Recalls; Withdrawals. Manufacturer shall have sole responsibility for initiating and managing any recall or withdrawal of the Packaged Products, and shall bear all costs and expenses relating thereto. At Manufacturer’s cost and expense, Sharp shall provide such assistance as Manufacturer may reasonably request in connection with any such withdrawal or recall. Upon receiving from any authority having jurisdiction any direction to withdraw or recall any Packaged Product from the market, the receiving party shall promptly notify the other party. Sharp shall have no liability with respect to any recall or withdrawal of Packaged Products except to the extent of Xxxxx'x negligence or willful misconduct or breach of the warranties set forth in Section 7.1, in which case Sharp's liability shall be limited to [***].
Recalls; Withdrawals. The Quality Agreement sets forth each Party’s rights and obligations with respect to recalls and withdrawals. If and to the extent such recall or withdrawal is caused by Supplied Material that contains a Deficiency or by PharmaZell’s negligence or willful misconduct or breach of this Agreement, PharmaZell shall reimburse Intercept for [**]; provided that, other than with respect to PharmaZell’s gross negligence or willful misconduct, PharmaZell’s liability pursuant to this Section 3.1(f), on a per claim basis, shall not exceed Fifteen Million United States Dollars ($15,000,000).
Recalls; Withdrawals. As between the parties, Galderma shall have the sole authority and responsibility to respond to any Governmental or Regulatory Authorities, including without limitation the FDA, concerning returns, field alerts, recalls or market withdrawals of the Product and shall be solely responsible for determining whether to issue a recall or withdrawal and for the costs associated with such action; provided, however, that if any such returns, field alerts, market withdrawals or recalls of Product are caused solely by actions or inactions by PhotoMedex constituting a breach of the provisions of this Agreement or a violation of Applicable Laws and Regulations, PhotoMedex shall bear all reasonable costs associated with such actions or inactions in connection therewith. Subject to Section 15.0, Galderma shall be under no liability whatsoever to compensate PhotoMedex or make any other payment to PhotoMedex for any decision to recall, initiate a market withdrawal or take any other corrective action with respect to the Product contemplated in this Section 9.7, unless such action results from a breach of the provisions of this Agreement or a violation of Applicable Laws and Regulations by Galderma or its Affiliates. Each party shall promptly (but in any case, not later than forty-eight (48) hours) notify the other party in writing of any order, request or directive of a court or other governmental or regulatory authority to recall or withdraw the Product.
Recalls; Withdrawals
