Common use of Recalls or Other Corrective Action Clause in Contracts

Recalls or Other Corrective Action. 9.7.1 In the United States. -------------------- (a) Adolor shall promptly notify GSK of any material actions to be taken by Adolor with respect to any recall or market withdrawal or other corrective action related to the Adolor Products in the United States prior to such action so as to permit GSK a reasonable opportunity to consult with Adolor with respect thereto. Adolor agrees to consider GSK's consultation; provided, however, nothing in this Section is intended to limit Adolor's ability to recall, withdraw or take any other corrective action relating to the Adolor Products in the United States. At Adolor's request, GSK shall provide reasonable assistance to Adolor in conducting such recall, market withdrawal or other corrective action in the United States. In accordance with the foregoing, Adolor shall make all decisions with respect to any recall, market withdrawals or any other corrective action related to the Adolor Products in the United States. (b) GSK shall promptly notify Adolor of any material actions to be taken by GSK with respect to any recall or market withdrawal or other corrective action related to the GI Products in the United States prior to such action so as to permit Adolor a reasonable opportunity to consult with GSK with respect thereto. To the extent Adolor reasonably believes any such action is likely to adversely affect the POI Product in the United States, Adolor shall notify GSK and GSK shall not take any action without the prior written consent of Adolor unless otherwise required by Law. In accordance with the foregoing, 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 GI Products in the United States. (c) 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. (d) Any documented, direct, out-of-pocket costs incurred (i.e., paid or accrued) by a Party with respect to participating in such recall, market withdrawal or other corrective action in the United States shall be deemed a Marketing Expense of such Party; provided, however, that if such recall, market withdrawal or other corrective action was caused by a Party's negligence, willful misconduct or breach of this Agreement occurring while the Collaboration Product was under such Party's or its distributors or manufacturers' control (e.g., mishandling or adulteration of the Collaboration Product in such Party's or its distributor's or manufacturers' warehouse), such Party shall reimburse the other Party for such costs and they shall not be deemed a Marketing Expense. In no event shall a Party or its Affiliates or sublicensees be deemed a distributor or manufacturer of the other Party under the preceding sentence.

Recalls or Other Corrective Action. 9.7.1 In the United States. -------------------- (a) Adolor Prior to the NDA Transfer Date, Depomed shall promptly notify GSK of any material actions to be taken by Adolor have final decision-making authority with respect to any recall (including recall of packaging and promotion materials), market withdrawals or market withdrawal or any other corrective action related to the Adolor 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 United States prior to such action so as to permit GSK a reasonable opportunity to consult with Adolor with respect thereto. Adolor agrees to consider GSK's consultation; provided, however, nothing in this Section is intended to limit Adolor's ability to recall, withdraw or take any other corrective action relating to the Adolor Products in the United StatesTerritory. At Adolor's Depomed’s request, GSK Santarus shall provide reasonable assistance to Adolor Depomed in conducting such recall, market withdrawal or other corrective action in (including retrieving Samples distributed by the United StatesSantarus Sales Force to Professionals). In accordance As the NDA holder, Depomed shall be responsible for all communications with the foregoing, Adolor shall make all decisions 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. (b) From and after the NDA Transfer Date, Santarus 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 Adolor Products Products. At Santarus’ request, Depomed shall provide assistance to Santarus in the United States. (b) GSK shall promptly notify Adolor of any material actions to be taken by GSK with respect to any recall or market withdrawal or other corrective action related to the GI Products in the United States prior to such action so as to permit Adolor a reasonable opportunity to consult with GSK with respect thereto. To the extent Adolor reasonably believes any such action is likely to adversely affect the POI Product in the United States, Adolor shall notify GSK and GSK shall not take any action without the prior written consent of Adolor unless otherwise required by Law. In accordance with the foregoing, 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 GI Products in the United States. (c) 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. (d) Any documented, direct, out-of-pocket costs incurred (i.e., paid or accrued) by a Party with respect to participating in conducting such recall, market withdrawal or other corrective action in as it relates to Products distributed by Depomed (including retrieving Samples distributed by the United States Depomed Sales Force to Professionals) or Manufactured by or on behalf of Depomed. As the NDA holder, Santarus shall be deemed a Marketing Expense of such Party; provided, however, that if such responsible for all communications with the FDA with respect to any Product recall, market withdrawal or other corrective action was caused by a Party's negligence, willful misconduct or breach of this Agreement occurring while the Collaboration Product was under such Party's or its distributors or manufacturers' control (e.g., mishandling or adulteration of the Collaboration Product in such Party's or its distributor's or manufacturers' warehouse), such Party shall reimburse the other Party for such costs and they shall not be deemed a Marketing Expense. In no event shall a Party or its Affiliates or sublicensees be deemed a distributor or manufacturer of the other Party under the preceding sentence.or

