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.
REGISTRATION OF THE PRODUCT. 1. In respect of the 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 obtain and maintain NDA APPROVAL for the PRODUCT in each country of the TERRITORY. [ * ] = 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.
REGISTRATION OF THE PRODUCT. 5.1 ELAN shall be responsible, at GEMINI's expense, for performing the following regulatory activities:
REGISTRATION OF THE PRODUCT. 5.1. Elan shall be responsible for the compilation and filing of the Regulatory Filings in respect of the Product with the FDA and shall be the holder of any FDA Approvals granted for the Product and the Party principally responsible for interaction with the FDA.
REGISTRATION OF THE PRODUCT. (a) Kamada undertakes to use its Commercially Reasonable Efforts to obtain and maintain in Kamada’s name, either directly or through subcontractors or an Affiliated Party, the EU Centralized Approval necessary for the Commercialization of the Product in the European Union through a centralized procedure at EMA. All expenses incurred in obtaining such EU Centralized Approval shall be borne by Kamada. It is hereby clarified that Kamada cannot guarantee that it will receive the EU Centralized Approval, the time period for obtaining such approval, or any condition that may be included in such approval. Kamada shall, at all times before obtaining the EU Centralized Approval, keep Chiesi reasonably and promptly informed of all material activities and results thereunder and consult with Chiesi as reasonably requested by Chiesi.
REGISTRATION OF THE PRODUCT. 5.1 NEWCO shall at its sole cost file, and NEWCO and SHEFFIELD shall use their reasonable best efforts to prosecute to approval, the MARKETING AUTHORIZATIONS for the PRODUCTS in the TERRITORY in accordance with the Plan and subject to the direction of the STEERING COMMITTEE.
REGISTRATION OF THE PRODUCT. 1. ELAN shall prepare and shall submit to the FDA, promptly upon completion of the Project, the completed ANDA for the PRODUCT and shall use its best efforts to obtain as soon as possible FDA approval of the ANDA. ELAN shall remit to THE CLIENT a completed copy of said ANDA within thirty (30) days of its filing with the FDA. ELAN shall at its sole discretion decide on the content of the ANDA, however, in the event that ELAN so requests, THE CLIENT shall assist and advise ELAN, such advice shall be provided free of charge unless THE CLIENT has provided prior notification of the cost to ELAN on the compilation of the ANDA.
REGISTRATION OF THE PRODUCT. 7.1 The PROJECT TEAM shall establish the regulatory procedure to be followed by ELAN and MINIMED in order to secure all necessary regulatory approvals to market the PRODUCT in the MAJOR MARKETS as swiftly as practicable. ELAN shall be responsible for filing and maintaining a DMF for the SYSTEM with the RHA in the MAJOR MARKETS. ELAN shall use reasonable endeavours in filing and maintaining each DMF with the RHA in the MAJOR MARKETS as swiftly as practicable.
REGISTRATION OF THE PRODUCT. 1. TARGON shall be responsible for the compilation, preparation, submission and prosecution to approval of the NDA and of all international registration applications for marketing approval. TARGON shall itself file the NDA and may at its option have its sub- licensees file one or more of the IRF. TARGON will use its reasonable efforts in prosecuting the NDA and the IRF to approval. TARGON shall thereafter maintain at its own cost the NDA and the REGULATORY APPROVALS for the TERM. The NDA and the IRF shall remain the property of TARGON, provided that TARGON shall allow ELAN access thereto to enable ELAN to fulfil its obligations and exercise its rights hereunder.
REGISTRATION OF THE PRODUCT. 5.1. Sheffield shall at its sole cost file, and Sheffield shall use its reasonable best efforts to prosecute to approval, the Marketing Authorizations for the Products in the Territory in accordance with the Plan and subject to the direction of the Steering Committee.
