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CO-PROMOTION AGREEMENT

Promotion Agreement

CO-PROMOTION AGREEMENT | Document Parties: AUXILIUM PHARMACEUTICALS INC | Oscient Pharmaceuticals Corp. You are currently viewing:
This Promotion Agreement involves

AUXILIUM PHARMACEUTICALS INC | Oscient Pharmaceuticals Corp.

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Title: CO-PROMOTION AGREEMENT
Governing Law: New York     Date: 5/6/2005

CO-PROMOTION AGREEMENT, Parties: auxilium pharmaceuticals inc , oscient pharmaceuticals corp.
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EXHIBIT 10

 

THE REGISTRANT HAS APPLIED FOR CONFIDENTIAL TREATMENT OF CERTAIN PROVISIONS OF THIS EXHIBIT WITH THE SECURITIES AND EXCHANGE COMMISSION. THE CONFIDENTIAL PORTIONS OF THIS EXHIBIT ARE BRACKETED AND MARKED WITH ASTERISKS ([**]) AND HAVE BEEN OMITTED. THE OMITTED PORTIONS OF THIS EXHIBIT WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.

 

CO-PROMOTION AGREEMENT

 

Between

 

Auxilium Pharmaceuticals, Inc.

 

And

 

Oscient Pharmaceuticals Corp.

 

Dated as of April 11, 2005

 


Table of Contents

 

 

 

 

 

 

 

 

 

 

1.0

  

DEFINITIONS

  

1

 

 

 

2.0

  

CO-PROMOTION OF PRODUCT

  

11

 

 

 

 

 

  

2.1

  

Grant of rights

  

11

 

 

 

 

 

  

2.2

  

Commercially Reasonable Efforts; minimum number of Details and PSRs

  

11

 

 

 

 

 

  

2.3

  

Management Steering Committee:

  

12

 

 

 

 

 

 

  

 

  

(a)

  

Creation and Overview

  

12

 

 

 

 

 

 

  

 

  

(b)

  

Responsibilities

  

12

 

 

 

 

 

 

  

 

  

(c)

  

Management Steering Committee Meetings

  

13

 

 

 

 

 

 

  

 

  

(d)

  

Management Steering Committee Decision Making

  

14

 

 

 

 

 

  

2.4

  

Marketing Committee

  

14

 

 

 

 

 

 

  

 

  

(a)

  

Creation and Overview

  

14

 

 

 

 

 

 

  

 

  

(b)

  

Responsibilities

  

15

 

 

 

 

 

 

  

 

  

(c)

  

Marketing Committee Meetings

  

15

 

 

 

 

 

 

  

 

  

(d)

  

Marketing Committee Decision Making

  

16

 

 

 

 

 

 

  

 

  

(e)

  

Decisions regarding certain Matters

  

16

 

 

 

 

 

  

2.5

  

Obligations Of The Parties And Their Affiliates

  

17

 

 

 

 

 

  

2.6

  

Oscient Level of PSRs; PSR Compensation

  

17

 

 

 

 

 

  

2.7

  

Co-Promotion Start Date

  

18

 

 

 

 

 

  

2.8

  

Promotion Plan

  

18

 

 

 

 

 

  

2.9

  

Marketing Budget; Allocation of Marketing Expenses

  

19

 

 

 

 

 

  

2.10

  

Additional Expenses

  

19

 

 

 

 

 

  

2.11

  

Promotional Activities

  

20

 

 

 

 

 

  

2.12

  

Promotional Materials

  

20

 

 

 

 

 

  

2.13

  

Co-Branding

  

20

 

 

 

 

 

  

2.14

  

Oscient PSR Training

  

20

 

 

 

 

 

  

2.15

  

Auxilium Supply and Manufacturing Responsibilities

  

21

 

 

 

 

 

  

2.16

  

Co-Promotion Reports

  

22

 

 

 

 

 

  

2.17

  

Inventory Reports

  

22

 

 

 

 

 

  

2.18

  

Trademark

  

22

 

 

 

 

 

  

2.19

  

TMF Option

  

22

 

i


 

 

 

 

 

 

 

 

  

2.20

  

Other Product Option

  

23

 

 

 

 

 

  

2.21

  

Other Commercialization Activities

  

23

 

 

 

3.0

  

TERM AND COMPENSATION

  

24

 

 

 

 

 

  

3.1

  

Term

  

24

 

 

 

 

 

  

3.2

  

First Extension Period

  

24

 

 

 

 

 

  

3.3

  

Second Extension Period

  

25

 

 

 

 

 

  

3.4

  

Expense Reports

  

26

 

 

 

 

 

  

3.5

  

Allocation of Gross Profit

  

27

 

 

 

 

 

  

3.6

  

Adjustments to the Profit Sharing Thresholds

  

27

 

 

 

 

 

  

3.7

  

Tail Period

  

28

 

 

 

 

 

  

3.8

  

Generic Entry

  

29

 

 

 

4.0

  

STATEMENTS AND REMITTANCE

  

29

 

 

 

 

 

  

4.1

  

Record of the number of Details

  

29

 

 

 

 

 

  

4.2

  

Record Gross Sales, Net Sales, Gross Profit, Marketing Budget expenses and Actual Cost

  

29

 

 

 

 

 

  

4.3

  

Record Promotional Material usage and purchases

  

29

 

 

 

 

 

  

4.4

  

Right to independent certified public accountant

  

29

 

 

 

 

 

  

4.5

  

Reimbursement for examination

  

29

 

 

 

 

 

  

4.6

  

Payment of taxes

  

30

 

 

 

 

 

  

4.7

  

Payment of PCP Gross Profits

  

30

 

 

 

 

 

  

4.8

  

Late Payment

  

30

 

 

 

 

 

  

4.9

  

Method of Payment

  

30

 

 

 

5.0

  

ADVERSE EVENTS, CONFIDENTIALITY AND INTELLECTUAL PROPERTY

  

30

 

 

 

 

 

  

5.1

  

Adverse Events and Regulatory Matters

  

30

 

 

 

 

 

  

5.2

  

Confidential Information

  

31

 

 

 

 

 

  

5.3

  

Disclosure to Affiliate

  

31

 

 

 

 

 

  

5.4

  

Public Announcements

  

31

 

 

 

 

 

  

5.5

  

Publications

  

31

 

 

 

 

 

  

5.6

  

Trademark

  

32

 

 

 

 

 

  

5.7

  

Copyright

  

32

 

 

 

 

 

  

5.8

  

Patents

  

33

 

