Product Withdrawal. With respect to a Product Withdrawal within the Territory, immediately after receipt of such notification, the JSC (or its co-chairpersons) shall discuss and, unless the Product Withdrawal is mandated by a Regulatory Authority, shall attempt to agree on whether to voluntarily implement the Product Withdrawal within the Territory. If a Regulatory Authority mandates that the Product Withdrawal within the Territory be implemented then ARIAD SWISSCO, in consultation with ARIAD US, shall initiate the Product Withdrawal within the Territory as and to the extent mandated by the Regulatory Authority and in compliance with Applicable Laws. In the case of a Product Withdrawal that is not mandated by Regulatory Authority, if the JSC (or its co-chairpersons) fail(s) to agree within a reasonably appropriate time period (depending upon the circumstances) whether to voluntarily implement or undertake a Product Withdrawal within the Territory, then ARIAD SWISSCO and/or the MAH shall have the right to make the determination whether or not to voluntarily implement such Product Withdrawal within the Territory; provided that, to the extent practicable prior to deciding to initiate a Product Withdrawal within the Territory, ARIAD SWISSCO shall or shall procure that the relevant MAH shall consider ARIAD US’s reasonable comments in good faith. ARIAD SWISSCO or its Sublicensees shall carry out such Product Withdrawal activities in consultation with ARIAD US, in a manner which enables the Parties to meet their respective Regulatory Requirements as expeditiously as possible, and in compliance with all Applicable Laws. In the event of a mandated or voluntary Product Withdrawal in the Territory, the Parties will consider whether such action is necessary also in the Reserved Territory. If either Party or the relevant MAH does not choose to undertake a voluntary Product Withdrawal in its respective territory, despite the other Party’s written recommendation that such Product Withdrawal should be undertaken, then, notwithstanding anything to the contrary herein, such Party shall indemnify and hold harmless the other Party from and against any Losses that may arise or result thereafter from such Party’s failure to undertake such Product Withdrawal following such written recommendation from the other Party pursuant to the procedures set forth in Section 22.3.
Product Withdrawal. This product may be withdrawn in future with due approval of IRDAI. However, in the event of withdrawal of the product, the insured shall be informed of the options available.
Product Withdrawal. In the event Osiris or NuVasive believes it may be necessary to conduct a recall, field correction, market withdrawal, stock recovery, or other similar action with respect to Product (a “Product Withdrawal”), NuVasive shall make all decisions as to such Product Withdrawal and Osiris shall cooperate with NuVasive in any Product Withdrawal. NuVasive shall bear all costs in connection with any such Product Withdrawal and NuVasive shall reimburse Osiris for all reasonable out-of-pocket expenses incurred by Osiris in connection with any such Product Withdrawal; provided, however, that if such Product Withdrawal is attributable to any breach, misrepresentation or non-fulfillment of any covenant, agreement, representation or warranty made or to be performed by Osiris under the Asset Purchase Agreement or this Agreement (including, without limitation, the failure of any Product supplied hereunder to meet the Osiris Product Warranty) or to the negligent act or omission or willful misconduct of Osiris, Osiris shall reimburse NuVasive for all costs reasonably incurred by NuVasive in connection with any such Product Withdrawal.
Product Withdrawal. There is a temporary withdrawal of the Product in the Territory in its entirety (i.e., the withdrawal does not relate to specific batches or lots) pursuant to Article 16 (Product Recall) below, the cause of which is other than a Prometheus Fault, and such withdrawal has continued in existence for more than sixty (60) days.
Product Withdrawal. Brocade will notify Sequent in writing at least [*] prior to withdrawal of a Product. Brocade will ship Product for open purchase orders that Brocade has accepted before the withdrawal date for an additional [*] after the withdrawal date. All EOL ("End of Life") purchase orders will be considered non-cancellable.
