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HUMAN HEALTH PRODUCT Sample Clauses

HUMAN HEALTH PRODUCT. EVENT AMOUNT (DOLLARS) ----- ---------------- $1,000,000.00 (i) Submission of INDA or initiation of human clinical testing in any country (whichever occurs first) (ii) Commencement of Phase III human clinical $2,000,000.00 trials in any country (iii) NDA/PLA Filing in any country for human $4,000,000.00 use
HUMAN HEALTH PRODUCT. EVENT AMOUNT (DOLLARS) ----- ---------------- $ [ * ] (i) Submission of INDA or initiation of human clinical testing in any country (whichever occurs first) (ii) Commencement of Phase III human clinical $ [ * ] trials in any country (iii) NDA/PLA Filing in any country for human $ [ * ] use [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

Related to HUMAN HEALTH PRODUCT

  • HEALTH PROGRAM 3701 Health examinations required by the Employer shall be provided by the Employer and shall be at the expense of the Employer. 3702 Time off without loss of regular pay shall be allowed at a time determined by the Employer for such medical examinations and laboratory tests, provided that these are performed on the Employer’s premises, or at a facility designated by the Employer. 3703 With the approval of the Employer, a nurse may choose to be examined by a physician of her/his own choice, at her/his own expense, as long as the Employer receives a statement as to the fitness of the nurse from the physician. 3704 Time off for medical and dental examinations and/or treatments may be granted and such time off, including necessary travel time, shall be chargeable against accumulated income protection benefits.

  • FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

  • 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.

  • 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.

  • Accident Prevention Health and Safety Committee The Employer and the Union agree that they mutually desire to maintain standards of safety and health in the Hospital in order to prevent accidents, injury and illness. its responsibilities, under the applicable legislation, the Hospital agrees to accept as a member of its Accident Prevention - Health Safety Committee at least one representative selected or appointed by the Union from amongst bargaining unit employees. Such Committee shall identify potential dangers and hazards, institute means of improving health and safety programs and recommend actions to be taken to improve conditions related to safety and health. The Hospital agrees to co-operate providing necessary information to Committee to its functions. Meetings shall be held every second month or more frequently at the call of--the chair required. The Committee shall maintain minutes of all meetings and make the same available for review. Any representative appointed or selected in accordance with hereof shall serve for a term of one calendar year from the date of appointment, which may be renewed for further periods of one year. Time off for such representative(s) to attend meetings of the Acci- dent Prevention - Health & Safety Committee in accord- ance with the foregoing shall be granted and time so spent attending such meetings shall be deemed to be work time for which the representative(s) shall be paid by the Hospital at his regular or premium rate as may be applicable. The Union agrees to endeavour to obtain the full co-operation of its membership in the observation of all safety rules and practices. Pregnant employees may request to be transferred from their current duties if, in the professional opinion of the employee's physician, the pregnancy may be at risk. If such a transfer is not feasible, the pregnant employee, if she so requests, will be granted an unpaid leave of absence before commencement of the maternity leave referred to in Article Where the Hospital identifies high risk areas where employees are exposed to Hepatitis the Hospital will provide, at no cost to the employees, a Hepatitis B vaccine.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • 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.

  • 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.

  • Alcohol and Drug Testing Employee agrees to comply with and submit to any Company program or policy for testing for alcohol abuse or use of drugs and, in the absence of such a program or policy, to submit to such testing as may be required by Company and administered in accordance with applicable law and regulations.

  • Behavioral Health Services – Mental Health and Substance Use Disorder Inpatient - Unlimited days at a general hospital or a specialty hospital including detoxification or residential/rehabilitation per plan year. Preauthorization may be required for services received from a non-network provider. 0% - After deductible 40% - After deductible Outpatient or intermediate careservices* - See Covered Healthcare Services: Behavioral Health Section for details about partial hospital program, intensive outpatient program, adult intensive services, and child and family intensive treatment. Preauthorization may be required for services received from a non-network provider. 0% - After deductible 40% - After deductible Office visits - See Office Visits section below for Behavioral Health services provided by a PCP or specialist. Psychological Testing 0% - After deductible 40% - After deductible Medication-assisted treatment - whenrenderedby a mental health or substance use disorder provider. 0% - After deductible 40% - After deductible Methadone maintenance treatment - one copayment per seven-day period of treatment. 0% - After deductible 40% - After deductible Outpatient - Benefit is limited to 18 weeks or 36 visits (whichever occurs first) per coveredepisode. 0% - After deductible 40% - After deductible In a physician's office - limited to 12 visits per plan year. 0% - After deductible 40% - After deductible Emergency room - When services are due to accidental injury to sound natural teeth. 0% - After deductible The level of coverage is the same as network provider. In a physician’s/dentist’s office - When services are due to accidental injury to sound natural teeth. 0% - After deductible 40% - After deductible Services connected to dental care when performed in an outpatient facility * 0% - After deductible 40% - After deductible Inpatient/outpatient/in your home 0% - After deductible 40% - After deductible (*) Preauthorization may be required for this service. Please see Preauthorization in Section 5 for more information. You Pay You Pay Outpatient durable medical equipment* - Must be provided by a licensed medical supply provider. 20% - After deductible 40% - After deductible Outpatient medical supplies* - Must be provided by a licensed medical supply provider. 20% - After deductible 40% - After deductible Outpatient diabetic supplies/equipment purchasedat licensed medical supply provider (other than a pharmacy). See the Summary of Pharmacy Benefits for supplies purchased at a pharmacy. 20% - After deductible 40% - After deductible Outpatient prosthesis* - Must be provided by a licensed medical supply provider. 20% - After deductible 40% - After deductible Enteral formula delivered through a feeding tube. Must be sole source of nutrition. 20% - After deductible 40% - After deductible Enteral formula or food taken orally * 20% - After deductible The level of coverage is the same as network provider. Hair prosthesis (wigs) - The benefit limit is $350 per hair prosthesis (wig) when worn for hair loss suffered as a result of cancer treatment. 20% - After deductible The level of coverage is the same as network provider. Coverage provided for members from birth to 36 months. The provider must be certified as an EIS provider by the Rhode Island Department of Human Services. 0% - After deductible The level of coverage is the same as network provider. Asthma management 0% - After deductible 40% - After deductible Hospital emergency room 0% - After deductible The level of coverage is the same as network provider.