Takeda Responsibilities Sample Clauses

Takeda Responsibilities. Subject to Applicable Law and this Section 6.2 (Regulatory Cooperation), Takeda will, at is sole expense, oversee, monitor, and manage all [***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406. regulatory interactions, communications, and filings with, and submissions to, the PMDA with respect to the TAK-385 Licensed Compound and TAK-385 Licensed Products in the Field in the Takeda Territory; provided that Takeda will provide Licensee with a copy of all proposed material Regulatory Materials filed with or submitted to any Regulatory Authority for Licensee’s review and comment sufficiently in advance of Takeda’s filing or submission thereof, and Takeda will reasonably consider incorporating any reasonable comments received from Licensee into such Regulatory Materials. Subject to Section 6.5 (Labeling Information Exchange), Takeda will have final decision making authority regarding all regulatory activities, including the Labeling strategy and the content of submissions within the Takeda Territory, subject to the terms and conditions of this Agreement. For the avoidance of doubt, to the extent any such Regulatory Materials are not prepared in English by Takeda in the normal course of business, Takeda shall not be required to translate any such Regulatory Materials into English for the purposes of this Section 6.2.2 (Takeda Responsibilities).
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Takeda Responsibilities. During the Research Program Term, TAKEDA shall: (a) provide ARCHEMIX with such TAKEDA Background Technology, and conduct such TAKEDA Research Activities, if any, as may be necessary or useful to further the objectives of the Research Program or as otherwise may be set forth in any Annual Research Plan; (b) pay ARCHEMIX each Quarterly FTE Payment in accordance with Section 5.2.1 and the R&D Funding to the extent the R&D Funding exceeds the Quarterly FTE Payments; (c) give ARCHEMIX not less than [***] days’ written notice in the event that TAKEDA requires a number of FTEs above [***] FTEs in any Fiscal Year; (d) commit such resources as are reasonably necessary to conduct the TAKEDA Research Activities, if any, set forth in any Annual Research Plan; and (e) use Commercially Reasonable Efforts to conduct the TAKEDA Research Activities, if any, set forth in any Annual Research Plan.
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Takeda Responsibilities. Takeda shall use reasonable efforts to promptly screen Compounds provided by Array against the [***]. In addition, Takeda shall provide Array with such support and assistance as Array may reasonably request, including without limitation, providing Array with SAR Information and other Takeda Technology.
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Takeda Responsibilities. Subject to Applicable Law, Section 9.4 and this Section 4.8(c), Takeda will, at its sole expense, oversee, monitor, and manage all regulatory interactions, communications, and filings with, and submissions to, Regulatory Authorities with respect to the Takeda Products and the Compound for use in the Manufacture of Takeda Products in the Takeda Field in the Territory; provided that Takeda will provide Day One with a copy of all proposed material Regulatory Submissions filed with or submitted to any Regulatory Authority for Day One’s review and comment sufficiently in advance of Takeda’s filing or submission thereof, and Takeda will reasonably consider in good faith incorporating comments received from Day One into such Regulatory Submissions. Subject to Section 4.11 and Section 9.4, Takeda will have final decision making authority regarding all regulatory activities, including the Labeling strategy and the content of submissions with respect to the Takeda Products and the Compound for the use in the Manufacture of Takeda Products in the Takeda Field, subject to the terms and conditions of this Agreement. Notwithstanding any provision to the contrary set forth in this Agreement, Takeda shall have sole control over and decision making authority with respect to the IO Combo Study and any Regulatory Submissions relating thereto, provided that Takeda will provide to Day One a copy of the final clinical study report for the IO Combo Study, which report Takeda may redact to the extent not related to TAK-580.
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Takeda Responsibilities. (i) Takeda shall undertake the responsibilities allocated to Takeda in the Joint Development Plan and the Joint Commercialization Plan under the direction and oversight of the SPC, with the understanding that Takeda shall be the lead Party and have primary responsibility for such activities;
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Related to Takeda Responsibilities

  • 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:

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

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

  • 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.

  • 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.

  • Other Responsibilities The delivery of any notices to, and the obtaining of any consents from, any Permitted Transferee with respect to any provision of this Agreement, including, but not limited to, Sections 7.1 and 7.4, shall be your sole responsibility, unless otherwise agreed to in writing between such Permitted Transferee and the Sponsor. Neither the Company nor the Sponsor shall be liable to any Permitted Transferee for your failure to deliver a notice to, or obtain a consent from, any Permitted Transferee with respect to any provision of this Agreement, including, but not limited to, Sections 7.1 and 7.4.

  • 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.

  • Additional Responsibilities The Sub-Advisor may, but shall not be under any duty to, perform services on behalf of the Fund which are not required by this Agreement upon the request of the Fund's Board of Directors. Such services will be performed on behalf of the Fund and the Sub-Advisor's charges in rendering such services will be billed monthly to the Fund, subject to examination by the Fund's independent certified public accountants. Payment or assumption by the Sub-Advisor of any Fund expense that the Sub-Advisor is not required to pay or assume under this Agreement shall not relieve the Sub-Advisor of any of its obligations to the Fund nor obligate the Sub-Advisor to pay or assume any similar Fund expenses on any subsequent occasions.

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

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