Recalls and Market Withdrawals. (a) If at any time during the Exclusive Period (i) any governmental or regulatory authority in the Territory issues a request, directive, or order that the Product be recalled or withdrawn, or (ii) a court of competent jurisdiction orders such a recall or withdrawal in the Territory, or (iii) either Party determines in its sole discretion that the Product should be recalled or withdrawn, the Parties shall take all appropriate corrective actions. The final decision of a Party to recall pursuant to (iii) of this subsection shall not be subject to arbitration under Article 13 of this Agreement (or any other legal action, subject to Section 13(g)), although the consequences to the other Party of any improper decision shall be subject to arbitration.
(b) If the negligent act or omission by one Party or the breach by one Party of an applicable product warranty (which, in the case of Product manufactured by ICN shall be the warranty contained in Section 8.4(a)) is the proximate cause of a recall or withdrawal under any provision of Section 3.7(a), that Party shall be solely responsible for such costs and expenses for its own account. If the negligent act or omission or breach of product warranty by one Party is not the proximate cause of such a recall or withdrawal, (i) the costs and expenses of notification and destruction or return of the recalled or withdrawn Product in connection with a recall or withdrawal resulting from a determination pursuant to Section 3.7(a)(iii), above shall be borne by the Party making such determination, and (ii) the costs and expenses of notification and destruction or return of the recalled or withdrawn Product in connection with a recall or withdrawal pursuant to Section 3.7(a)(i) or (ii) shall be borne equally by the Parties.
Recalls and Market Withdrawals. In the event Agile determines an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal of any Products manufactured by Corium under this Agreement, and any such recall or similar action is required as a result of Corium’s improper manufacture or packaging of the Product, Corium shall bear the expenses of such recall or similar action, up to a limit of: (i) [*] (ii) [*]. Such expenses of recall shall include, without limitation and without duplication (but subject to the limit identified above), [*]. The rights of Agile under this Section 7.4 shall be in addition to, and not in lieu of, any other rights that Agile may have under this Agreement.
Recalls and Market Withdrawals. As between the Parties, TYME shall have the sole right to determine whether to implement, and to implement, a recall, field alert, withdrawal or other corrective action related to the Product. TYME shall bear the cost and expense of any such recall, field alert, withdrawal or other corrective action. Each Party shall promptly (but in any case, not later than one (1) day after) notify the other Party in writing of any order, request or directive of a court or other Governmental Authority to recall or withdraw the Product.
Recalls and Market Withdrawals. If at any time (i) any governmental or regulatory authority in the Territory issues a request, directive, or order that the Product be recalled or withdrawn, or (ii) a court of competent jurisdiction orders such a recall or withdrawal in the Territory, or (iii) BioGeneriX determines that the Product should be recalled, BioGeneriX promptly shall notify Neose of such fact and any the reasons therefor.
Recalls and Market Withdrawals. PATHEON and RELYPSA will each maintain records necessary to permit a Recall of any Finished Products delivered to RELYPSA or its designee or customers of RELYPSA. Each Party will promptly notify the other by telephone (to be confirmed in writing) of any information which might affect the marketability, safety or effectiveness of the Finished Products or which might result in the Recall, or seizure of the Finished Products; provided, however, that RELYPSA [***]. Upon receiving this notice, each Party will stop making any further shipments of any Finished Products in its possession or control until a decision has been made by RELYPSA whether a Recall or some other corrective action is necessary. The decision to initiate a Recall or to take some other corrective action and the scope of such Recall or other corrective action, if any, will be made and implemented by RELYPSA. “Recall” means any action (i) by RELYPSA to recover title to or possession of quantities of the Finished Products sold or shipped to Third Parties (including the voluntary withdrawal of Finished Products from the market); or (ii) by any Authority to detain, destroy, recall, withdraw or require correction of any of the Finished Products. Recall will also include any action by either Party to refrain from selling or shipping quantities of the Finished Products to Third Parties which would have been subject to a Recall if sold or shipped.
Recalls and Market Withdrawals. In the event that either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in the Territory, or in the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with a Licensed Product, the Party that has determined the need for such recall or similar action, or the Party notified of such recall or similar action, shall, within [*], advise the other Party thereof by telephone or facsimile. Xxxxxxx, in consultation with Xxxxxxx, shall decide whether to conduct a recall in the Xxxxxxx Territory (except in the case of a government mandated recall, in which case Xxxxxxx may act without such advance consultation, but shall notify Xxxxxxx as soon as possible) and the manner in which any such recall shall be conducted. Xxxxxxx, in its sole discretion, shall decide whether to conduct a recall in the Xxxxxxx Territory and the manner in which any such recall shall be conducted. Each Party will make available to the other Party, upon request, all of such Party’s (and its Affiliates’) pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall. The costs and expenses of any such recall shall be borne by the Party whose actions or omissions caused the recall to be necessary or deemed advisable.
Recalls and Market Withdrawals. In the event Auxilium or GSK should become aware of information that may require a recall, field alert, Product withdrawal or field correction arising from any defect in the Product (collectively, an “Market Event”), it shall immediately notify the other Party in writing. To the extent reasonably practicable prior to initiating a Market Event in the Territory and in any event within [**] thereafter, Auxilium shall notify GSK of its intent to initiate a Market Event and, to the extent reasonably practicable, provide GSK a reasonable opportunity to comment on the merits or manner of such Market Event; provided, however, that Auxilium will have the sole right to determine the response to any Market Event and shall have sole responsibility for carrying out any such response. Auxilium will bear all costs of any action taken with respect to any Market Event, including costs associated with any recall, withdrawal or stock recovery (including mailings to health care professionals). The Parties acknowledge and agree that GSK shall have no liability for any Market Event and Auxilium shall indemnify GSK for any costs incurred under this Section 7.7.
Recalls and Market Withdrawals. If at any time (i) any governmental or regulatory authority issues a request, directive, or order that a Product be recalled or withdrawn, or (ii) a court of competent jurisdiction orders such a recall or withdrawal in a Major Market, or (iii) the Management Committee determines that a Product should be recalled in a Major Market, the parties shall take all appropriate corrective actions to effect the recall or withdrawal. If a dispute about the necessity of a recall can not be resolved in accordance with Section 15.1 hereof, either Collaborator may order a recall (without proceeding to arbitration under Section 15.2) if in its reasonable judgment it is required to do so by law. The cost and expenses of notification and destruction or return of the recalled or withdrawn Product in a Major Market shall be an Allowable Expense.
Recalls and Market Withdrawals. 12.1.1 In the event that:
Recalls and Market Withdrawals. Amarin shall have the sole right and responsibility, at its expense (but subject to Section 11.5), to control any product quarantine, recall, field correction, or withdrawal of the Product in the Territory. To the extent practicable, the Parties shall discuss the circumstances of any potential product quarantine, recall, field correction or withdrawal of any Product and possible appropriate courses of action. Each Party shall maintain complete and accurate records of any recall in its territory for such periods as may be required by Applicable Laws, but in no event for less than five (5) years.
