Cytokinetics Responsibilities Sample Clauses

Cytokinetics Responsibilities. Notwithstanding Section 6.3(a), Cytokinetics shall be responsible for the conduct of:
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Cytokinetics Responsibilities. Cytokinetics shall be primarily responsible for and shall lead (i) all Development works necessary to obtain Regulatory Approval of the Product by both the FDA and the EMA (the “Cytokinetics Global Development Activities”), and (ii) additional Development works to support country specific Regulatory Approval of the Product in the Cytokinetics Territory (the “Cytokinetics Country-Specific Development Activities”) ((i) and (ii) together, the “Cytokinetics Development Activities”). For clarity, Cytokinetics Global Development Activities include that certain open-label extension study of the Product referred to as CY 4033. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Sample 1
Cytokinetics Responsibilities. Cytokinetics shall be primarily responsible for and shall lead (i) all Development works necessary to obtain Regulatory Approval of the Product by both the FDA and the EMA (the “Cytokinetics Global Development Activities”), and (ii) additional Development works to support country specific Regulatory Approval of the Product in the Cytokinetics Territory (the “Cytokinetics Country-Specific Development Activities”) ((i) and (ii) together, the “Cytokinetics Development Activities”). For clarity, Cytokinetics Global Development Activities include that certain open-label extension study of the Product referred to as CY 4033.
Sample 1
Cytokinetics Responsibilities. Notwithstanding Section 5.3(a), Cytokinetics shall be responsible for (i) the conduct of the Phase 1 Clinical Trials of the Lead Compound and Phase 2 readiness activities (including [*], but excluding any activities allocated to [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to rule 24b-2 of the Securities Exchange Act of 1934, as amended. Astellas pursuant to subsection (a) above) pursuant to the Development Plan through the initiation of the first Phase 2 Clinical Trial for the Lead Compound (the “Phase 1 Work”), and (ii) other Development activities under the Development Plan [*].
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Related to Cytokinetics Responsibilities

  • 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.

  • 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:

  • 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.

  • Contractor Responsibilities It shall be Tenant’s responsibility to cause each of Tenant’s contractors and subcontractors to:

  • 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.

  • 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).

  • Owners Responsibilities Owner shall comply with the following provisions in a timely manner in accordance with the Project Schedule at no cost to Contractor:

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

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