Contractor-Initiated Proposals. If latent or unforeseen conditions require modifications to the Contract, Contractor may propose changes by submitting a request for a change to Architect.
Contractor-Initiated Proposals Sample Clauses
Related to Contractor-Initiated Proposals
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.
Trials The Ship shall run the following test and trials:
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.
Technical Proposals Technical proposal information will be streamlined, e.g., the Government anticipates written proposals consisting of thirty (30) pages or less stating compliance or exception to requirements, risks, assumptions and conflict of interest issues. Proposals shall not merely restate PWS/SOO requirements. Written technical proposals shall normally address: * Technical Approach and descriptive narrative of the contractor's understanding of the requested effort * PWS in response to a SOO * Integrated Master Plan (if applicable) * Integrated Master Schedule (if applicable) * Key Personnel Assigned * Quantities/Hours of Personnel by Labor Categories and narrative justification (if applicable) * Other Direct Costs (ODCs) (materials and supplies, travel, training, etc.(quantities and types only)) * Period of Performance * Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI) * Security (including clearance level) * Teaming Arrangement (including subcontracting; identify new ACAs) * Small Business Plan (if a large business) * Other Pertinent Data, such as assumptions made.
Technical Proposal The technical proposal may be presented in free format. It shall not exceed ten pages, not counting the CVs. It shall respect the following page limit and structure: • Technical methodology (max. 7 pages) • Quality management (max. 1 page) • Project management (max. 1 page) • Resource management (proposal (max. 1 page) + CVs of experts)
Proposing Integration Activities in the Planning Submission No integration activity described in section 6.3 may be proposed in a CAPS unless the LHIN has consented, in writing, to its inclusion pursuant to the process set out in section 6.3(b).
Disciplinary Investigations An employee who is the subject of a disciplinary investigation shall be informed in writing when the investigation is complete and of the determination of the investigation.
Office of Inspector General Investigative Findings Expert Review In accordance with Senate Bill 799, Acts 2021, 87th Leg., R.S., if Texas Government Code, Section 531.102(m-1)(2) is applicable to this Contract, Contractor affirms that it possesses the necessary occupational licenses and experience.
Submitting Investigator An investigator who submitted a genomic dataset to an NIH designated data repository (e.g., dbGaP). Study specific DUC addendum phs000178 : The Cancer Genome Atlas (TCGA) Public Posting of Genomic Summary Results - Not Allowed. NIH Data Access Committee (DAC) : NCI DAC Important Contacts : XXXXXX@xxxx.xxx.xxx; XXX@xxxx.xxx.xxx In the event of a data management incident, within 24 hours, please contact emails above.
