Common use of Product Recall Clause in Contracts

Product Recall. If at any time (a) any governmental agency having jurisdiction provides written notice to either Buyer or Supplier, or (b) either Buyer or Supplier have a reasonable basis to conclude that any Products or Deliverables contain a defect which could create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal or regulatory requirement, thereby making it advisable, or required, that such Products or Deliverables be subject to corrective action including, without limitation, recall, retrofit, refund, replacement and/or repair (hereinafter “Corrective Action”), Supplier or Buyer will promptly communicate relevant facts to each other. Buyer shall determine whether any Corrective Action involving the affected Products or Deliverables is warranted or advisable unless notice to that effect has been received from any governmental agency having jurisdiction. If Corrective Action is required under the law or Buyer determines that it is advisable, Supplier shall promptly undertake Corrective Actions, including those required by any applicable consumer product safety or similar law and the regulations thereunder, and shall file all necessary papers, descriptions of corrective action, and other related documents and carry out the Correction Action. Buyer shall cooperate with and assist Supplier in any such filings and Corrective Action; provided, however, that nothing contained in this Section shall preclude Buyer from taking such action, and in such event, Supplier shall cooperate with and assist Buyer in any such filings and implementing the Corrective Action it elects to undertake. To the extent the need for such Corrective Action is determined to have been caused by a defect, noncompliance or quality or performance deficiency which is the responsibility of Supplier, at Buyer’s election, Supplier shall perform all necessary Corrective Action at its sole expense, or Buyer shall perform such necessary Corrective Action and Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection therewith. In either case, Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection with any such (voluntary or mandatory) Corrective Action, including without limitation, the cost of locating, identifying and notifying Buyer’s customers, the cost of repairing, or where repair of the Product or Deliverables is impracticable or impossible, repurchasing or replacing the recalled Product or Deliverable, any costs of packing and shipping the recalled Product or Deliverable, and the cost of media notification, if such form of notification is necessary. The parties recognize that it is possible that other Supplier-provided products or deliverables might contain the same defect, noncompliance or quality or performance deficiency as do Products or Deliverables provided to Buyer. Buyer and Supplier agree that any Corrective Action involving Products or Deliverables provided to Buyer shall be treated separately and distinctly from similar Corrective Action of other products or deliverables of Supplier; provided that such separate and distinct treatment is lawful and Supplier shall in no event fail to provide at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Action. Each party shall consult the other before making any statements to the public or a governmental agency relating to potential safety hazards affecting Products or Deliverables, except where such consultation would prevent timely notification required by law. The provisions of this Section 23 shall survive any termination or expiration of this Contract.

Product Recall. If at any time (a) any governmental agency or regulatory authority having jurisdiction provides written notice to either Buyer or Supplier, or (b) either Buyer or Supplier have a reasonable basis to conclude that any Products or Deliverables contain a defect which could create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal or regulatory requirement, thereby making it advisable, or required, that such Products or Deliverables be subject to corrective action including, without limitation, recall, retrofit, refund, replacement and/or repair (hereinafter “Corrective Action”), Supplier or Buyer will promptly communicate relevant facts to each other. Buyer shall determine whether any Corrective Action involving the affected Products or Deliverables is warranted or advisable unless notice to that effect has been received from any governmental agency having jurisdiction. If Corrective Action is required under the law or Buyer determines that it is advisable, Supplier shall promptly undertake Corrective Actions, including those required by any applicable consumer product safety or similar law and the regulations thereunder, and shall file all necessary papers, descriptions of corrective action, and other related documents and carry out the Correction Corrective Action. Buyer shall cooperate with and assist Supplier in any such filings and Corrective Action; provided, however, that nothing contained in this Section shall preclude Buyer from taking such action, and in such event, Supplier shall cooperate with and assist Buyer in any such filings and implementing the Corrective Action it elects to undertake. To the extent the need for such Corrective Action is determined to have been caused by a defect, noncompliance or quality or performance deficiency which is the responsibility of Supplier, at Buyer’s election, Supplier shall perform all necessary Corrective Action at its sole expense, or Buyer shall perform such necessary Corrective Action and Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection therewith. In either case, Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection with any such (voluntary or mandatory) Corrective Action, including without limitation, the cost of locating, identifying and notifying Buyer’s customers, the cost of repairing, or where repair of the Product or Deliverables is impracticable or impossible, repurchasing or replacing the recalled Product or Deliverable, any costs of packing and shipping the recalled Product or Deliverable, and the cost of media notification, if such form of notification is necessary. The parties recognize that it is possible that other Supplier-provided products or deliverables might contain the same defect, noncompliance or quality or performance deficiency as do Products or Deliverables provided to Buyer. Buyer and Supplier agree that any Corrective Action involving Products or Deliverables provided to Buyer shall be treated separately and distinctly from similar Corrective Action of other products or deliverables of Supplier; provided that such separate and distinct treatment is lawful lawful, and Supplier shall in no event fail to provide at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Action. Each party Party shall consult the other before making any statements to the public or a governmental agency relating to potential safety hazards affecting the Products or Deliverables, except where such consultation would prevent timely notification required by law. The provisions of this Section 23 shall survive any termination or expiration of this Contract.

Product Recall. If at any time (a) Seller, Buyer, or any governmental agency or court having jurisdiction provides written notice to either Buyer or Supplier, or (b) either Buyer or Supplier have a reasonable basis to conclude determines that any Products Good or Deliverables contain part thereof contains a defect which could create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a quality or performance deficiency, or are (b) any Good is not in compliance with any applicable codethe specifications or Buyer’s standards and requirements such that in Buyer’s discretion such Good should be reworked or recalled, standard or legal or regulatory requirement, thereby making it advisable, or required, that such Products or Deliverables be subject to corrective action including, without limitation, recall, retrofit, refund, replacement and/or repair (hereinafter “Corrective Action”), Supplier or Buyer the parties will promptly communicate all relevant facts to each other. Buyer shall determine whether any Corrective Action involving the affected Products or Deliverables is warranted or advisable unless notice to that effect has been received from any governmental agency having jurisdiction. If Corrective Action is required under the law or Buyer determines that it is advisable, Supplier shall promptly other and undertake Corrective Actionsall corrective actions, including those required to meet all obligations imposed by any applicable consumer product safety law, regulations, or similar law and the regulations thereunderorders, and shall file all necessary papers, descriptions of corrective actionaction programs, and other related documents documents. Seller shall be responsible for all matters and carry out costs associated with the Correction Actionrecall, including but not limited to: (a) customer notification and contact; (b) all costs, expenses, liabilities, and losses incurred by Buyer, its affiliates, distributors, or customers (“Buyer Group”) in connection with the recall (and where applicable, any product of Buyer with which the recalled Goods have been packaged or integrated), including but not limited to refunds to customers, lost profits, transportation costs, and all other costs associated therewith; and (c) initial contact and report of the recall to any government agency having jurisdiction over the affected products. If a government agency initiates any inquiry or investigation relating to the Goods or similar goods manufactured or supplied by Seller, Seller shall notify Buyer immediately thereof and take reasonable steps to resolve the matter without exposing Buyer to any liability or risk. The parties shall cooperate with and assist Supplier each other in any such filings filing and Corrective Action; providedcorrective action, however, provided that nothing contained in this Section paragraph shall preclude Buyer a party from taking such action, and in such event, Supplier shall cooperate with and assist Buyer in action as may be required of it under any such filings and implementing the Corrective Action it elects to undertake. To the extent the need for such Corrective Action is determined to have been caused by a defect, noncompliance law or quality or performance deficiency which is the responsibility of Supplier, at Buyer’s election, Supplier shall perform all necessary Corrective Action at its sole expense, or Buyer shall perform such necessary Corrective Action and Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection therewith. In either case, Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection with any such (voluntary or mandatory) Corrective Action, including without limitation, the cost of locating, identifying and notifying Buyer’s customers, the cost of repairing, or where repair of the Product or Deliverables is impracticable or impossible, repurchasing or replacing the recalled Product or Deliverable, any costs of packing and shipping the recalled Product or Deliverable, and the cost of media notification, if such form of notification is necessary. The parties recognize that it is possible that other Supplier-provided products or deliverables might contain the same defect, noncompliance or quality or performance deficiency as do Products or Deliverables provided to Buyer. Buyer and Supplier agree that any Corrective Action involving Products or Deliverables provided to Buyer shall be treated separately and distinctly from similar Corrective Action of other products or deliverables of Supplier; provided that such separate and distinct treatment is lawful and Supplier shall in no event fail to provide at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Actionregulation. Each party shall consult the other party before making any statements statement to the public or a governmental agency concerning issues relating to potential safety hazards affecting Products or Deliverablesany Good provided hereunder, except where such consultation would prevent timely notification required by lawto be given under any applicable law or regulation. The provisions All of the actions and obligations set forth in this Section 23 paragraph shall be at Seller’s sole cost and expense. This paragraph shall survive any termination or expiration of this ContractOrder.

Product Recall. If at either party believes that a product recall is necessary or appropriate, it will promptly notify the other, and the parties will (unless such recall is required by law) discuss whether such recall is necessary or appropriate, and shall discuss the manner in which any time agreed or required recall shall be conducted. If a recall is not required by law and the parties cannot agree whether the recall is necessary or appropriate, either party may elect to conduct the recall in question The parties shall cooperate with each other in conducting any such recall. All out of pocket costs of a required or agreed recall insofar as such recall relates to Critical Reagents (aexcept printing and mailing costs incurred to notify customers of such recall), shall be borne by Ostex. All out of pocket costs of a required or agreed recall except insofar as such recall relates to Critical Reagents or the NTx Assay Technology ( except printing and mailing costs incurred to notify customers of such recall), shall be borne by Hologic. All costs of a recall to which the parties have not agreed shall be borne by the party that elects to conduct the recall, provided that if a court of competent jurisdiction determines that said recall was caused by (i) the fact that any governmental agency having jurisdiction provides written notice Critical Reagents or the NTx Assay Technology were in violation of applicable law or the terms of this contract, Hologic may obtain reimbursement by Ostex of all reasonable out of pocket costs and expenses of such recall (except for printing and mailing costs incurred to either Buyer or Suppliernotify customers of such recall), or (bii) either Buyer or Supplier have a reasonable basis to conclude the fact that any Products NTx Meter or Deliverables contain a defect which could create a potential safety hazard or unsafe condition, pose an unreasonable risk NTx Meter Strip(s) were otherwise in violation of serious injury or death, contain a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal or regulatory requirement, thereby making it advisable, or required, that such Products or Deliverables be subject to corrective action including, without limitation, recall, retrofit, refund, replacement and/or repair (hereinafter “Corrective Action”), Supplier or Buyer will promptly communicate relevant facts to each other. Buyer shall determine whether any Corrective Action involving the affected Products or Deliverables is warranted or advisable unless notice to that effect has been received from any governmental agency having jurisdiction. If Corrective Action is required under the law or Buyer determines that the terms of this contract, Ostex may obtain reimbursement by Hologic of all reasonable out of pocket costs and expenses of such recall (except for printing and mailing costs incurred to notify customers of such recall. Each party shall maintain complete and accurate records of all product sold by it is advisable, Supplier shall promptly undertake Corrective Actions, including those for such periods as required by any applicable consumer product safety or similar law and the regulations thereunder, and shall file all necessary papers, descriptions of corrective action, and other related documents and carry out the Correction Actionlaw. Buyer shall cooperate with and assist Supplier in any such filings and Corrective Action; provided, however, that nothing contained Nothing in this Section shall preclude Buyer from taking such action, and in such event, Supplier shall cooperate be construed to modify or limit any legal obligation of either party with and assist Buyer in respect to any such filings and implementing the Corrective Action it elects to undertake. To the extent the need for such Corrective Action is determined to have been caused by a defect, noncompliance or quality or performance deficiency which is the responsibility of Supplier, at Buyer’s election, Supplier shall perform all necessary Corrective Action at its sole expense, or Buyer shall perform such necessary Corrective Action and Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection therewith. In either case, Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection with any such (voluntary or mandatory) Corrective Action, including without limitation, the cost of locating, identifying and notifying Buyer’s customers, the cost of repairing, or where repair of the Product or Deliverables is impracticable or impossible, repurchasing or replacing the recalled Product or Deliverable, any costs of packing and shipping the recalled Product or Deliverable, and the cost of media notification, if such form of notification is necessary. The parties recognize that it is possible that other Supplier-provided products or deliverables might contain the same defect, noncompliance or quality or performance deficiency as do Products or Deliverables provided to Buyer. Buyer and Supplier agree that any Corrective Action involving Products or Deliverables provided to Buyer shall be treated separately and distinctly from similar Corrective Action of other products or deliverables of Supplier; provided that such separate and distinct treatment is lawful and Supplier shall in no event fail to provide at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Action. Each party shall consult the other before making any statements to the public or a governmental agency relating to potential safety hazards affecting Products or Deliverables, except where such consultation would prevent timely notification required by law. The provisions of this Section 23 shall survive any termination or expiration of this Contractrecall.

