Development-Related Responsibilities Sample Clauses

Development-Related Responsibilities. The JSC shall coordinate, liaise, review and discuss matters related to the Development of the Product in the Territory, the Reserved Territory and the Global Studies to be undertaken in accordance with this Agreement. Without limitation to the generality of the foregoing, it shall prepare and approve annual (or, if needed, more frequent) updates and revisions to the Development Register, will discuss and attempt to resolve disagreements escalated by any subcommittees or project teams that may be set up from time to time to discuss any specific issues in relation to Development and assume such other responsibilities as are set forth in this Agreement, or as mutually agreed in writing by duly authorized representatives of the Parties from time to time.
Sample 1Sample 2Sample 3See All (5)
AutoNDA by SimpleDocs
Development-Related Responsibilities. The JDCC shall be responsible for: (i) confirming and preparing annual (or, if needed, more frequent) updates and revisions to the Development Plan for the Territory prepared jointly by the Parties pursuant to Section 5.1; (ii) monitoring activities and progress under the Development Plan; (iii) overseeing the maintenance of all Marketing Authorizations in the Territory, including the performance of post-approval commitments in the Territory; (iv) overseeing the sharing of regulatory correspondence and other regulatory information, and overseeing planning and submissions for Marketing Authorizations in the Territory that are filed after the Effective Date; (v) subject to Article 5, overseeing further medical and development work for the Product in the Territory, including development of the Product for any New Indication or in any New Formulation as may be mutually agreed by the Parties; (vi) subject to Article 5, overseeing clinical trials, investigator-initiated trials, post-hoc data analyses, and sponsored research arrangements for the Territory; (vii) overseeing pharmacovigilance activities for the Territory; (viii) overseeing medical affairs activities for the Territory; (ix) developing a publication strategy in the Territory and review procedures for such publications; (x) attempting to resolve disagreements escalated by any subcommittees or project teams; and (xi) assuming such other responsibilities as are set forth in this Agreement, or as mutually agreed in writing by duly authorized representatives of the Parties from time to time.
Sample 1

Related to Development-Related Responsibilities

  • Development Responsibilities Unless the Parties agree in writing upon an alternate allocation of responsibility, the Parties shall have the following rights and obligations with respect to operational responsibilities under each Development Plan:

  • Client Responsibilities You are responsible for (a) assessing each participants’ suitability for the Training, (b) enrollment in the appropriate course(s) and (c) your participants’ attendance at scheduled courses.

  • Joint Responsibilities 2.1.1 University and Affiliate each will identify, and notify each other of, a person responsible for serving as its liaison during the course of this affiliation. The appointment of liaisons shall be subject to mutual approval of the parties.

  • Scope of Delegated Responsibilities (a) SELECTION OF ELIGIBLE FOREIGN CUSTODIANS. Subject to the provisions of this Section 3.2, the Foreign Custody Manager may place and maintain the Foreign Assets in the care of the Eligible Foreign Custodian selected by the Foreign Custody Manager in each country listed on Schedule A, as amended from time to time. In performing its delegated responsibilities as Foreign Custody Manager to place or maintain Foreign Assets with an Eligible Foreign Custodian, the Foreign Custody Manager shall determine that the Foreign Assets will be subject to reasonable care, based on the standards applicable to custodians in the country in which the Foreign Assets will be held by that Eligible Foreign Custodian, after considering all factors relevant to the safekeeping of such assets, including, without limitation the factors specified in Rule 17f-5(c)(1).

  • 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:

  • 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 Responsibilities The Parties will share responsibility for leading regulatory matters relating to the SYNGAP1 Co-Co Products, as described in this Section 6.9 (each Party, when designated as provided herein to provide such leadership with respect to designated activities is the “Lead Regulatory Party” with respect to such activities). With respect to each SYNGAP1 Co-Co Product, Acadia shall (x) lead the overall strategy for obtaining Regulatory Approval of such SYNGAP1 Co-Co Product (including labeling for such SYNGAP1 Co-Co Product), including by selecting the jurisdictions within which XXXx will be pursued and Execution Version the timing and order in which such approvals will be sought (“Regulatory Strategy”), and will be the Lead Regulatory Party with respect to such strategic activities with respect to such SYNGAP1 Co-Co Product, (y) be the Lead Regulatory Party with respect to the submission of any MAA for such SYNGAP1 Co-Co Product, and (z) following the first Regulatory Approval of such SYNGAP1 Co-Co Product, be the Lead Regulatory Party in connection with such SYNGAP1 Co-Co Product and with respect to Commercialization and regulatory activities (including post-marketing studies). Subject to the foregoing, the JSC shall designate a Party to lead all other pre-Regulatory Approval regulatory matters relating to each SYNGAP1 Co-Co Product in accordance with the applicable SYNGAP1 Co-Development Plan (each Party in such capacity will be deemed the Lead Regulatory Party with respect to such activities). The Lead Regulatory Party shall be responsible for (i) filing for in its name, and owning, all Regulatory Materials relating to regulatory activities with respect to such SYNGAP1 Co-Co Product in the relevant country, (ii) overseeing, monitoring, and coordinating all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority with respect to such activities; and (iii) interfacing, corresponding, and meeting with each Regulatory Authority with respect to such activities, in each case consistent with the Regulatory Strategy and applicable SYNGAP1 Co-Development Plan or SYNGAP1 Co-Commercialization Plan.

  • Fund Responsibilities 3.1. The management and control of the Fund are vested exclusively in the Fund’s governing body (e.g., the board of directors or trustees for a Fund that is a mutual fund or the Trustee for a Fund that is a collective trust, as applicable) and such officers and agents as may be appointed by the board from time to time, subject to the terms and provisions of the Fund’s Governing Documents. The Fund’s governing body and the duly appointed officers and agents appointed by the governing body on behalf of the Fund will make all decisions, perform all management functions relating to the operation of the Fund and shall authorize all Transactions. Without limiting the foregoing, the Fund shall:

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

Time is Money Join Law Insider Premium to draft better contracts faster.