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.
(b) The relevant contact person with respect to Adverse Events shall be: If to ASL: Facsimile No.: (000) 000 0000 Telephone No.: (000) 000 0000 E-mail: @xxxxxxxxxxxxxx.xxx If to Reliant: Reliant Medical Affairs Fax: 0-000-000-0000 Tel: 0-000-000-0000 0-000-000-0000
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. 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. 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. 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. Each Party shall notify the other Party of any quality complaints that it receives concerning any Product in the Territory within ninety-six (96) hours of receiving such complaint, except that all complaints concerning suspected or actual product tampering, contamination or any Product that is out-of-Specification shall be delivered within twenty-four (24) hours of receiving such complaint, and any complaint that includes a possible Adverse Drug Experience shall be reported to Manufacturer in accordance with Section 7.1(a)(i).
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. "PRODUCT QUALITY COMPLAINT" shall mean any complaint that questions the purity, identity, potency or quality of any Product, its packaging or labeling, any complaint that concerns any incident that causes any Product or its labeling to be mistaken for, or applied to, another article, any bacteriological contamination, any significant chemical, physical or other change or deterioration in any distributed Product or any failure of any Product to meet its applicable Specifications. Where the subject matter of the Product Quality Complaint relates in any way to the responsibilities of a Party under this Agreement or the duties performed by a Party hereunder, such Party shall, within three Business Days but not more than five days from receipt of written notice by such Party from the other Party or receipt by such Party of any other information from a Third Party constituting a Product Quality Complaint, initiate a complaint investigation at such Party's expense. Such Party shall conduct such investigation expeditiously. The investigating Party shall report its findings to the other Party's contact listed below in Section 6.1(b) or (c), as the case may be.
Product Quality Complaints. For so long as Bxxx, its Affiliate or permitted designee is the manufacturer of any Licensed Product, Bxxx will consult with Gxxxx, but Bxxx shall have responsibility, at its sole cost and expense, for handling all Product Quality Complaints concerning such Licensed Products in the Territory, except to the extent such Product Quality Complaint is attributable to Galen’s (or its designees’, subcontractors’ or Affiliates’) breach of their respective obligations or representations or warranties under this Agreement or the Supply Agreement, in which case, Gxxxx shall reimburse Bxxx for the reasonable cost and expense of handling such Product Quality Complaint. Gxxxx will provide reasonable cooperation and assistance to Bxxx upon request in connection therewith. Gxxxx shall inform Bxxx’x Vice President Regulatory Affairs (or his or her designee) of any Product Quality Complaint received within three (3) Business Days but no more than four (4) calendar days from the date received by Gxxxx. With respect to any Licensed Product that is not manufactured by Bxxx or its Affiliate under the Supply Agreement, Gxxxx shall have responsibility, at its sole cost and expense, for handling all Product Quality Complaints concerning such Licensed Product. “Product Quality Complaint” means any complaint that questions the purity, identity, potency or quality of any Licensed Product, its packaging, or labeling, or any complaint that concerns any incident that causes the drug 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 distributed drug product, or any failure of one or more distributed batches of the drug product to meet the specifications therefor in the applicable ANDA for such Licensed Product. Such information shall be sent to Bxxx as set forth in Section 4.5 above, and, upon receipt, Bxxx will initiate a complaint investigation. For Product Quality Complaints received by Bxxx relating to the Licensed Products, Bxxx will notify Gxxxx within three (3) Business Days but no more than four (4) days from the receipt date by Bxxx and, if manufactured by or for Bxxx, will initiate a complaint investigation. Bxxx shall conduct such investigation and report its findings to Galen’s Regulatory Affairs Department.
