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.
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.
Duties and Responsibilities of Manager During the Term of this Agreement, subject to the provisions of Section 3.1, Manager shall provide, in exchange for the Management Fee described herein, all such services as are necessary and appropriate for the day-to-day administration and management of Provider’s business in a manner consistent with good business practice, including, without limitation, those services set forth in this Article 2.
Joint Responsibilities In performing the Development Efforts, each party shall
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).
Delegation of Responsibilities The Advisor is authorized to delegate any or all of its rights, duties and obligations under this Agreement to one or more sub-advisors, and may enter into agreements with sub-advisors, and may replace any such sub-advisors from time to time in its discretion, in accordance with the 1940 Act, the Advisers Act, and rules and regulations thereunder, as such statutes, rules and regulations are amended from time to time or are interpreted from time to time by the staff of the Securities and Exchange Commission ("SEC"), and if applicable, exemptive orders or similar relief granted by the SEC and upon receipt of approval of such sub-advisors by the Board of Trustees and by shareholders (unless any such approval is not required by such statutes, rules, regulations, interpretations, orders or similar relief).
ALPS’ Responsibilities In connection with its performance of TA Web, ALPS shall:
Duties and Responsibilities of Executive During the Employment Period, Executive shall devote his full working time to (a) the business of the Company and its Affiliates and (b) performance of the duties and responsibilities assigned to Executive to the best of Executive’s ability and with reasonable diligence. Executive’s Employment shall also be subject to the policies maintained and established by the Company, as such policies may be amended from time to time. Executive shall at all times use his best efforts to comply in good faith with laws applicable to Executive’s actions on behalf of the Company and its Affiliates.
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.
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:
