Common use of Product Recalls Clause in Contracts

Product Recalls. In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with Product, or in the event a Party reasonably believes that an event, incident or circumstance has occurred that may result in the need for a voluntary or mandatory recall, market withdrawal or other corrective action regarding Product, such Party will promptly advise the other Party (in the case of Relief, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer; and in the case of Acer, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer) thereof by telephone or email. Relief will decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it will be required) or to take other corrective action in any country in Relief Territory and the manner in which any such recall, market withdrawal or corrective action will be conducted; provided, that Acer will have the right to participate in any meetings and to review and comment in advance on any communications with a Regulatory Authority in connection with a recall or pharmacovigilance matter in the Relief Territory and Relief will notify Acer prior to making any public disclosure of the recall, market withdrawal or corrective action and will keep Acer regularly informed regarding any such recall, market withdrawal or corrective action. Recall costs in the Relief Territory will be borne solely by Relief. Acer will decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it will be required) or to take other corrective action in any country in the Acer Territory and the manner in which any such recall, market withdrawal or corrective action will be conducted; provided, that Acer will notify Relief prior to making any public disclosure of the recall, market withdrawal or corrective action and will keep Relief regularly informed regarding any such recall, market withdrawal or corrective action. Recall costs in the Acer Territory will be borne by the Parties as they will be included in Distribution Costs. The Parties will exercise reasonable cooperation between them, as appropriate, to resolve Product complaints and share related data.

Product Recalls. 1. In the event (i) any Governmental Authority issues a request, directive or order that a Product be recalled, or (ii) a court of competent jurisdiction orders such a recall, or (iii) Aphria, after consultation with Aphria Diamond, reasonably determines that a Product should be recalled because the Product does not conform to Specifications, or (iv) Aphria Diamond, after consultation with Aphria, reasonably determines that a Product should be recalled for any reason, the Parties shall take all appropriate corrective actions reasonably requested by the other Party hereto or by any Governmental Authority. In the event that any Regulatory Authority issues or requests a such recall or takes similar action in connection with Productresults from the breach of Aphria Diamond’s representations, warranties and/or covenants under this Agreement, or in Aphria Diamond is otherwise responsible for the recall, Aphria Diamond shall be responsible for 100% of the Expenses of the Recall. In the event a Party reasonably believes that an eventthe recall results from the breach of Aphria’s representations, incident warranties and/or covenants under this Agreement, or circumstance has occurred that may result in Aphria is otherwise responsible for the need for a voluntary or mandatory recall, market withdrawal or other corrective action regarding Product, such Party will promptly advise Aphria shall be responsible for one hundred percent (100%) of Expenses of the other Party (in the case of Relief, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer; and in the case of Acer, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer) thereof by telephone or emailRecall. Relief will decide and have control of whether to conduct a recall or market withdrawal (except in In the event of a recall or market withdrawal mandated by a Regulatory Authoritythat is neither Party’s fault, in which case it will be required) or to take other corrective action in any country in Relief Territory and the manner in which any such recall, market withdrawal or corrective action will be conducted; provided, that Acer will have Parties shall evenly split the right to participate in any meetings and to review and comment in advance on any communications with a Regulatory Authority in connection with a recall or pharmacovigilance matter in the Relief Territory and Relief will notify Acer prior to making any public disclosure Expenses of the recall, market withdrawal or corrective action and will keep Acer regularly informed regarding any such recall, market withdrawal or corrective actionRecall. Recall costs in the Relief Territory will be borne solely by Relief. Acer will decide and have control of whether to conduct a recall or market withdrawal (except in In the event of a recall or market withdrawal mandated by a Regulatory Authoritythat is the fault of both Parties, in which case it will be required) or to take other corrective action in any country in the Acer Territory and Parties shall allocate the manner in which any Expenses of the Recall between each of the Parties based on each Party’s respective culpability for such recall, market withdrawal with the Parties acting reasonably. For the purposes of this Agreement, “Expenses of the Recall” shall mean the reasonable and direct costs and expenses of notification of customers and destruction or return of the recalled Product, as well as any reasonable and direct out-of-pocket costs, solely in connection with any corrective action will be conducted; providedtaken by Aphria Diamond. For greater certainty, that Acer will notify Relief prior to making any public disclosure Expenses of the recallRecall shall not include any indirect or consequential costs, market withdrawal or corrective action loss of profits, business revenues, business interruption and will keep Relief regularly informed regarding any such recallthe like, market withdrawal or corrective actionof either Party. Recall costs Aphria shall lead and conduct a recall in accordance with its standard operating procedures and the Acer Territory will be borne by Quality Agreement and Aphria Diamond shall fully cooperate with Aphria to assist with the Parties recall process as they will be included in Distribution Costs. The Parties will exercise reasonable cooperation between them, as appropriate, to resolve Product complaints and share related datanecessary.

