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COPROMOTION AGREEMENT

Promotion Agreement

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This Promotion Agreement involves

IMPAX LABORATORIES INC

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Title: COPROMOTION AGREEMENT
Date: 8/5/2009
Industry: Biotechnology and Drugs     Sector: Healthcare

COPROMOTION AGREEMENT, Parties: impax laboratories inc
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EXHIBIT 10.6

      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

IMPAX LABORATORIES, INC.

and

WYETH
acting through its
WYETH PHARMACEUTICALS DIVISION

July 16, 2008

 


 

TABLE OF CONTENTS

Page

 

 

 

 

 

 

 

 

 

1.

 

DEFINITIONS

 

 

1

 

 

 

 

 

 

 

 

 

 

2.

 

APPOINTMENT AND OBLIGATIONS

 

 

11

 

 

 

 

 

 

 

 

 

 

 

 

2.1.

 

Appointment

 

 

11

 

 

 

2.2.

 

Adjustment to Initiation Date

 

 

11

 

 

 

2.3.

 

Wyeth’s Option to Designate Substitute Products

 

 

11

 

 

 

2.4.

 

Permitted Subcontractors

 

 

13

 

 

 

2.5.

 

Undertaking not to Compete

 

 

13

 

 

 

2.6.

 

Obligations of Impax

 

 

13

 

 

 

2.7.

 

Obligations of Wyeth

 

 

22

 

 

 

2.8.

 

Coordination Meetings

 

 

24

 

 

 

2.9.

 

Ownership of Product

 

 

25

 

 

 

2.10.

 

No Distribution

 

 

27

 

 

 

 

 

 

 

 

 

 

3.

 

PAYMENTS

 

 

27

 

 

 

 

 

 

 

 

 

 

 

 

3.1.

 

Detail Fee

 

 

27

 

 

 

3.2.

 

Adjustments to Detail Price

 

 

27

 

 

 

3.3.

 

No Payment for Extra Details

 

 

28

 

 

 

3.4.

 

Incentive Fee

 

 

28

 

 

 

3.5.

 

Taxes and Withholding

 

 

28

 

 

 

3.6.

 

Currency

 

 

28

 

 

 

 

 

 

 

 

 

 

4.

 

RECORD KEEPING; REPORTING AND AUDITS

 

 

28

 

 

 

 

 

 

 

 

 

 

 

 

4.1.

 

Impax Records and Audits

 

 

28

 

 

 

4.2.

 

Impax Reports

 

 

29

 

 

 

4.3.

 

Market Research

 

 

30

 

 

 

4.4.

 

Wyeth Records and Audits

 

 

30

 

 

 

 

 

 

 

 

 

 

5.

 

RELATIONSHIP AND PUBLICITY

 

 

31

 

 

 

 

 

 

 

 

 

 

 

 

5.1.

 

Relationship of Parties

 

 

31

 

 

 

5.2.

 

Public Announcements

 

 

31

 

 

 

 

 

 

 

 

 

 

6.

 

REGULATORY COMPLIANCE

 

 

31

 

 

 

 

 

 

 

 

 

 

 

 

6.1.

 

Marketing Authorization

 

 

31

 

 

 

6.2.

 

Recalls

 

 

31

 

 

 

6.3.

 

Returns

 

 

31

 

 

 

6.4.

 

Adverse Drug Experiences

 

 

31

 

 

 

6.5.

 

Product Complaints

 

 

33

 

 

 

6.6.

 

Product Inquiries

 

 

34

 

 

 

6.7.

 

Communications with FDA

 

 

35

 

 

 

6.8.

 

Additional Responsibilities of the Parties

 

 

35

 

 


 

 

 

 

 

 

 

 

 

 

7.

 

REPRESENTATIONS, WARRANTIES AND COVENANTS

 

 

35

 

 

 

 

 

 

 

 

 

 

 

 

7.1.

 

Mutual Representations and Warranties

 

 

35

 

 

 

7.2.

 

Impax Representations and Warranties

 

 

36

 

 

 

7.3.

 

Wyeth Representations and Warranties

 

 

36

 

 

 

7.4.

 

Wyeth Covenants

 

 

37

 

 

 

7.5.

 

Other Opportunities

 

 

37

 

 

 

 

 

 

 

 

 

 

8.