Product Recall. If at any time (a) any governmental agency having jurisdiction provides written notice to either Buyer ACBL or SupplierSeller, or (b) either Buyer ACBL or Supplier Seller have a reasonable basis to conclude that any Products or Deliverables Item(s) contain a defect which could create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal or regulatory requirement, thereby making it advisable, or required, that such Products Item(s) be recalled and/or repaired, ACBL or Deliverables be subject to corrective action including, without limitation, recall, retrofit, refund, replacement and/or repair (hereinafter “Corrective Action”), Supplier or Buyer Seller will promptly communicate relevant facts to each other. Buyer ACBL shall determine whether any Corrective Action involving a recall of the affected Products or Deliverables Items is warranted or advisable unless notice to that effect has been received from any governmental agency having jurisdiction. If Corrective Action a recall is required under the law or Buyer ACBL determines that it is advisable, Supplier Seller shall promptly undertake Corrective Actionscorrective actions, including those required by any applicable consumer product safety protection or similar law and the regulations thereunder, and shall file all necessary papers, descriptions of or corrective actionaction programs, and other related documents and carry out the Correction Actioncorrection action programs. Buyer ACBL shall cooperate with and assist Supplier Seller in any such filings and Corrective Actioncorrective action; provided, however, that nothing contained in this Section shall preclude Buyer ACBL from taking such action, and in such event, Supplier Seller shall cooperate with and assist Buyer ACBL in any such filings and implementing the Corrective Action corrective action it elects to undertake. To the extent the need for such Corrective Action recall or rework is determined to have been caused by a defect, noncompliance defect or quality or performance deficiency which is the responsibility of SupplierSeller, at BuyerACBL’s election, Supplier Seller shall perform all necessary Corrective Action repairs or modifications at its sole expense, or Buyer ACBL shall perform such necessary Corrective Action repairs or modifications and Supplier Seller shall reimburse Buyer ACBL for all reasonable out-of-pocket costs and expenses incurred by Buyer ACBL in connection therewith. In either case, Supplier Seller shall reimburse Buyer ACBL for all reasonable out-of-pocket costs and expenses incurred by Buyer ACBL in connection with any such (voluntary or mandatoryrequired) Corrective Actionrecall, repair, replacement or refund program, including without limitation, the cost of locating, identifying and notifying Buyer’s customersItems, the cost of repairing, or where repair of the Product or Deliverables Item is impracticable or impossible, repurchasing or replacing the recalled Product or DeliverableItems, any costs and cost of packing and shipping the recalled Product or DeliverableItems, and the cost of media notificationnotifications, if such form of notification is necessary. The parties recognize that it is possible that other Supplier-provided products or deliverables might contain the same defect, noncompliance or quality or performance deficiency as do Products or Deliverables provided to Buyer. Buyer and Supplier agree that any Corrective Action involving Products or Deliverables provided to Buyer shall be treated separately and distinctly from similar Corrective Action of other products or deliverables of Supplier; provided that such separate and distinct treatment is lawful and Supplier shall in no event fail to provide at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Action. Each party shall consult the other before making any statements to the public or a governmental agency relating to potential safety hazards affecting Products or Deliverables, except where such consultation would prevent timely notification required by law. The provisions of this Section 23 shall survive any termination or expiration of this Contractneeded.

Product Recall. If at any time (a) Regulatory Authority in the Territory orders or requires the recall of any governmental agency having jurisdiction provides written notice to either Buyer or SupplierProduct in the Territory, or (b) either Buyer or Supplier have if in GSK's opinion a reasonable basis to conclude that any Products or Deliverables contain a defect which could create a potential safety hazard or unsafe conditionrecall is necessary in the Territory, pose an unreasonable risk of serious injury or death, contain a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal or regulatory requirement, thereby making it advisable, or required, that such Products or Deliverables be subject to corrective action including, without limitation, recall, retrofit, refund, replacement and/or repair (hereinafter “Corrective Action”), Supplier or Buyer GSK will promptly communicate relevant facts notify ALLERGAN and provide such information regarding such recall order or other information as may be reasonably requested by ALLERGAN. GSK shall, unless prohibited by applicable law, consult with ALLERGAN on the need for a recall and take all ALLERGAN submissions into account when making a decision whether to each otherinstigate a recall (such decision not to be unreasonably made). Buyer GSK shall determine whether be responsible for conducting any Corrective Action involving recall of Product in the affected Products or Deliverables is warranted or advisable unless notice Territory and ALLERGAN shall co-operate with GSK by providing all such information and assistance as may be reasonably required to that effect has been received from any governmental agency having jurisdiction. If Corrective Action is required under the law or Buyer determines that it is advisable, Supplier shall promptly undertake Corrective Actions, including those required by any applicable consumer product safety or similar law and the regulations thereunder, and shall file all necessary papers, descriptions of corrective action, and other related documents and carry out the Correction Action. Buyer shall cooperate with and assist Supplier in any implement such filings and Corrective Action; provided, however, that nothing contained in this Section shall preclude Buyer from taking such action, and in such event, Supplier shall cooperate with and assist Buyer in any such filings and implementing the Corrective Action it elects to undertakerecall. To the extent that any recall of the need Product is implemented as a result of ALLERGAN's failure to Manufacture Product in accordance with the terms and conditions of this Supply Agreement, ALLERGAN shall (i) bear all direct expenses incurred by GSK in connection with such recall, (ii) shall indemnify the GSK Indemnitees (as defined in Section 7.1) from any and all Liabilities (as defined in Section 7.1) incurred by any GSK Indemnitee, to the extent that these are proven to be attributable to ALLERGAN's failure to Manufacture Product in accordance with the terms and conditions of this Supply Agreement and (iii) shall either, at GSK's sole option, replace or credit GSK for such Corrective Action the cost of the relevant Lots of the Product subject to the recall. If a recall of Product is determined required due to any negligence or willful misconduct of a GSK Indemnitee, including without limitation any recall that could have been caused avoided but was not avoided due to a failure of GSK to perform the testing allowed by a defectSection 5.6, noncompliance or quality or performance deficiency which is the responsibility of Supplier, at Buyer’s election, Supplier GSK shall perform bear all necessary Corrective Action at its sole expense, or Buyer shall perform such necessary Corrective Action and Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection therewith. In either case, Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection with such recall and shall indemnify the ALLERGAN Indemnitees from and against any such (voluntary and all Liabilities incurred by an ALLERGAN Indemnitee that are proven to be attributable solely to the negligence or mandatory) Corrective Action, including without limitation, willful misconduct of GSK. If any Regulatory Authority outside the cost Territory orders or requires the recall of locating, identifying and notifying Buyer’s customers, the cost of repairing, or where repair any of the Product Products outside the Territory then ALLERGAN will promptly notify GSK and provide such information regarding such recall order or Deliverables is impracticable or impossibleother information as may be reasonably requested by GSK. EXCEPT AS SET FORTH IN ARTICLE 7 (INDEMNIFICATION), repurchasing or replacing the recalled Product or DeliverableEACH PARTY'S SOLE AND EXCLUSIVE REMEDIES FOR RECALLED PRODUCT SHALL BE LIMITED TO THE REMEDIES PROVIDED IN THIS SECTION AND, any costs of packing and shipping the recalled Product or DeliverableIF RELEVANT, and the cost of media notification, if such form of notification is necessary. The parties recognize that it is possible that other Supplier-provided products or deliverables might contain the same defect, noncompliance or quality or performance deficiency as do Products or Deliverables provided to Buyer. Buyer and Supplier agree that any Corrective Action involving Products or Deliverables provided to Buyer shall be treated separately and distinctly from similar Corrective Action of other products or deliverables of Supplier; provided that such separate and distinct treatment is lawful and Supplier shall in no event fail to provide at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Action. Each party shall consult the other before making any statements to the public or a governmental agency relating to potential safety hazards affecting Products or Deliverables, except where such consultation would prevent timely notification required by law. The provisions of this Section 23 shall survive any termination or expiration of this ContractTHE REMEDIES FOR FAILURE TO SUPPLY SET OUT IN THE LICENSE AGREEMENT.

