Common use of Recalls and Voluntary Withdrawals Clause in Contracts

Recalls and Voluntary Withdrawals. The Parties shall exchange their internal standard operating procedures (“SOPs”) for conducting product recalls reasonably in advance of the First Commercial Sale of any Licensed Product in the Territory, and shall discuss and resolve in writing any conflicts between such SOPs and issues relating thereto promptly after such exchange. If either Party becomes aware of information relating to any Licensed Product that indicates that a unit or batch of such Licensed Product may not conform to the specifications therefor, or that potential adulteration, misbranding, and/or other issues have arisen that relate to the safety or efficacy of Licensed Products, it shall promptly so notify the other Party. The Party having the right to control such recall pursuant to this Section 5.7(b) may, at its sole discretion, take appropriate courses of action, which shall be consistent with the internal SOP of such Party; provided however that such controlling Party shall promptly notify the other Party of any recall action being considered, and where practicable, consider the views of the non-controlling Party prior to taking any recall action. MPI shall have the right, [***] to control any recalls, field corrections, field alerts or withdrawals of any Licensed Product in the Licensed Territory. SGI shall have the right, [***], to control all recalls, field corrections, field alerts and withdrawals of any Licensed Product in the SGI Territory. MPI and SGI shall maintain complete and accurate records of any recall of Licensed Product according to its then current SOPs for such periods as may be required by applicable Laws, but in no event for less than [***].

Recalls and Voluntary Withdrawals. The Parties shall exchange their internal standard operating procedures (“SOPs”) for conducting product recalls reasonably in advance of the First Commercial Sale of any Licensed Product in the Territory, and shall discuss and resolve in writing any conflicts between such SOPs and issues relating thereto promptly after such exchange. If either Party becomes aware of information relating to any Licensed released Product that indicates that a unit or batch of such Licensed Product may not conform to the specifications thereforLicense, Development and Commercialization Agreement between Ampio and Daewoong thereof, or that potential adulteration, misbranding, and/or other issues have arisen that relate to the safety or efficacy of Licensed Productssuch released Product, it shall promptly so notify the other Party. To the extent Daewoong requires such information to comply with applicable Laws or to determine whether to conduct a recall, Ampio shall promptly disclose to Daewoong any CMC Information related to such nonconformance, adulteration, misbranding or other related issue. Daewoong shall have the right, at its expense (except as provided herein), to control any Product recall, field correction, or withdrawal of any released Product in the applicable jurisdiction in the Territory. Ampio shall have the right, at its expense, to control any Product recall, field correction, or withdrawal of any released Product in the Retained Territory. Ampio shall be responsible for all costs incurred for any recall, field correction, or withdrawal of any released Product for the Territory to the extent such event of recall, field correction, or withdrawal is due to the material breach by Ampio of this Agreement or the Supply Agreement. Daewoong shall be responsible for all other costs incurred for any recall, field correction, or withdrawal of any released Product for the Territory. The procedures and consequences of such recalls shall be defined in the Supply Agreement. The Party having the right to control such recall pursuant to this Section 5.7(b) 9.8 may, at its sole discretion, take appropriate courses of action, which shall be consistent with the internal SOP SOPs of such Party; provided however provided, however, that such controlling Party shall promptly notify the other Party of any recall action being considered, considered and where practicable, consider the views of the non-controlling Party prior to taking any recall action. MPI shall have the right, [***] to control any recalls, field corrections, field alerts or withdrawals of any Licensed Product in the Licensed Territory. SGI shall have the right, [***], to control all recalls, field corrections, field alerts and withdrawals of any Licensed Product in the SGI Territory. MPI and SGI Daewoong shall maintain complete and accurate records of any recall of Licensed Product according to its then current SOPs in the Territory for such periods as may be required by applicable Laws, but in no event for less than [***]three (3) years.

Recalls and Voluntary Withdrawals. The Parties shall exchange their internal standard operating procedures (“"SOPs”") for conducting product recalls reasonably in advance of the First Commercial Sale of any Licensed Product in the Licensed Territory, and shall discuss and resolve in writing any conflicts between such SOPs and issues relating thereto promptly after such exchange. If either Party becomes aware of information relating to any Licensed Product that indicates that a unit or batch of such Licensed Finished Product or Bulk Hematide may not conform to the specifications therefor, or that potential adulteration, misbranding, and/or other issues have arisen that relate to the safety or efficacy of Licensed Products, it shall promptly so notify the other Party. The Party having the right Joint Committee shall meet to control discuss such recall pursuant circumstances and to this Section 5.7(b) may, at its sole discretion, take consider appropriate courses of action, which shall be consistent with the internal SOP of the Party having the right to control such Party; provided however that such controlling Party recall pursuant to this Section 4.11. Collaborator shall promptly notify have the other Party right and responsibility to control any product recall, field correction, or withdrawal of any recall action being consideredProduct in the Licensed Territory that is required by Regulatory Authorities in the Licensed Territory, and where practicablethe allocation of expenses incurred in connection with such recall between the Parties shall be set forth in the Supply Agreement as described in Section 7.3. In addition, consider the views of the non-controlling Party prior to taking any recall action. MPI Collaborator shall have the right, [***] at its discretion, to control conduct any recallsproduct recall, field corrections, field alerts correction or withdrawals withdrawal of any Licensed Product in the Licensed TerritoryTerritory that is not so required by such Regulatory Authorities but that Collaborator deems to be appropriate, with the allocation of expenses incurred in connection with such recall between the Parties to be set forth in the Supply Agreement as described in Section 7.3. SGI As between the Parties, Affymax shall have the right, [***]at its expense, to control all recalls, field corrections, field alerts and withdrawals of any Licensed Product in the SGI Affymax Territory, provided, however, that Affymax shall use reasonable efforts (subject to its confidentiality obligations to the Third Party Partner, provided that Affymax shall, during the course of negotiation to enter into an agreement with such Third Party Partner, use reasonable efforts to secure its right to inform Collaborator of such event) to inform the Collaborator of such intention in advance in writing, if such recall may reasonably [*] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. MPI and SGI have a material effect in the Licensed Territory but such information is not otherwise required to be provided pursuant to Section 4.9(a). Collaborator shall maintain complete and accurate records of any recall of in the Licensed Product according to its then current SOPs Territory for such periods as may be required by applicable Laws, but in no event for less than [***]three (3) years.

