Drug Approval Applications. (a) Co-Promotion Territory. Consistent with the Development Plan but ---------------------- subject to the remainder of this Section 4.07, CTI shall be responsible for preparing and filing Drug Approval Applications and seeking Regulatory Approvals for Collaboration Products in the Co-Promotion Territory, including preparing all reports necessary as part of a Drug Approval Application. All such Drug Approval Applications shall be filed in the name of CTI, and a copy of each such Drug Approval Application shall be simultaneously provided to ORTHO. CTI shall be responsible for prosecuting such Drug Approval Applications and ORTHO shall have the right of cross-reference. In connection with all Drug Approval Applications being prosecuted by CTI under this Section 4.07(a), CTI agrees to provide ORTHO with a copy (which may be wholly or partly in electronic form) of all filings to regulatory agencies that it makes hereunder. The Parties shall consult and cooperate in the preparation of each Drug Approval Application and in obtaining Regulatory Approvals within the Co-Promotion Territory. CTI shall provide ORTHO with reasonable advance notice of any scheduled meeting with any regulatory agency relating to any Drug Approval Application, and ORTHO shall have the right to participate in any such meeting. CTI shall promptly furnish ORTHO with copies of all material correspondence CTI has had with any regulatory agency, and contact reports concerning material conversations or material meetings with any regulatory agency, in each case relating to any such Drug Approval Application. Upon receipt of Regulatory Approval of the Drug Approval Application for the first Collaboration Product hereunder, CTI shall submit an appropriate document to the regulatory agency designating ORTHO as the Regulatory Agent and thereafter ORTHO shall assume primary responsibility for dealings with the regulatory agency with respect thereto, including filing all supplements and other documents with such agency with respect to such existing Drug Approval Application. In the event that any regulatory agency threatens or initiates any action to remove a Collaboration Product from the market in the Co-Promotion Territory, ORTHO shall notify CTI of such communication within one business day of receipt by ORTHO. In connection with all Drug Approval Applications with respect to which ORTHO is Regulatory Agent, ORTHO agrees to provide CTI with a copy (which may be wholly or partly in electronic form)...
Drug Approval Applications. Consistent with the Development Plan and Development Budget and as directed by the JDC, the Parties will file applications for regulatory approval required before commercial sale or use of a Product as a drug in a country within the Territory ("Drug Approval Applications") and attempt to obtain regulatory approvals in each country in the Territory in which the Parties either individually or jointly intend to commercialize Products. JT will be responsible for filing in its name and shall own all regulatory submissions relating to Products including, without limitation, all INDs and NDAs, in each country in the JT Territory, in which Products will be commercialized. Tularik will be responsible for filing in its name and shall own all regulatory submissions, including, without limitation, all INDs and NDAs in each country in the Tularik Territory in which Products will be commercialized by Tularik. The JDC will be responsible for designating a Party to be responsible for filing all regulatory submissions in each country in the Co-Promotion Territory in which Products will be commercialized. The Party not responsible for filing regulatory submissions for Products in a country pursuant to this Agreement shall have a right to cross-reference to all such filings made by the other Party in any country. The Parties will cooperate in the preparation of all such regulatory filings and in obtaining Regulatory Approvals under this Section 3(i).
Drug Approval Applications. NovaMedica shall be entitled to file Drug Approval Applications and seek Regulatory Approvals for the Covered Products in the Territory, provided that such filing shall be subject to the oversight of the JDC. Prior to submitting any IND or Drug Approval Application, the Parties, through the JDC, shall consult and cooperate in preparing such filings, their content and scope. NovaMedica shall own all regulatory submissions, including all INDs, Drug Approval Applications and associated government licenses, approvals, and certificates for the Covered Products in the Territory.
Drug Approval Applications. Consistent with the Development Plan, GNE shall be responsible for, and will use commercially reasonable and diligent efforts in, filing Drug Approval Applications and seeking Regulatory Approvals for Licensed Products in the Territory. GNE shall own all regulatory submissions including all Drug Approval Applications for Licensed Products in the Territory.
