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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.

7


 

 

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

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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 ev


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