 

INDEMNIFICATION AND INSURANCE

 

 

37

 

 

 

 

 

 

 

 

 

 

 

 

8.1.

 

Indemnification by Impax

 

 

37

 

 

 

8.2.

 

Indemnification by Wyeth

 

 

38

 

 

 

8.3.

 

Defense of Actions; Settlements

 

 

38

 

 

 

8.4.

 

Limitation of Liability

 

 

38

 

 

 

8.5.

 

Insurance Requirements

 

 

39

 

 

 

 

 

 

 

 

 

 

9.

 

TERM AND TERMINATION

 

 

39

 

 

 

 

 

 

 

 

 

 

 

 

9.1.

 

Term

 

 

39

 

 

 

9.2.

 

Termination for Cause

 

 

39

 

 

 

9.3.

 

Termination by Wyeth

 

 

39

 

 

 

9.4.

 

Termination without Cause by Impax

 

 

39

 

 

 

9.5.

 

Effect of Termination

 

 

39

 

 

 

9.6.

 

Survival of Certain Provisions

 

 

40

 

 

 

 

 

 

 

 

 

 

10.

 

SAMPLES

 

 

40

 

 

 

 

 

 

 

 

 

 

 

 

10.1.

 

Provision of Samples

 

 

40

 

 

 

10.2.

 

Shipping and Distribution of Samples

 

 

40

 

 

 

10.3.

 

Compliance with PDMA

 

 

41

 

 

 

10.4.

 

Sample Carry Program

 

 

42

 

 

 

10.5.

 

Sampling Activity System Audit

 

 

44

 

 

 

10.6.

 

Investigation, Corrective & Preventative Actions

 

 

44

 

 

 

10.7.

 

Monitoring & Auditing Programs

 

 

44

 

 

 

10.8.

 

Responsibility for Compliance

 

 

45

 

 

 

10.9.

 

In-Transit Losses

 

 

45

 

 

 

10.10.

 

Improper Handling

 

 

45

 

 

 

10.11.

 

Indemnity for Failure to Comply

 

 

45

 

 

 

10.12.

 

Additional Requirements

 

 

45

 

 

 

 

 

 

 

 

 

 

11.

 

CONFIDENTIALITY

 

 

46

 

 

 

 

 

 

 

 

 

 

 

 

11.1.

 

Nondisclosure and Nonuse Obligations

 

 

46

 

 

 

11.2.

 

Permitted Disclosures

 

 

46

 

 

 

11.3.

 

Return of Confidential Information

 

 

47

 

 

 

11.4.

 

Disclosure of Agreement

 

 

47

 

 

 

11.5.

 

Equitable Relief

 

 

47

 

 

 

 

 

 

 

 

 

 

12.

 

MISCELLANEOUS

 

 

48

 

 

 

 

 

 

 

 

 

 

 

 

12.1.

 

Force Majeure

 

 

48

 

 

 

12.2.

 

Severability

 

 

48

 

 

 

12.3.

 

Assignability

 

 

48

 

ii


 

 

 

 

 

 

 

 

 

 

 

 

12.4.

 

Notices

 

 

49

 

 

 

12.5.

 

Governing Law; Jurisdiction

 

 

49

 

 

 

12.6.

 

Dispute Resolution

 

 

49

 

 

 

12.7.

 

No Waiver

 

 

49

 

 

 

12.8.

 

Headings; Defined Terms

 

 

50

 

 

 

12.9.

 

Counterparts

 

 

50

 

 

 

12.10.

 

Entire Agreement; Amendments

 

 

50

 

 

 

12.11.

 

Further Actions

 

 

50

 

iii


 

     SCHEDULES

 

 

 

 

 

Schedule 1.79

 

-

 

Sample Receipt Forms

 

 

 

 

 

Schedule 1.94

 

-

 

Wyeth Sales Training Program for the Initial Product Exhibit A to Schedule 1.94

 

 

 

 

 

Schedule 3.4

 

-

 

Sample Calculation of Incentive Fee

 

 

 

 

 

Schedule 7.3

 

-

 

Initial Product Patents

 

 

 

 

 

Schedule 6.4.6

 

-

 

Wyeth Form 1747(b)

 

 

 

 

 

Schedule 6.6

 

-

 

Wyeth Form 8202

iv


 

COPROMOTION AGREEMENT

     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:

1.

 

DEFINITIONS.

