Planned Interim Analyses Sample Clauses

Planned Interim Analyses. No interim analysis is planned for this study.
Sample 1
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Related to Planned Interim Analyses

  • Project Completion Report At the completion of construction and once a Project is placed in service, the Subrecipient must submit a Project Completion Report that includes the total number of units built and leased, affordable units built and leased, DR-MHP units built and leased, an accomplishment narrative, and the tenants names, demographics and income for each DR-MHP unit.

  • Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.

  • Project Completion The Contractor agrees to schedule a final job walk with the County. If required, the County will prepare a list of incomplete items, the “Punch List”. The Contractor agrees to complete the “Punch List” corrections and schedule a final project completion job walk. The County will sign the “Punch List” as completed when determined, the project is finished. The Contractor agrees to submit the following along with its final payment request:

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

  • Project Closeout a. Participate in final inspection to prepare punch lists for project contractor to correct and/or to complete listed items. Verify that items on punch lists have been completed successfully assist COUNTY Project Manager or designee to determine completion date and coordinate project close out. a. Coordinate the preparation, acceptance and distribution of project closeout documents in accordance with COUNTY Project Manager or designee procedures to clients.

  • Escrow Analysis If applicable, with respect to each Mortgage Loan, the Seller has within the last twelve months (unless such Mortgage was originated within such twelve month period) analyzed the required Escrow Payments for each Mortgage and adjusted the amount of such payments so that, assuming all required payments are timely made, any deficiency will be eliminated on or before the first anniversary of such analysis, or any overage will be refunded to the Mortgagor, in accordance with RESPA and any other applicable law;

  • Feasibility Study A feasibility study will identify the potential costs, service quality and other benefits which would result from contracting out the work in question. The cost analysis for the feasibility study shall not include the Employer’s indirect overhead costs for existing salaries or wages and benefits for administrative staff or for rent, equipment, utilities, and materials, except to the extent that such costs are attributable solely to performing the services to be contracted out. Upon completion of the feasibility study, the Employer agrees to furnish the Union with a copy if the feasibility study, the bid from the Apparent Successful Bidder and all pertinent information upon which the Employer based its decision to contract out the work including, but not limited to, the total cost savings the Employer anticipates. The Employer shall not go forward with contracting out the work in question if more than sixty percent (60%) of any projected savings resulting from the contracting out are attributable to lower employee wage and benefit costs.

  • Phase II A small portion of the work for the Phase II modifications to the Plattsburgh Substation will be performed by Transmission Owner, and the remainder will be performed by Clinton and Xxxxxxxxx. A detailed definition of the specific scope for Transmission Owner and Clinton and Xxxxxxxxx including interface points shall be defined during the design phase and, as such documents become available, copies will be delivered to the NYISO, Transmission Owner, Noble Altona Windpark, LLC and Marble River, LLC. The full scope includes the installation of wave traps, CCVT’s and modifications and/or additions to relaying on the MWP-1 and MWP- 2 lines. These lines will be reconfigured at the completion of Phase II to connect to Xxxxx and Xxxxxxx Substations on MWP-1 and the Xxxx Substation on MWP-2. Clinton and Xxxxxxxxx will design the upgrades and purchase the materials based on the outline specification that was prepared and issued by Transmission Owner. The work to be performed by Clinton and Xxxxxxxxx will include both the materials for the exterior and interior installations and items for Transmission Owner installation inside the control building in existing relay panels and communication racks. In addition, Clinton and Xxxxxxxxx will be responsible for the exterior and interior construction work and will provide construction management services in coordination with Transmission Owner. The civil design for the foundations and the electrical design for the cable runs to the control room will be designed by, as approved by Transmission Owner, and installed under the supervision and control of Clinton and Xxxxxxxxx. The equipment will be selected and procured in accordance with the specifications developed during the detailed engineering phase, copies of which shall be furnished to the NYISO, Transmission Owner, Noble Altona Windpark, LLC and Marble River, LLC. The construction of the foundations, structures, wave traps, CCTV and cable runs into the control building to the termination cabinets will be completed by Clinton and Xxxxxxxxx. The work at the Plattsburgh Substation will be installed under Transmission Owner’s CPP-1. Transmission Owner will provide Protection and Controls Engineering, install and terminate wiring from the termination cabinets to the control panels and relays, install relays and equipment in the existing panels, and will commission such work inside the 230kV control building. Transmission Owner will develop the communications protocols and data flow over the circuits.

  • Phase I In Phase I, the project will be connected as a tap to the Transmission Owner’s 230kV transmission line MWP-2 via one 230kV circuit breaker in series with one of two ring bus breakers for stuck breaker protection (one in each direction) and a tie-line breaker, as shown on the one-line diagram labeled CL-E-IA-01 attached to this Appendix A as Figure 1. The changes to the existing MWP-2 line protection for this arrangement are described in Phase I System Upgrades in Section II of this Appendix A.

  • Special Analyses It is hereby certified that these regulations will not have a significant economic impact on a substantial number of small entities. This certification is based on the fact that it is unlikely that a substantial number of small entities will hold REMIC residual interests. Therefore, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It also has been determined that sections 553(b) and 553(d) of the Administrative Procedure Act (5 U.S.C. chapter 5) do not apply to these regulations. The principal author of these regulations is Xxxxxxxx Xxxxxxxxxx. However, other personnel from the IRS and Treasury Department participated in their development. 26 CFR Part 1 Income taxes, Reporting and record keeping requirements.

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