Common use of Product Recalls Clause in Contracts

Product Recalls. (a) If, in the judgment of Supplier or BioForm, any Company Product defect or any government action requires a recall of, or the issuance of an advisory letter regarding, any Company Product, either party may undertake such recall or issue such advisory letter after consultation with the other party. Each party shall notify the other party in a timely manner prior to making any recall or issuing any advisory letter. The parties shall endeavor to reach an agreement prior to making any recall or issuing any advisory letter regarding the manner, text, and timing of any publicity to be given such matters in time to comply with any applicable legal or regulatory requirements, but such agreement will not be a precondition to any action that either party deems necessary to protect users of Company Product or to comply with any applicable governmental orders, regulations, or mandates. The parties agree to provide reasonable assistance to one another in the event of any recall or issuance of any advisory letter. BioForm shall have the right to manage any recall within the Territory so long as such management does not prevent Supplier from exercising its rights under this Section 6.10. (b) In the event of a recall of Company Product, Supplier shall correct noted deficiencies relating to its manufacture, packaging, testing, labeling, and Supplier’s storing or handling of Company Product (“Process Related Recalls”), if applicable, or cause the vendor of any material, component, or sub-assembly incorporated into such Company Product to do likewise with respect to such material, component, or sub-assembly and BioForm shall correct noted deficiencies related to matters for which it is responsible. For Process Related Recalls, Supplier shall, at BioForm’s option, either, at its cost replace each unit of the Company Product recalled (including units held in inventory by BioForm or its customers) with a corrected Company Product within a reasonable period of time, or refund the purchase price therefor. Supplier shall promptly pay or reimburse BioForm for all costs and expenses (including shipping, quality control testing, notification, and restocking costs) incurred by BioForm as a result of any recall or advisory letter (unless resulting from a deficiency caused by BioForm, in which case BioForm will reimburse Supplier for Supplier’s costs and expenses associated with such recall).

Product Recalls. Decisions with respect to recalls, withdrawals or other corrective actions (“Recall”) with respect to any Collaboration Product related to manufacturing or product quality issues shall be handled in accordance with the Commercial Supply Agreement. Decisions with respect to any other Recall related to any Collaboration Product in the Profit Sharing Territory or Royalty Product in its applicable territory shall be made only upon mutual agreement of the Parties; provided, however, that nothing herein shall prohibit either Party from initiating or conducting any Recall (i) mandated by a regulatory authority or applicable law, (ii) which in its reasonable judgment is, or such Party reasonably believes will result in, a Class I or Class II recall (under U.S. Food and Drug Administration regulations or its equivalent outside of the U.S.) or (iii) if a Party is the Independent Development Party in its sole discretion. The Parties shall cooperate with respect to any actions taken or public statements made in connection with any such Recall. Except as otherwise provided in this Section 6.10, the Parties will share all costs of a Recall with respect to any Collaboration Product in the Profit Sharing Territory as a Shared Promotion Expense. *Certain information on this page has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portions. An Independent Development Party shall bear all costs of a Recall with respect to any Royalty Product in the Royalty Territory. Notwithstanding the foregoing, a Party shall bear any and all costs of a recall, market withdrawal or other corrective action with respect to a Collaboration Product in the Territory, including the COGM for the Collaboration Product in question, to the extent the Recall is attributable to the fault of such Party and results from (a) Ifa grossly negligent or reckless act or omission or intentional misconduct of such Party (or its Affiliate, in the judgment of Supplier agent or BioFormsublicensee), any Company Product defect or any government action requires a recall of, or the issuance of an advisory letter regarding, any Company Product, either party may undertake such recall or issue such advisory letter after consultation with the other party. Each party shall notify the other party in a timely manner prior to making any recall or issuing any advisory letter. The parties shall endeavor to reach an agreement prior to making any recall or issuing any advisory letter regarding the manner, text, and timing of any publicity to be given such matters in time to comply with any applicable legal or regulatory requirements, but such agreement will not be a precondition to any action that either party deems necessary to protect users of Company Product or to comply with any applicable governmental orders, regulations, or mandates. The parties agree to provide reasonable assistance to one another in the event of any recall or issuance of any advisory letter. BioForm shall have the right to manage any recall within the Territory so long as such management does not prevent Supplier from exercising its rights under this Section 6.10. (b) In the event failure of a recall of Company Productthe Manufacturing Party to perform its responsibilities and Manufacture the Collaboration Product in compliance with specifications or with applicable laws, Supplier shall correct noted deficiencies relating to its manufacture, packaging, testing, labeling, and Supplier’s storing or handling of Company Product (“Process Related Recalls”), if applicableincluding applicable Good Manufacturing Practices, or cause the vendor (c) a breach of any material, component, laws or sub-assembly incorporated into such Company Product to do likewise with respect to such material, component, or sub-assembly and BioForm shall correct noted deficiencies related to matters for which it is responsible. For Process Related Recalls, Supplier shall, at BioForm’s option, either, at its cost replace each unit the terms of the Company Product recalled (including units held in inventory by BioForm or its customers) with a corrected Company Product within a reasonable period of time, or refund the purchase price therefor. Supplier shall promptly pay or reimburse BioForm for all costs and expenses (including shipping, quality control testing, notification, and restocking costs) incurred by BioForm as a result of any recall or advisory letter (unless resulting from a deficiency caused by BioForm, in which case BioForm will reimburse Supplier for Supplier’s costs and expenses associated with such recall)this Agreement.

