Regulatory Lead Responsibilities Sample Clauses

Regulatory Lead Responsibilities. Subject to Section 6.12, on a Collaboration Target-by-Collaboration Target basis, the Regulatory Lead will be solely responsible for all regulatory matters in the Territory relating to the Collaboration Candidates and Licensed Products Directed Against such Collaboration Target for which such Party is the Regulatory Lead. The Regulatory Lead will own all INDs, NDAs, Marketing Approvals, Regulatory Filings, Price Approvals and related regulatory documents in the Territory with respect to such Collaboration Candidates and Licensed Products Directed Against such Collaboration Target, including any drug master files maintained by such Regulatory Lead solely with respect thereto in the Territory. The role of Regulatory Lead may transition from one Party to the other Party as contemplated by the definition of such term, and the Parties will document such transition in writing. On a Collaboration Target-by-Collaboration Target basis, the Regulatory Lead will be the sole point of contact with Regulatory Authorities with respect to the Collaboration Candidates and Licensed Products Directed Against such Collaboration Target.
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Regulatory Lead Responsibilities. The JSC will discuss and determine whether to approve the regulatory strategy for the Licensed Products in the Profit-Share Territory (the “Profit-Share Regulatory Strategy”). The Regulatory Lead Party as determined by Section 6.1.1 (Regulatory Lead Responsibilities) or Section 6.1.2 (Regulatory Lead Responsibilities) or as otherwise designated by the JSC (the “Regulatory Lead Party”) will have [**].
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Regulatory Lead Responsibilities. Subject to Section 5.4, the Regulatory Lead will be solely responsible for all regulatory matters in the Field in the applicable Territory relating to the Licensed Candidates, Licensed Products, [***] Combinations, and Relay Pipeline Combinations for which such Party is the Regulatory Lead. The Regulatory Lead will own all INDs, NDAs, Regulatory Approvals, Regulatory Materials, and related regulatory documents in the Field in the Territory with respect to such Licensed Candidates, Licensed Products, [***] Pipeline Compounds, [***] Combinations, Relay Pipeline Products and Relay Pipeline Combinations including any drug master files maintained by such Regulatory Lead solely with respect thereto in the Territory. Notwithstanding anything herein to the contrary, the Regulatory Lead responsibilities with respect to Relay and Relay Pipeline Combinations apply only to the Relay Pipeline Products contained in a Relay Pipeline Combinations and the Relay Pipeline Combination taken as a whole but not with respect to the Relay Pipeline Combination Eligible Licensed Product contained therein on its own.
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Regulatory Lead Responsibilities. The Regulatory Lead will be solely responsible for all regulatory matters relating to the Licensed Compounds and Licensed Products in the applicable Territory during the time such Party is the Regulatory Lead in such Territory. The Regulatory Lead will own all INDs, NDAs, Regulatory Approvals, Regulatory Materials, and related regulatory documents in the Territory with respect to such Licensed Compounds or Licensed Products (in each case, as applicable), including any drug master files maintained by such Regulatory Lead solely with respect thereto in the applicable Territory during the time such Party is the Regulatory Lead in such Territory. Upon approval of the JSC, the role of Regulatory Lead may transition from one Party to the other Party.
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Related to Regulatory Lead Responsibilities

  • 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.

  • 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:

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

  • 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.

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

  • Client Responsibilities During the Term and subject to the provisions of this Schedule, Client shall at its expense (unless otherwise provided for herein) fulfill, or cause to be fulfilled by the Funds or otherwise, the Client obligations, if any, set forth in each Service Exhibit to this Schedule. Client hereby represents, warrants and covenants that the execution and delivery of this Schedule by Client and the performance of Client’s obligations under this Schedule have been duly authorized by all necessary action on the part of Client. Client must comply with the provisions of this Schedule. Client agrees that DST may seek relief from Client for any infringement of this Schedule such as, but not limited to, a material violation, breach, act of negligence or gross negligence, willful misconduct, misfeasance or malfeasance committed by Client or its officers, agents and assigns, in connection with Client’s obligations and responsibilities under this Schedule.

  • 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).

  • Regulatory Responsibility (a) Licensee, its Affiliates, and Sublicensees shall be the legal and beneficial owner of all Regulatory Approvals and Regulatory Materials for Licensed Product in the Territory, and Regulatory Materials relating to such Regulatory Approvals in the Territory shall be submitted by, and in the name of, Licensee (or its Affiliates or Sublicensees, as the case may be). All INDs and CTAs for the Existing Study shall be transferred to Licensee within *** days following the completion of the Existing Study, and thereafter the Licensee will be the sponsor under all INDs and CTAs relating to the Licensed Product. As such, Licensee shall be responsible for reporting all adverse drug reactions related to Licensed Products to the appropriate Regulatory Authorities in the relevant countries in the Territory, in accordance with Applicable Law of such countries. Licensee shall also be responsible for all meetings with Regulatory Authorities and all post-Regulatory Approval commitments to Regulatory Authorities.

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

  • 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.

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