Product Complaints and AE’s Sample Clauses

Product Complaints and AE’s. PURCHASER shall maintain complaint files with respect to the Product in accordance with cGMPs. [MANUFACTURER] will promptly notify PURCHASER by facsimile transmission of all Product complaints and AEs received by [MANUFACTURER] within two (2) days of its receipt thereof. All such notices shall be sent to the attention of the Director, Medical Affairs at PURCHASER, facsimile number (000) 000-0000. PURCHASER shall promptly provide [MANUFACTURER] with copies of any complaints received by PURCHASER relating to the manufacture or packaging of the Product. PURCHASER shall have responsibility for responding to all complaints, and for promptly providing [MANUFACTURER] with a copy of any responses to complaints relating to the manufacture or packaging of the Product. PURCHASER or its affiliates shall have responsibility for reporting all complaints relating to the Product to the FDA and any other regulatory authorities, including, but not limited to, complaints relating to the manufacture or packaging of the Product as well as adverse experience (AE) reports. PURCHASER will correspond with complainants as to any complaints associated with Product, whether received during or after the term hereof. [MANUFACTURER] will assist PURCHASER in investigating Product complaints relating to the manufacture or packaging of the Product by analyzing Product, manufacturing processes and components to determine the nature and cause of an alleged Product manufacturing defect or alleged Product failure. [MANUFACTURER] will also assist PURCHASER in the investigation of any Adverse Experience (AE) reported to either party when such AEs are reasonably believed to be attributable to the manufacture or packaging of the Product. If PURCHASER determines that any reasonable physical, chemical, biological or other evaluation should be conducted in relation to an AE or Product complaint relating to the manufacture or packaging of the Product, [MANUFACTURER] will conduct the evaluation and provide PURCHASER with a written report of such evaluation within thirty (30) days from receipt of PURCHASER’s written request for same, together with samples of the Product from the relevant lot.
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Related to Product Complaints and AE’s

  • Product Complaints Subdistributor shall promptly notify Distributor of (but in no event later than 24 hours after receipt), and provide, upon Distributor’s request, reasonable assistance to address and investigate, any complaint or adverse claim about any Product or its use of which Subdistributor becomes aware;

  • 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.

  • 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.

  • Customer Complaints Each party hereby agrees to promptly provide to the other party copies of any written or otherwise documented complaints from customers of Dealer received by such party relating in any way to the Offering (including, but not limited to, the manner in which the Shares are offered by the Dealer Manager or Dealer), the Shares or the Company.

  • 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.

  • 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.

  • Product Claims The parties acknowledge that NCR Voyix, not Apple, is responsible for addressing any claims you or any third party relating to the Software or your possession and/or use of the Software, including, but not limited to: (a) product liability claims; (b) any claim that the Software fails to conform to any applicable legal or regulatory requirement; and (c) claims arising under consumer protection or similar legislation.

  • Regulatory Investigations TCI and TLIC agree to cooperate fully in any insurance or judicial regulatory investigation or proceeding arising in connection with Contracts distributed under this Agreement. TCI and TLIC further agree to cooperate fully in any securities regulatory inspection, inquiry, investigation or proceeding or any judicial proceeding with respect to TLIC, TCI, their affiliates and their representatives to the extent that such inspection, inquiry, investigation or proceeding or judicial proceeding is in connection with Contracts distributed under this Agreement. Without limiting the foregoing: (a) TCI will be notified promptly of any customer complaint or notice of any regulatory inspection, inquiry investigation or proceeding or judicial proceeding received by TLIC with respect to TCI or any representative or which may affect TLIC’s issuance of any Contracts marketed under this Agreement; and (b) TCI will promptly notify TLIC of any customer complaint or notice of any regulatory inspection, inquiry, investigation or judicial proceeding received by TCI or any representative with respect to TLIC or its affiliates in connection with any Contracts distributed under this Agreement. In the case of a customer complaint, TCI and TLIC will cooperate in investigating such complaint and shall arrive at a mutually satisfactory response.

  • 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.

  • 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.

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