Common use of Recalls and Voluntary Withdrawals Clause in Contracts

Recalls and Voluntary Withdrawals. Each Party shall notify the other Party promptly but in no event later than [***] following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Product under any MAA or Regulatory Approval for the Product held by such Party and filed with Regulatory Authorities in the Territory, and shall include in such notice the reasoning behind such determination, and any supporting facts. Such Party shall have the sole right to make the final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal in the Territory; provided that prior to any implementation of such a recall, market suspension, or market withdrawal, the such Party shall, to the extent practical, consult with the other Party and shall consider the other Party’s comments in good faith. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 9.11, such Party shall be solely responsible for the execution thereof, and the other Party shall reasonably cooperate in all such recall efforts. Subject to ARTICLE 17, such Party shall be responsible for all costs of any such recall, market suspension, or market withdrawal; provided that, the other Party shall be responsible for the costs of any recall, market suspension, or market withdrawal with respect to a Product in the Territory to the extent such recall, market suspension, or market withdrawal is attributable to the other Party’s breach of its obligations hereunder or its negligence, recklessness or willful misconduct.

Recalls and Voluntary Withdrawals. Each The Party responsible for regulatory activities in a jurisdiction pursuant to Section 5.1 shall notify the other Party promptly but in no event later than [***] following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Product under any MAA or Regulatory Approval for the Product held by in such Party and filed with Regulatory Authorities in the Territoryjurisdiction, and shall include in such notice the reasoning behind such determination, and any supporting facts. Such Party Ovid, in the Ovid Territory, and Takeda, in the Takeda Territory, shall have the sole right and responsibility to make the final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal in the Territorysuch jurisdiction; provided that prior to any implementation of such a recall, market suspension, or market withdrawal, the such responsible Party shall, to the extent practical, consult with the other Party and shall consider the other Party’s comments in good faith. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 9.115.10, such the responsible Party shall be solely responsible for the execution thereofthereof in such jurisdiction, and the other Party shall reasonably cooperate in all such recall efforts. Subject to ARTICLE 17Article 14, such the responsible Party shall be responsible for all costs of any such recall, market suspension, or market withdrawal; provided that, the other Party shall be responsible for the costs of any recall, market suspension, or market withdrawal with respect to a Product in the Territory such jurisdiction to the extent such recall, market suspension, or market withdrawal is attributable to the other such Party’s breach of its obligations hereunder or its negligence, recklessness or willful misconduct. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.