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SALES AND MARKETING AGREEMENT | Document Parties: AKORN INC | Akorn-Strides, LLC You are currently viewing:
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AKORN INC | Akorn-Strides, LLC

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Title: SALES AND MARKETING AGREEMENT
Governing Law: New York     Date: 9/27/2004
Industry: Biotechnology and Drugs     Sector: Healthcare

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Exhibit 10.3

SALES AND MARKETING AGREEMENT

This Sales and Marketing Agreement, (“Agreement”) is made and entered into as of September 22, 2004 (“Effective Date”), by and between Akorn-Strides, LLC, a Delaware limited liability company having a principal place of business at 2500 Millbrook Drive, Buffalo Grove, Illinois 60089-4694 (“A-S”), and Akorn, Inc., a Louisiana corporation having a principal place of business at 2500 Millbrook Drive, Buffalo Grove, Illinois 60089-4694 (“Akron”), (each a “Party” and collectively the “Parties”).

RECITALS

     A. A-S is a new entity formed by Akorn and Strides Arcolab Limited, a company organized under the laws of India having a principal place of business at Strides House, Bilekahalli, Bannerghatta Road, Bangalore 560 076, India (“Strides”), to engage in the development and marketing of generic drug products;

     B. Pursuant to the Limited Liability Company Agreement of even date between Strides and Akorn, A-S desires to have Akorn assist it by providing certain sales, marketing and administrative services with respect to Products in the United States (as such term is defined below), and Akorn desires to assist A-S by providing certain sales, marketing and administrative services with respect to Products in the United States, pursuant to the terms and conditions of this Agreement.

     NOW, THEREFORE, in consideration of the mutual promises, covenants and obligations contained herein, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

ARTICLE 1

DEFINITIONS

     1.1 Affiliate. The term “Affiliate” means with respect to any Party, any party controlling, controlled by or under common control with any such Party. For purposes hereof, “control” and its derivatives means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of a Party, whether through the ownership of voting securities or voting interests, by contract or otherwise.

     1.2 cGMP. The term “cGMP” means current Good Manufacturing Practices as established by the FDA as the same may be amended from time to time.

     1.3 Commission. The term “Commission” has the meaning ascribed to it in Section 5.1.

     1.4 Commission Schedule. The term “Commission Schedule” has the meaning ascribed to it in Section 5.1.

     1.5 Commission Statement. The term “Commission Statement” has the meaning ascribed to it in Section 5.3.

 


 

     1.6 Epidemic Failure. The term “Epidemic Failure” means Product deficiencies resulting from defects in material, workmanship and/or manufacturing process that are in excess of one percent (1%) of the total number of Products shipped during any rolling six (6) month period.

     1.7 FDA. The term “FDA” means the United States Food and Drug Administration.

     1.8 Minimum Sales Requirement. The term “Minimum Sales Requirement” means, with respect to each separate Product, (i) to the extent that four (4) or more competitive products offering the same specific active pharmaceutical ingredient are approved by the FDA and commercially released and available in a Measurement Period in the Territory, a market share of five percent (5%) or greater in such Measurement Period with respect to such specific active pharmaceutical ingredient, as reported by IMS Health Incorporated; or (ii) to the extent that two (2) or three (3) competitive products offering the same specific active pharmaceutical ingredient are approved by the FDA and commercially released and available in a Measurement Period in the Territory, a market share of ten percent (10%) or greater in such Measurement Period with respect to such specific active pharmaceutical ingredient, as reported by IMS Health Incorporated; or (iii) to the extent that only one (1) competitive product offering the same specific active pharmaceutical ingredient is approved by the FDA and commercially released and available in a Measurement Period in the Territory, a market share of fifteen percent (15%) or greater in such Measurement Period with respect to such specific active pharmaceutical ingredient, as reported by IMS Health Incorporated.

     1.9 Intellectual Property Rights. The term “Intellectual Property Rights” means all United States and worldwide trademarks, service marks, trade dress, logos, copyrights, rights of authorship, inventions, patents, rights of inventorship, moral rights, rights of publicity and privacy, trade secrets, rights under unfair competition and unfair trade practices laws, and all other intellectual and industrial property rights related thereto.

