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Acorda Marketing Services Agreement

Effective Date: September 19, 2003
Parties:

Acorda Therapeutics, Cardinal Health

Sectors: Biotechnology / Pharmaceuticals
Governing Law:  New York
Exhibit 10.18


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.


RXPEDITE

ACORDA MARKETING SERVICES AGREEMENT


This Marketing Services Agreement (the "Agreement") is made effective as of September 19, 2003 (the "Effective Date"), by and between Cardinal Health PTS, Inc., a corporation with offices at 7000 Cardinal Place, Dublin, Ohio 43017 ("Cardinal Health") and Acorda Therapeutics, Inc., a Delaware corporation having its principal place of business at 15 Skyline Drive, Hawthorne, New York 10532 ("Client").


Background Information


A. Cardinal Health and its affiliates are engaged in the business of providing contract marketing, promotion, communication, sales and other related services to the pharmaceutical industry. Cardinal Health may perform such services directly or through one of its affiliates.


B. Cardinal Health 401, Inc. and inChord Communications, Inc. ("inChord") have together developed the RxPedite Program, pursuant to which they are able to provide pharmaceutical drug manufacturers with comprehensive outsourced marketing communications, selling and distribution/manufacturing capabilities to facilitate and enhance the commercialization of clients' pharmaceutical products.


C. Client is currently developing a product known as Fampridine SR , a therapy to improve neurological function in spinal cord injuries (the "Product"), and wishes to outsource certain commercialization services available under the RxPedite Program, as set forth in this Agreement.


Statement of Agreement


The parties hereby acknowledge the accuracy of the Background Information and agree as follows:


a71. Appointment/Exclusivity .


(a) Cardinal Health will provide medical education and sales force services to Client with respect to the Product as may be requested from time-to-time by Client and agreed to by Cardinal Health (collectively, the "Services"). Client hereby appoints Cardinal Health as the exclusive "Agency of Record" for medical education and sales force services relating to the Product and agrees that during the Term (as defined in Section 14(a)) it will not grant any other person or entity the right to provide medical education and sales force services relating to the Product anywhere in the United States; subject, however, to Section 1(b) below. In the event Client desires other commercialization services offered by Cardinal Health, such as drug development, manufacturing, storage, distribution, product return or recall, analytical or packaging services, the parties will negotiate the terms of such services in good faith.


(b) The parties acknowledge and agree that, notwithstanding any other provision of this Agreement, Client may enter into one or more collaboration or partnership agreements or other similar arrangements with third parties during the Term with respect to the


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development and commercialization of the Product (each, a "Partnering Agreement"). In any such event, Client will exercise all reasonable efforts to cause Cardinal Health to be selected as the vendor of choice for all or substantially all Services, with respect to the Product, to the extent that such Services are outsourced. If Cardinal Health is selected as the vendor for all or any portion of such Services, the parties will, if necessary, modify any then-current Workplans (as defined in Section 3(a)) including the Budgets therein, to reflect the modified Services as a result of such Partnering Agreement. If, despite the exercise by Client of all reasonable efforts to cause Cardinal Health to be selected as the vendor of choice, Cardinal Health is not selected to be the vendor of a substantial portion of the Services with respect to the Product in the United States as a result of the Partnering Agreement, then Cardinal Health will no longer be the Agency of Record for the Services relating to the Product, and either party may terminate this Agreement in accordance with the provisions of Sections 14(d) and 14(f).


a72. Services .


(a) Cardinal Health will, from time-to-time and/or upon request by Client during the Term, prepare and provide to Client, one or more proposed workplans (each, a "Proposed Workplan") outlining the specific Services that Cardinal Health proposes to perform on Client's behalf or that Client requests Cardinal Health to perform on its behalf. Such Services may include, but are not limited to: (i) recruiting and hiring specialty sales representatives appropriately qualified with the level of education and experience necessary for promoting the Product, (ii) training and maintaining specialty sales representatives for the Product, (iii) establishing a sales force of specialty sales representatives in the United States to promote the Product (the "Sales Force"), and (iv) providing medical education services.


(b) Each Proposed Workplan provided to Client pursuant to Section 2(a) will include, at a minimum, a detailed summary of the specific Services to be provided by Cardinal Health and Cardinal Health's good faith estimate of the anticipated fees and costs (a "Budget") associated with all projects ("Projects") to be undertaken by Cardinal Health under such Proposed Workplan. Client may request additional information to be included in a Proposed Workplan and Cardinal Health will use all reasonable efforts to provide such additional information. Each Proposed Workplan will be submitted for Client's approval under the procedures described in Section 3 below.


