Product Withdrawals and Recalls. If any Regulatory Authority in the Territory # threatens, initiates or advises any action to remove any Product from the market or # requires or advises FibroGen China, AstraZeneca, or any of their respective Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product, then FibroGen

Product Withdrawals and Recalls. In the event that either Party # becomes aware of an event, incident or circumstance that has occurred which may result in the need for a recall or other removal of the Product or any aspects thereof; # becomes aware that a Regulatory Authority is threatening or has initiated an action to remove the Product from the market; or # places a clinical trial for the Product on hold for clinical safety reasons, 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, and the Parties shall comply with the terms set forth in the Quality Agreement attached as Exhibit F (the “Quality Agreement”). QIAGEN shall have final authority to make all decisions relating to any recall, market withdrawal or other corrective action with respect to the Product in the Territory and shall be responsible for conducting any recalls or taking such other remedial action, and [[Organization A:Organization]] agrees, upon reasonable request by QIAGEN and at QIAGEN’s expense, to assist with respect to such recalls or remedial actions.

Recalls. If any of the Licensed Products pose a safety threat to the consumer, Licensee shall immediately recall such Licensed Products from the marketplace, and take any other measures Licensor may reasonably demand. If any of the Licensed Products are the subject of negative publicity due to poor quality and/or safety of the Licensed Products, Licensee shall, upon Licensor’s reasonable request, immediately recall such Licensed Products from the marketplace, and take any other measures Licensor may reasonably demand. Notwithstanding, Licensor shall be entitled to Royalties for all sales of Licensed Products that may be recalled for any reason. Licensee shall assume all the obligations, liabilities, costs and expenses relating in any recalls of Licensed Product under this Section 7.4.

Recalls. If # any Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, # a court of competent jurisdiction orders a Recall, or # VF determines that any Product should be Recalled or that a “Dear Doctor” letter is required relating the restrictions on the use of any Product, CCX will co-operate as reasonably required by VF, having regard to all applicable laws and regulations.

Recalls. If: # any Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled; # a court of competent jurisdiction orders a Recall; or # Client determines that any Product should be Recalled or that a "Dear Doctor" letter is required relating the restrictions on the use of any Product, then Patheon will co-operate as reasonably required by Client, having regard to all Applicable Laws.

Recalls. If # any Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about the Product, a written request that any Product be Recalled, # a court of competent jurisdiction orders a Recall, or # Client determines that any Product should be Recalled or that a "Dear Doctor" letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulations.

Recalls. If # any Authority issues a directive, order or, following the issuance of a safety warning or alert about the Supplied Product or Marketed Product, a written request that any Supplied Product or Marketed Product be Recalled, # a court of competent jurisdiction orders a Recall, or # Acorda determines that any Supplied Product or Marketed Product should be Recalled or that a “Dear Doctor” letter is required relating the restrictions on the use of any Supplied Product or Marketed Product, then Manufacturer shall co-operate as reasonably required by Acorda, having regard to all Applicable Laws.

Recalls. Each Party agrees to notify the other Party within ​ if it discovers any issue that it reasonably believes could lead to a Recall. If practicable, the Parties shall promptly, following notification, discuss the plans for a Recall, provided that the Parties shall have joint responsibility for determining whether a Recall in the Territory is necessary. If the Parties, through the JSC, decide that a Recall is necessary, the Parties shall work together to develop and implement a Recall plan, which, unless agreed otherwise, shall be implemented by AcelRx. All costs and expenses associated with implementing a Recall in the Territory shall be borne by AcelRx, except to the extent it arises from Aguettant’s failure to supply the Products in accordance with the Specifications or to transport the Products in accordance with Section 5.3. The Parties shall jointly determine the cause of a Recall, or in the event of disagreement between the Parties regarding such cause, an independent laboratory mutually agreed upon by the Parties shall determine such cause.

Recalls. If Customer recalls any Product (voluntarily and/or by order of a Regulatory Authority) and/or is required to respond to inquiries of Governmental Authorities relating to the Products, Lonza shall provide reasonable assistance to Customer in connection with the same. Customer shall pay Lonza for such assistance, unless such recall and/or inquiry is due to Lonza’s fault and/or Lonza is otherwise required to indemnify Customer in relation to such recall and/or inquiry pursuant to Clause 11.1.

Recalls. In the event of a Product incident, recall or field safety corrective action initiated by or on behalf of EyePoint or by a regulatory agency or court, following written notice thereof from EyePoint, Imprimis shall reasonably cooperate with EyePoint in effecting the reporting of an incident or the recall of the affected Products. EyePoint shall be responsible, at its sole expense, for conducting any recalls or field safety corrective actions pertaining to the Products, and EyePoint shall reimburse Imprimis for all out-of-pocket costs and expenses reasonably incurred by Imprimis in cooperating with EyePoint pursuant to the terms of this Section 4.4, except to the extent such costs and expenses result from Imprimis’ gross negligence, fraud or willful misconduct.