Common use of Product Recalls Clause in Contracts

Product Recalls. (a) If either Party reasonably decides or is required by any government authority or court of competent jurisdiction, to initiate a product recall, withdrawal or field correction with respect to, or if there is any governmental seizure of, the Product, the Party initiating or required to initiate such action will notify the other Party promptly of the details regarding such action, including providing copies of all relevant documentation concerning 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 HSL and LMI. (b) If any such recall, withdrawal, field correction or seizure occurs due solely to (i) failure of any Product produced by HSL hereunder to conform to Specifications (including, without limitation, being adulterated or misbranded) or any warranty or other requirement set forth in this Agreement, (ii) the failure of HSL to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree or (iii) the negligent or intentional wrongful act or omission of HSL in connection with the production of Product hereunder, then HSL shall bear the **** of any such seizure, recall, withdrawal or field correction and shall reimburse LMI for its ****, including any purchase price payments made to HSL and related taxes to the extent related to such recalled Product. To the extent any such recall, withdrawal, field correction or seizure occurs for any reason other than that set forth in the immediately preceding sentence, then LMI shall bear the **** of any such seizure, recall, withdrawal or field correction. If both HSL and LMI contribute to the cause of a seizure, recall, withdrawal or field correction, the cost and expense thereof will be shared in proportion to each Party’s contribution to the problem. 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 destruction or return of the recalled Product and all other out-of-pocket costs incurred in connection with such recall but shall not include a Party’s lost profits. HSL’s reimbursement for the costs of LMI Materials related to such recall, withdrawal or field correction is limited by Section 5.6(c).

Product Recalls. (a) If either Party reasonably decides If, in the judgment of Supplier or is required by BioForm, any Company Product defect or any government authority or court of competent jurisdiction, to initiate action requires a product recall, withdrawal or field correction with respect torecall of, or if there is the issuance of an advisory letter regarding, any governmental seizure of, the Company Product, either party may undertake such recall or issue such advisory letter after consultation with the Party initiating or required to initiate such action will other party. Each party shall notify the other Party promptly of the details regarding such action, including providing copies of all relevant documentation concerning such actionparty in a timely manner prior to making any recall or issuing any advisory letter. The Parties 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 assist each other not be a precondition to any action that either party deems necessary to protect users of Company Product or to comply with any applicable governmental orders, regulations, or mandates. The parties agree to provide reasonable assistance to one another in investigating the event of any recall or issuance of any advisory letter. BioForm shall have the right to manage any recall within the Territory so long as such situation and all regulatory contacts that are made and all activities concerning seizure, recall, withdrawal or field correction will be jointly coordinated by HSL and LMImanagement does not prevent Supplier from exercising its rights under this Section 6.10. (b) If In the event of a recall of Company Product, Supplier shall correct noted deficiencies relating to its manufacture, packaging, testing, labeling, and Supplier’s storing or handling of Company Product (“Process Related Recalls”), if applicable, or cause the vendor of any material, component, or sub-assembly incorporated into such Company Product to do likewise with respect to such material, component, or sub-assembly and BioForm shall correct noted deficiencies related to matters for which it is responsible. For Process Related Recalls, Supplier shall, at BioForm’s option, either, at its cost replace each unit of the Company Product recalled (including units held in inventory by BioForm or its customers) with a corrected Company Product within a reasonable period of time, or refund the purchase price therefor. Supplier shall promptly pay or reimburse BioForm for all costs and expenses (including shipping, quality control testing, notification, and restocking costs) incurred by BioForm as a result of any recall or advisory letter (unless resulting from a deficiency caused by BioForm, in which case BioForm will reimburse Supplier for Supplier’s costs and expenses associated with such recall, withdrawal, field correction or seizure occurs due solely to (i) failure of any Product produced by HSL hereunder to conform to Specifications (including, without limitation, being adulterated or misbranded) or any warranty or other requirement set forth in this Agreement, (ii) the failure of HSL to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree or (iii) the negligent or intentional wrongful act or omission of HSL in connection with the production of Product hereunder, then HSL shall bear the **** of any such seizure, recall, withdrawal or field correction and shall reimburse LMI for its ****, including any purchase price payments made to HSL and related taxes to the extent related to such recalled Product. To the extent any such recall, withdrawal, field correction or seizure occurs for any reason other than that set forth in the immediately preceding sentence, then LMI shall bear the **** of any such seizure, recall, withdrawal or field correction. If both HSL and LMI contribute to the cause of a seizure, recall, withdrawal or field correction, the cost and expense thereof will be shared in proportion to each Party’s contribution to the problem. 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 destruction or return of the recalled Product and all other out-of-pocket costs incurred in connection with such recall but shall not include a Party’s lost profits. HSL’s reimbursement for the costs of LMI Materials related to such recall, withdrawal or field correction is limited by Section 5.6(c).

