Laboratory Services Agreement

Exhibit 10.28


CONFIDENTIAL


LABORATORY SERVICES AGREEMENT


This Laboratory Services Agreement (" Agreement") effective as of April 1, 2003 (the " Effective Date") is between Acorda Therapeutics, Inc. with an address at 15 Skyline Drive, Hawthorne, New York 10532, USA (" Acorda") and Cardinal Health PTS, Inc. with an address of 160 Magellan Labs Ct., Morrisville, North Carolina, USA (" Cardinal Health").


Acorda and Cardinal Health agree to the following terms and conditions:


1. Services .


1.1 Cardinal Health agrees to provide to Acorda the laboratory services described in Quotes identified in Exhibit A to this Agreement, relating to Acorda's Stability Study on the compound, Fampridine, and as set out in the Protocols agreed to by the parties or previously approved by Elan (the "Protocols") and on any additional exhibit as may be mutually agreed by the parties in writing and attached hereto from time to time (the " Services"). Each such exhibit shall be incorporated by reference into this Agreement and shall be subject to the terms and conditions contained herein. Cardinal Health shall use reasonable commercial efforts to perform the Services in an efficient and timely manner and in accordance with the timeframes set out in the Quotes identified in Exhibit A. Cardinal Health agrees that there shall be no deviations from the provisions of the quotes identified in Exhibit A or from the Protocols or from any instructions provided to Cardinal Health in writing by Acorda without Acorda's prior written consent. Cardinal Health further agrees that all reports generated hereunder will meet the requirements set forth in the documents identified in Exhibit A, the Protocols and this Agreement. In the event of a conflict between the terms of this Agreement and the terms set forth in any quote identified in Exhibit A, or any quote later agreed to by the parties which is subject to this Agreement, the terms of this Agreement shall control.


1.2 Unless otherwise agreed to by the parties in writing, Acorda is solely responsible to (i) provide complete and accurate scientific data regarding Acorda's requirements for the Services, (ii) provide Cardinal Health with complete and accurate information necessary to develop the scope of work, and estimated or fixed costs for the Services, (iii) review and approve all Service instructions, the Protocols and any subsequent protocol or exhibit, (iv) if applicable, prepare all submissions to regulatory authorities.


2. Payment of Fees and Expenses .


2.1 Acorda will pay Cardinal Health for the Services actually rendered by Cardinal Health at the rates specified in the Quotes identified in Exhibit A and this Agreement. Cardinal


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Health may amend such rates once annually upon written notice to Acorda. Cardinal Health will invoice Acorda post completion of each Stability Test interval or as separately agreed for services provided under this Agreement. Acorda shall pay all amounts due within thirty (30) days of receipt of Cardinal Health's itemized invoices for work completed. Acorda will pay any sales, use, gross receipts, compensating or other taxes (excluding income and franchise taxes) required to be paid by Cardinal Health as a result of the Services and any other action necessary to fulfill the terms of this Agreement. Cardinal Health will charge a late payment fee of 1.5% per month, or the maximum amount permitted by law if less than 1.5% per month, for any undisputed payment not received within thirty (30) days from receipt of invoice by Acorda. All payments shall be made in United States Dollars unless otherwise agreed. Without limiting Cardinal Health's rights under law or in equity, Cardinal Health and its affiliates, parent or related entities, collectively or individually, may exercise a right of set-off against any and all amounts due to Cardinal Health from Acorda. For purposes of this Section 2.1, Cardinal Health, its affiliates, parent or related entities shall be deemed to be a single creditor.


2.2 Cardinal Health will be responsible for discharging all payments to its staff who will be providing the Services hereunder. Unless otherwise agreed to by the parties, and except as otherwise provided in this Agreement, Cardinal Health will be responsible for procuring and paying for all equipment necessary to carry out the Services. Cardinal Health shall maintain complete and accurate records verifying time and materials expended by Cardinal Health during the provision of the Services. These records shall be available for inspection, review and audit at reasonable times by Acorda and Cardinal Health, or its duly authorized representative, during and for one year following the termination of this Agreement. In no event shall Acorda be entitled to review Cardinal Health's financial, accounting or cost records at any time.


2.3 Each stability study has a stability management fee and stability storage fee as set forth in the quotes identified in Exhibit A and agreed to by the parties. There is a minimum billable amount of $2,500 per study phase (i.e., individual stability timepoint pulls, method transfers, etc.). Rush order services may be available for certain services as agreed to by the parties. Surcharges for such rush orders typically range from 10% to 300% of the cost for the rushed service, are agreed in advance by the parties and will be quoted separately as requested by Acorda. The cost of all reference standards, specialty chemicals and supplies, and HPLC or GC columns ordered by Cardinal Health for the Services will be billed to Acorda.


