Common use of DEVELOPMENT OF THE PRODUCT Clause in Contracts

DEVELOPMENT OF THE PRODUCT. 3.1. Subject to the provisions of this Article 3, Acorda shall use its reasonable efforts, as would be deemed commensurate with the achievement of its own business aims for a similar product of its own to conduct such part of the Project as the Parties mutually agree shall be conducted by Acorda. Subject to the provisions of this Article 3, Elan shall use its reasonable efforts, as would be deemed commensurate with the achievement of its own business aims for a similar product of its own, to conduct such part of the Project as the Parties mutually agree that shall be conducted by Elan. The allocation between the Parties of their respective responsibilities for conducting parts of the Project (i) is set forth in Schedule 9 - Technology Transfer Responsibilities, and (ii) shall be set forth in a development plan (the “Development Plan”) to be prepared and updated from time to time by Acorda in consultation with Elan, relating to the development of the Product, the current form of which is attached as Schedule 4 - NDA Timeline, and the Committee shall monitor the progress of such activities. Elan and Acorda each undertake that it shall carry out the respective studies, testing and activities set forth as Technology Transfer Responsibilities, in the Development Plan, and otherwise undertaken and conducted by it in good faith and in accordance with prevailing cGCP and cGLP and FDA standards and guidelines. 3.2. Provided that Elan uses reasonable endeavours to meet its obligations under this Agreement, Elan shall have no liability to Acorda as a result of any failure or delay of the Product to achieve one or more of the milestones set out in the Project and/or to obtain the NDA Approval or the approval of the regulatory authorities in one or more of the other countries of the Territory. Acorda shall have no liability to Elan as a result of any failure or delay of the Product to obtain the NDA Approval or the approval of the appropriate health regulatory authorities in one or more of the countries of the Territory. 3.3. The Parties hereby confirm that each shall undertake its respective part of the Project as a collaborative effort and that the provisions of this Agreement requires that each Party diligently carries out those tasks assigned to it under the Project and as otherwise agreed during the course of the Project. Each Party shall co-operate with the other in good faith particularly with respect to unknown problems or contingencies and shall perform its obligations in good faith and in a commercially reasonable, diligent and workmanlike manner. Each Party will update the other Party on the progress of the Project at meetings of the Committee. 3.4. Elan will supply Acorda with Acorda’s reasonable requirements of Product including clinical trial supplies to enable Acorda to carry out the Project. The Product shall be supplied by Elan EXW at Manufacturing Cost. 3.5. Acorda agrees to carry out and complete the Phase III programme in the United States of America to a standard and timeframe that a company of comparable size, stage of development and assets would use for a product of similar size and potential as the Product. 3.6. With respect to generating stability data on the oral Product in bulk tablet form, Elan and Acorda acknowledge and agree that (i) under the SCI Agreement and the MS Agreement, Elan had the responsibility for generating such data, (ii) pursuant to the Cardinal Agreement, Cardinal is currently performing such stability testing, (iii) the Technology Transfer Responsibilities shall govern the related responsibilities of the Parties, provided that the data resulting from such stability testing shall be provided to both Acorda and Elan, and Elan shall have the right to and responsibility for providing necessary and appropriate technical assistance and oversight of such stability testing (including having the right at its own expense to arrange for its employees involved in the Project to discuss the stability testing and its results with the technical personnel of Acorda and Cardinal upon reasonable notice and at reasonable times); and (iv) Elan shall incorporate such stability data into the CMC module that it will prepare for delivery to Acorda for inclusion in the NDA or any NDA Equivalent, pursuant to Article 3.8. 3.7. For the avoidance of doubt, the Parties hereby confirm that a primary objective of the Project is to generate the NDA and secure NDA Approval for the oral Product. As of the date of the SCI Agreement, the MS Agreement and the Amendment Date, it is the Parties’ expectation that the body of data so generated in the Project will also support such applications for Regulatory Approval that Acorda shall make in the other countries of the Territory. In the event however that such expectation proves unfounded or incorrect and further data is required to obtain such other approvals as are pursued by Acorda in the other countries of the Territory, Acorda shall determine the viability of proceeding further with the regulatory application and generation of the further data requirements. In the event that Acorda elects to continue, the Parties shall update the Development Plan to reflect the allocation between the Parties of conducting such additional activities. In such event, subject to and in accordance with the provisions of this Article 3, Elan shall be responsible for conducting such further activities and generating such further data as set forth in the Development Plan to allow Acorda to seek such further Regulatory Approvals in the Territory. Notwithstanding the foregoing, it is intended by the Parties that except as otherwise specifically set forth in a Development Plan agreed to by the Parties and subject to compliance with regulatory requirements, Acorda shall have primary responsibility and decision making authority with respect to development and marketing of Product. 3.8. Elan shall be responsible for the preparation and delivery to Acorda of the CMC Section in electronic and hard copy form and the latter in format suitable for inclusion in the NDA and any NDA Equivalent in accordance with applicable law and regulatory standards and as the Parties may mutually agree. Acorda shall provide Elan as soon as practicable with a copy of any comments received by Acorda from the FDA or any other regulatory authority relating to the CMC Section and Elan shall provide or, at Acorda’s request, cooperate with Acorda to provide, a response to such comments as soon as practicable. In the event that there is a deficiency in the CMC Section attributable to negligence by Elan in the activities conducted by Elan, then Elan shall be responsible for correcting such deficiency, at Elan’s expense, and shall use reasonable efforts to do so as soon as practicable. In the event Elan breaches the foregoing obligation, in addition to any other remedies available to Acorda, Acorda shall have the right to correct such deficiency or arrange to have a Third Party conduct any required activities necessary to correct such deficiency, at Elan’s expense, the cost of which may be offset against any amounts otherwise due Elan under this Agreement. Acorda shall be responsible for the maintenance of the CMC Section in accordance with applicable law and regulatory standards, at Acorda’s expense, provided that (i) Elan shall cooperate with and provide reasonable assistance to Acorda in connection with such maintenance; and (ii) any revisions, amendments or supplements to the CMC Section required by or resulting from the negligence of Elan in performing its obligations hereunder or under the Supply Agreement, or from any action taken by Elan on its own initiative, or taken by Acorda or any Acorda Designee on behalf of or at the request of Elan, including any changes made by Elan on its own initiative to its manufacturing processes or facilities, shall be at Elan’s expense; and (iii) Elan shall not make any changes to its manufacturing processes or facilities that would require an amendment or supplement to the CMC Section without first notifying Acorda of such changes and preparing and delivering to Acorda any required amendments or supplements to the CMC Section before the implementation of such changes. If Elan is required in any regulatory jurisdiction to file with any regulatory authority a DMF relating to Compound or Product, Elan shall at Acorda’s cost prepare and file in accordance with applicable regulatory requirements such DMF and Acorda shall have a right of reference thereto to the extent required by the NDA or any NDA Equivalent or in order to exercise its license rights under this Agreement. Similarly, if Elan is entitled to market, distribute and sell the Product in a particular country, and Acorda is required in any regulatory jurisdiction to file with any regulatory authority a DMF relating to Compound or Product, Acorda shall at Elan’s cost prepare and file in accordance with applicable regulatory requirements such DMF and Elan shall have a right of reference thereto to the extent required by the NDA or any NDA Equivalent or in order to exercise its rights under this Agreement.

