Customer Complaints and Adverse Events Sample Clauses

Customer Complaints and Adverse Events. 4.2.1 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. RESPONSIBILITIES
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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: [******]
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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).
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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.
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Customer Complaints and Adverse Events. All customer complaints will be managed in accordance with the Quality Agreement.
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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.
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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.

  • 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.

  • 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;

  • 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.

  • Litigation, Environmental and Labor Matters (a) There are no actions, suits, proceedings or investigations by or before any arbitrator or Governmental Authority pending against or, to the knowledge of the Borrower, threatened against or affecting the Borrower or any of its Subsidiaries (i) as to which there is a reasonable possibility of an adverse determination and that, if adversely determined, could reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect or (ii) that involve this Agreement or the Transactions.

  • 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.

  • Environmental Compliance and Reports Borrower shall comply in all respects with any and all Environmental Laws; not cause or permit to exist, as a result of an intentional or unintentional action or omission on Borrower's part or on the part of any third party, on property owned and/or occupied by Borrower, any environmental activity where damage may result to the environment, unless such environmental activity is pursuant to and in compliance with the conditions of a permit issued by the appropriate federal, state or local governmental authorities; shall furnish to Lender promptly and in any event within thirty (30) days after receipt thereof a copy of any notice, summons, lien, citation, directive, letter or other communication from any governmental agency or instrumentality concerning any intentional or unintentional action or omission on Borrower's part in connection with any environmental activity whether or not there is damage to the environment and/or other natural resources. Additional Assurances. Make, execute and deliver to Lender such promissory notes, mortgages, deeds of trust, security agreements, assignments, financing statements, instruments, documents and other agreements as Lender or its attorneys may reasonably request to evidence and secure the Loans and to perfect all Security Interests.

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