Recalls or Other Corrective Action. Each Party shall, as soon as practicable, notify the other Party of any recall information received by it in sufficient detail to allow the Parties to comply with any and all applicable Laws. GSK shall promptly notify Theravance of any material actions to be taken by GSK with respect to any recall or market withdrawal or other corrective action related to an Alliance Product prior to such action to permit Theravance a reasonable opportunity to consult with GSK with respect thereto. All costs and expenses with respect to a recall, market withdrawal or other corrective action shall be borne by GSK unless such recall, market withdrawal or other corrective action was due solely to the negligence, willful misconduct or breach of this Agreement by Theravance. GSK shall have sole responsibility for and shall make all decisions with respect to any recall, market withdrawals or any other corrective action related to the Alliance Products.
Recalls or Other Corrective Action. Pfizer and its Affiliates shall have the sole authority and responsibility to make all decisions with respect to any recall, market withdrawal or any other corrective action related to the Product. Pfizer shall promptly notify Distributor of any such recall, mandatory withdrawal or other corrective action regarding the Product in the Territory. If a corrective action is due to Pfizer's negligence, willful misconduct or breach of this Agreement, Pfizer shall reimburse Distributor for the Per System Fee paid by Distributor pursuant to SECTION 5.03 hereof for any orders of the Product subject to such corrective action (other than orders that have been resold by, and not returned to, Distributor), all of the reasonable costs and expenses actually incurred by Distributor in connection with such corrective action, including, but not limited to, costs of retrieving Product already delivered to customers, costs and expenses Distributor is required to pay for notification, shipping and handling charges, and such other costs as may be reasonably related to the corrective action. If a corrective action is due to Distributor's negligence, willful misconduct or breach of this Agreement, Distributor shall remain responsible for the Per System Fee paid by Distributor pursuant to SECTION 5.03 hereof for any orders of the Product subject to such corrective action and shall reimburse Pfizer for all the reasonable costs and expenses described above actually incurred by Pfizer in connection with such corrective action, including administration of the recall and such other actual costs as may be reasonably related to the corrective action. If a corrective action results from a cause other than the negligence, willful misconduct or breach of this Agreement of or by Distributor or Pfizer, the parties hereto shall share equally, all of the costs of the corrective action, including the Per System Fee paid by Distributor pursuant to SECTION 5.03 hereof for any orders of the Product subject to such corrective action (other than orders that have been resold by, and not returned to, Distributor). Prior to any reimbursements pursuant to this Section, the party claiming any reimbursement shall provide the other party with reasonably acceptable documentation of all reimbursable costs and expenses. Neither party will be liable to the other for Indirect Losses in connection with any corrective action undertaken pursuant to this Section.
Recalls or Other Corrective Action. 9.7.1 In the United States. --------------------
Recalls or Other Corrective Action. (a) Prior to the NDA Transfer Date, Depomed shall have final decision-making authority with respect to any recall (including recall of packaging and promotion materials), market withdrawals or any other corrective action related to the Products. Depomed shall promptly consult with Santarus with respect to any such actions proposed to be taken by Depomed (and in all events prior to the taking of such actions), including all actions that are reasonably likely to result in a material adverse effect on the marketability of the Products in the Territory. At Depomed’s request, Santarus shall provide assistance to Depomed in conducting such recall, market withdrawal or other corrective action (including retrieving Samples distributed by the Santarus Sales Force to Professionals). As the NDA holder, Depomed shall be responsible for all communications with the FDA with respect to any Product recall, market withdrawal or other corrective action; provided that (i) Depomed shall consult with Santarus prior to submitting any related documentation to the FDA, (ii) Depomed shall provide Santarus with copies of all communications received from or submitted to the FDA with respect to any such recall, market withdrawal or other corrective action within [***] after receipt or submission thereof and (iii) Santarus shall be permitted to accompany Depomed and take part in any meetings or discussions with FDA with respect to any such recall, market withdrawal or other corrective action.
Recalls or Other Corrective Action. Each Party shall, as soon as practicable, notify the other Party of any recall information received by it in sufficient detail to allow the Parties to comply with any and all applicable Laws. Clinigen shall promptly notify Theravance of any material actions to be taken by Clinigen with respect to any recall or market withdrawal or other corrective action related to the Licensed Product in the Territory prior to such action to permit Theravance a reasonable opportunity to consult with Clinigen with respect thereto. All costs and expenses with respect to a recall, market withdrawal or other corrective action in the Territory shall be borne by Clinigen, subject to Clinigen’s right to be indemnified pursuant to Section 12.02 if applicable. Clinigen shall have sole responsibility for and shall make all decisions with respect to any recall, market withdrawals or any other corrective action related to the Licensed Product in the Territory.