 

 

 

 

  

5.9

  

Injunctive Relief

  

34

 

ii


 

 

 

 

 

 

 

6.0

  

PRODUCT COMPLAINTS; INQURIES, WITHDRAWALS AND RECALLS

  

34

 

 

 

7.0

  

TERMINATION

  

35

 

 

 

 

 

  

7.1

  

Breach

  

35

 

 

 

 

 

  

7.2

  

Insolvency

  

36

 

 

 

 

 

  

7.3

  

Generics

  

36

 

 

 

 

 

  

7.4

  

Product Withdrawal

  

36

 

 

 

 

 

  

7.5

  

Competitive Product

  

36

 

 

 

 

 

  

7.6

  

Termination by Oscient

  

36

 

 

 

 

 

  

7.7

  

Termination by Auxilium for Failure to Detail

  

36

 

 

 

8.0

  

RIGHTS AND DUTIES UPON TERMINATION

  

37

 

 

 

 

 

  

8.1

  

Survival

  

37

 

 

 

 

 

  

8.2

  

Return of Materials

  

37

 

 

 

 

 

  

8.3

  

No Prejudice

  

37

 

 

 

9.0

  

WARRANTIES, REPRESENTATIONS AND COVENANTS

  

37

 

 

 

 

 

  

9.1

  

Auxilium and Oscient representations, warranties and covenants

  

37

 

 

 

 

 

  

9.2

  

Auxilium representation, warranties and covenants

  

38

 

 

 

 

 

  

9.3

  

Oscient acknowledgment concerning trademark and copyright

  

39

 

 

 

10.0

  

INDEMNIFICATION AND LIABILITY

  

40

 

 

 

11.0

  

MISCELLANEOUS

  

41

 

 

 

 

 

  

11.1

  

Arbitration

  

41

 

 

 

 

 

  

11.2

  

Non-Solicitation

  

42

 

 

 

 

 

  

11.3

  

Parties in Interest

  

42

 

 

 

 

 

  

11.4

  

Assignment

  

42

 

 

 

 

 

  

11.5

  

Force Majeure

  

42

 

 

 

 

 

  

11.6

  

Governing Law

  

42

 

 

 

 

 

  

11.7

  

Severability

  

42

 

 

 

 

 

  

11.8

  

Amendments

  

43

 

 

 

 

 

  

11.9

  

Notices

  

43

 

 

 

 

 

  

11.10

  

Entire Agreement.

  

43

 

 

 

 

 

  

11.11

  

No Waiver

  

43

 

 

 

 

 

  

11.12

  

Construction; Headings

  

43

 

 

 

 

 

  

11.13

  

Counterparts; Facsimile Signatures

  

43

 

iii


LIST OF EXHIBITS

 

 

 

 

Exhibit A:

 

Marketing Budget

 

 

Exhibit B:

 

Patents and patent applications that may cover the Product

 

 

Exhibit C:

 

List of trademarks

 

 

Exhibit D:

 

Management Steering Committee nominees

 

 

Exhibit E:

 

Gross Profit Allocation

 

 

Exhibit F:

 

Communications with FDA regarding Promotion of Product

 

iv


CO-PROMOTION AGREEMENT

 

This Agreement is made as of the 11 TH day of April, 2005 (the “Effective Date”), by and between Auxilium Pharmaceuticals, Inc., a Delaware corporation, with principal offices at 160 W. Germantown Pike, Norristown, PA 19401 (“ Auxilium ”) and Oscient Pharmaceuticals Corp., a Massachusetts corporation, with principal offices at 1000 Winter Street, Suite 2200, Waltham, MA, 02451, (“ Oscient ”) (with each of Auxilium and Oscient referred to herein individually as a “ Party ” and collectively as the “ Parties ”).

 

WITNESSETH

 

WHEREAS, Auxilium owns or licenses patent, trademark and other intellectual property rights to Product; and

 

WHEREAS, Auxilium intends to use its pharmaceutical sales force and distribution capability to market and promote Product in the Territory; and

 

WHEREAS, Oscient intends to use its pharmaceutical sales force to Co-Promote Product in the Territory; and

 

WHEREAS, Auxilium desires to complement the Detailing efforts of its pharmaceutical sales force promoting Product with the additional capability of Oscient’s sales force; and

 

WHEREAS, Oscient desires to participate in such Co-Promotion effort in order to expand its marketing activities in the Territory;

 

NOW, THEREFORE, in consideration of the covenants and obligations expressed herein and intending to be legally bound, the Parties hereto agree as follows:

 

1.0 DEFINITIONS

 

The following terms as used in this Agreement shall have the meanings set forth in this Article:

 

 

1.1

Actual Cost ” shall mean Auxilium’s fully burdened cost incurred in the development, production and/or manufacture of Promotional Materials, including, without limitation, raw material and labor costs and amounts paid to Third Parties in connection therewith, as determined in accordance with GAAP.

 

1


 

1.2

Adverse Experience ” means any undesirable, untoward or noxious event or experience associated with the clinical, commercial or other use, or occurring following administration, of Product in humans, occurring at any dose, whether expected, and whether considered related to or caused by Product, including such an event or experience as occurs in the course of the use of Product in professional practice, in a clinical trial, from overdose, whether accidental or intentional, from abuse, from withdrawal, or from a failure of expected pharmacological or biological therapeutic action of Product, and including those events or experiences that are required to be reported to any regulatory authority under applicable laws, including reports to the FDA under 21 C.F.R. section 314.80.

 

 

1.3

Affiliate ” shall mean any corporation, partnership or other entity which directly or indirectly controls, is controlled by or is under common control with a Party hereto. For the purpose of the foregoing, “control” shall mean the direct or indirect ownership of more than fifty percent (50%) of the voting stock in such corporation or other entity, or the de facto decision-making power in such corporation or entity, except that any equity owner of a Party that is not an operating entity engaged in business in the pharmaceutical industry shall not be deemed an Affiliate.

 

 

1.4

Aggregate Marketing Expense ” shall have the meaning set forth in Section 2.9 hereof.

 

 

1.5

AMA ” shall mean the American Medical Association.

 

 

1.6

Auxilium-Only Cohort ” shall mean PCPs detailed exclusively by Auxilium as specified in the final Detailing Plan to be completed within thirty (30) days from the Effective Date.

 

 

1.7

Average Testim Market Share ” shall mean the share of the Product in the Transdermal TRT Market, calculated as the quotient of (i) the total prescriptions of the Product dispensed divided by (ii) total prescriptions of all products dispensed in the Transdermal TRT Market, both measured by IMS Xponent data.