(c) Following approval by both parties of a Proposed Workplan for one or more Projects (as provided in Section 3(a)), Cardinal Health will, subject to Client's direction and instruction or any amendment of the approved Workplan in accordance with Section 7, perform or coordinate the performance of those Services that are included in such Workplan. Cardinal Health will exercise all reasonable efforts to perform the Services on a timely basis and within the Budget, and Client will exercise all reasonable efforts to assist Cardinal Health in doing so by making available to Cardinal Health all information pertaining to the Product that is necessary for Cardinal Health's performance of such Services and cooperating with Cardinal Health in expediting its review of all materials submitted by Cardinal Health for Client's approval.


(d) Cardinal Health will perform the Services under this Agreement through various affiliates of Cardinal Health. During the Term, Cardinal Health agrees that the specific


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Cardinal Health affiliates providing Services to Client under this Agreement will refrain from providing medical education and sales force services for any product that competes against the Product and has substantially the same indication as the Product, without first obtaining Client's written consent, which shall not be unreasonably withheld. For purposes of clarification, the foregoing restriction shall not restrict any Cardinal Health affiliate which is not providing Services to Client under this Agreement from providing medical education and sales force services to any other customer for products that compete against the Product.


a73. Client Approval .


(a) Each Proposed Workplan submitted to Client by Cardinal Health in Section 2 is subject to the review and written approval of Client prior to the time Cardinal Health or any of its affiliates incur liability to third parties in connection with the Projects contained in such Proposed Workplan. Once a Proposed Workplan is approved by both parties, such approved workplan shall be referred to as a "Workplan," and it shall govern the performance for Client of the Services covered by such Workplan. For clarity, neither Cardinal Health nor its affiliates will perform any Services or incur any expenses with respect to such Services, and Client will not be obligated to pay for any Services, except in accordance with a Workplan that has been approved by Client.


(b) All drafts of any proposed journal advertisements, training materials, media copy, advertisements or other promotional material used to promote the Product (collectively, the "Promotional Material") will be submitted to Client for review at least two (2) weeks prior to publication or use whenever practicable ; provided, however, that the arties understand and agree that such two (2) week period will necessarily be shortened from time to time to reflect special deadlines and circumstances not within the reasonable control of Cardinal Health. Client shall be solely responsible for reviewing and approving the content of all Promotional Material and related Services prior to use of such Promotional Material and performance of related Services to make certain that all content in such Promotional Material and any and all related Services comply with all federal, state and local laws and all applicable industry standards and practices generally applicable to Cardinal Health's and Client's industry, including, without limitation, any applicable research guidelines, ethics and standards established by the American Medical Association, the Food and Drug Administration ("FDA"), the standards and guidelines outlined in the PhRMA Code, the standards and guidelines outlined in the Office of Inspector General (OIG) Guidance, and the Federal Food, Drug and Cosmetic Act and the regulations promulgated thereunder (collectively, "Laws"). Client hereby acknowledges that Cardinal Health shall not conduct a legal review of the content of the Promotional Materials and/or related Services and that Cardinal Health is relying solely on Client to make certain that the content of Promotional Material and related Services comply with all Laws. Cardinal Health will ensure that the content of the final copy of Promotional Material and related Services is identical to the draft content of such Promotional Material and related Services as approved by Client.


(c) Client will have the right to make any editorial changes it desires prior to publication or use, with any charge for such change to be consistent with the budget procedures outlined in Section 3(d) below; provided, however, that Client must notify Cardinal Health in writing of either its approval or disapproval and/or required editing of Promotional Material as


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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.


promptly as practicable, but in no event less than forty-eight (48) hours prior to the planned publication or use.


(d) The initial Budget for a specific Project included in a Workplan will necessarily include fee and cost estimates based upon initial concepts and preliminary estimates, and Cardinal Health will be authorized to commence work and incur expenses on that particular Project based upon Client's approval of the Workplan containing such initial Budget and up to an amount not to exceed [* * *] of the fees and costs in such approved Budget. Cardinal Health will submit a revised Budget to Client at any time during performance of a Project if fees and costs for such Project are anticipated to exceed the initial Budget by more than [* * *], and this revised estimate must be approved by Client in writing before work on such Project continues. Once final concepts for a Project are approved and final fee and cost estimates can be obtained, Cardinal Health will submit a final Budget for Client's written approval if the initial Budget needs to be increased by more than [* * *] as a result of such final cost estimates. Cardinal Health will use all reasonable efforts to complete the Services within the approved Budget. In the case where, despite such efforts, cost estimates to complete the Services exceed the initial Budget by more than [* * *], Cardinal Health agrees to negotiate with Client in good faith a revised Budget that is acceptable to both parties. In any event, Client's written approval is required prior to any increase of the Budget for a Project by more than [* * *] from the initial Budget and for any further increases thereafter.