DEVELOPMENT OF THE PRODUCT. 3.1. Subject to 2.1 During the provisions Term of this Article 3, Acorda shall use its reasonable efforts, as would be deemed commensurate with the achievement of its own business aims for a similar product of its own to conduct such part of the Project as the Parties mutually agree shall be conducted by Acorda. Subject to the provisions of this Article 3, Elan shall use its reasonable efforts, as would be deemed commensurate with the achievement of its own business aims for a similar product of its own, to conduct such part of the Project as the Parties mutually agree that shall be conducted by Elan. The allocation between the Parties of their respective responsibilities for conducting parts of the Project Agreement, (i) is IMI will work with XxXXXX as herein set out in a collaborative alliance to develop and optimize the Products in accordance with the terms set forth in Schedule 9 - Technology Transfer Responsibilities, and herein; and (ii) XxXXXX will use commercially reasonable efforts to then commercialize the Products in the Field in the Territory in accordance with all Applicable Laws and the terms set forth herein. At XxXXXX’x expense, IMI agrees to conform the Product, including but without limitation the software, to reflect XxXXXX’x trademarks and commercially reasonable packaging, product format and labeling Specifications. Notwithstanding anything contained in this Agreement, IMI may, but shall not have the obligation, to develop any Product other than the Palm Test and the Tape Test, but may have the option to so develop other Products upon the mutual written agreement of the Parties. 2.2 As soon as reasonably practicable after the Effective Date, IMI shall: a) furnish XxXXXX with all copies of standard operating procedures (SOP’s) relating to Licensed Technology presently in IMI’s possession that it is free to disclose; and b) provide XxXXXX with access throughout the Term to any other information regarding manufacture of the Product that it is free to disclose. IMI shall keep XxXXXX reasonably informed during the Term of all material technical data, development, and improvements (including Improvements) within IMI’s Licensed Technology. After the receipt of Regulatory Approval from the FDA for a given Product, there shall be set forth in no change, improvement, or modification to that Product, or any component thereof, implemented or made by IMI without the prior written notification to and approval of XxXXXX. IMI further agrees that, after the receipt of Regulatory Approval from the FDA for a development plan (the “Development Plan”) to be prepared and updated from time to time by Acorda in consultation with Elangiven Product, relating no changes or modifications to the development method or process of manufacture or production of the Product, or any component thereof or raw material therefor, shall be made without prior written notification to and approval of XxXXXX. IMI and XxXXXX will further be provided with an opportunity to review all results of studies performed on each Product, including but not limited to the current form results of which is attached as Schedule 4 - NDA Timelinethe Clinical Trials that may be conducted on the Product in the Commercial Clinical Program and the Regulatory Clinical Program, and provide comments to each other regarding the Committee same. 2.2.1 IMI shall monitor be responsible for completing, managing and otherwise conducting all Clinical Trials on the progress Palm Test and the Tape Test for purposes of such activities. Elan and Acorda each undertake that it shall carry out the respective studies, testing and activities set forth as Technology Transfer Responsibilities, seeking Regulatory Approval thereon in the Development PlanU.S., European Union, and otherwise undertaken and conducted any other countries within the Territory during the Term as agreed upon by it in good faith and the Parties at IMI’s sole expense in accordance with prevailing cGCP the terms hereof, and cGLP shall further file and FDA standards own any such Registration or permit regarding the Product in the U.S., European Union, and guidelinesany such other countries agreed upon by the Parties at IMI’s sole expense (the "Regulatory Clinical Program".) IMI shall use Diligent Efforts to gain Regulatory Approval for the Tape Test for marketing in the United States within ***** (*****) years of the Effective Date. 3.22.2.2 For the period commencing on the date hereof and terminating on the fourth Year anniversary of the date hereof, IMI will use Diligent Efforts to conduct additional Clinical Trials, which are other than the Clinical Trials set forth with respect to the Regulatory Clinical Program, (the "Commercial Clinical Program") on the Palm Test Product and the Tape Test Product in such manner as agreed upon by IMI and XxXXXX in writing from time to time, the purpose of which shall be to provide data to support marketing objectives of XxXXXX relating to Products. Provided that Elan uses reasonable endeavours . Notwithstanding anything contained herein, XxXXXX and its Affiliates, at their sole discretion, shall be entitled to conduct their own additional Clinical Trials, which are other than the Clinical Trials performed with respect to the Commercial Clinical Program, on the Product at their own expense. The obligations of IMI pursuant to this subsection 2.2.2 shall terminate on the fourth anniversary of the Effective Date. 2.3 IMI shall, subject to the time limits set out in Section 2.2.2, bear all of its costs related to the Regulatory Clinical Program (as set forth in Section 2.2.1) and the Commercial Clinical Program (as set forth in Section 2.2.2), to meet Specifications mutually agreed upon by IMI and XxXXXX. Except as may otherwise be provided herein, the maximum cost to IMI of fulfilling its obligations under subsection 2.2.2 shall not, in a given Calendar Year, exceed ***** of XxXXXX’x aggregate worldwide Net Sales of the Product(s) in the immediately preceding Calendar Year (the "CCP Amount"), and XxXXXX shall bear all additional costs in excess of the CCP Amount in that same Calendar Year so long as such additional costs have been previously agreed upon by XxXXXX for that Calendar Year prior to commencing the Clinical Study at issue pursuant to the Commercial Clinical Program in accordance with this section 2.3. For greater certainty, IMI shall not be in breach of its obligations under this Agreement, Elan shall have no liability section 2.3 if compliance would require IMI to Acorda as a result of any failure or delay expend more than such CCP Amount. Notwithstanding the generality of the Product foregoing, prior to achieve one or more of the milestones set out in the Project and/or to obtain the NDA Approval or the approval of the regulatory authorities in one or more of the other countries of the Territory. Acorda shall have no liability to Elan as commencing a result of any failure or delay of the Product to obtain the NDA Approval or the approval of the appropriate health regulatory authorities in one or more of the countries of the Territory. 3.3. The Parties hereby confirm that each shall undertake its respective part of the Project as a collaborative effort and that the provisions of this Agreement requires that each Party diligently carries out those tasks assigned to it under the Project and as otherwise agreed during the course of the Project. Each Party shall co-operate with the other in good faith particularly with respect to unknown problems or contingencies and shall perform its obligations in good faith and in a commercially reasonable, diligent and workmanlike manner. Each Party will update the other Party on the progress of the Project at meetings of the Committee. 