 

 

1.8

Bentley Patent ” shall mean United States Patent Number 5,023,252, and any and all continuations, continuations-in-part, additions, divisions, renewals, extensions, re-examinations and reissues thereof and any and all foreign counterparts to which Auxilium has an exclusive license to make, have made, use and sell Product in certain territories, including the Territory.

 

2


 

1.9

Commercially Reasonable Efforts ” means efforts and resources normally used by a Party, taking into account the size, stage of development and level of resources of such Party, for a product, proposed product or technology owned by it or to which it has rights, which, as compared to the Product, is of similar commercial potential at a similar stage in its development or product life. Commercially Reasonable Efforts may include (a) promptly assigning responsibility for a Party’s obligations to specific employee(s) who are held accountable for progress and monitoring such progress on an ongoing basis, (b) setting and consistently seeking to achieve specific and meaningful objectives for carrying out such obligations, and (c) consistently making and implementing decisions and allocating resources designed to advance progress with respect to such objectives.

 

 

1.10

Confidential Information ” shall mean with respect to a Party, technical, financial and business information, including where appropriate and without limitation, trade secrets, billing practices and procedures, price lists, customer lists, training materials, Product information, marketing strategies, specifications, sales and service manuals, samples, proprietary correspondence, operational data, research, technical and/or manufacturing information designs, know-how and processes; and all tangible and intangible embodiments thereof, including, where appropriate and without limitation, all presentations, reports, documents and data in electronic form, that is owned or controlled by such Party or its Affiliates and disclosed by such Party to the other Party, including information provided by a Party to the other Party prior to the Effective Date, that is identified or acknowledged to be confidential at the time of disclosure, or that the receiving Party knows or has reason to know is or contains trade secrets or other proprietary information of the other Party; provided that Confidential Information shall not include information that (i) is in the receiving Party’s possession or is known to the receiving Party at the time of disclosure without an obligation to keep it confidential as evidenced by contemporaneous written records of the receiving Party, (ii) is generally available to the public or otherwise part of the public domain at the time of disclosure, (iii) is or becomes publicly known through no act of the receiving Party, (iv) was disclosed to the receiving Party by a Third Party who had no obligation of confidentiality as evidenced by contemporaneous written records of the receiving Party, (v) is developed independently by the receiving Party as evidenced by contemporaneous written records, (vi) is authorized to be released by the disclosing Party, (vii) is ordered by a court of competent jurisdiction to be disclosed, provided prompt notice of any such order is given to the disclosing Party and all reasonable steps are taken to secure a protective order for the Confidential Information.

 

 

1.11

Controlled Substances Act ” shall mean the Controlled Substances Act (21 U.S.C. 801 et seq .), as such statute may be amended and in force from time to time.

 

3


 

1.12

Co-Promote ” or “ Co-Promotion ” shall mean the joint marketing, promotion and Detailing of Product under a single Trademark by the Parties (or their respective Affiliates) in the Territory, pursuant to the Promotion Plan.

 

 

1.13

Co-Promotion Report ” shall mean a written report summarizing the marketing and Promotional Activities undertaken by a Party (or its relevant local Affiliates) during the previous quarter in connection with the applicable Promotion Plan.

 

 

1.14

Co-Promotion Start Date ” shall mean the date on which Oscient begins Detailing the Product pursuant to Section 2.7 hereof.

 

 

1.15

Co-Promotion Term ” shall mean the term described in Section 3.1 hereof.

 

 

1.16

Cost of Goods Sold ” shall mean, for any particular period, the total cost of goods of the Product sold in the Territory for such period, as determined in accordance with GAAP, including, but not limited to, (i) raw materials; (ii) fees paid to contract manufacturers; (iii) royalty payments to Bentley; (iv) personnel costs associated with quality assurance and manufacturing oversight; (v) distribution costs, including warehousing and freight; and (vi) product liability insurance. Auxilium’s current revenue recognition is based on units of the Product dispensed, therefore if Auxilium transitions after the Effective Date to revenue recognition based on Product shipped, any one-time adjustments relating to Auxilium’s transition to revenue recognition based on Product shipped shall be excluded.

 

 

1.17

Cost of Returns ” shall mean the product of (a) the Weighted Average Wholesale Acquisition Cost for a particular period, times (b) the number of Product units returned in a particular period, times (c) the sum of (i) wholesaler prompt pay discount of [**] %; (ii) Wholesaler Distribution Fee Percentage; (iii) return processing cost of [**] %; and (iv) destruction cost of [**] %. “Wholesaler Distribution Fee Percentage” shall be the sum of the Effective Distribution Fee Rate for each wholesaler that Auxilium has a distribution fee contract with in a particular period. The “Effective Distribution Fee Rate” for each wholesaler shall be the quotient of the total Product shipped in the preceding year to that wholesaler divided by the total Product shipped to all Auxilium customers in the preceding year times the contracted distribution fee rate for that wholesaler.

 

 

1.18

DEA ” shall mean the United States Drug Enforcement Administration, and any successor thereto.

 

4


 

1.19

Detail ” or “ Detailing ” shall mean a personal contact by a PSR with a health care practitioner for the purpose of providing information on or stimulating interest in the use or purchase of the Product.

 

 

1.20

Detailing Plan ” shall mean the document included within the Promotion Plan, prepared by the Marketing Committee and approved by the Management Steering Committee, describing the responsibilities of both Parties with respect to PCP Detailing. The Detailing Plan shall be approved in final form by the Management Steering Committee within thirty (30) days of the Effective Date based on the initial draft of the Detailing Plan executed by the Parties on or about the Effective Date. The Detailing Plan may be amended from time to time in accordance with the terms of the Agreement.

 

 

1.21

Effective Date ” shall mean the date referred to in the preamble to this Agreement.

 

 

1.22

FDA ” shall mean the United States Food and Drug Administration and any successor thereto.

 

 

1.23

FD&C Act ” shall mean The Federal Food, Drug and Cosmetic Act (21 U.S.C. 321 et seq .), as such statute may be amended and in force from time to time.

 

 

1.24

GAAP ” shall mean United States generally accepted accounting principles, consistently applied by Auxilium.

 

 

1.25

Generic Entry ” shall mean the first commercial sale of a product following final approval by the FDA under section 505(j) of the FD&C Act of an application for such product that identifies the Product as a reference listed drug in the application.

 

 

1.26

Gross Profit ” shall be equal to Gross Profit Margin multiplied by Net Sales.