Product Recalls. (a) If either Party becomes aware of information about distributed Product indicating that it may be non-conforming with respect to the Product Specifications or that there is potential adulteration, misbranding and/or any potential issues regarding safety or effectiveness with respect to the Product, it shall promptly serve written notice to that effect on the other Party. If such issue relates to the manufacture of the Product, Hospira shall initiate an investigation and assessment of such circumstances and shall provide Durata a written report of its findings and any proposed course of action to remedy such issue. (b) In the event: (i) any Regulatory Authority or other national government authority issues a request, directive or order that Product be recalled; (ii) a court of competent jurisdiction orders such a recall; or (iii) Durata reasonably determines that Product should be recalled, the Parties shall take all appropriate corrective actions, and shall cooperate in any governmental investigations surrounding the recall. In the event Hospira reasonably determines that Product should be recalled, Hospira shall provide notice to Durata including all relevant information that supports such determination by Hospira. Durata shall reasonably consider such information; provided that the institution of a recall shall be in Durata’s sole discretion, which discretion shall not be exercised unreasonably. Durata will have the responsibility for all communications with Regulatory Authorities and customers regarding any recall of Product. Hospira will give Durata any assistance that Durata may reasonably require to handle any recall. (c) In the event that such recall results from a manufacturing defect, including the breach of Hospira’s express warranties under Section 8.2(a), Hospira shall be responsible for, at Durata’s option, promptly replacing the quantity of Products that were recalled at no cost to Durata or reimbursing Durata for the cost of the Products that were recalled. In the event that Durata elects to have the recalled Product replaced, Hospira shall use commercially reasonable efforts to replace such Product as soon as possible. In the event that Durata elects to be reimbursed for the cost of the recalled Products, Hospira shall reimburse Durata within [**] days of receipt of request from Durata for reimbursement. In addition, Hospira agrees that it shall be responsible for the administrative expenses of any Regulatory Authority issues recall. For purposes of this Agreement, the administrative expenses of the recall shall include the expenses of notification and destruction or requests a recall or takes similar action in connection with return of the recalled Product, or and any costs associated with the distribution of the replacement Product (including the cost to replace API, up to the limitations stated in Section 5.4(d)), but shall not include lost profits of either Party, nor the cost to replace API in excess of the limitations stated in Section 5.4(d). In the event a Party reasonably believes that an eventthe recall does not result from the breach of Hospira’s express warranties under this Agreement, incident or circumstance has occurred that may result in Durata shall be responsible for the need for a voluntary or mandatory recall, market withdrawal or other corrective action regarding Product, such Party will promptly advise the other Party (in the case of Relief, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer; and in the case of Acer, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer) thereof by telephone or email. Relief will decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it will be required) or to take other corrective action in any country in Relief Territory and the manner in which any such recall, market withdrawal or corrective action will be conducted; provided, that Acer will have the right to participate in any meetings and to review and comment in advance on any communications with a Regulatory Authority in connection with a recall or pharmacovigilance matter in the Relief Territory and Relief will notify Acer prior to making any public disclosure expenses of the recall, market withdrawal or corrective action and will keep Acer regularly informed regarding any such recall, market withdrawal or corrective action. Recall costs in the Relief Territory will be borne solely by Relief. Acer will decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it will be required) or to take other corrective action in any country in the Acer Territory and the manner in which any such recall, market withdrawal or corrective action will be conducted; provided, that Acer will notify Relief prior to making any public disclosure of the recall, market withdrawal or corrective action and will keep Relief regularly informed regarding any such recall, market withdrawal or corrective action. Recall costs in the Acer Territory will be borne by the Parties as they will be included in Distribution Costs. The Parties will exercise reasonable cooperation between them, as appropriate, to resolve Product complaints and share related data.

Product Recalls. In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with a Collaborative Product, or in the event a Party reasonably believes that an event, incident or circumstance has occurred impacting product 22. [***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED data, quality, safety, or efficacy that may result in the need for a voluntary or mandatory recall, market withdrawal or other corrective action regarding a Collaborative Product, such Party will shall promptly so advise the other Party (in the case of Relief, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer; and in the case of Acer, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer) thereof by telephone or email. Relief will Tracon shall decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it will shall be required) or to take other corrective action in the Field in any country in Relief of the Collaborative Territory and the manner in which any such recall, market withdrawal or corrective action will shall be conducted; providedprovided that, that Acer will have the right Tracon shall (i) give prompt and due consideration to participate in any meetings and report by Eucure of any failure of Collaborative Product supplied by or on behalf of Eucure to review and comment in advance on Tracon to comply with any communications with a Regulatory Authority in connection with a recall or pharmacovigilance matter quality standard set forth in the Relief Territory Clinical Supply and Relief will Quality Agreement (or other supply agreement or quality agreement between the Parties); (ii) notify Acer Eucure prior to making any public disclosure of the recall, market withdrawal or corrective action action; and will (iii) shall keep Acer Eucure regularly informed regarding any such recall, market withdrawal or corrective action. Recall Tracon shall be solely responsible for all costs incurred in connection with any such recall, market withdrawal or corrective action for a Collaborative Product in the Relief Territory will Field in the Collaborative Territory, provided that to the extent the recall is a result of the failure of any Collaborative Product supplied by or on behalf of Eucure to Tracon to comply with any quality standard set forth in the Clinical Supply and Quality Agreement (or other supply agreement or quality agreement between the Parties), the costs of the recall shall be borne solely by ReliefEucure (except to the extent that such costs are exacerbated due to delay or inaction by Tracon after such failure to comply has been reported or become known to Tracon). Acer will Eucure shall decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it will shall be required) or to take other corrective action in any country in the Acer Eucure Territory and the manner in which any such recall, market withdrawal or corrective action will shall be conducted; provided, provided that Acer will Eucure shall notify Relief Tracon prior to making any public disclosure of the recall, market withdrawal or corrective action and will shall keep Relief Tracon regularly informed regarding any such recall, market withdrawal or corrective action. Recall Eucure shall be solely responsible for all costs incurred in connection with any such recall, market withdrawal or corrective action for a Collaborative Product in the Acer Territory will be borne by the Parties as they will be included in Distribution Costs. The Parties will exercise reasonable cooperation between them, as appropriate, to resolve Product complaints and share related dataEucure Territory.