a74. Joint Commercialization Committee . Promptly following the Effective Date, a joint commercialization committee (the "Committee") will be formed consisting of an equal number of representatives, such number to be mutually agreed by the parties, from each of Client, Cardinal Health, and inChord. Each party may replace any of its representatives at any time, and from time to time, by giving written notice to the other party. The Committee will be chaired by a Client representative, and the Committee will meet at such locations as reasonably determined by the chair to discuss and coordinate the overall marketing and sales strategy for the Product, relevant Workplans and Budgets therein associated with the Product, and any other relevant topics relating to the commercialization of the Product. The Committee will convene at least four (4) times annually or more frequently as the parties deem necessary and meetings may be held by audio or video teleconference, with the consent of each party; provided that at least one (1) meeting per calendar year shall be held in person. The parties agree that the purpose of the Committee is solely to provide a forum for the parties to discuss, monitor and coordinate activities and communications relating to the performance of the Services and provide recommendations relating thereto to the parties. The Committee does not have the authority to approve or modify Workplans or Budgets, or to amend this Agreement.


a75. Cardinal Health Compensation . In consideration for the Services that are rendered to Client under this Agreement, Cardinal Health will invoice Client and Client will pay Cardinal Health as follows:


(a) As compensation for performance by Cardinal Health and its affiliates of the Services, Client will pay a fee (the "Cardinal Health Fee") for each Project as specified in the approved Budget for such Project. Such Cardinal Health Fee for the Services performed in a particular month will be determined as follows:


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(i) Total fees for such Services shall be calculated based on the applicable Cardinal Health and its affiliates' rates as set forth in the applicable Budget; and


(ii) Such total fees then shall be reduced by the amount (if any) of the pre-determined discount amount to which Client is entitled (any such discount, a "Discount Amount"), where such Discount Amount will be determined as described in the Discount Matrix attached as Exhibit A, and such discounted fees shall be the "Cardinal Health Fee" for such Project for such month.


(b) The Cardinal Health Fee for each Project will be invoiced to Client by Cardinal Health on a monthly basis promptly after the beginning of each month as specified in the approved Budget, and Client will pay each such invoice within thirty (30) days of receipt thereof. Each such invoice will specify with reasonable detail all the charges for Services, and the basis for any Discount Amount used in arriving at the Cardinal Health Fee.


(c) All Discount Amounts actually allowed will be aggregated and, if applicable, paid to Cardinal Health by Client in accordance with the terms and conditions contained in the Discount Payment Matrix attached as Exhibit B.


(d) Client will reimburse Cardinal Health for actual, verifiable costs incurred for obtaining from third parties any printing, photography, market research, selling aids, direct mail, reference material, color graphic reproductions, exhibit panels, honoraria, conference/meeting expenses and other products, services and supplies purchased by Cardinal Health on behalf of Client for a Project under this Agreement ("Client Reimbursable Expenses") without Cardinal Health mark-up, provided, however, that the aggregate costs for such Client Reimbursable Expenses are included in the Budget of the relevant Workplan approved in advance by Client and is subject to the provisions of Section 3(d) with respect to any increase in such costs. Fifty percent (50%) of the estimated Client Reimbursable Expenses for each Workplan (as set forth in the applicable Budget) will be invoiced by Cardinal Health upon Client's approval of the Workplan, and the balance of the Client Reimbursable Expenses will be invoiced on a monthly basis after such initial advance payment has been fully credited against actual costs incurred (as shown by invoices provided and credits shown), as such expenses are incurred by Cardinal Health, or as otherwise agreed to by the parties as specified in the Budget. Client will pay each such invoice within thirty (30) days of receipt thereof.


(e) Client will reimburse Cardinal Health for its reasonable, verifiable travel expenses (including, without limitation, transportation, lodging and meals), fax, photocopying, telephone, overnight or other delivery, postage, shipping and other expenses associated with the performance of Services under this Agreement ("Out-of-Pocket Expenses"), without any Cardinal Health mark-up. An estimate of the Out-of-Pocket Expenses for each Project shall be included in the Budget of the relevant Workplan approved in advance by Client and is subject to the provisions of Section 3(d) with respect to any increase in such expenses. Out-of-Pocket Expenses will be invoiced by Cardinal Health on a monthly basis, as incurred, and Client will pay each such invoice within thirty (30) days of receipt thereof.


