Common use of Recalls or Other Corrective Action Clause in Contracts

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. Pfizer and its Affiliates Depomed shall have the sole authority responsibility for and responsibility to shall make all decisions with respect to any recallrecall (including recall of packaging and promotion materials), market withdrawal withdrawals or any other corrective action related to the Product. Pfizer Depomed shall promptly notify Distributor Xxxxxx of any such recallactions taken by Depomed, mandatory withdrawal or other corrective action regarding including all actions that are reasonably likely to result in a material adverse effect on the marketability of the Product in the Territory. If a corrective action is due At Depomed’s request, Xxxxxx shall provide assistance to Pfizer's negligenceDepomed in conducting such recall, willful misconduct market withdrawal 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 other corrective action (other than orders that have been resold byincluding retrieving Samples distributed by the Xxxxxx Sales Force to Professionals). With respect to any recall, and not returned tomarket withdrawal or corrective action initiated by Depomed as a result of Depomed becoming aware of any manufacturing defect in Product, Distributor)Depomed shall reimburse Xxxxxx for its reasonable, all of the reasonable documented, direct, out-of-pocket costs and expenses actually incurred by Distributor in connection with participating in such recall, market withdrawal or other corrective actionaction provided that Xxxxxx’x breach of its obligations hereunder is not a material cause of the recall, 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 market withdrawal or other costs as may be reasonably related to the corrective action. If Except as set forth above, Depomed shall be under no liability whatsoever to compensate Xxxxxx or make any other payment to Xxxxxx for any decision to recall, initiate a market withdrawal or take any other 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 respect 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 SectionProduct.

Recalls or Other Corrective Action. Pfizer and its Affiliates (a) PediatRx shall have the sole final decision-making authority and responsibility to make all decisions with respect to any recallrecall (including recall of packaging and promotion materials), market withdrawal withdrawals or any other corrective action related to the Product. Pfizer PediatRx shall promptly notify Distributor of consult with Apricus with respect to any such recallactions proposed to be taken by PediatRx (and in all events prior to the taking of such actions), mandatory withdrawal or other corrective action regarding including all actions that are reasonably likely to result in a material adverse effect on the marketability of the Product in the Territory. If a corrective action is due At PediatRx’s request, Apricus shall provide assistance to Pfizer's negligencePediatRx in conducting such recall, willful misconduct market withdrawal 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 other corrective action (including retrieving Samples distributed by the Apricus Sales Force to Professionals). As the ANDA holder, PediatRx shall be responsible for all communications with the FDA with respect to any Product recall, market withdrawal or 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 ; provided that (i) PediatRx shall consult with Apricus prior to customers, costs and expenses Distributor is required to pay for notification, shipping and handling charges, and such other costs as may be reasonably submitting any related documentation to the FDA, (ii) PediatRx shall provide Apricus 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 two (2) business days after receipt or submission thereof and (iii) Apricus shall be permitted to accompany PediatRx and take part in any meetings or discussions with FDA with respect to any such recall, market withdrawal or other 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. Pfizer Each Party shall, as soon as practicable but in no case later than two (2) Business Days after receipt, notify the other Party of any information received by it that could reasonably form the basis for a recall, market withdrawal or other corrective action of the Licensed Products in the Field, in sufficient detail to allow the Parties to comply with any and all applicable Laws to the ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. extent such level of detail is available to the reporting Party. Each Party shall promptly notify the other Party of any material actions to be taken with respect to any recall or market withdrawal or other corrective action related to Licensed Product in the Field prior to such action to permit each Party a reasonable opportunity to consult with the other Party with respect thereto, and upon the request of either Party, the Parties will endeavor to hold a JSC meeting to discuss any recall of the Licensed Product in the Field; provided that any such meeting shall not delay the initiation of any recall. All costs and expenses incurred in accordance with this Section 7.05 with respect to a recall, market withdrawal or other corrective action with respect to the Licensed Products in the Field in the U.S (“U.S. Recall Costs”) shall be Shared Expenses, split between the Parties proportionate to share of the Operating Profit (Loss) to which each Party is entitled pursuant to Exhibit F, unless such recall, market withdrawal or other corrective action was solely caused by the material breach of this Agreement or the Co-Promotion Agreement, gross negligence or willful misconduct by the other Party (in which case the other Party shall pay all such costs and expenses). All costs and expenses with respect to a recall, market withdrawal or other corrective action incurred by MYLAN or its Affiliates or sublicensees with respect to Licensed Product in the Field in a ROW Country (other than a Reverted Country) (“ROW Recall Expenses” and, together with “U.S. Recall Costs”, “Recall Costs) shall have be borne by MYLAN unless such recall, market withdrawal or other corrective action was solely caused by the sole authority gross negligence, willful misconduct or material breach of this Agreement by THERAVANCE (in which case THERAVANCE will pay all such costs and responsibility to make expenses). Without limiting Section 3.01(c)(x), all final decisions with respect to any recall, market withdrawal withdrawals or any other corrective action related to the ProductLicensed Product in the Field in the Territory shall be made by MYLAN as the Marketing Authorization holder. Pfizer shall promptly notify Distributor of MYLAN will keep THERAVANCE reasonably informed with respect to any such recallrecalls, mandatory withdrawal market withdrawals or other corrective action regarding with respect to the Product Licensed Products in the TerritoryField in the Territory and will consider any comments from THERAVANCE with respect thereto in good faith. If a THERAVANCE will keep MYLAN reasonably informed with respect to any recalls, market withdrawals or other 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 respect 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 Licensed Products in the Per System Fee paid by Distributor pursuant to SECTION 5.03 hereof for any orders of Field outside 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 SectionTerritory.