Product Recalls. Decisions with respect to recalls, withdrawals or other corrective actions (“Recall”) with respect to any Collaboration Product related to manufacturing or product quality issues shall be handled in accordance with the Commercial Supply [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Agreement. Decisions with respect to any other Recall related to any Collaboration Product shall be made only upon mutual agreement of the Parties; provided, however, that nothing herein shall [ * ] Party [ * ] or [ * ] any [ * ] (i) [ * ] by a [ * ] or [ * ] or (ii) which in [ * ] is, or such Party [ * ] will [ * ], a [ * ] or [ * ] (under [ * ], or [ * ] of the [ * ]). The Parties shall cooperate with respect to any actions taken or public statements made in connection with any such Recall. Except as otherwise provided in this Section 5.10, the Parties will share all costs of a Recall with respect to any Collaboration Product as Sales and Marketing Costs. Notwithstanding the foregoing, a Party shall bear any and all costs of a Recall, market withdrawal or other corrective action with respect to a Collaboration Product in the Territory, including the Manufacturing Costs for the Collaboration Product in question, to the extent the Recall is attributable to the fault of such Party and results from (a) Ifa grossly negligent or reckless act or omission or intentional misconduct of such Party (or its Affiliate, in the judgment of Supplier agent or BioFormpermitted sublicensee), any Company Product defect or any government action requires a recall of, or the issuance of an advisory letter regarding, any Company Product, either party may undertake such recall or issue such advisory letter after consultation with the other party. Each party shall notify the other party in a timely manner prior to making any recall or issuing any advisory letter. The parties shall endeavor to reach an agreement prior to making any recall or issuing any advisory letter regarding the manner, text, and timing of any publicity to be given such matters in time to comply with any applicable legal or regulatory requirements, but such agreement will not be a precondition to any action that either party deems necessary to protect users of Company Product or to comply with any applicable governmental orders, regulations, or mandates. The parties agree to provide reasonable assistance to one another in the event of any recall or issuance of any advisory letter. BioForm shall have the right to manage any recall within the Territory so long as such management does not prevent Supplier from exercising its rights under this Section 6.10. (b) In in the event case such Party is the Lead Manufacturing Party, the failure of the Lead Manufacturing Party or its Affiliate, agent or sublicensee to perform its responsibilities and Manufacture the Collaboration Product in compliance with the specifications (as set forth in the Commercial Supply Agreement), or with applicable Laws, including applicable Good Manufacturing Practices, (c) any defect or condition introduced by a recall Party, its Affiliates or permitted sublicensees following delivery of Company Productthe Collaboration Product from the Lead Manufacturing Party or its contract manufacturer, Supplier shall correct noted deficiencies relating to into a Collaboration Product or its manufacture, packaging, testing, packaging or labeling, and Supplier’s storing or handling of Company Product (“Process Related Recalls”), if applicable, or cause the vendor d) a breach of any material, component, Laws or sub-assembly incorporated into the terms of this Agreement by such Company Product to do likewise with respect to such material, component, or sub-assembly and BioForm shall correct noted deficiencies related to matters for which it is responsible. For Process Related Recalls, Supplier shall, at BioForm’s option, either, at its cost replace each unit of the Company Product recalled (including units held in inventory by BioForm or its customers) with a corrected Company Product within a reasonable period of time, or refund the purchase price therefor. Supplier shall promptly pay or reimburse BioForm for all costs and expenses (including shipping, quality control testing, notification, and restocking costs) incurred by BioForm as a result of any recall or advisory letter (unless resulting from a deficiency caused by BioForm, in which case BioForm will reimburse Supplier for Supplier’s costs and expenses associated with such recall)Party.