3.4. Elan will supply Acorda with Acorda’s reasonable requirements of Product including clinical trial supplies to enable Acorda to carry out the Project. The Product shall be supplied by Elan EXW at Manufacturing Cost. 3.5. Acorda agrees to carry out and complete the Phase III programme in the United States of America to a standard and timeframe that a company of comparable size, stage of development and assets would use Clinical Study for a product Commercial Clinical Program, IMI shall provide a written report to the JSC that sets forth, at a minimum: a) an estimate of similar size and potential as the Product. 3.6. With respect to generating stability data on the oral Product in bulk tablet form, Elan and Acorda acknowledge and agree all planned expenditures for activities that (i) under the SCI Agreement and the MS Agreement, Elan had the responsibility for generating such data, (ii) may be performed pursuant to the Cardinal Agreement, Cardinal is currently performing such stability testing, (iii) the Technology Transfer Responsibilities shall govern the related responsibilities of the Parties, provided that the data resulting from such stability testing shall be provided to both Acorda and Elan, and Elan shall have the right to and responsibility for providing necessary and appropriate technical assistance and oversight of such stability testing Clinical Study (including having the right at its own expense to arrange for its employees involved any costs that may be incurred by IMI hereunder in the Project to discuss the stability testing and its results connection with the technical personnel of Acorda and Cardinal upon reasonable notice and at reasonable timessuch Clinical Study); and b) a schedule of when the payments of such costs will become due (iv) Elan the "CCP Budget"). IMI agrees to use Diligent Efforts to fully and accurately disclose to XxXXXX all information required to be set forth on the CCP Budgets. IMI shall incorporate such stability data into update and revise each CCP Budget for ongoing Commercial Clinical Programs during the CMC module that it first Fiscal Quarter of each Calendar Year. IMI will prepare for delivery to Acorda for inclusion in the NDA or any NDA Equivalent, not commence work pursuant to Article 3.8. 3.7. For any new Clinical Study for a Commercial Clinical Program, and will not subsequently continue such work after the avoidance first Fiscal Quarter of doubteach Calendar Year thereafter, without first receiving the Parties hereby confirm that a primary objective of the Project is to generate the NDA and secure NDA Approval JSC’s written approval for the oral Product. As of CCP Budget therefor (the date of the SCI Agreement, the MS Agreement and the Amendment Date, it is the Parties’ expectation that the body of data so generated in the Project will also support such applications for Regulatory Approval that Acorda shall make in the other countries of the Territory"Approved CCP Budget"). In the event however that, for a given Calendar Year, the actual costs incurred for a Commercial Clinical Program exceed the maximum CCP Amount that such expectation proves unfounded or incorrect and further data IMI is required to obtain spend for that Calendar Year, then XxXxxx agrees to pay all costs associated with such other approvals study that exceed the CCP Amount for that Calendar Year (the "Excess CCP Costs") so long as are pursued such Excess CCP Costs were previously approved by Acorda in the other countries of the Territory, Acorda shall determine the viability of proceeding further with the regulatory application and generation of the further data requirements. In the event JSC for that Acorda elects to continue, the Parties shall update the Development Plan to reflect the allocation between the Parties of conducting such additional activities. In such event, subject to and in accordance with the provisions of this Article 3, Elan shall be responsible for conducting such further activities and generating such further data Calendar Year as set forth in the Development Plan Approved CCP Budget. If the Excess CCP Costs exceeded the total amount of the Approved CCP Budget, then IMI and XxXXXX agree to allow Acorda to seek such further Regulatory Approvals equally share in the Territorypayment of such excess amounts. 2.4 Either IMI or XxXXXX may suggest changes to the scope, activities, direction or sequence of the research and development on the Products, including without limitation product design goals, specifications, and schedules, which shall be effected upon mutual agreement of the Parties, all of which shall be dealt with by the Joint Steering Committee, subject to the provisions of Section XVIII. 2.5 Any intellectual property rights, including without limitation, patents, patent applications, inventions, and know-how (hereinafter referred to as "Intellectual Property") owned or controlled by either Party prior to the Parties’ entering into this Agreement shall remain the property of such Party, subject only to the rights and licenses granted herein. 2.5.1 Any Intellectual Property that is first conceived and first reduced to practice during the Term of this Agreement solely by personnel employed by or on behalf of IMI shall remain the property of IMI, subject to the rights and licenses granted herein. 2.5.2 Any Intellectual Property that is first conceived and first reduced to practice during the Term of this Agreement solely by personnel employed by or on behalf of XxXXXX shall remain the property of XxXXXX, subject to the rights and licenses granted herein. 2.5.3 Any Intellectual Property that is first conceived or first reduced to practice during the Term of this Agreement by personnel employed by or on behalf of XxXXXX and personnel employed by or on behalf of IMI (other than the Intellectual Property described in Section 2.5.1 and Section 2.5.2) shall remain the joint property of IMI and XxXXXX, subject to the rights and licenses granted herein ("Joint Intellectual Property"). The Parties agree to keep the Joint Intellectual Property in confidence and not to publicly disclose the same except in accordance with Section XV. Notwithstanding the foregoing, it is intended by the Parties agree that except as otherwise specifically set forth in a Development Plan agreed to by the Parties and subject to compliance with regulatory requirements, Acorda shall have primary responsibility and decision making authority with respect to development and marketing of Product. 3.8. Elan shall be responsible for the preparation and delivery to Acorda of the CMC Section in electronic and hard copy form and the latter in format suitable for inclusion in the NDA and any NDA Equivalent in accordance with applicable law and regulatory standards and as the Parties may mutually agree. Acorda shall provide Elan as soon as practicable with a copy of any comments received by Acorda from the FDA or any other regulatory authority Intellectual Property relating to the CMC Section Palm Test and Elan the Tape Test, which is conceived and reduced to practice on or before the Effective Date of this Agreement shall provide ornot constitute Joint Intellectual Property, but shall be deemed to be part of the Licensed Technology. 2.5.4 Any Intellectual Property which is owned or controlled, either in whole or in part, by IMI during the Term of this Agreement and acquired or developed after the Effective Date shall be added to the Licensed Technology to the extent that the Intellectual Property is relevant to the manufacture, use, sale or Registration of the Products, ("IMI Improvement Intellectual Property") (and, for greater certainty, the IMI Improvement Intellectual Property shall not include the Intellectual Property identified on Appendix H as at Acorda’s request, cooperate with Acorda to provide, a response to such comments as soon as practicable. the date hereof). 