Product Withdrawal. Oscient may, by written notice to Auxilium, immediately terminate this Agreement in the event of (i) a governmental seizure, injunction or restraining order preventing the sale of the Product not cured by Auxilium within 90 days after the date of such seizure, injunction or restraining order, or (ii) the FDA’s withdrawal or revocation of the NDA.
Product Withdrawal. The voluntary withdrawal or institution of any action or proceeding by the FDA or similar Governmental Authority to order the withdrawal of any Product or Product category from the market or to enjoin a Loan Party, such Loan Party’s Subsidiaries or any representative of a Loan Party or its Subsidiaries from testing, manufacturing, processing, assembly, packaging, labeling, marketing, importing, exporting, selling or distributing any Product or Product category that has, individually or in the aggregate, resulted (or could reasonably be expected, individually or in the aggregate, to result) in a Material Adverse Effect, (ii) the institution of any action or proceeding by the DEA, the FDA, or any other Governmental Authority to revoke, suspend, reject, withdraw, limit, or restrict any Regulatory Required Permit held by a Loan Party, its Subsidiaries or any representative of a Loan Party or its Subsidiaries, which, in each case of this clause (ii), has, individually or in the aggregate resulted (or could reasonably be expected, individually or in the aggregate, to result) in a Material Adverse Effect, (iii) the commencement of any enforcement action against a Loan Party, a Loan Party’s Subsidiaries or any representative of a Loan Party or its Subsidiaries (with respect to the business of a Loan Party or its Subsidiaries) by the DEA, the FDA, or any other Governmental Authority which has, individually or in the aggregate, resulted (or could reasonably be expected, individually or in the aggregate, to result) in a Material Adverse Effect, or (iv) the occurrence of adverse test results in connection with a Product which has, individually or in the aggregate, resulted (or could reasonably be expected, individually or in the aggregate, to result) in a Material Adverse Effect.
Product Withdrawal. A Scope of Work covering a particular Product will automatically terminate without any further action by either Party if the Product containing such Product is withdrawn as a result of FDA or EMA actions or voluntarily withdrawn by Zogenix or if Zogenix decides to cease development activities for such Product.
Product Withdrawal. If Manufacturer or Buyer determines that any End Product sold to an End Customer or to End Customers may be Defective, at Manufacturer or Buyer's request, Buyer and Manufacturer shall work together to ensure the withdrawal of all similar End Product from sale or use and either return such End Product to Manufacturer (pursuant to the terms of 10.3(ii)) or destroy the End Product. Notwithstanding the limitations of 10.3, Buyer and Manufacturer shall work together, on a best efforts basis, to return all withdrawn End Product or destroy all withdrawn End Product and, unless any such defect has been caused or contributed to by any of the factors described under 10.2, Manufacturer shall (a) promptly repair or replace all such returned End Product or (b) promptly replace such destroyed End Product, in either case pursuant to the terms of 10.3(iv). THIS 10.4 SETS FORTH BUYER'S SOLE REMEDY AND MANUFACTURER'S ENTIRE LIABILITY FOR ANY GOODS THAT ARE WITHDRAWN UNDER THIS 10.4.
Product Withdrawal. The voluntary withdrawal or institution of any action or proceeding by the FDA or similar Governmental Authority to order the withdrawal of any Product or Product category from the market or to enjoin the Borrower, the Borrower’s Subsidiaries or any representative of a Borrower or its Subsidiaries from testing, manufacturing, processing, assembly, packaging, labeling, marketing, distribution, import/export, or selling or distributing any Product or Product category that has or could reasonably be expected to have a Material Adverse Effect, (ii) the institution of any action or proceeding by the FDA, or any other Governmental Authority to revoke, suspend or withdraw any Regulatory Required Permit held by Borrower, its Subsidiaries or any representative of Borrower or its Subsidiaries, which, in each case, has or could reasonably be expected to result in Material Adverse Effect, or (iii) the commencement of any enforcement action against Borrower or Borrower’s Subsidiaries by the FDA, or any other Governmental Authority which has or could reasonably be expected to result in a Material Adverse Effect.
