Common use of Product Withdrawals and Recalls Clause in Contracts

Product Withdrawals and Recalls. In the event that either Party (a) determines that an event, incident, or circumstance has occurred which may result in the need for a recall or other removal of the Product or any lot or lots thereof from the market in the Field in the Territory; (b) becomes aware that a Governmental Authority in the Territory is threatening or has initiated an action to remove the Product from the market; or (c) is required by any Governmental Authority in the Territory to distribute a “Dear Doctor” letter or its equivalent, regarding use of the Product, such Party shall promptly advise the other Party in writing with respect thereto, and shall provide to such other Party copies of all relevant correspondence, notices, and the like. Solvay shall be responsible for conducting any recall of the Product in the Field, whether voluntary or involuntary, or taking such other remedial action required by Applicable Laws or agreed to by the Parties. At Solvay’s request, Depomed shall assist Solvay with respect to any such recall or remedial action, and will provide Solvay with all information that Solvay may request in connection with its dealings with a Governmental Authority in connection with such recall or remedial action. If any recall of the Product is implemented as a result of Depomed’s material breach of its obligations under this Agreement or its negligence, Depomed shall bear that portion of all direct expenses incurred by Solvay in connection with such recall attributable to such material breach or negligence. For any and all recalls of Product in the Field in the Territory required due to any other reason, Solvay shall bear all expenses incurred in connection with such recall.

Product Withdrawals and Recalls. In the event that either Party (a) determines that an event, incident, or circumstance has occurred which may result in the need for a recall or other removal of the Product or any lot or lots thereof from the market in the Field in the Territory; (b) becomes aware that a Governmental Authority in the Territory is threatening or has initiated an action to remove the Product from the market; or (c) is required by any Governmental Authority in the Territory to distribute a “Dear Doctor” letter or its equivalent, regarding use of the Product, such Party shall promptly advise the other Party in writing with respect thereto, and shall provide to such other Party copies of all relevant correspondence, notices, and the like. Solvay shall be responsible for conducting any recall of the Product in the Field, whether voluntary or involuntary, or taking such other remedial action required by Applicable Laws or agreed to by the Parties. At Solvay’s request, Depomed Xxxxxxx shall assist Solvay with respect to any such recall or remedial action, and will provide Solvay with all information that Solvay may request in connection with its dealings with a Governmental Authority in connection with such recall or remedial action. If any recall of the Product is implemented as a result of Depomed’s material breach of its obligations under this Agreement or its negligence, Depomed shall bear that portion of all direct expenses incurred by Solvay in connection with such recall attributable to such material breach or negligence. For any and all recalls of Product in the Field in the Territory required due to any other reason, Solvay shall bear all expenses incurred in connection with such recall.