Workplan For Detailing Services

Exhibit 10.19

Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.


WORKPLAN FOR DETAILING SERVICES


This Workplan for Detailing Services ("Workplan") is dated as of September 19, 2003 ("Effective Date") by and between Cardinal Health PTS, Inc. ("Cardinal Health") with a place of business at 7000 Cardinal Place, Dublin, Ohio, and Acorda Therapeutics, Inc. ("Acorda"), having a principal place of business at 15 Skyline Drive, Hawthorne, New York 10532.


Background Information Cardinal Health and Acorda are parties to the RxPedite Acorda Marketing Services Agreement dated September 19, 2003 ("RxPedite Agreement"). Cardinal Health provides a number of marketing related services to Acorda pursuant to the terms of the RxPedite Agreement as set forth in specific Workplans agreed to by the parties. The parties desire to set forth the terms and conditions upon which Cardinal Health will provide Representatives to Detail certain products for Acorda as provided herein and in the RxPedite Agreement. This Workplan is subject to the terms and conditions of the RxPedite Agreement and is incorporated by reference therein. In the event of a conflict between the terms of the RxPedite Agreement and this Workplan, the RxPedite Agreement shall control.


ARTICLE I

DEFINITIONS


1.1. Definitions. Initially capitalized terms used in this Workplan that are not otherwise defined in this Article 1 or elsewhere in this Workplan shall have the meanings as such terms are defined in the RxPedite Agreement.


(a) "Act" means the Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder from time to time.


(b) "Agency" means any governmental regulatory authority in the Territory responsible for granting approvals for the sale or maintaining regulatory oversight of the Products, including, without limitation, the FDA.


(c) "Cardinal Health Employee" means individually, any Representative, Manager, National Account Manager, National Sales Director, or Medical Science Liaison, and "Cardinal Health Employees" means, collectively, all of the foregoing.


(d) "FDA" means the United States Food and Drug Administration and any successor agency having substantially the same functions.


(e) "Detail" means an interactive, face-to-face visit by a Representative with a Target Customer or his or her legally empowered designee in the Territory, during which the FDA-approved indicated uses, safety, effectiveness, contraindications, side effects, warnings and other relevant characteristics of one of the Products are described by the Representative in a fair and balanced manner consistent with the requirements of the Act, and using, as necessary or


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desirable, the Product Labeling and the Product Promotional Materials. When used as a verb, "Detail" or "Detailing" shall mean to engage in a Detail as defined in this Section 1.1(e).


(f) "Manager" means an individual hired by and retained as an employee of Cardinal Health to supervise activities of Representatives under this Workplan, including district sales managers, regional sales directors, a National Sales Director, and a Project Manager.


(g) "Medical Science Liaison" means an individual hired by Cardinal Health to educate target physicians on current trends relating to the Product, its approved indications, and other functions agreed to by the parties.


(h) "MSL Commencement Date" means the date upon which Acorda delivers a written request to Cardinal Health for the recruitment and hiring of the Medical Science Liaisons as provided in Section 2.4.


(i) "NAM Commencement Date" means the date upon which Acorda delivers a written request to Cardinal Health for the recruitment and hiring of the National Account Managers as provided in Section 2.3.


(j) "National Account Manager" means an individual hired by Cardinal Health to manage national sales accounts for Products, including without limitation, accounts with wholesalers, managed care institutions, etc.


(k) "National Sales Director" means an individual hired by Cardinal Health to supervise activities of Representatives, National Account Managers and Medical Science Liaisons under this Workplan and other functions agreed to by the parties.


(l) "PDMA" means the Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder from time to time.


(m) "Product Labeling" means all labels and other written, printed, or graphic matter provided by the Acorda relating directly to Product labeling, including (i) any container or wrapper utilized with a Product, or (ii) any written material accompanying a Product, including, without limitation, Product package inserts.


(n) "Product Promotional Materials" means all written, printed or graphic material provided by Acorda to Cardinal Health, including Product Labeling, intended for use by Representatives during a Detail, including visual aids, file cards, premium items, clinical studies, reprints, drug information updates and any other promotional support items that Acorda deems necessary or appropriate to conduct the Program. Product Promotional Materials shall include FDA approved material provided by Acorda relating to indicated uses, safety, effectiveness, contraindications, side effects, warnings and other relevant characteristics of each of the Products.


(o) "Products" means the pharmaceutical products to be detailed by Representatives and marketed by Acorda as set forth on attached Schedule 1.1(o), as such


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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.


schedule may be amended to include other Acorda products by mutual agreement between the parties.