Product Recalls. In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with Product, or in the event a 12.1 If either Party reasonably believes that an eventdecides to or is required by any law, incident government authority or circumstance has occurred that may result in the need for court of competent jurisdiction to initiate a voluntary or mandatory recall, market withdrawal or other corrective action regarding field correction with respect to any Clinical Development Product or Commercial Product, or if there is any governmental seizure (including any threatened governmental seizure) of any Clinical Development Product or Commercial Product or any products containing Clinical Development Product or Commercial Product supplied hereunder, the Party initiating or required to initiate such Party action, or responding to the seizure or threatened seizure will promptly advise notify the other Party (promptly of the details regarding such action. The Parties will assist each other in investigating any such situation and all regulatory contacts that are made and all activities concerning seizure, recall, withdrawal or field correction will be jointly coordinated by Schering and CoTherix, with CoTherix serving as the case primary point of Relief, contact for communications involving the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer; and in the case of Acer, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer) thereof by telephone or email. Relief will decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Health Regulatory Authority. Each Party will provide the other with copies of all communications submitted to and received from any governmental entity, and copies of all other documents, records or data in which case it will be required) connection with any such seizure, recall, withdrawal or to take other corrective action in any country in Relief Territory and the manner in which field correction. 12.2 If any such recall, market withdrawal, field correction or seizure occurs due solely to the breach by Schering of any warranty pursuant to Section 11.2 above, then Schering shall bear the full cost and expense of any such seizure, recall, withdrawal or corrective action will be conducted; provided, that Acer will have the right to participate in any meetings and to review and comment in advance on any communications with a Regulatory Authority in connection with a recall or pharmacovigilance matter in the Relief Territory and Relief will notify Acer prior to making any public disclosure of the recall, market withdrawal or corrective action and will keep Acer regularly informed regarding field correction. If any such recall, market withdrawal, field correction or seizure occurs solely for any reason other than that set forth in the immediately preceding sentence, then (except as set forth below) CoTherix shall bear the full cost and expense of any such seizure, recall, withdrawal or corrective actionfiled correction. Recall costs in If both CoTherix and Schering contribute to the Relief Territory cause of a seizure, recall, withdrawal or field correction, the cost and expense thereof will be borne solely by Reliefshared in proportion to each Party’s contribution to the problem. Acer will decide For the purposes of this Agreement, the expenses of any recall, withdrawal, field correction or seizure shall include, without limitation, the out-of-pocket expenses of notification and have control destruction or return of whether to conduct a recall the recalled Clinical Development Product or market withdrawal (except Commercial Product and all other out-of-pocket costs incurred in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it will be required) or to take other corrective action in any country in the Acer Territory and the manner in which any connection with such recall, market withdrawal but shall not include internal costs or corrective action will charges, or any administrative or overhead charge, or any indirect, incidental, special or consequential damages of either Party (including without limitation any damages arising from lost profits) under any circumstances. 12.3 Disposal or destruction of Clinical Development Product or Commercial Product shall be conducted; provided, that Acer will notify Relief prior to making any public disclosure carried out or arranged for by the Party which is in possession of the recall, market withdrawal Clinical Development Product or corrective action and will keep Relief regularly informed regarding any such recall, market withdrawal Commercial Product when decision about disposal or corrective action. Recall costs in the Acer Territory will be borne by the Parties as they will be included in Distribution Costs. The Parties will exercise reasonable cooperation between them, as appropriate, to resolve Product complaints and share related datadestruction thereof is made.

Product Recalls. (a) In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with Producta Supplied Item in the Territory, or in the event a either Party reasonably believes determines that an event, incident or circumstance has occurred that may result in the need for a voluntary Supplied Item recall or mandatory recall, market withdrawal in the Territory, the Party notified of or other corrective desiring such recall or similar action regarding Productshall, such Party will promptly within 24 hours, advise the other Party (in the case of Relief, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer; and in the case of Acer, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer) thereof by telephone (confirmed by email or emailfacsimile), email or facsimile. Relief will decide The Parties shall, to the extent practicable, endeavor to discuss and have control of agree upon whether to conduct recall or withdraw such Supplied Item in the Territory; provided that if such discussion is not practicable or if the Parties fail to so agree within an appropriate time period (recognizing the exigencies of the situation), then such recall or withdrawal shall be undertaken. If any Regulatory Authority issues or requests a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it will be required) or to take other corrective takes similar action in any country in Relief Territory and the manner in which any such recall, market withdrawal or corrective action will be conducted; provided, that Acer will have the right to participate in any meetings and to review and comment in advance on any communications with a Regulatory Authority in connection with a Supplied Item in the Territory, or a Party decides that a recall or pharmacovigilance matter withdrawal of a Supplied Item in the Relief Territory and Relief will notify Acer prior to making any public disclosure is necessary, Cardiome shall be responsible for conducting such recall or withdrawal in the Territory in accordance with Applicable Law, the requirements of the applicable Regulatory Authority, and SteadyMed’s instructions. The costs of conducting such recall or withdrawal shall be allocated as set forth below in Section 5.8(b). To the extent that it is necessary or appropriate to communicate with any person in the Territory, including any Regulatory Authority, the media or any customer, concerning any recall, market withdrawal withdrawal, other remedial action, event, incidence or corrective action and will keep Acer regularly informed regarding any such recall, market withdrawal or corrective action. Recall costs circumstance concerning a Supplied Item in the Relief Territory, as between the Parties, Cardiome shall be responsible for such communication. (b) Any recall conducted, or required to be conducted, by Cardiome with respect to a Supplied Item in the Territory will be borne solely by Relief. Acer will decide conducted at Cardiome’s sole cost and have control of whether expense, unless the fact or circumstance giving rise to the need to conduct a such recall was proximately caused in whole or market withdrawal (except in the event of a recall or market withdrawal mandated part by a Regulatory Authoritybreach of, in which case it will be required) or to take other corrective action in any country in non-compliance with, this Agreement or the Acer Territory Quality Agreement by SteadyMed or by both Parties (such breach or non-compliance, a “Fault”; and the manner Party(ies) at Fault, the “At-Fault Party(ies)”). If Cardiome believes in which any good faith that SteadyMed is at Fault, Cardiome shall notify SteadyMed in writing thereof as soon as possible after Cardiome first receives notice or otherwise becomes aware that such recallrecall is required, market withdrawal and if SteadyMed believes in good faith that Cardiome is at Fault, SteadyMed shall so notify Cardiome as soon as possible after receipt of notice from Cardiome. Within [*] after SteadyMed’s receipt of notice from Cardiome, the Parties will attempt in good faith to reach mutual written agreement as to the relative Fault (if any) of each Party in causing the fact or corrective action will be conducted; provided, that Acer will notify Relief prior circumstance giving rise to making any public disclosure of such recall and as to how the recall, market withdrawal or corrective action associated costs and will keep Relief regularly informed regarding any such recall, market withdrawal or corrective action. Recall costs in the Acer Territory will expenses should be borne by the Parties. If the Parties as they are unable to reach mutual written agreement within an additional [*], then the Parties shall mutually select an independent expert with at least [*] of industry experience with recalls of pharmaceutical products to determine whether or not one or both of the Parties is/are at Fault and, if so, to assess the relative Fault (if any) of the At-Fault Party(ies). SteadyMed and Cardiome shall promptly respond to the independent expert’s requests for information that the independent expert deems necessary to make his/her determination. The determination of the independent expert will be included binding on the Parties. Responsibility for the costs and expenses incurred by Cardiome in Distribution Costs. The conducting a recall of Supplied Item and the fees and costs of the independent expert shall be allocated as set forth below: (i) If the independent expert determines that neither Party is at Fault or that only Cardiome is at Fault, then Cardiome shall be solely responsible for the costs and expenses of conducting such recall and for the fees and costs of the independent expert. (ii) If the independent expert determines that both Parties will exercise are at Fault, then the reasonable cooperation between themand documented out-of-pocket (i.e., external) costs and expenses incurred by Cardiome in conducting the recall and the fees and costs of the independent expert shall be shared by the Parties in proportion to their relative Fault as appropriatedetermined by the independent expert. (iii) If the independent expert determines that only SteadyMed is at Fault, to resolve Product complaints then the reasonable and share related datadocumented out-of-pocket (i.e., external) costs and expenses incurred by Cardiome in conducting the recall and the fees and costs of the independent expert shall be borne entirely by SteadyMed.