Product Recalls. (a) If either In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with a Product, or in the event a Party reasonably decides believes that an event, incident or is required by any government authority or court of competent jurisdiction, to initiate circumstance has occurred that may result in the need for a product recall, market withdrawal or field correction with respect to, or if there is any governmental seizure of, the other corrective action regarding a Product, the such Party initiating or required to initiate such action will notify shall promptly advise the other Party promptly thereof by telephone or facsimile. Following such notification, AstraZeneca shall decide and have control of whether to conduct a recall or market withdrawal (except in the details regarding such actionevent of a recall or market withdrawal mandated by a Regulatory Authority, including providing copies of all relevant documentation concerning such action. The Parties will assist each in which case it shall be required) or to take other corrective action in investigating any such situation country and all regulatory contacts that are made and all activities concerning seizure, recall, withdrawal or field correction will be jointly coordinated by HSL and LMI. (b) If the manner in which any such recall, withdrawal, field correction or seizure occurs due solely to (i) failure of any Product produced by HSL hereunder to conform to Specifications (including, without limitation, being adulterated or misbranded) or any warranty or other requirement set forth in this Agreement, (ii) the failure of HSL to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree or (iii) the negligent or intentional wrongful act or omission of HSL in connection with the production of Product hereunder, then HSL shall bear the **** of any such seizure, recall, market withdrawal or field correction and corrective action shall reimburse LMI for its ****, including any purchase price payments made to HSL and related taxes to the extent related to such recalled Product. To the extent be conducted; provided that AstraZeneca shall keep Targacept regularly informed regarding any such recall, withdrawalmarket withdrawal or corrective action. AstraZeneca shall bear all expenses of any such recall, field correction market withdrawal or seizure occurs corrective action (including expenses for notification, destruction and return of the affected Product and any reason other than refund to customers of amounts paid for such Product); provided, however, that set forth in the immediately preceding sentence, then LMI Targacept shall bear the **** expense of any such seizure, recall, withdrawal or field correction. If both HSL and LMI contribute a recall to the cause extent that such recall resulted from any breach by Targacept of a seizureits obligations hereunder or under the applicable Co-Promotion Agreement or Targacept’s or any of its Affiliates’ negligence or willful misconduct, recall, withdrawal provided that Targacept shall not be deemed to be negligent or field correction, in breach solely for complying with the cost and expense thereof will be shared in proportion to each Party’s contribution to training provided by AstraZeneca under the problem. For the purposes of this applicable Co-Promotion Agreement, with AstraZeneca’s standard operating procedures as may be provided under the expenses of any recallapplicable Co-Promotion Agreement or otherwise with direction from AstraZeneca if the activities required by such training, withdrawal, field correction procedures or seizure shall include, without limitation, the out-of-pocket expenses of notification and destruction other direction would themselves constitute negligence or return of the recalled Product and all other out-of-pocket costs incurred in connection with such recall but shall not include a Party’s lost profits. HSL’s reimbursement for the costs of LMI Materials related to such recall, withdrawal or field correction is limited by Section 5.6(c)breach.

Product Recalls. (a) If either Party reasonably decides or is required by any government authority or court of competent jurisdiction, to initiate a product recall, withdrawal or field correction with respect to, or if there is any governmental seizure of, the Product, the Party initiating or required to initiate such action will notify the other Party promptly of the details regarding such action, including providing copies of all relevant documentation concerning 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 HSL COV and LMI. (b) If any such recall, withdrawal, field correction or seizure occurs due solely to (i) failure of any Product produced by HSL COV hereunder to conform to Specifications (including, without limitation, being adulterated or misbranded) or any warranty or other requirement set forth in this Agreement, (ii) the failure of HSL COV to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree or (iii) the negligent or intentional wrongful act or omission of HSL COV in connection with the production of Product hereunder, then HSL COV shall bear the **** full cost and expense of any such seizure, recall, withdrawal or field correction and shall reimburse LMI for its ****, including any purchase price payments made to HSL COV and related taxes to the extent related to such recalled Product. To the extent If any such recall, withdrawal, field correction or seizure occurs solely for any reason other than that set forth in the immediately preceding sentence, then LMI shall bear the **** full cost and expense of any such seizure, recall, withdrawal or field correction. If both HSL COV and LMI contribute to the cause of a seizure, recall, withdrawal or field correction, the cost and expense thereof will be shared in proportion to each Party’s contribution to the problem. 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 destruction or return of the recalled Product and all other out-of-pocket costs incurred in connection with such recall recall, but shall not include a Party’s lost profits. HSL’s reimbursement for the costs profits of LMI Materials related to such recall, withdrawal either Party under any circumstances or field correction is limited by Section 5.6(c)any administrative or overhead charge.

Product Recalls. In the event (a) If either Party reasonably decides or is required by any government authority issues a request, directive or order that the Product be recalled, or (b) a court of competent jurisdiction, to initiate jurisdiction orders such a product recall, withdrawal or field correction (c) Allergan and Ista, after consultation with respect toeach other, determine that the Product should be recalled, or (d) either Allergan or Ista, after consultation with each other, if there is any governmental seizure of, the Product, the Party initiating or legally required to initiate such action will notify the other Party promptly of the details regarding such action, including providing copies of all relevant documentation concerning 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 HSL and LMI. (b) If any make such recall, withdrawaldoes so, field correction the parties shall take all appropriate corrective actions, and shall cooperate in the investigations surrounding the recall. Allergan shall handle notification of customers and return of Product from customers. The owner of the relevant regulatory approval shall handle all communications and requests with regulatory agencies regarding any recalls. If such recall results from any cause or seizure occurs due solely to (i) failure event arising from a sole responsibility of any Product produced by HSL hereunder to conform to Specifications (including, without limitation, being adulterated or misbranded) or any warranty or other requirement Ista as set forth in this AgreementAgreement or in the Supply Agreement or is solely attributable to Ista, (ii) Ista shall be responsible for all expenses of the failure of HSL to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree or (iii) the negligent or intentional wrongful act or omission of HSL in connection with the production of Product hereunder, then HSL shall bear the **** of recall and Allergan may deduct any such seizureexpenses borne by Allergan from any payment due to Ista under this Agreement. If such recall results from a sole responsibility of Allergan as set forth in this Agreement or in the Supply Agreement or is solely attributable to Allergan, recall, withdrawal or field correction Allergan shall be responsible for the expenses of recall and shall reimburse LMI Ista for its ****, including any purchase price payments made to HSL and related taxes to the extent related to such recalled Product. To the extent any expenses incurred by Ista for such recall. In the event that the recall results from any cause(s) or event(s) arising from a joint responsibility of the parties or partially from a responsibility of Ista and partially from a responsibility of Allergan, withdrawal, field correction or seizure occurs Ista and Allergan shall be jointly responsible for any reason other than that set forth in expenses of the immediately preceding sentence, then LMI shall bear the **** of any such seizure, recall, withdrawal or field correction. If both HSL and LMI contribute to the cause of a seizure, recall, withdrawal or field correction, the cost and expense thereof will be shared recall in proportion to each Party’s contribution such party's proximate fault with respect to the problemrecall. If the parties are unable to agree on the allocation of such fault, then such dispute shall be subject to the dispute resolution provisions of Section 15. For the purposes purpose of this Agreement, the expenses of any recall, withdrawal, field correction or seizure recall shall include, without limitation, the out-of-pocket expenses of notification and destruction or return of the recalled Product, cost for the Product recalled, legal expenses, inventory write-offs and all other out-of-pocket costs incurred in connection with such recall penalties resulting from Third Party contracts, but shall not include a Party’s goodwill, lost profits. HSL’s reimbursement for the costs of LMI Materials related to such recall, withdrawal profits or field correction is limited by Section 5.6(c)other similar intangible or speculative claims.

