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 of the Company that is received by either Purchaser or the Company 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 the Company 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. (a) PERIMMUNE shall maintain an appropriate record of all claims made or to be made regarding the Product's performance. The parties shall share with each other all data on confirmed lot-specific Product complaints including, but not limited to, complaints or information regarding performance and/or allegations or reports of any negative effect from the use or misuse of such affected lot of Product as soon as such data is available. Each party will provide reasonable assistance to the other in resolving customer complaints to the extent the complaint arises out of any fault or omission of the party whose assistance is requested. However, MENTOR shall have sole responsibility and authority to interact directly with MENTOR's customers in the resolution of such complaints and PERIMMUNE agrees that it will only interact with MENTOR in such matters.
(b) PERIMMUNE shall evaluate and investigate all customer complaints in connection with the Product which may be brought to its attention, in writing, by MENTOR, provided that such complaints (i) have been confirmed by MENTOR's QA/QC or technical service personnel using the same standards for confirmation which MENTOR uses for products other than the Product and (ii) are believed in good faith by MENTOR to arise out of a fault or omission attributable to PERIMMUNE. Within twenty (20) calendar days following receipt from MENTOR of the original notification of each such complaint, PERIMMUNE agrees to provide MENTOR with a written interim or final complaint investigation report. All such Product complaints reported to PERIMMUNE by MENTOR shall be reviewed monthly by PERIMMUNE until closure, and a summary report thereof will be provided by PERIMMUNE to MENTOR.
(c) PERIMMUNE will report to MENTOR all data and/or information pertaining to adverse reports on any lot of Product supplied by PERIMMUNE for distribution by MENTOR which would have an adverse impact on performance of the Product.
(d) Should there be a difference of opinion between PERIMMUNE and MENTOR regarding whether a field notification or recall is necessary, MENTOR will exercise the right to notify its customers without delay.
Product Complaints. Each Party shall maintain a record of all complaints it receives with respect to the Product (each, a "Product Complaint"). For purposes of this Section 6.3, a "Product Complaint" is a report of an actual or potential failure of the Product to meet the standards set forth in regulatory filings or in agreements among the Parties. The responsibilities of the Parties with respect to (a) notification of the Product Complaint from the receiving Party to the other Party and (b) the handling of Product Complaints shall all be performed in accordance with a procedure to be mutually agreed by the Parties after the Effective Date.
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.