Product Recalls. (a) In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with Producta Supplied Item in the Territory, or in the event a either Party reasonably believes determines that an event, incident or circumstance has occurred that may result in the need for a voluntary Supplied Item recall or mandatory recall, market withdrawal in the Territory, the Party notified of or other corrective desiring such recall or similar action regarding Productshall, such Party will promptly within 24 hours, advise the other Party (in the case of Relief, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer; and in the case of Acer, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer) thereof by telephone (confirmed by email or emailfacsimile), email or facsimile. Relief will decide The Parties shall, to the extent practicable, endeavor to discuss and have control of agree upon whether to conduct recall or withdraw such Supplied Item in the Territory; provided that if such discussion is not practicable or if the Parties fail to so agree within an appropriate time period (recognizing the exigencies of the situation), then such recall or withdrawal shall be undertaken. If any Regulatory Authority issues or requests a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it will be required) or to take other corrective takes similar action in any country in Relief Territory and the manner in which any such recall, market withdrawal or corrective action will be conducted; provided, that Acer will have the right to participate in any meetings and to review and comment in advance on any communications with a Regulatory Authority in connection with a Supplied Item in the Territory, or a Party decides that a recall or pharmacovigilance matter withdrawal of a Supplied Item in the Relief Territory and Relief will notify Acer prior to making any public disclosure is necessary, Cardiome shall be responsible for conducting such recall or withdrawal in the Territory in accordance with Applicable Law, the requirements of the applicable Regulatory Authority, and SteadyMed’s instructions. The costs of conducting such recall or withdrawal shall be allocated as set forth below in Section 5.8(b). To the extent that it is necessary or appropriate to communicate with any person in the Territory, including any Regulatory Authority, the media or any customer, concerning any recall, market withdrawal withdrawal, other remedial action, event, incidence or corrective action and will keep Acer regularly informed regarding any such recall, market withdrawal or corrective action. Recall costs circumstance concerning a Supplied Item in the Relief Territory, as between the Parties, Cardiome shall be responsible for such communication. (b) Any recall conducted, or required to be conducted, by Cardiome with respect to a Supplied Item in the Territory will be borne solely by Relief. Acer will decide conducted at Cardiome’s sole cost and have control of whether expense, unless the fact or circumstance giving rise to the need to conduct a such recall was proximately caused in whole or market withdrawal (except in the event of a recall or market withdrawal mandated part by a Regulatory Authoritybreach of, in which case it will be required) or to take other corrective action in any country in non-compliance with, this Agreement or the Acer Territory Quality Agreement by SteadyMed or by both Parties (such breach or non-compliance, a “Fault”; and the manner Party(ies) at Fault, the “At-Fault Party(ies)”). If Cxxxxxxx believes in which any good faith that SteadyMed is at Fault, Cardiome shall notify SteadyMed in writing thereof as soon as possible after Cardiome first receives notice or otherwise becomes aware that such recallrecall is required, market withdrawal and if SteadyMed believes in good faith that Cardiome is at Fault, SteadyMed shall so notify Cardiome as soon as possible after receipt of notice from Cardiome. Within [...***...] after SteadyMed’s receipt of notice from Cardiome, the Parties will attempt in good faith to reach mutual written agreement as to the relative Fault (if any) of each Party in causing the fact or corrective action will be conducted; provided, that Acer will notify Relief prior circumstance giving rise to making any public disclosure of such recall and as to how the recall, market withdrawal or corrective action associated costs and will keep Relief regularly informed regarding any such recall, market withdrawal or corrective action. Recall costs in the Acer Territory will expenses should be borne by the Parties. If the Parties as they are unable to reach mutual written agreement within an additional [...***...], then the Parties shall mutually select an independent expert with at least [...***...] of industry experience with recalls of pharmaceutical products to determine whether or not one or both of the Parties is/are at Fault and, if so, to assess the relative Fault (if any) of the At-Fault Party(ies). SteadyMed and Cxxxxxxx shall promptly respond to the independent expert’s requests for information that the independent expert deems necessary to make his/her determination. The determination of the independent expert will be included binding on the Parties. Responsibility for the costs and expenses incurred by Cardiome in Distribution Costs. The conducting a recall of Supplied Item and the fees and costs of the independent expert shall be allocated as set forth below: (i) If the independent expert determines that neither Party is at Fault or that only Cardiome is at Fault, then Cardiome shall be solely responsible for the costs and expenses of conducting such recall and for the fees and costs of the independent expert. (ii) If the independent expert determines that both Parties will exercise are at Fault, then the reasonable cooperation between themand documented out-of-pocket (i.e., external) costs and expenses incurred by Cxxxxxxx in conducting the recall and the fees and costs of the independent expert shall be shared by the Parties in proportion to their relative Fault as appropriatedetermined by the independent expert. (iii) If the independent expert determines that only SteadyMed is at Fault, to resolve Product complaints then the reasonable and share related datadocumented out-of-pocket (i.e., external) costs and expenses incurred by Cxxxxxxx in conducting the recall and the fees and costs of the independent expert shall be borne entirely by SteadyMed.

