Product Complaints and Adverse Event Reports Sample Clauses

Product Complaints and Adverse Event Reports. Integrator will ensure that End User reports all End User complaints regarding the HealthPresence Products promptly to Cisco’s Technical Assistance Center, using the keyword “HealthPresence.” Notwithstanding the foregoing, in the event Integrator becomes aware of an event involving a death or serious injury that may have been caused by a HealthPresence Product or a failure of the HealthPresence Products to meet performance specifications or otherwise fail to perform in accordance with their intended use such that there is a risk of potential death or serious injury to a user, patient or other person in close proximity to the HealthPresence Product (an “Event Requiring Notice to Cisco”), Integrator shall provide written notification to Cisco of an Event Requiring Notice to Cisco within twenty-four
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Product Complaints and Adverse Event Reports. From and after the Effective Date, Purchaser shall be responsible for responding to any complaint regarding the Product that is received by either Purchaser or Seller on or after the Effective Date from any source and for investigating and analyzing such complaint and making required reports to the FDA and equivalent foreign governmental entities, regardless of whether the Product involved was sold by Seller or Purchaser; provided that Purchaser shall promptly provide Seller with notice and copies of all correspondence with any such entities to the extent such correspondence relates to the Product sold under Seller’s labeler code, and Seller shall reasonably cooperate and assist Purchaser in a timely manner with such reporting obligations by furnishing copies of product complaints and other relevant documents for which Seller receives. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (a) Without limiting the foregoing, in the event that Seller receives any adverse experience report with respect to the Product (an “AE Report”), Seller will: (i) notify Purchaser of such AE Report and provide Purchaser with copies of all source documents relating to such AE Report (in each case, via email to the AE Report email address specified below, with confirmation to the Purchaser primary contact specified below, or to such other email address and primary contact as may be specified by Purchaser upon written notice to Seller (the “Purchaser PV Contact”)), and will use commercially reasonable efforts to provide such notice to Purchaser within two (2) calendar days of receipt of such AE Report (and in any event will provide such notice to Purchaser within five (5) calendar days of receipt of such AE Report) and (ii) promptly provide Purchaser with the original source documents relating to such AE Report via express courier addressed to the Purchaser PV Contact. Purchaser and Seller, on a monthly basis, will reconcile adverse experience reports relating to the Product received during the twelve (12) month period following the Closing, so as to ensure that all AE Reports received by Seller were also received by Purchaser. (b) The initial Purchaser PV Contact shall be as follows: Primary contact Name: Xxxxxxx X. Xxxxxxx Job Title: Head of Global Drug Safety & Risk Management Tel: +...
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Related to Product Complaints and Adverse Event Reports

  • 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.

  • 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.

  • 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.

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

  • 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.

  • 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.

  • 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.

  • Incident Reports Any serious occurrence involving a beneficiary, outside the normal routine of the OTP (see TRICARE Operations Manual (XXX), Chapter 7, Section 4), shall be reported to the referring military providers and/or Military Treatment Facility (MTF)/Enhanced Multi-Service Market (eMSM) referral management office (on behalf of the military provider), and DHA, and/or a designee, as follows: (a) An incident of a life-threatening accident, patient death, patient disappearance, suicide attempt, incident of cruel or abusive treatment, or any equally dangerous situation involving a beneficiary, shall be reported by telephone on the next business day with a full written report within seven days. (b) The incident and the following report shall be documented in the patient’s clinical record. (c) Notification shall be provided, if appropriate, to the parents, legal guardian, or legal authorities.

  • 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.

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