Product Recalls. (a) If either Party reasonably decides In the event that the Company obtains information that a Product or is required by any government authority portion thereof should be alleged or court proven not to meet the Specifications, labeling or Product Registration for such Product, Company shall notify BMS immediately after the Company obtains such information and both Parties shall cooperate fully regarding the investigation and disposition of competent jurisdiction, any such matter. BMS and the Company shall each maintain such traceability records as are sufficient and as may be necessary to initiate permit a product recall, product withdrawal or field correction of any Product. In the event (a) any applicable regulatory authority should issue a request, directive or order that a Product be recalled or withdrawn, (b) a court of competent jurisdiction orders such a recall or withdrawal or (c) (i) the Company determines that any Product already in interstate or international commerce presents a risk of injury or deception or is otherwise defective and that recall or withdrawal of such Product is appropriate or (ii) BMS determines that any Product already in interstate or international commerce presents a risk of injury or deception or is otherwise defective and that recall or withdrawal of such Product is appropriate and such determination is consented to in writing by the Company (each of the events in (a), (b) and (c), a “Recall”), each Party shall give telephonic notice (to be confirmed in writing) to the other within twenty-four (24) hours of the receipt of notice of any such event. The Company shall have sole responsibility for carrying out the Recall, and shall consult with respect toBMS in determining, or if there is any governmental seizure ofand thereafter use commercially reasonable efforts in taking, the Product, the all corrective action in connection with a Recall. Each Party initiating or required will provide full cooperation and assistance to initiate such action will notify the other Party promptly in connection therewith as may be requested by the other Party, including, in the case of the details regarding such actionCompany, including providing copies BMS within two (2) business days of all relevant documentation concerning such actionreceipt by the Company of notice of the Recall a list of customers who received any recalled or withdrawn Product. 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 Company shall be jointly coordinated by HSL and LMI. (b) If any such recall, withdrawal, field correction or seizure occurs due solely to (i) failure of any Product produced by HSL hereunder to conform to Specifications (including, without limitation, being adulterated or misbranded) or any warranty or other requirement set forth in this Agreement, (ii) the failure of HSL to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree or (iii) the negligent or intentional wrongful act or omission of HSL in connection with the production of Product hereunder, then HSL shall bear the *responsible *** of any such seizure, recall, withdrawal or field correction and shall reimburse LMI for its ****, including any purchase price payments made to HSL and related taxes except to the extent related such Recall is attributable to such recalled Product. To BMS’ failure to manufacture the extent any such recall, withdrawal, field correction or seizure occurs for any reason other than that set forth Product in the immediately preceding sentence, then LMI accordance with Section 5.02(a) in which event BMS shall bear the **** of any that are so attributable to such seizureactions by BMS. Otherwise, recall, withdrawal all Recalls or field correction. If both HSL and LMI contribute to withdrawals shall be solely the cause of a seizure, recall, withdrawal or field correction, the cost and expense thereof will be shared in proportion to each Party’s contribution to the problem. 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 destruction or return responsibility of the recalled Product and all other out-of-pocket costs incurred in connection with such recall but shall not include a Party’s lost profits. HSL’s reimbursement for the costs of LMI Materials related to such recall, withdrawal or field correction is limited by Section 5.6(c)Company.

