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.
13.2 Distributor shall maintain accurate and detailed records of the customers it delivers Products to and the Products delivered, for such periods as are required by all applicable laws, regulations and directives. B may examine and make copies of any records required as part of a traceability program at reasonable times during business hours. Distributor’s customer lists, invoices and other traceability records are confidential information of Distributor protected under the confidentiality provisions in this Agreement.
13.3 The obligations of the Parties upon the occurrence of an adverse event in respect of any Products covered by this Agreement are set out in Exhibit F.
13.4 B and Distributor agree that the procedure for field corrective action in respect of any Product shall be as set out in Exhibit G. Distributor agrees to abide by these guidelines in the event a product recall is required.
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.
7.4.2 Product Recall - CLIENT is responsible for instituting a PRODUCTS recall due to any defect considered sufficiently serious. CLIENT will notify C*P of any recall which may be due to the manufacturing of PRODUCTS. C*P will provide a rapid initial response and a full report within ten working 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.
8.2 Each party shall notify the other party of any regulatory action taken by a Regulatory Authority concerning the safety of the API within two (2) days of the action being taken and will provide the other party with complete information concerning that action. In addition, each party will notify the other of any action taken anywhere concerning the safety of any Finished Product produced with the API, promptly upon becoming aware of the action being taken.
8.3 In the event of a voluntary or mandatory recall of a quantity of the Finished Product which is materially attributable to the API purchased from Plantex or which results from any negligent act or omission of Plantex, Plantex agrees that it will assume all risk of loss and will indemnify and hold Purepac and its Affiliates harmless from any and all loss (except incidental or consequential loss, such as, for example, loss of business or of profits), liability, damage, claim, cost and expense (including, without limitation, reasonable attorney's fees and liabilities for personal injury suffered by any person) (collectively, "Loss") directly or indirectly arising from or incidental to any such recall of Finished Product, less any insurance recoveries paid to Purepac or its Affiliates.
8.4 In the event of a voluntary or mandatory recall of a quantity of the Finished Product which is not materially attributable to the API or which has not resulted from any negligent act or omission of Plantex, Purepac agrees that it will assume all risk of loss and will indemnify and hold Plantex and its Affiliates harmless from any and all Loss directly or indirectly arising from or incidental to any such recall of Finished Product.
8.5 In addition to the obligations set forth in Sections 8.2, 8.3 and 8.4 hereof, each party will disclose to the other party all regulatory notices or recalls which relate to the API within seven (7) days of receipt of such notice or knowledge of such recall.
Product Complaints and Recalls. 18.1 If Supplier receives a complaint related to the Products, Supplier will refer such complaint and all related information in writing to Compass within five (5) business days. Upon receiving notice of a complaint, Supplier will provide the following information to Compass: Products affected including name, lot number (if available), description of the complaint, source of the complaint, and date of discovery.
18.2 In the event that Compass or any Authority determines that any Products are subject to be recalled or withdrawn from distribution, Compass will promptly inform Supplier in writing. Compass will notify any regulatory agencies of any recall, and will be responsible for coordinating all necessary activities regarding the action taken. Supplier and Compass agree to cooperate fully regarding any proposed recall, Product withdrawal, or field correction, and the Parties agree to keep each other advised, and to exchange copies of such documentation as may be required, to assure regulatory compliance. Compass will have the right to implement any such recall campaign and return defective Products to Supplier or destroy such Products, as determined by Compass in its reasonable discretion. If a recall campaign is implemented, at Compass’ option, Supplier shall promptly replace any defective Products and provide such replacement Products to Compass. Supplier will be liable for all of Compass’ costs associated with any recall campaign if such recall campaign is based upon a reasonable determination that the Products fail to conform to the warranties set forth in this Agreement; provided, however, that Supplier shall not be responsible for any costs associated with any recall campaign to the extent the recall is the result of any defect in Compass' specifications, designs, instructions or manuals for the Products.
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.
7.4.2 Product Recall - POZEN is responsible for instituting a PRODUCTS recall due to any defect considered sufficiently serious. POZEN will notify C*P of any recall which may be due to the manufacturing of PRODUCTS. C*P will provide a rapid initial response, perform investigations and provide a full report within ten working days.
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. 7.4.1 Product Complaints - ORPHAN is responsible for receiving and initially investigating any PRODUCTS complaints. ORPHAN 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 ORPHAN, C*P will promptly perform investigations for these problems. Investigation reports will be forwarded to ORPHAN within 30 days.
7.4.2 Product Recall - ORPHAN is responsible for instituting a PRODUCTS recall due to any defect considered sufficiently serious. ORPHAN will notify C*P of any recall which may be due to the manufacturing of PRODUCTS. C*P will provide a rapid initial response, perform investigations and provide a full report within ten working days.
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. 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.