Product Recall. If at In the event that: (i) a Regulatory Authority or any time other governmental agency or authority issues a request or orders that the Finished Product be recalled; (ii) a court of competent jurisdiction in the Territory orders that the Finished Product be recalled; or (iii) Oscient reasonably determines, after consultation with MIOL, that the Finished Product should be recalled or a notice is required relating to restrictions on use of the Finished Product, MIOL and Sub-Distributor shall attend to the same, as determined by the mutual agreement of Oscient and MIOL, and the Parties shall co-operate in a manner which is appropriate and take all appropriate corrective action. In the event such action results from: (a) any governmental agency having jurisdiction provides written notice Oscient’s negligence or willful misconduct, Oscient shall be responsible for the expenses thereof or, if applicable, a proportionate share of such recall costs according to either Buyer or Supplierthe extent to which Oscient is responsible, or (b) either Buyer MIOL’s, its Affiliate’s and/or Third-Party Manufacturer’s and/or Sub-Distributor’s negligence or Supplier have willful misconduct, MIOL shall be responsible for the expenses thereof or, if applicable, a reasonable basis proportionate share of such recall costs according to conclude that any Products or Deliverables contain a defect which could create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal or regulatory requirement, thereby making it advisable, or required, that such Products or Deliverables be subject to corrective action including, without limitation, recall, retrofit, refund, replacement and/or repair (hereinafter “Corrective Action”), Supplier or Buyer will promptly communicate relevant facts to each other. Buyer shall determine whether any Corrective Action involving the affected Products or Deliverables is warranted or advisable unless notice to that effect has been received from any governmental agency having jurisdiction. If Corrective Action is required under the law or Buyer determines that it is advisable, Supplier shall promptly undertake Corrective Actions, including those required by any applicable consumer product safety or similar law and the regulations thereunder, and shall file all necessary papers, descriptions of corrective action, and other related documents and carry out the Correction Action. Buyer shall cooperate with and assist Supplier in any such filings and Corrective Action; provided, however, that nothing contained in this Section shall preclude Buyer from taking such action, and in such event, Supplier shall cooperate with and assist Buyer in any such filings and implementing the Corrective Action it elects to undertake. To the extent to which they are responsible; and (c) otherwise, Oscient and MIOL shall share equally the need for such Corrective Action is determined to have been caused expenses of the action. For purposes of this Agreement, the expenses of the action shall be the expenses of notification and return or destruction (if authorized by a defect, noncompliance or quality or performance deficiency which is Oscient) of the responsibility of Supplier, at Buyer’s election, Supplier shall perform all necessary Corrective Action at its sole expense, or Buyer shall perform such necessary Corrective Action and Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection therewith. In either case, Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection with any such (voluntary or mandatory) Corrective Action, including without limitationFinished Product, the cost of locating, identifying and notifying Buyer’s customers, the cost of repairing, or where repair replacement of the Product or Deliverables is impracticable or impossibleFinished Product, repurchasing or replacing the recalled Product or Deliverable, and any costs directly associated with the distribution of packing replacement Finished Product. Oscient, MIOL, Third-Party Manufacturer and shipping the recalled Product or Deliverable, and the cost of media notification, if Sub-Distributor shall cooperate fully with one another in carrying out such form of notification is necessaryaction. The parties recognize that it is possible that other Supplier-provided products or deliverables might contain the same defect, noncompliance or quality or performance deficiency as do Products or Deliverables provided to Buyer. Buyer and Supplier agree that any Corrective Action involving Products or Deliverables provided to Buyer shall be treated separately and distinctly from similar Corrective Action of other products or deliverables of Supplier; provided that such separate and distinct treatment is lawful and Supplier shall in no event fail to provide at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Action. Each party shall consult the other before making any statements to the public or a governmental agency relating to potential safety hazards affecting Products or Deliverables, except where such consultation would prevent timely notification required by law. The provisions [*] = Portions of this Section 23 shall survive any termination or expiration exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this Contractexhibit has been filed separately with the Commission.

Product Recall. If at either BMS or Otsuka discovers or becomes aware of any time fact, condition, circumstance or event (awhether actual or potential) concerning or related to Product that may reasonably require recall or market withdrawal of Product or a “Dear Doctor” letter relating to Product, such party shall communicate such fact, condition, circumstance or event promptly to the other party. In the event (i) any governmental agency having or regulatory body issues a request, directive or order that Product be recalled; (ii) a court of competent jurisdiction provides written notice to either Buyer or Supplier, orders that Product be recalled; or (biii) either Buyer or Supplier have a reasonable basis to conclude that any Products or Deliverables contain a defect which could create a potential safety hazard or unsafe conditionthe PDC (in the Territory) and Otsuka (in the Reserved Territory) reasonably determine, pose an unreasonable risk of serious injury or death, contain a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal or regulatory requirement, thereby making it advisable, or requiredafter mutual consultation, that such Products Product should be recalled or Deliverables withdrawn from the market or that a “Dear Doctor” letter should be subject sent relating to corrective action includinguse of Product, without limitation, recall, retrofit, refund, replacement and/or repair (hereinafter “Corrective Action”), Supplier or Buyer will promptly communicate relevant facts to each other. Buyer the parties shall determine whether any Corrective Action involving the affected Products or Deliverables is warranted or advisable unless notice to that effect has been received from any governmental agency having jurisdiction. If Corrective Action is required under the law or Buyer determines that it is advisable, Supplier shall promptly undertake Corrective Actions, including those required by any applicable consumer product safety or similar law and the regulations thereunder, and shall file take all necessary papers, descriptions of corrective action, and other related documents and carry out the Correction Action. Buyer shall cooperate appropriate remedial actions with and assist Supplier in any such filings and Corrective Actionrespect thereto; provided, however, that nothing contained Otsuka, in this Section its sole discretion, shall preclude Buyer from taking such action, and finally determine any recall matters in such event, Supplier shall cooperate with and assist Buyer in any such filings and implementing the Corrective Action it elects to undertakeReserved Territory. To the extent the need for such Corrective Action that it is determined necessary or appropriate to have been caused by a defect, noncompliance or quality or performance deficiency which is the responsibility of Supplier, at Buyer’s election, Supplier shall perform all necessary Corrective Action at its sole expense, or Buyer shall perform such necessary Corrective Action and Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection therewith. In either case, Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection communicate with any such (voluntary person or mandatory) Corrective Actionentity in the Territory, including without limitationbut not limited to any governmental agency or regulatory body, the media or any customer, concerning any such fact, condition, circumstance or event, BMS (in the United States and European Union, as contract service provider of Otsuka, and as Otsuka’ s exclusive * CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTION HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION licensee in the Rest of Territory) shall be the primary contact concerning remedial action. The party that is at fault for giving rise to the fact, condition, circumstance or event resulting in the recall or withdrawal of Product, as determined by an independent testing laboratory or a mutually acceptable regulatory consultant familiar both with the circumstances and with the allocation of responsibilities between the parties under this Agreement, shall bear all expense of the recall or Product withdrawal, including the costs of preparation of customer lists and letters, mailing expenses, media notices and other public announcements and any other necessary notice, destruction or return of the recalled or withdrawn Product, the cost of locating, identifying shipping and notifying Buyer’s customers, the cost of repairing, or where repair of the Product or Deliverables is impracticable or impossible, repurchasing or replacing the recalled Product or Deliverable, any costs of packing and shipping the recalled Product or Deliverablefreight, and the cost of media notification, if such form of notification is necessarythe recalled or withdrawn Product. The parties recognize that If it is possible determined that other Supplier-provided products or deliverables might contain the same defectparties share joint responsibility, noncompliance or quality or performance deficiency as do Products or Deliverables provided to Buyer. Buyer and Supplier agree that any Corrective Action involving Products or Deliverables provided to Buyer then they shall be treated separately and distinctly from similar Corrective Action share such expense in accordance with their allocated percentage of other products or deliverables of Supplier; provided that such separate and distinct treatment is lawful and Supplier shall in no event fail to provide at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Action. Each party shall consult the other before making any statements to the public or a governmental agency relating to potential safety hazards affecting Products or Deliverables, except where such consultation would prevent timely notification required by law. The provisions of this Section 23 shall survive any termination or expiration of this Contractresponsibility.

Product Recall. If at any time (a) any governmental agency having jurisdiction provides written notice to either Buyer or SupplierIf a recall is required by applicable Law, or (b) either if Buyer or Supplier have reasonably determines that a reasonable basis to conclude that any Products or Deliverables contain a defect which could recall is advisable because the goods may create a potential safety hazard or unsafe conditionhazard, pose an unreasonable risk of serious injury or death, contain a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal or regulatory requirement, thereby making it advisableor contain a defect or non-conformance with the requirements of this Order occurring or likely to occur in multiple goods, which such defects or required, that such Products non- conformances are substantially similar or Deliverables be subject to corrective action including, without limitation, recall, retrofit, refund, replacement and/or repair have substantially similar causes or effects (hereinafter collectively a “Corrective ActionSerial Defect”), Supplier or Buyer will the parties shall promptly communicate relevant such facts to each other. Buyer shall determine whether any Corrective Action involving the affected Products or Deliverables is warranted or advisable unless notice to that effect has been received from any governmental agency having jurisdiction. If Corrective Action is required under the law or Buyer determines that it is advisableAt Buyer’s request, Supplier shall promptly undertake Corrective Actionsdevelop a corrective action plan satisfactory to Buyer, including those which shall include all actions required to recall and/or repair the goods and any actions required by any applicable consumer product Law (“Corrective Action Plan”) for Buyer’s review and approval. At Buyer’s election, Xxxxx may develop the Corrective Action Plan. In no event shall Buyer and Supplier’s failure to agree on the Corrective Action Plan delay the timely notification of a potential safety hazard, non- compliance or similar law Serial Defect to users of the goods, cause either party to be non-compliant with applicable Law Or prevent Buyer from taking reasonable actions to prevent injury or damage to persons, equipment or other property. Supplier and the regulations thereunder, and shall file all necessary papers, descriptions of corrective action, and other related documents and carry out the Correction Action. Buyer shall cooperate with and assist Supplier each other in any such filings and Corrective Action; providedcorrective actions and/or filings, howeverif applicable. (b) To the extent a recall is required by applicable Law, that nothing contained in this Section shall preclude Buyer from taking such actionor due to a potential safety hazard, and in such eventnon–compliance or Serial Defect, which is caused by Supplier, Supplier shall cooperate with indemnify and assist hold Buyer in any such filings and implementing the Corrective Action it elects to undertake. To the extent the need for such Corrective Action is determined to have been caused by a defect, noncompliance or quality or performance deficiency which is the responsibility of Supplier, at Buyer’s election, Supplier shall perform all necessary Corrective Action at its sole expense, or Buyer shall perform such necessary Corrective Action and Supplier shall reimburse Buyer for harmless from all reasonable out-of-pocket costs and expenses incurred by Buyer in connection therewith. In either case, Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection with any such (voluntary recall, repair, replacement or mandatory) Corrective Actionrefund program, including without limitation, all costs related to: (i) investigating and/or inspecting the cost of locating, identifying and affected goods; (ii) notifying Buyer’s customers, the cost of ; (iii) repairing, or where repair of the Product or Deliverables goods is impracticable or impossible, repurchasing or replacing the recalled Product or Deliverable, any costs of goods; (iv) packing and shipping the recalled Product or Deliverable, goods; and the cost of (v) media notification, if such form of notification is necessary. The parties recognize that it is possible that other Supplier-provided products or deliverables might contain the same defect, noncompliance or quality or performance deficiency as do Products or Deliverables provided to Buyer. Buyer and Supplier agree that any Corrective Action involving Products or Deliverables provided to Buyer shall be treated separately and distinctly from similar Corrective Action of other products or deliverables of Supplier; provided that such separate and distinct treatment is lawful and Supplier shall in no event fail to provide at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Action. Each party shall consult the other before making any statements to the public or a governmental agency relating to such recall, potential safety hazards affecting Products hazard, non-compliance or DeliverablesSerial Defect, except where such consultation would prevent timely notification required by lawLaw. The provisions of this Section 23 shall survive any termination or expiration of this Contract.7.4

