Project Management Plan 3.2.1 Developer is responsible for all quality assurance and quality control activities necessary to manage the Work, including the Utility Adjustment Work. Developer shall undertake all aspects of quality assurance and quality control for the Project and Work in accordance with the approved Project Management Plan, Good Industry Practice and applicable Law.
3.2.2 Developer shall develop the Project Management Plan and its component parts, plans and other documentation in accordance with the requirements set forth in Section 1.5.2.5
Utilization Management Contractor shall maintain a utilization management program that complies with applicable laws, rules and regulations, including Health and Safety Code § 1367.01 and other requirements established by the applicable State Regulators responsible for oversight of Contractor.
Program Management 1.1.01 Implement and operate an Immunization Program as a Responsible Entity
1.1.02 Identify at least one individual to act as the program contact in the following areas:
1. Immunization Program Manager;
Development Program RWJPRI shall be [**] and have [**] in consultation with the JDAC, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDAC, shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right to prepare and file, and shall be the owner of, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established by RWJPRI. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following:
(i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and
(ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT.
(iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION;
(iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests and the like.
Development Services During the term of this Agreement, the Provider agrees to provide to or on behalf of the Port the professional services and related items described in Exhibit A (collectively, the “Development Services”) in accordance with the terms and conditions of this Agreement. The Provider specifically agrees to include at least one Port representative in any economic development negotiations or discussions in which the Provider is involved concerning (i) a port-related business prospect or (ii) a business transaction which will ultimately require Port involvement, financial or otherwise.
Project Management and Coordination The Engineer shall coordinate all subconsultant activity to include quality of and consistency of work and administration of the invoices and monthly progress reports. The Engineer shall coordinate with necessary local entities.
Construction Management Plan Contractor shall prepare and furnish to the Owner a thorough and complete plan for the management of the Project from issuance of the Proceed Order through the issuance of the Design Professional's Certificate of Material Completion. Such plan shall include, without limitation, an estimate of the manpower requirements for each trade and the anticipated availability of such manpower, a schedule prepared using the critical path method that will amplify and support the schedule required in Article 2.1.5 below, and the Submittal Schedule as required in Article 2.2.3. The Contractor shall include in his plan the names and resumés of the Project Superintendent, Project Manager and the person in charge of Safety.
Project Management Project Management Institute (PMI) certified project manager executing any or all of the following: • Development of Project Charter • Development of project plan and schedule • Coordination and scheduling of project activities across customer and functional areas • Consultation on operational and infrastructure requirements, standards and configurations • Facilitate project status meetings • Timely project status reporting • Address project issues with functional areas and management • Escalation of significant issues to customers and executive management • Manage project scope and deliverable requirements • Document changes to project scope and schedule • Facilitate and document project closeout
Construction Management Services a. A-E may be required to review and recommend approval of submittals, shop drawings, Request for Information (RFI) and/or calculations for temporary structures such as trench shoring, false work and other temporary structural forms.
b. A-E may be required to review and advise the County Representative on the overall project schedule, including staging and completion dates, duration, milestones, and interfaces. Immediately notify Representative if the proposed work schedule does not conform to the contract documents, including the plans, specifications, and permits or that may require special inspection or testing, or work stoppage.
c. Review on a monthly basis the project schedule and/or Critical Path Method (CPM) schedule submitted by the Construction Contractor. Make recommendations concerning the Construction Contractor’s adherence thereto. Recommend possible solutions to scheduling problems so as to complete the project on time, within budget, and in accordance with the contract drawings and specifications.
d. Review scope of work and identify potential contract change orders. Prepare independent cost estimates for any changes resulting from design revisions or change in field conditions. Prepare and recommend for approval all contract change orders.
e. Evaluate the merit of any potential claims or requests for equitable adjustment submitted by the Construction Contractor. Prepare analysis of potential claims include recommendations regarding settlement of the claims.
f. Assist County staff in project related issues with other Agencies, or departments, engineering and material testing support firms, CEQA consultants, utilities agencies, etc.
g. Assist in community outreach meetings and media relations
h. Review for acceptance/approval of Storm Water Pollution Prevention Plan (SWPPP) in accordance with the general Permit of Discharges of Storm Water Associated with Construction Activity (Construction General Permit, including dewatering/diversion plans per the State’s DeMinimus Permit).
Information Systems Acquisition Development and Maintenance a. Client Data – Client Data will only be used by State Street for the purposes specified in this Agreement.