(f) Sales, use and other taxes will be included in the Budget and reimbursed by Client in a similar manner to other expenses associated with each Project; provided, however,


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that Cardinal Health will be responsible for all federal, state and local taxes imposed on Cardinal Health's income or in connection with the employment of Cardinal Health's full or part-time employees.


a76. Payment Terms . Cardinal Health will submit invoices to Client on a monthly basis or as otherwise agreed by the parties in writing. Payment terms will be net thirty (30) days from the date of the receipt, with interest accruing on any late payment at the rate of one and one-half percent (1.5%) per month until paid. Cardinal Health will provide Client with appropriate supporting detail with each invoice to allocate expenses by Project and the specific activities undertaken in such Project. All payments due under Section 5 will be made payable to: the Cardinal Health entity named on the relevant invoice and mailed to the address set forth on such Cardinal Health invoice. Client and Cardinal Health will meet periodically to review projected fees and costs compared to actual fees and costs on all Projects, and appropriate adjustments will be made to Workplans as necessary from time to time to reflect mutually approved changes in the scope of the work to be performed.


a77. Amending Workplans . Subject to the terms of this Section 7, Client reserves the right to modify or cancel any previously approved Workplan. In such event, Cardinal Health will promptly take all reasonable steps necessary or appropriate to carry out Client's instructions; provided, however, that Client will continue to be responsible for paying Cardinal Health for (a) all work performed and expenses incurred prior to Cardinal Health's receipt of notification of such change, provided that such work and expenses were incurred by Cardinal Health on Client's behalf in accordance with the relevant Workplan approved by Client, (b) all non-cancelable commitments incurred by Cardinal Health prior to its receipt of notification of such change, provided that such commitments were incurred by Cardinal Health on Client's behalf in accordance with the relevant Workplan approved by Client, (c) all expenses incurred by Cardinal Health in carrying out Client's revised instructions, and (d) any other cancellation or other similar fees specifically agreed to by the parties in a Workplan, if any. Notwithstanding the foregoing, Client may not modify or cancel Projects in a fashion that would be inconsistent with Agency's role as the exclusive "Agency of Record" under Section 1.


a78. Ownership of Technology; Work Made For Hire . Client will maintain ownership and maintenance of the NDA, all clinical/scientific data and any other information related to the Product.


(a) Work Product. Cardinal Health agrees and acknowledges that, unless otherwise agreed to by the parties in a Workplan, Client will own all right, title and interest in and to all ideas, artwork, illustrations, audiovisual works, audio recordings, images, photographs, video, graphics, multimedia works, on-line products, sounds, text, notes, sketches, drawings, reports, inventions and Promotional Material, whether patentable or copyrightable, or other copyrightable works conceived or created by Cardinal Health or Cardinal Health's affiliates or third party subcontractors in the course of performing the Services pursuant to this Agreement and which are accepted and paid for by Client (collectively, the "Work Product"). Such Work Product will be deemed "works made for hire," and in any event, Cardinal Health hereby assigns to Client, and shall cause its affiliates and subcontractors (as applicable) to assign to Client, all right, title and interest in and to such Work Product and all intellectual property rights related thereto. If Work Product is lost, damaged, or destroyed while in Cardinal Health's custody or


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control, Cardinal Health will be liable to Client for the replacement cost of such Work Product. Upon Client's request at any time during the Term or thereafter, Cardinal Health will promptly transfer all Work Product to Client.


(b) Brand Features. Subject to retained third party rights disclosed to Client in advance in accordance with Section 9, all trademark(s), trade name(s), logo(s), slogan(s), and advertising plan(s) that are created by Cardinal Health and/or its affiliates for Client and which are accepted and paid for by Client under this Agreement (the "Brand Features") will be the property of Client and regarded as "works made for hire." Cardinal Health will not adopt, suggest or recommend the use of any Promotional Material or Brand Feature of which Cardinal Health knows, or in the exercise of reasonable diligence, should know, is identical to or confusingly similar to that being used by a third party. Cardinal Health hereby assigns to Client, and shall cause its affiliates and subcontractors (as applicable) to assign to Client, all of its rights, title and interest to such items, together with all of the goodwill associated therewith, subject only to reserved third party rights.


(c) Further Acts. Cardinal Health and its affiliates shall cooperate with Client or its designee(s), both during and after the Term, to execute such documents and take such other actions as Client deems necessary for Client to obtain ownership and to apply for, secure, and maintain copyright, trademark or other proprietary protection of Work Product and Brand Features in the United States and/or worldwide. Cardinal Health will not be responsible for initiating any such application, but will cooperate with Client as reasonably requested. Client will pay or reimburse Cardinal Health for any out-of-pocket expenses associated with such cooperation. If Client is unable for any reason to secure Cardinal Health's signature to any document required to apply for or execute any copyright, trademark or other applications with respect to an ...

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Agreement#: AG-463220
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