2.6 In the event that there is a deficiency published patent application or a granted patent results from the IMI Improvement Intellectual Property, such patent application(s) and patent(s): a) shall be included in the CMC Section attributable Licensed Patents so long as such patent application(s) and patent(s) are relevant to negligence by Elan in the activities conducted by Elanmanufacture, then Elan use, sale or Registration of the Products, and b) shall be responsible added to Appendix G, which is attached hereto and made a part hereof, within thirty (30) days of filing or grant, whichever is applicable. Otherwise, for correcting such deficiency, at Elan’s expense, and shall use reasonable efforts to do so as soon as practicable. In the event Elan breaches the foregoing obligation, in addition to any other remedies available to Acorda, Acorda shall have the right to correct such deficiency or arrange to have a Third Party conduct any required activities necessary to correct such deficiency, at Elan’s expense, the cost purposes of which may be offset against any amounts otherwise due Elan under this Agreement. Acorda , such IMI Improvement Intellectual Property relating to the manufacture, use, sale or registration of the Product shall be responsible for regarded as Licensed Know How. 2.7 IMI shall update and amend the maintenance list of patent applications and patents within the CMC Section Licensed Patents as set forth in accordance with applicable law Appendix H and regulatory standards, at Acorda’s expense, provided that Appendix G no less frequently than one (i1) Elan shall cooperate with and provide reasonable assistance to Acorda in connection with such maintenance; and (ii) any revisions, amendments or supplements to the CMC Section required by or resulting from the negligence of Elan in performing its obligations hereunder or under the Supply Agreement, or from any action taken by Elan on its own initiative, or taken by Acorda or any Acorda Designee on behalf of or at the request of Elan, including any changes made by Elan on its own initiative to its manufacturing processes or facilities, shall be at Elan’s expense; and (iii) Elan shall not make any changes to its manufacturing processes or facilities that would require an amendment or supplement to the CMC Section without first notifying Acorda of such changes and preparing and delivering to Acorda any required amendments or supplements to the CMC Section before the implementation of such changes. If Elan is required in any regulatory jurisdiction to file with any regulatory authority a DMF relating to Compound or Product, Elan shall at Acorda’s cost prepare and file in accordance with applicable regulatory requirements such DMF and Acorda shall have a right of reference thereto to the extent required by the NDA or any NDA Equivalent or in order to exercise its license rights under this Agreement. Similarly, if Elan is entitled to market, distribute and sell the Product in a particular country, and Acorda is required in any regulatory jurisdiction to file with any regulatory authority a DMF relating to Compound or Product, Acorda shall at Elan’s cost prepare and file in accordance with applicable regulatory requirements such DMF and Elan shall have a right of reference thereto to the extent required by the NDA or any NDA Equivalent or in order to exercise its rights under this Agreementtime per Calendar Year.

DEVELOPMENT OF THE PRODUCT. 3.1. Subject to the provisions of this Article 3, Acorda shall use its reasonable efforts, as would be deemed commensurate with the achievement of its own business aims for a similar product of its own to conduct such part of the Project as the Parties mutually agree shall be conducted by Acorda. Subject to the provisions of this Article 3, Elan shall use its reasonable efforts, as would be deemed commensurate with the achievement of its own business aims for a similar product of its own, to conduct such part of the Project as the Parties mutually agree that shall be conducted by Elan. The allocation between the Parties of their respective responsibilities for conducting parts of the Project (i) is set forth in Schedule 9 - Technology Transfer Responsibilities, and (ii) shall be set forth in a development plan (the “Development Plan”) to be prepared and updated from time to time by Acorda in consultation with Elan, relating to the development of the Product, the current form of which is attached as Schedule 4 - NDA Timeline, and the Committee shall monitor the progress of such activities. Elan and Acorda each undertake that it shall carry out the respective studies, testing and activities set forth as Technology Transfer Responsibilities, in the Development Plan, and otherwise undertaken and conducted by it in good faith and in accordance with prevailing cGCP and cGLP and FDA standards and guidelines. 3.2. Provided that Elan uses reasonable endeavours to meet its obligations under this Agreement, Elan shall have no liability to Acorda as a result of any failure or delay of the Product to achieve one or more of the milestones set out in the Project and/or to obtain the NDA Approval or the approval of the regulatory authorities in one or more of the other countries of the Territory. Acorda shall have no liability to Elan as a result of any failure or delay of the Product to obtain the NDA Approval or the approval of the appropriate health regulatory authorities in one or more of the countries of the Territory. 3.3. The Parties hereby confirm that each shall undertake its respective part of the Project as a collaborative effort and that the provisions of this Agreement requires that each Party diligently carries out those tasks assigned to it under the Project and as otherwise agreed during the course of the Project. Each Party shall co-operate with the other in good faith particularly with respect to unknown problems or contingencies and shall perform its 17 obligations in good faith and in a commercially reasonable, diligent and workmanlike manner. Each Party will update the other Party on the progress of the Project at meetings of the Committee. 3.4. Elan will supply Acorda with Acorda’s reasonable requirements of Product including clinical trial supplies to enable Acorda to carry out the Project. The Product shall be supplied by Elan EXW at Manufacturing Cost. 3.5. Acorda agrees to carry out and complete the Phase III programme in the United States of America to a standard and timeframe that a company of comparable size, stage of development and assets would use for a product of similar size and potential as the Product. 3.6. With respect to generating stability data on the oral Product in bulk tablet form, Elan and Acorda acknowledge and agree that (i) under the SCI Agreement and the MS Agreement, Elan had the responsibility for generating such data, (ii) pursuant to the Cardinal Agreement, Cardinal is currently performing such stability testing, (iii) the Technology Transfer Responsibilities shall govern the related responsibilities of the Parties, provided that the data resulting from such stability testing shall be provided to both Acorda and Elan, and Elan shall have the right to and responsibility for providing necessary and appropriate technical assistance and oversight of such stability testing (including having the right at its own expense to arrange for its employees involved in the Project to discuss the stability testing and its results with the technical personnel of Acorda and Cardinal upon reasonable notice and at reasonable times); and (iv) Elan shall incorporate such stability data into the CMC module that it will prepare for delivery to Acorda for inclusion in the NDA or any NDA Equivalent, pursuant to Article 3.8. 