Regulatory Applications and Responsibilities Sample Clauses

Regulatory Applications and Responsibilities. 5.1.1 QIAGEN shall be primarily responsible for taking all actions necessary or useful for obtaining Regulatory Approval of the Product in each country (or other jurisdiction) in the Territory, including, without limitation, conducting all communications with any appropriate Regulatory Authority with respect to each regulatory submission in support of obtaining Regulatory Approval for the Product in the Territory. Such responsibility shall include preparing and filing all reports, amendments, supplements and other documents with such Regulatory Authorities with respect to or as part of an application for Regulatory Approval of the Product. QIAGEN shall only sell Products (a) in jurisdictions where QIAGEN has received all necessary Regulatory Approvals or (b) to Laboratory Licensees in accordance with Applicable Laws.
Sample 1
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Regulatory Applications and Responsibilities. 5.1.1 QIAGEN shall be primarily responsible for taking all actions necessary or useful for obtaining Regulatory Approval of the Product in each country (or other jurisdiction) in the Territory, including, without limitation, conducting all communications with any appropriate Regulatory Authority with respect to each regulatory submission in support of obtaining Regulatory Approval for the Product in the Territory. Such responsibility shall include preparing and filing all reports, amendments, supplements and other documents with such Regulatory Authorities with respect to or as part of an application for Regulatory Approval of the Product. QIAGEN shall only sell Products (a) in jurisdictions where QIAGEN has received all necessary Regulatory Approvals or (b) to Laboratory Licensees in accordance with Applicable Laws. * CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
Sample 1

Related to Regulatory Applications and Responsibilities

  • Development Responsibilities From and after the Effective Date, BMS shall assume sole responsibility for the Development of Compounds and Products in the Field in the Territory during the Term at its own cost and expense (including responsibility for all funding, resourcing and decision-making, subject to Sections 3.3 and 3.4), except with respect to the performance by Ambrx of the Research Program activities assigned to Ambrx pursuant to the Research Plan and as otherwise may be agreed upon by the Parties in writing. BMS, by itself or through its Affiliates and Sublicensees, shall use Diligent Efforts to Develop a Compound or Product in the Field in accordance with the Development Plan for the purpose of obtaining a Regulatory Approval in each Major Market. For clarity, it is understood and acknowledged that Diligent Efforts in the Development of Compounds and Products may include sequential implementation of Clinical Trials and/or intervals between Clinical Trials for data interpretation and clinical program planning and approval.

  • Regulatory Responsibilities Following the approval by the FDA of an ANDA, Xxxx shall be solely responsible, with Corium’s reasonable assistance, for maintaining the ANDA for the Product including any necessary periodic reporting requirements. Furthermore, Xxxx shall be responsible for all adverse event reporting as required by the Act. Xxxx agrees to perform these activities in conformance with cGMP, the ANDA specifications and the Act. Xxxx shall provide Corium with copies of all material correspondence from or to regulatory authorities in the Territory relating to the maintenance of the ANDA.

  • Term Position and Responsibilities (a) Term of Employment. ------------------ Unless the Employee's employment shall sooner terminate pursuant to Section 6, the Employer shall employ the Employee for a term commencing on April 1, 1997 and ending on March 31, 1998 (the "Initial Term"), and the Employee's employment shall continue thereafter at will.

  • Specific Responsibilities In addition to its overall responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ activities under this Agreement, the JSC shall in particular:

  • Position and Responsibilities During the term of Executive’s employment hereunder, Executive agrees to serve as an Executive Vice President of the Bank. Executive shall perform administrative and management services for the Bank which are customarily performed by persons in a similar executive officer capacity. During said period, Executive also agrees to serve as an officer and director of any subsidiary of the Bank or the Company, if elected.

  • Joint Responsibilities In performing the Development Efforts, each party shall

  • Roles and Responsibilities The project team shall comprise personnel from Intel and lmpinj. Intel shall: • Assign a project lead to provide project guidance and responses to Impinj’s questions and who has the authority to accept Impinj deliverables • To the extent Intel deems necessary or desirable, assign engineering resources on a full or part-time basis and provide the name of Intel’s engineering lead at SOW signing • Travel to lmpinj facilities as Intel deems necessary or desirable for engineering meetings and review of contract deliverables Impinj shall: • Assign a technical project lead acceptable to Intel who shall have the authority to execute all deliverable commitments • Assign engineering resources on a full or part-time basis and provide the name of lmpinj’s engineering lead at SOW signing • Travel to Intel facilities as necessary for engineering meetings and review of deliverables • Use commercially reasonable efforts to demonstrate performance of the Xxxxxxxx *** that meets or exceeds the specifications included in Appendix A • Impinj shall not be responsible of ***

  • ALPS’ Responsibilities In connection with its performance of TA Web, ALPS shall:

  • Role and Responsibilities During the Employment Period, the Executive shall serve as Chief Commercial Officer of the Company, and shall perform such employment duties as are usual and customary for such position. The Executive shall report directly to the Chief Executive Officer of the Company. At the Company’s request, the Executive shall serve the Company and/or its subsidiaries and affiliates in other capacities in addition to the foregoing, consistent with the Executive’s position as Chief Commercial Officer of the Company. In the event that the Executive serves in any one or more such additional capacities, the Executive’s compensation shall not be increased beyond that specified in Section 2(b) hereof. In addition, in the event the Executive’s service in one or more of such additional capacities is terminated, the Executive’s compensation, as specified in Section 2(b) hereof, shall not be diminished or reduced in any manner as a result of such termination, provided that the Executive otherwise remains employed under and performs the services contemplated by this Agreement.

  • Regulatory Affairs Each Party shall advise the other Party of any regulatory action of which it is aware which would affect the Product in any country of the Territory.

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