Recalls or Other Corrective Action. 9.7.1 In Each Party shall, as soon as practicable but in no case later than two (2) Business Days after receipt, notify the United Statesother 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. -------------------- (a) Adolor 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 GSK the other Party of any material actions to be taken by Adolor with respect to any recall or market withdrawal or other corrective action related to the Adolor Products Licensed Product in the United States Field prior to such action so as to permit GSK each Party a reasonable opportunity to consult with Adolor 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. Adolor agrees to consider GSK's consultation; provided, however, nothing All costs and expenses incurred in accordance with this Section is intended 7.05 with respect to limit Adolor's ability to a recall, withdraw market withdrawal or take any other corrective action relating with respect to the Adolor Licensed Products in the United States. At Adolor's requestField in the U.S (“U.S. Recall Costs”) shall be Shared Expenses, GSK shall provide reasonable assistance split between the Parties proportionate to Adolor in conducting 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 United StatesField in a ROW Country (other than a Reverted Country) (“ROW Recall Expenses” and, together with “U.S. Recall Costs”, “Recall Costs) shall be borne by MYLAN unless such recall, market withdrawal or other corrective action was solely caused by the gross negligence, willful misconduct or material breach of this Agreement by THERAVANCE (in which case THERAVANCE will pay all such costs and expenses). In accordance with the foregoingWithout limiting Section 3.01(c)(x), Adolor shall make all final decisions with respect to any recall, market withdrawals or any other corrective action related to the Adolor Products Licensed Product in the United States. (b) GSK Field in the Territory shall promptly notify Adolor of any material actions to be taken made by GSK MYLAN as the Marketing Authorization holder. MYLAN will keep THERAVANCE reasonably informed with respect to any recall or recalls, market withdrawal withdrawals or other corrective action related with respect to the GI Licensed Products in the United States prior to such action so as to permit Adolor a reasonable opportunity to consult with GSK Field in the Territory and will consider any comments from THERAVANCE with respect theretothereto in good faith. To the extent Adolor THERAVANCE will keep MYLAN reasonably believes any such action is likely to adversely affect the POI Product in the United States, Adolor shall notify GSK and GSK shall not take any action without the prior written consent of Adolor unless otherwise required by Law. In accordance with the foregoing, GSK shall have sole responsibility for and shall make all decisions informed with respect to any recallrecalls, market withdrawals or any other corrective action related with respect to the GI Licensed Products in the United StatesField outside the Territory. (c) 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. (d) Any documented, direct, out-of-pocket costs incurred (i.e., paid or accrued) by a Party with respect to participating in such recall, market withdrawal or other corrective action in the United States shall be deemed a Marketing Expense of such Party; provided, however, that if such recall, market withdrawal or other corrective action was caused by a Party's negligence, willful misconduct or breach of this Agreement occurring while the Collaboration Product was under such Party's or its distributors or manufacturers' control (e.g., mishandling or adulteration of the Collaboration Product in such Party's or its distributor's or manufacturers' warehouse), such Party shall reimburse the other Party for such costs and they shall not be deemed a Marketing Expense. In no event shall a Party or its Affiliates or sublicensees be deemed a distributor or manufacturer of the other Party under the preceding sentence.

Recalls or Other Corrective Action. 9.7.1 In Each Party shall, as soon as practicable but in no case later than two (2) Business Days after receipt, notify the United Statesother 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. -------------------- (a) Adolor 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 GSK the other Party of any material actions to be taken by Adolor with respect to any recall or market withdrawal or other corrective action related to the Adolor Products Licensed Product in the United States Field prior to such action so as to permit GSK each Party a reasonable opportunity to consult with Adolor 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. Adolor agrees to consider GSK's consultation; provided, however, nothing All costs and expenses incurred in accordance with this Section is intended 7.05 with respect to limit Adolor's ability to a recall, withdraw market withdrawal or take any other corrective action relating with respect to the Adolor Licensed Products in the United States. At Adolor's requestField in the U.S ("U.S. Recall Costs") shall be Shared Expenses, GSK shall provide reasonable assistance split between the Parties proportionate to Adolor in conducting 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 United StatesField in a ROW Country (other than a Reverted Country) ("ROW Recall Expenses" and, together with "U.S. Recall Costs", "Recall Costs) shall be borne by MYLAN unless such recall, market withdrawal or other corrective action was solely caused by the gross negligence, willful misconduct or material breach of this Agreement by THERAVANCE (in which case THERAVANCE will pay all such costs and expenses). In accordance with the foregoingWithout limiting Section 3.01(c)(x), Adolor shall make all final decisions with respect to any recall, market withdrawals or any other corrective action related to the Adolor Products Licensed Product in the United States. (b) GSK Field in the Territory shall promptly notify Adolor of any material actions to be taken made by GSK MYLAN as the Marketing Authorization holder. MYLAN will keep THERAVANCE reasonably informed with respect to any recall or recalls, market withdrawal withdrawals or other corrective action related with respect to the GI Licensed Products in the United States