Adverse Event Reporting and Product Recall. (a) Each Party agrees to provide the other Party with the necessary safety information required by Regulatory Health Authorities to comply with Applicable Laws. AstraZeneca will hold the safety database for the Licensed Compounds and the Licensed Products and Ardelyx will provide safety information as required by Applicable Laws, in a timely manner. As promptly as possible following the Effective Date and in any event prior to the initiation of the Initial Studies, the IBS-C Study or any other Clinical Trial to be performed by Ardelyx under this Agreement, the Parties will enter into a detailed safety agreement (the “Safety Agreement”), governing, among other things, appropriate adverse event reporting procedures relating to Licensed Products and reflecting the provisions set forth above in this Section 4.7(a).
(b) In the event that any government agency or authority issues or requests a recall or takes similar action in connection with the Licensed Compounds or the Licensed Products, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal, the Party notified of or desiring such recall or market withdrawal shall promptly advise the other Party thereof. Following notification of a recall, AstraZeneca shall have the right to decide whether to conduct a recall or market withdrawal (except in the case of a government-mandated recall) in the Territory and shall have control of the manner in which any such recall or market withdrawal shall be conducted. AstraZeneca shall bear the expenses of any recall of a Licensed Product.
Adverse Event Reporting and Product Recall. (a) Each Party agrees to provide the other Party with the necessary safety information required by Regulatory Health Authorities to comply with Applicable Laws. Ardelyx will hold the safety database for the Licensed Compounds and the Licensed Products and FOSUN will provide safety information as required by Applicable Laws, in a timely manner. As promptly as possible following the Effective Date, but no later than the commencement of the first clinical trial by FOSUN in the Territory, the Parties will enter into a detailed safety agreement (the “Safety Agreement”), governing, among other things, appropriate adverse event reporting procedures relating to Licensed Products and reflecting the provisions set forth above in this Section 4.06(a). The Parties shall also enter into a detailed pharmacovigilance agreement at such time as the phase of Development of a Licensed Product by a Party, its Affiliates or Sublicensees would make such an agreement necessary or advisable.
(b) In the event that any government agency or authority issues or requests a recall or takes similar action in connection with the Licensed Compounds or the Licensed Products, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal, the Party notified of or desiring such recall or market withdrawal shall promptly advise the other Party thereof.
Adverse Event Reporting and Product Recall. (a) Each Party agrees to provide the other Party with the necessary safety information required by Regulatory Health Authorities to comply with Applicable Laws. EOC will maintain an adverse event database for clinical trials conducted in the Territory (“Territory Safety Database”) at its sole cost and expense. EOC shall be responsible for (i) reporting to the applicable Regulatory Health Authorities in the Territory, all quality complaints, adverse events and safety data related to the Product for clinical trials conducted in the Territory under the Development Plan and (ii) responding to safety issues and to all requests of Regulatory Health Authorities related to such safety issues with respect to the Product in the Field in the Territory, in each case ((i) and (ii)), in accordance with Applicable Law, the Pharmacovigilance Agreement and in consultation with Aadi. Aadi shall report to EOC, in accordance with the procedures set forth in the Pharmacovigilance Agreement, all adverse events occurring in the conduct of the activities by or on behalf of Aadi in the Territory for inclusion in the Territory Safety Database. EOC shall, to the extent permitted by applicable laws, at all times provide to Aadi access to the Territory Safety Database, and shall transfer the data included therein to Aadi for inclusion in the global adverse event database for the Product in accordance with the Pharmacovigilance Agreement and as reasonably requested by Aadi. As between the Parties, Aadi shall maintain a global adverse event database for the Product, at Aadi's cost and expense, except that within [***] of receipt of an invoice therefor, EOC shall reimburse Aadi for that portion of such costs and expenses resulting from EOC's Development and Commercialization of Products in the Territory. As promptly as possible following the Effective Date, but no later than [***] after the Effective Date or otherwise agreed by both Parties, the Parties will enter into a detailed pharmacovigilance agreement (the “Pharmacovigilance Agreement”), governing, among other things, appropriate adverse event reporting procedures and pharmacovigilance responsibilities of the Parties relating to Product and reflecting the provisions set forth above in this Section 4.07(a). Certain identified information marked with [***] has been excluded from this exhibit because it is not material and is of the type that the registrant treats as private and confidential.
(b) In the event that any Governmental Bod...
Adverse Event Reporting and Product Recall. (a) Each Party agrees to provide the other Party with the necessary safety information required by Regulatory Health Authorities to comply with Applicable Laws. Revance will hold the safety database for the Product and Fosun will provide safety information as required by Applicable Laws, in a timely manner. As promptly as possible following the Effective Date, but no later than six (6) months after the Effective Date or otherwise agreed by both Parties, the Parties will enter into a detailed pharmacovigilance agreement (the “Pharmacovigilance Agreement”), governing, among other things, appropriate adverse event reporting procedures and pharmacovigilance responsibilities of the Parties relating to Product and reflecting the provisions set forth above in this Section 4.07(a).