Recalls or Other Corrective Action. Cygnus shall have sole responsibility and shall make all decisions in its sole discretion with respect to any recall, market withdrawals or any other corrective action related to the Product, including the right to cease all sales of Product in the Territory or the sales and marketing of the Product in the Territory. Cygnus shall promptly notify Sankyo of all recalls and all other decisions or notifications (including, without limitation, notifications to or from the FDA) relating to recalls, market withdrawals or other such corrective action relating to the Product. At Cygnus’ request, Sankyo shall use its commercially reasonable efforts to assist Cygnus in conducting such recall, market withdrawal or other corrective action, and any documented out-of-pocket costs incurred by Sankyo with respect to participating in such recall, market withdrawal or other corrective action shall be reimbursed by Cygnus. In the event that a Product recall, market withdrawal or corrective action results in the situation where there are no Net Sales of any Product due to Product recall, market withdrawal or corrective action, then the Term will be extended for twice the number of days such recall, market withdrawal or corrective action is in effect, however, the Advertising and Promotional Amount set forth in Section 4.1(l) shall be suspended during the time period where there are no Net Sales of any Product. In the event that there are no Net Sales of any Product for six (6) months, then Sankyo may terminate this Agreement pursuant to Section 11.3.
Recalls or Other Corrective Action. Depomed shall have sole responsibility for and shall make all decisions with respect to any recall (including recall of packaging and promotion materials), market withdrawals or any other corrective action related to the Product. Depomed shall promptly notify King of any such actions taken by Depomed, including all actions that are reasonably likely to result in a material adverse effect on the marketability of the Product in the Territory. At Depomed’s request, King shall provide assistance to Depomed in conducting such recall, market withdrawal or other corrective action (including retrieving Samples distributed by the King Sales Force to Professionals). With respect to any recall, market withdrawal or corrective action initiated by Depomed as a result of Depomed becoming aware of any manufacturing defect in Product (other than Product manufactured by King in accordance with Section 6.6), Depomed shall reimburse King for its reasonable, documented, direct, out-of-pocket costs incurred in connection with participating in such recall, market withdrawal or other corrective action provided that King’s breach of its obligations hereunder is not a material cause of the recall, market withdrawal or other corrective action. Except as set forth above, Depomed shall be under no liability whatsoever to compensate King or make any other payment to King for any decision to recall, initiate a market withdrawal or take any other corrective action with respect to the Product.
Recalls or Other Corrective Action. (a) Ucyclyd shall have sole authority and responsibility for, and shall make all decisions with respect to, any recall, market withdrawals or any other corrective action related to the Marketed Products during the Pre-Closing Period. Ucyclyd shall promptly (but in any event within ***) notify Hyperion in the event that Ucyclyd decides to initiate any recall or market withdrawal of a Marketed Product.
Recalls or Other Corrective Action. As among the parties, Santarus and VeroScience shall have responsibility for and shall mutually agree on all decisions with respect to any recall (including recall of packaging and Promotional Materials), market withdrawals or any other corrective action related to the Product in the Territory; provided, that either Santarus or VeroScience may initiate a recall due to bona fide safety or efficacy concerns. Santarus and VeroScience shall promptly consult with one another with respect to any such actions proposed to be taken in the Territory (and in all events prior to the taking of such actions, subject to applicable Legal Requirements), including all actions that are reasonably likely to result in a material adverse effect on the marketability of the Product in the Territory. Santarus and VeroScience (and through VeroScience, S2) shall equally share the reasonable, documented, direct, out-of-pocket costs incurred in connection with participating in such recall, market withdrawal or other corrective action. For clarity, the remedies under this Section 5.7 shall in no event limit the rights or remedies of the parties under this Agreement, including the right to seek damages and costs that may be available under this Agreement. *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Recalls or Other Corrective Action. Zogenix shall have sole responsibility for and shall make all decisions with respect to any recall (including recall of packaging and promotion materials), market withdrawals, or any other corrective action related to the Product. Zogenix shall promptly consult with Astellas with respect to any such actions proposed to be taken by Zogenix (and in all events reasonably in advance of the taking of such actions), including all actions that are reasonably likely to result in a material adverse effect on the marketability of the Product in the Territory. At Zogenix’s request, Astellas shall provide reasonable assistance to Zogenix in conducting such recall, market withdrawal, or other corrective action (including retrieving Samples distributed by the Astellas Sales Force to Professionals). [***].
