Notification of Complaints. Upon any Party receiving or becoming aware of any complaint involving the possible failure of the A1PI IV Product, in any location in the world, to meet any requirement of applicable law or regulation, and any serious or unexpected side effect, injury, toxicity or sensitivity reaction or any unexpected incidents associated with the distribution of the A1PI IV Product, whether or not determined to be attributable to the A1PI IV Product (i) such Party shall notify the other Party about such complaint and provide initial information about such complaint to the other Party within [*****] and shall provide all information about such complaint within [*****], (ii) promptly provide to the other Party copies of any complaints, and provide at the time of submission copies of any submissions to any Regulatory Authority regarding such complaints and (iii) with respect to adverse events, comply with the provisions of Section 11.4(c) above. Xxxxxx shall have responsibility for investigating such complaint in the Xxxxxx Territory, with cooperation and assistance from Kamada in the Xxxxxx Territory, and shall immediately inform Kamada of any information discovered in the course of the investigation that could show that the complaint is justified and that it resulted from Kamada’s actions or omissions.
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Samples: Exclusive Manufacturing, Supply and Distribution Agreement (Kamada LTD), Exclusive Manufacturing, Supply and Distribution Agreement (Kamada LTD)
Notification of Complaints. Upon any Party receiving or becoming aware of any complaint involving the possible failure of the A1PI IV Product, in any location in the world, to meet any requirement of applicable law or regulation, and any serious or unexpected side effect, injury, toxicity or sensitivity reaction or any unexpected incidents associated with the distribution of the A1PI IV Product, whether or not determined to be attributable to the A1PI IV Product Product, (i) such Party shall notify the other Party about such complaint and provide initial information about such complaint to the other Party within [*****] and shall provide all information about such complaint within [*****], (ii) promptly provide to the other Party copies of any complaints, and provide at the time of submission copies of any submissions to any Regulatory Authority regarding such complaints complaints, and (iii) with respect to adverse events, comply with the provisions of Section 11.4(c7.5(c) above. Xxxxxx Bxxxxx shall have responsibility for investigating such complaint in the Xxxxxx Bxxxxx Territory, with cooperation and assistance from Kamada in the Xxxxxx Bxxxxx Territory, and shall immediately inform Kamada of any information discovered in the course of the investigation that could show that the complaint is justified and that it resulted from Kamada’s actions or omissions. [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission.
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Notification of Complaints. Upon any Party receiving or becoming aware of any complaint involving the possible failure of the A1PI IV Product, in any location in the world, to meet any requirement of applicable law or regulation, and any serious or unexpected side effect, injury, toxicity or sensitivity reaction or any unexpected incidents associated with the distribution of the A1PI IV Product, whether or not determined to be attributable to the A1PI IV Product Product, (i) such Party shall notify the other Party about such complaint and provide initial information about such complaint to the other Party within [*****] and shall provide all information about such complaint within [*****], (ii) promptly provide to the other Party copies of any complaints, and provide at the time of submission copies of any submissions to any Regulatory Authority regarding such complaints complaints, and (iii) with respect to adverse events, comply with the provisions of Section 11.4(c7.5(c) above. Xxxxxx shall have responsibility for investigating such complaint in the Xxxxxx Territory, with cooperation and assistance from Kamada in the Xxxxxx Territory, and shall immediately inform Kamada of any information discovered in the course of the investigation that could show that the complaint is justified and that it resulted from Kamada’s actions or omissions. [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission.
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