Product Recalls. In Each party shall promptly notify the event that other party if any Regulatory Authority issues batch of the Product is alleged or requests proven to be the subject of a recall or takes similar action in connection with Product, or in the event a Party reasonably believes that an event, incident or circumstance has occurred that may result in the need for a voluntary or mandatory recall, market withdrawal or correction ordered by the FDA or any other corrective action regarding Product, such Party will promptly advise the other Party (regulatory authority in the case Territory. The parties shall cooperate in good faith to handle and dispose of Reliefsuch recall, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer; and in the case of Acer, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer) thereof by telephone or email. Relief will decide and have control of whether to conduct a recall or market withdrawal (except or correction; provided, however, that in the event of a recall or disagreement as to any matters related to such recall, market withdrawal mandated by a Regulatory Authorityor correction, in which case it will be required) or to take other corrective action in any country in Relief Territory and the manner in which ORPHAN’S decision shall prevail. ORPHAN shall bear [ * ] costs of any such recall, market withdrawal or corrective action will be conducted; provided, that Acer will have the right to participate in any meetings and to review and comment in advance on any communications with a Regulatory Authority in connection with a recall or pharmacovigilance matter in the Relief Territory and Relief will notify Acer prior to making any public disclosure of the recall, market withdrawal or corrective action and will keep Acer regularly informed regarding any correction unless such recall, market withdrawal or corrective action. Recall costs in correction was solely the Relief Territory will be borne solely by Relief. Acer will decide and have control result of whether to conduct a recall Catalytica’s negligence or market withdrawal (except in the event willful misconduct, or breach of a recall or market withdrawal mandated by a Regulatory AuthorityArticle 8.1(b), in which case it will be required) Catalytica shall [ * ] bear [ * ] cost of administering such recall, market withdrawal, or correction; provided, however, in no event shall Catalytica’s aggregate liability with regard to take other corrective action in any country in the Acer Territory and the manner in which any such recall, market withdrawal or corrective action correction exceed [ * ]. Catalytica will not bear the cost for recalls made as a result of errors that could have been detected by ORPHAN through acceptance and rejection testing as outlined in this Article 9. ORPHAN shall in all events be conducted; provided, that Acer will notify Relief prior to making responsible for conducting any public disclosure of the recallrecalls, market withdrawal withdrawals or corrective action and will keep Relief regularly informed regarding any such recallcorrections with respect to the Product. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, market withdrawal or corrective action. Recall costs in the Acer Territory will be borne by the Parties as they will be included in Distribution Costs. The Parties will exercise reasonable cooperation between themMARKED BY BRACKETS, as appropriateHAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, to resolve Product complaints and share related dataAS AMENDED.

Product Recalls. In (a) If, in the event that judgement of AMS or BSC, after consultation with the other, any Regulatory Authority issues defect relating to a Company Product sold by BSC or requests any government action requires a recall or takes similar action in connection with Productof, or the issuance of an advisory letter regarding, any Company Product sold by BSC, either party may undertake such recall or issue such advisory letter after consultation with the other party. Each party shall notify the other party in a timely manner prior to making any recall or issuing any advisory letter. The parties shall endeavor to reach an agreement prior to making any recall or issuing any advisory letter regarding the manner, text and timing of any publicity to be given such matters in time to comply with any applicable legal or regulatory requirements, but such agreement will not be a precondition to any action that either party deems necessary to protect users of the Company Products or to comply with any applicable governmental orders or mandates. The parties agree to provide reasonable assistance to one another in the event of any recall or issuance of any advisory letter. AMS shall promptly pay or reimburse BSC for the reasonable costs of effecting such recall or issuing such advisory letter, including without limitation costs related to return of recalled AMS-Developed Products (including shipping, quality control testing, notification and restocking costs) if and to the extent such recall results from a Party reasonably believes that an event, incident or circumstance has occurred that may result defect in the need for a voluntary design or mandatory recall, market withdrawal manufacture of such AMS-Developed Product recalled or from literature or other corrective action regarding information supplied by AMS that relates to such AMS-Developed Product. AMS shall not be responsible for the cost and expense of any recall which results from an act or omission of BSC with respect to such Company Product. Notwithstanding anything in this Agreement to the contrary, such Party will promptly advise BSC shall have the other Party right to manage any recall within the Territory. (in the case of Relief, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer; and in the case of Acer, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officerb) thereof by telephone or email. Relief will decide and have control of whether to conduct a recall or market withdrawal (except in In the event of a recall of any Company Product, AMS shall correct any deficiency relating to its manufacturing, packaging, testing, labeling, storing or market withdrawal mandated handling of such Company Product, if applicable, and shall either, at BSC's election, at AMS' cost replace each unit of the Company Product recalled (including without limitation units held in inventory by a Regulatory Authority, in which case it will be requiredBSC or its customers) or to take other corrective action in any country in Relief Territory and the manner in which any such recall, market withdrawal or corrective action will be conducted; provided, that Acer will have the right to participate in any meetings and to review and comment in advance on any communications with a Regulatory Authority in connection with corrected Company Product within a recall reasonable period of time, or pharmacovigilance matter in refund the Relief Territory and Relief will notify Acer prior to making any public disclosure of the recall, market withdrawal or corrective action and will keep Acer regularly informed regarding any such recall, market withdrawal or corrective action. Recall costs in the Relief Territory will be borne solely by Relief. Acer will decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it will be required) or to take other corrective action in any country in the Acer Territory and the manner in which any such recall, market withdrawal or corrective action will be conducted; provided, that Acer will notify Relief prior to making any public disclosure of the recall, market withdrawal or corrective action and will keep Relief regularly informed regarding any such recall, market withdrawal or corrective action. Recall costs in the Acer Territory will be borne by the Parties as they will be included in Distribution Costs. The Parties will exercise reasonable cooperation between them, as appropriate, to resolve Product complaints and share related datapurchase price therefor.

