Common use of Product Complaints Clause in Contracts

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. (a) PERIMMUNE Should either party experience any quality problem of any specific lot(s) of Product supplied to SIGMA by IVAX DIAGNOSTICS, such party will notify the other in writing by facsimile prior to the initiation of a MDR, MDVS, field correction or recall and the parties shall maintain an appropriate record of all claims made or to be made consult with each other regarding the Product's performanceproper course of action, provided that each party retains the right to correct quality problems, as it deems appropriate, with or without the concurrence of the other. All information about Product complaints shall be considered "Confidential Information" under the terms of this Agreement. (b) Either party shall immediately notify the other party in writing should it become aware of any defect or condition that renders any lot(s) of Product supplied by IVAX DIAGNOSTICS to SIGMA in violation of the United States Food, Drug and Cosmetic Act, or of a similar law of any jurisdiction or country where the Product is sold. The parties shall share with each other all data on confirmed lot-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 Products 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 SIGMA shall have sole responsibility and authority to interact directly with MENTORSIGMA's customers in the resolution of such complaints and PERIMMUNE IVAX DIAGNOSTICS agrees that it will only interact with MENTOR SIGMA in such matters. (bc) PERIMMUNE IVAX DIAGNOSTICS shall evaluate and investigate all customer complaints in connection with the Product Products which may be brought to its attention, in writing, by MENTOR, SIGMA; provided that such complaints (i) have been confirmed by MENTOR's QA/QC or technical service personnel SIGMA using the same standards for confirmation which MENTOR SIGMA's uses for products other than the Product IVAX DIAGNOSTICS Products and (ii) which are believed in good faith by MENTOR SIGMA to arise out of a fault or omission attributable to PERIMMUNEIVAX DIAGNOSTICS. Within twenty (20) calendar days following receipt from MENTOR SIGMA of the original notification of each such complaint, PERIMMUNE IVAX DIAGNOSTICS agrees to provide MENTOR SIGMA with a written interim or final complaint investigation report. All such Product complaints reported to PERIMMUNE IVAX DIAGNOSTICS by MENTOR SIGMA shall be reviewed monthly by PERIMMUNE IVAX DIAGNOSTICS until closure, and a summary report thereof will be provided by PERIMMUNE IVAX DIAGNOSTICS to MENTORSIGMA. (cd) PERIMMUNE IVAX DIAGNOSTICS will report to MENTOR SIGMA all data and/or information pertaining to adverse reports on any lot of Product supplied by PERIMMUNE IVAX DIAGNOSTICS for distribution by MENTOR SIGMA, which would have an a materially adverse impact on performance of the ProductProducts. (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 (aor its respective Affiliate) PERIMMUNE shall maintain an appropriate record use its Commercially Reasonable Efforts to within two (2) Business Days after receipt, but not longer than five (5) Business Days after receipt, provide the other Party (or its respective Affiliate) with written notice via facsimile of all claims made complaints it receives that relate to, or arise from, GSK Supplied Product, including those concerning manufacture, packaging, labeling, safety or efficacy of GSK Supplied Product. Notwithstanding the foregoing, each Party (or its respective Affiliate) shall use its Commercially Reasonable Efforts to be made regarding within one (1) Business Day after receipt provide the other Party (or its respective Affiliate) with written notice via facsimile of all reports of complaints of tampering or contamination that relate to, or arise from, GSK Supplied Product's performance. GSK (or its Affiliate) will investigate all complaints associated with the manufacture, packaging, labeling, safety or efficacy of GSK Supplied Product and provide a written summary to PAR (or its Affiliates). PAR (or its Affiliate) will investigate all other complaints associated with the GSK Supplied Product and will provide a written summary to GSK (or its Affiliate). The parties shall share responsible Party (or its Affiliate) also will provide a written response on each complaint to each complainant with a copy to the other Party. The Parties (and their respective Affiliates) will reasonably cooperate with each other all data on confirmed lot-specific concerning the investigation of GSK Supplied Product complaints includingcomplaints, but not limited toincluding GSK’s (or its Affiliate’s) testing of GSK Supplied Product and review of documents, 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 and will provide reasonable assistance such information as reasonably requested by the other Party (or its respective Affiliate) in connection with such investigations; provided however, that neither Party (nor their respective Affiliates) shall have any obligation to provide its confidential business information to the other Party unless required by Applicable Law. The Parties (or their respective Affiliates) shall collaborate in resolving customer developing procedures for providing information on GSK Supplied Product 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 inquiries and such procedures will be outlined in the resolution of such complaints Quality Agreement. Nothing in this Section 5.8(a) shall affect the Parties’ (and PERIMMUNE agrees that it will only interact their respective Affiliates’) obligations with MENTOR respect to pharmacovigilance reporting, as detailed in such mattersSection 4.4. (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. (a) PERIMMUNE Should either