3.7. For the avoidance of doubt, the Parties hereby confirm that a primary objective of the Project is to generate the NDA and secure NDA Approval for the oral Product. As of the date of the SCI Agreement, the MS Agreement and the Amendment Date, it is the Parties’ expectation that the body of data so generated in the Project will also support such applications for Regulatory Approval that Acorda shall make in the other countries of the Territory. In the event however that such expectation proves unfounded or incorrect and further data is required to obtain such other approvals as are pursued by Acorda in the other countries of the Territory, Acorda shall determine the viability of proceeding further with the regulatory application and generation of the further data requirements. In the event that Acorda elects to continue, the Parties shall update the Development Plan to reflect the allocation between the Parties of conducting such additional activities. In such event, subject to and in accordance with the provisions of this Article 3, Elan shall be responsible for conducting such further activities and generating such further data as set forth in the Development Plan to allow Acorda to seek such further Regulatory Approvals in the Territory. Notwithstanding the foregoing, it is intended by the Parties that except as otherwise specifically set forth in a Development Plan agreed to by the Parties and subject to compliance with regulatory requirements, Acorda shall have primary responsibility and decision making authority with respect to development and marketing of Product. 3.8. Elan shall be responsible for the preparation and delivery to Acorda of the CMC Section in electronic and hard copy form and the latter in format suitable for inclusion in the NDA and any NDA Equivalent in accordance with applicable law and regulatory standards and as the Parties may mutually agree. Acorda shall provide Elan as soon as practicable with a copy of any comments received by Acorda from the FDA or any other regulatory authority relating to the CMC Section and Elan shall provide or, at Acorda’s request, cooperate with Acorda to provide, a response to such comments as soon as practicable. In the event that there is a deficiency in the CMC Section attributable to negligence by Elan in the activities conducted by Elan, then Elan shall be responsible for correcting such deficiency, at Elan’s expense, and shall use reasonable efforts to do so as soon as practicable. In the event Elan breaches the foregoing obligation, in addition to any other remedies available to Acorda, Acorda shall have the right to correct such deficiency or arrange to have a Third Party conduct any required activities necessary to correct such deficiency, at Elan’s expense, the cost of which may be offset against any amounts otherwise due Elan under this Agreement. Acorda shall be responsible for the maintenance of the CMC Section in accordance with applicable law and regulatory standards, at Acorda’s expense, provided that (i) Elan shall cooperate with and provide reasonable assistance to Acorda in connection with such maintenance; and (ii) any revisions, amendments or supplements to the CMC Section required by or resulting from the negligence of Elan in performing its obligations hereunder or under the Supply Agreement, or from any action taken by Elan on its own initiative, or taken by Acorda or any Acorda Designee on behalf of or at the request of Elan, including any changes made by Elan on its own initiative to its manufacturing processes or facilities, shall be at Elan’s expense; and (iii) Elan shall not make any changes to its manufacturing processes or facilities that would require an amendment or supplement to the CMC Section without first notifying Acorda of such changes and preparing and delivering to Acorda any required amendments or supplements to the CMC Section before the implementation of such changes. If Elan is required in any regulatory jurisdiction to file with any regulatory authority a DMF relating to Compound or Product, Elan shall at Acorda’s cost prepare and file in accordance with applicable regulatory requirements such DMF and Acorda shall have a right of reference thereto to the extent required by the NDA or any NDA Equivalent or in order to exercise its license rights under this Agreement. Similarly, if Elan is entitled to market, distribute and sell the Product in a particular country, and Acorda is required in any regulatory jurisdiction to file with any regulatory authority a DMF relating to Compound or Product, Acorda shall at Elan’s cost prepare and file in accordance with applicable regulatory requirements such DMF and Elan shall have a right of reference thereto to the extent required by the NDA or any NDA Equivalent or in order to exercise its rights under this Agreement.. ARTICLE 4 [NOT USED] 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. ARTICLE 5 FINANCIAL PROVISIONS

DEVELOPMENT OF THE PRODUCT. 3.1. Subject to 2.1 During the provisions Term of this Article 3, Acorda shall use its reasonable efforts, as would be deemed commensurate with the achievement of its own business aims for a similar product of its own to conduct such part of the Project as the Parties mutually agree shall be conducted by Acorda. Subject to the provisions of this Article 3, Elan shall use its reasonable efforts, as would be deemed commensurate with the achievement of its own business aims for a similar product of its own, to conduct such part of the Project as the Parties mutually agree that shall be conducted by Elan. The allocation between the Parties of their respective responsibilities for conducting parts of the Project Agreement, (i) is IMI will work with XxXXXX as herein set out in a collaborative alliance to develop and optimize the Products in accordance with the terms set forth in Schedule 9 - Technology Transfer Responsibilities, and herein; and (ii) XxXXXX will use commercially reasonable efforts to then commercialize the Products in the Field in the Territory in accordance with all Applicable Laws and the terms set forth herein. At XxXXXX’x expense, IMI agrees to conform the Product, including but without limitation the software, to reflect XxXXXX’x trademarks and commercially reasonable packaging, product format and labeling Specifications. Notwithstanding anything contained in this Agreement, IMI may, but shall not have the obligation, to develop any Product other than the Palm Test and the Tape Test, but may have the option to so develop other Products upon the mutual written agreement of the Parties. 2.2 As soon as reasonably practicable after the Effective Date, IMI shall: a) furnish XxXXXX with all copies of standard operating procedures (SOP’s) relating to Licensed Technology presently in IMI’s possession that it is free to disclose; and b) provide XxXXXX with access throughout the Term to any other information regarding manufacture of the Product that it is free to disclose. IMI shall keep XxXXXX reasonably informed during the Term of all material technical data, development, and improvements (including Improvements) within IMI’s Licensed Technology. After the receipt of Regulatory Approval from the FDA for a given Product, there shall be set forth in no change, improvement, or modification to that Product, or any component thereof, implemented or made by IMI without the prior written notification to and approval of XxXXXX. IMI further agrees that, after the receipt of Regulatory Approval from the FDA for a development plan (the “Development Plan”) to be prepared and updated from time to time by Acorda in consultation with Elangiven Product, relating no changes or modifications to the development method or process of manufacture or production of the Product, or any component thereof or raw material therefor, shall be made without prior written notification to and approval of XxXXXX. IMI and XxXXXX will further be provided with an opportunity to review all results of studies performed on each Product, including but not limited to the current form results of which is attached as Schedule 4 - NDA Timelinethe Clinical Trials that may be conducted on the Product in the Commercial Clinical Program and