Product Recalls. (a) If, in the judgment of Supplier Seller or BioFormBuyer, any Company Product defect or any government action requires a recall of, or the issuance of an advisory letter regarding, any Company Product, either party may Party shall undertake such recall or issue such advisory letter only after notification to and consultation with the other partyParty. Each party Party shall notify the other party Party within ** ** of becoming aware (as such phrase is defined in 21 CFR 803) of any issue that could lead to a timely manner prior field action related to making any recall or issuing any advisory letterthe Products. The parties Parties shall endeavor to reach an agreement prior to making any recall or issuing any advisory letter regarding the manner, text, text and timing of any publicity to be given in such matters in time to comply with any applicable legal or regulatory requirements, but such agreement will not be a precondition to any action that either party Party deems necessary to protect users of Company Product Products or to comply with any applicable governmental orders, regulations, orders or mandates. The parties Parties agree to provide reasonable assistance to one another in the event of any recall or issuance of any advisory letter. BioForm Notwithstanding anything in this Agreement to the contrary, Buyer shall have the right to manage any recall within the Territory so long as such management does not prevent Supplier from exercising its rights under this Section 6.10Product recall. (b) In the event of a recall of Company Product, Supplier Seller shall correct noted deficiencies any deficiency relating to its manufacturemanufacturing, packaging, testing, labeling, and Supplier’s storing or handling of Company Product (“Process Related Recalls”)Product, if applicable, or cause the vendor of any material, component, or sub-assembly incorporated into such Company Product to do likewise with respect to such material, component, or sub-assembly assembly, and BioForm shall correct noted deficiencies related to matters for which it is responsible. For Process Related Recalls, Supplier shall, at BioFormSeller’s option, either, either (i) at its cost replace each unit of the Company Product recalled (including units held in inventory by BioForm Buyer or its customers) with a corrected Company Product within a reasonable period of time, or (ii) refund the Buyer’s purchase price thereforthereof. Supplier Seller shall promptly pay or reimburse BioForm Buyer for all its costs and expenses (including i.e., shipping, quality control testing, and notification, and restocking costs) incurred by BioForm Buyer as a result of any recall or advisory letter letter; provided, however, that if the recall is related to requirements or Specifications (unless resulting from a deficiency caused by BioFormi.e., in which case BioForm materials, design or process changes, and Product claims) originating with Buyer, then Buyer will reimburse Supplier for Supplier’s pay the costs and expenses associated with incurred for such recall).. BUYER: __________ Page 10 of 24 SELLER: __________

Product Recalls. (a) If, in the judgment of Supplier Seller or BioFormBuyer, any Company Product defect or any government action requires a recall of, or the issuance of an advisory letter regarding, any Company Product, either party may Party shall undertake such recall or issue such advisory letter only after notification to and consultation with the other partyParty. Each party Party shall notify the other party Party within ** ** of becoming aware (as such phrase is defined in 21 CFR 803) of any issue that could lead to a timely manner prior field action related to making any recall or issuing any advisory letterthe Products. The parties Parties shall endeavor to reach an agreement prior to making any recall or issuing any advisory letter regarding the manner, text, text and timing of any publicity to be given in such matters in time to comply with any applicable legal or regulatory requirements, but such agreement will not be a precondition to any action that either party Party deems necessary to protect users of Company Product Products or to comply with any applicable governmental orders, regulations, orders or mandates. The parties Parties agree to provide reasonable assistance to one another in the event of any recall or issuance of any advisory letter. BioForm Notwithstanding anything in this Agreement to the contrary, Buyer shall have the right to manage any recall within the Territory so long as such management does not prevent Supplier from exercising its rights under this Section 6.10Product recall. (b) In the event of a recall of Company Product, Supplier Seller shall correct noted deficiencies any deficiency relating to its manufacturemanufacturing, packaging, testing, labeling, and Supplier’s storing or handling of Company Product (“Process Related Recalls”)Product, if applicable, or cause the vendor of any material, component, or sub-assembly incorporated into such Company Product to do likewise with respect to such material, component, or sub-assembly assembly, and BioForm shall correct noted deficiencies related to matters for which it is responsible. For Process