 

 

 

The following capitalized terms shall have the following meanings for all purposes of this Agreement:

 

1.1.

 

“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

 


 

 

 

 

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.

 

 

1.2.

 

“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.

 

 

1.3.

 

“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.

 

 

1.4.

 

“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.

 

 

1.5.

 

“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.

 

 

1.6.

 

“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.

 

 

1.7.

 

“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.

 

 

1.8.

 

“Breach” shall have the meaning set forth in Section 9.2.

 

 

1.9.

 

“Breaching Party” shall have the meaning set forth in Section 9.2.

2


 

 

1.10.

 

“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.

 

 

1.11.

 

“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.

 

 

1.12.

 

“Claims” shall have the meaning set forth in Section 8.1.

 

 

1.13.

 

“Commercially Reasonable Efforts” shall mean commercially reasonable efforts and resources.

 

 

1.14.

 

“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.

 

 

1.15.

 

“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.

 

 

1.16.

 

“Contract Year” shall mean any of Contract Year 1, Contract Year 2 or Contract Year 3.

 

 

1.17.

 

“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.

 

 

1.18.

 

“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.

 

 

1.19.

 

“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.

 

 

1.20.

 

“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.

 

 

1.21.

 

“Cumulative Detail Maximum” shall have the meaning set forth m Section 2.6.12(a).

 

 

1.22.

 

“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.

3


 

 

1.23.

 

“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.)

 

 

1.24.

 

“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.

 

 

1.25.

 

“Disclosing Party” shall mean the Party who is disclosing its Confidential Information to the Receiving Party.

 

 

1.26.

 

“Early Initiation Notice” shall have the meaning set forth in Section 2.2.

 

 

1.27.

 

“Extra Detail” shall have the meaning set forth in Section 2.6.12(b).

 

 

1.28.

 

“FDA” shall mean the United States Food and Drug Administration, or any successor entity thereto.

 

 

1.29.

 

“FD&C Act” shall mean the United States Federal Food, Drug, and Cosmetic Act, as amended, and the rules and regulations promulgated thereunder.

 

 

1.30.

 

“Impax Baseline PSR Cost” shall mean the Impax PSR Cost for the twelve (12) month period prior to the Initiation Date.

 

 

1.31.

 

“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.

 

 

1.32.

 

“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.

 

 

1.33.

 

“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.

4


 

 

1.34.

 

“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.

 

 

1.35.

 

“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.

 

 

1.36.

 

“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.

 

 

1.37.

 

“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.

 

 

1.38.

 

“Impax Sales Force” shall mean the Impax PSRs and the Impax Sales Management Team.

 

 

1.39.

 

“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.

 

 

1.40.

 

“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.

 

 

1.41.

 

“IMS” shall mean IMS Health Incorporated.

 

 

1.42.

 

“Incentive Fee” shall have the meaning set forth in Section 3.4.

5


 

 

 

1.43.

 

“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.

 

 

1.44.

 

“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:

 

(a)

 

XXXXX

 

 

(b)

 

XXXXX.

 

 

 

 

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 .

 

 

1.45.

 

“Indemnified Party” shall have the meaning set forth in Section 8.3.

 

 

1.46.

 

“Indemnifying Party” shall have the meaning set forth in Section 8.3.

 

 

1.47.

 

“Initial Product” shall mean desvenlafaxine tablets currently Marketed by Wyeth under the brand name PRISTIQ™ in the Territory.

 

 

1.48.

 

“Initial Training” shall have the meaning set forth in Section 2.6.8(a).

 

 

1.49.

 

“Initiation Date” shall mean July 1, 2009, or such earlier date as may be established pursuant to Section 2.2.

 

 

1.50.

 

“Market” shall mean, when used as a verb, to market, sell, distribute, Promote, or advertise a product.

 

 

1.51.

 

“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.

 

 

1.52.

 

“Minimum Detail Requirement” shall have the meaning set forth in Section 2.6.12(a).

 

 

1.53.

 

“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.

6


 

 

 

1.54.

 

“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.

 

 

1.55.

 

“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.

 

 

1.56.

 

“New Hire Training” shall have the meaning set forth in Section 2.6.8(b).

 

 

1.57.

 

“Non-Breaching Party” shall have the meaning set forth in Section 9.2.

 

 

1.58.