Product Recalls. (a) If 8.4.1 In the event that either Party reasonably decides or is required by believes it may be necessary to conduct a Recall of any government authority or court of competent jurisdiction, to initiate a product recall, withdrawal or field correction with respect to, or if there is any governmental seizure of, the Product, the Party initiating or required to initiate such action will it shall notify the other Party thereof as soon as reasonably practicable, and the Parties shall promptly consult with each other as to how best to proceed and use Commercially Reasonable Efforts in assisting one another; it being understood and agreed that the final decision as to any Recall of the details regarding such actionany Product shall be made by PDL; provided that, including providing copies of all relevant documentation concerning such actionneither Party shall be prohibited hereunder from taking any action that it is required to take by applicable Law. The Parties will assist each other in investigating shall establish and maintain a system for implementing any such situation Recall and managing all regulatory contacts that are made and all activities concerning seizure, recall, withdrawal or field correction will be jointly coordinated by HSL and LMIrelated communication and/or correspondence with the relevant Regulatory Authorities. (b) If 8.4.2 To the extent any such recallRecall or Seizure does not arise out of, withdrawalor relate to, field correction or seizure occurs due solely to (i) failure occur as a direct result of any Product produced by HSL hereunder to conform to Specifications (includingbreach of any representation, without limitation, being adulterated or misbranded) or any warranty or other requirement covenant of GMN herein, or a breach of this Agreement by GMN, or the gross negligence or willful misconduct of GMN or, GMN’s failure to follow the procedures set forth in this Agreement, (ii) the failure of HSL to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree or (iii) the negligent or intentional wrongful act or omission of HSL in connection with the production of Product hereunder, then HSL shall bear the **** of any such seizure, recall, withdrawal or field correction and shall reimburse LMI for its Technical Information after [****]* Successful Batches, including any purchase price payments made to HSL and other than non-material deviations from the Technical Information, PDL shall reimburse GMN for its reasonable costs related taxes to the extent related to such recalled Productthereto. To the extent any such recallRecall or Seizure arises out of, withdrawalor relates to, field correction or seizure occurs for as a direct result of any reason other than that breach of any representation, warranty or covenant of GMN herein, or a breach of this Agreement by GMN, or the gross negligence or willful misconduct of GMN, or, GMN’s failure to follow the procedures set forth in the immediately preceding sentence, then LMI shall bear the Technical Information after [****]* of any such seizureSuccessful Batches, recallother than non-material deviations from the Technical Information, withdrawal or field correction. If both HSL and LMI contribute to the cause of a seizure, recall, withdrawal or field correction, the cost and expense thereof will be shared in proportion to each Party’s contribution to the problem. For the purposes of this Agreement, the expenses of any recall, withdrawal, field correction or seizure GMN shall include, without limitation, the out-of-pocket expenses of notification and destruction or return of the recalled Product and all other out-of-pocket reimburse PDL for its reasonable costs incurred in connection with such recall but shall not include a Party’s lost profits. HSL’s reimbursement for the costs of LMI Materials related to such recall, withdrawal or field correction is limited by Section 5.6(c)thereto.

Product Recalls. (a) If either Party reasonably decides or is required by any government authority or court of competent jurisdiction, to initiate a product recall, withdrawal or field correction with respect to, or if there is any governmental seizure of, the Product, the Party initiating or required to initiate such action will Each party shall promptly notify the other Party promptly party in the event of any recall, market withdrawal or correction of Product ordered by any regulatory authority, whether in the details regarding such actionTerritory, including providing copies of all relevant documentation concerning such actionthe United States, or anywhere in the world. The Parties will assist each other parties shall cooperate in investigating good faith in relation to the handling and disposal of a recall, market withdrawal or correction in the Territory. The costs of any such situation and all regulatory contacts that are made and all activities concerning seizure, recall, market withdrawal or field correction will shall be jointly coordinated borne by HSL the parties in accordance with Sections 5.2 (b) and LMI(c) below. (b) If Subject to Section 5.2(c) below, in the event of a recall, market withdrawal or correction (i) by reason of the failure of all or part of the Product supplied by Jazz [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKET BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. Pharmaceuticals to meet the Product Specifications, any requirement of the FDA or any Marketing Authorization or other requirement of applicable law that is not the result of any action or omission of UCB or its Subdistributors or Sublicensees as described in paragraph (c) below or (ii) because Product that meets the Product Specifications, supplied by Jazz Pharmaceuticals, is inherently defective, unsafe, dangerous or may harm users of the Product, Jazz Pharmaceuticals shall bear the costs of such recall, withdrawalmarket withdrawal or correction (including without limitation UCB’s reasonable attorneys’ fees). (c) In the event of a recall, field market withdrawal or correction or seizure occurs due solely to (i) failure by reason of any Product produced by HSL hereunder to conform to Specifications (including, without limitation, being adulterated or misbranded) or any warranty or other requirement set forth in this Agreement, (ii) the failure of HSL UCB to comply in all material respects have obtained or properly maintained or complied with a Marketing Authorization or as a result of UCB’s (or its Subdistributors’, Sublicensees’ or Third Party manufacturers’) breach of any applicable lawof their obligations under this Agreement (including without limitation Section 3.7), ruleor the willful misconduct or negligent acts or omissions of UCB (or its Subdistributors, regulationSublicensees’ or Third Party manufacturers’), guideline, standard, court order or decree or (iii) the negligent or intentional wrongful act or omission of HSL in connection with the production of Product hereunder, then HSL UCB shall bear the **** all costs of any such seizure, recall, withdrawal or field correction and shall reimburse LMI for its ****, including any purchase price payments made to HSL and related taxes to the extent related to such recalled Product. To the extent any such recall, market withdrawal, field or correction or seizure occurs for any reason other than that set forth in the immediately preceding sentence, then LMI shall bear the **** of any such seizure, recall, withdrawal or field correction. If both HSL and LMI contribute to the cause of a seizure, recall, withdrawal or field correction, the cost and expense thereof will be shared in proportion to each Party’s contribution to the problem. For the purposes of this Agreement, the expenses of any recall, withdrawal, field correction or seizure shall include, (including without limitation, the out-of-pocket expenses of notification and destruction or return of the recalled Product and all other out-of-pocket costs incurred in connection with such recall but shall not include a Party’s lost profits. HSL’s reimbursement for the costs of LMI Materials related to such recall, withdrawal or field correction is limited by Section 5.6(climitation Jazz Pharmaceuticals’ reasonable attorneys’ fees).