 

 

1.27

Gross Profit Margin ” shall be equal to Net Sales of Product, less the Cost of Goods Sold, divided by such Net Sales. Gross Profit Margin shall be set equal to [**] % for Year 1. Thereafter the Gross Profit Margin for each successive Year will be equal to the actual Gross Profit Margin for the then preceding Year (e.g., Year 2 Gross Profit Margin will be equal to Year 1 actual Gross Profit Margin).

 

5


 

1.28

Gross Sales ” shall mean, for any particular period, the total amount invoiced in the Territory by Auxilium for the Product shipped during such period, if Auxilium’s revenue recognition methodology as reported for such period is based on Product shipped; or total units of the Product dispensed in the Territory, as measured using IMS NPA and NSP data, multiplied by the Weighted Average Wholesale Acquisition Cost for such period, if Auxilium’s revenue recognition methodology as reported for such period is based on units of the Product dispensed. Auxilium’s current revenue recognition is based on units of the Product dispensed, therefore if Auxilium transitions after the Effective Date to revenue recognition based on Product shipped, any one-time adjustments relating to Auxilium’s transition to revenue recognition based on Product shipped shall be excluded.

 

 

1.29

Management Steering Committee ” shall mean the committee consisting of three senior representatives from each Party (one representing each of sales/marketing, finance and business development), with a Chairperson designated by Auxilium, which is charged with overseeing all strategic aspects of the Promotional Activities and supervises the Marketing Committee as described in more detail in this Agreement.

 

 

1.30

Marketing Budget ” shall mean the total annual marketing budget for the Product, as approved annually by the Management Steering Committee, which sets forth all marketing expenses, including, without limitation, PCP-directed speaker and medical education programs, PCP advisory boards, Promotional Materials, clinical publications, samples, coupons, and, to the extent approved by the Management Steering Committee, Phase IIIb trials and Phase IV trials. The Marketing Budget will include certain items that will be used both in (a) PCP-directed marketing activities performed by the Parties, and (b) Specialist-directed marketing activities performed by Auxilium. Therefore, the Marketing Budget will contain PCP and Specialist sections. Promotion Materials used exclusively for Specialists are not included in the Marketing Budget, except for speakers’ training. The Marketing Budget for Year 1 shall be approved in final form by the Management Steering Committee within thirty (30) days of the Effective Date based on the initial draft of the Marketing Budget attached hereto as Exhibit A.

 

 

1.31

Marketing Committee ” shall mean the committee consisting of three representatives from each Party (one representing each of sales, marketing and finance), with a Chairperson designated by Auxilium, which is charged with managing all operational aspects of the Promotional Activities as described in more detail in this Agreement. The Marketing Committee is responsible for developing the Promotion Plan, including the Marketing Budget and Detailing Plan, which Promotion Plan must be approved by the Management Steering Committee. The Marketing Committee is supervised by the Management Steering Committee.

 

6


 

1.32

Marketing Expense ” shall mean 50% of the Aggregate Marketing Expense.

 

 

1.33

Marketing Plan ” shall mean the document included within the Promotion Plan, prepared by the Marketing Committee and approved by the Management Steering Committee, which sets forth the responsibilities of both Auxilium and Oscient with respect to marketing the Product to PCPs, including (i) Co-Promote pre-launch promotional and educational programs, (ii) Co-Promote launch promotional and educational programs, (iii) positioning and message strategy to PCPs, (iv) Promotion Materials, (v) advertising materials, (vi) educational materials, (vii) product management direction and (viii) annual sales forecasts for the Product. The Marketing Plan may be amended from time to time in accordance with the terms of this Agreement.

 

 

1.34

NDA ” shall mean any and all New Drug Applications submitted to the FDA under Section 505 or 512 of the FD&C Act and applicable regulations related to Product including, without limitation, full NDAs, Supplemental NDAs (SNDAs), and “paper” NDAs and abbreviated NDAs (ANDAs), by Auxilium relating to the Product during the term of this Agreement.

 

 

1.35

Net Sales ” shall mean Gross Sales less all reductions from Gross Sales as reported by Auxilium and consistently applied under GAAP, including, but not limited to (i) cash discounts; (ii) rebates; (iii) patient coupons; and (iv) Cost of Returns.

 

 

1.36

Oscient-Only Cohort ” shall be a group of physicians, elected by Oscient as specified in the final Detailing Plan within thirty (30) days of the Effective Date from one of the following groups:

 

 

(a)

[**] physicians (defined as those physicians who comprise the smallest number of physicians responsible for [**] % of prescriptions in a defined market) in the Transdermal TRT market who are detailed exclusively by Oscient as specified in the final Detailing Plan to be completed within thirty (30) days from the Effective Date; or

 

 

(b)

[**] physicians selected from those physicians that will be called on initially by Oscient to Detail the Product, which may include the physicians in group (a) of this definition. If Oscient elects to have the group described in this clause (b) become the Oscient-Only Cohort, it shall select, and notify Auxilium in writing of, the [**] individuals comprising this group by December 31, 2005. In the event that Oscient has not notified Auxilium as described above, clause (a) above shall apply in determining the Oscient-Only Cohort.

 

7


 

1.37

Other Product ” shall mean any product, other than the Product, that (i) contains testosterone as the active ingredient, (ii) is indicated for the treatment of male hypogonadism and (iii) is either owned by or licensed to Auxilium.

 

 

1.38

Patents ” shall mean those patents and patent applications in which Auxilium has rights, including, for example, ownership rights or rights though an exclusive or non-exclusive license, that may cover the Product, including the Bentley Patent and other such patents and applications listed on Exhibit B, and all continuations, continuations-in-part, additions, divisions, renewals, extensions, re-examinations and reissues thereof.

 

 

1.39

PCP ” shall mean Primary Care Physician, defined as including all AMA specialty designations other than urologists, endocrinologists and a cohort of HIV-treating physicians agreed to by the Parties in writing on or about the Effective Date.

 

 

1.40

PCP Gross Profit ” shall mean Gross Profit Margin multiplied by PCP Net Sales.

 

 

1.41

PCP Gross Sales ” shall mean, for a particular period, the product of (i) total units of the Product dispensed in the Territory during such period, as measured using IMS NPA and NSP data multiplied by (ii) the quotient obtained by dividing PCP units of the Product dispensed in the Territory during such period by total units of the Product dispensed in the Territory during such period, each as measured using IMS Xponent data, multiplied by (iii) Weighted Average Wholesale Acquisition Cost for such period.

