Common use of Adverse Event Reporting; Product Complaints Clause in Contracts

Adverse Event Reporting; Product Complaints. Purchaser shall have the responsibility in the Territory for complying with all regulatory filings, reporting requirements and other matters which relate solely to Purchaser acting as a distributor of the Product to Purchaser Customers in the Territory and Seller shall cooperate with Purchaser as reasonably necessary to accomplish the foregoing. All other regulatory reporting matters (including investigating, evaluating and reporting Adverse Events and other Product complaints) shall be Seller’s responsibility. In this regard, Seller shall be responsible for all reporting to regulatory authorities of all Adverse Events associated with the use of Product. Purchaser shall notify Seller of any report of an Adverse Event concerning the Product within five (5) calendar days of receipt of the report and provide Seller with information as required by Applicable Laws or as reasonably requested by Seller. Purchaser shall cooperate with Seller as necessary to report such Adverse Event when so required under Applicable Laws. Purchaser shall also notify Seller within 10 days of any complaints related to the Product of which it becomes aware regarding problems with the Product other than those associated with Adverse Events, and Seller shall meet and confer periodically with Purchaser with respect to Seller’s responses to such complaints and whether any remedial actions by Purchaser are indicated as necessary or appropriate by the pattern of complaints, which actions shall be at the expense of the party to the extent its improper acts or omissions caused such complaints.

Adverse Event Reporting; Product Complaints. Purchaser shall have the responsibility in the Territory for complying with all regulatory filings, reporting requirements and other matters which relate solely to Purchaser acting as a distributor of the Product to Purchaser Customers in the Territory and Seller shall cooperate with Purchaser as reasonably necessary to accomplish the foregoing. All other regulatory reporting matters (including investigating, evaluating and reporting Adverse Events and other Product complaints) shall be Seller’s 's responsibility. In this regard, Seller shall be responsible for all reporting to regulatory authorities of all Adverse Events associated with the use of Product. Purchaser shall notify Seller of any report of an Adverse Event concerning the Product within five (5) calendar days of receipt of the report and provide Seller with information as required by Applicable Laws or as reasonably requested by Seller. Purchaser shall cooperate with Seller as necessary to report such Adverse Event when so required under Applicable Laws. Purchaser shall also notify Seller within 10 days of any complaints related to the Product of which it becomes aware regarding problems with the Product other than those associated with Adverse Events, and Seller shall meet and confer periodically with Purchaser with respect to Seller’s 's responses to such complaints and whether any remedial actions by Purchaser are indicated as necessary or appropriate by the pattern of complaints, which actions shall be at the expense of the party to the extent its improper acts or omissions caused such complaints.