Development Funding Responsibilities Sample Clauses

Development Funding Responsibilities. THERAVANCE shall be responsible for and pay all Registration Expenses for Initial Indications to support an NDA submission for such indications in the US for the Target Label from [*] to the time of FDA approval of the Initial Indications; provided, however, that: (i) should such costs and expenses exceed [*], then to the extent incurred in a manner consistent with the Basic Development Plan and the Detailed Development Plan (for post-Effective Date costs and expenses) ASTELLAS shall pay to THERAVANCE an amount equal to [*]; provided, however, that ASTELLAS shall not be obligated to pay THERAVANCE more than [*] pursuant to this clause (i) without ASTELLAS’ prior written consent; and (ii) should such costs and expenses (incurred in a manner consistent with the Basic Development Plan and Detailed Development Plan, for post-Effective Date costs and expenses) be less than [*]. THERAVANCE represents that Registration Expenses from [*] total approximately [*]. Within thirty (30) days after the Effective Date, THERAVANCE shall (in conjunction with and as part of providing the Detailed Development Plan) provide for JSC review a budget for all remaining Registration Expenses. Thereafter, quarterly, THERAVANCE shall provide actual-to-budget Registration Expense expenditures for the past quarter as well as an updated budget for JSC review. All Registration Expenses shall be reported to the JSC on a quarterly basis and the amounts owed by one Party to the other, as applicable, determined by the JSC at the appropriate time (in the case of (ii), no later than thirty (30) days after receipt of the US Marketing Authorization for the Licensed Product for the Initial Indications). Any dispute regarding an amount owed will be handled by the normal dispute mechanism (see Section 3.06). Payments will be made within twenty (20) Business Days of the determination by the JSC. ASTELLAS shall be responsible for and pay all costs and expenses for Development activities beyond the scope of those activities covered by the Registration Expenses. To the extent this would involve covering any costs or expenses incurred by or for THERAVANCE or its Affiliate, such costs and expenses must be specifically [*]=CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. budgeted for in advance in accordance with Section 3.04 (provided that in no event shall ASTELLAS be obligated to cover or reimb...
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Related to Development Funding 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.

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

  • 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).

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

  • Development Funding (a) Viewray will pay 3D Line the then U.S. Dollar equivalent of €[***] within three (3) days of the Effective Date for the engineering services required to develop/ deliver the Deliverable described in Section 2.1(a)(i).

  • 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:

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

  • 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.

  • 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.

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

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