Complaints and ADE's Sample Clauses

Complaints and ADE's. Novartis shall have the sole responsibility for responding to questions and complaints from Novartis customers and for reporting adverse drug events ("ADE") as defined by applicable regulation to the relevant Regulatory Authorities, unless otherwise required by applicable laws, rules and regulations. Questions or complaints received by Cell Genesys shall be immediately referred to Novartis. The parties shall keep each other promptly and fully informed of any information concerning any ADE or pharmaceutical technical complaints coming to their knowledge with regard to any Option Product regardless of the origin of such information. Cell Genesys shall cooperate as reasonably required to allow Cell Genesys to determine the cause of and resolve any customer questions and complaints. Such assistance shall include follow-up investigations, including testing. In addition, as soon as possible in light of the circumstances, Cell Genesys shall provide Novartis with all requested information in order to assist Novartis in responding properly to questions or complaints relating to the Bulk Products. [*] Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
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Related to Complaints and ADE's

  • COMPLAINTS AND GRIEVANCES 7.01 If an employee has a complaint concerning the application, interpretation, administration, or alleged violation of any of the provisions of this Agreement, he/she shall take the matter up orally with his/her immediate Supervisor or designate within five (5) business days after the circumstance giving rise to the complaint. The Supervisor or designate will give his/her answer to the 7.02 If such complaint or question is not settled to the satisfaction of the employee, then the following steps of the grievance procedure may be invoked in order. It is understood that a grievance must be lodged within five (5) business days after receiving the Supervisor’s or designate response to the complaint as per article 7.01. STEP 1 Any employee grievance shall be set forth in writing, in duplicate, and shall be presented to the Supervisor. The submissions shall include reference to the specific clause and article of the Agreement allegedly violated or misinterpreted and redress sought. The Supervisor shall review the grievance and reply in writing to the Union within five (5) business days, giving his/her disposition and his/her reason thereof. STEP 2 If a settlement has not been reached under Step 1, the employee may within five (5) business days of the Supervisor's reply, refer the grievance to the Administrator of the Home, at interest, or his/her nominee. The Administrator of the Home or his/her nominee together with the employee and his/her Supervisor, and his/her Xxxxxxx, shall meet within five (5) business days of reference to the Administrator of the Home. The Administrator of the Home shall give his/her reply in writing to the Union within five (5) business days after date of meeting. STEP 3 If settlement has not been reached under Step 2, the employee may refer the grievance to his/her Union Grievance Committee which may within five (5) business days of the Administrator's reply refer the grievance to the Director of Human Resources or his/her designate. Within five (5) business days the Director of Human Resources or his/her designate together with such other representation as may be chosen to represent the Employer shall meet with the Union Grievance Committee to discuss the grievance. At this meeting a full-time representative of the Union may be present, if his/her presence is requested by the Employer or the Union. Written reply to the grievance shall be given to the Union within five (5) business days after such meeting. If a grievance is not settled to the satisfaction of either party to this Agreement by the procedure outlined above, then either party may, within ten (10) working days of the reply of the Director of Human Resources, refer the grievance to arbitration in accordance with the provisions contained in Article 9. 7.03 Any of the time allowances provided in the Article may be extended by mutual agreement in writing between the Union and the Employer. 7.04 Notwithstanding the provisions of the Ontario Labour Relations Act, any grievance not initiated or appealed at any stage of the grievance procedure, including reference to arbitration within the limits stipulated, shall be considered settled on the basis of the last decision and NOT subject to further appeal. 7.05 No employee written reprimand shall be entered in an employee's personnel file unless the employee and Local Recording Secretary or designate are given a copy of such written reprimand. 7.06 Saturdays and Sundays and paid holidays shall not be considered working days within the scope of this Article.

  • Procurement Related Complaints and Administrative Review 49.1 The procedures for making a Procurement-related Complaint are as specified in the TDS. 49.2 A request for administrative review shall be made in the form provided under contract forms.

  • COMPLAINTS AND INVESTIGATIONS 1. This article applies to complaints or allegations made externally and not from normal supervisory activities. 2. A department head shall be responsible for ensuring that all allegations of misconduct or other complaints against an employee on which any action is to be taken or a record is to be made shall be investigated. The investigator shall be allowed to interview the complainant prior to notifying the employee.

  • Complaints If you have a complaint relating to the sale of energy by us to you, or this contract generally, you may lodge a complaint with us in accordance with our standard complaints and dispute resolution procedures. Note: Our standard complaints and dispute resolution procedures are published on our website.

  • Complaints and Appeals As a Premera member, you have the right to offer your ideas, ask questions, voice complaints and request a formal appeal to reconsider decisions we have made. Our goal is to listen to your concerns and improve our service to you. If you need an interpreter to help with oral translation, please call us. Customer Service will be able to guide you through the service. We would like to hear from you. If you have an idea, suggestion, or opinion, please let us know. You can contact us at the addresses and telephone numbers found on the back cover. Please call us when you have questions about a benefit or coverage decision, our services, or the quality or availability of a healthcare service. We can quickly and informally correct errors, clarify benefits, or take steps to improve our service. We suggest that you call your provider of care when you have questions about the healthcare they provide.

  • Complaints Investigation The employee who complains of harassment under the provisions of the Human Rights Code must first comply with the Employer’s harassment policy procedures before filing a grievance or human rights complaint.

  • Legal Actions A Receiver may bring, prosecute, enforce, defend and abandon any action, suit or proceedings in relation to any Security Asset which he thinks fit.

  • Lawsuits There is no lawsuit, tax claim or other dispute pending or threatened against the Borrower which, if lost, would impair the Borrower's financial condition or ability to repay the loan, except as have been disclosed in writing to the Bank.

  • Delays and Complaints Delivery delays and service complaints will be monitored on a continual basis. Documented inability to perform under the conditions of the contract, via the Complaint to Vendor process (PUR 7017 form) contemplated for this Contract, may result in default proceedings and cancellation.

  • Complaints and Compensation If you have a complaint of any kind, please be sure to let us know. We will do our utmost to resolve the issue. You can put your complaint in writing to us at:

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