Hepatitis B Vaccine Where the Hospital identifies high risk areas where employees are exposed to Hepatitis B, the Hospital will provide, at no cost to the employees, a Hepatitis B vaccine.
Speech Therapy This plan covers speech therapy services when provided by a qualified licensed provider and part of a formal treatment plan for: • loss of speech or communication function; or • impairment as a result of an acute illness or injury, or an acute exacerbation of a chronic disease. Speech therapy services must relate to: • performing basic functional communication; or • assessing or treating swallowing dysfunction. See Autism Services when speech therapy services are rendered as part of the treatment of autism spectrum disorder. The amount you pay and any benefit limit will be the same whether the services are provided for habilitative or rehabilitative purposes.
Biological Samples If so specified in the Protocol, Institution and Principal Investigator may collect and provide to Sponsor or its designee Biological Samples (“Biological Samples”). 12.2.
Therapies Acupuncture and acupuncturist services, including x-ray and laboratory services. • Biofeedback, biofeedback training, and biofeedback by any other modality for any condition. • Recreational therapy services and programs, including wilderness programs. • Services provided in any covered program that are recreational therapy services, including wilderness programs, educational services, complimentary services, non- medical self-care, self-help programs, or non-clinical services. Examples include, but are not limited to, Tai Chi, yoga, personal training, meditation. • Computer/internet/social media based services and/or programs. • Recreational therapy. • Aqua therapy unless provided by a physical therapist. • Maintenance therapy services unless it is a habilitative service that helps a person keep, learn or improve skills and functioning for daily living. • Aromatherapy. • Hippotherapy. • Massage therapy rendered by a massage therapist. • Therapies, procedures, and services for the purpose of relieving stress. • Physical, occupational, speech, or respiratory therapy provided in your home, unless through a home care program. • Pelvic floor electrical and magnetic stimulation, and pelvic floor exercises. • Educational classes and services for speech impairments that are self-correcting. • Speech therapy services related to food aversion or texture disorders. • Exercise therapy. • Naturopathic, homeopathic, and Christian Science services, regardless of who orders or provides the services. Vision Care Services • Eye exercises and visual training services. • Lenses and/or frames and contact lenses for members aged nineteen (19) and older. • Vision hardware purchased from a non-network provider. • Non-collection vision hardware. • Lenses and/or frames and contact lenses unless specifically listed as a covered healthcare service.
Rhytidectomy Scar revision, regardless of symptoms. • Sclerotherapy for spider veins. • Skin tag removal. • Subcutaneous injection of filling material. • Suction assisted Lipectomy. • Tattooing or tattoo removal except tattooing of the nipple/areola related to a mastectomy. • Treatment of vitiligo. • Standby services of an assistant surgeon or anesthesiologist. • Orthodontic services related to orthognathic surgery. • Cosmetic procedures when performed primarily: o to refine or reshape body structures or dental structures that are not functionally impaired; o to improve appearance or self-esteem; or o for other psychological, psychiatric or emotional reasons. • Drugs, biological products, hospital charges, pathology, radiology fees and charges for surgeons, assistant surgeons, attending physicians and any other incidental services, which are related to cosmetic surgery.
Diagnostic procedures to aid the Provider in determining required dental treatment.
Research Use The Requester agrees that if access is approved, (1) the PI named in the DAR and (2) those named in the “Senior/Key Person Profile” section of the DAR, including the Information Technology Director and any trainee, employee, or contractor1 working on the proposed research project under the direct oversight of these individuals, shall become Approved Users of the requested dataset(s). Research use will occur solely in connection with the approved research project described in the DAR, which includes a 1-2 paragraph description of the proposed research (i.e., a Research Use Statement). Investigators interested in using Cloud Computing for data storage and analysis must request permission to use Cloud Computing in the DAR and identify the Cloud Service Provider (CSP) or providers and/or Private Cloud System (PCS) that they propose to use. They must also submit a Cloud Computing Use Statement as part of the DAR that describes the type of service and how it will be used to carry out the proposed research as described in the Research Use Statement. If the Approved Users plan to collaborate with investigators outside the Requester, the investigators at each external site must submit an independent DAR using the same project title and Research Use Statement, and if using the cloud, Cloud Computing Use Statement. New uses of these data outside those described in the DAR will require submission of a new DAR; modifications to the research project will require submission of an amendment to this application (e.g., adding or deleting Requester Collaborators from the Requester, adding datasets to an approved project). Access to the requested dataset(s) is granted for a period of one (1) year, with the option to renew access or close-out a project at the end of that year. Submitting Investigator(s), or their collaborators, who provided the data or samples used to generate controlled-access datasets subject to the NIH GDS Policy and who have Institutional Review Board (IRB) approval and who meet any other study specific terms of access, are exempt from the limitation on the scope of the research use as defined in the DAR.
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.
Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.
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.
