Analysis of All Other Efficacy endpoints. Details of the analyses for all other efficacy endpoints will be documented in the SAP.
Analysis of All Other Efficacy endpoints Sample Clauses
Related to Analysis of All Other Efficacy endpoints
Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.
Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.
Treatment Program Testing The Employer may request or require an employee to undergo drug and alcohol testing if the employee has been referred by the employer for chemical dependency treatment or evaluation or is participating in a chemical dependency treatment program under an employee benefit plan, in which case the employee may be requested or required to undergo drug or alcohol testing without prior notice during the evaluation or treatment period and for a period of up to two years following completion of any prescribed chemical dependency treatment program.
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.
Justification and Anticipated Results The Privacy Act requires that each matching agreement specify the justification for the program and the anticipated results, including a specific estimate of any savings. 5 U.S.C. § 552a(o)(1)(B).
Vaccination and Inoculation (a) The Employer agrees to take all reasonable precautions, including in-service seminars, to limit the spread of infectious diseases among employees.
Constructability Review Prepare detailed interdisciplinary constructability review within Fourteen (14) days of receipt of the plans from the District that:
Pets and Animals Except for service animals as defined in law, Resident shall maintain no pets or animals (including mammals, reptiles, birds, fish, rodents and insects) upon the premises, nor allow visitors or guests to do so, other than: (Pets’ Name). In consideration for the community allowing Resident to maintain such said pet Resident shall pay a $750.00 Non-Refundable Pet fee. In addition there will be a $50.00 pet fee charged each month.
Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.
MEASUREMENT AND VERIFICATION The goal of this task is to report the benefits resulting from this project. Project team may use in- house expertise of the project demonstration site or use third party vendor for measurement and verification (M&V) of GHG and energy consumption reduction. The Recipient shall: • Enter into agreement with M&V subcontractor per Task 1.9 (if using outside vendor) • Coordinate site visits with the M&V subcontractor at the demonstration site(s) • Develop M&V protocol for pre-installation measurement (and calculations) following Section II.B.2 of the grant solicitation manual3: o Electric, natural gas and/or other fossil fuel consumption and greenhouse gas emissions (use appropriate emissions factor from Attachment 8 of the grant solicitation) of the equipment/process/system(s)/sub-system(s) that are be upgraded and/or replaced and/or modified; and o If necessary, ensure installation of sub-metering equipment and data loggers for pre/post data analysis. • Prepare and provide a detailed M&V Plan for each project demonstration site to include but not be limited to: o A description of the monitoring equipment and instrumentation which will be used; o A description of the key input parameters and output metrics which will be measured; o A description of the M&V protocol and analysis methods to be employed; and o A description of the independent, third-party measurement and verification services to be employed, if applicable. • Perform three months (or shorter period as approved in writing by the CAM) of pre- installation measurements (and calculations) based on the M&V protocol for pre- installation. • Prepare and provide a Pre-Installation M&V Findings Report that includes M&V protocol, pre-install measurements (and calculations), analysis, and results performed in this task. • Develop M&V protocol for post-installation measurements (and calculations) of: o Electric, natural gas and/or other fossil fuel consumption and greenhouse gas emissions (use appropriate emissions factor from Attachment 8 of the grant solicitation) of the equipment/process/system(s)/sub-system(s) that will be upgraded and/or replaced and/or modified. Perform 12 months (or shorter period as approved in writing by the CAM) of post- installation measurements based on M&V protocol for post-installation. • Provide a summary of post-installation M&V progress in Progress Report(s) (see subtask 1.5) which shall include but not be limited to: o A narrative on operational highlights from the reporting period, including any stoppages in operation and why; and o A summary of M&V findings from the reporting period. • Analyze post-installation electrical, natural gas and/or other fossil fuel consumption and GHG emissions. 3 GFO-18-903, Food Production Investment Program, California Energy Commission, November 2018. xxxxx://xxx.xxxxxx.xx.xxx/contracts/GFO-18-903/000_FPIP_Solicitation_Manual.docx • Prepare and provide a Post-installation M&V Findings Report that includes M&V protocol, pre and post install measurements (and calculations), analysis, and results performed in this task. Results should at a minimum report on the reduction of electricity, natural gas and/or other fossil fuel usage and reductions of GHG emissions that directly result from this project.
