Product Recall. In the event that either Party believes it may be necessary to conduct a recall, field correction, market withdrawal, stock recovery, or other similar action with respect to any Product which was sold under this Agreement (a “Recall”), AYTU and TRIS shall promptly consult with each other in good faith as to how best to proceed, it being understood and agreed that the final decision as to any Recall of any Product sold by AYTU or its Subsidiaries or its Sublicensees shall be made by AYTU, as AYTU is responsible for notifying regulatory agencies of any recall market withdrawals, etc., provided, however, that neither Party shall be prohibited hereunder from taking any action that it is required to take by Applicable Law. Each of TRIS and AYTU shall make a permanent, complete and accurate record of all costs incurred by it in connection with any Product recall.

Product Recall. Any mandatory product recall shall be required pursuant to any order or directive of any Governmental Authority affecting the products manufactured, sold or distributed by the Borrower or any of its Subsidiaries, if the aggregate sales price of the products so recalled shall, individually or together with all other similar recalls of such products during any twelve consecutive month period, equal or exceed $50,000,000; or

Product recall

Withdrawal or Recall of Products. If ​ or any governmental authority determines that any Product sold to ​ is materially defective and a recall campaign is necessary, ​ will have the right to implement such recall campaign and will coordinate the return of defective Product by ​ to ​ or order ​ to destroy such recalled Product, as determined by ​ in its reasonable discretion, at ​’s sole cost and risk.

#​ will be liable for all of ​’s costs associated with any recall campaign, including without limitation, if ​ does not elect to have the Product be exchanged, the price paid for the Product, if such recall campaign is based upon a reasonable determination that the Product materially failed to conform to the warranties set forth in this Agreement.

exceed our product recall insurance coverage limits and harm to our reputation, which could have a material adverse effect on our business, results of operations and financial condition. In addition, a product recall may require significant management time and attention and may adversely impact on the value of our brands. Product recalls may lead to greater scrutiny by federal or state regulatory agencies and increased litigation, which could have a material adverse effect on our business, results of operations and financial condition.

In the event of a recall of any Product in the Territory (which shall be done by ACADIA at its sole discretion but in compliance with all applicable laws, rules and regulations), ACADIA must pay all costs in association with such recall in the Territory, including reimbursement for the cost of any faulty Product supplied by ACADIA or any Sub-Licensee, subject to Neuren’s indemnification obligation under clause 21.3.

Product Recalls. Prior to [[Organization A:Organization]] proceeding with the In-Licensing, in the event that a governmental entity issues a request, directive, or order, or ​ determines, in its sole discretion, to recall or retrieve some or all of the Lead Compound by way of a recall, market withdrawal or other corrective action (“Recall”), ​ shall, in cooperation with [[Organization A:Organization]], as reasonably requested by [[Organization A:Organization]], conduct such Recall (and any subsequent investigation by ​ into the cause of the Recall). ​ shall make every reasonable effort to notify [[Organization A:Organization]] promptly following its determination that any event, incident, or circumstance has occurred that may result in a need for a Recall. ​ shall have the sole right to determine whether to conduct and control a Recall; provided, that to the extent practicable, ​ shall consult with [[Organization A:Organization]], through a special meeting of the JDC, prior to any implementation of any such Recall. If a Recall is mandated by a Regulatory Authority, ​ shall initiate such a Recall in compliance with Applicable Law. […​…].

If the cause or reason of any Recall or seizure of any Product sold by AYTU or its Subsidiaries or its Sublicensees is the result of TRIS’ Fault and AYTU’s Fault, then TRIS and AYTU shall be responsible for the payment of reasonable and documented out-of-pocket costs and expenses incurred by either Party in connection with the Recall or seizure and all damages to or claims by Third Parties associated with or resulting from such Recall or seizure in proportion to the relative fault of each Party in causing such Recall or seizure.

Product Markings. To the extent permitted by applicable Law, Commercializing Party shall include on all packaging and promotional materials for each Product a designation # that the Product incorporates the Licensed Protocol and/or Kaufmann Intellectual Property Rights and # if applicable, that the Product is manufactured under license from the Licensor, which designation must comply with applicable Law and otherwise be in form and substance reasonably acceptable to Licensor. Commercializing Party shall also ensure that all sublicensees and subcontractors mark Products accordingly.