(p) "Program" means the program of Detailing the Products in the Territory to be conducted by the Representatives pursuant to this Workplan and the RxPedite Agreement during the Term of this Workplan, as defined in Section 10.1.


(q) "Program Launch" means the first Monday following the completion of the Training Program (as defined in Section 3.1) by at least [***] of the Representatives.


(r) "Representative" means an individual hired by and retained as an employee of Cardinal Health to conduct Detailing of Products in connection with the Program. As sometimes used in this Workplan, "Representatives" shall also include "Managers."


(s) "Representative Commencement Date" shall mean the date upon which Acorda delivers a written request to Cardinal Health for the recruitment and hiring of the Representatives as provided in Section 2.1.


(t) "Target" or "Target Customer" means a physician or other specialist identified by Acorda.


(u) "Territory" means the geographical area specified in the attached Schedule 1.1(t).


ARTICLE II

GENERAL SCOPE OF ACTIVITIES


2.1 Furnishing Representatives. Upon receipt of a written request from Acorda, Cardinal Health shall commence the recruitment and hiring of at least [***] Representatives within a timeframe to be mutually agreed upon by the parties. Cardinal Health shall assign Representatives for such Target Customers, in such numbers, and in such Territories as shall be designated by Acorda during the Term of this Workplan. Each Representative shall Detail his or her assigned Target Customers based on the general direction given by Acorda's designated management team and as mutually agreed to by Cardinal Health, such agreement not to be unreasonably withheld. Except as otherwise provided in Section 2.5, the duties of such Representatives shall be exclusively to Detail the Products and perform other related activities deemed necessary for the establishment and maintenance of new and existing customers of the Products in the Territory.


2.2 Furnishing Managers and National Sales Director . Upon receipt of a written request from Acorda authorizing the recruitment of the Representatives, Cardinal Health shall commence the recruitment and hiring of [***] Managers and [***] National Sales Director to supervise the activities of Representatives, National Account Managers and Medical Science Liaisons and to perform this Workplan.


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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.


2.3 Furnishing National Account Managers . Upon receipt of a written request from Acorda, Cardinal Health shall commence the recruitment and hiring of [***] National Account Managers within a timeframe to be mutually agreed upon by the parties and to perform the functions described on Schedule 2.3.


2.4 Furnishing Medical Science Liaisons . Upon receipt of a written request from Acorda, Cardinal Health shall commence the recruitment and hiring of [***] Medical Science Liaisons within a timeframe to be mutually agreed upon by the parties and to perform the functions described on Schedule 2.4.


2.5. Sales Force Syndication . During the Term, the primary activity of the Cardinal Health Employees will be the marketing and promotion of the Product in the Territory, provided, however, that Cardinal Health will have the right to propose to Acorda syndication of any additional capacity of the Representatives to other products from third party healthcare companies. Upon Acorda's acceptance of such proposal, the parties will negotiate in good faith a decrease in the Service Fees to reflect such syndication by Cardinal Health. Cardinal Health may not syndicate such additional sales force capacity absent written approval of the proposal by Acorda, including approval of the negotiated adjustment in the Service Fees. Acorda will consider any such proposed syndication in good faith, taking into account the type of product, target audience and level of sales effort for such product.


2.6 Scope of Activities. The parties shall perform the following activities as applicable to each in connection with the Program:


(a) Cardinal Health will recruit, interview and hire as its employees the Cardinal Health Employees. Cardinal Health will use its best efforts to ensure that Cardinal Health Employees have prior experience and training in the pharmaceutical industry or other health care-related fields or such other experience deemed mutually acceptable by Acorda and Cardinal Health. Cardinal Health shall use its best efforts to ensure that the Cardinal Health Employees have satisfactory references from prior employers. Cardinal Health shall have the sole authority to reject any applicant for employment as a Cardinal Health Employee. Acorda may, at its sole cost and expense, participate with Cardinal Health in the interviewing of Cardinal Health Employees. If Cardinal Health rejects an applicant and thereafter hires such applicant at the request of Acorda, Acorda shall indemnify and hold Cardinal Health harmless from any Claim (as defined in the RxPedite Agreement) arising as a result of such Cardinal Health Employee's wrongful or negligent acts or omissions.