prior to such action so as to permit Adolor a reasonable opportunity to consult with GSK Field in the Territory and will consider any comments from THERAVANCE with respect theretothereto in good faith. To the extent Adolor THERAVANCE will keep MYLAN reasonably believes any such action is likely to adversely affect the POI Product in the United States, Adolor shall notify GSK and GSK shall not take any action without the prior written consent of Adolor unless otherwise required by Law. In accordance with the foregoing, GSK shall have sole responsibility for and shall make all decisions informed with respect to any recallrecalls, market withdrawals or any other corrective action related with respect to the GI Licensed Products in the United StatesField outside the Territory. (c) 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. (d) Any documented, direct, out-of-pocket costs incurred (i.e., paid or accrued) by a Party with respect to participating in such recall, market withdrawal or other corrective action in the United States shall be deemed a Marketing Expense of such Party; provided, however, that if such recall, market withdrawal or other corrective action was caused by a Party's negligence, willful misconduct or breach of this Agreement occurring while the Collaboration Product was under such Party's or its distributors or manufacturers' control (e.g., mishandling or adulteration of the Collaboration Product in such Party's or its distributor's or manufacturers' warehouse), such Party shall reimburse the other Party for such costs and they shall not be deemed a Marketing Expense. In no event shall a Party or its Affiliates or sublicensees be deemed a distributor or manufacturer of the other Party under the preceding sentence.

Recalls or Other Corrective Action. 9.7.1 In the United States. -------------------- (a) Adolor PediatRx shall promptly notify GSK of any material actions to be taken by Adolor have final decision-making authority with respect to any recall (including recall of packaging and promotion materials), market withdrawals or market withdrawal or any other corrective action related to the Adolor Products Product. PediatRx shall promptly consult with Apricus with respect to any such actions proposed to be taken by PediatRx (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 Product in the United States prior to such action so as to permit GSK a reasonable opportunity to consult with Adolor with respect thereto. Adolor agrees to consider GSK's consultation; provided, however, nothing in this Section is intended to limit Adolor's ability to recall, withdraw or take any other corrective action relating to the Adolor Products in the United StatesTerritory. At Adolor's PediatRx’s request, GSK Apricus shall provide reasonable assistance to Adolor PediatRx in conducting such recall, market withdrawal or other corrective action in (including retrieving Samples distributed by the United StatesApricus Sales Force to Professionals). In accordance As the ANDA holder, PediatRx shall be responsible for all communications with the foregoing, Adolor shall make all decisions FDA with respect to any Product recall, market withdrawals or any other corrective action related to the Adolor Products in the United States. (b) GSK shall promptly notify Adolor of any material actions to be taken by GSK with respect to any recall or market withdrawal or other corrective action action; provided that (i) PediatRx shall consult with Apricus prior to submitting any related documentation to the GI Products in FDA, (ii) PediatRx shall provide Apricus with copies of all communications received from or submitted to the United States prior to such action so as to permit Adolor a reasonable opportunity to consult with GSK with respect thereto. To the extent Adolor reasonably believes any such action is likely to adversely affect the POI Product in the United States, Adolor shall notify GSK and GSK shall not take any action without the prior written consent of Adolor unless otherwise required by Law. In accordance with the foregoing, GSK shall have sole responsibility for and shall make all decisions FDA with respect to any recall, market withdrawals or any other corrective action related to the GI Products in the United States. (c) 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. (d) Any documented, direct, out-of-pocket costs incurred (i.e., paid or accrued) by a Party with respect to participating in such recall, market withdrawal or other corrective action in the United States within two (2) business days after receipt or submission thereof and (iii) Apricus shall be deemed a Marketing Expense of such Party; provided, however, that if 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. (b) With respect to any recall, market withdrawal or corrective action with respect to Product, (i) PediatRx shall be responsible for the out-of-pocket costs associated with such recall, market withdrawal or corrective action to the extent relating to Product Manufactured by it, and (ii) Apricus shall be responsible for the out-of-pocket costs associated with such recall, market withdrawal or corrective action to the extent relating to Product Manufactured by it. To the extent the recall, market withdrawal or corrective action relates to Product Manufactured by both parties, the responsibility for out-of-pocket costs associated therewith shall be equitably apportioned between the parties based on the relative amount of Product affected that was caused Manufactured by a Party's negligenceeach party. For clarity, willful misconduct any unreimbursed costs incurred by Apricus under this Section 3.7(b) may be included by Apricus as COGS, Sales and Marketing Expenses or breach of this Agreement occurring while the Collaboration Product was under such Party's or its distributors or manufacturers' control (e.g.General and Administrative Expenses, mishandling or adulteration of the Collaboration Product in such Party's or its distributor's or manufacturers' warehouse), such Party shall reimburse the other Party for such costs and they shall not be deemed a Marketing Expense. In no event shall a Party or its Affiliates or sublicensees be deemed a distributor or manufacturer of the other Party under the preceding sentenceas applicable.

