Clinical Trial or Study Sample Clauses

Clinical Trial or Study. Covered Services include coverage for Prior Authorized medical treatment received as part of a clinical trial or study if the following provisions apply:  The clinical trial or study is conducted in the state of Nevada and the medical treatment is provided: 1. In a Phase I, Phase II, Phase III or Phase IV clinical trial or study for the treatment of cancer or other life-threatening disease or condition; 2. In a Phase II, Phase III or Phase IV clinical trial or study for the treatment of chronic fatigue syndrome; 3. For cardiovascular disease (cardiac/stroke) which is not life-threatening, for which, as SHL determines, a clinical trial meets the qualifying clinical trial criteria stated below. 4. For surgical musculoskeletal disorders of the spine, hip and knees, which are not life-threatening, for which, as SHL determines, a clinical trial meets the qualifying clinical trial criteria stated below. 5. Other diseases or disorders which are not life-threatening not life-threatening, for which, as SHL determines, a clinical trial meets the qualifying clinical trial criteria stated below  The clinical trial or study is approved by one of the following entities: 1. An agency of the National Institutes of Health (NIH) as set forth in 42 U.S.C. § 281 (b); 2. The Centers for Disease Control and Prevention (CDC); 3. The Agency for Healthcare Research and Quality (AHRQ); 4. Centers for Medicare and Medicaid Services (CMS); 5. A cooperative group; 6. A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants; 7. The Department of Veterans Affairs, the Department of Defense or the Department of Energy as long as the study or investigation has been reviewed and approved through a system of peer review that is determined by the Secretary of Health and Human Services to meet the both of following criteria:  Comparable to the system of peer review of studies and investigations used by the National Institutes of Health.  Ensures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.  The study or investigation is conducted under an investigational new drug application reviewed by the U.S. Food and Drug Administration;  The study or investigation is a drug trial that is exempt from having such an investigational new drug application;  The clinical trial must have a written protocol that describes a scientifically...
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Clinical Trial or Study.  The initial consultation to determine whether the Insured is eligible to participate in the clinical trial or study;  Any drug or device that is approved for sale by the FDA without regard to whether the approved drug or device has been approved for use in the medical treatment of the Insured, if the drug or device is not paid for by the manufacturer, distributor, or Provider;  Services normally covered under this Plan that are required as a result of a medical treatment or related complications provided in the clinical trial or study when not provided by the sponsor of the clinical trial or study;  Services required for the clinically appropriate monitoring of the Insured during the clinical trial or study when not provided by the sponsor of the clinical trial or study. Benefits for Covered Services in connection with a clinical trial or study are payable under this Plan to the same extent as any other Illness or Injury. Covered Services available for the clinical trial or study will be provided by a Plan Provider. If the Insured must utilize a Non-Plan Provider, then the Non-Plan Provider shall be reimbursed at the same rate authorized to Plan Providers of similar services and the Non-Plan Provider shall accept SHL’s rate of reimbursement as payment in full. SHL will require a copy of the clinical trial or study certification approval, the Insured’s signed statement of consent, and any other materials related to the scope of the clinical trial or study relevant to the coverage of medical treatment.
Sample 1
Clinical Trial or Study. Covered Services include coverage for Prior Authorized medical treatment received as part of a clinical trial or study if the following provisions apply:  The clinical trial or study is conducted in the state of Nevada and the medical treatment is provided: 1. In a Phase I, Phase II, Phase III or Phase IV clinical trial or study for the treatment of cancer or other life-threatening disease or condition; 2. In a Phase II, Phase III or Phase IV clinical trial or study for the treatment of chronic fatigue syndrome; 3. For cardiovascular disease (cardiac/stroke) which is not life-threatening, for which, as SHL determines, a clinical trial meets the qualifying clinical trial criteria stated below. 4. For surgical musculoskeletal disorders of the spine, hip and knees, which are not life-threatening, for which, as SHL determines, a clinical trial meets the qualifying clinical trial criteria stated below. 5. Other diseases or disorders which are not life-threatening not life-threatening, for which, as SHL determines, a clinical trial meets the qualifying clinical trial criteria stated below  The clinical trial or study is approved by one of the following entities: 1. An agency of the National Institutes of Health (NIH) as set forth in 42 U.S.C. § 281 (b); 2. The Centers for Disease Control and Prevention (CDC); 3. The Agency for Healthcare Research and Quality (AHRQ); 4. Centers for Medicare and Medicaid Services (CMS); 5. A cooperative group; 6. A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants;
Sample 1

Related to Clinical Trial or Study

  • 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.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • 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.

  • Trials The Ship shall run the following test and trials: (1) Harbour Acceptance Tests, including setting to work of the various equipment;

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in xxxx rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, 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 Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

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