Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.
Supplier Development lf the Buyer identifies problems in supplier performance based on supplier monitoring, he shall initiate improvement measures at the Supplier. The Buyer shall pursue the possibilities of continuous improvement of the Supplier. The supplier audit is a form of supplier development; the exchange of information and experience between the Buyer and the Supplier also serves this purpose.
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.
Synchronization, Commissioning and Commercial Operation 5.1.1 The SPG shall give PGVCL at least thirty (30) days’ advanced preliminary written notice and at least fifteen (15) days’ advanced final written notice, of the date on which it intends to synchronize the Solar Power Project to the Grid System.
5.1.2 Subject to Article 5.1.1, the Power Project may be synchronized by the SPG to the Grid System when it meets all the connection conditions prescribed in applicable Grid Code then in effect and otherwise meets all other Indian legal requirements for synchronization to the Grid System.
5.1.3 The synchronization equipment and all necessary arrangements / equipment including RTU for scheduling of power generated from the Project and transmission of data to the concerned authority as per applicable regulation shall be installed by the SPG at its generation facility of the Power Project at its own cost. The SPG shall synchronize its system with the Grid System only after the approval of synchronization scheme is granted by the head of the concerned substation/ and checking/verification is made by the concerned authorities of the PGVCL.
5.1.4 The SPG shall immediately after each synchronization/tripping of generator, inform the sub-station of the Grid System to which the Power Project is electrically connected in accordance with applicable Grid Code. In addition, the SPG will inject in-firm power to grid from time to time to carry out operational/ functional test prior to commercial operation. For avoidance of doubt, it is clarified that Synchronization / Connectivity of the Project with the grid shall not to be considered as Commissioning of the Project.
5.1.5 The SPG shall commission the Project within nine (9) Months from the Date of execution of this PPA. Declaration of COD shall be certified by the commissioning committee.
5.1.6 The Parties agree that for the purpose of commencement of the supply of electricity by SPG to PGVCL, liquidated damages for delay etc., the Scheduled Commissioning Date as defined in this Agreement shall be the relevant date.
Design Development Phase 1.3.1 Based on the approved Schematic Design Documents, model(s) and any adjustments to the Program of Requirements, BIM Execution Plan or Amount Available for the Construction Contract authorized by the Owner, the Architect/Engineer shall prepare, for approval by the Owner and review by the Construction Manager, Design Development Documents derived from the model(s) in accordance with Owner’s written requirements to further define and finalize the size and character of the Project in accordance with the BIM Execution Plan, “Facility Design Guidelines” and any additional requirements set forth in Article 15. The Architect/Engineer shall review the Design Development documents as they are being modeled at intervals appropriate to the progress of the Project with the Owner and Construction Manager at the Project site or other location specified by Owner in the State of Texas. The Architect/Engineer shall utilize the model(s) to support the review process during Design Development. The Architect/Engineer shall allow the Construction Manager to utilize the information uploaded into Owner’s PMIS to assist the Construction Manager in fulfilling its responsibilities to the Owner.
1.3.2 As a part of Design Development Phase, Architect/Engineer shall accomplish model coordination, aggregation and “clash detection” to remove conflicts in design between systems, structures and components. Architect/Engineer shall utilize Owner’s PMIS to accomplish model coordination and collaborate with Construction Manager in the resolution of critical clashes identified by the Construction Manager. Architect/Engineer shall demonstrate and provide written assurance to Owner that conflicts/collisions between models have been resolved.
1.3.3 The Architect/Engineer shall review the Estimated Construction Cost prepared by the Construction Manager, and shall provide written comments.
1.3.4 Before proceeding into the Construction Document Phase, the Architect/Engineer shall obtain Owner’s written acceptance of the Design Development documents and approval of the mutually established Amount Available for the Construction Contract and schedule.
1.3.5 The Architect/Engineer shall prepare presentation materials including an animation derived from the model(s) as defined in “Facility Design Guidelines” at completion of Design Development and if so requested shall present same to the Board of Regents at a regular meeting where scheduled within the state.
1.3.6 The Architect/Engineer shall prepare preliminary recommended furniture layouts for all spaces where it is deemed important to substantiate the fulfillment of program space requirements, or to coordinate with specific architectural, mechanical and electrical elements.
1.3.7 Architect/Engineer shall assist the Owner, if requested, with seeking approval of the Project by the Texas Higher Education Coordinating Board (THECB). Such assistance shall include (i) the preparation of a listing of the rooms and square footages in the Project, and (ii) the preparation of project cost information, in accordance with THECB Guidelines. This information shall be provided at the completion of the Design Development Phase when requested by the Owner. The listing of rooms and square footages shall then be updated to reflect any changes occurring during construction and provided to the Owner at Substantial Completion.
1.3.8 At the completion of the Design Development Phase, or such other time as Owner may specify to Architect/Engineer, at Owner’s sole option and discretion, Owner will furnish Architect/Engineer with a Guaranteed Maximum Price proposal prepared by Construction Manager based upon the Design Development documents prepared by the Architect/Engineer and approved by the Owner. The Architect/Engineer shall assist the Owner and endeavor to further and advocate the Owner’s interests in Owner’s communications with the Construction Manager in an effort to develop a Guaranteed Maximum Price proposal acceptable to Owner, in Owner’s sole option and discretion. If the Owner does not accept the Construction Manager’s Guaranteed Maximum Price proposal, the Architect/Engineer shall participate with the Owner and Construction Manager in constructability reviews and shall revise the documents as necessary in order to reach an agreement. If the Construction Manager’s Guaranteed Maximum Price proposal exceeds the Schematic Design Phase Estimated Construction Cost prepared by, or otherwise accepted by the Construction Manager due to an increase in the scope of the Project caused by further development of the design documents by the Architect/Engineer to the extent that such could not be reasonably inferred by the Construction Manager from the Schematic Design documents, and Owner directs Architect/Engineer to revise the documents, the Architect/Engineer shall revise the documents at its own expense so that the Guaranteed Maximum Price proposal for constructing the Project shall not exceed the Owner’s Amount Available for the Construction Contract and any previously approved Estimated Construction Costs. If it is determined to be in the Owner’s best interest, instead of requiring the Architect/Engineer to revise the Drawings and Specifications, the Owner reserves the right to accept a Guaranteed Maximum Price proposal that exceeds the stipulated Amount Available for the Construction Contract. The Architect/Engineer shall analyze the final Guaranteed Maximum Price proposal document, together with its supporting assumptions, clarifications, and contingencies, and shall submit a detailed written analysis of the document to the Owner. Such analysis shall include, without limitation, reference to and explanation of any inaccurate or improper assumptions and clarifications. The A/E will not be required to make revisions to the documents at its own expense under the provisions of this paragraph if the Owner’s rejection of the Guaranteed Maximum Price proposal is not due to a failure of the A/E to provide the services otherwise required herein.
1.3.9 After the Guaranteed Maximum Price has been accepted, the Architect/Engineer shall incorporate necessary revisions into the Design Development documents. The A/E will not be required to make revisions to the documents at its own expense under the provisions of this paragraph if the revisions are required as the result of inaccurate assumptions and clarifications made in the development of the Guaranteed Maximum Price proposal that are not due to a failure of the A/E to provide the services otherwise required herein.