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 ...
REGISTRATION OF THE PRODUCT. ELAN shall be responsible, at GEMINI's expense, for performing the following regulatory activities:
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.
(b) Kamada shall be responsible for obtaining and maintaining the Product packing, labeling, and instructions for use (collectively, the “Labeling”) for the Product purchased under this Agreement for Commercialization within the Territory, and shall use its Commercially Reasonable Efforts to receive approvals from the relevant Regulatory Authorities in the Territory for such Labeling (the “Labeling Approvals”) with respect to any country in the Territory in which sales will be initiated in accordance with the Marketing Plan. All expenses paid to any relevant Regulatory Authority in obtaining such Labeling Approvals shall be borne by Kamada. Chiesi shall cooperate with Kamada, to the extent requested by Kamada, in the design of such Labeling, in communicating with the relevant Regulatory Authorities and in applying for the Labeling Approvals as Kamada's authorized representative. The Product will be packed, including internal leaflets, in such a manner as to comply with the Labeling Approvals, the EU Centralized Approval and with any other Regulatory Approval. The presentation of the final pack (e.g. monthly pack, two monthly pack) and its content, including the Device (for first treatment) and Device Accessories (for routine deliveries) will be discussed and decided between the Parties and in accordance with marketing, reimbursement considerations and Applicable Laws and Guidelines in each country.
(c) Chiesi shall be responsible, as Kamada's authorized representative, for obtaining and maintaining, and undertakes to obtain and maintain using its Commercially Reasonable Efforts, all Reimbursement Approvals for the Product in the Territory ...
REGISTRATION OF THE PRODUCT. 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. Prior to the AMENDMENT DATE, ELAN has been responsible for the compilation, preparation, submission and prosecution to approval of the NDA for the PRODUCT in each country of the TERRITORY. ***Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission
REGISTRATION OF THE PRODUCT. The Parties recognize the expertise developed by SCHEIN in prosecuting ANDAs in the TERRITORY as well as the proprietary and confidential nature of ELAN'S PATENT RIGHTS and ELAN KNOW HOW which shall be contained in the Regulatory Filing. Having regard to the foregoing criteria the Parties hereby confirm their intention and desire to collaborate and co-operate so as to obtain FDA APPROVAL for the PRODUCTS in a timely fashion. ELAN shall consult with SCHEIN during the preparation of the REGULATORY FILING and shall allow SCHEIN an opportunity to review all of the sections of the ANDA, except the confidential portions of the CMC SECTION relating to formulation and manufacturing processes. Prior to submitting the REGULATORY FILING to the FDA. ELAN shall consider any amendments to the REGULATORY FILING which may be suggested by SCHEIN but ELAN shall at its sole discretion decided on the ultimate content of the REGULATORY FILING.
REGISTRATION OF THE PRODUCT. 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. 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. 3.1 The Parties will cooperate with one another on the filing for registration targeting the applicable Countries within the Territory. [ ]
3.2 VGN shall be responsible for the creation and maintenance of the Registration Dossier, including all clinical trial protocols and reports, any variations or modifications and for maintaining its facilities, processes and documentation in compliance with the applicable regulations [ ].
3.3 OA will act as the local sponsor of the registration, [ ], and VGN will provide any and all necessary assistance in order to achieve Market Authorization throughout the Territory at the earliest possible date.
REGISTRATION OF THE PRODUCT. The registration of PRODUCT before the Health Authorities (the “FDA”) in the TERRITORY shall be carried out by BIOVAXYS on behalf of PROCARE as manufacturer of the PRODUCT (the “Registration Deadline”). In this regard, the Parties agree that:
a) BIOVAXYS will have no rights to the registration of the PRODUCT, which must be done exclusively in favour of PROCARE.
b) All costs relative to such registration shall be borne by BIOVAXYS.
c) BIOVAXYS in collaboration with PROCARE, and upon PROCARE’s prior approval, shall prepare all documents for presentation to the FDA in view of registration of the PRODUCTS in the country.
d) PROCARE shall provide BIOVAXYS with any current data in PROCARE’s possession required by the FDA for Product registration or to reasonably support FDA Product registration. If the PRODUCT is not registered before the FDA on or before the Registration Deadline for causes directly attributable to FDA or the need for additional data from PROCARE, the Parties will discuss and negotiate in good faith an extension of the for this Agreement.
