Common use of REGISTRATION OF THE PRODUCT Clause in Contracts

REGISTRATION OF THE PRODUCT. 6.1. As is stated at Article 3.7, a primary objective of the Project is to generate the NDA and to secure NDA Approval. As of the date of this Agreement, it is the Parties’ expectation that the body of data so generated during the Project will support such applications for Regulatory Approval that Acorda shall make in the other countries of the Territory. 6.2. Subject to the review by the Committee pursuant to Article 10 and to Elan’s preparation and delivery to Acorda of the CMC Section in form and substance acceptable for inclusion in the NDA (as well as any revisions thereto as may be mandated or requested by the FDA), and to the other provisions of this Article 6, Acorda shall have the right and responsibility for filing, shall use its reasonable efforts to prosecute to approval, and shall own the NDA. It is acknowledged that Elan has assigned the IND to Acorda. Within ninety (90) days following the completion of the Project as determined by the Committee, Acorda shall submit the NDA for filing with the FDA. 6.3. Acorda shall not alter the Specifications or any part of the CMC Section unless (a) by agreement with Elan, or (b) mandated by the FDA or other regulatory authority. In either case, Acorda shall promptly notify Elan and for changes made after NDA Approval, shall be responsible for Elan’s reasonable expenses associated with required changes to its manufacturing license(s). 6.4. Subject to Elan preparing and delivering to Acorda the CMC Section as set forth in this Agreement, Acorda shall be responsible for obtaining all Regulatory Approvals necessary for Elan to package the Product into final market packaging. Acorda shall be responsible for obtaining all applicable FDA and other state and local regulatory approvals for the distribution of the Product in the United States of America and elsewhere. Elan shall co-operate with Acorda in obtaining such approvals. 6.5. Acorda shall maintain at its own cost the NDA (and shall bear the cost of any amendments or supplements to the CMC Section, other than those requested by Elan, which costs shall be borne by Elan) with the FDA during the period that Acorda and/or its Designees are marketing the Product. Acorda shall continue to maintain the NDA with the FDA, at Elan’s request and expense, if Elan acquires the right to a licence in the United States or any other country in which the NDA is relied upon as the primary application for Regulatory Approval pursuant to Article 2.11.3 for such term thereafter during which Elan and/or its designees (for which purpose the definition of Designee as set out in Article 1 shall apply mutatis mutandis) is marketing the Product. Acorda hereby agrees to provide to Elan a copy of the NDA within thirty (30) days of the submission thereof to the FDA. Acorda shall also furnish a copy to Elan of all other regulatory filings and other material correspondence with the FDA and other regulatory authorities within thirty (30) days of submission. The NDA and any NDA Equivalent or application for Regulatory Approval filed in Territory for the Product shall remain the property of Acorda, provided that Acorda shall allow Elan access thereto to enable Elan to fulfil its obligations and exercise its rights hereunder. 6.6. During the NDA registration procedure, Acorda shall keep Elan promptly and fully advised of Acorda’s registration activities, progress and procedures during Committee meetings. Elan and Acorda shall each before proceeding with any FDA filings, meetings or telephone conferences, inform and discuss the participation of the other with respect to any such proposed dealings with the FDA relating to the Product and shall promptly provide to that other copies of all correspondence with, and all documents and applications filed with, or submitted by it to, any regulatory authority with respect to Product; provided, however, that that the Parties acknowledge and agree that Acorda shall be the primary contact with the FDA and any other regulatory authority in the Territory with respect to Product. 6.7. It is hereby acknowledged that there are inherent uncertainties involved in the development and registration of pharmaceutical products with the FDA or any other regulatory body in the United States of America insofar as obtaining approval is concerned and that such uncertainties form part of the business risk involved in undertaking the form of commercial collaboration as set forth in this Agreement. Therefore, save for using its reasonable efforts, neither Party shall have any liability to the other solely as a result of any failure of the Product to achieve the approval of the FDA, or any other regulatory body in the United States of America. 6.8. Acorda shall also be responsible for the filing and prosecution at its own cost of the regulatory applications with the regulatory authorities in Japan, the Major European Markets and in such other countries of the Territory as it elects and Elan shall cooperate fully with Acorda in connection with such activities. The provisions of Articles 6.1 to 6.7 inclusive shall apply, mutatis mutandis, to Acorda’s and Elan’s obligations vis a vis Japan, the Major European Markets and such other countries of the Territory.