 

 

1.42

PCP Gross Profit Allocation Report ” shall mean the report delivered by Auxilium to Oscient pursuant to Section 3.5 hereof, which shall include, for the applicable period, (i) PCP Gross Sales, (ii) PCP Net Sales, (iii) PCP Gross Profit and (iv) the number of units and prescriptions for the Product during the applicable period. Also included shall be detail of the adjustments to reflect any under- or over-allocation of PCP Gross Profit to Oscient from the preceding quarter based on the actual results of the preceding quarter as compared to the estimates that were used to calculate PCP Gross Profits for such preceding quarter.

 

 

1.43

PCP Net Sales ” shall mean PCP Gross Sales multiplied by the ratio of Net Sales to Gross Sales for the applicable period.

 

 

1.44

PDE ” or “ Primary Detail Equivalent ” shall mean either one (1) Primary Detail or two (2) Secondary Details conducted by a Party.

 

8


 

1.45

Post Generic Gross Profit ” for each twelve month period following a Generic Entry in the Territory shall be equal to the sum of (i) the Gross Profit Margin during the last Year preceding Generic Entry in the Territory plus (ii) the percentage points by which Auxilium’s obligation to pay Third Party royalties on Net Sales of Product decreases after expiration of the Bentley Patent in the Territory multiplied by the PCP Net Sales for each such twelve month period following the Generic Entry.

 

 

1.46

Primary Detail ” shall mean a Detail in the first mention position and consuming the greatest amount of time spent (approximately 60-70%) during a call to a health care practitioner.

 

 

1.47

Product ” shall mean (i) any product identified in NDA number 21-454, including any amendments or supplements to such NDA, or (ii) a TRT product requiring a license under the Bentley Patents to make, have made, use or sell such product in the Territory.

 

 

1.48

Promotion Materials ” or “ Promotional Materials ” shall mean promotional, advertising, communication and educational materials relating to the Product for use in connection with the marketing, promotion, Detailing and sale of the Product for Co-Promotion to PCPs in the Territory, and the content thereof, and shall include, without limitation, promotional literature, Product samples, Product support materials, field communication, educational, training or clinical publications, and other promotional materials provided by Auxilium to Oscient to prepare for or to be used in Detailing Product.

 

 

1.49

Promotion Plan ” shall mean the document, approved by the Management Steering Committee, that includes the Marketing Plan (including the Marketing Budget) and the Detailing Plan. The Promotion Plan for Year 1 will be finalized by the Parties within thirty (30) days of the Effective Date.

 

 

1.50

Promotional Activities ” shall mean Co-Promote pre- and post-Product launch activities, including, without limitation, all activities related to promotion, Detailing, and sampling of the Product in the Territory to PCPs. Promotional Activities shall also include Phase IIIb and IV clinical trials as approved by the Management Steering Committee.

 

 

1.51

PSR ” shall mean professional sales representatives.

 

 

1.52

Quarterly Marketing Expense ” shall be equal to 50% of the Aggregate Marketing Expense (as defined in Section 2.9 hereof) for a particular quarter.

 

9


 

1.53

Secondary Detail ” shall mean a Detail in the second mention position and consuming approximately 30-40% of time spent during a call to a health care practitioner.

 

 

1.54

Specialists ” shall mean urologists, endocrinologists and a cohort of HIV-treating physicians agreed to in writing between the Parties on or about the date hereof.

 

 

1.55

Supply Interruption ” shall exist when (i) there is no Product at ICS (or any other Third Party distributor used by Auxilium) and (ii) the supply of Product at wholesalers and warehouses is sufficient to meet demand for no more than [**] (based on demand for the most recent 90 days).

 

 

1.56

Territory ” shall mean the United States of America.

 

 

1.57

Third Party ” shall mean any party other than either of the Parties or their Affiliates.

 

 

1.58

TMF ” shall mean transmucosal film containing testosterone as licensed to Auxilium and currently under joint development by Formulation Technologies, LLC, d/b/a PharmaForm and Auxilium.

 

 

1.59

Trademarks ” shall mean those trademarks used by Auxilium with respect to the marketing or promotion of the Product as of the Effective Date and from time to time after the Effective Date, as listed on Exhibit C, which Exhibit shall be amended from time to time to include any additional trademarks used from time to time in the promotion of the Product after the Effective Date.

 

 

1.60

TRT ” shall mean testosterone replacement therapy for the treatment of male hypogonadism.

 

 

1.61

Transdermal TRT Market ” shall mean the total market sales, as reported by IMS data, of the following TRT gel products in the Territory: [**] ; provided that, in the event any new transdermal gel TRT product enters the market in the Territory, the Parties will discuss in good faith whether or not to include such product in this definition.

 

 

1.62

Weighted Average Wholesale Acquisition Cost ” shall mean the unit weighted average Wholesale Acquisition Cost of the units dispensed during a period, as calculated by Auxilium and reported to Oscient in the PCP Gross Profit Allocation Report.

 

10


 

1.63

Wholesale Acquisition Cost ” shall mean the list price for the Product to wholesalers or direct purchasers, not including prompt pay or other discounts, rebates or reductions in price.

 

 

1.64

Year ” shall refer to time periods as follows: Year 1 shall be the period commencing on May 1, 2005 and ending on December 31, 2005; Years 2-6 refer to the successive 12-month periods beginning on January 1, wherein Year 2 is 2006, Year 3 is 2007, Year 4 is 2008, Year 5 is 2009 and Year 6 is 2010; Year 7 shall be the period commencing on January 1, 2011 and ending on April 30, 2011.

 

2.0 CO-PROMOTION OF PRODUCT

 

 

2.1

Auxilium hereby grants to Oscient the right, and Oscient accepts the obligation during the term of this Agreement and under the conditions herein imposed, to exclusively promote and Detail the Product jointly with Auxilium to PCPs in the Territory, all as further described herein.