Product Recall. If at any time (a) Regulatory Authority in the Territory orders or requires the recall of any governmental agency having jurisdiction provides written notice to either Buyer or SupplierProduct in the Territory, or (b) either Buyer or Supplier have if in GSK's opinion a reasonable basis to conclude that any Products or Deliverables contain a defect which could create a potential safety hazard or unsafe conditionrecall is necessary in the Territory, pose an unreasonable risk of serious injury or death, contain a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal or regulatory requirement, thereby making it advisable, or required, that such Products or Deliverables be subject to corrective action including, without limitation, recall, retrofit, refund, replacement and/or repair (hereinafter “Corrective Action”), Supplier or Buyer GSK will promptly communicate relevant facts notify ALLERGAN and provide such information regarding such recall order or other information as may be reasonably requested by ALLERGAN. GSK will, unless prohibited by Applicable Law, consult ALLERGAN on the need for a recall and take all ALLERGAN submissions into account when making a decision of whether to each otherinstigate or recall (such decision not to be unreasonably made). Buyer shall determine whether GSK will be responsible for conducting any Corrective Action involving recall in the affected Products or Deliverables is warranted or advisable unless notice Territory and ALLERGAN will co-operate with GSK by providing all such information and assistance as may be reasonably required to that effect has been received from any governmental agency having jurisdiction. If Corrective Action is required under the law or Buyer determines that it is advisable, Supplier shall promptly undertake Corrective Actions, including those required by any applicable consumer product safety or similar law and the regulations thereunder, and shall file all necessary papers, descriptions of corrective action, and other related documents and carry out the Correction Action. Buyer shall cooperate with and assist Supplier in any implement such filings and Corrective Action; provided, however, that nothing contained in this Section shall preclude Buyer from taking such action, and in such event, Supplier shall cooperate with and assist Buyer in any such filings and implementing the Corrective Action it elects to undertakerecall. To the extent that any recall of the need for Product is implemented as a result of Manufacturer's failure to Manufacture (as defined in the Supply Agreement) Product in accordance with the terms and conditions of the Supply Agreement, ALLERGAN will (a) bear all direct expenses incurred by GSK in connection with such Corrective Action is determined recall, (b) indemnify the GSK Indemnitees (as defined in Section 8.1) from any and all Liabilities (as defined in Section 8.1) incurred by the GSK Indemnitees to have been caused by a defectthe extent that these are proven to be attributable to the Manufacturer's failure to Manufacture Product in accordance with the terms and conditions of the Supply Agreement, noncompliance or quality or performance deficiency which is the responsibility of Supplierand (c) either, at Buyer’s electionGSK's sole option, Supplier shall perform replace or credit GSK for the cost of the relevant Lots (as defined in the Supply Agreement) of Product subject to the recall. If a recall is required due to any negligence or willful misconduct of a GSK Indemnitee, GSK will bear all necessary Corrective Action at its sole expense, or Buyer shall perform such necessary Corrective Action and Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer ix xxxxxxxxxx xxxx xuch recall and will indemnify the ALLERGAN Indemnitees (as defined in connection therewith. In either case, Supplier shall reimburse Buyer for Section 8.2) from and against any and all reasonable out-of-pocket costs and expenses Liabilities incurred by Buyer in connection with the ALLERGAN Indemnitees that are proven to be attributable solely to the negligence or willful misconduct of GSK. If any such (voluntary Regulatory Authority outside the Territory orders or mandatory) Corrective Action, including without limitation, requires the cost recall of locating, identifying and notifying Buyer’s customers, the cost of repairing, or where repair any of the Product Products outside the Territory then ALLERGAN will promptly notify GSK and provide such information regarding such recall order or Deliverables is impracticable or impossibleother information as may be reasonably requested by GSK. Except as set forth in Article 8, repurchasing or replacing the each Party's sole and exclusive remedies for recalled Product or Deliverable, any costs of packing and shipping the recalled Product or Deliverable, and the cost of media notification, if such form of notification is necessary. The parties recognize that it is possible that other Supplier-provided products or deliverables might contain the same defect, noncompliance or quality or performance deficiency as do Products or Deliverables provided to Buyer. Buyer and Supplier agree that any Corrective Action involving Products or Deliverables provided to Buyer shall be treated separately and distinctly from similar Corrective Action of other products or deliverables of Supplier; provided that such separate and distinct treatment is lawful and Supplier shall in no event fail to provide at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Action. Each party shall consult the other before making any statements limited to the public or a governmental agency relating to potential safety hazards affecting Products or Deliverables, except where such consultation would prevent timely notification required by law. The provisions of remedies provided in this Section 23 shall survive any termination or expiration of this Contract5.7.

Product Recall. If at any time (a) any governmental agency having jurisdiction provides written notice a.The Parties will cooperate in good faith to either Buyer or Supplierrespond to all customer inquiries and complaints relating to the Licensed Products and the record keeping and reporting relating thereto. Licensor will provide all reasonable assistance requested by Licensee in ​ ​ investigating customer complaints, incidents, or near incidents regarding the Products (b) either Buyer or Supplier have each a reasonable basis to conclude that “Customer Complaint”). In the event any Products or Deliverables contain regulatory authority seizes any Licensed Product, requests a defect which could create recall of any Licensed Product (a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal or regulatory requirement, thereby making it advisable, or required, that such Products or Deliverables be subject to corrective action including, without limitation, recall, retrofit, refund, replacement and/or repair (hereinafter “Corrective ActionRegulatory Recall”), Supplier or Buyer will otherwise notifies Licensor or Licensee of any violation or potential violation of any Applicable Law (each a “Regulatory Issue”), the first Party who received a notification from the applicable regulatory authority must promptly communicate relevant facts to each other. Buyer shall determine whether any Corrective Action involving (i) notify the affected Products or Deliverables is warranted or advisable unless notice to that effect has been received from any governmental agency having jurisdiction. If Corrective Action is required under other Party and (ii) provide the law or Buyer determines that it is advisable, Supplier shall promptly undertake Corrective Actions, including those required by other Party with a copy of any applicable consumer product safety Regulatory Recall letter or similar law equivalent written notification. In the event of a Customer Complaint or Regulatory Issue, Licensee shall immediately cease distribution of the Licensed Products and the regulations thereunderParties will work together and cooperate in good faith to promptly remediate such Customer Complaint or Regulatory Issue, as applicable. Each Party shall be responsible for each such Party’s costs associated with such Customer Complaint or Regulatory Issue, provided that in the event the Customer Complaint or Regulatory Issue arises due to the actions or inaction of Licensee or matters within the responsibility of Licensee hereunder (including failure to comply with Applicable Law in the Territories), all direct out of pocket costs of Licensor for third party testing, travel for personnel and regulatory fines shall file all necessary papers, descriptions of corrective action, and other related documents and carry out the Correction Action. Buyer shall cooperate with and assist Supplier in any such filings and Corrective Action; provided, however, that nothing contained in this Section shall preclude Buyer from taking such actionbe borne by Licensee, and in such event, Supplier shall cooperate with and assist Buyer in any such filings and implementing the Corrective Action it elects event the Customer Complaint or Regulatory Issue arises due to undertake. To the extent the need for such Corrective Action is determined to have been caused by a defect, noncompliance actions or quality inaction of Licensor or performance deficiency which is matters within the responsibility of SupplierLicensor hereunder, at Buyer’s election, Supplier shall perform all necessary Corrective Action at its sole expense, or Buyer shall perform such necessary Corrective Action and Supplier shall reimburse Buyer for all reasonable out-of-direct out of pocket costs of Licensee for third part testing, travel for personnel and expenses incurred regulatory fines shall be borne by Buyer in connection therewithLicensor. In either caseMoreover, Supplier shall reimburse Buyer for the Parties will each provide information reasonably requested by the other Party to investigate the cause and extent of such Customer Complaint or Regulatory Issue, as applicable. Licensee agrees to consult with Licensor on all reasonable out-of-pocket costs and expenses incurred by Buyer product liability claims, proceedings or actions brought against Licensor in connection with the Licensed Products and to take such action with respect to the defense of any such (voluntary claim or mandatory) Corrective Action, including without limitation, lawsuit as Licensor may reasonably request in order to protect the cost interests of locating, identifying and notifying Buyer’s customers, the cost of repairing, or where repair of the Product or Deliverables is impracticable or impossible, repurchasing or replacing the recalled Product or Deliverable, any costs of packing and shipping the recalled Product or Deliverable, Licensor and the cost of media notificationCompany IP or the goodwill associated with therewith, if such form of notification is necessary. The parties recognize that it is possible that other Supplier-provided products or deliverables might contain the same defect, noncompliance or quality or performance deficiency as do Products or Deliverables provided to Buyer. Buyer and Supplier agree that any Corrective Action involving Products or Deliverables provided to Buyer which shall be treated separately and distinctly from similar Corrective Action at Licensee’s expense or, solely in the case of other products claims relating expressly to Company IP or deliverables of Supplier; provided that such separate and distinct treatment is lawful and Supplier shall in no event fail to provide Licensor packaging materials, at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Action. Each party shall consult the other before making any statements to the public or a governmental agency relating to potential safety hazards affecting Products or Deliverables, except where such consultation would prevent timely notification required by law. The provisions of this Section 23 shall survive any termination or expiration of this ContractLicensor’s expense.

Product Recall. If at any time Relevant Regulatory Authority recommends, requests or requires the recall of any of the Products due to an act, omission or breach by HAMELN with respect to its obligations, covenants or warranties herein or HAMELN deems it necessary to initiate a voluntary recall of any batch of Products due to an act, omission or breach by HAMELN with respect to its obligations, covenants or warranties herein, HAMELN will immediately notify LICENSEE of such recall and will consult with LICENSEE regarding the timely compliance with all applicable regulations and requirements pertaining to that recall. In the event of such a product recall, HAMELN will reimburse LICENSEE (i) within fifteen (15) days of such recall all amounts paid by LICENSEE for Product subject to the recall; and (ii) within fifteen (15) days of LICENSEE’s invoice together with supporting documentation from the applicable wholesalers, all costs incurred by LICENSEE with respect to wholesaler recall costs; and (iii) within fifteen (15) days of LICENSEE’s invoice, all other costs incurred with respect to the administration and implementation of the recall, including, but not limited to, (a) any governmental agency having jurisdiction provides written notice to either Buyer or Supplier, or notification/approval of Relevant Regulatory Authorities; (b) either Buyer notification to Product distributors/agents and customers and/or contractors; (c) market withdrawal or Supplier have a field correction; (d) return/destruction of recalled Products; and (e) reasonable basis legal costs. If any Relevant Regulatory Authority recommends, requests or requires the recall of any of the Products due to conclude that any Products an act, omission or Deliverables contain a defect which could create a potential safety hazard breach by LICENSEE with respect to its obligations, covenants or unsafe conditionwarranties herein, pose an unreasonable risk LICENSEE will immediately notify HAMELN of serious injury or death, contain a quality or performance deficiency, or are not in such recall and will consult with HAMELN regarding the timely compliance with any all applicable coderegulations and requirements pertaining to that recall. In the event of such a product recall, standard or legal or regulatory requirementLICENSEE will pay for all costs incurred with respect to the administration and implementation of such recall and LICENSEE will reimburse HAMELN within fifteen (15) days of HAMELN’s invoice, thereby making it advisableall costs incurred by HAMELN with respect to the administration and implementation of the recall, or required, that such Products or Deliverables be subject to corrective action including, without limitationbut not limited to, recall, retrofit, refund, replacement (a) notification/approval of Relevant Regulatory Authorities; (b) notification to Product distributors/agents and customers and/or repair contractors; (hereinafter “Corrective Action”), Supplier c) market withdrawal or Buyer will promptly communicate relevant facts to each other. Buyer shall determine whether any Corrective Action involving the affected Products or Deliverables is warranted or advisable unless notice to that effect has been received from any governmental agency having jurisdiction. If Corrective Action is required under the law or Buyer determines that it is advisable, Supplier shall promptly undertake Corrective Actions, including those required by any applicable consumer product safety or similar law field correction; (d) return/destruction of recalled Products; and the regulations thereunder, and shall file all necessary papers, descriptions of corrective action, and other related documents and carry out the Correction Action. Buyer shall cooperate with and assist Supplier in any such filings and Corrective Action; provided, however, that nothing contained in this Section shall preclude Buyer from taking such action, and in such event, Supplier shall cooperate with and assist Buyer in any such filings and implementing the Corrective Action it elects to undertake(e) reasonable legal costs. To the extent that a product recall is not clearly due to an act, omission or breach by either Party with respect to its obligations, covenants or warranties herein, then the need for such Corrective Action is determined Parties shall mutually discuss and negotiate in good faith an equitable solution with respect to have been caused by a defect, noncompliance or quality or performance deficiency which is costs related to the responsibility of Supplier, at Buyer’s election, Supplier shall perform all necessary Corrective Action at its sole expense, or Buyer shall perform such necessary Corrective Action administration and Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection therewith. In either case, Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection with any such (voluntary or mandatory) Corrective Action, including without limitation, the cost of locating, identifying and notifying Buyer’s customers, the cost of repairing, or where repair implementation of the Product or Deliverables is impracticable or impossible, repurchasing or replacing recall. Both Parties shall cooperate and use best efforts to minimize the recalled Product or Deliverable, any costs of packing and shipping the recalled Product or Deliverable, and the cost of media notification, if such form of notification is necessary. The parties recognize that it is possible that other Supplier-provided products or deliverables might contain the same defect, noncompliance or quality or performance deficiency as do Products or Deliverables provided to Buyer. Buyer and Supplier agree that any Corrective Action involving Products or Deliverables provided to Buyer shall be treated separately and distinctly from similar Corrective Action of other products or deliverables of Supplier; provided that such separate and distinct treatment is lawful and Supplier shall in no event fail to provide at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Action. Each party shall consult the other before making any statements to the public or a governmental agency relating to potential safety hazards affecting Products or Deliverables, except where such consultation would prevent timely notification required by law. The provisions of this Section 23 shall survive any termination or expiration of this Contractproduct recall.