REGISTRATION OF THE PRODUCT. 6.11. As is stated at Article 3.7, a primary objective In respect of the Project is to generate PRODUCT, COMPANY shall be responsible for the filing of the NDA with the FDA and all other relevant regulatory agencies in the TERRITORY and shall consult with ELAN in this regard. COMPANY shall use its commercially reasonable efforts to secure obtain and maintain NDA ApprovalAPPROVAL for the PRODUCT in each country of the TERRITORY. As [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. 2. COMPANY shall notify ELAN of the date of this Agreement, it is submission of any NDA for the Parties’ expectation that the body of data so generated during the Project will support such applications for Regulatory Approval that Acorda shall make PRODUCT in the other countries TERRITORY and shall also notify ELAN of the Territory. 6.2NDA APPROVAL of any registration application as soon as is reasonably possible following said approval. Subject COMPANY shall allow ELAN access to the review by NDA for the Committee pursuant to Article 10 United States of America and to Elan’s preparation and delivery to Acorda of the CMC Section in form and substance acceptable for inclusion in the NDA (as well as any revisions thereto other registration applications as may be mandated or requested required. COMPANY shall also furnish ELAN with a copy of any further regulatory filings and submissions and its correspondence with the FDA relevant to the PRODUCT. 3. Each party shall notify the other as soon as possible of any notification received by that party from the FDA), and or any other regulatory authority to conduct an inspection of its manufacturing or other facilities used in the manufacturing, packaging, storage or handling of the PRODUCT. Copies of all correspondence relevant to the PRODUCT with the regulatory authority will be provided to the other provisions of this Article 6, Acorda party. 4. COMPANY and ELAN shall have discuss on an ongoing basis the right and responsibility for filing, shall use its reasonable efforts to prosecute to approval, and shall own the NDA. It is acknowledged that Elan has assigned the IND to Acorda. Within ninety (90) days following the completion regulatory status of the Project as determined by PRODUCT in the Committee, Acorda shall submit TERRITORY whether at meetings of the NDA for filing with the FDAPROJECT TEAM or otherwise. 6.35. Acorda shall not alter the Specifications or any part of the CMC Section unless (a) by agreement with Elan, or (b) mandated by the FDA or other regulatory authority. In either case, Acorda shall promptly notify Elan and for changes made after NDA Approval, shall be responsible for Elan’s reasonable expenses associated with required changes to its manufacturing license(s). 6.4. Subject to Elan preparing and delivering to Acorda the CMC Section as set forth in this Agreement, Acorda COMPANY shall be responsible for obtaining all Regulatory Approvals FDA, and other approvals necessary for Elan COMPANY to package the Product PRODUCT into final market packaging. Acorda shall be responsible marketing packaging and for obtaining all applicable FDA and other state and local regulatory approvals for the distribution of the Product PRODUCT in the United States of America and elsewhereTERRITORY. Elan ELAN shall co-operate with Acorda COMPANY in obtaining such approvals. 6.56. Acorda ELAN shall maintain at provide to COMPANY scientific data from the works performed during its own cost development of the NDA (PRODUCT which comprises the CMC SECTION and the biopharmaceutics package corresponding to the data as specified in Appendix B. COMPANY shall undertake to protect the confidentiality of ELAN’s formulation, engineering and manufacturing processes for the PRODUCT in its dealings with permitted sub-licensees or approved sub-contractor and shall bear where possible refrain from transmitting such information within the cost CMC SECTION to permitted sub-licensees. 7. Save as otherwise outlined in this Agreement, the costs and expenses of any amendments or supplements filings and proceedings made by ELAN at the request of COMPANY to the CMC Section, other than those requested by Elan, which costs shall be borne by Elan) with the FDA during the period that Acorda and/or its Designees are marketing the Product. Acorda shall continue to maintain the NDA with the FDA, at Elan’s request and expense, if Elan acquires the right to a licence in the United States or any other country governmental authority in respect of the PRODUCT hereunder shall be paid by [ * ]. 