Product Complaints and Incident Reporting Sample Clauses

Product Complaints and Incident Reporting. NK and Aspect shall inform each other (in writing) quarterly of any and all customer complaints that have come to their attention during the prior quarter regarding the BISx System or BIS Sensors that V.8. 12-5-06 Initials: 13/31 BISx INTERNATIONAL LICENSE AGREEMENT were used in conjunction with a NK Patient Monitor and relating to Aspect technology. Both parties will cooperate and use reasonable efforts to resolve such customer complaints. Closure of any such customer complaints relating to the BISx System or NK Patient Monitor will occur when the problem is resolved. Closure of any such customer complaint relating solely to Products or BIS Sensors will occur when the problem is resolved. NK and Aspect shall inform each other in writing of all known and/or reported incidents relating to the Products, distributed by NK and/or used in conjunction with NK Patient Monitors, within 2 business days of making a determination by NK or Aspect that such event may require reporting under any applicable regulatory or other governmental reporting requirements, including without limitation incidents involving death or serious injury, malfunctions that, if recurrent, may cause or contribute to death or serious injury or other material quality problems or concerns; provided, however, for the purposes of clarity, if such reportable event involves a third party product into which the BISx System or other Aspect product has been incorporated, but the cause of reportable incident was some other aspect or attribute of such third party product, then the notification requirement in this paragraph shall not apply. Aspect will be responsible for reporting such incidents to the appropriate regulatory authority for the BISx System and BIS Sensors in the United States and NK will guide Aspect with any reporting requirements in Japan. NK will be responsible for reporting such incidents to the appropriate regulatory authority for the NK Patient Monitor. Both parties shall fully cooperate with each other as may be necessary to comply with any reporting obligations regarding such incidents or quality concerns. If FDA or other authorities contact either party to inquire about or investigate the Products sold to NK under this Agreement, the contacted party, unless required to maintain confidentiality by such authorities, shall inform the other party immediately thereof. The parties shall cooperate closely to clear any regulatory issues or potential regulatory issues promptly.
Sample 1
AutoNDA by SimpleDocs
Product Complaints and Incident Reporting. Marquette and Aspect shall inform each other in writing immediately about any event that may require incident reporting in any country. Marquette and Aspect shall inform each other in writing within two (2) business days of a customer complaint regarding the Marquette BIS/EEG Module, the Aspect Products, or (within the Territory) Aspect BIS Sensors. Both parties will cooperate and use commercially reasonable efforts to resolve such customer complaints. Closure of any customer complaint relating to the Marquette BIS/EEG Module will occur when Marquette notifies Aspect that the problem is resolved. Closure of any customer complaint relating solely to Aspect Products or Aspect Sensors will occur when Aspect notifies Marquette that the problem is resolved.
Sample 1Sample 2
Product Complaints and Incident Reporting. Draeger and Aspect shall inform each other's Regulatory Affairs office (in writing) within [**] about any event involving mutually used technology that may require mandatory incident reporting to US & International Regulatory Agencies. Draeger and Aspect shall inform each other (in writing) within [**] business days of a customer complaint regarding the Draeger BISx System or Aspect BIS Sensors that were used in conjunction with a Draeger BISx System and relating to Aspect technology. Both parties will cooperate and use commercially reasonable efforts to resolve such customer complaints. Closure of any customer such complaints relating to the Draeger BISx will occur when Draeger notifies Aspect that the problem is resolved. Closure of any customer complaint relating solely to Aspect Products or Aspect BIS Sensors will occur when Aspect notifies Draeger that the problem is resolved.
Sample 1
Product Complaints and Incident Reporting. Datascope and Aspect shall inform each other in writing immediately about any event that may require incident reporting in any country. Datascope and Aspect shall inform each other in 11/32 ASPECT / DATASCOPE OEM DEVELOPMENT AND PURCHASE AGREEMENT writing within [**] business days of a customer complaint regarding the Datascope [**] System, the Aspect Products, or (outside the United States) Aspect BIS Sensors. Both parties will cooperate and use commercially reasonable efforts to resolve such customer complaints. Closure of any customer complaint relating to the Datascope [**] will occur when Datascope notifies Aspect that the problem is resolved. Closure of any customer complaint relating solely to Aspect Products or Aspect Sensors will occur when Aspect notifies Datascope that the problem is resolved.
Sample 1
Product Complaints and Incident Reporting. Dixtal and Aspect shall inform each other in writing immediately about any event that may require incident reporting in any country. Dixtal and Aspect shall inform each other in writing within two (2) business days of a customer complaint regarding the Dixtal BIS Module, the Aspect Products, or (within the Territory) Aspect BIS Sensors. Both parties will cooperate and use commercially reasonable efforts to resolve such customer complaints. Closure of any customer complaint relating to the Dixtal BIS Module will occur when Dixtal notifies Aspect that the problem is resolved. Closure of any customer complaint relating solely to Aspect Products or Aspect Sensors will occur when Aspect notifies Dixtal that the problem is resolved.
Sample 1
Product Complaints and Incident Reporting. Marquette and CDIC ----------------------------------------- shall inform each other by telephone and in writing promptly upon receiving notice of any event that may require incident reporting in any country. Marquette and CDIC shall inform each other in writing within two (2) business days of a customer complaint regarding the Marquette ICG Module, the CDIC Products, or CDIC DSB Sensors. The Parties shall cooperate and use commercially reasonable efforts to resolve such customer complaints in a timely manner. Closure of any customer complaint relating to the Marquette ICG Module shall occur when Marquette notifies CDIC that the problem has been resolved. Closure of any customer complaint relating solely to CDIC Products or CDIC DSB Sensors shall occur when CDIC notifies Marquette that the problem has been resolved.
Sample 1
Product Complaints and Incident Reporting. Philips and CDIC shall inform each other by telephone and in writing promptly upon receiving notice of any event that may require incident reporting in any country. Philips and CDIC shall inform each other in writing within two (2) business days of a customer complaint regarding the Philips ECG Products, the CDIC Products, DSB Sensors, or the ECG Device. The Parties shall cooperate and use commercially reasonable efforts to resolve such customer complaints in a timely manner. Closure of any customer complaint relating to the ICG/ECG Device or Philips ECG Products shall occur when CONFIDENTIAL TREATMENT REQUESTED Philips notifies CDIC that the problem has been resolved satisfactorily. Closure of any customer complaint relating solely to CDIC Products or DSB Sensors shall occur when CDIC notifies Philips that the problem has been resolved satisfactorily.
Sample 1
AutoNDA by SimpleDocs