Product Recalls. In Each party promptly shall notify the event that other if any Regulatory Authority issues Batch of Product is alleged or requests proven to be the subject of a recall or takes similar action in connection with Product, or in the event a Party reasonably believes that an event, incident or circumstance has occurred that may result in the need for a voluntary or mandatory recall, market withdrawal or other corrective action regarding correction. Halozyme shall be responsible for coordinating any recall, market withdrawal or field correction of Product, such Party will promptly advise the other Party (in the case of Relief, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer; and in the case of Acer, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer) thereof by telephone or email. Relief will decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it will be required) or to take other corrective action in any country in Relief Territory and the manner in which any such recall, market withdrawal or corrective action correction shall be conducted in accordance with the provisions of the Quality Agreement. Xxxxxx will be conducted; provided, that Acer provide Halozyme with access to and copies of all consignees and distribution records for the Product and will have cooperate with Halozyme in the right to participate in any meetings and to review and comment in advance on any communications execution of the recall action. Halozyme shall provide Xxxxxx with a Regulatory Authority in connection with a recall or pharmacovigilance matter in the Relief Territory and Relief will notify Acer prior copy of all documents relating to making any public disclosure of the recall, market withdrawal or corrective action and will keep Acer regularly informed regarding any such recall, market withdrawal or corrective actionfield correction. Recall costs Xxxxxx shall cooperate with Halozyme (including providing Halozyme with all data, information and documents requested by Halozyme) in the Relief Territory will be borne solely by Relief. Acer will decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it will be required) or to take other corrective action in any country in the Acer Territory and the manner in which any connection with such recall, market withdrawal or corrective action will be conducted; providedfield correction, that Acer will notify Relief prior to making any public disclosure at Halozyme's expense. Unless such recall is caused solely by the negligence, omission or willful misconduct of Xxxxxx or solely by Xxxxxx'x breach of its warranties or obligations under this Agreement, Halozyme and Xxxxxx shall equally share all of the recall, market withdrawal or corrective action costs and will keep Relief regularly informed regarding any expenses of such recall, market withdrawal or corrective actionfield correction; provided, however, that if a recall, market withdrawal or field correction is necessary because both (i) the Product does not conform to the Product Specifications, and (ii) such non-conformity is solely due to the negligence, omission or willful misconduct of Xxxxxx, or solely by Xxxxxx'x breach of its warranties or obligations under this *** Confidential material redacted and submitted separately to the Commission Agreement, Xxxxxx will bear all reasonable costs associated with such recall, market withdrawal or field correction (including but not limited to costs associated with receiving and administering the recalled Product and notification of the recall to those persons whom Halozyme deems appropriate) and such costs shall not be included within Production Costs or Other Costs. Recall costs in If such recall is due solely to the Acer Territory will be borne API not conforming to the API Specifications or caused solely by the Parties as they will be included in Distribution Costs. The Parties will exercise reasonable cooperation between themnegligence, as omission or willful misconduct of Halozyme, or solely by Halozyme's breach of its warranties or obligations under this Agreement, Halozyme shall bear all costs of such recall, market withdrawal or field correction (including but not limited to costs associated with receiving and administering the recalled Product and notification of the recall to those persons whom Halozyme deems appropriate, to resolve Product complaints and share related data).

Product Recalls. In the event that: (a) any governmental or other regulatory or administrative authority, agency, department, board or court, tribunal or judicial, administrative or arbitration tribunal, and any relevant counterpart or corollary thereof or thereto (each a “Governmental or Regulatory Authority”) issues a directive or order that a Product manufactured or supplied by the Manufacturer hereunder be recalled; or (b) a court of competent jurisdiction orders such a recall; or (c) Customer reasonably determines that any such Product should be recalled, the parties will collaborate, provide all reasonable assistance, and take all appropriate corrective actions to protect the public’s health and preserve the Product’s good will and reputation. If a recall is due to (a) or (b), the party primarily responsible for the cause of the recall will assume responsibility for all such costs and expenses and will reimburse the other party for any costs and expenses incurred by such party. If a recall is due to (c), Customer will initially bear the expenses of the recall until primary responsibility for the cause of the recall is determined, at which time the party primarily responsible for the cause of the recall will assume responsibility for all such costs and expenses and will reimburse the other party for all costs and expenses incurred by such party. If the recall is due to non-conformance with applicable foreign, national, federal, state or local Law, statute or ordinance, judgment, order or decree, or any rule, regulation, or published guidelines, or any statement having the effect of Law, promulgated by any Governmental or Regulatory Authority issues or requests (each a recall or takes similar action in connection with Product“Law” and collectively, “Laws”), failure to meet the Specifications, or in if such recall is otherwise due to the event a Party reasonably believes that an event, incident actions or circumstance has occurred that may result in negligence of the need for a voluntary or mandatory recall, market withdrawal or other corrective action regarding Product, such Party will promptly advise the other Party (in the case of ReliefManufacturer, the Chief Executive Officer or another senior executive designated in advance by Manufacturer will automatically be considered the Chief Executive Officer; and in the case of Acer, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer) thereof by telephone or email. Relief will decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, party primarily responsible in which case it the Manufacturer will be requiredresponsible for all Expenses of Recall (defined below) or and will hold Customer, Authorized Purchasers and their respective officers, employees, directors, agents and representatives harmless and indemnify them for their damages and liabilities. Notwithstanding anything to take other corrective action the contrary herein, in any country in Relief Territory and no event will the manner in which any such recall, market withdrawal or corrective action will be conducted; provided, that Acer will have the right to participate in any meetings and to review and comment in advance on any communications with a Regulatory Authority in connection with Manufacturer initiate a recall or pharmacovigilance matter in of Products. For the Relief Territory and Relief purpose of this Agreement, “Expenses of Recall” will notify Acer prior include, without limitation, the expenses of notification to making Customer’s customers, any public disclosure taxes/duties that are not recoverable, the expenses of return and/or destruction of the recallrecalled Products, market withdrawal any necessary Product rework and replacement expense, any penalties or corrective action fines that are assessed by retailers or distributors, any legal expenses (including attorneys’ fees) incurred, and will keep Acer regularly informed regarding any such recall, market withdrawal or corrective action. Recall costs in the Relief Territory will be borne solely by Relief. Acer will decide and have control of whether to conduct other reasonable expenses incurred as a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it will be required) or to take other corrective action in any country in the Acer Territory and the manner in which any such recall, market withdrawal or corrective action will be conducted; provided, that Acer will notify Relief prior to making any public disclosure result of the recall, market withdrawal or corrective action and will keep Relief regularly informed regarding any such recall, market withdrawal or corrective above-mentioned action. Recall costs in the Acer Territory will be borne by the Parties as they will be included in Distribution Costs. The Parties will exercise reasonable cooperation between them, as appropriate, to resolve Product complaints and share related data.