the Regulatory Clinical Program, and provide comments to each other regarding the Committee same. 2.2.1 IMI shall monitor be responsible for completing, managing and otherwise conducting all Clinical Trials on the progress Palm Test and the Tape Test for purposes of such activities. Elan and Acorda each undertake that it shall carry out the respective studies, testing and activities set forth as Technology Transfer Responsibilities, seeking Regulatory Approval thereon in the Development PlanU.S., European Union, and otherwise undertaken and conducted any other countries within the Territory during the Term as agreed upon by it in good faith and the Parties at IMI’s sole expense in accordance with prevailing cGCP the terms hereof, and cGLP shall further file and FDA standards own any such Registration or permit regarding the Product in the U.S., European Union, and guidelinesany such other countries agreed upon by the Parties at IMI’s sole expense (the “Regulatory Clinical Program”.) IMI shall use Diligent Efforts to gain Regulatory Approval for the Tape Test for marketing in the United States within ***** (*****) years of the Effective Date. 3.22.2.2 For the period commencing on the date hereof and terminating on the fourth Year anniversary of the date hereof, IMI will use Diligent Efforts to conduct additional Clinical Trials, which are other than the Clinical Trials set forth with respect to the Regulatory Clinical Program, (the “Commercial Clinical Program”) on the Palm Test Product and the Tape Test Product in such manner as agreed upon by IMI and XxXXXX in writing from time to time, the purpose of which shall be to provide data to support marketing objectives of XxXXXX relating to Products. Provided that Elan uses reasonable endeavours . Notwithstanding anything contained herein, XxXXXX and its Affiliates, at their sole discretion, shall be entitled to conduct their own additional Clinical Trials, which are other than the Clinical Trials performed with respect to the Commercial Clinical Program, on the Product at their own expense. The obligations of IMI pursuant to this subsection 2.2.2 shall terminate on the fourth anniversary of the Effective Date. 2.3 IMI shall, subject to the time limits set out in Section 2.2.2, bear all of its costs related to the Regulatory Clinical Program (as set forth in Section 2.2.1) and the Commercial Clinical Program (as set forth in Section 2.2.2), to meet Specifications mutually agreed upon by IMI and XxXXXX. Except as may otherwise be provided herein, the maximum cost to IMI of fulfilling its obligations under subsection 2.2.2 shall not, in a given Calendar Year, exceed ***** of XxXXXX’x aggregate worldwide Net Sales of the Product(s) in the immediately preceding Calendar Year (the “CCP Amount”), and XxXXXX shall bear all additional costs in excess of the CCP Amount in that same Calendar Year so long as such additional costs have been previously agreed upon by XxXXXX for that Calendar Year prior to commencing the Clinical Study at issue pursuant to the Commercial Clinical Program in accordance with this section 2.3. For greater certainty, IMI shall not be in breach of its obligations under this Agreement, Elan shall have no liability section 2.3 if compliance would require IMI to Acorda as a result of any failure or delay expend more than such CCP Amount. Notwithstanding the generality of the Product foregoing, prior to achieve one or more of the milestones set out in the Project and/or to obtain the NDA Approval or the approval of the regulatory authorities in one or more of the other countries of the Territory. Acorda shall have no liability to Elan as commencing a result of any failure or delay of the Product to obtain the NDA Approval or the approval of the appropriate health regulatory authorities in one or more of the countries of the Territory. 3.3. The Parties hereby confirm that each shall undertake its respective part of the Project as a collaborative effort and that the provisions of this Agreement requires that each Party diligently carries out those tasks assigned to it under the Project and as otherwise agreed during the course of the Project. Each Party shall co-operate with the other in good faith particularly with respect to unknown problems or contingencies and shall perform its obligations in good faith and in a commercially reasonable, diligent and workmanlike manner. Each Party will update the other Party on the progress of the Project at meetings of the Committee. 3.4. Elan will supply Acorda with Acorda’s reasonable requirements of Product including clinical trial supplies to enable Acorda to carry out the Project. The Product shall be supplied by Elan EXW at Manufacturing Cost. 3.5. Acorda agrees to carry out and complete the Phase III programme in the United States of America to a standard and timeframe that a company of comparable size, stage of development and assets would use Clinical Study for a product Commercial Clinical Program, IMI shall provide a written report to the JSC that sets forth, at a minimum: a) an estimate of similar size and potential as the Product. 3.6. With respect to generating stability data on the oral Product in bulk tablet form, Elan and Acorda acknowledge and agree all planned expenditures for activities that (i) under the SCI Agreement and the MS Agreement, Elan had the responsibility for generating such data, (ii) may be performed pursuant to the Cardinal Agreement, Cardinal is currently performing such stability testing, (iii) the Technology Transfer Responsibilities shall govern the related responsibilities of the Parties, provided that the data resulting from such stability testing shall be provided to both Acorda and Elan, and Elan shall have the right to and responsibility for providing necessary and appropriate technical assistance and oversight of such stability testing Clinical Study (including having the right at its own expense to arrange for its employees involved any costs that may be incurred by IMI hereunder in the Project to discuss the stability testing and its results connection with the technical personnel of Acorda and Cardinal upon reasonable notice and at reasonable timessuch Clinical Study); and b) a schedule of when the payments of such costs will become due (iv) Elan the “CCP Budget”). IMI agrees to use Diligent Efforts to fully and accurately disclose to XxXXXX all information required to be set forth on the CCP Budgets. IMI shall incorporate such stability data into update and revise each CCP Budget for ongoing Commercial Clinical Programs during the CMC module that it first Fiscal Quarter of each Calendar Year. IMI will prepare for delivery to Acorda for inclusion in the NDA or any NDA Equivalent, not commence work pursuant to Article 3.8. 3.7. For any new Clinical Study for a Commercial Clinical Program, and will not subsequently continue such work after the avoidance first Fiscal Quarter of doubteach Calendar Year thereafter, without first receiving the Parties hereby confirm that a primary objective of the Project is to generate the NDA and secure NDA Approval JSC’s written approval for the oral Product. As of CCP Budget therefor (the date of the SCI Agreement, the MS Agreement and the Amendment Date, it is the Parties’ expectation that the body of data so generated in the Project will also support such applications for Regulatory Approval that Acorda shall make in the other countries of the Territory“Approved CCP Budget”). In the event however that, for a given Calendar Year, the actual costs incurred for a Commercial Clinical Program exceed the maximum CCP Amount that such expectation proves unfounded or incorrect and further data IMI is required to obtain spend for that Calendar Year, then XxXxxx agrees to pay all costs associated with such other approvals study that exceed the CCP Amount for that Calendar Year (the “Excess CCP Costs”) so long as are pursued such Excess CCP Costs were previously approved by Acorda in the other countries of the Territory, Acorda shall determine the viability of proceeding further with the regulatory application and generation of the further data requirements. In the event JSC for that Acorda elects to continue, the Parties shall update the Development Plan to reflect the allocation between the Parties of conducting such additional activities. In such event, subject to and in accordance with the provisions of this Article 3, Elan shall be responsible for conducting such further activities and generating such further data Calendar Year as set forth in the Development Plan Approved CCP Budget. If the Excess CCP Costs exceeded the total amount of the Approved CCP Budget, then IMI and XxXXXX agree to allow Acorda to seek such further Regulatory Approvals equally share in the Territorypayment of such excess amounts. 