Product Recall. If at any time (a) any governmental agency having jurisdiction provides written notice a. The Parties will cooperate in good faith to either Buyer or Supplierrespond to all customer inquiries and complaints relating to the Licensed Products and the record keeping and reporting relating thereto. Licensor will provide all reasonable assistance requested by Licensee in investigating customer complaints, incidents, or near incidents regarding the Products (b) either Buyer or Supplier have each a reasonable basis to conclude that “Customer Complaint”). In the event any Products or Deliverables contain regulatory authority seizes any Licensed Product, requests a defect which could create recall of any Licensed Product (a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal or regulatory requirement, thereby making it advisable, or required, that such Products or Deliverables be subject to corrective action including, without limitation, recall, retrofit, refund, replacement and/or repair (hereinafter “Corrective ActionRegulatory Recall”), Supplier or Buyer will otherwise notifies Licensor or Licensee of any violation or potential violation of any Applicable Law (each a “Regulatory Issue”), the first Party who received a notification from the applicable regulatory authority must promptly communicate relevant facts to each other. Buyer shall determine whether any Corrective Action involving (i) notify the affected Products or Deliverables is warranted or advisable unless notice to that effect has been received from any governmental agency having jurisdiction. If Corrective Action is required under other Party and (ii) provide the law or Buyer determines that it is advisable, Supplier shall promptly undertake Corrective Actions, including those required by other Party with a copy of any applicable consumer product safety Regulatory Recall letter or similar law equivalent written notification. In the event of a Customer Complaint or Regulatory Issue, the Parties will work together and cooperate in good faith to promptly remediate such Customer Complaint or Regulatory Issue, as applicable. Each Party shall be responsible for each such Party’s costs associated with such Customer Complaint or Regulatory Issue, provided that in the regulations thereunderevent the Customer Complaint or Regulatory Issue arises due to the actions or inaction of Licensee or matters within the responsibility of Licensee hereunder (including failure to comply with Applicable Law in the Territory), and all out of pocket costs of Licensor shall file all necessary papers, descriptions of corrective action, and other related documents and carry out the Correction Action. Buyer shall cooperate with and assist Supplier in any such filings and Corrective Action; provided, however, that nothing contained in this Section shall preclude Buyer from taking such actionbe borne by Licensee, and in such event, Supplier shall cooperate with and assist Buyer in any such filings and implementing the Corrective Action it elects event the Customer Complaint or Regulatory Issue arises due to undertake. To the extent the need for such Corrective Action is determined to have been caused by a defect, noncompliance actions or quality inaction of Licensor or performance deficiency which is matters within the responsibility of SupplierLicensor hereunder, at Buyer’s election, Supplier shall perform all necessary Corrective Action at its sole expense, or Buyer shall perform such necessary Corrective Action and Supplier shall reimburse Buyer for all reasonable out-of-direct out of pocket costs of Licensee shall be borne by Licensor. Moreover, the Parties will each provide information reasonably requested by the other Party to investigate the cause and expenses incurred by Buyer in connection therewithextent of such Customer Complaint or Regulatory Issue, as applicable. In either caseLicensee agrees to consult with Licensor on all product liability claims, Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer proceedings or actions brought against Licensor in connection with the Licensed Products and to take such action with respect to the defense of any such (voluntary claim or mandatory) Corrective Action, including without limitation, lawsuit as Licensor may reasonably request in order to protect the cost interests of locating, identifying and notifying Buyer’s customers, the cost of repairing, or where repair of the Product or Deliverables is impracticable or impossible, repurchasing or replacing the recalled Product or Deliverable, any costs of packing and shipping the recalled Product or Deliverable, Licensor and the cost of media notificationMarks or the goodwill associated with therewith, if such form of notification is necessary. The parties recognize that it is possible that other Supplier-provided products or deliverables might contain the same defect, noncompliance or quality or performance deficiency as do Products or Deliverables provided to Buyer. Buyer and Supplier agree that any Corrective Action involving Products or Deliverables provided to Buyer which shall be treated separately and distinctly from similar Corrective Action of other products or deliverables of Supplier; provided that such separate and distinct treatment is lawful and Supplier shall in no event fail to provide at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Action. Each party shall consult the other before making any statements to the public or a governmental agency relating to potential safety hazards affecting Products or Deliverables, except where such consultation would prevent timely notification required by law. The provisions of this Section 23 shall survive any termination or expiration of this ContractLicensor’s expense.

Product Recall. If at Each Party shall promptly notify the other Party in writing of any time (a) order, request or directive of a court or other governmental authority or other decision to recall or withdraw any governmental agency having jurisdiction provides written notice of the Product in any jurisdiction. In the event that either Party believes it may be necessary to either Buyer or Supplierconduct a recall, field correction, market withdrawal, stock recovery, or other similar action with respect to any Product which was sold under this Agreement (b) either Buyer or Supplier have a reasonable basis "Recall"), [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] they shall promptly consult with each other in good faith as to conclude how best to proceed, it being understood and agreed that the final decision as to any Products or Deliverables contain a defect which could create a potential safety hazard or unsafe condition, pose an unreasonable risk Recall of serious injury or death, contain a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal or regulatory requirement, thereby making it advisable, or requiredProduct shall be made by LICENSEE; provided however, that such Products or Deliverables neither Party shall be subject to corrective prohibited hereunder from taking any action including, without limitation, recall, retrofit, refund, replacement and/or repair (hereinafter “Corrective Action”), Supplier or Buyer will promptly communicate relevant facts to each other. Buyer shall determine whether any Corrective Action involving the affected Products or Deliverables is warranted or advisable unless notice to that effect has been received from any governmental agency having jurisdiction. If Corrective Action is required under the law or Buyer determines that it is advisablerequired to take by Applicable Law. Each of Nastech and LICENSEE shall make a permanent, Supplier complete and accurate record of all costs incurred by it in connection with any Product recall, a copy of which shall promptly undertake Corrective Actions, including those required by any applicable consumer product safety be delivered to the other party upon its request as soon after the completion of such recall or similar law and seizure as practically may be done. If the regulations thereunder, and shall file all necessary papers, descriptions of corrective action, and other related documents and carry out the Correction Action. Buyer shall cooperate with and assist Supplier in any such filings and Corrective Action; provided, however, that nothing contained in this Section shall preclude Buyer from taking such action, and in such event, Supplier shall cooperate with and assist Buyer in any such filings and implementing the Corrective Action it elects to undertake. To the extent the need for such Corrective Action is determined to have been caused by a defect, noncompliance or quality or performance deficiency which is the responsibility of Supplier, at Buyer’s election, Supplier shall perform all necessary Corrective Action at its sole expensecause of, or Buyer reason for, said recall is attributable to the negligence or breach of this Agreement by LICENSEE or is associated with any general recall of other products of LICENSEE, the total cost of the recall to the parties shall perform such necessary Corrective Action and Supplier be borne by LICENSEE. If the cause of, or reason for, said recall or seizure is attributable to the negligence or breach of this Agreement by Nastech or is associated with any general recall of other products of Nastech, then Nastech shall reimburse Buyer LICENSEE for all reasonable out-of-pocket costs and expenses incurred by Buyer it in connection therewitheffecting such recall or seizure. In either caseIf the reason for the Recall is not attributable to Nastech or Licensee according to the foregoing and is due to reasons beyond the reasonable control of the Parties, Supplier then the Parties shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection with any such (voluntary or mandatory) Corrective Action, including without limitation, equally share the cost of locatingsuch Recall and shall promptly reimburse each other as applicable. If Nastech and LICENSEE cannot agree which party is at fault or whether the recall was reasonably beyond the control of the parties, identifying then an independent technical expert, acceptable to both, will be designated to make the determination. The so designated technical expert shall not be an employee, consultant, officer, director or shareholder of or otherwise associated with any party or an Affiliate of any party. The technical expert's determination shall be, in the absence of fraud or manifest error, binding and notifying Buyer’s customersconclusive upon the parties. In the case of fraud or manifest error, the cost dispute resolution mechanism of repairing, or where repair of the Product or Deliverables is impracticable or impossible, repurchasing or replacing the recalled Product or Deliverable, any costs of packing and shipping the recalled Product or Deliverable, and the cost of media notification, if such form of notification is necessary. The parties recognize that it is possible that other Supplier-provided products or deliverables might contain the same defect, noncompliance or quality or performance deficiency as do Products or Deliverables provided to Buyer. Buyer and Supplier agree that any Corrective Action involving Products or Deliverables provided to Buyer Article XVII shall be treated separately and distinctly from similar Corrective Action of other products or deliverables of Supplier; provided that such separate and distinct treatment is lawful and Supplier shall in no event fail to provide at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Action. Each party shall consult the other before making any statements to the public or a governmental agency relating to potential safety hazards affecting Products or Deliverables, except where such consultation would prevent timely notification required by law. The provisions of this Section 23 shall survive any termination or expiration of this Contractapply.

