Development and Registration Responsibilities Sample Clauses

Development and Registration Responsibilities. 3.1.1 Prior to the Effective Date IMPAX has performed the following development and registration activities:
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Development and Registration Responsibilities. 3.1.1 At its sole cost and expense, Sinetica shall be responsible and liable for developing the Products and filing and obtaining approval of the MAs with the FDA. Within seven (7) days after receiving notice of approval of the MA(s) for the Product(s), Sintetica shall file the necessary documentation to transfer the approved MA(s) to ETON’s name.
Development and Registration Responsibilities. 3.1.1 At its sole cost and expense, Aucta shall be responsible and liable for all development and manufacturing activities required for the filing and approval of the Dossiers for the Products in and for the Territory, including without limitation all costs and management of any required pre-approval and post-approval clinical or other studies.

Related to Development and Registration 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.

  • 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:

  • 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.

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

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

  • Monitoring Responsibilities The Custodian shall furnish annually to the Fund, during the month of June, information concerning the foreign sub-custodians employed by the Custodian. Such information shall be similar in kind and scope to that furnished to the Fund in connection with the initial approval of this Contract. In addition, the Custodian will promptly inform the Fund in the event that the Custodian learns of a material adverse change in the financial condition of a foreign sub-custodian or any material loss of the assets of the Fund or in the case of any foreign sub-custodian not the subject of an exemptive order from the Securities and Exchange Commission is notified by such foreign sub-custodian that there appears to be a substantial likelihood that its shareholders' equity will decline below $200 million (U.S. dollars or the equivalent thereof) or that its shareholders' equity has declined below $200 million (in each case computed in accordance with generally accepted U.S. accounting principles).

  • Company Responsibilities The Company will undertake responsibilities as set forth below:

  • Trust Responsibilities In connection with its use of AVA, the Trust, through its service providers, shall:

  • Development Activities NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.

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