(b) Cardinal Health shall have sole and exclusive authority to discipline or terminate the employment of the Cardinal Health Employees. Acorda may reasonably request that a Cardinal Health Employee be terminated or reassigned if such Cardinal Health Employee's activities or conduct are not adequately (i) achieving the performance goals of the Product, or (ii) complying with Acorda requirements for Detailing the Product. Cardinal Health shall use its best efforts to comply with such request; provided that such action complies with applicable laws and is in accordance with Cardinal Health's policies and procedures, as determined by Cardinal Health's human resources manager. In the event Cardinal Health determines that its policies and procedures or applicable laws prohibit the termination or reassignment of any Cardinal Health


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Employee so requested by Acorda, it shall notify Acorda of such determination and submit a corrective action plan for Acorda's approval. In any event, if a Cardinal Health Employee fails to comply with all applicable laws and regulations, or breaches Cardinal Health's obligations under the RxPedite Agreement or this Workplan, then the parties shall take the actions set forth in Section 2.8..


(c) Cardinal Health shall cause each Cardinal Health Employee to attend and successfully complete the Training Program (as defined in Section 3.1) conducted by Acorda for each of the Products prior to participating in the Program. Any Cardinal Health Employee who does not successfully complete all requirements of the Training Program shall be removed and replaced by another Cardinal Health Employee who shall comply with such requirements.


(d) Cardinal Health's Managers shall periodically accompany Representatives on Details, conduct field evaluations of the Representatives and the Program, including time supervision, territory management, and reporting, and be available to review such evaluations with the Acorda's coordinator of the Program. At Acorda's request, Cardinal Health shall permit Acorda or its designated representative to review Cardinal Health's evaluations relating to the foregoing and to accompany the Representatives on such Details.


(e) Acorda shall provide Cardinal Health without cost with sufficient quantities of the Product Promotional Materials and Product Labeling for the performance and supervision of Detailing. Acorda shall be solely responsible for the preparation, content, and method of distribution of the Product Promotional Materials and the Product Labeling. In connection with the Detailing of the Products, the Cardinal Health Employees shall use only the Product Labeling and the Product Promotional Materials provided by Acorda; and under no circumstances shall Cardinal Health or the Cardinal Health Employees develop, create, or use any other promotional material or literature for the Detailing of the Products. Representatives and National Account Managers shall limit their verbal statements and claims regarding the Products, including efficacy and safety, to those that are consistent with the Product Labeling and the Product Promotional Materials, and Cardinal Health shall require that Representatives and National Account Managers so limit their statements and claims. Acorda shall advise Cardinal Health immediately of any inaccuracy or incompleteness of the Product Promotional Materials or the Product Labeling, and upon such notice Cardinal Health and the Cardinal Health Employees shall immediately cease the use of any portion or all of the Product Promotional Materials or Product Labeling so identified by Acorda.


(f) The Representatives and National Account Managers shall not add, delete, or modify claims of efficacy or safety in the Detailing of the Products, nor make any changes (including underlining or otherwise highlighting any language or adding any notes thereto) in the Product Promotional Materials.


(g) The Cardinal Health Employees shall not make any disparaging, untrue, or misleading statements about any of Acorda or its Affiliates, employees, competitors, or competing products.


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(h) Representatives and National Account Managers shall Detail the Products in strict adherence to all applicable laws, regulations, and professional requirements, including, but not limited to, the Act, the Medicare and Medicaid Anti-Kickback Statute, and the American Medical Association Gifts to Physicians from Industry Guidelines.


(i) The Cardinal Health Employees shall remain under the direct authority and control of Cardinal Health, but shall cooperate with the members of Acorda and shall receive advice and direction related to Detail activities on the Products from Acorda and Cardinal Health mutually. Acorda shall make all decisions with respect to the overall strategy in connection with the Detailing of the Products in accordance with applicable laws and Cardinal Health Employees shall comply with such decisions. Any Acorda personnel interacting with Cardinal Health Employees shall not discipline the Cardinal Health Employees or implement terms or conditions of employment or personnel policies and/or practices with respect to the Cardinal Health Employees or otherwise control the daily activities of the Cardinal Health Employees. Acorda shall provide Cardinal Health with copies of all reports, memoranda, audits and other data it develops pertaining to (i) the Cardinal Health Employees, Detailing, and the Program within fifteen (15) days of the preparation of such documents, and (ii) any negligent or wrongful acts or omissions of the Cardinal Health Employees as promptly as practicable.