Product Recalls. (a) If either Party reasonably decides if (i) any regulatory authority withdraws the approval to sell the Product in such country or is required by issues a directive or request that the Product be recalled for product safety reasons relating to the Product; or (ii) any government regulatory authority or court of competent jurisdictionjurisdiction issues a request, to initiate a product recall, withdrawal directive or field correction with respect to, or if there is any governmental seizure of, order that the Product, the Party initiating or required to initiate such action will notify the other Party promptly of the details regarding such action, including providing copies of all relevant documentation concerning 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 Product be jointly coordinated by HSL and LMI. (b) If any such recall, withdrawal, field correction or seizure occurs due solely to (i) failure of any Product produced by HSL hereunder to conform to Specifications (including, without limitation, being adulterated or misbranded) or any warranty or other requirement set forth in this Agreement, (ii) the failure of HSL to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree recalled; or (iii) Cubist shall reasonably determine that the negligent 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 that such recall results from the non-, late- or intentional wrongful act or omission misperformance by DSM of HSL its obligations hereunder except for reasons of Force Majeure, DSM shall up to an aggregate maximum amount of [ ]* be responsible for all expenses of the recall (except that in connection the event of a contributory fault of Cubist DSM and Cubist shall share such expenses accordingly) and DSM shall promptly replace such Product at no additional cost to Cubist consistent with directions received from the production appropriate governmental authority. In all other cases, Cubist shall be responsible for the expenses of Product hereunder, then HSL shall bear the **** of any such seizure, recall, withdrawal or field correction and shall reimburse LMI for its ****, including any purchase price payments made to HSL and related taxes to the extent related to such recalled Product. To the extent any such recall, withdrawal, field correction or seizure occurs for any reason other than that set forth in the immediately preceding sentence, then LMI shall bear the **** of any such seizure, recall, withdrawal or field correction. If both HSL and LMI contribute to the cause of a seizure, recall, withdrawal or field correction, the cost and expense thereof will be shared in proportion to each Party’s contribution to the problemof replacement Product. For the purposes of this Agreement, the expenses of any recall, withdrawal, field correction or seizure recall shall include, without limitation, the out-of-pocket expenses of notification and destruction or return of the recalled Product and all other out-of-pocket costs incurred in connection with such recall recall, but shall not include lost profits of either party. (b) In the event a Party’s lost profitsregulatory authority orders the withdrawal of Product from any country, Cubist shall not be obligated to purchase the Product or sell the Product in such country from the date of such withdrawal and until Cubist is again authorized to sell Product in such country, and DSM shall not be obligated to supply the Product to Cubist in such country for such period. HSL’s reimbursement for If such a withdrawal decision is final and not appealable, the costs of LMI Materials related minimum offtake obligations pursuant to such recall, withdrawal or field correction is limited by Section 5.6(c)3.2 will be adjusted accordingly. * Confidential treatment requested: Material has been omitted and filed with the Commission.

Product Recalls. In the event (i) any Regulatory Authority issues a request, directive or order that Product be recalled, (ii) a court of competent jurisdiction orders such a recall, or (iii) King as holder of the applicable NDA shall reasonably determine that 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 as applicable NDA holder determines that Product should be recalled, to the extent possible, King shall consult with Inyx prior to taking any corrective actions. In the event of any Product recall, withdrawal, or field correction resulting solely from Inyx’s negligence or any cause or event arising from the failure of Inyx to manufacture, test, store or handle Bulk Forms or Products in accordance with cGMP and the Specifications, (a) If either Party reasonably decides or is required by any government authority or court of competent jurisdiction, to initiate a product recall, withdrawal or field correction Inyx shall bear all reasonable costs associated with respect to, or if there is any governmental seizure of, the Product, the Party initiating or required to initiate such action will notify the other Party promptly of the details regarding such action, including providing copies of all relevant documentation concerning 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 HSL and LMI. (b) If any such recall, withdrawal, field correction or seizure occurs due solely to (i) failure of any Product produced by HSL hereunder to conform to Specifications (including, without limitation, being adulterated or misbranded) or any warranty or other requirement set forth in this Agreement, (ii) the failure of HSL to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree or (iii) the negligent or intentional wrongful act or omission of HSL in connection with the production of Product hereunder, then HSL shall bear the **** of any such seizure, recall, withdrawal or field correction and shall reimburse LMI for its ****, including any purchase price payments made to HSL and related taxes to the extent related to such recalled Product. To the extent any such recall, withdrawal, field correction or seizure occurs for any reason other than that set forth in the immediately preceding sentence, then LMI shall bear the **** of any such seizure, recall, withdrawal or field correction. If both HSL and LMI contribute to the cause of a seizure, recall, withdrawal or field correction, which shall include the cost and expense thereof will be shared in proportion to each Party’s contribution to the problem. 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 destruction or return of the recalled Product and all other documented out-of-pocket costs incurred in connection with such recall but shall not include a Partyrecall, and (b) Inyx shall, subject to King’s lost profits. HSL’s reimbursement election, either supply the Product, without charge to King, in an amount sufficient to replace the amount of the Product recalled, withdrawn or subject to field correction, or refund King, or give credit to King against outstanding receivables due from King against the purchase price for shipments of the Product to be delivered to King in the future, in amounts equal to *** for Products so recalled, withdrawn or subjected to field correction, plus reasonable transportation costs of LMI Materials related incurred by King with respect to such Product. All costs associated with any other type of Product recall, withdrawal withdrawal, or field correction is limited by Section 5.6(c)shall be deemed Collaboration Costs and will be ***.

