR
information to Wyeth no later than thirty (30) days prior to
the initiation of the Initial Training.
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2.6.14
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Promotional Claims
. Impax shall limit the
claims of efficacy and safety for the Product made by Impax
Personnel to those which are consistent with (i) Wyeth’s
approved labeling for the Product in the Territory and
(ii) the Wyeth Sales Training Program. Impax shall not add,
delete or modify claims of efficacy or safety in its Detailing of
the Product nor make any changes in Promotion materials and
literature provided by Wyeth. Impax’s Detailing of the
Product shall be in strict adherence to all regulatory,
professional and legal requirements including, without limitation,
FDA’s regulations and guidelines concerning the advertising
and promotion of prescription drug products, the American Medical
Association’s Guidelines on Gifts to Physicians, the PhRMA
Code on Interactions with Health Care Professionals, the ACCME
Standards for Commercial Support of Continuing Medical Education,
the Wyeth Policy on Sales and Marketing Practices, and any
amendments or updates applicable to any of the foregoing. Upon
notice to Impax of any breach of this Section 2.6.14, Impax
shall ensure that there is no continuance of any such offending
activity. Without limiting any other provision of this Agreement or
any remedy Wyeth may have hereunder, any breach of the previous
sentence or any intentional breach by Impax of the other provisions
of this Section 2.6.14 by Impax shall constitute a material
breach for the purposes of Section 9.2.
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2.6.15
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Promotional Materials
. The determination of
the content and the quantity of any promotional materials related
to the Product shall, subject to Section 2.7.7, be the sole
responsibility of Wyeth. Wyeth shall send such promotional
material, at its own expense, to Impax at a single location within
the Territory and Impax shall be responsible, at its own expense,
for distributing such promotional materials to the Impax Sales
Force. In connection with the Detailing of the Product, Impax shall
use only promotional materials provided by Wyeth which shall be
used only for the purposes of this Agreement and all unused
quantities of such promotional materials shall be returned to Wyeth
upon expiration or earlier termination of this Agreement. Impax
shall not, and shall cause its Permitted Subcontractors, each
member of the Impax Sales Force to not, alter, in any way, any
promotional materials provided by Wyeth hereunder. All copyright
and other intellectual property rights in said promotional
materials shall remain vested solely in Wyeth. Impax shall not
create, distribute or use sales, promotion or
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other similar
material relating to the Product without the prior written consent
of Wyeth. If any promotional materials provided to Impax by Wyeth
need to be withdrawn from use for any reason, Wyeth shall notify
Impax of such withdrawal and Impax shall cooperate with Wyeth in
effectuating any such withdrawal. Wyeth shall reimburse Impax for
any reasonable and documented incremental out-of-pocket costs
incurred by Impax in connection with conducting such withdrawal,
except to the extent the withdrawal is attributable to (a) the
breach of this Agreement by Impax or (b) the negligence or
intentional misconduct of Impax or any of the Impax Personnel, in
which event Impax shall (i) bear its own costs in connection
with taking such actions and (ii) reimburse Wyeth for any
reasonable and documented out-of-pocket costs incurred by Wyeth in
connection with conducting such withdrawal to the extent that such
withdrawal is attributable to such breach, negligence or
intentional misconduct.
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2.6.16
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Sample Receipt Forms
. Each Impax PSR shall
complete a Sample Receipt Form with respect to each Sample
disbursed by such Impax PSR. In each instance where a Sample is
disbursed, the Impax PSR providing such Sample shall ensure that
the Neurologist receiving such Sample signs the applicable Sample
Receipt Form in acknowledgment of receipt of such Sample. Each
Impax PSR shall mail to Impax or Impax’s Permitted
Subcontractor (as determined by Impax), in pre-addressed,
postage-paid envelopes provided by Impax, or send via electronic
means, on a regular basis no less frequently than quarterly the
original completed Sample Receipt Forms for Sample disbursements
performed by such Impax PSR during the period covered by the
report. A copy of all such Sample Receipt Forms shall be kept by
Impax or its Permitted Subcontractor. Impax shall ensure that each
Impax PSR fills out the Sample Receipt Forms accurately, completely
and timely. For the avoidance of doubt, the foregoing obligations
are in addition to the procedures set forth in
Article 10.