(j) Cardinal Health shall supply Representatives, National Account Managers and Medical Science Liaisons with fleet vehicles for their use in performing and supervising the Detailing. Acorda shall reimburse Cardinal Health for all reasonable out-of-pocket costs and expenses ( i.e. , airline tickets and other travel expenses, hotel, rent-a-car, fuel, business meals, travel meals, etc.) of the Cardinal Health Employees to the extent directly incurred in connection with performing services pursuant to this Workplan and subject to compliance with a budget to be mutually agreed upon by Acorda and Cardinal Health for the costs and expenses referenced in this subparagraph for each Territory. Cardinal Health shall obtain prior approval for any such costs or expenses that exceed the budget.


(k) Acorda shall provide Cardinal Health with a list of Target Customers in the Territory and with data on prescriptions and sales in the Territory for Cardinal Health's use in performing this Workplan. Acorda shall also provide Cardinal Health with such other sales and marketing information concerning the Products that is obtained or prepared during the Term of this Workplan.


2.7. Orders for Products . Acorda shall be solely responsible for establishing the terms and conditions of the sale of the Products, including without limitation, the price at which the Products will be sold, whether sales of the Products will be subject to any discounts, the method of distribution of the Products, and whether any credit will be granted or refused in connection with the sale or return of any Product. Acorda shall be exclusively responsible for accepting and filling all purchase orders for the Products, billing and returns for the Products, and all other activities in connection with the sale and delivery of the Products, other than Detailing. If any Cardinal Health Employee receives an order for the Products, he/she shall immediately transmit such order to Acorda for further handling and communications with the submitter of the order, including acceptance or rejection, which shall be in Acorda's sole discretion.


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2.8 Wrongful Acts and Omissions . Each party shall notify the other in writing as promptly as practicable of any such material alleged negligent or wrongful acts or omissions on the part of any Cardinal Health Employee of which it becomes aware along with a plan to remedy such acts or omissions, and Acorda shall provide Cardinal Health with a reasonable opportunity to remedy such acts or omissions, and if indicated, to replace the involved Cardinal Health Employee(s). Cardinal Health shall be responsible for all such acts or omissions except that Acorda shall be responsible for any such acts undertaken by any Cardinal Health Employee pursuant to the express direction, and under the direct control or supervision, of Acorda or its employees.


2.9. Vacancies/Turnover . In the event of a vacancy in any Cardinal Health Employee position due to resignation, reassignment or termination of a Representative, Cardinal Health shall use its best efforts to fill any such vacancy within a nine (9) week period. Acorda shall be responsible for paying the Service Fee (as defined in Section 6.1 below) during such vacancy, unless such vacancy exceeds the nine (9) week period, in which event, the associated Service Fee for vacancy of such Representative, National Account Manager, or Medical Science Liaison shall be suspended after the nine (9) week period and shall resume once the vacancy is filled by Cardinal Health. All recruiting and other related expenses for filling a vacancy shall be borne by Cardinal Health; provided, however, that Acorda shall be responsible for all recruiting and other related expenses for filling any vacancy occurring pursuant to Acorda's request for reassignment or termination other than a request pursuant to Section 2.8, or resulting from a Cardinal Health Employee's failure to comply with any one or more of the provisions of Section 2.6. In addition, if Acorda desires to interview any candidates, Acorda shall bear its own cost of attending any final interview conducted by Cardinal Health or the costs of any separate interview arranged for by Acorda.


2.10. Management Reports . Cardinal Health shall provide Acorda with monthly reports in the form set forth in Schedule 2.10 within fifteen (15) days after the end of each month. At the request of Acorda, Cardinal Health shall furnish Acorda at reasonable times such documentation as Acorda reasonably requests for purposes of verifying the accuracy of any monthly report.


2.11. Project Manager . Cardinal Health shall appoint a Project Manager to serve as a liaison between Cardinal Health, Representatives and Acorda regarding the performance by Cardinal Health and Acorda of their respective obligations under this Workplan.


ARTICLE III TRAINING


3.1. Training Programs .


(a) Acorda shall conduct a training program (of approximately five (5) days duration) for the Cardinal Health Employees prior to the commencement of the Program, which shall include such medical and technical information about the Products and such sales training as Acorda, along with Cardinal Health, deems necessary and appropriate (the "Training


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Program"). The Training Program shall also include instruction on compliance with applicable laws. Cardinal Health shall assist Acorda with the Training Program only to the extent requested by Acorda.


(b) In order to qualify for assignment in a Territory, a Representative must demonstrate thorough knowledge of the Products by passing Acorda approved Product tests at a level of proficiency agr ...