2.4 All required investigational studies or additional Acorda requests not outlined in this Agreement, the Protocols or an exhibit to this Agreement will be invoiced for the cost of performance at the standard hourly rate, plus associated fees. Cardinal Health reserves the right to expend up to 16 hours per occurrence to complete all required investigational work (such as OOS investigations, troubleshooting chromatographic methods, etc.) without approval from Acorda. If the additional work requires more than 16 hours, Cardinal Health will contact Acorda prior to continuation. Additional work will be performed based on verbal agreement from Acorda and will be documented on a Cardinal Health Telephone Conversation Record (TCR).


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3. Term .


This Agreement shall commence on the Effective Date and shall continue for a period of three (3) years (the " Term"), unless mutually extended by the parties or terminated according to the terms of this Agreement.


4. Confidentiality .


The parties Agree that the Services performed hereunder and all communications in relation to such Services shall be governed by the terms of the Confidential Disclosure Agreement between Elan Corporation, Cardinal Health and Acorda, attached hereto as Exhibit B .


5. Ownership


5.1 All specimens, biological materials, data and information necessary for Cardinal Health to conduct the Services, under this Agreement, will be provided by Acorda to Cardinal Health, and shall remain the sole and exclusive property of Acorda. At all times, Acorda shall have the full and free right to use any and all information generated by Cardinal Health in the conduct of the Services ("Data") in any way deemed by Acorda to be necessary or advisable, either directly or through agents or otherwise, without payment of any compensation to Cardinal Health for same, except as herein specifically provided.


5.2 All intellectual property rights subsisting in or relating to any calculations, Data, specifications, papers, documents, any other items, material or information generated by Cardinal Health in the performance of the Services or any study are vested in Acorda, save only that Cardinal Health shall have the rights to any general material such as Standard Operating Procedures, software, and any innovative laboratory methodology or process developed in the course of the Services. Cardinal Health agrees that Acorda shall be entitled to own and control all proprietary technology and all financial, operating, training ideas, data, processes, procedures and materials, including works of expression, all copyrights, all patent rights, and all trade secret rights in such works that are developed, written, or conceived by Cardinal Health under this Agreement, to the extent that they relate to the Services or performance of the requirements of this Agreement. Cardinal Health shall promptly disclose to Acorda any such Intellectual Property, and shall make, execute and deliver any and all instruments and documents and perform any and all acts, necessary to obtain, maintain and enforce patents, trademarks and copyrights for such Intellectual Property, and shall make, execute and deliver any and all instruments and documents and perform any and all acts, necessary to obtain, maintain and enforce patents, trademarks and copyrights for such Intellectual Property as Acorda may desire in any and all countries. All costs and expenses of application and prosecution of such patents, trademarks and copyrights shall be paid by Acorda.


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6. Work Quality; Regulatory Compliance; Inspection; Other Representations and Warranties .


6.1 Cardinal Health agrees to carry out the Services and maintain records and the Data during and after the Term of this Agreement in compliance with all applicable Federal, State and local legal and regulatory requirements, including, without limitation, Guidelines issued by the International Conference on Harmonisation (" ICH/GCP"), and any requirements of the United States Food and Drug Administration (" FDA") and the United States Drug Enforcement Administration (together, " Laws"). Acorda's remedies for Cardinal Health's failure to meet the warranties set forth in this section shall be as set forth in Section 15.3.


6.2 Neither Cardinal Health nor any of Cardinal Health's employees rendering the Services pursuant to this Agreement is under investigation by the FDA for debarment action or is presently debarred pursuant to the Generic Drug Enforcement Act of 1992. Cardinal Health shall notify Acorda immediately upon any inquiry concerning or the commencement of any such proceeding concerning Cardinal Health or any such employee.


6.3 If, with respect to any study or Services provided under this Agreement any governmental or regulatory authority conducts or gives notice to Cardinal Health of its intent to conduct an inspection at Cardinal Health's facilities which are used in the performance of the Services or take any other regulatory action with respect to such facilities, Cardinal Health will promptly give Acorda notice thereof, including all information pertinent thereto.


6.4 Cardinal Health hereby represents and warrants to Acorda that performance of the Services as contemplated by this Agreement will not result in the breach or violation of any contract, arrangement or understanding which Cardinal Health may have with any third party.


6.5 Cardinal Health shall use reasonable commercial efforts and shall take all reasonable endeavours and shall take all reasonable precautions to ensure that all Data provided for the purposes of and/or resulting from the provision of the Services shall be protected against all risk of loss thereof. In addition, Cardinal Health shall warrant that all electronic Data provided hereunder is backed up onto backup media tape on a daily basis and stored in a secure off-site location.


6.6 At a minimum, all Data shall be retained by Cardinal Health for a period of ten (10) years following completion of the applicable study or such longer period as may be required by applicable Laws. Cardinal Heal ...