8. COMPANY shall indemnify and hold harmless ELAN, its agents and employees from and against all claims, damages, losses, liabilities and expenses to which ELAN, its agents, and employees may become subject related to or arising out of COMPANY’s bad faith, negligence or intentional misconduct in connection with the NDA is relied upon as the primary application for Regulatory Approval pursuant to Article 2.11.3 for such term thereafter during which Elan and/or its designees (for which purpose the definition of Designee as set out in Article 1 shall apply mutatis mutandis) is marketing the Product. Acorda hereby agrees to provide to Elan a copy filing or maintenance of the NDA within thirty (30) days of in the submission thereof to the FDATERRITORY. Acorda shall also furnish a copy to Elan of all other regulatory filings and other material correspondence with the FDA and other regulatory authorities within thirty (30) days of submission. The NDA and any NDA Equivalent or application for Regulatory Approval filed in Territory for the Product shall remain the property of Acorda[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, provided that Acorda shall allow Elan access thereto to enable Elan to fulfil its obligations and exercise its rights hereunderMARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. 6.6. During the NDA registration procedure, Acorda shall keep Elan promptly and fully advised of Acorda’s registration activities, progress and procedures during Committee meetings. Elan and Acorda shall each before proceeding with any FDA filings, meetings or telephone conferences, inform and discuss the participation of the other with respect to any such proposed dealings with the FDA relating to the Product and shall promptly provide to that other copies of all correspondence with, and all documents and applications filed with, or submitted by it to, any regulatory authority with respect to Product; provided, however, that that the Parties acknowledge and agree that Acorda shall be the primary contact with the FDA and any other regulatory authority in the Territory with respect to Product. 6.79. It is hereby acknowledged that there are inherent uncertainties involved in the research, development and registration of pharmaceutical products with the FDA or any and other regulatory body in the United States of America agencies insofar as obtaining approval is concerned and that such uncertainties form part of the business risk involved in undertaking the form of commercial collaboration as set forth in this Agreement. Therefore, save for using its their reasonable efforts, neither Party ELAN and COMPANY shall have any no liability to the other solely as a result of any failure of the Product PRODUCT to successfully achieve the approval of the FDA, FDA or any other regulatory body in the United States of AmericaTERRITORY. 6.810. Acorda Notwithstanding the foregoing provisions of Article VI, COMPANY may call upon ELAN to carry out all or part of the work necessary to obtain regulatory approval in the TERRITORY. [ * ]. 11. COMPANY may conduct any pharmacokinetic, clinical, non-clinical safety studies, pharmacoeconomic, or any other market analysis, study or test on the PRODUCT without first informing ELAN. In the event that COMPANY does conduct such analysis, study or test, COMPANY shall also own said data and information which shall thereafter form part of the COMPANY KNOW-HOW. COMPANY shall provide ELAN with a copy of any such analysis, study or test performed by COMPANY. 12. Subject to Article II, paragraph 11, ELAN shall be responsible entitled to file for NDA APPROVAL for the filing and prosecution at its own cost PRODUCT in any country which ceases to be a part of the regulatory applications TERRITORY, or in the TERRITORY in the event of termination of this Agreement or in any country where COMPANY has a non-exclusive licence in accordance with Article V paragraph 6.2. Where a royalty is payable by ELAN to COMPANY in accordance with Article V. paragraph 3.7 of the regulatory authorities in JapanAgreement, COMPANY shall permit ELAN or ELAN’s designee without charge to conduct sufficient cross-referencing to, any and all pending NDAs or NDA APPROVALS for the Major European Markets and in such other PRODUCT for the relevant country or countries of the Territory as it elects and Elan shall cooperate fully with Acorda in connection with such activities. The provisions of Articles 6.1 to 6.7 inclusive shall apply, mutatis mutandis, to Acorda’s and Elan’s obligations vis a vis Japan, the Major European Markets and such other countries of the TerritoryTERRITORY.