Product Recall. If at any time (a) Regulatory Authority in the Territory orders or requires the recall of any governmental agency having jurisdiction provides written notice to either Buyer or SupplierProduct in the Territory, or (b) either Buyer or Supplier have if in GSK's opinion a reasonable basis to conclude that any Products or Deliverables contain a defect which could create a potential safety hazard or unsafe conditionrecall is necessary in the Territory, pose an unreasonable risk of serious injury or death, contain a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal or regulatory requirement, thereby making it advisable, or required, that such Products or Deliverables be subject to corrective action including, without limitation, recall, retrofit, refund, replacement and/or repair (hereinafter “Corrective Action”), Supplier or Buyer GSK will promptly communicate relevant facts notify ALLERGAN and provide such information regarding such recall order or other information as may be reasonably requested by ALLERGAN. GSK will, unless prohibited by Applicable Law, consult ALLERGAN on the need for a recall and take all ALLERGAN submissions into account when making a decision of whether to each otherinstigate or recall (such decision not to be unreasonably made). Buyer shall determine whether GSK will be responsible for conducting any Corrective Action involving recall in the affected Products or Deliverables is warranted or advisable unless notice Territory and ALLERGAN will co-operate with GSK by providing all such information and assistance as may be reasonably required to that effect has been received from any governmental agency having jurisdiction. If Corrective Action is required under the law or Buyer determines that it is advisable, Supplier shall promptly undertake Corrective Actions, including those required by any applicable consumer product safety or similar law and the regulations thereunder, and shall file all necessary papers, descriptions of corrective action, and other related documents and carry out the Correction Action. Buyer shall cooperate with and assist Supplier in any implement such filings and Corrective Action; provided, however, that nothing contained in this Section shall preclude Buyer from taking such action, and in such event, Supplier shall cooperate with and assist Buyer in any such filings and implementing the Corrective Action it elects to undertakerecall. To the extent that any recall of the need for Product is implemented as a result of Manufacturer's failure to Manufacture (as defined in the Supply Agreement) Product in accordance with the terms and conditions of the Supply Agreement, ALLERGAN will (a) bear all direct expenses incurred by GSK in connection with such Corrective Action is determined recall, (b) indemnify the GSK Indemnitees (as defined in Section 8.1) from any and all Liabilities (as defined in Section 8.1) incurred by the GSK Indemnitees to have been caused by a defectthe extent that these are proven to be attributable to the Manufacturer's failure to Manufacture Product in accordance with the terms and conditions of the Supply Agreement, noncompliance or quality or performance deficiency which is the responsibility of Supplierand (c) either, at Buyer’s electionGSK's sole option, Supplier shall perform replace or credit GSK for the cost of the relevant Lots (as defined in the Supply Agreement) of Product subject to the recall. If a recall is required due to any negligence or willful misconduct of a GSK Indemnitee, GSK will bear all necessary Corrective Action at its sole expense, or Buyer shall perform such necessary Corrective Action and Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer ix xxxxxxxxxx xxxx xuch recall and will indemnify the ALLERGAN Indemnitees (as defined in connection therewith. In either case, Supplier shall reimburse Buyer for Section 8.2) from and against any and all reasonable out-of-pocket costs and expenses Liabilities incurred by Buyer in connection with the ALLERGAN Indemnitees that are proven to be attributable solely to the negligence or willful misconduct of GSK. If any such (voluntary Regulatory Authority outside the Territory orders or mandatory) Corrective Action, including without limitation, requires the cost recall of locating, identifying and notifying Buyer’s customers, the cost of repairing, or where repair any of the Product Products outside the Territory then ALLERGAN will promptly notify GSK and provide such information regarding such recall order or Deliverables is impracticable or impossibleother information as may be reasonably requested by GSK. Except as set forth in Article ERROR! REFERENCE SOURCE NOT FOUND., repurchasing or replacing the each Party's sole and exclusive remedies for recalled Product or Deliverable, any costs of packing and shipping the recalled Product or Deliverable, and the cost of media notification, if such form of notification is necessary. The parties recognize that it is possible that other Supplier-provided products or deliverables might contain the same defect, noncompliance or quality or performance deficiency as do Products or Deliverables provided to Buyer. Buyer and Supplier agree that any Corrective Action involving Products or Deliverables provided to Buyer shall be treated separately and distinctly from similar Corrective Action of other products or deliverables of Supplier; provided that such separate and distinct treatment is lawful and Supplier shall in no event fail to provide at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Action. Each party shall consult the other before making any statements limited to the public or a governmental agency relating to potential safety hazards affecting Products or Deliverables, except where such consultation would prevent timely notification required by law. The provisions of remedies provided in this Section 23 shall survive any termination or expiration of this Contract5.8.

Product Recall. If at an authorized government agency of the United States shall seize any time (a) CombiPatch Product or if Novogyne in its sole judgment deems it necessary to initiate a voluntary recall of any governmental agency having jurisdiction provides written notice to either Buyer CombiPatch Product for any reason, Novogyne shall immediately notify Noven of such seizure or Supplier, or (b) either Buyer or Supplier have a reasonable basis to conclude that any Products or Deliverables contain a defect which could create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a quality or performance deficiency, or are not in recall and shall consult with Noven regarding the timely compliance with any all pertinent state or federal regulations pertaining thereto. Notification of the applicable codeGRB authorities by the Parties shall be coordinated. Furthermore, standard each Party shall make a permanent, complete and accurate record of all costs incurred by its connection therewith, a copy of which shall be delivered to the other Party as soon after the completion of such recall or legal or regulatory requirement, thereby making it advisable, or required, that such Products or Deliverables seizure as practically may be subject to corrective action including, without limitation, recall, retrofit, refund, replacement and/or repair (hereinafter “Corrective Action”), Supplier or Buyer will promptly communicate relevant facts to each other. Buyer shall determine whether any Corrective Action involving the affected Products or Deliverables is warranted or advisable unless notice to that effect has been received from any governmental agency having jurisdictiondone. If Corrective Action the cause of or reason for said recall or seizure arises from or is required under the law attributable to Noven's gross negligence or Buyer determines that it is advisablebreach of this Supply Agreement, Supplier shall promptly undertake Corrective Actions, including those required by any applicable consumer product safety or similar law and the regulations thereunder, and shall file all necessary papers, descriptions of corrective action, and other related documents and carry out the Correction Action. Buyer shall cooperate with and assist Supplier in any such filings and Corrective Action; provided, however, that nothing contained in this Section shall preclude Buyer from taking such action, and in such event, Supplier shall cooperate with and assist Buyer in any such filings and implementing the Corrective Action it elects to undertake. To the extent the need for such Corrective Action is determined to have been caused by a defect, noncompliance or quality or performance deficiency which is the responsibility of Supplier, at Buyer’s election, Supplier shall perform all necessary Corrective Action at its sole expense, or Buyer shall perform such necessary Corrective Action and Supplier Noven shall reimburse Buyer Novogyne for all reasonable out-of-pocket costs and expenses incurred by Buyer Novogyne in connection therewitheffecting such recall or seizure, including all reasonable credits extended to Novogyne's customers as a result thereof. In either caseIf the cause of or reason for said recall or seizure is directly attributable to the failure of Novogyne to properly store, Supplier transport or care for any CombiPatch Product while such CombiPatch Product was in Novogyne's possession, Novogyne shall reimburse Buyer Noven for all reasonable out-of-pocket costs and expenses incurred by Buyer Noven at Novogyne's request in connection with any effecting such (voluntary recall or mandatory) Corrective Actionseizure. If the Parties cannot agree which Party is at fault, including without limitationthen an independent technical expert, acceptable to both Parties, will be designated to make the cost of locating, identifying and notifying Buyer’s customers, the cost of repairing, or where repair of the Product or Deliverables is impracticable or impossible, repurchasing or replacing the recalled Product or Deliverable, any costs of packing and shipping the recalled Product or Deliverable, and the cost of media notification, if such form of notification is necessarydetermination. The parties recognize that it is possible that other Supplier-provided products so designated technical expert shall not be an employee, consultant, officer, director or deliverables might contain the same defect, noncompliance shareholder of or quality otherwise associated with either Party or performance deficiency as do Products or Deliverables provided to Buyer. Buyer and Supplier agree that any Corrective Action involving Products or Deliverables provided to Buyer shall be treated separately and distinctly from similar Corrective Action of other products or deliverables of Supplier; provided that such separate and distinct treatment is lawful and Supplier shall in no event fail to provide at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Action. Each party shall consult the other before making any statements to the public or a governmental agency relating to potential safety hazards affecting Products or Deliverables, except where such consultation would prevent timely notification required by lawan Affiliate. The provisions technical expert's determination shall be, in the absence of this Section 23 shall survive any termination fraud or expiration of this Contractmanifest error, binding and conclusive upon both Parties.

Product Recall. If at (i) Purchaser shall have responsibility after Closing for the management of all proceedings relating to product recalls for Business Products sold by the Business prior to the Closing, and all costs, Liabilities and expenses relating to any time such product recall shall be the sole responsibility of Seller (athe “Product Recall Liabilities”). In the event that after the Closing Date, Purchaser (A) any governmental agency having jurisdiction provides written receives notice with respect to either Buyer a product recall relating to Business Products manufactured or Supplier, sold by the Business prior to the Closing Date or (bB) either Buyer or Supplier have a determines in Purchaser’s reasonable basis to conclude that any Products or Deliverables contain a defect which could create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal or regulatory requirement, thereby making it advisable, or required, that such Products or Deliverables be subject to corrective action including, without limitation, recall, retrofit, refund, replacement and/or repair (hereinafter “Corrective Action”), Supplier or Buyer will promptly communicate relevant facts to each other. Buyer shall determine whether any Corrective Action involving the affected Products or Deliverables is warranted or advisable unless notice to that effect has been received from any governmental agency having jurisdiction. If Corrective Action is required under the law or Buyer determines business judgment that it is advisable, Supplier or is required by a notice from a Governmental Authority, to undertake a recall of any Business Products manufactured or sold by the Business prior to the Closing Date, then, in each case, Purchaser shall promptly undertake Corrective Actions(1) notify Seller of such circumstance within 20 Business Days of the receipt of such notice or the date of such determination, as applicable, and (2) not enter into any agreement with any claimants with respect to such product recall or with a Governmental Authority, without first permitting Seller the reasonable opportunity to review and comment on such agreement or proposed recall. In connection therewith, Purchaser shall provide Seller with reasonable access in a manner that shall not unduly interfere with Purchaser’s operations of the Business to Purchaser’s employees who would be in a position to evaluate the merits of any product recall. Such employees will assist Seller and Purchaser shall consider Seller’s comments in good faith in deciding whether to enter into an agreement with any claimant, including those required any Governmental Authority. If Seller does not respond within 15 Business Days after receipt of notice thereof, such claims shall be considered to be approved by any applicable consumer product safety or similar law and the regulations thereunder, and shall file all necessary papers, descriptions Seller for purposes of corrective action, and other related documents and carry out the Correction Action. Buyer shall cooperate with and assist Supplier in any such filings and Corrective Action; provided, however, that nothing contained in this Section 2.02. No delay or failure to give such notice by Purchaser to Seller shall preclude Buyer from taking such actionadversely affect any of the rights or remedies that Purchaser has under this Agreement, and in such event, Supplier shall cooperate with and assist Buyer in any such filings and implementing the Corrective Action it elects or alter or relieve Seller of its obligations to undertake. To indemnify Purchaser except to the extent that such delay or failure has materially prejudiced Seller. Purchaser shall undertake or honor, as applicable, with respect to the need for such Corrective Action is determined Business Products manufactured or sold prior to have been caused by a defectthe Closing Date, noncompliance or quality or performance deficiency which is the responsibility of Supplier, at Buyer’s election, Supplier shall perform all necessary Corrective Action at its sole expense, or Buyer shall perform such necessary Corrective Action and Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer Warranty Claims (in connection therewith. In either each case, Supplier shall reimburse Buyer for all reasonable out-of-pocket costs not involving product recall, death, personal injury, other injury to persons or damage to property) in substantially the same manner as undertaken, processed, approved and expenses incurred performed, as the case may be, by Buyer Seller and its Affiliates in connection with any such (voluntary or mandatory) Corrective Action, including without limitation, the cost of locating, identifying and notifying Buyer’s customers, the cost of repairing, or where repair of the Product or Deliverables is impracticable or impossible, repurchasing or replacing the recalled Product or Deliverable, any costs of packing and shipping the recalled Product or Deliverable, and the cost of media notification, if such form of notification is necessary. The parties recognize that it is possible that other Supplier-provided products or deliverables might contain the same defect, noncompliance or quality or performance deficiency as do Products or Deliverables provided to Buyer. Buyer and Supplier agree that any Corrective Action involving Products or Deliverables provided to Buyer shall be treated separately and distinctly from similar Corrective Action of other products or deliverables of Supplier; provided that such separate and distinct treatment is lawful and Supplier shall in no event fail to provide at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Action. Each party shall consult the other before making any statements Business prior to the public or a governmental agency relating to potential safety hazards affecting Products or Deliverables, except where such consultation would prevent timely notification required by law. The provisions of this Section 23 shall survive any termination or expiration of this ContractClosing Date.

