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;
Product Complaints. Distributor agrees to use its reasonable efforts to promptly report to Supplier all available information concerning any product complaints not related to death or serious injury that it is aware of. This information will be reported to assist Supplier in monitoring the quality and safety of its Products, and to allow Supplier to meet its reporting obligations under the United States Medical Device Reporting regulations (21 CFR 803.1 et seq.) and Medical Device Vigilance Guidelines, if applicable. Information concerning such product complaints may be reported to the Supplier either verbally or in writing. A “product complaint’ is any written or oral expression of dissatisfaction as to the identity, quality, durability, reliability, safety, effectiveness, or performance of a Product. Product complaints associated with a death or serious injury, or a malfunction that could reasonably be expected to result in a death or serious injury if the malfunction recurs, or any adverse event relating to a Product, will be reported to Supplier immediately upon Distributor’s knowledge of that information.
Product Complaints. MTI will promptly provide notice to ev3 of the occurrence of any of the following: (a) receipt of any Product quality claims or complaints or other written legal claims or complaints, (b) receipt of any medical claims, complaints or problems, or (c) receipt of any written communication from any applicable regulatory agency pertaining to the Products.
Product Complaints. From and after the Closing, Purchaser shall be solely responsible for responding to any complaint regarding the Products that is received by either Purchaser or Seller after the Closing Date from any source and for investigating and analyzing such complaint and making required reports to FDA, regardless of whether the Products involved were sold by Seller or Purchaser.
Product Complaints. Each party shall immediately inform the other by telephone or facsimile of quality, health or safety related concerns or inquiries that raise potentially serious and unexpected quality, health or safety concerns as to any of the Products. All such other information not involving any of the above shall be transmitted to the other party within three (3) business days following receipt.
Product Complaints ev3 will promptly provide notice to MTI of the occurrence of any of the following within the Territory: (a) receipt of any Product quality claims or complaints or other written legal claims or complaints, (b) receipt of any medical claims, complaints or problems, or (c) receipt of any written communication from any applicable regulatory agency pertaining to the Products.
Product Complaints. Prometheus shall provide prompt notice to GSK in writing of any and all complaints that Prometheus receives which implicate GSK's manufacturing or other processes at the Facility. Any and all complaints of which GSK becomes aware relating to any Product shall promptly be forwarded to Prometheus' senior quality officer or his designee. Written notification between the Parties shall be given as defined in the Quality Agreement. Prometheus shall be responsible for all complaint interactions with any Third Party complainant and, subject to Section 6.7, any Product replacement if required.
Product Complaints. Seller will collect, investigate, and timely respond to complaints or inquiries from Hillrom relating to safety, quality, or efficacy of Products and will initiate corrective actions as necessary. To the extent Seller investigates any complaints relating to the safety, efficacy, or quality of Products, Seller will notify Hillrom within fifteen (15) days of Seller’s findings. Seller shall maintain a complaint file and records relating to each complaint as required by Legal Requirements.
Product Complaints. Nipro shall promptly investigate and monitor ------------------ all Customer and/or regulatory complaints and/or correspondence concerning the use of the FreeStyle Products in the Territory. Nipro shall use commercially reasonable efforts to advise TheraSense of all complaints alleging patient injury promptly, if possible within twenty four (24) hours, but not more than five (5) days business days following the date Nipro receives such complaint, and of all other complaints relating to the FreeStyle Products as promptly as possible but not more than five (5) business days following the date Nipro receives such complaint. In addition, within fifteen (15) calendar days following the date Nipro receives such complaint, Nipro shall also provide TheraSense with a materially complete written report relating thereto. Any notice to TheraSense under this Section 8.10 shall be sent via facsimile and overnight delivery service to the attention of TheraSense's Vice President of Regulatory Affairs or to such other address or person as TheraSense may designate by notice.
Product Complaints. Disetronic shall promptly investigate and monitor ------------------ all Customer and/or regulatory complaints and/or correspondence concerning the use of the FreeStyle Products in the FreeStyle Territory. Disetronic shall advise TheraSense of all complaints alleging patient injury within twenty four (24) hours, and of all other complaints relating to the FreeStyle Products as promptly as possible but not more than five (5) business day following the date Disetronic receives such complaint. In addition, within fifteen (15) calendar days following the date Disetronic receives such complaint, Disetronic shall also provide TheraSense with a materially complete written report relating thereto. Any notice to TheraSense under this Section 7.11 shall be sent via facsimile and email to the attention of TheraSense's Vice President of Regulatory Affairs or to such other address or person as TheraSense may designate by notice. Receipt of both (i) a legible facsimile and (ii) an email shall constitute legal notice under this Section 7.11, and such notice shall be deemed given upon the latter of (i) or (ii) if not simultaneously dated. Without limiting the effectiveness of legal notice by facsimile and email as set forth above, if requested by the notified party, the notifying party shall also send such notice via overnight delivery. If Disetronic fails to submit timely any report pursuant to this Section 7.11, TheraSense may require that Disetronic pay in full prior to shipment of any orders by TheraSense until such report is submitted.