     1.10 Measurement Period. The term “Measurement Period” means with respect to each Product, the period beginning with the date that the Product is first delivered to Akorn in production quantities, following approval of the applicable ANDA (as defined in the OEM Agreement ) by the FDA, or an annual anniversary thereof, and ending in each case twelve (12) months thereafter.

     1.11 Net Sales. The term “Net Sales” means the total amounts charged for A-S’ sale of Products, less applicable sales and use taxes, insurance and freight charges, Product returns and similar Product defect credits, and customary allowances and trade discounts, provided that such adjustments related to Product returns, defects and customary allowances and trade discounts are detailed in the applicable Commission Statement pursuant to Section 5.3 below and shall not exceed eight percent (8%) of A-S’ gross sales for Products in any calendar year, and provided that if A-S resells any returned Products, such sales will be included in Net Sales subject to a Commission in the quarter in which the returned Products are resold. The amounts for returned Products shall be deducted in the quarter when A-S actually receives the returned Products. No other deductions shall be made from Net Sales. Notwithstanding anything else to the contrary, Net Sales shall not include any amounts charged for A-S’ sale of specific Products (i) for which Akorn failed to meet the Minimum Sales Requirement in a Measurement Period; (ii) for which

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such third party service provider was engaged by A-S within thirty (30) calendar days of such failure for the purpose of providing sales, marketing and administrative services for such Product; (iii) which are attributable to the efforts of such third party service provider; and (iv) which such third party service provider actually fulfills and is paid a commission by A-S.

     1.12 OEM Agreement. The term “OEM Agreement” means the OEM Agreement of even date between Strides and A-S.

     1.13 Products. The term “Products” means the A-S products manufactured by Strides pursuant to the OEM Agreement.

     1.14 Services. The term “Services” means the sales, marketing and administrative services more fully set forth in ARTICLE 3 below.

     1.15 Strides. The term “Strides” has the meaning ascribed to it in Recital A.

     1.16 Term. The term “Term” has the meaning ascribed to it in Section 8.1.

     1.17 Territory. The term “Territory” means the United States.

     1.18 Trademarks. The term “Trademarks” has the meaning ascribed to it in Section 4.1.

ARTICLE 2

APPOINTMENT OF AKORN

     2.1 Appointment of Akorn. A-S hereby appoints Akorn for the Term as its exclusive provider of Services for the Territory. Akorn hereby accepts this appointment and agrees to perform the Services within the Territory during the Term in accordance with the terms and conditions of this Agreement.

     2.2 Failure to Attain Minimum Sales Requirement. Notwithstanding anything else to the contrary, should Akorn fail to meet the Minimum Sales Requirement in a Measurement Period with respect to any Product, then the appointment of Akorn set forth in Section 2.1 above shall, with respect to such specific Product only for which the Minimum Sales Requirement was not achieved, become non-exclusive and A-S shall have the option, within thirty (30) calendar days of such failure, to retain a third party service provider for the purpose of providing on a non-exclusive basis sales, marketing and administrative services for such Product. A-S shall exercise such option by notifying Akorn in writing, within thirty (30) calendar days of the end of the applicable Measurement Period, of the non-exclusive appointment of the third party service provider for the purpose of providing sales, marketing and administrative services for such Product. Notwithstanding any appointment by A-S of such third party service provider, Akorn shall retain the non-exclusive right to provide Services for such Product for the Territory, and shall continue to receive Commissions for all Net Sales of such Product as more fully provided herein.

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ARTICLE 3

SCOPE OF SERVICES

     3.1 Product Marketing. During the Term Akorn shall use commercially reasonable efforts to solicit orders for, and to promote and market, the Products in the Territory. Akorn shall use mutually-approved marketing materials in its marketing efforts for the Products. The Parties shall use commercially reasonable efforts to mutually develop a marketing plan for the Products in the Territory. If the Parties are unable to mutually develop such a marketing plan, then Akorn shall propose a marketing plan to A-S. Akorn’s proposed separate marketing plan must be approved by A-S before Akorn implements the same, and A-S’ approval will not be unreasonably withheld.

     3.2 Advertising. Akorn shall advertise and promote the Products in the Territory in a manner that will enhance the goodwill associated with the Products and with the Trademarks.

