Development and Approval. It will prepare a Project budget that, after FTA has provided its approval, will be:
(1) Designated the “Approved Project Budget,” and
(2) Incorporated by reference and made part of its Underlying Agreement,
Development and Approval. No later than January 1 of each year, the program managers of each program that is implemented, in whole or in part, for ABAG and of each program implemented for the LCPs will develop a schedule for the development of the Budget and Work Program for their respective program for the next fiscal year. Each schedule will take into account the processes and timelines for the applicable MTC, ABAG and LCP policy bodies to approve a Budget and Work Plan. Each Budget and Work Program will include all of the following that is applicable to that program for that year:
(a) description of programmatic activities for that fiscal year;
(b) proposals for expansion of a current programmatic activity;
(c) proposals for a new program (see section 4.2 regarding funding new programs);
(d) description of programmatic activities that will be discontinued in that fiscal year;
(e) a budget showing the revenue(s) needed to support the proposed Work Plan for that budget year;
(f) identification of the source of the revenue(s) described in subsection (e) and
(g) any contingency plan(s) needed to address programmatic uncertainties or budgetary shortfalls. Each Budget and Work Plan that is approved by all the applicable MTC, ABAG and LCP policy bodies will be implemented in accordance with section 4.2. The Deputy Executive Director for Local Government Services will be responsible for securing the approval of the LCP policy bodies. If a Budget and Work Plan is not approved by all the applicable MTC, ABAG and LCP policy bodies, the prior year’s Budget and Work Plan will remain in effect until the new Budget and Work Plan is approved. The parties may at their discretion use the dispute resolution procedures contained in Section 13 to resolve any differences on proposed new Budget and Work Plans. Following consultation with ABAG and the FAN Executive Committee, MTC will administer the current FAN portfolio in runout mode such that there will be no new debt issuance under the FAN name. During the FAN runout mode, MTC will evaluate the current FAN debt portfolio for refinancing opportunities and make recommendations to the FAN Executive Committee to authorize refinancing of debt issues that meet credit and economic conditions developed and approved by the FAN Executive Committee. The consolidated staff working for MTC will, no later than October 31, 2017, create a successor ABAG-affiliated conduit financing authority, which shall be a new legal entity with a new name and a new governing bo...
Development and Approval. It will prepare a Project Description that, after the State has provided its approval, will be:
a) Designated the “Approved Project Description”, and
b) Made part of the Project Grant Agreement.
Development and Approval. It shall prepare a Project budget that, after the State has provided its approval, will be:
a) Designated the “Approved Project Budget,” and
b) Made part of the Project Grant Agreement.
Development and Approval. It will prepare a budget for its Tribal Transit Project that, upon approval by FTA, will be designated the “Approved Project Budget,” and will be incorporated by reference and made part of the underlying Grant Agreement.
Development and Approval. Alfacell shall use its commercially reasonable efforts to obtain and maintain (and shall have the sole right and responsibility for obtaining and maintaining) all necessary Regulatory Approvals in the Territory for Product. All Regulatory Approvals shall be obtained and maintained in the name of Alfacell. Distributor shall, at its sole cost and expense, provide all cooperation reasonably requested by Alfacell in connection with its Product development and obtaining and maintaining of Product Regulatory Approval. Distributor shall not perform any Product development, including the conduct of preclinical, clinical, marketing, or post-marketing studies on Product absent the express prior written consent of Alfacell. Any permitted studies shall be conducted with the participation of and at the direction of Alfacell.
Development and Approval. Notwithstanding the establishment of the JSC, but subject to Section 3.5, Incyte shall have the sole right to prepare and approve the Detailing Plan and Global Branding Strategy, including any amendments thereto.
Development and Approval. Rohto shall obtain and maintain (and shall have the sole right and responsibility for obtaining and maintaining), at its sole cost and expense (including any fees, commissions or amounts otherwise payable to any brokers, agents, advisors, consultants or facilitators that Rohto may retain or engage in connection with the Regulatory Approvals), all necessary Regulatory Approvals for Products in the Channel in the Territory. OMP shall, at its sole cost and expense, provide technical assistance reasonably requested by Rohto in obtaining and maintaining Product Regulatory Approvals in the Channel in the Territory. Rohto shall not conduct clinical trials or any Product development activities without the prior written consent of OMP. On request from OMP, Rohto will permit OMP to access all information, materials or documents which Rohto has prepared for submission to, or which Rohto has submitted to, the authorities for obtaining Regulatory Approvals for each of the Products, provided however, such accessed information shall not be used by OMP other than for checking Rohto’s process of the Regulatory Approvals and quality of Products.
Development and Approval. Prior to the First Commercial Sale of the Product for the Initial Indication or any Co-Developed Indication in the Licensed Territory, 3SBio shall develop the Promotional Materials with the guidance of AMAG, through its representatives to the JSC, which may include, upon 3SBio’s request, providing to 3SBio corresponding promotional materials used by AMAG in the AMAG Territory (the “AMAG Materials”). AMAG hereby grants to 3SBio the right, during the Term, to use and create derivative works of the AMAG Materials, solely to the extent necessary or useful to create Promotional Materials as approved by AMAG. 3SBio shall use the AMAG Materials solely in preparing the Promotional Materials and for no other purpose. In addition, 3SBio shall submit any newly developed Promotional Materials to the JSC for review and approval. AMAG, through its JSC representatives, shall review all Promotional Materials for consistency with the AMAG Materials and other AMAG promotional, training and advertising materials. 3SBio shall not use in its Commercialization efforts any Promotional Materials without the prior written consent of AMAG, not to be unreasonably withheld, conditioned, or delayed. Once approved by AMAG, the Promotional Materials shall be used solely in connection with the Commercialization of the Product under this Agreement. 3SBio shall be solely responsible for all expenses incurred in the development and production of Promotional Materials.
Development and Approval
