Licensed Product Complaints. Bioventus shall cooperate with Q-Med in investigating and resolving customer complaints concerning the Licensed Product, including, to the extent practicable and feasible, obtaining relevant medical records, interviewing the administering physician and obtaining such other information as is necessary to a full understanding of the patient’s complaint, subject to compliance with applicable laws relating to the privacy of patient records. Among other things, the Parties shall promptly establish and implement a system for exchange of complaint and adverse event information between the Parties sufficient to allow each Party to comply with its respective indemnification obligations hereunder and under the New US License Agreement and adverse event reporting obligations, which shall include appropriate provisions for recording worldwide customer complaints relating to Licensed Product and prompt notice to the other Party of significant and/or potentially reportable adverse events. Bioventus shall cooperate fully with Q-Med in dealing with product complaints concerning the Licensed Product and shall take such action to promptly resolve such complaints as may be reasonably requested by Q-Med. Bioventus shall provide accurate and timely information to Q-Med about all complaints and adverse events, and shall otherwise cooperatively undertake investigations and provide information and analysis as reasonably requested by Q-Med. Bioventus shall provide appropriate medical advisory support to patients and physicians concerning the use of the Licensed Product and responding to product complaints and adverse events.
Licensed Product Complaints. Distributor and MPL each shall maintain complaint files for Licensed Products in accordance with Good Manufacturing Practices. Distributor and MPL each shall record any complaints received with respect to the Licensed Products substantially in the format attached hereto as EXHIBIT 6.08. MPL shall promptly provide to Distributor written notice (using the form specified in Section 6.08(a) above) of any complaints (and will provide copies of any written complaints) received by MPL with respect to any Licensed Product. Distributor shall promptly provide to MPL written notice (substantially in the format specified in Section 6.08(a) above) of any complaints (and will provide copies of any written complaints) received by Distributor with respect to any Licensed Product. Distributor shall have responsibility for responding to all complaints, and for promptly providing MPL with a copy of any responses to complaints, relating to the Licensed Products, including but not limited to complaints from competitors regarding promotional activities by Distributor. MPL shall cooperate with Distributor to provide any information MPL, in good faith, deems necessary to respond to such complaints. MPL shall have sole responsibility at its expense for reporting any complaints relating to the Licensed Products to the FDA (and any other Governmental Authority where required), including, but not limited to, complaints relating to the manufacture of the Licensed Products as well as adverse drug experience reports.
Licensed Product Complaints. BioAlliance will notify NovaDel within five (5) days of any customer complaints that relate to the Manufacture of Licensed Product. NovaDel shall conduct investigations to determine the validity and cause of the complaint and *** Portion for which confidential treatment requested.
Licensed Product Complaints. MITEK shall promptly communicate to ANIKA by facsimile, telephone or email (and confirm any such telephone communication as instructed at the time) any complaint received from users of the Licensed Product, in the configuration supplied by ANIKA. Each notification of a complaint shall contain, but not be limited to, the lot number, dosage size, expiration date, indication for actual use and description of circumstances involved in the failure of the Unit(s) in question. Each complaint notification will contain all the information available to MITEK at that time, including all information then available which is required in the ANIKA Complaint Form attached hereto as Exhibit F, and a summary of the proposed action to be taken by MITEK to comply with its legal obligations. MITEK will provide additional information promptly as it becomes available. MITEK acknowledges that complaint investigation is the responsibility of ANIKA, but MITEK reserves the right to directly contact its customers.
Licensed Product Complaints. The Parties shall determine which Party shall be responsible for complaint investigation by reference to their respective responsibilities under Applicable Law. Each Party shall promptly communicate to the other Party by facsimile, telephone or email (and confirm any such telephone communication as instructed at the time) any complaint received in respect of the Licensed Product in the configuration supplied by the other Party. To the extent applicable or known by the notifying Party, each notification of a complaint shall contain, but not be limited to, the lot number, dosage size, expiration date, indication for actual use, description of circumstances involved in the failure of the Unit(s) in question, and any other pertinent information available at that time to the Party that receives such complaint. The Parties shall reasonably cooperate to address the complaint, including providing access to employees with knowledge of facts pertinent to such complaint and making available all relevant documentation. For avoidance of doubt and notwithstanding the foregoing, nothing in this Section 12.2 is intended to shift between the Parties responsibilities under Applicable Law concerning complaints related to Licensed Products.