2.4 Either IMI or XxXXXX may suggest changes to the scope, activities, direction or sequence of the research and development on the Products, including without limitation product design goals, specifications, and schedules, which shall be effected upon mutual agreement of the Parties, all of which shall be dealt with by the Joint Steering Committee, subject to the provisions of Section XVIII. 2.5 Any intellectual property rights, including without limitation, patents, patent applications, inventions, and know-how (hereinafter referred to as "Intellectual Property") owned or controlled by either Party prior to the Parties’ entering into this Agreement shall remain the property of such Party, subject only to the rights and licenses granted herein. 2.5.1 Any Intellectual Property that is first conceived and first reduced to practice during the Term of this Agreement solely by personnel employed by or on behalf of IMI shall remain the property of IMI, subject to the rights and licenses granted herein. 2.5.2 Any Intellectual Property that is first conceived and first reduced to practice during the Term of this Agreement solely by personnel employed by or on behalf of XxXXXX shall remain the property of XxXXXX, subject to the rights and licenses granted herein. 2.5.3 Any Intellectual Property that is first conceived or first reduced to practice during the Term of this Agreement by personnel employed by or on behalf of XxXXXX and personnel employed by or on behalf of IMI (other than the Intellectual Property described in Section 2.5.1 and Section 2.5.2) shall remain the joint property of IMI and XxXXXX, subject to the rights and licenses granted herein (“Joint Intellectual Property”). The Parties agree to keep the Joint Intellectual Property in confidence and not to publicly disclose the same except in accordance with Section XV. Notwithstanding the foregoing, it is intended by the Parties agree that except as otherwise specifically set forth in a Development Plan agreed to by the Parties and subject to compliance with regulatory requirements, Acorda shall have primary responsibility and decision making authority with respect to development and marketing of Product. 3.8. Elan shall be responsible for the preparation and delivery to Acorda of the CMC Section in electronic and hard copy form and the latter in format suitable for inclusion in the NDA and any NDA Equivalent in accordance with applicable law and regulatory standards and as the Parties may mutually agree. Acorda shall provide Elan as soon as practicable with a copy of any comments received by Acorda from the FDA or any other regulatory authority Intellectual Property relating to the CMC Section Palm Test and Elan the Tape Test, which is conceived and reduced to practice on or before the Effective Date of this Agreement shall provide ornot constitute Joint Intellectual Property, but shall be deemed to be part of the Licensed Technology. 2.5.4 Any Intellectual Property which is owned or controlled, either in whole or in part, by IMI during the Term of this Agreement and acquired or developed after the Effective Date shall be added to the Licensed Technology to the extent that the Intellectual Property is relevant to the manufacture, use, sale or Registration of the Products, (“IMI Improvement Intellectual Property”) (and, for greater certainty, the IMI Improvement Intellectual Property shall not include the Intellectual Property identified on Appendix H as at Acorda’s request, cooperate with Acorda to provide, a response to such comments as soon as practicable. the date hereof). 2.6 In the event that there is a deficiency published patent application or a granted patent results from the IMI Improvement Intellectual Property, such patent application(s) and patent(s): a) shall be included in the CMC Section attributable Licensed Patents so long as such patent application(s) and patent(s) are relevant to negligence by Elan in the activities conducted by Elanmanufacture, then Elan use, sale or Registration of the Products, and b) shall be responsible added to Appendix G, which is attached hereto and made a part hereof, within thirty (30) days of filing or grant, whichever is applicable. Otherwise, for correcting such deficiency, at Elan’s expense, and shall use reasonable efforts to do so as soon as practicable. In the event Elan breaches the foregoing obligation, in addition to any other remedies available to Acorda, Acorda shall have the right to correct such deficiency or arrange to have a Third Party conduct any required activities necessary to correct such deficiency, at Elan’s expense, the cost purposes of which may be offset against any amounts otherwise due Elan under this Agreement. Acorda , such IMI Improvement Intellectual Property relating to the manufacture, use, sale or registration of the Product shall be responsible for regarded as Licensed Know How. 2.7 IMI shall update and amend the maintenance list of patent applications and patents within the CMC Section Licensed Patents as set forth in accordance with applicable law Appendix H and regulatory standards, at Acorda’s expense, provided that Appendix G no less frequently than one (i1) Elan shall cooperate with and provide reasonable assistance to Acorda in connection with such maintenance; and (ii) any revisions, amendments or supplements to the CMC Section required by or resulting from the negligence of Elan in performing its obligations hereunder or under the Supply Agreement, or from any action taken by Elan on its own initiative, or taken by Acorda or any Acorda Designee on behalf of or at the request of Elan, including any changes made by Elan on its own initiative to its manufacturing processes or facilities, shall be at Elan’s expense; and (iii) Elan shall not make any changes to its manufacturing processes or facilities that would require an amendment or supplement to the CMC Section without first notifying Acorda of such changes and preparing and delivering to Acorda any required amendments or supplements to the CMC Section before the implementation of such changes. If Elan is required in any regulatory jurisdiction to file with any regulatory authority a DMF relating to Compound or Product, Elan shall at Acorda’s cost prepare and file in accordance with applicable regulatory requirements such DMF and Acorda shall have a right of reference thereto to the extent required by the NDA or any NDA Equivalent or in order to exercise its license rights under this Agreement. Similarly, if Elan is entitled to market, distribute and sell the Product in a particular country, and Acorda is required in any regulatory jurisdiction to file with any regulatory authority a DMF relating to Compound or Product, Acorda shall at Elan’s cost prepare and file in accordance with applicable regulatory requirements such DMF and Elan shall have a right of reference thereto to the extent required by the NDA or any NDA Equivalent or in order to exercise its rights under this Agreementtime per Calendar Year.

