Product Complaints/Reports. The parties expect that APOLLO shall receive any complaint, claim or adverse reaction report regarding the Product. However (and except as otherwise noted below) in the event that ESTABLISHMENT receives any complaint, claim or adverse reaction report regarding any Product, including, but not limited to, notices from a competent Regulatory Authority regarding any regulatory non-compliance of a Product, upon notice, ESTABLISHMENT shall within a reasonable time frame provide APOLLO with all information related to such complaint, report, or notice and such additional information regarding the Product as may be reasonably requested. ESTABLISHMENT shall provide as much information as it has, to allow APOLLO comply with the competent Regulatory Authority requirements for complaint handling. If Product contains a defect which could or did cause death or serious bodily injury, ESTABLISHMENT shall immediately provide APOLLO with a complete description of all relevant details known to ESTABLISHMENT concerning any such incident, including but not limited to, a description of any defect and such other information which may be necessary to report to the competent Regulatory Authority or any Ministry of Health. APOLLO is responsible for filing any/all MDR Reports as required by the competent Regulatory Authority.
Product Complaints/Reports. Flextronics shall notify LumiraDx promptly after receiving any complaint or return and provide LumiraDx with a complete copy of the complaint and all other relevant information and shall provide reasonable assistance to LumiraDx in resolving or addressing any such complaint.
Product Complaints/Reports. Except as otherwise noted below, in the event that Supplier receives any complaint, claim or adverse reaction report regarding any Product or regarding any regulatory non-compliance of Product, Supplier shall within [**] business days in case of critical issues and within [**] days in case of non-critical issues, provide Kala with all information contained in such complaint, report, or notice and such additional information regarding the Product as may be reasonably requested. If any complaint related to the Product contains a defect that could or did cause death or serious bodily injury. Supplier shall immediately provide Kala with a complete description of all relevant details known to Supplier concerning any such incident, including but not limited to, a description of any defect and such other information that may be necessary to report the incident to the FDA or any other Ministry of Health.
Product Complaints/Reports. Each Party shall promptly provide the other Party notice of any information regarding real or potential defects and complaints about the Products or would reasonably be material to the safety of them for their intended use. Each Party shall reasonably cooperate with the other in sharing any information that may constitute a complaint related to the Products. The Parties shall further use reasonable efforts to assist one another in investigating and correcting any problems that end user customers may experience with the Products, and implement any corrective action or communication. Vendor shall reimburse Distributor for the cost and expense incurred in the performance of those actions.
Product Complaints/Reports. Customer shall be responsible for handling all complaints and inquiries related to the Products made by users of the Products, and any reporting requirements related thereto. Subject to compliance with applicable laws and regulations, Flextronics shall promptly provide to Customer any information received by Flextronics regarding any compliant or adverse event with respect to the Products. Each party shall reasonably cooperate with the other in sharing any information that may constitute a complaint related to the Products.
Product Complaints/Reports. Supplier shall promptly provide to CCI any information received by Supplier regarding real or potential deficiencies or defects in the Products and any information that might otherwise constitute a complaint about the Products or would reasonably be considered material to the safety of the Products and/or the Product’s intended use. Each party shall reasonably cooperate with the other in sharing any information that may constitute a complaint related to the Products or services. Supplier shall at all times reasonably cooperate with any requests arising from a CCI investigation, inspection or inquiry regarding the Products.
Product Complaints/Reports. Except as otherwise noted below, in the event that Command receives any complaint, claim or adverse reaction report regarding any Product, including, but not limited to, notices from the FDA regarding any regulatory non-compliance of Product, Command shall provide KORU with all information contained in such complaint, report, or notice and such additional information regarding the Product as may be reasonably requested. Command shall comply with FDA requirements for complaint handling. If Product contains a defect which could or did cause death or serious bodily injury, Command shall immediately provide KORU with a complete description of all relevant details known to Command concerning any such incident, including but not limited to, a description of any defect and such other information which may be necessary to report the incident to the FDA or any other Ministry of Health. KORU is responsible for filing any/all MDR Reports as required by the FDA.
Product Complaints/Reports. Purchaser shall handle all complaints and inquiries related to the Product made by users of the Product and any reporting requirements related thereto. Each Party shall reasonably cooperate with the other in sharing any information that may constitute a complaint related to the Product. Seller will reimburse Purchaser for all direct expenses reasonably related to complaints related to materially defective Product.
Product Complaints/Reports shall be responsible for handling all complaints and inquiries related to the Products, and any reporting requirements related thereto. Either Party shall promptly provide to the other any information received by it regarding real or potential deficiencies or defects in the Products and any information that might otherwise constitute a complaint about the Products or would reasonably be considered material to the safety of the Products for their intended use. Each Party shall reasonably cooperate with the other in sharing any information that may constitute a complaint related to the Products and shall designate a representative responsible for the exchange of such information and all other regulatory information required to be shared under this Agreement. ***** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Product Complaints/Reports. Except as otherwise noted below, in the event that Oishi receives any complaint, claim or adverse reaction report regarding any Product, including, but not limited to, notices from the FDA (or any other Governmental Authority) regarding any regulatory non-compliance of Product, Developer shall within seven (7) business days, provide Scilex with all information contained in such complaint, report, or notice and such additional information regarding the Product as may be reasonably requested. Oishi shall comply with FDA (or any other Governmental Authority) requirements tor complaint handling. If Product contains a defect which could or did cause death or serious bodily injury, Oishi shall immediately provide Scilex with a complete description of all relevant details known to Oishi concerning any such incident, including but not limited to, a description of any defect and such other information which may be necessary to report the incident to the FDA or any other Governmental Authority.