Drug Approval Applications. 21 5.6 TRANSFER OF REGULATORY FILINGS AND REGULATORY APPROVALS ....... 21 5.7 ADVERSE EVENT REPORTING; CUSTOMER COMPLAINTS .................. 21 5.8 COMMUNICATIONS ................................................ 22 5.9 APPLICATIONS FOR REGULATORY EXCLUSIVITY ....................... 23 5.10 RECALLS ....................................................... 23 5.11 MANUFACTURING ................................................. 24 5.12 COMPLIANCE WITH LAWS AND REGULATIONS .......................... 24
Drug Approval Applications. Amgen shall own (be the sponsor and party of record of) all Drug Approval Applications for Collaboration Products in the Territory, and ViaCell shall own (be the sponsor and party of record of) all Drug Approval Applications for Cell Therapy Products in the Territory.
Drug Approval Applications. (a) Consistent with the Development Plan and under the direction of the JDC, but subject to the remainder of this Section 8.1, SPI shall be responsible for preparing and filing Drug Approval Applications and seeking Regulatory Approvals for the Products for the Initial Indications and, if applicable, Additional Indications and/or New Formulations in the Initial Territory, including preparing all reports necessary as part of a Drug Approval Application. All such Drug Approval Applications shall be filed in the name of SPI.
Drug Approval Applications. Xxxxxxx shall be responsible for preparing and filing for Regulatory Approval of the Licensed Products in the Territory. Xxxxxxx will file the drug approval applications in its own name and shall be responsible for prosecuting them. After filing for Regulatory Approval, Xxxxxxx shall use commercially reasonable efforts to obtain such approval in each country of the Territory where it has decided to seek Regulatory Approval. Xxxxxxx shall keep DTI reasonably informed as to the progress of such drug approval applications and of any issues raised by the relevant regulatory agencies together with Xxxxxxx' proposed response. Xxxxxxx shall report to DTI concerning its progress in obtaining Regulatory Approval on a periodic basis, but not less than every (6) months. In the event any regulatory agency threatens or initiates any action to remove a Licensed Product from the market in any country of the Territory, Xxxxxxx shall immediately notify DTI of such communication. DTI shall use commercially reasonable efforts to cooperate with Xxxxxxx in Xxxxxxx'x performance of its obligations under this Section 3.6 including preparation for and participation with Xxxxxxx when meeting with regulatory authorities.
Drug Approval Applications. Warner shall be responsible for and shall own all regulatory submissions filed in countries in the Territory. The Parties will cooperate in the preparation of each application for regulatory approval and in obtaining Regulatory Approvals under this Section 4.6. Notwithstanding the above, with the prior approval of the Executive Committee, GenVec shall file the IND for the first Collaboration Product and in such event GenVec shall be the owner of such IND; provided, however, within thirty (30) days of Warner's written request, GenVec shall transfer such IND to Warner.
Drug Approval Applications. Techniclone will use its reasonable best efforts to schedule as soon as is practical, a meeting with the FDA (the "Conversion Meeting") for the purpose, INTER ALIA, of extending the Existing Trial into a Phase III Clinical Trial. Schering shall be responsible for preparing, filing, and prosecuting Drug Approval Applications and seeking Regulatory Approvals for the Product in all countries in the Territory wherein Schering, in good faith and in the exercise of reasonable business judgment, determines it is commercially reasonable to do so, including preparing all reports necessary as part of a Drug Approval Application. All such Drug Approval Applications shall be filed in the name of Schering, and a copy of each such Drug Approval Application shall be promptly provided to Techniclone. In connection with all Drug Approval Applications being prosecuted by Schering under this Section 3.03, Schering agrees to provide Techniclone with a copy (which may be wholly or partly in electronic form) of all filings to regulatory agencies that it makes hereunder within thirty (30) days after written request by Techniclone, at no cost to Techniclone.