Related Recalls, Supplier shall, at BioFormSeller’s option, either, either (i) at its cost replace each unit of the Company Product recalled (including units held in inventory by BioForm Buyer or its customers) with a corrected Company Product within a reasonable period of time, or (ii) refund the Buyer’s purchase price thereforthereof. Supplier Seller shall promptly pay or reimburse BioForm Buyer for all its costs and expenses (including i.e., shipping, quality control testing, and notification, and restocking costs) incurred by BioForm Buyer as a result of any recall or advisory letter letter; provided, however, that if the recall is related to requirements or Specifications (unless resulting from a deficiency caused by BioFormi.e., in which case BioForm materials, design or process changes, and Product claims) originating with Buyer, then Buyer will reimburse Supplier for Supplier’s pay the costs and expenses associated with incurred for such recall).. BUYER: Page 10 of 24 SELLER:

Product Recalls. Decisions with respect to recalls, withdrawals or other corrective actions (“Recall") with respect to any Collaboration Product related to manufacturing or product quality issues shall be handled in accordance with the Commercial Supply Agreement. Decisions with respect to any other Recall related to any Collaboration Product shall be made only upon mutual agreement of the Parties; provided, however, [*]. The Parties shall cooperate with respect to any actions taken or public statements made in connection with any such Recall. Except as otherwise provided in this Section 5.10, the Parties will share all costs of a Recall with respect to any Collaboration Product as Sales and Marketing Costs. Notwithstanding the foregoing, a Party shall bear any and all costs of a Recall, market withdrawal or other corrective action with respect to a Collaboration Product in the Territory, including the Manufacturing Costs for the Collaboration Product in question, to the extent the Recall is attributable to the fault of such Party and results from (a) Ifa grossly negligent or reckless act or omission or intentional misconduct of such Party (or its Affiliate, in the judgment of Supplier agent or BioFormpermitted sublicensee), any Company Product defect or any government action requires a recall of, or the issuance of an advisory letter regarding, any Company Product, either party may undertake such recall or issue such advisory letter after consultation with the other party. Each party shall notify the other party in a timely manner prior to making any recall or issuing any advisory letter. The parties shall endeavor to reach an agreement prior to making any recall or issuing any advisory letter regarding the manner, text, and timing of any publicity to be given such matters in time to comply with any applicable legal or regulatory requirements, but such agreement will not be a precondition to any action that either party deems necessary to protect users of Company Product or to comply with any applicable governmental orders, regulations, or mandates. The parties agree to provide reasonable assistance to one another in the event of any recall or issuance of any advisory letter. BioForm shall have the right to manage any recall within the Territory so long as such management does not prevent Supplier from exercising its rights under this Section 6.10. (b) In in the event case such Party is the Lead Manufacturing Party, the failure of the Lead Manufacturing Party or its Affiliate, agent or sublicensee to perform its responsibilities and Manufacture the Collaboration Product in compliance with the specifications (as set forth in the Commercial Supply Agreement), or with applicable Laws, including applicable Good Manufacturing Practices, (c) any defect or condition introduced by a recall Party, its Affiliates or permitted sublicensees following delivery of Company Productthe Collaboration Product from the Lead Manufacturing Party or its contract manufacturer, Supplier shall correct noted deficiencies relating to into a Collaboration Product or its manufacture, packaging, testing, packaging or labeling, and Supplier’s storing or handling of Company Product (“Process Related Recalls”), if applicable, or cause the vendor d) a breach of any material, component, Laws or sub-assembly incorporated into the terms of this Agreement by such Company Product to do likewise with respect to such material, component, or sub-assembly and BioForm shall correct noted deficiencies related to matters for which it is responsible. For Process Related Recalls, Supplier shall, at BioForm’s option, either, at its cost replace each unit of the Company Product recalled (including units held in inventory by BioForm or its customers) with a corrected Company Product within a reasonable period of time, or refund the purchase price therefor. Supplier shall promptly pay or reimburse BioForm for all costs and expenses (including shipping, quality control testing, notification, and restocking costs) incurred by BioForm as a result of any recall or advisory letter (unless resulting from a deficiency caused by BioForm, in which case BioForm will reimburse Supplier for Supplier’s costs and expenses associated with such recall)Party.