Product Recall. If there is a recall of any of the Products, any of its ingredients and components or any product incorporating the Products ("Recalled Product"), the Supplier shall provide reasonable assistance to Unilever in developing a recall strategy and shall cooperate with Unilever and the Buyers and any applicable governmental agency, entity or authority (“Governmental Body”) in monitoring the recall operation and in preparing such reports as may be required. No Supplier shall voluntarily initiate any recall of Products (or any product incorporating the Products) without the prior written consent of Unilever not to be unreasonably withhold. Each Supplier shall, at the request of Unilever or any time Buyer give Unilever and each Buyer all reasonable assistance in locating and recovering any Products or Recalled Products that are not in accordance with the requirements of the Contract. Each Supplier shall immediately notify and provide copies to Unilever of any communications, whether relating to recalls or otherwise, with any Governmental Body. The Supplier, at its own cost, shall rework or destroy all Recalled Products that are defective on delivery to the relevant Buyers in compliance with all applicable laws, rules or regulations and Unilever's reasonable instructions. The Supplier will not disclose or make available to any third party any information related to the recall. 12 Confidentiality Unilever, the Buyers and Unilever Group companies (“Discloser”) will disclose or make available to each Supplier, before and after the date of adoption of the Contract and any UPC, information about or relating to its products, the ingredients and components of the Materials, the Buyer’s use of the Products, Specifications, business ideas, processes and strategies, marketing information and other information relating to its business (“Confidential Information”). Each Supplier undertakes (a) any governmental agency having jurisdiction provides written notice to either Buyer or Supplier, or keep all Confidential Information strictly confidential and (b) either Buyer or Supplier have a reasonable basis not to conclude that use any Products or Deliverables contain a defect which could create a potential safety hazard or unsafe condition, pose an unreasonable risk Confidential Information for any purpose other than in complying with its obligations under the Contract and (c) not to disclose any Confidential Information to any person other than its officers and employees except to the extent it is necessary for the purpose of serious injury or death, contain a quality or performance deficiency, or are performing its obligations under the Contract. The aforementioned shall not apply to the extent it is information in compliance with any applicable code, standard or legal or regulatory requirement, thereby making it advisable, or required, that such Products or Deliverables be subject to corrective action including, without limitation, recall, retrofit, refund, replacement and/or repair (hereinafter “Corrective Action”), the public domain through no fault of the Supplier or Buyer will promptly communicate relevant facts to each other. Buyer shall determine whether any Corrective Action involving the affected Products or Deliverables is warranted or advisable unless notice to that effect has been received from any governmental agency having jurisdiction. If Corrective Action it is required under the law or Buyer determines that to disclose it is advisable, Supplier shall promptly undertake Corrective Actions, including those required by any applicable consumer product safety or similar law and the regulations thereunder, and shall file all necessary papers, descriptions of corrective action, and other related documents and carry out the Correction Action. Buyer shall cooperate with and assist Supplier in any such filings and Corrective Action; provided, however, that nothing contained in this Section shall preclude Buyer from taking such action, and in such event, Supplier shall cooperate with and assist Buyer in any such filings and implementing the Corrective Action it elects to undertake. To the extent the need for such Corrective Action is determined to have been caused by a defect, noncompliance or quality or performance deficiency which is the responsibility of Supplier, at Buyer’s election, Supplier shall perform all necessary Corrective Action at its sole expense, or Buyer shall perform such necessary Corrective Action and Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection therewith. In either case, Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection with any such (voluntary or mandatory) Corrective Action, including without limitation, the cost of locating, identifying and notifying Buyer’s customers, the cost of repairing, or where repair of the Product or Deliverables is impracticable or impossible, repurchasing or replacing the recalled Product or Deliverable, any costs of packing and shipping the recalled Product or Deliverable, and the cost of media notification, if such form of notification is necessary. The parties recognize that it is possible that other Supplier-provided products or deliverables might contain the same defect, noncompliance or quality or performance deficiency as do Products or Deliverables provided to Buyer. Buyer and Supplier agree that any Corrective Action involving Products or Deliverables provided to Buyer shall be treated separately and distinctly from similar Corrective Action of other products or deliverables of Supplier; provided that such separate and distinct treatment is lawful and Supplier shall in no event fail to provide at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Action. Each party shall consult the other before making any statements to the public or a governmental agency relating to potential safety hazards affecting Products or Deliverables, except where such consultation would prevent timely notification required by law. The provisions Each Supplier shall be responsible for all breaches of this Section 23 Condition by its officers and employees. All Confidential Information shall be returned to the Discloser or destroyed at its discretion. The obligations of confidentiality set out in the Contract shall survive any termination the application of the Contract in whole or expiration of this Contractin part.

Product Recall. If at any time (a) any governmental agency or regulatory authority having jurisdiction provides written notice to either Buyer or Supplier, or (b) either Buyer or Supplier have a reasonable basis to conclude that any Products or Deliverables contain a defect which could create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal or regulatory requirement, thereby making it advisable, or required, that such Products or Deliverables be subject to corrective action including, without limitation, recall, retrofit, refund, replacement and/or repair (hereinafter “Corrective Action”), Supplier or Buyer will promptly communicate relevant facts to each other. Buyer shall determine whether any Corrective Action involving the affected Products or Deliverables is warranted or advisable unless notice to that effect has been received from any governmental agency having jurisdiction. If Corrective Action is required under the law or Buyer determines that it is advisable, Supplier shall promptly undertake Corrective Actions, including those required by any applicable consumer product safety or similar law and the regulations thereunder, and shall file all necessary papers, descriptions of corrective action, and other related documents and carry out the Correction Action. Buyer shall cooperate with and assist Supplier in any such filings and Corrective Action; provided, however, that nothing contained in this Section shall preclude Buyer from taking such action, and in such event, Supplier shall cooperate with and assist Buyer in any such filings and implementing the Corrective Action it elects to undertake. To the extent the need for such Corrective Action is determined to have been caused by a defect, noncompliance or quality or performance deficiency which is the responsibility of Supplier, at Buyer’s election, Supplier shall perform all necessary Corrective Action at its sole expense, or Buyer shall perform such necessary Corrective Action and Supplier shall reimburse Buyer for all reasonable out-of-of- pocket costs and expenses incurred by Buyer in connection therewith. In either case, Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection with any such (voluntary or mandatory) Corrective Action, including without limitation, the cost of locating, identifying and notifying Buyer’s customers, the cost of repairing, or where repair of the Product or Deliverables is impracticable or impossible, repurchasing or replacing the recalled Product or Deliverable, any costs of packing and shipping the recalled Product or Deliverable, and the cost of media notification, if such form of notification is necessary. The parties recognize that it is possible that other Supplier-provided products or deliverables might contain the same defect, noncompliance or quality or performance deficiency as do Products or Deliverables provided to Buyer. Buyer and Supplier agree that any Corrective Action involving Products or Deliverables provided to Buyer shall be treated separately and distinctly from similar Corrective Action of other products or deliverables of Supplier; provided that such separate and distinct treatment is lawful and Supplier shall in no event fail to provide at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Action. Each party shall consult the other before making any statements to the public or a governmental agency relating to potential safety hazards affecting Products or Deliverables, except where such consultation would prevent timely notification required by law. The provisions of this Section 23 shall survive any termination or expiration of this Contract.

Product Recall. If at any time (a) any governmental agency having jurisdiction provides written notice to either Buyer or Supplier, or (b) either Buyer or Supplier have a reasonable basis to conclude that any Products or Deliverables contain a defect which could create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal or regulatory requirement, thereby making it advisable, or required, that such Products or Deliverables be subject to corrective action including, without limitation, product recall, retrofit, refund, replacement and/or repair (hereinafter “Corrective Action”), Supplier or Buyer will promptly communicate relevant facts to each other. Buyer shall determine whether any Corrective Action involving the affected Products or Deliverables is warranted or advisable unless notice to that effect has been received from any governmental agency having jurisdiction. If Corrective Action is required under the law or Buyer determines that it is advisable, Supplier shall promptly undertake Corrective Actions, including those required by any applicable consumer product safety or similar law and the regulations thereunder, and shall file all necessary papers, descriptions of corrective action, and other related documents and carry out the Correction Action. Buyer shall cooperate with and assist Supplier in any such filings and Corrective Action; provided, however, that nothing contained in this Section shall preclude Buyer from taking such action, and in such event, Supplier shall cooperate with and assist Buyer in any such filings and implementing the Corrective Action it elects to undertake. To the extent the need for such Corrective Action is determined to have been caused by a defect, noncompliance or quality or performance deficiency which is the responsibility of Supplier, at Buyer’s election, Supplier shall perform all necessary Corrective Action at its sole expense, or Buyer shall perform such necessary Corrective Action and Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection therewith. In either case, Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection with any such (voluntary or mandatory) Corrective Action, including without limitation, the cost of locating, identifying and notifying Buyer’s customers, the cost of repairing, or where repair of the Product or Deliverables is impracticable or impossible, repurchasing or replacing the recalled Product or DeliverableProduct, any costs of packing and shipping the recalled Product or DeliverableProduct, and the cost of media notification, if such form of notification is necessary. The parties recognize that it is possible that other Supplier-provided manufactured products or deliverables might contain the same defect, noncompliance or quality or performance deficiency as do Products or Deliverables provided to manufactured for Buyer. Buyer and Supplier agree that any Corrective Action involving Products or Deliverables provided to for Buyer shall be treated separately and distinctly from similar Corrective Action of other products or deliverables of Supplier; provided that such separate and distinct treatment is lawful and Supplier shall in no event fail to provide at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Action. Each party shall consult the other before making any statements to the public or a governmental agency relating to potential safety hazards affecting Products or DeliverablesProducts, except where such consultation would prevent timely notification required by law. The provisions of this Section 23 shall survive any termination or expiration of this Contract.