REGISTRATION OF THE PRODUCT. 6.1. As is stated 5.1 NEWCO shall at Article 3.7, a primary objective of the Project is to generate the NDA and to secure NDA Approval. As of the date of this Agreement, it is the Parties’ expectation that the body of data so generated during the Project will support such applications for Regulatory Approval that Acorda shall make in the other countries of the Territory. 6.2. Subject to the review by the Committee pursuant to Article 10 and to Elan’s preparation and delivery to Acorda of the CMC Section in form and substance acceptable for inclusion in the NDA (as well as any revisions thereto as may be mandated or requested by the FDA)its sole cost file, and to the other provisions of this Article 6, Acorda shall have the right NEWCO and responsibility for filing, SHEFFIELD shall use its their reasonable best efforts to prosecute to approval, the MARKETING AUTHORIZATIONS for the PRODUCTS in the TERRITORY in accordance with the Plan and shall own subject to the NDA. It is acknowledged that Elan has assigned the IND to Acorda. Within ninety (90) days following the completion direction of the Project as determined by the Committee, Acorda shall submit the NDA for filing with the FDASTEERING COMMITTEE. 6.3. Acorda shall not alter the Specifications or any part of the CMC Section unless (a) by agreement with Elan, or (b) mandated by the FDA or other regulatory authority. In either case, Acorda shall promptly notify Elan and for changes made after NDA Approval, shall be responsible for Elan’s reasonable expenses associated with required changes to its manufacturing license(s). 6.4. Subject to Elan preparing and delivering to Acorda the CMC Section as set forth in this Agreement, Acorda shall be responsible for obtaining all Regulatory Approvals necessary for Elan to package the Product into final market packaging. Acorda shall be responsible for obtaining all applicable FDA and other state and local regulatory approvals for the distribution of the Product in the United States of America and elsewhere. Elan shall co-operate with Acorda in obtaining such approvals. 6.5. Acorda 5.2 NEWCO shall maintain at its own cost the NDA (and shall bear the cost of any amendments or supplements to the CMC Section, other than those requested by Elan, which costs shall be borne by Elan) with the FDA MARKETING AUTHORIZATIONS during the period that Acorda and/or its Designees are NEWCO is marketing the ProductPRODUCTS. Acorda NEWCO shall continue to maintain the NDA with MARKETING AUTHORIZATIONS in the FDA, applicable countries at Elan’s ELAN'S request and expense, if Elan ELAN acquires the right to a licence in the United States or any other country in which the NDA is relied upon as the primary application for Regulatory Approval license pursuant to Article 2.11.3 2.9 for such term thereafter during which Elan ELAN and/or its designees (for which purpose the definition of Designee as set out in Article 1 shall apply mutatis mutandis) is marketing the Product. Acorda PRODUCTS, and NEWCO hereby agrees to provide to Elan a copy of ELAN, or at ELAN'S option to transfer and assign to ELAN, the NDA MARKETING AUTHORIZATIONS and any applications for regulatory approval within thirty (30) days of the submission thereof to the FDAapplicable authority. Acorda NEWCO shall also furnish a copy to Elan of ELAN all other regulatory filings and other material correspondence with the FDA and other regulatory authorities within thirty (30) days of submission. The NDA and any NDA Equivalent or application for Regulatory Approval filed in Territory for the Product shall remain the property of Acorda, provided that Acorda shall allow Elan access thereto to enable Elan to fulfil its obligations and exercise its rights hereunder. 6.6. 5.3 During the NDA registration procedureprocedure for MARKETING AUTHORIZATIONS, Acorda NEWCO shall keep Elan ELAN promptly and fully advised of Acorda’s NEWCO's registration activities, progress and procedures during Committee meetingsprocedures. Elan and Acorda NEWCO shall each before proceeding with notify ELAN immediately of any FDA filings, meetings or telephone conferences, inform and discuss the participation of the other with respect to any such proposed dealings with the FDA relating to the Product and shall promptly provide to that other copies of all correspondence with, and all documents and applications filed with, or submitted inspection by it to, any regulatory authority with respect to Product; provided, however, that that the Parties acknowledge and agree that Acorda shall be the primary contact with the FDA and any other regulatory authority in the Territory with respect to Product. 6.7. It is hereby acknowledged that there are inherent uncertainties involved in the development and registration of pharmaceutical products with the FDA or any other regulatory body authority of the manufacturing or other facilities used in the United States of America insofar as obtaining approval is concerned and that such uncertainties form part clinical research, manufacturing, packaging, storage or handling of the business risk involved in undertaking the form PRODUCTS. Copies of commercial collaboration as set forth in this Agreement. Therefore, save for using its reasonable efforts, neither Party shall have any liability to the other solely as a result of any failure of the Product to achieve the approval of the FDA, or any other regulatory body in the United States of America. 6.8. Acorda shall also be responsible for the filing and prosecution at its own cost of the regulatory applications all correspondence with the regulatory authorities in Japanauthority will be provided to ELAN. 5.4 NEWCO shall indemnify and hold harmless ELAN, the Major European Markets its agents and in such other countries employees from and against all claims, damages, losses, liabilities and expenses to which ELAN, its agents, and employees may become subject related to or arising out of the Territory as it elects NEWCO's and Elan shall cooperate fully with Acorda SHEFFIELD'S bad faith, negligence or intentional misconduct in connection with such activities. The provisions of Articles 6.1 to 6.7 inclusive shall apply, mutatis mutandis, to Acorda’s and Elan’s obligations vis a vis Japan, the Major European Markets and such other countries filing or maintenance of the TerritoryMARKETING AUTHORIZATIONS.

