Common use of Product Recalls Clause in Contracts

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) a grossly negligent or reckless act or omission or intentional misconduct of such Party (or its Affiliate, agent or sublicensee), (b) the failure of the Manufacturing Party to perform its responsibilities and Manufacture the Collaboration Product in compliance with specifications or with applicable laws, including applicable Good Manufacturing Practices, or (c) a breach of any laws or the terms of 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 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, [ * ] or (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 6.105.10, 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 Sales 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 TerritoryMarketing Costs. Notwithstanding the foregoing, a Party shall bear any and all costs of a recallRecall, market withdrawal or other corrective action with respect to a Collaboration Product in the Territory, including the COGM 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) a grossly negligent or reckless act or omission or intentional misconduct of such Party (or its Affiliate, agent or permitted sublicensee), (b) in the 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 lawsLaws, including applicable Good Manufacturing Practices, (c) any defect or condition introduced by a Party, its Affiliates or permitted sublicensees following delivery of the Collaboration Product from the Lead Manufacturing Party or its contract manufacturer, into a Collaboration Product or its packaging or labeling, or (cd) a breach of any laws Laws or the terms of this AgreementAgreement by such Party.

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 6.105.10, 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 Sales 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 TerritoryMarketing Costs. Notwithstanding the foregoing, a Party shall bear any and all costs of a recallRecall, market withdrawal or other corrective action with respect to a Collaboration Product in the Territory, including the COGM 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) a grossly negligent or reckless act or omission or intentional misconduct of such Party (or its Affiliate, agent or permitted sublicensee), (b) in the 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 lawsLaws, including applicable Good Manufacturing Practices, (c) any defect or condition introduced by a Party, its Affiliates or permitted sublicensees following delivery of the Collaboration Product from the Lead Manufacturing Party or its contract manufacturer, into a Collaboration Product or its packaging or labeling, or (cd) a breach of any laws Laws or the terms of this AgreementAgreement by such Party. *Confidential Treatment Requested.

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 6.105.10, 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 Sales 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 TerritoryMarketing Costs. Notwithstanding the foregoing, a Party shall bear any and all costs of a recallRecall, market withdrawal or other corrective action with respect to a Collaboration Product in the Territory, including the COGM 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) a grossly negligent or reckless act or omission or intentional misconduct of such Party (or its Affiliate, agent or permitted sublicensee), (b) in the 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 lawsLaws, including applicable Good Manufacturing Practices, (c) any defect or condition introduced by a Party, its Affiliates or permitted sublicensees following delivery of the Collaboration Product from the Lead Manufacturing Party or its contract manufacturer, into a Collaboration Product or its packaging or labeling, or (cd) a breach of any laws Laws or the terms of this AgreementAgreement by such Party. [ * ] = 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.

Product Recalls. Decisions with respect to recallsEach Party shall promptly notify the other Party of any information received by it that could reasonably form the basis for a recall, withdrawals market withdrawal or other corrective action of a Product, in sufficient detail to allow the Parties to comply with any and all Applicable Law to the extent such level of detail is available to the reporting Party. Each Party shall promptly notify the other Party of any material actions (“Recall”) to be taken with respect to any Collaboration Product recall or market withdrawal or other corrective action related to manufacturing or product quality issues shall be handled in accordance a Product prior to such action to permit each Party a reasonable opportunity to consult with the Commercial Supply Agreementother Party with respect thereto. Decisions All costs and expenses incurred by the Parties and not reimbursed by a Third Party, 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 the Products shall be Commercialization Expenses, shared by the Parties in accordance with the Profit Share Percentage. All final decisions with respect to any recall, market withdrawals or any other corrective action related to the Product in the TerritoryTerritory shall be made by Mylan as the Regulatory Approval holder, including except that liability of a Party to a Third Party associated with any such recall, market withdrawals or any other corrective action will be addressed under Article 8. Each Party will keep the COGM for the Collaboration Product in questionother Party reasonably informed with respect to any recalls, market withdrawals or other corrective action with respect to the extent Products in the Recall is attributable to the fault of Territory and will consider any comments from such other Party and results from (a) a grossly negligent or reckless act or omission or intentional misconduct of such Party (or its Affiliate, agent or sublicensee), (b) the failure of the Manufacturing Party to perform its responsibilities and Manufacture the Collaboration Product with respect thereto in compliance with specifications or with applicable laws, including applicable Good Manufacturing Practices, or (c) a breach of any laws or the terms good faith. Confidential Portions of this Agreement.Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. Confidential Treatment Requested by Momenta Pharmaceuticals, Inc.