Common use of Recalls or Other Corrective Action Clause in Contracts

Recalls or Other Corrective Action. (a) Prior to the NDA Transfer Date, Depomed shall have final decision-making authority with respect to any recall (including recall of packaging and promotion materials), market withdrawals or any other corrective action related to the Products. Depomed shall promptly consult with Santarus with respect to any such actions proposed to be taken by Depomed (and in all events prior to the taking of such actions), including all actions that are reasonably likely to result in a material adverse effect on the marketability of the Products in the Territory. At Depomed’s request, Santarus shall provide assistance to Depomed in conducting such recall, market withdrawal or other corrective action (including retrieving Samples distributed by the Santarus Sales Force to Professionals). As the NDA holder, Depomed shall be responsible for all communications with the FDA with respect to any Product recall, market withdrawal or other corrective action; provided that (i) Depomed shall consult with Santarus prior to submitting any related documentation to the FDA, (ii) Depomed shall provide Santarus with copies of all communications received from or submitted to the FDA with respect to any such recall, market withdrawal or other corrective action within [***] after receipt or submission thereof and (iii) Santarus shall be permitted to accompany Depomed and take part in any meetings or discussions with FDA with respect to any such recall, market withdrawal or other corrective action.

Recalls or Other Corrective Action. (a) Prior to the NDA Transfer Date, Depomed shall have final decision-making authority sole responsibility for and shall make all decisions with respect to any recall (including recall of packaging and promotion materials), market withdrawals or any other corrective action related to the Products. Depomed shall promptly consult with Santarus with respect to any such actions proposed to be taken by Depomed (and in all events prior to the taking of such actions), including all actions that are reasonably likely to result in a material adverse effect on the marketability of the Products in the Territory. At Depomed’s request, Santarus shall provide assistance to Depomed in conducting such recall, market withdrawal or other corrective action (including retrieving Samples distributed by the Santarus Sales Force to Professionals). As the NDA holder, Depomed shall be responsible for all communications with the FDA with With respect to any Product recall, market withdrawal or corrective action initiated by Depomed as a result of Depomed becoming aware of any manufacturing defect in Products (other corrective action; provided that (i) than Products manufactured by Santarus in accordance with Section 6.6), Depomed shall consult reimburse Santarus for its reasonable, documented, direct, out-of-pocket costs incurred in connection with Santarus prior to submitting any related documentation to the FDA, (ii) Depomed shall provide Santarus with copies of all communications received from or submitted to the FDA with respect to any participating in such recall, market withdrawal or other corrective action within [***] after receipt provided that a breach of the provisions of this Agreement, or submission thereof and (iii) a violation of Legal Requirements, by Santarus shall be permitted to accompany Depomed and take part in any meetings or discussions with FDA with respect to any such is not a material cause of the recall, market withdrawal or other corrective action. Except as set forth above, but subject to Depomed’s indemnification obligations under Section 11.1, Depomed shall be under no liability whatsoever to compensate Santarus or make any other payment to Santarus for any decision to recall, initiate a market withdrawal or take any other corrective action with respect to the Products, unless such actions results from a breach of the provisions of this Agreement or a violation of Legal Requirements by Depomed.