Product Recalls. In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with a Collaborative Product, or in the event a Party reasonably believes that an event, incident or circumstance has occurred that may result in the need for a voluntary or mandatory recall, market withdrawal or other corrective action regarding a Collaborative Product, such Party will shall promptly so advise the other Party (in the case of ReliefTracon, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive OfficerOfficer of 3DMed and Jiangsu Alphamab; and in the case of Acer3DAlpha, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive OfficerOfficer of 3DMed and Jiangsu Alphamab) thereof and the Leading Company by telephone or emailfacsimile. Relief will The Leading Company shall decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it will shall be required) or to take other corrective action in any country in Relief of the Collaborative Territory and the manner in which any such recall, market withdrawal or corrective action will shall be conducted; provided, provided that Acer will have the right to participate in any meetings and to review and comment in advance on any communications with a Regulatory Authority in connection with a recall or pharmacovigilance matter in Leading Company shall notify the Relief Territory and Relief will notify Acer Parties prior to making any public disclosure of the recall, market withdrawal or corrective action and will shall keep Acer the Parties regularly informed regarding any such recall, market withdrawal or corrective action. Recall costs in the Relief Territory will shall be borne solely by Reliefthe Leading Company, provided that where the recall is a result of an actual or suspected [***], the costs of the recall shall be borne [***]. Acer will 3DAlpha shall decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it will shall be required) or to take other corrective action in any country in outside of the Acer Collaborative Territory and the manner in which any such recall, market withdrawal or corrective action will shall be conducted; provided, provided that Acer will 3DAlpha shall notify Relief Tracon prior to making any public disclosure of the recall, market withdrawal or corrective action and will shall keep Relief Tracon regularly informed regarding any such recall, market withdrawal or corrective action. Recall costs in outside the Acer Collaborative Territory will shall be borne by the Parties as they will be included in Distribution Costs. The Parties will exercise reasonable cooperation between them, as appropriate, to resolve Product complaints and share related datasolely by 3DAlpha.

Product Recalls. (a) In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with Producta Supplied Item in the Territory, or in the event a either Party reasonably believes determines that an event, incident or circumstance has occurred that may result in the need for a voluntary Supplied Item recall or mandatory recall, market withdrawal in the Territory, the Party notified of or other corrective desiring such recall or similar action regarding Productshall, such Party will promptly within 24 hours, advise the other Party (in the case of Relief, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer; and in the case of Acer, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer) thereof by telephone (confirmed by email or emailfacsimile), email or facsimile. Relief will decide The Parties shall, to the extent practicable, endeavor to discuss and have control of agree upon whether to conduct recall or withdraw such Supplied Item in the Territory; provided that if such discussion is not practicable or if the Parties fail to so agree within an appropriate time period (recognizing the exigencies of the situation), then such recall or withdrawal shall be undertaken. If any Regulatory Authority issues or requests a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it will be required) or to take other corrective takes similar action in any country in Relief Territory and the manner in which any such recall, market withdrawal or corrective action will be conducted; provided, that Acer will have the right to participate in any meetings and to review and comment in advance on any communications with a Regulatory Authority in connection with a Supplied Item in the Territory, or a Party decides that a recall or pharmacovigilance matter withdrawal of a Supplied Item in the Relief Territory and Relief will notify Acer prior to making any public disclosure is necessary, Cardiome shall be responsible for conducting such recall or withdrawal in the Territory in accordance with Applicable Law, the requirements of the applicable Regulatory Authority, and SteadyMed’s instructions. The costs of conducting such recall or withdrawal shall be allocated as set forth below in Section 5.8(b). To the extent that it is necessary or appropriate to communicate with any person in the Territory, including any Regulatory Authority, the media or any customer, concerning any recall, market withdrawal withdrawal, other remedial action, event, incidence or corrective action and will keep Acer regularly informed regarding any such recall, market withdrawal or corrective action. Recall costs circumstance concerning a Supplied Item in the Relief Territory, as between the Parties, Cardiome shall be responsible for such communication. (b) Any recall conducted, or required to be conducted, by Cardiome with respect to a Supplied Item in the Territory will be borne solely by Relief. Acer will decide conducted at Cardiome’s sole cost and have control of whether expense, unless the fact or circumstance giving rise to the need to conduct a such recall was proximately caused in whole or market withdrawal (except in the event of a recall or market withdrawal mandated part by a Regulatory Authoritybreach of, in which case it will be required) or to take other corrective action in any country in non-compliance with, this Agreement or the Acer Territory Quality Agreement by SteadyMed or by both Parties (such breach or non-compliance, a “Fault”; and the manner Party(ies) at Fault, the “At-Fault Party(ies)”). If Cardiome believes in which any good faith that SteadyMed is at Fault, Cardiome shall notify SteadyMed in writing thereof as soon as possible after Cardiome first receives notice or otherwise becomes aware that such recallrecall is required, market withdrawal and if SteadyMed believes in good faith that Cardiome is at Fault, SteadyMed shall so notify Cardiome as soon as possible after receipt of notice from Cardiome. Within [redacted in accordance with Section 12.2(3) of National Instrument 51-102] after SteadyMed’s receipt of notice from Cardiome, the Parties will attempt in good faith to reach mutual written agreement as to the relative Fault (if any) of each Party in causing the fact or corrective action will be conducted; provided, that Acer will notify Relief prior circumstance giving rise to making any public disclosure of such recall and as to how the recall, market withdrawal or corrective action associated costs and will keep Relief regularly informed regarding any such recall, market withdrawal or corrective action. Recall costs in the Acer Territory will expenses should be borne by the Parties. If the Parties as they are unable to reach mutual written agreement within an additional [redacted in accordance with Section 12.2(3) of National Instrument 51-102], then the Parties shall mutually select an independent expert with at least [redacted in accordance with Section 12.2(3) of National Instrument 51-102] of industry experience with recalls of pharmaceutical products to determine whether or not one or both of the Parties is/are at Fault and, if so, to assess the relative Fault (if any) of the At-Fault Party(ies). SteadyMed and Cardiome shall promptly respond to the independent expert’s requests for information that the independent expert deems necessary to make his/her determination. The determination of the independent expert will be included binding on the Parties. Responsibility for the costs and expenses incurred by Cardiome in Distribution Costs. The conducting a recall of Supplied Item and the fees and costs of the independent expert shall be allocated as set forth below: (i) If the independent expert determines that neither Party is at Fault or that only Cardiome is at Fault, then Cardiome shall be solely responsible for the costs and expenses of conducting such recall and for the fees and costs of the independent expert. (ii) If the independent expert determines that both Parties will exercise are at Fault, then the reasonable cooperation between themand documented out-of-pocket (i.e., external) costs and expenses incurred by Cardiome in conducting the recall and the fees and costs of the independent expert shall be shared by the Parties in proportion to their relative Fault as appropriatedetermined by the independent expert. (iii) If the independent expert determines that only SteadyMed is at Fault, to resolve Product complaints then the reasonable and share related datadocumented out-of-pocket (i.e., external) costs and expenses incurred by Cardiome in conducting the recall and the fees and costs of the independent expert shall be borne entirely by SteadyMed.

