For Safety or Regulatory Concerns Sample Clauses

For Safety or Regulatory Concerns. Astellas may terminate this Agreement on a Product-by-Product basis effective upon thirty (30) days’ prior written notice to Ambit at any time referencing this Section 9.2.2 and providing Ambit with all clinical data supporting such termination together with a detailed written explanation of why Astellas believes that the Adverse Safety/Tox Results (as defined below) justify discontinuing all development and Commercialization hereunder. For purposes of the foregoing, “Adverse Safety/Tox Results” means, with respect to a particular Product, results from activities hereunder that provide a reasonable basis for the discontinuance by Astellas of all further development or Commercialization of such Products for use in the Field because the risk profile of such Product makes it unlikely that Regulatory Approval within the Field can be obtained or maintained for such Product in any of the U.S., EU or Japan. In the event that Ambit disputes Astellas’s decision to terminate in accordance with this Section 9.2.2, the Parties shall promptly refer such dispute for resolution pursuant to Section 10.7 and, if Astellas desires to terminate this Agreement for convenience regardless of the outcome of the dispute resolution procedure, Astellas shall provide Ambit with written notice of such intent, in which case Astellas shall be deemed to have provided Ambit with notice of termination pursuant to Section 9.2.1 as of the date that Astellas provided notice of its intent to terminate pursuant to this Section 9.2.2. Termination of this Agreement shall be effective upon the earlier to occur of (A) the expiration of the notice period provided in Section 9.2.1 and (B) conclusion of the dispute resolution process in Astellas’s favor. Without limitation of the foregoing, in the event that Astellas terminates this Agreement pursuant to this Section 9.2.2 with respect to the Lead Product, it shall have the right to terminate this Agreement simultaneously with respect to all Products by so specifying in writing to Ambit.
View SourceView Similar (4)

Related to For Safety or Regulatory Concerns

  • REGULATORY REQUIREMENTS/SAFETY Goods/Services supplied by Contractor shall meet all OSHA and other safety-related federal, state, local, and/or tribal regulatory requirements applicable to the Goods/Services.

  • Child Safety BCHS values children from all backgrounds and is committed to making our community a safe, nurturing and welcoming place for children to grow and develop. We are committed to making sure ALL children reach their individual potential.

  • Joint Occupational Health and Safety Committee The Employer and the Union recognize the role of the joint Occupational Health and Safety Committee in promoting a safe and healthful workplace. The parties agree that a Joint Occupational Health and Safety Committee shall be established for each Employer covered by this Collective Agreement. The Committee shall govern itself in accordance with the provisions of the Industrial Health and Safety Regulations made pursuant to the Workers’ Compensation Act. The Committee shall be as between the Employer and the Union, with equal representation, and with each party appointing its own representatives. Representatives of the Union shall be chosen by the Union membership or appointed by the Union. All minutes of the meetings of the Joint Occupational Health & Safety Committee will be recorded in a mutually agreeable format and will be sent to the Union. The Union further agrees to actively pursue with the other Health Care Unions a Joint Union Committee for the purposes of this Article. The Employer agrees to provide or cause to be provided to Employer members of the Joint Occupational Health and Safety Committee adequate training and orientation to the duties and responsibilities of committee members to allow the incumbents to fulfil those duties competently. The Union agrees to provide or cause to be provided to Union members of the Joint Occupational Health and Safety Committee adequate training and orientation to the duties and responsibilities of committee members to allow the incumbents to fulfil those duties competently. Such training and orientation shall take place within six (6) months of taking office.

  • Occupational Health and Safety Committee ‌ (a) The parties agree that a joint occupational health and safety committee will be established. The Committee shall govern itself in accordance with the provisions of the Occupational Health and Safety Regulations made pursuant to the Workers Compensation Act. The Committee shall be between the Employer and the Union, with equal representation, and with each party appointing its own representatives. The Union agrees to actively pursue with the other Health Care unions, where more than one union is certified with the Employer, a joint union/employer committee for the purposes of the Occupational Health and Safety Regulations. (b) Employees who are members of the Committee shall be granted leave without loss of pay or receive straight-time regular wages while attending meetings of the Joint Committee. Employees who are members of the Committee shall be granted leave without loss of pay or receive straight-time regular wages to participate in joint workplace inspections and joint accident investigations at the request of the Committee pursuant to the WCB Occupational Health and Safety Regulations. Committee meetings, workplace inspections and accident investigations shall be scheduled during normal working hours whenever practicable. (c) The Occupational Health and Safety Committee shall have as part of its mandate the jurisdiction to receive complaints or concerns regarding workload problems which are safety-related, the right to investigate such complaints, the right to define the problem and the right to make recommendations for a solution. Where the Committee determines that a safety-related workload problem exists, it shall inform the Employer. Within 21 days thereafter, the Employer shall advise the Committee what steps it has taken or proposes to take to rectify the safety-related workload problem identified by the Committee. If the Union is not satisfied with the Employer's response, it may refer the matter to the Industry Trouble shooter for a written recommendation. (d) No employee shall be disciplined for refusal to work when excused by the provisions of the

  • OCCUPATIONAL HEALTH AND SAFETY 34.01 The parties recognize the need for a safe and healthy workplace. The Employer shall be responsible for providing safe and healthy working conditions. The Employer and Employees will take all reasonable steps to eliminate, reduce or minimize all workplace safety hazards. Occupational health and safety education, training and instruction provided by the Employer, shall be paid at the Basic Rate of Pay, to fulfill the requirements for training, instruction or education set out in the Occupational Health and Safety Act, Regulation or Code. (a) There shall be an Occupational Health and Safety Committee (Committee), which shall be composed of representatives of the Employer and representatives of the Local and may include others representing recognized functional bargaining units. This Committee shall meet once a month, and in addition shall meet within 10 days of receiving a written complaint regarding occupational health or safety. An Employee shall be paid the Employee’s Basic Rate of Pay for attendance at Committee meetings. A request to establish separate committees for each site or grouping of sites shall not be unreasonably denied. The Employer shall provide training at no cost to all Employees on the Committee to assist them in performing their duties on the Committee. Training shall be paid at the Employee’s Basic Rate of Pay. (b) Minutes of each meeting shall be taken and shall be approved by the Employer, the Local, and other bargaining groups, referred to in (a), prior to circulation. (c) The purpose of the Committee is to consider such matters as occupational health and safety and the Local may make recommendations to the Employer in that regard. (d) If an issue arises regarding occupational health or safety, the Employee or the Local shall first seek to resolve the issue through discussion with the applicable immediate supervisor in an excluded management position. If the issue is not resolved satisfactorily, it may then be forwarded in writing to the Committee. (e) The Committee shall also consider measures necessary to ensure the security of each Employee on the Employer’s premises and the Local may make recommendations to the Employer in that regard. (f) (i) Should an issue not be resolved by the Committee, the issue shall be referred to the Chief Executive Officer (CEO). A resolution meeting between the Local and the CEO, or designate(s), shall take place within 21 calendar days of the issue being referred to the CEO. The CEO or designate(s) shall reply in writing to the Local within seven (7) calendar days of the resolution meeting.