Related to Product Complaints and Incident Reporting

  • 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 Event Reporting Sage shall adhere, and shall require that its Affiliates, Sublicensees, co-marketers and distributors adhere, to all requirements of applicable law and regulations that relate to the reporting and investigation of any adverse event, including without limitation an unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease, whether or not considered Captisol. Probe Study Product-related or Licensed Product-related, which occurs or worsens following administration of Captisol, Probe Study Product or Licensed Product. Sage shall provide CyDex with copies of ***Text Omitted and Filed Separately with the Securities and Exchange Commission Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4) and 230.406 all reports of any such adverse event which is serious (any such adverse event involving Captisol, the Probe Study Product or the Licensed Product that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in disability, congenital anomaly or is medically important (i.e., may require other medical or surgical intervention to prevent other serious criteria from occurring)) which Sage has reason to believe are associated with Captisol within 10 business days following (i) Sage’s submission of any such report to any regulatory agency, or (ii) receipt from Sage’s Sublicensee, co-marketer or distributor of any such report to any regulatory agency. Sage shall also advise CyDex regarding any proposed labeling or registration dossier changes affecting Captisol. Reports from Sage shall be delivered to the attention of Chief Scientific Officer, CyDex, with a copy to General Counsel, Ligand, at the address set forth in Section 14.7. The parties shall mutually cooperate with regard to investigation of any such serious adverse event, whether experienced by Sage, CyDex or any other Affiliate, Sublicensee, co-marketer or distributor of CyDex or Sage.

  • 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.

  • Incident Reporting Transfer Agent will use commercially reasonable efforts to promptly furnish to Fund information that Transfer Agent has regarding the general circumstances and extent of such unauthorized access to the Fund Data.

  • 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 Investigations Pacific Mutual, PEN, Selling Broker-Dealer and General Agent agree to cooperate fully in any insurance regulatory investigation or proceeding or judicial proceeding arising in connection with the Contracts distributed under this Agreement. Pacific Mutual, PEN, Selling Broker-Dealer and General Agent further agree to cooperate fully in any securities regulatory investigation or proceeding with respect to Pacific Mutual, PEN, Selling Broker-Dealer and General Agent, their affiliates and their agents or representatives to the extent that such investigation or proceeding is in connection with the Contracts distributed under this Agreement. Without limiting the foregoing:

  • Complaints Deal with complaints and correspondence of Institutions and Account holders directed to or brought to the attention of the Administrator;

  • Environmental Matters; Reporting The Credit Parties will observe and comply with, all laws, rules, regulations and orders of any government or government agency relating to health, safety, pollution, hazardous materials or other environmental matters to the extent non-compliance could result in a material liability or otherwise have a material adverse effect on the Borrower and the Subsidiaries taken as a whole. The Borrower will give the Administrative Agent prompt written notice of any violation as to any environmental matter by any Credit Party and of the commencement of any judicial or administrative proceeding relating to health, safety or environmental matters (a) in which an adverse effect on any operating permits, air emission permits, water discharge permits, hazardous waste permits or other permits held by any Credit Party which are material to the operations of such Credit Party, or (b) which will or threatens to impose a material liability on such Credit Party to any Person or which will require a material expenditure by such Credit Party to cure any alleged problem or violation.

  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

  • 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.

Time is Money Join Law Insider Premium to draft better contracts faster.