Regulatory Activities Beginning on the Effective Date and to the extent UGNX remains the Lead Development Party with respect to a particular territory, subject to and in accordance with the terms and conditions of this Agreement and the requirements of Applicable Laws, UGNX, shall: (a) use Commercially Reasonable Efforts to file (or have filed) all Regulatory Filings with respect to the Licensed Products in the Field in order to obtain Marketing Approvals in each country in the Territory and the European Territory (or to obtain the European Centralized Approval in the European Core Territory) and in order to obtain Pricing and/or Reimbursement Approvals in the Profit Share Territory; (b) respond in a timely fashion to requests for data and information from Regulatory Authorities with respect to the Licensed Products in the Field in the Territory and the European Territory; and (c) meet with officials of the Regulatory Authorities at such times as may be requested by such Regulatory Authorities with respect to the Core Development Activities (“Regulatory Activities”), provided that KHK will have primary responsibility for obtaining, and UGNX shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals for the Licensed Products in the Field in the European Territory. For the avoidance of doubt, UGNX will be responsible for obtaining, and KHK will provide all assistance reasonably requested by UGNX, in relation to Pricing and/or Reimbursement Approvals, if any, for the Licensed Products in the Field in the Profit Share Territory as part of the UGNX Core Development Activities, it being understood that the costs incurred by UGNX in connection with such activities will be shared equally (50/50). All such Regulatory Activities will be conducted in a manner consistent with the Core Development Plan and coordinated by the JSC in accordance with Article 3. Without limiting the applicability of the foregoing and the remainder of this Article 5, UGNX shall interface with the applicable Regulatory Authority(ies) and, through the JDC, shall keep KHK reasonably informed of all material events and developments occurring in the course of the Regulatory Activities, including scheduled UGNX regulatory strategy discussions and meetings with Regulatory Authorities in the Territory and the European Territory relating to the Licensed Products in the Field.
Mastectomy Services Inpatient
Disaster Recovery and Business Continuity The Parties shall comply with the provisions of Schedule 5 (Disaster Recovery and Business Continuity).
Radiation Therapy/Chemotherapy Services This plan covers chemotherapy and radiation services. This plan covers respiratory therapy services. When respiratory services are provided in your home, as part of a home care program, durable medical equipment, supplies, and oxygen are covered as a durable medical equipment service.
Outpatient Dental Anesthesia Services This plan covers anesthesia services received in connection with a dental service when provided in a hospital or freestanding ambulatory surgical center and: • the use of this is medically necessary; and • the setting in which the service is received is determined to be appropriate. This plan also covers facility fees associated with these services. This plan covers dental care for members until the last day of the month in which they turn nineteen (19). This plan covers services only if they meet all of the following requirements: • listed as a covered dental care service in this section. The fact that a provider has prescribed or recommended a service, or that it is the only available treatment for an illness or injury does not mean it is a covered dental care service under this plan. • dentally necessary, consistent with our dental policies and related guidelines at the time the services are provided. • not listed in Exclusions section. • received while a member is enrolled in the plan. • consistent with applicable state or federal law. • services are provided by a network provider.
AIR OR WATER POLLUTION VIOLATION Under the State laws, the Contractor shall not be: (1) in violation of any order or resolution not subject to review promulgated by the State Air Resources Board or an air pollution control district; (2) subject to cease and desist order not subject to review issued pursuant to Section 13301 of the Water Code for violation of waste discharge requirements or discharge prohibitions; or (3) finally determined to be in violation of provisions of federal law relating to air or water pollution.
Environmental Services 1. Preparation of Environmental Documentation (CEQA/NEPA) including but not limited to the following: a. Initial Study b. Categorical Exemption (CE) c. Notice of Exemption (XXX) d. Negative Declaration (ND) e. Mitigated Negative Declaration (MND) f. Notice of Preparation (NOP) g. Environmental Impact Report (EIR) i. Initial Document (Screen Check/Administrative Draft) ii. Addendum iii. Supplemental
Disaster Services In the event of a local, state, or federal emergency, including natural, man-made, criminal, terrorist, and/or bioterrorism events, declared as a state disaster by the Governor, or a federal disaster declared by the appropriate federal official, Grantee may be called upon to assist the System Agency in providing the following services: i. Community evacuation; ii. Health and medical assistance; iii. Assessment of health and medical needs; iv. Health surveillance; v. Medical care personnel; vi. Health and medical equipment and supplies; vii. Patient evacuation; viii. In-hospital care and hospital facility status; ix. Food, drug and medical device safety; x. Worker health and safety; xi. Mental health and substance abuse; xii. Public health information; xiii. Vector control and veterinary services; and xiv. Victim identification and mortuary services.
High Risk Activities 1. The Software is not fault-tolerant and is not designed, manufactured or intended for use or resale as on-line control equipment in hazardous environments requiring fail-safe performance, such as in the operation of nuclear facilities, aircraft navigation or communication systems, air traffic control, direct life support machines, or weapons systems, in which the failure of the Software could lead directly to death, personal injury, or severe physical or environmental damage ("High Risk Activities"). Syncro and its suppliers specifically disclaim any express or implied warranty of fitness for High Risk Activities.
Preventive Care and Early Detection Services This plan covers, early detection services, preventive care services, and immunizations or vaccinations in accordance with state and federal law, including the Affordable Care Act (ACA), as set forth below and in accordance with the guidelines of the following resources: • services that have an A or B rating in the current recommendations of the U.S. Preventative Services Task Force (USPSTF); • immunizations recommended by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention; • preventive care and screenings for infants, children, and adolescents as outlined in the comprehensive guidelines supported by the Health Resources and Services Administration (HRSA); or • preventive care and screenings for women as outlined in the comprehensive guidelines as supported by HRSA. Covered early detection services, preventive care services and adult and pediatric immunizations or vaccinations are based on the most currently available guidelines and are subject to change. The amount you pay for preventive services will be different from the amount you pay for diagnostic procedures and non-preventive services. See the Summary of Medical Benefits and the Summary of Pharmacy Benefits for more information about the amount you pay. This plan covers the following preventive office visits. • Annual preventive visit - one (1) routine physical examination per plan year per • Pediatric preventive office and clinic visits from birth to 35 months - 11 visits; • Well Woman annual preventive visit - one (1) routine gynecological examination per plan year per female member.