 

 

2.2

Subject to the terms of this Agreement, each Party (and its Affiliates) shall use Commercially Reasonable Efforts to fulfill all responsibilities assigned to it under any then applicable Promotion Plan and shall perform such responsibilities in compliance with all applicable laws and regulations. In addition, Auxilium shall use Commercially Reasonable Efforts to promote the Product to Specialists, including, but not limited to, investing in sales and marketing initiatives for Specialists. In connection with the foregoing, Oscient shall perform the minimum number of Details with the minimum number of PSRs as set forth in this Agreement, and Auxilium shall use Commercially Reasonable Efforts to employ not less than [**] full time PSRs, of whom at least [**] % are employees of Auxilium (subject to fluctuations in such number resulting from vacancies, employee turnover and similar reasons). Subject to Section 2.6(b), Auxilium shall perform (a) not less than [**] PDEs to PCPs, of which at least [**] are Primary Details, and not less than [**] PDEs to Specialists, of which at least [**] are Primary Details in Year 1; (b) not less than [**] PDEs to PCPs, of which at least [**] are Primary Details, and not less than [**] PDEs to Specialists, of which at least [**] are Primary Details in Years 2-6; and (c) not less than [**] PDEs to PCPs, of which at least [**] are Primary Details, and not less than [**] PDEs to Specialists, of which at least [**] are Primary Details in Year 7.

 

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2.3

Management Steering Committee :

 

 

(a)

Creation and Overview : Each Party shall nominate three (3) members to the Management Steering Committee. The nominated members from each Party are listed on the attached Exhibit D. The Parties may agree to change the total number of representatives on the Management Steering Committee, provided that the Parties always have an equal number of representatives. The Chairperson of the Management Steering Committee shall be a representative of Auxilium. Each Party may replace any of its Management Steering Committee representatives at any time upon written notice to the other Party. Upon written notice provided to the other Party at least one week prior to the date of the meeting, any member of the Management Steering Committee may invite non-members to participate in the discussions and meetings of the Management Steering Committee so long as such non-member is an employee of a Party or an agent of a Party bound by obligations of confidentiality no less strict than Section 5.2 of this Agreement. The Parties understand and agree that non-members do not have the right to vote. Each Party shall be responsible for all travel and related costs of its own representatives to attend meetings of, and otherwise participate on, the Management Steering Committee.

 

 

(b)

Responsibilities : The purpose of the Management Steering Committee shall be (i) to supervise the Marketing Committee and (ii) to oversee all strategic aspects of the Promotional Activities, including, without limitation, the following:

 

 

1.

Reviewing and approving the Promotion Plan formulated by the Marketing Committee;

 

 

2.

Reviewing and approving any changes to the Promotion Plan; and

 

 

3.

Considering and acting upon such other matters as are specified in this Agreement.

 

In addition to the foregoing, Auxilium shall keep Oscient reasonably informed of the following matters through the Management Steering Committee and shall reasonably consider all input and comments from Oscient regarding such matters; provided that Auxilium shall be solely responsible for all decisions regarding such matters in its sole, reasonable discretion:

 

 

i.

Prices, discounts, rebates, reductions, chargebacks and similar policies for the Product in the Territory;

 

 

ii.

Managed care strategies and decisions;

 

 

iii.

Pharmacovigilance and drug safety matters;

 

12


 

iv.

Recalls, market withdrawals, and any other corrective actions related to any Product in the Territory;

 

 

v.

Medical inquiries from healthcare providers and responses to such inquiries;

 

 

vi.

Status of third party manufacturing arrangements;

 

 

vii.

Reporting of pricing information to the government in accordance with all applicable laws; and

 

 

viii.

Planning and conducting Phase IIIb and IV trials for the Product that are ongoing on the Effective Date (which trials shall be conducted at Auxilium’s sole expense, unless otherwise agreed to by the Parties).

 

 

(c)

Management Steering Committee Meetings . The Management Steering Committee shall meet no less frequently than quarterly following the quarterly meetings of the Marketing Committee and at such other times and at such places as shall be mutually agreed by the Parties. Meetings will be in person or by video or teleconference, as the Parties may agree. In the event that a Management Steering Committee member of a Party cannot attend a meeting, such Party shall have the right to nominate another representative of that Party to attend and vote at the meeting, provided that such representative is reasonably experienced in the areas for which such Management Steering Committee member is responsible. In-person meetings shall be held at such location as mutually agreed upon by the Parties. The Chairperson shall prepare and distribute to the Management Steering Committee members an agenda for each Management Steering Committee meeting at least ten (10) business days before the meeting. A Management Steering Committee representative of the Party hosting the meeting shall serve as Secretary of that meeting. The Secretary of the meeting shall prepare and distribute to all members of the Management Steering Committee draft minutes of the meeting within five (5) business days after of the meeting for review and comment by the other Management Steering Committee members. Such minutes shall provide a description in reasonable detail of the discussions at the meeting and a list of any actions, decisions or determinations approved by the Management Steering Committee. After receipt of comments from other Management Steering Committee members and incorporation of such comments as appropriate in the draft minutes, the Secretary shall provide the Chairperson with the final draft minutes. The Chairperson shall distribute the final minutes of each meeting to the members of the Management Steering Committee for final review and approval as soon as practicable after a meeting. Minutes will be approved no later than the next meeting of the Management Steering Committee.

 

13


 

(d)

Management Steering Committee Decision Making . At least a majority of the members of the Management Steering Committee shall constitute a quorum for any meeting of the Management Steering Committee, provided that at least two (2) members from each Party are present. All decisions of the Management Steering Committee shall be made on a unanimous basis of all Management Steering Committee members participating in the meeting where a quorum is present. If the Management Steering Committee cannot reach agreement with respect to a particular issue before it within three (3) business days, then the Auxilium Chairperson and a Management Steering Committee member selected by Oscient shall meet again (via phone or videoconference) within four (4) business days after the date of the Management Steering Committee meeting on such matter and will negotiate in good faith to reach consensus. If the Auxilium Chairperson and the Oscient Management Steering Committee member are unable to reach agreement after five (5) business days, subject to Section 2.5, the Auxilium Chairperson will have the authority to make a final decision on the matter, which decision shall be made in good faith and consistent with the objectives and intent of this Agreement. For clarity, the Management Steering Committee cannot in any way amend or modify the terms or provisions of this Agreement or increase the Marketing Budget as it pertains to Oscient without Oscient’s consent.

 

 

2.4

Marketing Committee :

 

 

(a)

Creation and Overview : Within thirty (30) days following the Effective Date, each Party shall nominate three (3) members to the Marketing Committee. The Parties may agree to change the total number of representatives on the Marketing Committee, provided that the Parties always have an equal number of representatives. The Chairperson of the Marketing Committee shall be a representative of Auxilium. Each Party may replace any of its Marketing Committee representatives at any time upon written notice to the other Party. Upon written notice provided to the other Party at least one week prior to the date of the meeting, any member of the Marketing Committee may invite non-members to participate in the discussions and meetings of the Management Steering Committee so long as such non-member is an employee of the Party or an agent of a Party bound by obligations of confidentiality no less strict than Section 5.2 of this Agreement. The Parties understand and agree that non-members do not have the right to vote. Each Party shall be responsible for all travel and related costs for its own representatives to attend meetings of, and otherwise participate on, the Marketing Committee.