Product Recalls. (a) If either Party reasonably decides or such Party is required by any government authority or court of competent jurisdiction, to initiate a product Product recall, withdrawal or field correction with respect to, or if there is any governmental seizure of, the ProductProduct(s), then the Party initiating or required to initiate such action will notify the other Party promptly of the details regarding such action, including providing copies of all relevant documentation concerning such action. The Parties will assist each other in investigating initiate and conduct 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 HSL and LMIrecall pursuant to the terms set forth in the Quality Agreement. (b) If To the extent that any such recall, withdrawal, field correction or seizure occurs due solely to (i) failure of any Product Product(s) produced by HSL CMO hereunder to conform to Specifications (including, without limitation, including being adulterated or misbranded, but excluding the failure of any LMI Materials to conform to their respective specifications other than due to CMO’s fault) or any warranty or other requirement set forth in this AgreementAgreement (it being acknowledged and agreed by the Parties that compliance with release Specifications followed by a legitimate field complaint shall not be deemed to be a failure to conform to Specifications), (ii) the failure of HSL CMO to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree or (iii) the negligent or intentional wrongful act or omission of HSL CMO in connection with the production of Product Product(s) hereunder, then HSL CMO shall bear the **** cost and expense of any such seizure, recall, withdrawal or field correction and shall reimburse LMI (including reimbursement for its ****, including any purchase price payments made to HSL CMO and related taxes or credits to the extent related to such recalled ProductProduct(s)). To the extent that any such recall, withdrawal, field correction or seizure occurs for due to any reason other than that set forth in the immediately preceding sentence, then LMI shall bear the **** cost and expense of any such seizure, recall, withdrawal or field correctioncorrection with respect to the Product(s) recalled by LMI. If both HSL CMO and LMI other factors contribute to the cause of a seizure, recall, withdrawal or field correction, then the cost and expense thereof will be shared in proportion to each PartyCMO’s contribution and such other factors’ respective contributions to the problemproblem with respect to the Product(s) recalled by LMI. 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 destruction or return of the recalled Product Product(s) and all other out-of-pocket costs or credits incurred in connection with such recall but shall not include a Party’s lost profits. HSL’s reimbursement for the costs of LMI Materials related to such recall, withdrawal or field correction is limited by Section 5.6(c).

Product Recalls. 5.1. In the event that (a) If either Party reasonably decides or is required by any government authority issues a request, directive or order that Products be recalled, (b) a court of competent jurisdiction, to initiate jurisdiction orders such a product recall, withdrawal or (c) Customer and Supplier jointly determine that Products should be recalled, the parties shall take all appropriate corrective actions as jointly determined by Supplier and Customer, and shall cooperate with each other in the investigations surrounding the recall. In the event that Customer and Supplier do not jointly agree whether a recall is necessary after consultation, Customer shall have the final determination on whether or not to issue such recall and Supplier agrees to cooperate with Customer during the recall process, subject to all applicable FDA regulations. 5.2. To the extent that a recall, withdrawal, field correction, or governmental seizure of Product is due to (i) the failure of Product to conform to applicable Specifications, (ii) the failure of Supplier to comply in any material respect with its obligations hereunder or with any applicable law, rule, regulation, standard, court order or decree, standard operating procedure, or GMP, or with Customer’s consent decree with the FDA, or (iii) the gross negligence or intentionally wrongful act or omission by Supplier in its manufacturing of any Product or in its performance of its obligations hereunder, then Supplier shall bear the cost and expense of any such recall, withdrawal, field correction or seizure, and upon demand from Customer shall promptly indemnify Customer in accordance with Section 12 for costs and expenses incurred by Customer in connection therewith. To the extent that a recall, withdrawal, field correction, or governmental seizure of Product is due to any other reason, including, without limitation, the Specifications or Customer Know-How. Customer shall bear the cost and expense of such recall, withdrawal, field correction or seizure, and upon demand from Supplier shall promptly indemnify Supplier in accordance with Section 12 for costs and expenses incurred by Supplier in connection therewith. Should a party become aware of a Product seizure or of facts and circumstances that might justify the recall or withdrawal of or corrective action with respect to, or if there is any governmental seizure of, the to a Product, the Party initiating or required to initiate such action that party will notify the other Party party promptly of the details regarding such action, including providing copies of all relevant documentation concerning such actionaction or facts. The Parties parties will assist each other cooperate in investigating any such situation situation, and all regulatory contacts that are made and all activities concerning seizure, recall, withdrawal or field correction will be jointly initiated and coordinated by HSL and LMIjointly. (b) If any 5.3. Subject to Sections 5.1 and 5.2, except as otherwise required by law or governmental regulation, Customer will be solely responsible for investigating and responding to all inquiries, complaints and adverse events regarding Products. Supplier agrees to provide such recallassistance as Customer shall reasonably request and, withdrawalif requested by Customer, field correction or seizure occurs due solely Supplier agrees to (i) failure lead investigations related to such at its facilities. 5.4. As soon as either party becomes aware, it shall give the other party prompt written notice of any defect or alleged defect in a Product, any injury alleged to have occurred as a result of the use or applicable of a Product, and any circumstances that may reasonably be expected to give rise to litigation or recall of a Product produced by HSL hereunder to conform to Specifications (includingor regulatory action that may affect the sale or manufacture of a Product, without limitationspecifying, being adulterated or misbranded) or any warranty or other requirement set forth in this Agreement, (ii) the failure of HSL to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree or (iii) the negligent or intentional wrongful act or omission of HSL in connection with the production of Product hereunder, then HSL shall bear the **** of any such seizure, recall, withdrawal or field correction and shall reimburse LMI for its ****, including any purchase price payments made to HSL and related taxes to the extent related known, the time, place and circumstances thereof and the names and addresses of the Persons involved. Each party shall also furnish promptly to the other party copies of all papers received in respect of any claim, action or suit arising out of such recalled Productalleged defect, injury or regulatory action. 5.5. To If Supplier concludes that Product cannot consistently meet Specifications, or if Customer or the extent any such recall, withdrawal, field correction or seizure occurs for any reason other than FDA requires changes that set forth in the immediately preceding sentenceSupplier cannot reasonably implement, then LMI shall bear Supplier will work in good faith with Customer to test and implement reasonable changes at Customer’s request in order to consistently meet the **** of any Specifications or such seizurerequirements, recall, withdrawal or field correction. If both HSL and LMI contribute to the cause of a seizure, recall, withdrawal or field correction, the cost and expense thereof will be shared in proportion to each Party’s contribution to the problem. 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 destruction or return of the recalled Product and all other out-of-pocket costs incurred in connection with such recall but shall not include a Party’s lost profits. HSL’s reimbursement for the costs of LMI Materials related to such recall, withdrawal or field correction is limited by Section 5.6(c)if possible.