Product Recalls. (a) If, in the judgment of Supplier Seller or BioFormBuyer, any Company Product defect or any government action requires a recall of, or the issuance of an advisory letter regarding, any Company Product, either party may Party shall undertake such recall or issue such advisory letter only after notification to and consultation with the other partyParty. Each party Party shall notify the other party Party within ** ** Business Days of becoming aware (as such phrase is defined in 21 CFR 803) of any issue that could lead to a timely manner prior field action related to making any recall or issuing any advisory letterthe Products. The parties Parties shall endeavor to reach an agreement prior to making any recall or issuing any advisory letter regarding the manner, text, text and timing of any publicity to be given in such matters in time to comply with any applicable legal or regulatory requirements, but such agreement will not be a precondition to any action that either party Party deems necessary to protect users of Company Product Products or to comply with any applicable governmental orders, regulations, orders or mandates. The parties Parties agree to provide reasonable assistance to one another in the event of any recall or issuance of any advisory letter. BioForm Notwithstanding anything in this Agreement to the contrary, Buyer shall have the right to manage any recall within the Territory so long as such management does not prevent Supplier from exercising its rights under this Section 6.10Product recall. (b) In the event of a recall of Company Product, Supplier Seller shall correct noted deficiencies any deficiency relating to its manufacturemanufacturing, packaging, testing, labeling, and Supplier’s storing or handling of Company Product (“Process Related Recalls”)Product, if applicable, or cause the vendor of any material, component, or sub-assembly incorporated into such Company Product to do likewise with respect to such material, component, or sub-assembly assembly, and BioForm shall correct noted deficiencies related to matters for which it is responsible. For Process Related Recalls, Supplier shall, at BioFormSeller’s option, either, either (i) at its cost replace each unit of the Company Product recalled (including units held in inventory by BioForm Buyer or its customers) with a corrected Company Product within a reasonable period of time, or (ii) refund the Buyer’s purchase price thereforthereof. Supplier Seller shall promptly pay or reimburse BioForm Buyer for all its costs and expenses (including i.e., shipping, quality control testing, and notification, and restocking costs) incurred by BioForm Buyer as a result of any recall or advisory letter letter; provided, however, that if the recall is related to requirements or Specifications (unless resulting from a deficiency caused by BioFormi.e., in which case BioForm materials, design or process changes, and Product claims) originating with Buyer, then Buyer will reimburse Supplier for Supplier’s pay the costs and expenses associated with incurred for such recall).