REGISTRATION OF THE PRODUCT. 6.11. As is stated at Article 3.7TARGON shall be responsible for the compilation, a primary objective preparation, submission and prosecution to approval of the Project is to generate the NDA and to secure of all international registration applications for marketing approval. TARGON shall itself file the NDA Approval. As and may at its option have its sub- licensees file one or more of the date of this Agreement, it is the Parties’ expectation that the body of data so generated during the Project IRF. TARGON will support such applications for Regulatory Approval that Acorda shall make in the other countries of the Territory. 6.2. Subject to the review by the Committee pursuant to Article 10 and to Elan’s preparation and delivery to Acorda of the CMC Section in form and substance acceptable for inclusion in the NDA (as well as any revisions thereto as may be mandated or requested by the FDA), and to the other provisions of this Article 6, Acorda shall have the right and responsibility for filing, shall use its reasonable efforts to prosecute in prosecuting the NDA and the IRF to approval, and . TARGON shall own the NDA. It is acknowledged that Elan has assigned the IND to Acorda. Within ninety (90) days following the completion of the Project as determined by the Committee, Acorda shall submit the NDA for filing with the FDA. 6.3. Acorda shall not alter the Specifications or any part of the CMC Section unless (a) by agreement with Elan, or (b) mandated by the FDA or other regulatory authority. In either case, Acorda shall promptly notify Elan and for changes made after NDA Approval, shall be responsible for Elan’s reasonable expenses associated with required changes to its manufacturing license(s). 6.4. Subject to Elan preparing and delivering to Acorda the CMC Section as set forth in this Agreement, Acorda shall be responsible for obtaining all Regulatory Approvals necessary for Elan to package the Product into final market packaging. Acorda shall be responsible for obtaining all applicable FDA and other state and local regulatory approvals for the distribution of the Product in the United States of America and elsewhere. Elan shall co-operate with Acorda in obtaining such approvals. 6.5. Acorda shall thereafter maintain at its own cost the NDA (and shall bear the cost of any amendments or supplements to REGULATORY APPROVALS for the CMC Section, other than those requested by Elan, which costs shall be borne by Elan) with the FDA during the period that Acorda and/or its Designees are marketing the Product. Acorda shall continue to maintain the NDA with the FDA, at Elan’s request and expense, if Elan acquires the right to a licence in the United States or any other country in which the NDA is relied upon as the primary application for Regulatory Approval pursuant to Article 2.11.3 for such term thereafter during which Elan and/or its designees (for which purpose the definition of Designee as set out in Article 1 shall apply mutatis mutandis) is marketing the Product. Acorda hereby agrees to provide to Elan a copy of the NDA within thirty (30) days of the submission thereof to the FDA. Acorda shall also furnish a copy to Elan of all other regulatory filings and other material correspondence with the FDA and other regulatory authorities within thirty (30) days of submissionTERM. The NDA and any NDA Equivalent or application for Regulatory Approval filed in Territory for the Product IRF shall remain the property of AcordaTARGON, provided that Acorda TARGON shall allow Elan ELAN access thereto to enable Elan ELAN to fulfil its obligations and exercise its rights hereunder. 6.62. During TARGON shall consult with ELAN on the preparation of the NDA registration procedure, Acorda and the IRF and shall keep Elan promptly and fully advised of Acorda’s registration activities, progress and procedures during Committee meetingssupply ELAN with a copy thereof prior to submission. Elan and Acorda shall each before proceeding TARGON will also supply ELAN with any FDA filings, meetings or telephone conferences, inform and discuss the participation copies of the IRF should ELAN request a copy or extracts thereof. Where a sub-licensee undertakes such registration activity on behalf of TARGON outside the United States of America, TARGON shall use reasonable efforts to ensure that its sub-licensee provides ELAN with a copy of the application dossier, should ELAN so request. TARGON shall copy ELAN on all correspondence with FDA concerning the NDA and undertakes to keep ELAN fully informed of progress with the IRF. TARGON shall immediately notify ELAN of the NDA APPROVAL and of all REGULATORY APPROVALS in the international territory as soon as possible after such is known to it. 3. TARGON and/or its sub-licensees shall undertake to maintain in force all registration approvals for the PRODUCT at its/their cost, including the filing of all reports required or requested by the regulatory authorities, such as adverse event reporting. 