Common use of PRODUCT RECALLS OR WITHDRAWAL Clause in Contracts

PRODUCT RECALLS OR WITHDRAWAL. If at any time or from time to time during the Term: (a) any Competent Authority of any country in the Territory requests Strata to recall or withdraw the Product; (b) a court of competent jurisdiction issues an order or directive for the Product to be recalled or withdrawn; or (c) if a voluntary recall or withdrawal of the Product is contemplated by Strata (individually or collectively, a “Recall”), then Strata shall carry out any Recall in the Territory in as expeditious a manner as reasonably possible to preserve the goodwill and reputation of the Product and the goodwill and reputation of the Parties. Strata shall in all events be responsible for conducting any Recall in the Territory, market withdrawals or corrections with respect to the Product in the Territory. Strata shall maintain records of all sales and distribution of Product and customers sufficient to adequately administer a Recall for the period required by Applicable Law. Micrologix shall cooperate as reasonably requested by Strata in connection with any such Recall. Strata will be responsible for complying with all Applicable Laws and Governmental Approvals during the Recall and will be responsible for all interactions with appropriate Competent Authorities, including, the FDA Office of Compliance in the U.S. and the appropriate FDA local district office(s) in the U.S. Strata shall be responsible for preparing and timely submitting any reports any other documentation required by the Competent Authorities in connection with any such Recall.

PRODUCT RECALLS OR WITHDRAWAL. If at any time or from time to time during the Term: (a) any Competent Authority of any country in the Territory requests Strata to recall or withdraw the Product; (b) a court of competent jurisdiction issues an order or directive for the Product to be recalled or withdrawn; or (c) if a voluntary recall or withdrawal of the Product is contemplated by Strata (individually or collectively, a “"Recall”"), then Strata shall carry out any Recall in the Territory in as expeditious a manner as reasonably possible to preserve the goodwill and reputation of the Product and the goodwill and reputation of the Parties. Strata shall in all events be responsible for conducting any Recall in the Territory, market withdrawals or corrections with respect to the Product in the Territory. Strata shall maintain records of all sales and distribution of Product and customers sufficient to adequately administer a Recall for the period required by Applicable Law. Micrologix shall cooperate as reasonably requested by Strata in connection with any such Recall. Strata will be responsible for complying with all Applicable Laws and Governmental Approvals during the Recall and will be responsible for all interactions with appropriate Competent Authorities, including, the FDA Office of Compliance in the U.S. and the appropriate FDA local district office(s) in the U.S. Strata shall be responsible for preparing and timely submitting any reports any other documentation required by the Competent Authorities in connection with any such Recall.

PRODUCT RECALLS OR WITHDRAWAL. If at any time or from time to time during the Term: (a) any Competent Authority of any country in the Territory requests Strata Fujisawa to recall or withdraw the Product; (b) a court of competent jurisdiction issues an order or directive for the Product to be recalled or withdrawn; or (c) if a voluntary recall recall, withdrawal or withdrawal correction of the Product is contemplated by Strata Fujisawa (individually or collectively, a “"Recall”"), then Strata Fujisawa shall carry out any Recall in the Territory in as expeditious a manner as reasonably possible to preserve the goodwill and reputation of the Product and the goodwill and reputation of the Parties. Strata Fujisawa shall in all events be responsible for conducting any Recall in the Territory, market withdrawals or corrections Territory with respect to the Product in the Territory. Strata Fujisawa shall maintain records of all sales and distribution of Product and customers sufficient to adequately administer a Recall for the period required by Applicable Law. Micrologix Cardiome shall cooperate as reasonably requested by Strata Fujisawa in connection with any such Recall. Strata Fujisawa will be responsible for complying with all Applicable Laws and Governmental Approvals during the Recall and will be responsible for all interactions with appropriate Competent Authorities, including, including the FDA Office of Compliance in the U.S. and the appropriate FDA local district office(s) in the U.S. Strata Fujisawa shall be responsible for preparing and timely submitting any reports any other documentation required by the Competent Authorities in connection with any such Recall.

PRODUCT RECALLS OR WITHDRAWAL. If at any time or from time to time during the Term: (a) any Competent Authority of any country in the Territory requests Strata Fujisawa to recall or withdraw the Product; (b) a court of competent jurisdiction issues an order or directive for the Product to be recalled or withdrawn; or (c) if a voluntary recall recall, withdrawal or withdrawal correction of the Product is contemplated by Strata Fujisawa (individually or collectively, a “Recall”), then Strata Fujisawa shall carry out any Recall in the Territory in as expeditious a manner as reasonably possible to preserve the goodwill and reputation of the Product and the goodwill and reputation of the Parties. Strata Fujisawa shall in all events be responsible for conducting any Recall in the Territory, market withdrawals or corrections Territory with respect to the Product in the Territory. Strata Fujisawa shall maintain records of all sales and distribution of Product and customers sufficient to adequately administer a Recall for the period required by Applicable Law. Micrologix Cardiome shall cooperate as reasonably requested by Strata Fujisawa in connection with any such Recall. Strata Fujisawa will be responsible for complying with all Applicable Laws and Governmental Approvals during the Recall and will be responsible for all interactions with appropriate Competent Authorities, including, including the FDA Office of Compliance in the U.S. and the appropriate FDA local district office(s) in the U.S. Strata Fujisawa shall be responsible for preparing and timely submitting any reports any other documentation required by the Competent Authorities in connection with any such Recall.