Common use of Voluntary Recall Clause in Contracts

Voluntary Recall. Each Party shall notify the other Party in writing of any facts relating to the advisability of a voluntary recall or withdrawal of the Product from any market. Auxilium shall have the right, acting reasonably, to initiate a voluntary recall in the countries in which it holds the Marketing Authorizations. In case of a voluntary recall initiated by Auxilium, Auxilium shall immediately give written notice to Ipsen of such action and all particulars thereof and review with Ipsen the proposed manner in which the recall is to be carried out. In the event Ipsen reasonably believes a voluntary Product recall or withdrawal in the Territory should be made for reasons of patient safety, Ipsen shall promptly notify Auxilium of its belief in writing and provide Auxilium with all supporting information or documentation. Auxilium’s approval must be obtained in writing, within a time period reasonable in the specific circumstance, for any voluntary recall and any notice of or letters relating to any recall. In the event that Ipsen and Auxilium cannot agree that a voluntary recall should be made for safety reasons and Ipsen decides to definitively withdraw from marketing the Product for product safety related concerns (such as pharmacovigilence issues) in any country in the Territory, Ipsen shall not take any action towards voluntarily withdrawing the Product from the market but Ipsen shall revert all license rights as granted under Section 2 of this Agreement with respect to the affected countries to Auxilium in a timely manner.

Voluntary Recall. Each Party shall notify the other Party in writing of any facts relating to the advisability of a voluntary recall or withdrawal of the Product from any market. Auxilium shall have the right, acting reasonably, to initiate a voluntary recall in the countries in which it holds the Marketing AuthorizationsVoluntary Recall. In case of a voluntary recall initiated by Auxilium, Auxilium shall immediately give written notice to Ipsen the Distributor of such action and all particulars thereof and review with Ipsen the Distributor the proposed manner in which the recall is to be carried out. In the event Ipsen that Distributor believes that a voluntary recall should be initiated, Auxilium shall be consulted prior to the decision of (i) whether a voluntary recall or other removal of Product shall be made; and (ii) the manner of communicating and executing any voluntary Product recall or withdrawal. In the event Distributor reasonably believes a voluntary Product recall or withdrawal in the Territory should be made for reasons of patient safety, Ipsen Distributor shall promptly notify Auxilium of its belief ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. in writing and provide Auxilium with all supporting information or documentation. Auxilium’s approval must be obtained in writing, within a time period reasonable in the specific circumstance, for any voluntary recall and any notice of of, or letters relating to to, any recall. In the event that Ipsen distributor and Auxilium cannot agree that a voluntary recall should be made for safety reasons and Ipsen decides reasons, Distributor shall have the right to definitively withdraw from marketing terminate the Agreement, remove the Product for product safety related concerns (such as pharmacovigilence issues) in any country in the Territory, Ipsen shall not take any action towards voluntarily withdrawing the Product bearing its trademarks from the market but Ipsen shall revert all license rights as granted under Section 2 of this Agreement with respect within a reasonable time and to notify its customers that the affected countries to Auxilium in a timely mannerProduct will no longer be distributed by Distributor.