4. All such regulatory activity shall be undertaken at the cost of TARGON and/or its sub-licensees. 5. ELAN shall at its option file Drug Master File(s) ("DMF") for the PRODUCT in its own name and shall be responsible for all interaction with FDA, and where applicable other with respect REGULATORY AUTHORITIES, concerning the DMF. -------------------------------------------------------------------------------- 6. TARGON shall undertake to any such proposed protect the confidentiality of ELAN's formulation, engineering and manufacturing processes for the PRODUCT in its dealings with the FDA relating to the Product sub-licensees and shall promptly provide where possible refrain from transmitting such information within the relevant CMC SECTION of registration dossiers to sub-licensees. TARGON undertakes that other copies the CMC SECTION of the NDA shall not be transmitted, or access thereto given to its sub-licensees without the prior written consent of ELAN. Unless required by law, TARGON undertakes that the CMC SECTION of the IRF shall not be transmitted, or access thereto given to its sub- licensees without the prior written consent of ELAN. 7. TARGON shall indemnify and hold harmless ELAN, its agents and employees from and against all correspondence withclaims, damages, losses, liabilities and expenses to which ELAN, its agents, and all documents and applications filed withemployees may become subject related to or arising out of TARGON's bad faith, gross negligence or submitted by it to, any regulatory authority with respect to Product; provided, however, that that the Parties acknowledge and agree that Acorda shall be the primary contact intentional misconduct in connection with the FDA filing or maintenance or failure to file or maintain or prosecute the NDA. ELAN shall indemnify and any other regulatory authority hold harmless TARGON, its agents and employees from and against all claims, damages, losses, liabilities and expenses to which TARGON, its agents, and employees may become subject related to or arising out of ELAN's bad faith, gross negligence or intentional misconduct in connection with the Territory with respect filing or maintenance or failure to Productfile or maintain or prosecute the NDA. 6.78. It is hereby acknowledged that there are inherent uncertainties involved in the development and registration of pharmaceutical products with the FDA or any other regulatory body in the United States of America REGULATORY AUTHORITIES insofar as obtaining approval is concerned and that such uncertainties form part of the business risk involved in undertaking the form of commercial collaboration as set forth in this Agreement. Therefore, save for using its reasonable efforts, neither Party shall have any liability to the other solely as a result of any failure of the Product PRODUCT to achieve the approval of the FDA or the other REGULATORY AUTHORITIES. 9. Save as otherwise outlined in this Agreement, the costs and expenses of any filings and proceedings made by TARGON to the FDA, including post approval studies required by the FDA or any other regulatory body Governmental Authority in respect of the United States of AmericaPRODUCT, and to maintain the FDA approval hereunder shall be paid by TARGON. TARGON may elect to conduct post approval studies whether or not mandated by the FDA provided that TARGON shall bear all costs associated with such studies. 6.810. Acorda TARGON shall also be responsible not conduct any technical analysis, study or test on the formulations of the PRODUCT without the prior agreement of ELAN, save for the filing routine quality tests required to verify conformance with the SPECIFICATIONS. In the event that TARGON does conduct such analysis, study or test, then such data and prosecution at its information shall be transmitted to ELAN, who shall own cost said data and information which shall thereafter form part of the regulatory applications with the regulatory authorities in Japan, the Major European Markets and in such other countries KNOW-HOW. -------------------------------------------------------------------------------- Page 33 of the Territory as it elects and Elan shall cooperate fully with Acorda in connection with such activities. The provisions of Articles 6.1 to 6.7 inclusive shall apply, mutatis mutandis, to Acorda’s and Elan’s obligations vis a vis Japan, the Major European Markets and such other countries of the Territory.54