Product Recall. If at any time (aPetSmart will have the sole right to negotiate and enter into a settlement(s) with any governmental agency having jurisdiction provides or official with respect to any potential fine, penalty, issue, or liability related to a Non-Conforming Product or any allegation that the Product fails to comply with Applicable Laws or industry standards. Vendor may request that any Non-Conforming Products be returned to Vendor for examination at Vendor's sole cost and expense. Such return by PetSmart will not be deemed a waiver of any right or remedy that PetSmart may have as a result of or in connection with such Non-Conforming Products. Vendor shall not sell or otherwise dispose of the any such Non- Conforming Products or parts and components without the written consent of PetSmart. Vendor shall immediately give PetSmart written notice of (i) all quality control test results and data for any Product that do not satisfy the PetSmart Requirements; (ii) any known or suspected deviation in standard manufacturing processes that results in a Non-Conforming Product; (iii) any Product that fails or is alleged to either Buyer or Supplierhave failed to comply with any consumer product safety requirement contained in the specifications, industry standards, or standards promulgated by a governmental agency or Applicable Laws; or (biv) either Buyer any defect, issue or Supplier have design regarding a reasonable basis to conclude Product that any Products or Deliverables contain a defect which could create a potential risk of injury to an individual or animal. If Vendor receives notice of a recall, harmful ingredients, or defects in the Product, Vendor shall notify PetSmart immediately. Vendor shall promptly furnish to PetSmart all documentation, information and data regarding the Product necessary or helpful to PetSmart, as determined in PetSmart’s sole discretion, to aid PetSmart to comply with its legal obligations or to mitigate any safety hazard posed by a Product. If PetSmart is required or chooses, in its sole discretion, to recall, give public notice of hazard or defect associated with, withdraw from its proposed chain of resale, remove from its shelves, return to Vendor, or otherwise dispose of or render unusable (a "Recall") any Product purchased from Vendor for any reason, and whether or not such Product otherwise complies with the PetSmart Requirements, Vendor will reimburse PetSmart for all amounts paid or incurred by it in connection with such Recall within thirty (30) Business Days after receipt of PetSmart's invoice. In addition to any other right provided in this Agreement or by law, PetSmart may, at its sole discretion, immediately cancel any or all P.O.s, suspend all deliveries of Products, or terminate this Agreement if: (i) Vendor fails to promptly begin remedying an alleged non-compliance, risk or defect of the types referred to above; (ii) a governmental agency concludes that any Product fails to comply with any consumer product safety laws, requirements, rules, specifications, or standards in any jurisdiction where the Products are sold; or (iii) Vendor fails to promptly and fully cooperate with PetSmart in the investigation of any product safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal or regulatory requirement, thereby making it advisable, or required, that such Products or Deliverables be subject to corrective action including, without limitation, recall, retrofit, refund, replacement and/or repair (hereinafter “Corrective Action”), Supplier or Buyer will promptly communicate relevant facts to each other. Buyer shall determine whether any Corrective Action involving the affected Products or Deliverables is warranted or advisable unless notice to that effect has been received from any governmental agency having jurisdiction. If Corrective Action is required under the law or Buyer determines that it is advisable, Supplier shall promptly undertake Corrective Actions, including those required by any applicable consumer product safety or similar law and the regulations thereunder, and shall file all necessary papers, descriptions of corrective action, and other related documents and carry out the Correction Action. Buyer shall cooperate with and assist Supplier in any such filings and Corrective Action; provided, however, that nothing contained in this Section shall preclude Buyer from taking such action, and in such event, Supplier shall cooperate with and assist Buyer in any such filings and implementing the Corrective Action it elects to undertake. To the extent the need for such Corrective Action is determined to have been caused by a defect, noncompliance or quality or performance deficiency which is the responsibility of Supplier, at Buyer’s election, Supplier shall perform all necessary Corrective Action at its sole expense, or Buyer shall perform such necessary Corrective Action and Supplier shall reimburse Buyer for all reasonable outNon-of-pocket costs and expenses incurred by Buyer in connection therewith. In either case, Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection with any such (voluntary or mandatory) Corrective Action, including without limitation, the cost of locating, identifying and notifying Buyer’s customers, the cost of repairing, or where repair of the Product or Deliverables is impracticable or impossible, repurchasing or replacing the recalled Product or Deliverable, any costs of packing and shipping the recalled Product or Deliverable, and the cost of media notification, if such form of notification is necessary. The parties recognize that it is possible that other Supplier-provided products or deliverables might contain the same defect, noncompliance or quality or performance deficiency as do Products or Deliverables provided to Buyer. Buyer and Supplier agree that any Corrective Action involving Products or Deliverables provided to Buyer shall be treated separately and distinctly from similar Corrective Action of other products or deliverables of Supplier; provided that such separate and distinct treatment is lawful and Supplier shall in no event fail to provide at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Action. Each party shall consult the other before making any statements to the public or a governmental agency relating to potential safety hazards affecting Products or Deliverables, except where such consultation would prevent timely notification required by law. The provisions of this Section 23 shall survive any termination or expiration of this ContractConforming Product.

Product Recall. If at any time (a) any governmental agency having jurisdiction provides written notice to either Buyer or Supplier, or (b) either Buyer or Supplier have a reasonable basis to conclude that any Products or Deliverables contain a defect which could create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal or regulatory requirement, thereby making it advisable, or required, that such Products or Deliverables be subject to corrective action including, without limitation, product recall, retrofit, refund, replacement and/or repair (hereinafter “Corrective Action”"corrective action"), Supplier or Buyer will promptly communicate relevant facts to each other. Buyer shall determine whether any Corrective Action corrective action involving the affected Products or Deliverables is warranted or advisable unless notice to that effect has been received from any governmental agency having jurisdiction. If Corrective Action corrective action is required under the law or Buyer determines that it is advisable, Supplier shall promptly undertake Corrective Actionscorrective actions, including those required by any applicable consumer product safety or similar law and the regulations thereunder, and shall file all necessary papers, descriptions of corrective action, and other related documents and carry out the Correction Actioncorrection action. Buyer shall cooperate with and assist Supplier in any such filings and Corrective Actioncorrective action; provided, however, that nothing contained in this Section shall preclude Buyer from taking such action, and in such event, Supplier shall cooperate with and assist Buyer in any such filings and implementing the Corrective Action corrective action it elects to undertake. To the extent the need for such Corrective Action corrective action is determined to have been caused by a defect, noncompliance or quality or performance deficiency which is the responsibility of Supplier, at Buyer’s election, Supplier shall perform all necessary Corrective Action corrective action at its sole expense, or Buyer shall perform such necessary Corrective Action corrective action and Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection therewith. In either case, Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection with any such (voluntary or mandatory) Corrective Actioncorrective action, including without limitation, the cost of locating, identifying and notifying Buyer’s customers, the cost of repairing, or where repair of the Product or Deliverables is impracticable or impossible, repurchasing or replacing the recalled Product or DeliverableProduct, any costs of packing and shipping the recalled Product or DeliverableProduct, and the cost of media notification, if such form of notification is necessary. The parties recognize that it is possible that other Supplier-provided manufactured products or deliverables might contain the same defect, noncompliance or quality or performance deficiency as do Products or Deliverables provided to manufactured for Buyer. Buyer and Supplier agree that any Corrective Action corrective action involving Products or Deliverables provided to for Buyer shall be treated separately and distinctly from similar Corrective Action corrective action of other products or deliverables of Supplier; provided that such separate and distinct treatment is lawful and Supplier shall in no event fail to provide at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Actioncorrective action. Each party shall consult the other before making any statements to the public or a governmental agency relating to potential safety hazards affecting Products or DeliverablesProducts, except where such consultation would prevent timely notification required by law. The provisions of this Section 23 shall survive any termination or expiration of this Contract.

Product Recall. If at In the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or other removal of the Product, or any time lot or lots thereof, from the market outside or within the Territory, such Party shall advise the other Party and the Parties shall consult with respect thereto. In the event that, within the Territory, (a) any governmental agency having jurisdiction provides written notice to either Buyer government authority issues a request, directive or Supplierorder that the Product be recalled, or (b) either Buyer or Supplier have a reasonable basis to conclude that any Products or Deliverables contain court of competent jurisdiction orders such a defect which could create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a quality or performance deficiencyrecall, or are not in compliance (c) Otsuka and ISTA, after consultation with any applicable codeeach other, standard or legal or regulatory requirement, thereby making it advisabledetermine that the Product should be recalled, or required(d) either Otsuka or ISTA is otherwise legally required to make such recall, that the Parties shall take all appropriate corrective actions, and shall cooperate in the investigations surrounding the recall. No action under this Section 9.3 is intended to either interfere with or impede the legal obligations of the holder of the relevant regulatory approval. The holder of the relevant regulatory approval shall handle (i) all communications and requests with regulatory agencies regarding any recalls, and (ii) notification of customers and return of Product from customers. Except as provided below, if a Product (or any lot or lots thereof) is recalled or otherwise removed from the market, the costs and expenses of such Products recall or Deliverables removal shall be subject to corrective action includingborne by Otsuka except as set forth below. For the purpose of this Agreement, the expenses of recall shall include, without limitation, recallthe expenses of notification and destruction or return of the recalled Product, retrofitcost for the Product recalled, refundlegal expenses, replacement and/or repair (hereinafter “Corrective Action”)inventory write-offs and penalties resulting from Third Party contracts, Supplier but shall not include goodwill, lost profits or Buyer will promptly communicate relevant facts to each otherother similar intangible or speculative claims. Buyer shall determine whether any Corrective Action involving the affected Products or Deliverables is warranted or advisable unless notice to that effect has been received If such recall results from any governmental agency having jurisdictioncause or event arising from a sole responsibility of ISTA as set forth in this Agreement or is solely attributable to ISTA, ISTA shall be responsible for all expenses of the recall and Otsuka may deduct any such expenses borne by Otsuka from any payment due to ISTA under this Agreement. If Corrective Action such recall results from a sole responsibility of Otsuka as set forth in this Agreement or is required under solely attributable to Otsuka, Otsuka shall be responsible for the law or Buyer determines that it is advisable, Supplier shall promptly undertake Corrective Actions, including those required by any applicable consumer product safety or similar law and the regulations thereunder, expenses of recall and shall file all necessary papers, descriptions of corrective action, and other related documents and carry out the Correction Action. Buyer shall cooperate with and assist Supplier in any such filings and Corrective Action; provided, however, that nothing contained in this Section shall preclude Buyer from taking such action, and in such event, Supplier shall cooperate with and assist Buyer in any such filings and implementing the Corrective Action it elects to undertake. To the extent the need reimburse ISTA for such Corrective Action is determined to have been caused by a defect, noncompliance or quality or performance deficiency which is the responsibility of Supplier, at Buyer’s election, Supplier shall perform all necessary Corrective Action at its sole expense, or Buyer shall perform such necessary Corrective Action and Supplier shall reimburse Buyer for all reasonable out-of-pocket costs and expenses incurred by Buyer in connection therewithISTA 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 Otsuka, ISTA and Otsuka shall be jointly responsible for expenses of the recall in proportion to each such Party's proximate fault with respect to the recall. 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 16.2. This Section 9.3 shall not limit any rights either case, Supplier shall reimburse Buyer for all reasonable out-of-pocket costs Party may have pursuant to Section 4.1.2 and expenses incurred by Buyer in connection with any such (voluntary or mandatory) Corrective Action, including without limitation, the cost Articles 10 and 13 of locating, identifying and notifying Buyer’s customers, the cost of repairingthis Agreement, or where repair of the Product or Deliverables is impracticable or impossible, repurchasing or replacing the recalled Product or Deliverable, any costs of packing and shipping the recalled Product or Deliverable, and the cost of media notification, if such form of notification is necessary. The parties recognize that it is possible that other Supplier-provided products or deliverables might contain the same defect, noncompliance or quality or performance deficiency as do Products or Deliverables provided to Buyer. Buyer and Supplier agree that any Corrective Action involving Products or Deliverables provided to Buyer shall be treated separately and distinctly from similar Corrective Action of other products or deliverables of Supplier; provided that such separate and distinct treatment is lawful and Supplier shall in no event fail to provide at least the same protection to Buyer on such Products or Deliverables as Supplier provides to its other customers in connection with similar Corrective Action. Each party shall consult the other before making any statements rights either Party may have pursuant to the public or a governmental agency relating to potential safety hazards affecting Products or Deliverables, except where such consultation would prevent timely notification required by law. The provisions of this Section 23 shall survive any termination or expiration of this ContractSupply Agreement.