Adverse Events and Product Complaints Sample Clauses

Adverse Events and Product Complaints. Tris or its Affiliates will communicate to IPC or the agent contracted by IPC to manage Adverse Events pertaining to the Product on its behalf, any adverse event or product complaint (quality defect) reports received within (3) business days of Tris first learning of any such adverse event or complaint. IPC or its agent shall confirm receipt to Tris. If Tris does not receive confirmation of their receipt of the adverse event or product complaint report from IPC or its agent, Tris will re-send the report within forty-eight (48) hours and xxxx the report as resent. The cost of any such agent shall be borne entirely by IPC; provided, however, that if such agent was recommended by Tris and the rates negotiated by Tris, the initial set-up cost shall be fully borne by IPC and the monthly allocated cost associated with Adverse Event reporting for the Product for such agent (determined in accordance with such negotiated rates) shall be initially paid by Tris and deducted from Gross Sales in determining Net Sales. In the event either party becomes aware of (i) any adverse drug experience or reaction or other information indicating that any Product has any toxicity, sensitivity reactions or have otherwise been alleged to cause illness or injury of any kind or are adulterated, (ii) any product complaints made by customers or that will or could cause a field alert to be issued or (iii) any out-of-specification results or deviations from the approved manufacturing process that might in any manner adversely affect any Product or its supply hereunder, that party shall provide the other party with all data or other information reasonably available that the other party may reasonably require in connection with any reports or correspondence that either party is required to file with any governmental authority relative to the Product(s) in question. At all times during the term hereof, either party will notify the other promptly (i.e., within three (3) business days) if a party becomes aware of an occurrence of any of the events described in clauses (i), (ii) or (iii) of the immediately preceding sentence.
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Adverse Events and Product Complaints. Each Party shall (i) adhere to all requirements of applicable Laws which relate to the reporting and investigation of AEs anywhere in the Territory and keep the other Party informed of such matters, (ii) promptly inform the other Party of any material safety or health incidents related to any Final Product or Injection Catheter, including the use, manufacture, labeling or packaging of any of the foregoing, and (iii) promptly inform the other Party upon becoming aware of any unusual or unexpected reactions or events, malfunctions, safety or efficacy of or attributable to any Product or VEGF-2 or Injection Catheter and/or any Regulatory Authority action related thereto.
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Adverse Events and Product Complaints. Covetrus shall report to Vendor any adverse event, and/or product complaint, involving animals associated with any Product, whether or not considered to be product related, and whether or not used according to the label. In addition, Vendor shall report all product/manufacturing defects or product complaints (any communication that alleges deficiencies related to the identity, quality, purity, durability, reliability, safety, effectiveness, or performance) involving the Product to Covetrus. A reportable event may also include an environmental or residue- related observation. These events should be reported by each party to the other party within three (3) days and will provide the following information: (a) Reporter: name, address and phone number of animal owner and/or veterinarian; (b) Event: summary of what happened, when, concurrent treatments, how the reaction was treated and outcome of reaction, details of the alleged product complaint; (c) Animal: species, breed, age, weight, number treated, number reacted, number died, other health problems, state of health at time of reaction; (d)
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Adverse Events and Product Complaints. Distributor shall report to Vendor any adverse event, and/or product complaint, involving animals associated with any Product, whether or not considered to be product related, and whether or not used according to the label. In addition, Vendor shall report all product/manufacturing defects or product complaints (any communication that alleges deficiencies related to the identity, quality, purity, durability, reliability, safety, effectiveness, or performance) involving the Product distributed by Distributor to Distributor. A reportable event may also include an environmental or residue-related observation. These events should be reported by each party to the other party within three days and will provide the following information:
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Adverse Events and Product Complaints 
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Related to Adverse Events and Product Complaints

  • 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;

  • 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.

  • Environmental Studies Promptly conduct and complete, at Borrower’s expense, all such investigations, studies, samplings and testings as may be requested by Lender or any governmental authority relative to any substance, or any waste or by-product of any substance defined as toxic or a hazardous substance under applicable federal, state, or local law, rule, regulation, order or directive, at or affecting any property or any facility owned, leased or used by Borrower.

  • Product Claims You acknowledge that Company, not an App Distributor, is responsible for addressing any claims of yours or any third party relating to the Company application or your possession and/or use of the Company application, including, but not limited to: (i) product liability claims; (ii) any claim that the Company application fails to conform to any applicable legal or regulatory requirement; and (iii) claims arising under consumer protection or similar legislation. (5)

  • Regulatory Investigations It shall be the Administrator’s duty and responsibility, and not the Owner Trustee’s duty and responsibility, to cause the Trust to respond to, defend, participate in or otherwise act in connection with any regulatory, administrative, governmental, investigative or other proceeding or inquiry relating in any way to the Trust, its assets or the conduct of its business.

  • Complaints and Investigations 1. This article applies to complaints or allegations made externally and not from normal supervisory activities.

  • Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.

  • Environmental Matters; Environmental Reviews (a) Each Restricted Person will comply in all material respects with all Environmental Laws now or hereafter applicable to such Restricted Person as well as all contractual obligations and agreements with respect to environmental remediation or other environmental matters and shall obtain, at or prior to the time required by applicable Environmental Laws, all environmental, health and safety permits, licenses and other authorizations necessary for its operations and will maintain such authorizations in full force and effect.

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