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2.6.17
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Communications with Sales
Representatives . Impax shall have full
responsibility for the dissemination of information regarding the
Product to the Impax Sales Force based on information provided by
Wyeth. All written communications from Impax to any member of the
Impax Sales Force containing any substantive drug information about
the Product other than the Product name, description and price
shall be subject to prior written approval by Wyeth. Communications
such as tactical memos, competitive alerts and other routine
business reports which contain no substantive drug information
about the Product shall not require approval by Wyeth.
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2.6.18
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Sales Force Compensation
Plan . Impax
shall establish and, throughout the Term, maintain a sales force
compensation and incentive plan. The Impax sales force compensation
and incentive plan may provide for
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compensation
based, in part, on activities outside of Impax’s
responsibilities under this Agreement (e.g., the promotion of other
pharmaceutical products by the Impax PSRs to the extent permitted
by this Agreement), provided, however , that such sales
force compensation and incentive plan shall include, for each
member of the Impax Sales Force, as part of the total target bonus
compensation available to be earned, a target bonus compensation
based on performance of the Product which shall represent a portion
of the total available target bonus compensation equivalent to the
effort such member of the Impax Sales Force is to apply to
activities relating to the Product being Detailed under this
Agreement expressed as a percentage of the overall work effort of
such member in Promoting all products on which such target bonus
may be based, and provided, further , that the percentage of
such target bonus compensation based on activities under this
Agreement shall in no event be XXXXX percent ( XXXXX
%).
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2.7
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Obligations of Wyeth
.
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2.7.1
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Marketing Planning, Strategy and
Content .
Wyeth shall have exclusive responsibility and authority for all
Marketing planning and strategy for the Product and the content of
promotional message(s) for the Product. Wyeth reserves the right,
at its sole discretion and at any time, to change the Marketing and
sales strategy and tactics for the Product, the promotional
message(s) for the Product and the marketing budget for the
Product.
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2.7.2
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Product Promotion
Guidelines .
Wyeth shall provide Impax with a complete copy of the Wyeth Policy
on Sales and Marketing Practices no later than thirty
(30) days prior to the Initiation Date. Wyeth may subsequently
revise the Wyeth Policy on Sales and Marketing Practices upon
written notice to Impax, which notice shall specify all relevant
revisions to the then-current Wyeth Policy on Sales and Marketing
Practices.
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2.7.3
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Target Neurologists
. Wyeth shall have
exclusive responsibility and authority for the establishment and
maintenance of a list of no fewer than three thousand five hundred
(3,500) Target Neurologists (the “Target List”). Impax
shall provide Wyeth with Impax’s list of potential Target
Neurologists at least ninety (90) days prior to the Initiation
Date. Wyeth shall provide the initial Target List to Impax at least
thirty (30) days prior to the Initiation Date, with the
Parties’ expectation being that substantially all of the
Target Neurologists on the initial Target List shall have been
selected from Impax’s list. For clarity, any individual who
is included on the Target List shall be deemed a Target
Neurologist, regardless of whether such individual’s
credentials meet the technical definition of the term
“Neurologist” in Section 1.55. Wyeth shall update the
Target List with substitute
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Neurologists on
a semi-annual basis such that the Target List contains at least
three thousand five hundred (3,500) Neurologists. The Target List
may be modified by Wyeth on a more frequent basis from time to time
within its reasonably exercised discretion upon sixty
(60) days prior written notice to Impax.
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2.7.4
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Pricing . Wyeth shall have exclusive
responsibility and authority with respect to the pricing of the
Product. Wyeth shall inform Impax of list price increases or
decreases for the Product in the Territory at the time such
information is generally announced to the trade by
Wyeth.
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2.7.5
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Distribution and Sale of
Product .
Except to the extent that Impax distributes Samples of the Product
to Neurologists in accordance with this Agreement, Wyeth shall have
the sole right and responsibility to arrange for all distribution
of the Product in the Territory, to effect and account for all
sales of the Product in the Territory, and to establish and modify
the terms and conditions with respect to the sale of the Product in
the Territory, including any terms and conditions relating to or
affecting the price at which the Product will be sold, any discount
attributable to payments on receivables, distribution of the
Product, credit to be granted or refused and the like.
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(a)
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Wyeth shall cause its sales trainers
to conduct an Initial Training of all of the members of the Impax
Sales Force with respect to the Product and the Detailing thereof
in accordance with the Wyeth Sales Training Program, it being
understood and agreed that Impax is responsible for general sales
trai
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