DEVELOPMENT OF THE PRODUCT. 3.13.1 NEWCO shall be responsible for the cost of the development, registration, manufacture and marketing of the PRODUCTS, in accordance with the PLAN and subject to the direction of the STEERING COMMITTEE, and NEWCO and SHEFFIELD shall each use its reasonable best efforts, as would be deemed commensurate with the achievement by SHEFFIELD of the business aims for a similar product of its own, to conduct the PROJECT. Subject to the provisions of this Article 3, Acorda ELAN shall use its reasonable efforts, as would be deemed commensurate with the achievement of its own business aims for a similar product of its own to conduct such part of the Project as the Parties mutually agree shall be conducted by Acorda. Subject to the provisions of this Article 3, Elan shall use its reasonable best efforts, as would be deemed commensurate with the achievement of its own business aims for a similar product of its own, to conduct such part of the Project PROJECT as the Parties mutually agree that shall be conducted by Elan. The allocation between the Parties of their respective responsibilities for conducting parts of the Project (i) is set forth in Schedule 9 - Technology Transfer Responsibilities, and (ii) shall be set forth in a development plan (the “Development Plan”) to be prepared and updated from time to time by Acorda in consultation with Elan, relating to the development of the Product, the current form of which is attached as Schedule 4 - NDA Timeline, and the Committee shall monitor the progress of such activities. Elan and Acorda each undertake that it shall carry out the respective studies, testing and activities set forth as Technology Transfer Responsibilities, in the Development Plan, and otherwise undertaken and conducted by it in good faith and ELAN in accordance with prevailing cGCP and cGLP and FDA standards and guidelinesthe PLAN. 3.2. Provided 3.2 Each Party hereby confirms that Elan uses reasonable endeavours to meet its obligations under this Agreement, Elan shall have no liability to Acorda as a result of any failure or delay of the Product to achieve one or more of the milestones set out in the Project and/or to obtain the NDA Approval or the approval of the regulatory authorities in one or more of the other countries of the Territory. Acorda shall have no liability to Elan as a result of any failure or delay of the Product to obtain the NDA Approval or the approval of the appropriate health regulatory authorities in one or more of the countries of the Territory. 3.3. The Parties hereby confirm that each it shall undertake its respective part of the Project PROJECT as a collaborative effort and that the provisions of this Agreement requires that each Party diligently carries out those tasks assigned to it under the Project PROJECT and as otherwise agreed during the course of the ProjectPROJECT. Each Party shall co-operate with the other in good faith particularly with respect to unknown problems or contingencies and shall perform its obligations in good faith and in a commercially reasonable, diligent and workmanlike manner. Each Party will update the other Party on the progress of the Project at meetings of the CommitteePROJECT. 3.4. Elan will supply Acorda with Acorda’s reasonable requirements of Product including clinical trial supplies to enable Acorda to carry out the Project. The Product shall be supplied by Elan EXW at Manufacturing Cost. 3.5. Acorda agrees to carry out and complete the Phase III programme in the United States of America to a standard and timeframe that a company of comparable size, stage of development and assets would use for a product of similar size and potential as the Product. 3.6. With respect to generating stability data on the oral Product in bulk tablet form, Elan and Acorda acknowledge and agree that (i) under the SCI Agreement and the MS Agreement, Elan had the responsibility for generating such data, (ii) pursuant to the Cardinal Agreement, Cardinal is currently performing such stability testing, (iii) the Technology Transfer Responsibilities shall govern the related responsibilities of the Parties, provided that the data resulting from such stability testing shall be provided to both Acorda and Elan, and Elan shall have the right to and responsibility for providing necessary and appropriate technical assistance and oversight of such stability testing (including having the right at its own expense to arrange for its employees involved in the Project to discuss the stability testing and its results with the technical personnel of Acorda and Cardinal upon reasonable notice and at reasonable times); and (iv) Elan shall incorporate such stability data into the CMC module that it will prepare for delivery to Acorda for inclusion in the NDA or any NDA Equivalent, pursuant to Article 3.8. 3.7. 3.3 For the avoidance of doubt, the Parties hereby confirm that a primary objective of the Project PROJECT is to generate procure MARKETING AUTHORIZATIONS in the NDA and secure NDA Approval MAJOR MARKETS for the oral ProductPRODUCTS. As of the date of the SCI Agreement, the MS Agreement and the Amendment DateEFFECTIVE DATE, it is the Parties’ ' expectation that the body of data so generated in the Project PROJECT will also support such applications for Regulatory Approval regulatory approval that Acorda NEWCO shall make in the other countries of the TerritoryTERRITORY. In the event however that such expectation proves unfounded or incorrect and further data is required to obtain such other approvals as are pursued by Acorda NEWCO in the other countries of the TerritoryTERRITORY, Acorda NEWCO shall determine the viability of proceeding further with the regulatory application and generation of the further data requirements. In the event that Acorda NEWCO elects to continue, the Parties shall update agree on the Development Plan program of work to reflect the allocation between the Parties of conducting be undertaken to generate such additional activities. In such event, subject to data and the apportioning of tasks therefor in accordance with the other provisions of this Article 3, Elan shall be responsible for conducting such further activities and generating such further data as set forth in the Development Plan to allow Acorda to seek such further Regulatory Approvals in the Territory. Notwithstanding the foregoing, it is intended by the Parties that except as otherwise specifically set forth in a Development Plan agreed to by the Parties and subject to compliance with regulatory requirements, Acorda shall have primary responsibility and decision making authority with respect to development and marketing of Product. 3.8. Elan 3.4 NEWCO shall be responsible mark or have marked the patent numxxx(s) on all PRODUCTS or otherwise reasonably communicate to the trade concerning the existence of any ELAN PATENT RIGHTS, SHEFFIELD PATENT RIGHTS, NEWCO PATENT RIGHTS or JOINT PATENT RIGHTS for the preparation and delivery countries within the TERRITORY in such a manner as to Acorda of the CMC Section in electronic and hard copy form and the latter in format suitable for inclusion in the NDA and any NDA Equivalent in accordance with applicable law and regulatory standards and as the Parties may mutually agree. Acorda shall provide Elan as soon as practicable with a copy of any comments received by Acorda from the FDA or any other regulatory authority relating to the CMC Section and Elan shall provide or, at Acorda’s request, cooperate with Acorda to provide, a response to such comments as soon as practicable. In the event that there is a deficiency in the CMC Section attributable to negligence by Elan in the activities conducted by Elan, then Elan shall be responsible for correcting such deficiency, at Elan’s expenseensure compliance with, and shall use reasonable efforts enforceability under, all applicable laws, including, without limitation, 35 United States Code Section 287, as xxx xxxx xxx xx amended from time to do so as soon as practicable. In the event Elan breaches the foregoing obligation, in addition to any other remedies available to Acorda, Acorda shall have the right to correct such deficiency or arrange to have a Third Party conduct any required activities necessary to correct such deficiency, at Elan’s expense, the cost of which may be offset against any amounts otherwise due Elan under this Agreement. Acorda shall be responsible for the maintenance of the CMC Section in accordance with applicable law and regulatory standards, at Acorda’s expense, provided that (i) Elan shall cooperate with and provide reasonable assistance to Acorda in connection with such maintenance; and (ii) any revisions, amendments or supplements to the CMC Section required by or resulting from the negligence of Elan in performing its obligations hereunder or under the Supply Agreement, or from any action taken by Elan on its own initiative, or taken by Acorda or any Acorda Designee on behalf of or at the request of Elan, including any changes made by Elan on its own initiative to its manufacturing processes or facilities, shall be at Elan’s expense; and (iii) Elan shall not make any changes to its manufacturing processes or facilities that would require an amendment or supplement to the CMC Section without first notifying Acorda of such changes and preparing and delivering to Acorda any required amendments or supplements to the CMC Section before the implementation of such changes. If Elan is required in any regulatory jurisdiction to file with any regulatory authority a DMF relating to Compound or Product, Elan shall at Acorda’s cost prepare and file in accordance with applicable regulatory requirements such DMF and Acorda shall have a right of reference thereto to the extent required by the NDA or any NDA Equivalent or in order to exercise its license rights under this Agreement. Similarly, if Elan is entitled to market, distribute and sell the Product in a particular country, and Acorda is required in any regulatory jurisdiction to file with any regulatory authority a DMF relating to Compound or Product, Acorda shall at Elan’s cost prepare and file in accordance with applicable regulatory requirements such DMF and Elan shall have a right of reference thereto to the extent required by the NDA or any NDA Equivalent or in order to exercise its rights under this Agreementtime.