Product Complaints and Recalls. TransMedics, or their distribution partner, is responsible for receiving and initially evaluating any PRODUCT complaints. TransMedics will promptly notify Fresenius of all technical complaints received. TransMedics is responsible for reporting complaints to the appropriate regulatory authority, including adverse drug events reports. Fresenius is responsible to notify TransMedics immediately of any issues that could result in a PRODUCT recall. PRODUCT issues arising from stability data or other manufacturing issues that meet Field Alert Report criteria will be communicated by Fresenius to TransMedics in writing within five (5) business days. TransMedics, with data and assistance provided by Fresenius as may be reasonably requested by TransMedics, is responsible for filing Field Alerts. Recalls of the PRODUCTS will be conducted in accordance with all applicable laws and regulations; provided, however, that the final decision concerning any recalls and the conduct of any recall shall be made by TransMedics, with such assistance by Fresenius as may be reasonably requested by TransMedics.
Product Complaints and Recalls. 13.1 In the event that Distributor receives any complaints regarding the Products, it shall notify B immediately and shall comply with the applicable regulatory requirements of the Territory and the United States FDA regulatory requirements within the requisite time periods. Distributor will make a preliminary evaluation of each complaint it receives from customers and will conduct all follow-up and communications with customers which it deems appropriate with input from and discussion with B. B shall evaluate customer complaints and provide its findings to Distributor.
Product Complaints and Recalls. 7.4.1 Product Complaints - CLIENT is responsible for receiving and initially investigating any PRODUCTS complaints. CLIENT will notify C*P of any problems thought to be due to manufacture, which are found during the distribution of the product. When requested by CLIENT, C*P will promptly perform investigations for these problems. Investigation reports will be forwarded to CLIENT within 30 days.
Product Complaints and Recalls. 8.1 During the term of this Agreement, Plantex will assist Purepac with any necessary investigation arising from product complaints or Adverse Drug Events relating to the Finished Products. Such assistance shall include Plantex's re-testing the API at the reasonable request of Purepac and forwarding the results of such testing to Purepac as soon as reasonably possible. Plantex may charge Purepac for reasonable costs incurred related to this assistance, including but not limited to travel expenses and re-testing lab time.
Product Complaints and Recalls. 7.5.1 Product Complaints: Barrier is responsible for receiving and initially investigating any Product complaints. Barrier will notify DSM of any problems thought to be due to manufacture which are found during the distribution of the product. Upon receipt of the notice of complaints, DSM will promptly perform investigations for these problems. Investigation reports will be forwarded to Barrier within thirty (30) days following the date of receipt by DSM. Barrier is responsible for reporting any complaint to the appropriate regulatory authority including adverse drug events reports. Any complaint received by DSM will be immediately forwarded to Barrier.
Product Complaints and Recalls. 7.4.1 Product Complaints - POZEN is responsible for receiving and initially investigating any PRODUCTS complaints. POZEN will notify C*P of any problems thought to be due to manufacture, which are found during the distribution of the PRODUCTS. When requested by POZEN, C*P will promptly perform investigations for these problems. Investigation reports will be forwarded to POZEN within 30 days.
Product Complaints and Recalls. AADi shall manage and resolve all Third Party complaints, grievances, product quality and any and all matters relating to any product recalls with respect to any Licensed Product in the Territory. To the extent such Third Party complaints are a result of product quality, Abraxis will reasonably collaborate with AADi in a timely fashion to resolve such issues.
Product Complaints and Recalls. Enzon is responsible for receiving and initially evaluating any PRODUCT complaints. Enzon will promptly notify SkyePharma of all complaints received. Recalls of the PRODUCTS will be conducted in accordance with the appropriate SUPPLY AGREEMENT entered into by SkyePharma and Enzon. SkyePharma is responsible for reporting complaints to the appropriate regulatory authority, including adverse drug-events reports. Any complaint relating to any PRODUCT received by SkyePharma will be promptly forwarded to Enzon. SkyePharma, with data and assistance provided by Enzon, is responsible for filing Field Alerts.
Product Complaints and Recalls a. Product Complaints—CEPHALON is responsible for receiving and initially investigating any PRODUCTS complaints. CEPHALON will notify PATHEON of any problems thought to be due to manufacture, which are found during distribution of the product. When requested by CEPHALON, PATHEON will promptly perform investigations for these problems. Investigation reports will be forwarded to CEPHALON within [**].
Product Complaints and Recalls. From and after the Closing, the Parties will handle complaints, recalls, and market withdrawals as set forth in the Commercial Supply Agreement