 

14


 

(b)

Responsibilities : The purpose of the Marketing Committee shall be to oversee all operational aspects of the Promotional Activities, including, without limitation, the following:

 

 

1.

Formulating the Promotion Plan to be reviewed and approved by the Management Steering Committee;

 

 

2.

Developing and updating, as necessary, marketing guidelines for the Product branding, positioning, core messages, and other tactical plans;

 

 

3.

Preparing short-term and long-term sales forecasts in the Territory;

 

 

4.

Developing and approving the Promotional Materials and Promotional Activities, subject to regulatory review and approval by Auxilium; and

 

 

5.

Considering and acting upon such other matters as are specified in this Agreement.

 

 

(c)

Marketing Committee Meetings . The Marketing Committee shall meet no less frequently than quarterly and at such other times and at such places as shall be mutually agreed by the Parties. Meetings will be in-person or by video or teleconference, as the Parties may agree. In the event that a Marketing Committee member of a Party cannot attend a meeting, such Party shall have the right to nominate another representative of that Party to attend and vote at the meeting, provided that such representative is reasonably experienced in the areas for which such Marketing Committee member is responsible. In-person meetings shall be held at such location as mutually agreed upon by the Parties. The Chairperson shall prepare and distribute to the Marketing Committee members an agenda for each Marketing Committee meeting at least ten (10) business days before the meeting. A Marketing Committee representative of the Party hosting the meeting shall serve as Secretary of that meeting. The Secretary of the meeting shall prepare and distribute to all members of the Marketing Committee draft minutes of the meeting within five (5) business days after of the meeting for review and comment by the other Marketing Committee members. Such minutes shall provide a description in reasonable detail of the discussions at the meeting and a list of any actions, decisions or determinations approved by the Marketing Committee. After receipt of comments from other Marketing Committee members and incorporation of such comments as appropriate in the draft minutes, the Secretary shall provide the Chairperson with the final draft minutes. The Chairperson shall distribute the final minutes of each meeting to the members of the Marketing Committee for final review and approval. Minutes will be approved no later than the next meeting of the Marketing Committee.

 

15


 

(d)

Marketing Committee Decision Making . At least a majority of the members of the Marketing Committee shall constitute a quorum for any meeting of the Marketing Committee, provided that at least two (2) members from each Party are present. All decisions of the Marketing Committee shall be made on a unanimous basis of all Marketing Committee members participating in the meeting where a quorum is present. If the Marketing Committee cannot reach agreement with respect to a particular issue before it within three (3) business days, then the Auxilium Chairperson and a Marketing Committee member selected by Oscient shall meet again (via phone or videoconference) within four (4) business days after the date of the Marketing Committee meeting on such matter and will negotiate in good faith to reach consensus. If the Auxilium Chairperson and the Oscient Marketing Committee member are unable to reach agreement after five (5) business days, subject to Section 2.5, the Auxilium Chairperson will have the authority to make a final decision on the matter, which decision shall be made in good faith and consistent with the objectives and intent of this Agreement. For clarity, the Marketing Committee cannot in any way amend or modify the terms or provisions of this Agreement.

 

 

(e)

Decisions Regarding Certain Matters . Notwithstanding any other provisions of this Agreement, final decisions regarding the following matters over which the Parties are in dispute and are unable to resolve despite using good faith efforts under the provisions of Sections 2.3(e) and 2.4(d) shall, in lieu of resolution by decision of the Auxilium Chairperson, be resolved by mutual agreement between the Chief Executive Officer of Auxilium and the Chief Executive Officer of Oscient:

 

 

1.

Final approval of the Detailing Plan for any Year;

 

 

2.

Final decisions regarding short-term or long-term sales forecasts for the Product; and

 

 

3.

Final decisions regarding the Marketing Budget for any Year.

 

Notwithstanding the foregoing, in the event that the Chief Executive Officer of Auxilium and the Chief Executive Officer of Oscient are unable to reach mutual agreement concerning the matters specified in any of clauses (1) to (3) above in this section within five (5) business days, then both Parties agree that such matters shall be resolved by arbitration in accordance with Section 11.1 of this Agreement; provided that, for purposes of this Section only, the Parties shall jointly appoint one arbitrator and within the number of days agreed upon by the Parties and the single arbitrator, each Party shall submit to the arbitrator a written proposed resolution of the matter in dispute. The arbitrator shall choose one of the proposals as the final and binding resolution of such dispute. If

 

16


a Party does not submit a proposal within time period agreed upon, the proposal of the other Party shall be binding. In the event that the Parties shall fail to agree upon the choice of an arbitrator, then the arbitration shall proceed in accordance with Section 11.1 of this Agreement.

 

 

2.5

Obligations Of The Parties And Their Affiliates . The Parties shall cause their respective designees on the Management Steering Committee, the Marketing Committee and their respective executive officers to take the actions and make the decisions provided herein to be taken and made by such respective designees and executive officers in the manner and within the applicable time periods provided herein. To the extent a Party performs any of its obligations hereunder through any Affiliate of such Party, such Party shall be fully responsible and liable hereunder and thereunder for any failure of such performance, and each Party agrees that it will cause each of its Affiliates to comply with any provision of this Agreement which restricts or prohibits a Party from taking any specified action. Moreover, each Party shall take all actions under this Agreement (including the exercise by Auxilium of its discretion as permitted under this Article 2) in good faith and consistent with the intent of the Parties as evidenced by this Agreement.

 

 

2.6

Oscient Level of PSRs and Detailing; PSR Compensation .