Product Recalls. (a) If, in In the judgment of Supplier event that any Regulatory Authority issues or BioForm, any Company Product defect or any government action requires requests a recall ofor takes similar action in connection with a Product, or the issuance of an advisory letter regarding, any Company Product, either party may undertake such recall or issue such advisory letter after consultation with the other party. Each party shall notify the other party in a timely manner prior to making any recall or issuing any advisory letter. The parties shall endeavor to reach an agreement prior to making any recall or issuing any advisory letter regarding the manner, text, and timing of any publicity to be given such matters in time to comply with any applicable legal or regulatory requirements, but such agreement will not be a precondition to any action that either party deems necessary to protect users of Company Product or to comply with any applicable governmental orders, regulations, or mandates. The parties agree to provide reasonable assistance to one another in the event a Party reasonably believes that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or other corrective action regarding a Product, such Party shall promptly advise the designated senior officer (the Chief Executive Officer in the case of any ARIAD and the President of Global Human Health in the case of MERCK) of the other Party thereof by telephone or facsimile. Following such notification, the Responsible Party shall decide and have control of whether to conduct a recall or issuance of any advisory letter. BioForm shall have the right to manage any recall within the Territory so long as such management does not prevent Supplier from exercising its rights under this Section 6.10. market withdrawal (b) In except in the event of a recall of Company Product, Supplier shall correct noted deficiencies relating to its manufacture, packaging, testing, labeling, and Supplier’s storing or handling of Company Product (“Process Related Recalls”), if applicable, or cause the vendor of any material, component, or sub-assembly incorporated into such Company Product to do likewise with respect to such material, component, or sub-assembly and BioForm shall correct noted deficiencies related to matters for which it is responsible. For Process Related Recalls, Supplier shall, at BioForm’s option, either, at its cost replace each unit of the Company Product recalled (including units held in inventory market withdrawal mandated by BioForm or its customers) with a corrected Company Product within a reasonable period of time, or refund the purchase price therefor. Supplier shall promptly pay or reimburse BioForm for all costs and expenses (including shipping, quality control testing, notification, and restocking costs) incurred by BioForm as a result of any recall or advisory letter (unless resulting from a deficiency caused by BioFormRegulatory Authority, in which case BioForm will reimburse Supplier for Supplier’s costs it shall be required) or to take other corrective action in any country and expenses associated with the manner in which any such recall), market withdrawal or corrective action shall be conducted; provided that the Responsible Party shall keep the Participating Party regularly informed regarding any such recall, market withdrawal or corrective action. In the U.S. Territory, either Responsible Party may elect to require (following discussions among the designated senior officers of the Parties) a recall or market withdrawal of the Product. ARIAD shall be responsible for conducting any recall or market withdrawal of the Product in the U.S. Territory. Subject to any contrary provisions specifically set forth in the Supply Agreement, all expenses incurred by the Responsible Party in connection with any such recall, market withdrawal or corrective action (including, without limitation, expenses for notification, destruction and return of the affected Product and any refund to customers of amounts paid for such Product) shall (a) with respect to Royalty-Bearing Products, be the sole responsibility of MERCK and (b) with respect to Co-Promoted Product, be a Commercialization Expense.

Product Recalls. (a) If, in the judgment of Supplier either Manufacturer or BioFormDistributor, any Company defect relating to any BIS-Screen Product defect sold by Distributor or any government action requires a recall of, or the issuance of an advisory letter regarding, any Company ProductBIS-Screen Product sold by Distributor, either party may undertake such recall or issue such advisory letter after consultation with the other party. Each party shall notify the other party in a timely manner prior to making any recall or issuing any advisory letter. The parties shall endeavor to reach an agreement prior to making any recall or issuing any advisory letter regarding the manner, text, text and timing of any publicity to be given such matters in time to comply with any applicable legal or regulatory requirements, but such agreement will not be a precondition to any action that either party deems necessary to protect users of Company Product the BIS-Screen Products or to comply with any applicable governmental orders, regulations, orders or mandates. The parties agree to provide reasonable assistance to one another in the event of any recall or issuance of any advisory letter. BioForm The party responsible for the defect giving rise to the recall shall promptly pay or reimburse Distributor for the reasonable costs of effecting such recall or issuing such advisory letter, including without limitation costs related to return of recalled BIS-Screen Products (including shipping, quality control testing, notification and restocking costs). If and to the extent such recall results from a defect in the design or manufacture of such BIS-Screen Product recalled or from literature or other information supplied by Manufacturer that relates to such BIS-Screen Product, Manufacturer shall be deemed responsible for the defect giving rise to the recall. Manufacturer shall not be responsible for the cost and expense of any recall which results from an act or omission of Distributor with respect to such BIS-Screen Product. Notwithstanding anything in this Agreement to the contrary, Distributor shall have the right to manage any recall within the Territory so long as such management does not prevent Supplier from exercising its rights under this Section 6.10of any BIS-Screen Product then being distributed by Distributor. (b) In the event of a recall of Company Productany BIS-Screen Product then being distributed by Distributor, Supplier Manufacturer shall correct noted deficiencies any deficiency relating to its manufacturemanufacturing, packaging, testing, labeling, and Supplier’s storing or handling of Company Product (“Process Related Recalls”)such BIS-Screen Product, if applicable, or cause the vendor of any material, component, or sub-assembly incorporated into such Company Product to do likewise with respect to such material, component, or sub-assembly and BioForm shall correct noted deficiencies related to matters for which it is responsible. For Process Related Recalls, Supplier shall, at BioForm’s option, either, at its Distributor's election, (i) at Manufacturer's cost replace each unit of the Company BIS-Screen Product recalled (including without limitation units held in inventory by BioForm Distributor or its customers) with a corrected Company BIS-Screen Product within a reasonable period of time, or (ii) refund the purchase price therefor. Supplier shall promptly pay or reimburse BioForm for all costs and expenses (including shipping, quality control testing, notification, and restocking costs) incurred by BioForm as a result of any recall or advisory letter (unless resulting from a deficiency caused by BioForm, in which case BioForm will reimburse Supplier for Supplier’s costs and expenses associated with such recall).