Recalls or Other Corrective Action. Pfizer Each Party shall, as soon as practicable but in no case later than two (2) Business Days after receipt, notify the other Party of any information received by it that could reasonably form the basis for a recall, market withdrawal or other corrective action of the Licensed Products in the Field, in sufficient detail to allow the Parties to comply with any and all applicable Laws to the ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. ​ extent such level of detail is available to the reporting Party. Each Party shall promptly notify the other Party of any material actions to be taken with respect to any recall or market withdrawal or other corrective action related to Licensed Product in the Field prior to such action to permit each Party a reasonable opportunity to consult with the other Party with respect thereto, and upon the request of either Party, the Parties will endeavor to hold a JSC meeting to discuss any recall of the Licensed Product in the Field; provided that any such meeting shall not delay the initiation of any recall. All costs and expenses incurred in accordance with this Section 7.05 with respect to a recall, market withdrawal or other corrective action with respect to the Licensed Products in the Field in the U.S ("U.S. Recall Costs") shall be Shared Expenses, split between the Parties proportionate to share of the Operating Profit (Loss) to which each Party is entitled pursuant to Exhibit F, unless such recall, market withdrawal or other corrective action was solely caused by the material breach of this Agreement or the Co-Promotion Agreement, gross negligence or willful misconduct by the other Party (in which case the other Party shall pay all such costs and expenses). All costs and expenses with respect to a recall, market withdrawal or other corrective action incurred by MYLAN or its Affiliates or sublicensees with respect to Licensed Product in the Field in a ROW Country (other than a Reverted Country) ("ROW Recall Expenses" and, together with "U.S. Recall Costs", "Recall Costs) shall have be borne by MYLAN unless such recall, market withdrawal or other corrective action was solely caused by the sole authority gross negligence, willful misconduct or material breach of this Agreement by THERAVANCE (in which case THERAVANCE will pay all such costs and responsibility to make expenses). Without limiting Section 3.01(c)(x), all final decisions with respect to any recall, market withdrawal withdrawals or any other corrective action related to the ProductLicensed Product in the Field in the Territory shall be made by MYLAN as the Marketing Authorization holder. Pfizer shall promptly notify Distributor of MYLAN will keep THERAVANCE reasonably informed with respect to any such recallrecalls, mandatory withdrawal market withdrawals or other corrective action regarding with respect to the Product Licensed Products in the TerritoryField in the Territory and will consider any comments from THERAVANCE with respect thereto in good faith. If a THERAVANCE will keep MYLAN reasonably informed with respect to any recalls, market withdrawals or other 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 respect 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 Licensed Products in the Per System Fee paid by Distributor pursuant to SECTION 5.03 hereof for any orders of Field outside 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 SectionTerritory.

Recalls or Other Corrective Action. Pfizer and its Affiliates (a) Prior to the Closing Date, Depomed shall have final decision-making authority with respect to any recall (including recall of packaging and Promotional Materials), market withdrawals or any other corrective action as may be reasonably required related to the sole authority commercial distribution of the Products. Depomed shall promptly consult with Collegium with respect to any such actions proposed to be taken by Depomed (and responsibility in all events prior to make the taking Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions marked [***]. of such actions), including all decisions actions that are reasonably likely to result in a material adverse effect on the marketability of the Products in the Territory. Prior to the Closing Date, Depomed shall be responsible for all communications with the FDA with respect to any Product recall, market withdrawal or other corrective action related to the commercial distribution of the Products; provided that (i) Depomed shall consult with Collegium prior to submitting any related documentation to the FDA and (ii) Depomed shall provide Collegium 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 two Business Days after receipt or submission thereof. After the Closing Date, Depomed shall promptly consult with Collegium with respect to any recall, market withdrawal or any other corrective action related actions proposed to be taken by Depomed outside the ProductTerritory, if any, that are reasonably likely to result in a material adverse effect on the marketability of the Products in the Territory. Pfizer Depomed shall promptly notify Distributor provide Collegium with copies of all communications received from regulatory authorities located outside the Territory with respect to any such recall, mandatory market withdrawal or other corrective action regarding the Product in the Territory. If within two (2) Business Days after Depomed’s receipt; and Depomed shall provide Collegium with a corrective action is due to Pfizer's negligence, willful misconduct or breach copy of this Agreement, Pfizer shall reimburse Distributor for the Per System Fee paid any related communications sent by Distributor pursuant to SECTION 5.03 hereof for any orders of the Product subject Depomed to such corrective action (other than orders that have been resold by, and not returned to, Distributor), all regulatory authorities at the time 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 Sectionsubmission.