Product Recalls. (a) If either Party reasonably decides In the event that the Company obtains information that a Product or is required by any government authority portion thereof should be alleged or court proven not to meet the Specifications, labeling or Product Registration for such Product, Company shall notify BMS immediately after the Company obtains such information and both Parties shall cooperate fully regarding the investigation and disposition of competent jurisdiction, any such matter. BMS and the Company shall each maintain such traceability records as are sufficient and as may be necessary to initiate permit a product recall, product withdrawal or field correction of any Product. In the event (a) any applicable regulatory authority should issue a request, directive or order that a Product be recalled or withdrawn, (b) a court of competent jurisdiction orders such a recall or withdrawal or (c) (i) the Company determines that any Product already in interstate or international commerce presents a risk of injury or deception or is otherwise defective and that recall or withdrawal of such Product is appropriate or (ii) BMS determines that any Product already in interstate or international commerce presents a risk of injury or deception or is otherwise defective and that recall or withdrawal of such Product is appropriate and such determination is consented to in writing by the Company (each of the events in (a), (b) and (c), a "Recall"), each Party shall give telephonic notice (to be confirmed in writing) to the other within twenty-four (24) hours of the receipt of notice of any such event. The Company shall have sole responsibility for carrying out the Recall, and shall consult with respect toBMS in determining, or if there is any governmental seizure ofand thereafter use commercially reasonable efforts in taking, the Product, the all corrective action in connection with a Recall. Each Party initiating or required will provide full cooperation and assistance to initiate such action will notify the other Party promptly in connection therewith as may be requested by the other Party, including, in the case of the details regarding such actionCompany, including providing copies BMS within two (2) business days of all relevant documentation concerning such actionreceipt by the Company of notice of the Recall a list of customers who received any recalled or withdrawn Product. The Parties will assist each other in investigating Company shall be responsible for all expenses of effecting 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 HSL and LMI. Recall (b) If any such recall, withdrawal, field correction or seizure occurs due solely to (i) failure of any Product produced by HSL hereunder to conform to Specifications (including, without limitation, being adulterated or misbranded) or any warranty or other requirement set forth in this Agreement, (ii) the failure of HSL to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree or (iii) the negligent or intentional wrongful act or omission of HSL in connection with the production of Product hereunder, then HSL shall bear the **** of any such seizure, recall, withdrawal or field correction and shall reimburse LMI for its ****, including any purchase price payments made to HSL and related taxes to the extent related to such recalled Product. To the extent any such recall, withdrawal, field correction or seizure occurs for any reason other than that set forth in the immediately preceding sentence, then LMI shall bear the **** of any such seizure, recall, withdrawal or field correction. If both HSL and LMI contribute to the cause of a seizure, recall, withdrawal or field correction, the cost and expense thereof will be shared in proportion to each Party’s contribution to the problem. 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 incurred by the Company and destruction or return of the recalled Product and all other out-of-pocket costs incurred BMS in connection with such recall but cooperation), except to the extent such Recall is attributable to BMS' failure to manufacture the Product in accordance with Section 5.02(a) in which event BMS shall not include a Party’s lost profits. HSL’s reimbursement reimburse the Company for the its reasonable costs of LMI Materials related and expenses incurred (including credits to customers for such Recalls or withdrawal) that are so attributable to such recallactions by BMS. Otherwise, withdrawal all Recalls or field correction is limited by Section 5.6(c)withdrawals shall be solely the responsibility of the Company.

Product Recalls. (a) If 8.4.1 In the event that either Party reasonably decides or is required by believes it may be necessary to conduct a Recall of any government authority or court of competent jurisdiction, to initiate a product recall, withdrawal or field correction with respect to, or if there is any governmental seizure of, the Product, the Party initiating or required to initiate such action will it shall notify the other Party thereof as soon as reasonably practicable, and the Parties shall promptly consult with each other as to how best to proceed and use Commercially Reasonable Efforts in assisting one another; it being understood and agreed that the final decision as to any Recall of the details regarding such actionany Product shall be made by PDL; provided that, including providing copies of all relevant documentation concerning such actionneither Party shall be prohibited hereunder from taking any action that it is required to take by applicable Law. The Parties will assist each other in investigating shall establish and maintain a system for implementing any such situation Recall and managing all regulatory contacts that are made related communication and/or correspondence with the relevant Regulatory Authorities. * Certain information on this page has been omitted and all activities concerning seizure, recall, withdrawal or field correction will be jointly coordinated by HSL and LMIfiled separately with the SEC. Confidential treatment has been requested with respect to the omitted portions. (b) If 8.4.2 To the extent any such recallRecall or Seizure does not arise out of, withdrawalor relate to, field correction or seizure occurs due solely to (i) failure occur as a direct result of any Product produced by HSL hereunder to conform to Specifications (includingbreach of any representation, without limitation, being adulterated or misbranded) or any warranty or other requirement covenant of GMN herein, or a breach of this Agreement by GMN, or the gross negligence or willful misconduct of GMN or, GMN’s failure to follow the procedures set forth in this Agreement, (ii) the failure of HSL to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree or (iii) the negligent or intentional wrongful act or omission of HSL in connection with the production of Product hereunder, then HSL shall bear the **** of any such seizure, recall, withdrawal or field correction and shall reimburse LMI for its Technical Information after [****]* Successful Batches, including any purchase price payments made to HSL and other than non-material deviations from the Technical Information, PDL shall reimburse GMN for its reasonable costs related taxes to the extent related to such recalled Productthereto. To the extent any such recallRecall or Seizure arises out of, withdrawalor relates to, field correction or seizure occurs for as a direct result of any reason other than that breach of any representation, warranty or covenant of GMN herein, or a breach of this Agreement by GMN, or the gross negligence or willful misconduct of GMN, or, GMN’s failure to follow the procedures set forth in the immediately preceding sentence, then LMI shall bear the Technical Information after [****]* of any such seizureSuccessful Batches, recallother than non-material deviations from the Technical Information, withdrawal or field correction. If both HSL and LMI contribute to the cause of a seizure, recall, withdrawal or field correction, the cost and expense thereof will be shared in proportion to each Party’s contribution to the problem. For the purposes of this Agreement, the expenses of any recall, withdrawal, field correction or seizure GMN shall include, without limitation, the out-of-pocket expenses of notification and destruction or return of the recalled Product and all other out-of-pocket reimburse PDL for its reasonable costs incurred in connection with such recall but shall not include a Party’s lost profits. HSL’s reimbursement for the costs of LMI Materials related to such recall, withdrawal or field correction is limited by Section 5.6(c)thereto.