 

“Non-Target Neurologist” shall mean a Neurologist practicing in the Territory who is not a Target Neurologist.

 

 

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.

 

 

1.60.

 

“Permitted Subcontractor” shall have the meaning set forth in Section 2.4.

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1.61.

 

“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.

 

 

1.62.

 

“Prescribing Information” shall mean the prescribing information published by Wyeth in connection with the Marketing of the Product.

 

 

1.63.

 

“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.

 

 

1.64.

 

“Primary Detail Price” shall have the meaning set forth in Section 3.1.

 

 

1.65.

 

“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.

 

 

1.66.

 

“Product Substitution Notice” shall have the meaning set forth in Section 2.3.1.

 

 

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.

 

 

1.68.

 

“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.

 

 

1.69.

 

“Quarterly Details” shall mean the number of Cumulative Details performed by Impax during a given Calendar Quarter.

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1.70.

 

“Quarterly Meeting” shall mean those meetings between Impax and Wyeth as described in Section 2.8.

 

 

1.71.

 

“Receiving Party” shall mean the Party who is receiving Confidential Information from the Disclosing Party.

 

 

1.72.

 

“Refresher Training” shall have the meaning set forth in Section 2.7.6(c).

 

 

1.73.

 

“Retired Neurologist” shall mean a Neurologist that is deceased or is no longer practicing in the Territory.

 

 

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.

 

 

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.

 

 

1.76.

 

“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.

 

 

1.77.

 

“Sample Audit” shall have the meaning set forth in Section 10.5.

 

 

1.78.

 

“Sample Carry Program” shall have the meaning set forth in Section 10.4.

 

 

1.79.

 

“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.

 

 

1.80.

 

“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

9


 

 

 

 

Detail involves the communication of information with respect to no more than three (3) products.

 

 

1.81.

 

“Secondary Detail Price” shall have the meaning set forth in Section 3.1.

 

 

1.82.

 

“Substitution Date” shall have the meaning set forth in Section 2.3.1.

 

 

1.83.

 

“Target List” shall have the meaning set forth in Section 2.7.3.

 

 

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.

 

 

1.85.

 

“Target Neurologists” shall mean the group of Neurologists identified by Wyeth on the then-current Target List.

 

 

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.

 

 

1.87.

 

“Tier 2 Target Neurologists” shall mean any Target Neurologist other than a Tier 1 Target Neurologist.

 

 

1.88.

 

“Term” shall have the meaning set forth in Section 9.1.

 

 

1.89.

 

“Territory” shall mean the fifty (50) states of the United States and the District of Columbia.

 

 

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.

 

 

1.91.

 

“Third Party” shall mean any Person other than Wyeth, Impax or any of their respective Affiliates.

 

 

1.92.

 

“Trademark” shall have the meaning set forth in Section 2.9.2.

 

 

1.93.

 

“Wyeth Improvements” shall have the meaning set forth in Section 2.9.6.

 

 

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.

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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.

 

 

2.2

 

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.

 

 

2.3

 

Wyeth’s Option to Designate Substitute Products .

 

2.3.1

 

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.

 

2.3.2

 

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.

 

2.3.3

 

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.

 

 

2.4

 

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.

 

2.5

 

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.

 

2.6

 

Obligations of Impax .

 

 

2.6.1

 

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.

 

2.6.2

 

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

 

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.

 

 

2.6.4

 

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.

 

2.6.5

 

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.

 

2.6.6

 

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.

 

 

2.6.7

 

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.

 

2.6.8

 

Sales Training .

 

 

(a)

 

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).

 

(b)

 

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.

 

 

(c)

 

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.

 

(d)

 

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

 

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.

 

 

2.6.10

 

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.

 

2.6.11

 

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.

 

 

2.6.12

 

Performance of Details .

 

(a)

 

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)

 

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.

 

 

(c)

 

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.

 

2.6.13

 

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.

 

2.6.14

 

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.

 

 

2.6.15

 

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.

 

2.6.16

 

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.

 

 

2.6.17

 

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.

 

2.6.18

 

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 %).

 

2.7

 

Obligations of Wyeth .

 

 

2.7.1

 

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.

 

2.7.2

 

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.

 

 

2.7.3

 

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.

 

2.7.4

 

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.

 

 

2.7.5

 

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.

 

2.7.6

 

Training ,

 

 

(a)

 

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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