3-DAA Combined Therapy Sample Clauses

3-DAA Combined Therapy. (i) The Parties intend, pursuant to this Agreement, to collaborate to conduct clinical trial(s) of the 3-DAA Combined Therapy, which shall include (x) a clinical trial in healthy volunteers to evaluate drug-drug interactions among the 435 Compound, 055 Compound and the Idenix Compound (hereinafter “3-DAA DDI Trial”) and (y) unless a Safety Reason arises in the 3-DAA DDI Trial that precludes the development of the 3-DAA Combined Therapy, a Phase 2 clinical trial evaluating the 3-DAA Combined Therapy (the “3-DAA Phase 2 Trial”) (each, a “Collaboration Trial,” and collectively, the “Collaboration Trials”). Unless 2.1(b)(i)(y) applies, Idenix shall proceed with the 3-DAA Phase 2 Trial after the results of the 3-DAA DDI Trial are received and in the event that Idenix fails to proceed with the conduct of the 3-DAA Phase 2 Trial, in addition to any other remedies that may be available to Xxxxxxx under this Agreement, the Parties agree that the grant provided to Idenix in 3.1(ii) below relating to the Joint Study Data will be automatically revoked except for communications by Idenix to Regulatory Authorities. (ii) Each of the Collaboration Trials of Section 2.1(b)(i) shall be conducted in accordance with a protocol (the “Protocol”) to be agreed upon by the Parties through agreement of the JDC, with such amendments as may be agreed upon by the JDC; provided that (A) the Protocol for the 3-DAA DDI Trial shall be similar to the Protocol for the 2-DAA DDI Trial attached hereto as Exhibit A and (B) Xxxxxxx will provide the initial synopsis of the Protocol design for the 3-DAA Phase 2 Trial and the Protocol for such Clinical Trial shall be based upon such synopsis. If the Parties fail to agree on (x) the final Protocol for the 3-DAA DDI Trial for the 3-DAA Combined Therapy on or before [**], or such later date as may be agreed upon by the Parties, or (y) the final Protocol for the 3-DAA Phase 2 Trial within [**] business days after each Party receives the results from the 3-DAA DDI Trial, or such later date as may be agreed upon by the Parties, then in each case such dispute shall be referred to the Executive Officers for resolution. If in each case the Executive Officers are unable to reach resolution within [**] business days after such referral to them, then the final decision regarding the final Protocol will be made by the Executive Officer of Xxxxxxx, so long as any suggestions by Xxxxxxx do not exceed more than [**] percent ([**]%) of the allocated Collaboration ...
AutoNDA by SimpleDocs

Related to 3-DAA Combined Therapy

  • Speech Therapy This plan covers speech therapy services when provided by a qualified licensed • 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.

  • Professional Development; Adverse Consequences of School Exclusion; Student Behavior The Board President or Superintendent, or their designees, will make reasonable efforts to provide ongoing professional development to Board members about the adverse consequences of school exclusion and justice-system involvement, effective classroom management strategies, culturally responsive discipline, appropriate and available supportive services for the promotion of student attendance and engagement, and developmentally appropriate disciplinary methods that promote positive and healthy school climates, i.e., Senate Bill 100 training topics. The Board will conduct periodic self-evaluations with the goal of continuous improvement. New Board Member Orientation The orientation process for newly elected or appointed Board members includes:

  • 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.

  • Diagnostic procedures to aid the Provider in determining required dental treatment.

  • 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.

  • 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.

  • Skilled Care in a Nursing Facility This plan covers skilled nursing services in a skilled nursing facility if: • the services are prescribed by a physician: • your condition needs skilled nursing services, skilled rehabilitation services or skilled nursing observation; • the services are provided by or supervised by licensed technical or professional medical personnel; and • the services are not custodial care, respite care, day care, or for the purpose of assisting with activities of daily living.

  • DISADVANTAGED BUSINESS ENTERPRISE OR HISTORICALLY UNDERUTILIZED BUSINESS REQUIREMENTS The Engineer agrees to comply with the requirements set forth in Attachment H, Disadvantaged Business Enterprise or Historically Underutilized Business Subcontracting Plan Requirements with an assigned goal or a zero goal, as determined by the State.

  • 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.

  • 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.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!