     3.3 Pricing and Terms of Purchase. A-S shall have the absolute right to establish and change the prices charged and terms governing the sale of the Products in the Territory. All sales of Product in the Territory shall be subject to A-S’ standard sales order terms and conditions, as may be amended from time to time by A-S.

     3.4 Sales Efforts. Akorn shall transmit or cause to be transmitted to A-S any order and all inquiries or complaints concerning Products originating from the Territory. Akorn shall additionally provide, on request, assistance and advice to customers in the Territory concerning the handling, storage and use of Products. Such advice and assistance shall be in accordance with A-S’ published data sheets and specifications for the Products. All sales of Products in the Territory, notwithstanding Akorn’s provision of the Services, shall be solely made by A-S and for the account of A-S.

     3.5 Selling Standards. Akorn shall comply with written selling and marketing standards established by the mutual written agreement of the Parties, as may be modified from time to time by the mutual written agreement of the Parties during the Term.

     3.6 Administrative Services. For each Product sold by A-S within the Territory, Akorn shall generate an invoice made payable to A-S. At least monthly, Akorn shall provide A-S with a current statement of account, listing all invoices outstanding and any payments made and credits given since the date of the previous statement. Any funds collected by Akorn with respect to Net Sales shall be paid to A-S.

     3.7 Product Fulfillment. Akorn shall ship Product pursuant to purchase order(s) issued from the Territory. A-S shall ensure that Akorn has sufficient inventories of Products to properly fulfill Product orders in the Territory.

     3.8 Personnel and Facilities. Akorn shall maintain and be responsible for, at its sole cost, its own sales, marketing and service personnel and facilities to enable Akorn to properly perform its obligations hereunder.

     3.9 Compliance with Laws. Akorn will comply with all applicable laws and regulations that govern its activities under this Agreement.

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     3.10 Akorn Business Practices. Akorn shall use commercially reasonable efforts to conduct business in a manner that reflects favorably on the Products and A-S’ goodwill and reputation.

     3.11 Own Account. Akorn shall conduct its business for its own account, as an independent contractor, in its own name, and not as an agent, employee, or partner of A-S or actually, impliedly or ostensibly hold itself out as such. Except as herein expressly provided, Akorn shall determine in its own judgment how best to perform its obligations hereunder, and A-S has no right to control such matters.

     3.12 Expenses. All expenses incurred by Akorn in connection with the Services pursuant to this Agreement shall be at the sole cost of Akorn and A-S shall not be responsible or liable therefor.

ARTICLE 4

TRADEMARKS

     4.1 Use of Trademarks. Pursuant to the terms and conditions of this Agreement and during the Term, A-S hereby grants Akorn an exclusive license to use the composite proprietary mark “Akorn-Strides/Arcolab” and associated logos, trade dress and/or trade names of A-S utilized in association with the Products (collectively “Trademarks”) only in its advertising and/or promotional materials for the Products; provided, however, that A-S reserves all rights of ownership and control over the Trademarks and the right to restrict any use which A-S in its sole discretion believes poses a serious threat or could be detrimental to the Trademarks or A-S’ goodwill or reputation. Akorn shall not at any time do anything or act in any way that would or might adversely affect the value or validity of any Trademarks or other intellectual property belonging to A-S. Akorn shall immediately notify A-S in writing upon becoming aware of any intellectual property infringement or imitation of any intellectual property of A-S or of any facts that Akorn believes might constitute infringement or imitation. Akorn acknowledges that all use of the Trademarks by Akorn shall inure to the benefit of and be on behalf of A-S.

     4.2 Use Approval. Prior to using the Trademarks in any advertising and/or promotional material for the Products that is not provided by A-S, Akorn shall forward an exemplar of each such advertising and/or promotional materials to A-S for its advance approval, consult with and obtain the written approval of A-S for such materials, which approval shall not be unreasonably withheld.

     4.3 Alteration. Akorn shall not remove, alter or obliterate any Trademarks or badges or any other tags affixed to the Products, nor shall it add any other names or marks except with the prior written consent of A-S.

ARTICLE 5

FINANCIAL PROVISIONS

     5.1 Compensation. As compensation for Services rendered under this Agreement, A-S shall pay to Akorn a commission on the Net Sales of Products originatin


 
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