Product Quality Complaints. (a) Complaints that concern any incident that causes the Product or its labeling to be mistaken for, or applied to, another article or any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the Product, or any failure of one or more distributed batches of the Product to meet the Specifications shall be telephoned to both parties promptly upon receipt.
Product Quality Complaints. DISTRIBUTOR shall notify MACH 3 immediately in writing of any product quality complaints and any product packaging quality complaints from any party, including, without limitation, wholesalers, retailers, consumers, or governmental entities. DISTRIBUTOR agrees to coordinate any response to such complaints with MACH 3 and to follow instructions of MACH 3 and that of MACH 3 in dealing with any such complaints.
Product Quality Complaints. Distributor shall notify Company of any Product Quality Complaint promptly and in any event within twenty-four (24) hours of Distributor’s receipt of such Product Quality Complaint. Distributor shall provide Company with such further information and assistance in investigating such Product Quality Complaint as Company may reasonably request.
Product Quality Complaints. Express shall notify ATG in writing immediately of any Product quality complaints and any Product packaging quality complaints from any party, including, without limitation, wholesalers, retailers, consumers, or governmental entities. Express agrees to coordinate any response to such complaints with ATG and to follow ATG’s instructions in dealing with any such complaints. 12.
Product Quality Complaints. (a) The Company shall have sole responsibility, at its expense, for responding to all Product Quality Complaints received from Third Parties. BMS shall reimburse the Company for *** incurred by the Company for any Product Quality Complaint solely due to a *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
Product Quality Complaints. With respect to Product Quality Complaints received by a CAM or other Spectrum Personnel, such Spectrum Personnel shall promptly refer such Product Quality Complaint to Eagle’s call center for management of the report. With respect to Product Quality Complaints received by mail (or other written communication), Spectrum shall forward all correspondence to Eagle by secure e-mail or fax within two (2) business days after Spectrum’s receipt thereof. Notwithstanding the foregoing, Spectrum shall promptly, but in any event within one (1) day, notify Eagle of any information that it receives or generates that may require a recall, field alert, withdrawal or other corrective action related to the Product. Spectrum shall promptly, but in any event within two (2) days, notify Eagle of any information Spectrum receives regarding any threatened or pending action by the FDA or other Regulatory Authority which may affect any of the Products or the continued development or marketing of any Product. In the event of any Adverse Event involving the quality of a Product, the terms of Section 9.1 shall apply. Spectrum shall, at Eagle’s expense, cooperate with Eagle’s reasonable requests and use its Commercially Reasonable Efforts to assist Eagle, as may be reasonably requested by Eagle, in connection with (a) preparing any and all reports with respect to any of the Products in the Territory for submission to any Regulatory Authority, and (b) investigating and responding to any Product Quality Complaint related to any of the Products in the Territory. Eagle will inform Spectrum of any Product quality-related matters that may adversely affect the Product(s).
Product Quality Complaints. During the term CRTX or its designated agent shall have the full responsibility for responding to complaints from CRTX's Product Quality Complaints. XXX shall promptly notify CRTX in writing of any and all Product Quality Complaints received by XXX in accordance with a procedure mutually agreed to by the parties. All out-of-pocket costs incurred in respect of this Section 6.10 shall be borne by CRTX.
Product Quality Complaints. Subject to the terms of this Agreement, if, after conducting the reportability review set forth in Section 4.02(a), CMS determines that such information constitutes a Product Quality Complaint, it shall conduct, at its own cost, an investigation of such complaint pursuant to its internal quality standard operating procedures subject to this Section 5.01. CMS shall submit to the RMC a written report detailing a Product Quality Complaint reported in the Territory within seven (7) Business Days of it becoming aware of such complaint. Such report shall be in the English language and any source documents in another language shall be translated into English by CMS at CMS’s sole cost. CMS shall ensure that each Product Quality Complaint report shall include the following information: (a) name and contact information of reporter; (b) date of complaint; (c) Unique Device Identifier number; (d) whether the Product is the result of the Importation Paradigm or the Localization Paradigm; (e) if the Product is the result of the Localization Paradigm, the site(s) where the Bulk Product was Manufactured to the Finished Product; (f) description of the complaint; (g) whether such complaint is substantially similar to other complaints, and a reasonable description of such similarities; (h) whether the reporter used the Product in a manner consistent with its intended use; (i) how the reporter obtained the Product; (j) the name of reporter’s physician or any Person who may have prescribed the Product or directed the reporter to use the Product; and (k) any other information reasonably requested by Gelesis. CMS also will provide any information, within two (2) Business Days of request, requested by Gelesis or its agent for purposes of conducting its own investigation as to a Product Quality Complaint.
Product Quality Complaints. All Product Quality Complaints shall be dealt with in accordance with the Quality Agreement and the procedures agreed pursuant to Section 4.11(d). Xxxx will consult with Kos, but Xxxx shall have responsibility, at its sole cost and expense, for handling all Product Quality Complaints concerning Licensed Products, except to the extent such Product Quality Complaint is attributable to Kos' (or its designees', subcontractors' or Affiliates') breach of their respective obligations or representations or warranties under this Agreement, in which case, Kos shall reimburse Xxxx for the reasonable cost and expense of handling such Product Quality Complaint. At Xxxx'x cost and expense, Kos will provide reasonable cooperation and assistance to Xxxx upon request in connection therewith. Kos shall inform Xxxx'x Drug Safety Department of any Product Quality Complaint received by Kos within two (2) Business Days from the date received by Kos. Such information shall be sent to Xxxx as set forth in Section 4.11 above, and, upon receipt, Xxxx will initiate a complaint investigation. For Product Quality Complaints received by Xxxx relating to the Licensed Products, Xxxx will notify Kos within two (2) Business Days from the receipt date by Xxxx and will initiate a complaint investigation. Xxxx shall conduct such investigation and report its findings to Kos' Regulatory Affairs Department.
Product Quality Complaints. (a) Subject to Sections 6.1(b) through (d), Purchaser shall be responsible for responding to all Product Quality Complaints with respect to the Products. Both Parties shall cooperate to effect any resolutions with respect to any Product Quality Complaint. "
