Customer Complaints and Adverse Events. Will maintain procedures and satisfactory quality control standards and record keeping practices for receiving and handling PRODUCT quality complaints (PQCs) and adverse events. X X 4.2.2 Will collect and log all information relating to PQCs and adverse events. X X ***Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Customer Complaints and Adverse Events. Distributor shall report to Seller as without undue delay after such complaint has come to Distributor´s attention, any complaint from a customer concerning the use of a Product or any report of an adverse patient reaction from being treated with a Product. In the event of death or an unanticipated serious deterioration in a patient's state of health, the report shall be provided by Distributor to Seller immediately. Reports shall be made to Seller’s Quality Assurance Department via e-mail: [******] CC: [******]

Customer Complaints and Adverse Events. NTI, as required by cGMP, shall maintain all customer complaint and adverse event files relating to Drug Products. Any such complaints received by BPS shall be forwarded to NTI. NTI shall be responsible reviewing each such complaint or adverse event to determine the need for an investigation or the need to report such complaint or adverse event to the FDA, as required by cGMP. NTI shall send to BPS all Drug Product performance or manufacturing-related complaints which require investigation, and shall provide to BPS a list of, and a sample of, all Batches of Drug Product which are the subject of such complaints. BPS shall conduct an investigation, if required by applicable SOPs, for each such Batch of Drug Product for which BPS receives such sample from NTI, and BPS shall report its findings and follow-up of each such investigation to NTI. NTI shall make a copy of these complaint files available to BPS in the event they are required by BPS during an FDA inspection related to a Drug Product(s).

Customer Complaints and Adverse Events. Xxxxxxx, as required by cGMP, shall maintain all customer complaint and adverse event files. Any such complaints received by Xxxxxxxx shall be forwarded to Xxxxxxx. Xxxxxxx shall be responsible for the review of the complaint or adverse event to determine the need for an investigation or the need to report to the FDA or any other applicable Regulatory Authority as required by cGMP. Xxxxxxx shall send to Xxxxxxxx all Contracted Product complaints received by Xxxxxxx which require investigation (and shall provide to Xxxxxxxx all Contracted Product which is the subject of such complaints). Xxxxxxxx shall conduct an evaluation for each Contracted Product complaint and further investigate those complaints pursuant to Xxxxxxxx SOPs. Xxxxxxxx shall report findings and follow-up of each investigation to Xxxxxxx within [****]. Xxxxxxx shall make these complaint files available to Xxxxxxxx in the event they are required during an FDA inspection.

Customer Complaints and Adverse Events. AMYLIN shall maintain all customer complaint and adverse event files. Any such complaints received by XXXXXX shall be forwarded to AMYLIN. AMYLIN shall be responsible for the review of the complaint or adverse event to determine the need for an investigation or the need to report to the applicable Regulatory Authority as required. AMYLIN shall send to XXXXXX all Product performance or manufacturing-related complaints which require investigation and shall provide to XXXXXX Product which is the subject of such complaints in accordance with the Quality Agreement. If XXXXXX receives such returned samples, XXXXXX shall conduct an investigation for each Product performance or manufacturing-related complaint and shall report findings and follow-up of each investigation to AMYLIN at no cost to AMYLIN. AMYLIN shall make these complaint files available to XXXXXX in the event they are required during an inspection by a Regulatory Authority. Typical timelines are five (5) calendar days for notification and twenty-eight (28) calendar days for completion of investigations.

Customer Complaints and Adverse Events. All customer complaints will be managed in accordance with the Quality Agreement.

Related to Customer Complaints and Adverse Events

Adverse Events Subsequent to the date hereof, there shall not have occurred any of the following: (i) a suspension or material limitation in trading in securities generally on the New York Stock Exchange, the NASDAQ National Market or the NASDAQ Global Market, (ii) a general moratorium on commercial banking activities in the People’s Republic of China or New York, (iii) the outbreak or escalation of hostilities involving the United States or the People’s Republic of China or the declaration by the United States or the People’s Republic of China of a national emergency or war if the effect of any such event specified in this clause (iii) in your reasonable judgment makes it impracticable or inadvisable to proceed with the public offering or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus, or (iv) such a material adverse change in general economic, political, financial or international conditions affecting financial markets in the United States or the People’s Republic of China having a material adverse impact on trading prices of securities in general, as, in your reasonable judgment, makes it impracticable or inadvisable to proceed with the public offering of the Shares or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus.
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.
No Adverse Events Between the date hereof and the Closing Date, neither the business, assets or condition, financial or otherwise, of the Company taken as a whole shall have been materially adversely affected in any manner.
Adverse Event Reporting Both Parties acknowledge the obligation to comply with the Protocol and / or applicable regulations governing the collection and reporting of adverse events of which they may become aware during the course of the Clinical Trial. Both Parties agree to fulfil and ensure that their Agents fulfil regulatory requirements with respect to the reporting of adverse events.
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 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.
Notice of Suits, Adverse Events Furnish Agent with prompt notice of (i) any lapse or other termination of any Consent issued to any Borrower by any Governmental Body or any other Person that is material to the operation of any Borrower's business, (ii) any refusal by any Governmental Body or any other Person to renew or extend any such Consent; and (iii) copies of any periodic or special reports filed by any Borrower with any Governmental Body or Person, if such reports indicate any material change in the business, operations, affairs or condition of any Borrower, or if copies thereof are requested by Lender, and (iv) copies of any material notices and other communications from any Governmental Body or Person which specifically relate to any Borrower.
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.
Patent Filing Responsibilities and Costs 1. The invention and patent rights herein apply to any patent application or patents covering an invention made under this Agreement. Each Party is responsible for its own costs of obtaining and maintaining patents covering sole inventions of its employees. The Parties may agree otherwise, upon the reporting of any invention (sole or joint) or in any license granted. 2. Partner shall include the following in patent applications for an invention made jointly between NASA employees, its Related Entity employees and Partner employees: The invention described herein may be manufactured and used by or for the U.S. Government for U.S. Government purposes without the payment of royalties thereon or therefore.

Customer Complaints and Adverse Events Sample Clauses

Filter & Search

Related Clauses

Parent Clauses

Related to Customer Complaints and Adverse Events