 

 

(a)

(i) Oscient agrees that within [**] , it shall replace any agent PSRs with PSRs who are employees of Oscient; provided that, up to [**] % of Oscient’s PSRs may be non-employee agents of Oscient. Oscient shall use Commercially Reasonable Efforts to employ a minimum of [**] full time PSRs, at its own cost, to Detail Product, subject to fluctuations in such number resulting from vacancies, employee turn-over and similar reasons. Oscient further agrees that the number of agent PSRs Detailing Product under this Agreement will not exceed [**] % of the number of PSRs up to the first [**] PSRs. Notwithstanding the foregoing, Oscient has the sole option to expand the number of PSRs promoting the Product beyond [**] with any combination of employees and non-employee agents determined by Oscient, with the deployment of any such additional PSRs to be set forth in an amendment to the Promotion Plan; provided, however, that Oscient employees shall annually perform a number of Details for the Product that is not less than the greater of (x) [**] PDEs or (y) [**] % of the PDEs required by the applicable Detailing Plan to be performed by Oscient and further provided, Oscient employees shall annually perform at least [**] % of the Primary Details required by the applicable Detailing Plan. In the event Oscient decides to allocate more than [**] PSRs for detailing the Product, unless otherwise agreed by the Parties, Oscient’s calling audience will continue to be PCPs, and Auxilium will retain exclusive detailing rights to Specialists as defined in Section 1.55; and

 

17


(ii) Oscient shall perform [**] PDEs of which at least [**] are Primary Details in Year 1, [**] PDEs of which at least [**] are Primary Details in Years 2-6 and [**] PDEs of which at least [**] are Primary Details in Year 7.

 

 

(b)

Compensation of Oscient PSRs . A minimum of [**] % of the variable compensation which each of the initial [**] Oscient PSRs can earn for each POA during each Year shall be based upon achievement of goals related to the Product. If Oscient increases the number of PSRs Detailing the Product as permitted under this Agreement and increases the number of PDEs for the Product at least in proportion to the increase in the number of PSRs, a minimum of [**] % of the variable compensation to which each of Oscient’s PSRs Detailing the Product can earn for each POA during each Year shall be based upon achievement of goals related to the Product.

 

Compensation of Auxilium PSRs . The percentages specified below of the variable compensation which each of the Auxilium PSRs (for both PCP and specialists) can earn for each POA during each Year shall be based upon achievement of goals related to the Product:

 

For Year 1: [**] %

 

For Years 2 through 4: [**] % if Auxilium is, at the time, promoting no more than [**] products (including the Product) and [**] % if Auxilium is, at the time, promoting more than [**] products.

 

In addition, during Years 2 through 4, if Auxilium is promoting [**] products (including the Product), it may elect to allocate a minimum of [**] % of its variable compensation to the Product. However, if Auxilium elects to allocate less than [**] % of its variable compensation to the Product (while promoting [**] products), Auxilium will commit an additional [**] PDEs annually toward Details for PCPs for the Product.

 

For Years 5 through 7: [**] % if Auxilium is, at the time, promoting no more than [**] products (including the Product) and [**] % if Auxilium is, at the time, promoting more than [**] products.

 

 

2.7

Co-Promotion Start Date . Oscient shall start detailing the Product no later than May 9, 2005, with no less than [**] PSRs (subject to the provisions of Section 2.6) by May 15, 2005, in accordance with the Promotion Plan. Oscient shall hire one full time marketing person promptly after the Effective Date and shall dedicate such person to marketing activities associated with the Product.

 

 

2.8

Promotion Plan . A final draft of the Promotion Plan for Year 1 will be approved by the Management Steering Committee within 30 days of the Effective Date based on the initial draft of the Detailing Plan to be agreed by the Parties in

 

18


writing on or about the Effective Date. The Promotion Plan shall be amended from time to time as determined necessary by either the Management Steering Committee or the Marketing Committee, with any such amendment to be approved by the Management Steering Committee. The Promotion Plan shall include, among other things, the Detailing Plan and Marketing Plan.

 

 

2.9

Marketing Budget; Allocation of Marketing Expenses . The budget for Product promotion shall be under the direction of the Marketing Committee, supervised by the Management Steering Committee and set forth in the Marketing Budget. No later than November 1st of the preceding calendar year, the Management Steering Committee shall approve a new Marketing Budget for that Year. The Parties acknowledge that many of the items to be included in the Marketing Budget will also be used by Auxilium in its Specialist-directed marketing activities. The Marketing Committee will indicate, for each item in the Marketing Budget, the percentage of that item’s cost to be allocated to the Auxilium Specialist marketing budget. The Marketing Budget will therefore contain a PCP component, to be shared equally between the Parties, and a Specialist component, to be funded by Auxilium only. In addition, the Marketing Budget will provide: (1) an estimated breakdown of the spending by category; and (2) an estimated breakdown of spending by quarter, for each category. The Marketing Budget shall also identify which Party will pay for each spending category, and the Parties’ marketing expenditures during each quarter shall be recorded in terms of total, PCP and Specialist marketing. Each Party may elect to include certain prescription data costs in the Marketing Budget, to be shared equally between the Parties as PCP Marketing Expense. For Oscient, such costs shall be its cost of purchasing IMS NPA, NSP, and Xponent data to be used to fulfill its obligations under the Agreement, up to a maximum of $ [**] per year. For Auxilium, such costs shall be 50% of its annual cost of purchasing IMS NPA, NSP, and Xponent data. In Year 2, the Parties intend to spend on PCP marketing approximately $ [**] . A new 2-year target level for the marketing spend will be established upon the extension of the Agreement at the end of Years 2 and 4. The aggregate actual expenses incurred by the Parties for PCP marketing shall be referred to herein as the “Aggregate Marketing Expense”. To the extent that a Party has paid more than 50% of the Aggregate Marketing Expense in a quarter, an adjustment will be made such that each Party has incurred 50% of the Aggregate Marketing Expense for that quarter (the “Quarterly Expense True-up”), with such adjustment being made pursuant to Section 4.7 hereof. In addition, the Quarterly Expense True Up will be adjusted such that Auxilium has paid 100% of the Specialist marketing expenditures.

 

 

2.10

Additional Expenses . In addition to the foregoing Marketing Budget expenses, each Party shall be responsible for all costs associated with its respective sales force, including, without limitation, salaries, bonuses, and field support funds of $ [**] per PSR per year.

 

19


 

2.11

Promotional Activities . Promotional Activities for the Product shall be under the direction of the Marketing Committee, supervised by the Management Steering Committee, and set forth in the Promotion Plan. All Promotional Activities shall be approved by the Marketing Committee; provided that, notwithstanding the provisions of this Agreement regarding decision making matters within the Marketing Committee, neither Party shall be required to perform any Promotional Activities which it believes in good faith violate legal or regulatory requirements.

 

 

2.12

Promotional Materials. During the term of this Agreement, Auxilium shall create and develop all Promotional Materials relating to the Product for distribution in the Territory. All Promotional Materials shall be approved by the Marketing Committee; provided that, notwithstanding the provisions of this Agreement regarding decisions making matters within the Marketing Committee, neither Party shall be required to use any Promotional Materials which it believes in good faith violate legal or regulatory requirements


 
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