party experience any quality problem of any specific lot(s) of Product supplied to SIGMA by IVAX DIAGNOSTICS, such party will notify the other in writing by facsimile prior to the initiation of a MDR, MDVS, field correction or recall and the parties shall maintain an appropriate record of all claims made or to be made consult with each other regarding the Product's performanceproper corrective action, provided that each party retains the right to correct quality problems, as it deems appropriate, with or without the concurrence of the other. All information about Product complaints shall be considered "Confidential Information" under the terms of this Agreement. (b) Either party shall immediately notify the other party in writing should it become aware of any defect or condition that renders any lot(s) of Product supplied by IVAX DIAGNOSTICS to SIGMA in violation of the United States Food, Drug and Cosmetic Act, or of a similar law of any jurisdiction or country where the Product is sold. The parties shall share with each other all data on confirmed lot-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 Products 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 SIGMA shall have sole responsibility and authority to interact directly with MENTORSIGMA's customers in the resolution of such complaints and PERIMMUNE IVAX DIAGNOSTICS agrees that it will only interact with MENTOR SIGMA in such matters. (bc) PERIMMUNE IVAX DIAGNOSTICS shall evaluate and investigate all customer complaints in connection with the Product Products 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 SIGMA; which MENTOR uses for products other than the Product and (ii) are believed in good faith by MENTOR SIGMA to arise out of a fault or omission attributable to PERIMMUNEIVAX DIAGNOSTICS. Within twenty (20) calendar days following receipt from MENTOR SIGMA of the original notification of each such complaint, PERIMMUNE IVAX DIAGNOSTICS agrees to provide MENTOR SIGMA with a written interim or final complaint investigation reportreport as well as corrective and preventive actions if applicable. All such Product complaints reported to PERIMMUNE IVAX DIAGNOSTICS by MENTOR SIGMA shall be reviewed monthly by PERIMMUNE IVAX DIAGNOSTICS until closure, and a summary report thereof will be provided by PERIMMUNE IVAX DIAGNOSTICS to MENTORSIGMA. (cd) PERIMMUNE IVAX DIAGNOSTICS will report to MENTOR SIGMA all data and/or information pertaining to adverse reports on any lot of Product supplied by PERIMMUNE IVAX DIAGNOSTICS for distribution by MENTOR SIGMA, which would have an a materially adverse impact on performance of the ProductProducts. (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. (a) PERIMMUNE shall maintain an appropriate record of Collagen will receive locally, and promptly investigate and monitor, 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 Customer complaints including, but not limited to, complaints or information regarding performance and/or allegations or reports of any negative effect from correspondence concerning 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 requestedLicensed Products worldwide. HoweverCollagen will maintain complaints files during the course of this Agreement, MENTOR shall have sole responsibility its extensions and authority to interact directly with MENTOR's customers in the resolution for a period of such complaints and PERIMMUNE agrees that it will only interact with MENTOR in such matters5 years thereafter. (b) PERIMMUNE shall evaluate and investigate Collagen advise ArthroCare of all customer complaints in connection with relating to the Product which may be brought to its attentionLicensed Products as promptly as possible but no more than two (2) business days following the date Collagen receives such complaint. In addition, in writing, by MENTOR, provided that such complaints within fifteen (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 (2015) calendar days following receipt from MENTOR of the original notification of each date Collagen receives such complaint, PERIMMUNE agrees to Collagen shall also provide MENTOR ArthroCare with a written interim pt electronic report of such complaint. Upon ArthroCare’s request, Collagen shall either: (1) investigate and gather ant reasonable additional information regarding such complaints that is requested by ArthroCare; or final complaint investigation report(2) provide ArthroCare with the relevant Customer names, phone numbers and/or addresses so that ArthroCare may gather this information. All such Product complaints reported Any notice to PERIMMUNE by MENTOR ArthroCare under this section 11.2 shall be reviewed monthly sent via facsimile and overnight delivery service to the attention of ArthroCare’s Vice President of Quality and Regulatory Affairs at (000) 000-0000 or such other address or person as ArthroCare may designate by PERIMMUNE until closure, and notice. Collagen shall also provide to ArthroCare a summary report thereof will be provided written quarterly listing of Customer and/or regulatory complaints received by PERIMMUNE to MENTORCollagen during the previous quarter. (c) PERIMMUNE will report Any and all MDR (FDA CFR §§ 803,804) near incident or incident (per EC Vigilance requirements) complaints reporting shall be mutually reviewed prior 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 submission of the Productsame to the FDA or Competent Authority. ArthroCare’s decision to file adverse incident reports shall be final and any such reports shall be reported in ArthroCare’s name. Any reports of substantial unanticipated adverse effects for injury or potential injury by the Licensed Products shall be reported to the other party within seven (7) days. (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.