Recalls or Other Corrective Action. 9.7.1 In the United States. -------------------- (a) Adolor Prior to the NDA Transfer Date, Depomed shall promptly notify GSK of any material actions to be taken by Adolor have final decision-making authority with respect to any recall (including recall of packaging and promotion materials), market withdrawals or market withdrawal or any other corrective action related to the Adolor 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 United States prior to such action so as to permit GSK a reasonable opportunity to consult with Adolor with respect thereto. Adolor agrees to consider GSK's consultation; provided, however, nothing in this Section is intended to limit Adolor's ability to recall, withdraw or take any other corrective action relating to the Adolor Products in the United StatesTerritory. At Adolor's Depomed’s request, GSK Santarus shall provide reasonable assistance to Adolor Depomed in conducting such recall, market withdrawal or other corrective action in (including retrieving Samples distributed by the United StatesSantarus Sales Force to Professionals). In accordance As the NDA holder, Depomed shall be responsible for all communications with the foregoing, Adolor shall make all decisions 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. (b) From and after the NDA Transfer Date, Santarus 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 Adolor Products Products. At Santarus’ request, Depomed shall provide assistance to Santarus in the United States. (b) GSK shall promptly notify Adolor of any material actions to be taken by GSK with respect to any recall or market withdrawal or other corrective action related to the GI Products in the United States prior to such action so as to permit Adolor a reasonable opportunity to consult with GSK with respect thereto. To the extent Adolor reasonably believes any such action is likely to adversely affect the POI Product in the United States, Adolor shall notify GSK and GSK shall not take any action without the prior written consent of Adolor unless otherwise required by Law. In accordance with the foregoing, 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 GI Products in the United States. (c) 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. (d) Any documented, direct, out-of-pocket costs incurred (i.e., paid or accrued) by a Party with respect to participating in conducting such recall, market withdrawal or other corrective action in as it relates to Products distributed by Depomed (including retrieving Samples distributed by the United States Depomed Sales Force to Professionals) or Manufactured by or on behalf of Depomed. As the NDA holder, Santarus shall be deemed a Marketing Expense responsible for all communications with the FDA with respect to any Product recall, market withdrawal or other corrective action; provided that Santarus shall provide Depomed with copies of such Party; provided, however, that if 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. (c) With respect to any recall, market withdrawal or corrective action with respect to Product, (i) Depomed shall be responsible for the out-of-pocket costs associated with such recall, market withdrawal or corrective action to the extent relating to Product Manufactured prior to the Effective Date, and (ii) Santarus shall be responsible for the out-of-pocket costs associated with such recall, market withdrawal or corrective action to the extent relating to Product Manufactured on or after the Effective Date. To the extent the recall, market withdrawal or corrective action relates to Product Manufactured before and after the Effective Date, the responsibility for out-of-pocket costs associated therewith shall be equitably apportioned between the parties based on the relative amount of Product affected that was caused Manufactured before the Effective Date and the relative amount of Product affected that was Manufactured on or after the Effective Date. (d) Notwithstanding Section 6.7(c) above, in the event of a recall, market withdrawal or other corrective action with respect to Product manufactured at Patheon’s Caguas or Manati facilities in Puerto Rico that results from the presence of 2,4,6-tribromoanisole, or TBA, Santarus and Depomed shall share equally all out-of-pocket costs (other than Product returns) associated with such recall, market withdrawal or other corrective action that are incurred by a Party's negligenceeither party, willful misconduct including inventory write-offs and costs and expenses associated with product liability, as adjusted for any amounts or breach of other consideration recovered from Third Party manufacturers or other Third Parties or insurance proceeds received. With respect to Product returns arising from any recall, market withdrawal or other corrective action covered by this Agreement occurring while the Collaboration Product was under such Party's or its distributors or manufacturers' control (e.g., mishandling or adulteration of the Collaboration Product in such Party's or its distributor's or manufacturers' warehouseSection 6.7(d), the parties will work in good faith to ensure that (i) the parties share equally manufacturing costs of Product that replaces returned Product and (ii) royalties on Product distributed to replace returned Product are payable at the same rate in effect when such Party shall reimburse the other Party for such costs and they shall not be deemed a Marketing Expense. In no event shall a Party or its Affiliates or sublicensees be deemed a distributor or manufacturer of the other Party under the preceding sentenceProduct is returned.