Product Recalls. In (a) If, in the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with Productreasonable judgment of IMX on an individual basis, or in the event reasonable judgment of IMX and Rapiscan on a Party reasonably believes that mutual basis, any Product defect or any government action requires a recall of, or the issuance of an event, incident or circumstance has occurred that may result in the need for a voluntary or mandatory recall, market withdrawal or other corrective action advisory letter regarding any Product, either Party may undertake such recall or issue such advisory letter, after consultation with the other Party. Each Party will promptly advise shall notify the other Party (in a timely manner prior to making any recall or issuing any advisory letter. The Parties shall endeavor to reach an agreement prior to making any recall or issuing any advisory letter regarding the manner, text and timing of any publicity to be given such matters in time to comply with any applicable legal or regulatory requirements, but such agreement will not be a precondition to any action that either Party deems necessary to protect users of the Products or to comply with any applicable governmental orders or mandates. The Parties agree to provide reasonable assistance to one another in the case event of Relief, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer; and in the case of Acer, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer) thereof by telephone or email. Relief will decide and have control of whether to conduct a any recall or market withdrawal issuance of any advisory letter. The party responsible for the cause of the recall shall promptly pay or reimburse the non-responsible party for the reasonable costs of effecting such recall or issuing such advisory letter, including costs related to return of recalled Products and refunding to the non-responsible party any purchase price paid for recalled Products. Notwithstanding anything in this Agreement to the contrary, Rapiscan shall have the right to manage any Product recall within the Territory. (except in b) In the event of a recall of any Product, IMX shall correct any deficiency relating to its manufacturing, packaging, testing, labeling, storing or market withdrawal mandated handling of such product, if applicable, and shall, at Rapiscan’s option, either, at IMX’s sole cost replace each unit of the Product recalled (including units held in inventory by a Regulatory Authority, in which case it will be requiredRapiscan or its customers) or to take other corrective action in any country in Relief Territory and the manner in which any such recall, market withdrawal or corrective action will be conducted; provided, that Acer will have the right to participate in any meetings and to review and comment in advance on any communications with a Regulatory Authority in connection with corrected Product within a recall reasonable period of time, or pharmacovigilance matter in refund the Relief Territory full purchase price therefore. IMX shall reimburse Rapiscan for all costs and Relief will notify Acer prior to making expenses (including shipping, quality control testing, notification and restocking costs) incurred by Rapiscan as a result of any public disclosure of the recall, market withdrawal or corrective action and will keep Acer regularly informed regarding any such recall, market withdrawal or corrective action. Recall costs in the Relief Territory will be borne solely by Relief. Acer will decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it will be required) or to take other corrective action in any country in the Acer Territory and the manner in which any such recall, market withdrawal or corrective action will be conducted; provided, that Acer will notify Relief prior to making any public disclosure of the recall, market withdrawal or corrective action and will keep Relief regularly informed regarding any such recall, market withdrawal or corrective action. Recall costs in the Acer Territory will be borne by the Parties as they will be included in Distribution Costs. The Parties will exercise reasonable cooperation between them, as appropriate, to resolve Product complaints and share related data.

Product Recalls. (a) In the event (i) any Governmental Authority issues a request, directive, or order that Authorized Generic Product be recalled, (ii) a court of competent jurisdiction orders such a recall, or (iii) King as holder of the applicable Regulatory Approval shall reasonably determine that Authorized Generic Product should be recalled, withdrawn, or a field correction issued, the Parties shall take all appropriate corrective actions, and shall cooperate in the investigations surrounding the recall. In the event that King determines that Authorized Generic Product should be recalled, to the extent possible, King shall consult with Core prior to taking any Regulatory Authority issues or requests a recall or takes similar action in connection with Product, or in the event a Party reasonably believes that an event, incident or circumstance has occurred that may result in the need for a voluntary or mandatory recall, market withdrawal or other corrective action regarding Product, such Party will promptly advise the other Party (in the case of Relief, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer; and in the case of Acer, the Chief Executive Officer or another senior executive designated in advance by the Chief Executive Officer) thereof by telephone or emailactions. Relief will decide and have control of whether to conduct a recall or market withdrawal (except in In the event of a recall Authorized Generic Product recall, withdrawal, or market withdrawal mandated by a Regulatory Authorityfield correction resulting solely from Core’s negligence or any cause or event arising from the failure of Core to Manufacture Authorized Generic Product in accordance with GMP, in which case it will be required) or to take other corrective action in any country in Relief Territory the Manufacturing Process, and the manner in which any Specifications, Core shall bear all reasonable costs associated with such recall, market withdrawal withdrawal, or corrective action will be conducted; providedfield correction, that Acer will have which shall include the right to participate in any meetings expenses of notification and to review destruction or return of the recalled Authorized Generic Product and comment in advance on any communications with a Regulatory Authority all other documented out-of-pocket costs incurred in connection with such recall. All costs associated with any other type of Authorized Generic Product recall, withdrawal, or field correction shall be borne by King. [*** Confidential treatment requested pursuant a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been separately filed with the Commission.] (b) If there is any dispute concerning which Party’s acts or omissions gave rise to such recall of Authorized Generic Product, such dispute shall be referred for decision to an independent expert, acting as an expert and not as an arbitrator, to be appointed by agreement between King and Core. In the event the Parties are unable to agree upon such expert within 20 days, either Party may exercise any right or pharmacovigilance matter remedy available to it, including litigation. The decision of such independent expert shall be in writing and, except for manifest error on the Relief Territory and Relief will notify Acer prior to making any public disclosure face of the recalldecision, market withdrawal or corrective action shall be binding on both King and will keep Acer regularly informed regarding any Core. The costs of such recall, market withdrawal or corrective action. Recall costs in the Relief Territory will be borne solely by Relief. Acer will decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it will be required) or to take other corrective action in any country in the Acer Territory and the manner in which any such recall, market withdrawal or corrective action will be conducted; provided, that Acer will notify Relief prior to making any public disclosure of the recall, market withdrawal or corrective action and will keep Relief regularly informed regarding any such recall, market withdrawal or corrective action. Recall costs in the Acer Territory will independent expert shall be borne by the Parties as they will Party who is ultimately found to be included responsible for the recall by the independent expert. After such determination, costs shall be paid by the responsible Party in Distribution Costs. The Parties will exercise reasonable cooperation between them, as appropriate, to resolve Product complaints and share related dataaccordance with Section 3.2.