(b) In the event that any government agency or authority issues or requests a recall or takes similar action in connection with the Product, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal, the Party notified of or desiring such recall or market withdrawal shall promptly advise the other Party thereof. Fosun shall be responsible for any costs associated with a Product recall that is caused by damage during distribution, sales and marketing and related Commercialization activities in the Territory, while Revance shall be responsible for any costs associated with a Product recall that is caused by damage during manufacturing.
Adverse Event Reporting and Product Recall. Each Party agrees to provide the other Party with the necessary safety information required by Regulatory Authorities GDSVF&H\ ****Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. US-DOCS\97178923.5 to comply with Applicable Laws. Histogenics will hold the safety database for the Products and MEDINET will provide safety information as required by Applicable Laws, in a timely manner. Additional details regarding product recall and the Parties' respective pharmacovigilance activities and responsibilities will be set forth in the Parties' Master Quality, Supply and Pharmacovigilance Agreement.
Adverse Event Reporting and Product Recall. 6.1. The Parties shall comply with all Applicable Laws regarding the reporting of adverse experiences to the relevant authorities and hereby agree to the procedures attached hereto as Schedule 2 regarding such reporting and the exchange of adverse experience information.
6.2. In the event of an actual or threatened recall of the Product is required or recommended by a Competent Authority within the Territory or if recall of the Product is (i) reasonably deemed advisable by Distributor, Distributor’s Affiliates, or by Supplier, or (ii) jointly deemed advisable by Distributor and Supplier, such recall shall be promptly implemented, directed and administered by Supplier in a manner which is appropriate and reasonable under the circumstances and in conformity with accepted trade practices and the Technical Agreement.
6.3. The costs of the recall of the Product, including the cost of replacement quantities of Product, if any are needed or desired by Distributor, shall be borne by Supplier; provided that if the recall is due to Distributor’s negligent acts or omissions in handling, storing or packaging the Product or Distributor’s failure to comply with Applicable Laws, then the costs of the recall shall be borne by Distributor. Without limiting the generality of the foregoing, Distributor will have no obligation to pay costs of recalls of Product to the extent such recalls are (i) due to the withdrawal or cancellation of any approval for the Product by a Competent Authority, (ii) caused by actions of Third Parties occurring after such Product is sold by Distributor, (iii) due to packaging or labeling defects for which Supplier has responsibility or (iv) due to any breach by Supplier of its duties under this Agreement or Applicable Laws.
6.4. If Supplier is responsible for bearing the costs of a recall, Supplier will reimburse Distributor for all its reasonable costs and expenses of such recall.
6.5. If Distributor is responsible for bearing the costs of a recall, Distributor will reimburse Supplier for all its reasonable costs and expenses of such recall and Distributor shall be entitled but not obliged to take over and perform the recall of the Product and Supplier shall provide Distributor, at Distributor’s expense, with all such reasonable assistance as may be required by Distributor.
6.6. Each Party shall keep the other and the Joint Transition Team fully and promptly informed of any notification, event or other information, whether received directly or ind...
Adverse Event Reporting and Product Recall. Each Party agrees to provide the other Party with the necessary safety information required by Regulatory Health Authorities to comply with Applicable Laws. Ardelyx shall hold the safety database for the Licensed Compounds and the Licensed Products and KHK shall provide safety information as required by Applicable Laws, in a timely manner. As promptly as possible following the Effective Date, but no later than the commencement of the first clinical trial by KHK in the Territory, the Parties shall enter into a detailed safety agreement (the “Safety Agreement”), governing, among other things, appropriate adverse event reporting procedures relating to Licensed Products and reflecting the provisions set forth above in this Section 4.06.
Adverse Event Reporting and Product Recall. MedImmune will hold the safety database for the Licensed Antibodies and the Licensed Products and Innate will provide safety information as required by Applicable Laws, in a timely manner. Within [***] of the Effective Date and in any event prior to the initiation of the Development, the Parties will enter into a detailed safety agreement (the “Safety Agreement”), governing, among other things, appropriate adverse event reporting procedures relating to Licensed Products and reflecting the provisions set forth above in this Section 4.24.
Adverse Event Reporting and Product Recall. Adverse Event Reporting
7.1. A report is required when either Party becomes aware of information that reasonably suggests the Product has or may have caused or contributed to a Serous Adverse Event (as defined below) or a Non-Serious Adverse event (as defined below). The reporting Party shall report:
7.1.1 a Serious Adverse Event to the other Party within 24 hours from the time such Party first becomes aware of such Serious Adverse Event
7.1.2 a Non-Serious Adverse Event within 10 Business Days from the time such Party first becomes aware of such Non-Serious Adverse Event; provided, however, that medical and scientific judgment should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life threatening or result in death or hospitalisation but may jeopardise the patient or may require intervention to prevent a Serious Adverse Event outcome.
Adverse Event Reporting and Product Recall. The Parties shall comply with all Applicable Laws regarding the reporting of adverse experiences to the relevant authorities and hereby agree to the procedures attached hereto as Schedule 2 regarding such reporting and the exchange of adverse experience information.