Product Recalls. (a) If either Each Party reasonably decides shall promptly (but in no event later than two (2) Business Days) notify the other Party upon becoming aware of (i) any information concerning any Product that may adversely impact the quality, purity, safety or is required effectiveness of such Product or (ii) (A) the issuance by any government authority Regulatory Agency or other Governmental Authority of a request, directive or order that one or more Products be recalled, (B) the ordering by a court of competent jurisdiction of such a recall or (C) the reasonable determination by Alvogen or Alvotech that a Product should be recalled (any such recall, a “Recall”). In the event of a Recall requested, directed or ordered by a Regulatory Agency or court of competent jurisdiction, to initiate the Parties shall jointly develop a product recall, withdrawal or field correction strategy with respect toto completing such Recall in accordance with the terms and conditions of such Recall. Alvogen shall be responsible for communication to its customers regarding any Recall and, or if there is subject to Section 5.11(b), for retrieving any governmental seizure of, the Product, the Party initiating or required Products that have been sold to initiate such action will notify the other Party promptly of the details regarding such action, including providing copies of all relevant documentation concerning 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 HSL and LMIits customers. (b) Except as set forth below, Alvotech shall bear all costs and expenses of, and shall be responsible for all corrective actions associated with, each Recall. Notwithstanding the foregoing, if Alvotech reasonably determines in good faith that any Recall resulted from Alvogen’s handling, use, storage, import, transport, distribution or sale of the applicable Product, then Alvotech shall provide Alvogen with written notice of such determination (the “Determination Notice”). Unless Alvogen provides Alvotech with written notice within two (2) months following its receipt of the Determination Notice that it agrees to bear all costs and expenses of such Recall, then Alvotech may request that the Executive Steering Committee appoint, and upon receipt of such request the Executive Steering Committee shall appoint, an independent Third Party with relevant expertise in medical product recalls (an “Evaluator”), to determine the relative degree of fault of each of Alvogen and Alvotech with regard to such Recall. If either Alvotech or Alvogen objects to the appointment of such Third Party by the Executive Steering Committee, each of Alvogen and Alvotech shall be entitled to nominate an Evaluator, and such Evaluators shall then choose a third Evaluator, which shall investigate and determine the relative percentages of fault of each of Alvogen and Alvotech with regard to the Recall, and each of Alvogen and Alvotech shall cooperate with such Evaluator in its investigation and determination. Upon the decision of the Evaluator, each of Alvotech and Alvogen shall then promptly pay its respective percentage of the aggregate costs and expenses for the Recall incurred by both such Parties, reimbursing the other such Party as necessary. If Alvotech is determined to be entirely at fault for the Recall, Alvotech shall promptly replace the quantity of Products that were recalled at no cost to Alvogen or reimburse or credit, as determined by Alvotech, Alvogen for any amounts previously paid to Alvotech by Alvogen for such recallrecalled Product under Section 7.9. If Alvogen is determined to be entirely at fault for the Recall, withdrawalthen Alvogen shall reimburse Alvotech for (i) the Alvotech Lost Profits resulting from such Recall and (ii) all costs and expenses of such Recall, field correction including corrective actions associated therewith. In addition, without limiting either Alvotech’s or seizure occurs due solely Alvogen’s obligation to indemnify the other under any provision of this Agreement, costs and expenses of a Recall shall include, with regard to either Alvotech or Alvogen, any and all actual out-of-pocket costs and/or liabilities reasonably incurred by such Party in connection therewith, including all expenses of notification and destruction and all out-of-pocket administrative expenses relating to any recall (e.g., out-of-pocket expenses relating to (i) failure the shipment, storage, testing and disposal of any Product produced by HSL hereunder to conform to Specifications (including, without limitation, being adulterated or misbranded) or any warranty or other requirement set forth in this Agreementsuch recalled Product, (ii) the failure preparation and maintenance of HSL reports and records related to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree or such Recall and (iii) the negligent notifications to any customer, distributor or intentional wrongful act or omission user of HSL in connection with the production of Product hereunder, then HSL shall bear the **** of any such seizure, recall, withdrawal or field correction and shall reimburse LMI for its ****, including any purchase price payments made to HSL and related taxes to the extent related to such recalled Product. To the extent any such recall, withdrawal, field correction or seizure occurs for any reason other than that set forth in the immediately preceding sentence, then LMI shall bear the **** of any such seizure, recall, withdrawal or field correction. If both HSL and LMI contribute to the cause of a seizure, recall, withdrawal or field correction, the cost and expense thereof will be shared in proportion to each Party’s contribution to the problem). For the purposes of this Agreement, the administrative expenses of any recall, withdrawal, field correction or seizure a Recall shall include, without limitation, include the out-of-pocket reasonable expenses of notification and destruction or return of the recalled Product Product, and all other out-of-any actual out of pocket costs incurred associated with the distribution of the replacement Product in connection with such recall but shall not include a Party’s lost profits. HSL’s reimbursement exchange for the costs of LMI Materials related to such recall, withdrawal or field correction is limited by Section 5.6(c)recalled Product.