Product Recalls. Decisions with respect to recalls, withdrawals or other corrective actions (“Recall”) with respect to any Collaboration Product related to manufacturing or product quality issues shall be handled in accordance with the Commercial Supply Agreement. Decisions with respect to any other Recall related to any Collaboration Product shall be made only upon mutual agreement of the Parties; provided, however, [ * ]. The Parties shall cooperate with respect to any actions taken or public statements made in connection with any such Recall. Except as otherwise provided in this Section 5.10, the Parties will share all costs of a Recall with respect to any Collaboration Product as Sales and Marketing Costs. Notwithstanding the foregoing, a Party shall bear any and all costs of a Recall, market withdrawal or other corrective action with respect to a Collaboration Product in the Territory, including the Manufacturing Costs for the Collaboration Product in question, to the extent the Recall is attributable to the fault of such Party and results from (a) Ifa grossly negligent or reckless act or omission or intentional misconduct of such Party (or its Affiliate, in the judgment of Supplier agent or BioFormpermitted sublicensee), any Company Product defect or any government action requires a recall of, or the issuance of an advisory letter regarding, any Company Product, either party may undertake such recall or issue such advisory letter after consultation with the other party. Each party shall notify the other party in a timely manner prior to making any recall or issuing any advisory letter. The parties shall endeavor to reach an agreement prior to making any recall or issuing any advisory letter regarding the manner, text, and timing of any publicity to be given such matters in time to comply with any applicable legal or regulatory requirements, but such agreement will not be a precondition to any action that either party deems necessary to protect users of Company Product or to comply with any applicable governmental orders, regulations, or mandates. The parties agree to provide reasonable assistance to one another in the event of any recall or issuance of any advisory letter. BioForm shall have the right to manage any recall within the Territory so long as such management does not prevent Supplier from exercising its rights under this Section 6.10. (b) In in the event case such Party is the Lead Manufacturing Party, the failure of the Lead Manufacturing Party or its Affiliate, agent or sublicensee to perform its responsibilities and Manufacture the Collaboration Product in compliance with the specifications (as set forth in the Commercial Supply Agreement), or with applicable Laws, including applicable Good Manufacturing Practices, (c) any defect or condition introduced by a recall Party, its Affiliates or permitted sublicensees following delivery of Company Productthe Collaboration Product from the Lead Manufacturing Party or its contract manufacturer, Supplier shall correct noted deficiencies relating to into a Collaboration Product or its manufacture, packaging, testing, packaging or labeling, and Supplier’s storing or handling of Company Product (“Process Related Recalls”), if applicable, or cause the vendor d) a breach of any materialLaws or the terms of this Agreement by such Party. [ * ] = Certain confidential information contained in this document, componentmarked by brackets, or sub-assembly incorporated into such Company Product has been omitted and filed separately with the Securities and Exchange Commission pursuant to do likewise with respect to such material, component, or sub-assembly and BioForm shall correct noted deficiencies related to matters for which it is responsible. For Process Related Recalls, Supplier shall, at BioForm’s option, either, at its cost replace each unit Rule 24b-2 of the Company Product recalled (including units held in inventory by BioForm or its customers) with a corrected Company Product within a reasonable period Securities Exchange Act of time1934, or refund the purchase price therefor. Supplier shall promptly pay or reimburse BioForm for all costs and expenses (including shipping, quality control testing, notification, and restocking costs) incurred by BioForm as a result of any recall or advisory letter (unless resulting from a deficiency caused by BioForm, in which case BioForm will reimburse Supplier for Supplier’s costs and expenses associated with such recall)amended.