REGISTRATION OF THE PRODUCT. 6.1. As is stated at Article 3.7, a primary objective of the Project is to generate the NDA and to secure NDA Approval. As of the date of this Agreement, it is the Parties’ expectation that the body of data so generated during the Project will support such applications for Regulatory Approval that Acorda shall make in the other countries of the Territory. 6.2. Subject to the review by the Committee pursuant to Article 10 and to Elan’s preparation and delivery to Acorda of the CMC Section in form and substance acceptable for inclusion in the NDA (as well as any revisions thereto as may be mandated or requested by the FDA), and to the other provisions of this Article 6, Acorda shall have the right and responsibility for filing, shall use its reasonable efforts to prosecute to approval, and shall own the NDA. It is acknowledged that Elan has assigned the IND to Acorda. Within ninety (90) days following the completion of the Project as determined by the Committee, Acorda shall submit the NDA for filing with the FDA. 6.3. Acorda shall not alter the Specifications or any part of the CMC Section unless (a) by agreement with Elan, or (b) mandated by the FDA or other regulatory authority. In either case, Acorda shall promptly notify Elan and for changes made after NDA Approval, shall be responsible for Elan’s reasonable expenses associated with required changes to its manufacturing license(s). 6.4. Subject to Elan preparing and delivering to Acorda the CMC Section as set forth in this Agreement, Acorda shall be responsible for obtaining all Regulatory Approvals necessary for Elan to package the Product into final market packaging. Acorda shall be responsible for obtaining all applicable FDA and other state and local regulatory approvals for the distribution of the Product in the United States of America and elsewhere. Elan shall co-operate with Acorda in obtaining such approvals. 6.5. Acorda shall maintain at its own cost the NDA (and shall bear the cost of any amendments or supplements to the CMC Section, other than those requested by Elan, which costs shall be borne by Elan) with the FDA during the period that Acorda and/or its Designees are marketing the Product. Acorda shall continue to maintain the NDA with the FDA, at Elan’s request and expense, if Elan acquires the right to a licence in the United States or any other country in which the NDA is relied upon as the primary application for Regulatory Approval pursuant to Article 2.11.3 for such term thereafter during which Elan and/or its designees (for which purpose the definition of Designee as set out in Article 1 shall apply mutatis mutandis) is marketing the Product. Acorda hereby agrees to provide to Elan a copy of the NDA within thirty (30) days of the submission thereof to the FDA. Acorda shall also furnish a copy to Elan of all other regulatory filings and other material correspondence with the FDA and other regulatory authorities within thirty (30) days of submission. The NDA and any NDA Equivalent or application for Regulatory Approval filed in Territory for the Product shall remain the property of Acorda, provided that Acorda shall allow Elan access thereto to enable Elan to fulfil its obligations and exercise its rights hereunder. 6.6. During the NDA registration procedure, Acorda shall keep Elan promptly and fully advised of Acorda’s registration activities, progress and procedures during Committee meetings. Elan and Acorda shall each before proceeding with any FDA filings, meetings or telephone conferences, inform and discuss the participation of the other with respect to any such proposed dealings with the FDA relating to the Product and shall promptly provide to that other copies of all correspondence with, and all documents and applications filed with, or submitted by it to, any regulatory authority with respect to Product; provided, however, that that the Parties acknowledge and agree that Acorda 27 shall be the primary contact with the FDA and any other regulatory authority in the Territory with respect to Product. 6.7. It is hereby acknowledged that there are inherent uncertainties involved in the development and registration of pharmaceutical products with the FDA or any other regulatory body in the United States of America insofar as obtaining approval is concerned and that such uncertainties form part of the business risk involved in undertaking the form of commercial collaboration as set forth in this Agreement. Therefore, save for using its reasonable efforts, neither Party shall have any liability to the other solely as a result of any failure of the Product to achieve the approval of the FDA, or any other regulatory body in the United States of America. 6.8. Acorda shall also be responsible for the filing and prosecution at its own cost of the regulatory applications with the regulatory authorities in Japan, the Major European Markets and in such other countries of the Territory as it elects and Elan shall cooperate fully with Acorda in connection with such activities. The provisions of Articles 6.1 to 6.7 inclusive shall apply, mutatis mutandis, to Acorda’s and Elan’s obligations vis a vis Japan, the Major European Markets and such other countries of the Territory.