Drug Approval Applications. (A) FALK [***************] for and shall use [************************ ******************] in filing all Drug Approval Applications and seeking Regulatory Approvals for the Licensed Product in the Territory in the Field; provided that ALTUS shall assist FALK in preparing and filing such Drug Approval Applications and seexxxx such Regulatory Approvals. FALK shall pay [*********] associated with the preparation, filing, xxxxecution, meetings, communications, and review by regulatory agencies of such Drug Approval Applications and Regulatory Approvals (including the activities set forth in Section 4.5). The Regulatory Approvals for the Licensed Product in the Territory shall be prosecuted and obtained in the name of FALK; provided that any such Regulatory Approvals shall be obtained xx xhe joint name of FALK and ALTUS if permitted under applicable rules and Portions ox xxis Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential treatment under Rule 406 of the Securities Act. regulations, and provided further that ALTUS shall be permitted to cross-reference such Drug Approval Applications and Regulatory Approvals that are in FALK's name. In the event that the laws or regulations in a country xx xxx Territory do not allow the Licensed Product to be registered solely in the name of FALK, FALK shall register the Licensed Product at its discretion (i) [*******************************************************] or (ii) [***************************************************]. Prior to submitting any Drug Approval Application, FALK shall discuss with the Steering Committee the scope and general xxxtent of such Drug Approval Application. The Steering Committee may review and comment on all Drug Approval Applications, and such comments will be ******** by FALK to the [****************]. All Drug Approval Applications to be xxxed by or on behalf of FALK for the Licensed Product in the Territory must be approved by AXXXX in advance in writing. Regulatory documents or copies thereof for each filing shall be centralized and held at the offices of ALTUS, provided, however, that FALK shall be entitled to obtain and keep copies of originals of any xxxh documents but only for the uses specifically set forth in this Agreement. Each Party will immediately notify the other Party of any material developments relating to the clinical development of the Licensed Product, including, without li...
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. 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. 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. 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. (a) RESPONSIBILITY. Alliance shall be responsible in the Alliance Territory for preparing and filing Drug Approval Applications and seeking Regulatory Approvals for the Product, including preparing all reports necessary as part of a Drug Approval Application. All such Drug Approval Applications shall be filed in the name of Alliance. Alliance shall be responsible for prosecuting such Drug Approval Applications. In the event that any regulatory agency threatens or initiates any action to remove a Product from the market, Alliance shall notify Schering of such communication within one Business Day of receipt by Alliance so long as Schering has, or may have, marketing rights under Article IV.
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.
