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.
Studies. The preclinical studies and clinical trials conducted by, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries participated, were and, if still pending are being, conducted in all material respects in accordance with the experimental protocols established for each study and trial and with all applicable local, state and federal laws, rules and regulations, including, without limitation, the Federal Food, Drug, and Cosmetic Act and its applicable implementing regulations; the descriptions of the results of such studies and trials contained in the General Disclosure Package or the Final Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the General Disclosure Package and the Final Prospectus, the Company is not aware of any studies or trials, the results of which are inconsistent with or otherwise call into question the study and trial results described or referred to in the General Disclosure Package or the Final Prospectus; and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing preclinical studies or clinical trials conducted or proposed to be conducted by or on behalf of the Company.
Studies. Any amounts due to the City under this pay back requirement shall be deducted from the member’s final paycheck, including any applicable vacation pay, holiday pay, sick leave, etc. The member shall make the arrangements for payment of any additional balance due with the Director of Human Resources or designee before the member’s last day of employment. The Director of Human Resources or designee will review exemptions to the repayment on a case by case basis.
Studies. The Contractor shall conduct an annual Enrollee satisfaction survey beginning six (6) months following enrollment regarding quality, availability, accessibility and satisfaction of care. A description of the methodology to be used in conducting the survey, the percentage of the Enrollees to be surveyed and other survey requirements will be provided to the Plan by the Division. To ensure comparability of results, all Enrollees will receive the same set of questions. The results of the survey and action plans derived from these results must be filed with the Division at least ninety (90) days following completion. The Contractor shall also perform a minimum of four focused studies each year on topics prevalent and significant to the population served. Due to the critical importance of the area of obesity to the Medicaid population, this area should be selected annually for study providing continuous evaluation. At least three (3) other clinical or health service delivery areas completing the required total of four (4) should be selected annually for study from the following topics: Hypertension, Diabetes, Asthma, Congestive Heart Disease, Hemophilia, and Organ Transplants. All studies are to be completed within ninety (90) days prior to the end of the contract year. The Contractor must assure the Division that QM studies are based on adverse or questionable health outcomes, quality issues affecting access to care or other QM studies related specifically to the quality of services provided. The Contractor shall maintain and make available to the Division, CMS, Office of Inspector General (OIG), the Medicaid Fraud Control Unit, and State and Federal Auditors, all studies, reports, protocols, standards, work plans, work sheets, committee minutes, committee reports to the Board of Directors, medical records, and such further documentation as may be required by the Division, concerning quality management activities and corrective actions. In addition to those set forth herein, CMS, in consultation with the State, and other stakeholders, may specify additional performance measures and topics for performance improvement projects to be undertaken by the Contractor.
Studies. Buyer's approval of all soils, engineering, seismic, environmental, topography, hazardous waste, geotechnical, wetlands, drainage and other studies that may be deemed necessary by Buyer or required by any governmental agency in connection with the Property and Buyer's planned development and use of the Property.
Studies. He must have completed professional studies that allow him to perform his position efficiently;
Studies. 8.5.1 The Buyer may, at its own expense, conduct studies regarding the Service and the level of service. The Air Operator’s employees shall assist in conducting such studies to a reasonable extent and shall supply the required information. No separate compensation shall be payable for the Air Operator’s obligation to assist.
Studies. He must meet the qualifications required for the efficient performance of such position;
Studies. Tenant acknowledges receipt of a copy of that certain Final Environmental Site Assessment Cascades Business Park Lots 3, 4 and 00-00, Xxxxxx, Xxxxxxxxxx dated July 23, 1999 and prepared by Xxxxxxx Xxxxxx Associates and Environmental Site Assessment Update dated August 7, 2001, prepared by Xxxxxxx ESE (collectively, "Hazardous Substance Reports"). Landlord, except as provided in the following sentence of this paragraph, makes no representations or <PAGE> -68- warranties whatsoever to Tenant regarding: (i) the Hazardous Substance Reports (including, without limitation, the contents and/or accuracy thereof); or (ii) the presence or absence of toxic or Hazardous Materials in, at, or under the Premises, the Building or the Industrial Center. Landlord does state to Tenant that: (i) Landlord has not authorized any other studies for hazardous or toxic materials at the Premises or Building other than the Hazardous Substance Reports; (ii) Landlord does not know of any surveys for toxic or Hazardous Materials at the Premises or the Building other than the Hazardous Substance Reports, and (iii) to Landlord's knowledge, the Hazardous Substances Reports delivered are true and complete copies of the original Hazardous Substances Reports. Notwithstanding the preceding sentence, Tenant: (a) shall not rely on and Tenant hereby represents to Landlord that it has not relied on the Hazardous Substance Reports; and (b) shall make such studies and investigations, conduct such tests and surveys, and engage such specialists as Tenant deems appropriate to fairly evaluate the Premises and any risks from hazardous or toxic materials. In connection with any inspections or tests to be conducted by Tenant at the Premises or Building, Tenant shall first notify Landlord of each proposed inspection or test and the scope, impact, and intent thereof and obtain Landlord's written consent to perform the same. Tenant shall restore the Premises and the property on which the leased premises are located to the condition existing immediately prior to any such test and/or inspection. Tenant may, at Tenant's sole cost and expense, obtain non-intrusive Phase I Environmental Report in accordance with the most recent ASTM Standards from a reputable environmental consultant (the "Updated Reports"). Landlord agrees to provide Tenant's environmental consultant with access to the Premises for purposes of preparing its Updated Reports and otherwise reasonably cooperate with that environmental consultant at n...