Recalls and Voluntary Withdrawals. The Parties shall exchange and provide timely updates to their internal standard operating procedures (“"SOPs”") for conducting product recalls reasonably in advance of the First Commercial Sale of any Licensed Product in the Licensed Territory, and shall discuss and resolve in writing any conflicts between such SOPs and issues relating thereto promptly after such exchange. If either Party becomes aware of information relating to any Licensed Product that indicates that a unit or batch of such Licensed Finished Product or Bulk API may not conform to the specifications therefor, or that potential adulteration, misbranding, and/or or other issues have arisen that relate to the safety or efficacy of Licensed Productsthe Product, it shall promptly so notify the other Party. The Party having the right JSC shall meet to control discuss such recall pursuant circumstances and to this Section 5.7(b) may, at its sole discretion, take consider and decide appropriate courses of action, which shall be consistent with the internal SOP of such Party; provided however Takeda. The Party that such controlling Party holds the applicable Regulatory Approval shall promptly notify have the other Party right and responsibility to control any product recall, field correction, or withdrawal of any recall action being consideredProduct in the Licensed Territory that is required by Regulatory Authorities in the Licensed Territory, and where practicablethe allocation of expenses incurred in connection with such recall between the Parties shall be made as follows: (i) if the recall is due to manufacturing defect (in accordance with then prevailing U.S. product liability Laws, consider unless otherwise agreed upon by the views Parties in the Supply Agreement) of Bulk API, then Affymax shall bear all such expenses, (ii) if the non-controlling Party prior recall is due to taking manufacturing defect (in accordance with then prevailing U.S. product liability Laws, unless otherwise agreed upon by the Parties in the Supply Agreement) of Finished Product (other than due to manufacturing defect of Bulk API), then Takeda shall bear all such expenses, (iii) if the recall is due to both of (i) and (ii), then the Parties shall share all such expenses proportionately and (iv) otherwise, as follows: (1) 100% to Takeda to the extent attributable to a recall in any country in the Royalty Territory; (2) treated as Commercial Expenses to the extent attributable to a recall actionin the U.S., or (3) or as otherwise may be agreed for one or more territories in the Supply Agreement as described in Section 7.3. MPI In addition, Takeda shall have the right, [***] at its discretion, to control conduct any recallsproduct recall, field corrections, field alerts correction or withdrawals withdrawal of any Licensed Product in the Licensed Territory. SGI Territory that is not so required by such Regulatory Authorities but that Takeda deems to be appropriate, and the allocation of expenses incurred in connection with such recall between the Parties shall have the right, [***], to control all recalls, field corrections, field alerts and withdrawals of any Licensed Product be as set forth in the SGI Territoryimmediately preceding sentence. MPI and SGI Takeda shall maintain complete and accurate records of any recall of in the Licensed Product according to its then current SOPs Territory for such periods as may be required by applicable Laws, but in no event for less than [***]three (3) years.

Recalls and Voluntary Withdrawals. The Parties Each Party shall exchange their internal provide the other Party with its standard operating procedures (“SOPs”) for conducting product recalls reasonably in advance of the First Commercial Sale of any Licensed the Product in the Licensed Territory, and the Parties shall discuss and resolve in writing any conflicts between such SOPs and issues relating thereto promptly after such exchange. If either Party becomes aware of information relating to any Licensed Product that indicates that a unit or batch of such Licensed Product may not conform to the specifications therefor, or that potential adulteration, misbranding, and/or other issues have arisen that relate to the safety or efficacy of Licensed Productsthe Product, it shall promptly so notify the other Party. The Party having the right JSC shall meet to control discuss such recall pursuant circumstances and to this Section 5.7(b) may, at its sole discretion, take consider appropriate courses of action, which shall be consistent with the internal SOP of the Party having the right to control such Party; provided however that such controlling Party shall promptly notify the other Party of any recall action being considered, and where practicable, consider the views of the non-controlling Party prior pursuant to taking any recall actionthis Section 4.9. MPI 3SBio shall have the right, [***] at its expense, to control any recallsproduct recall, field correctionscorrection, field alerts or withdrawals withdrawal of any Licensed the Product in the Licensed Territory. SGI As between the Parties, AMAG shall have the right, [***]at its expense, to control all recalls, field corrections, field alerts and withdrawals of any Licensed the Product in the SGI AMAG Territory. MPI and SGI 3SBio shall maintain complete and accurate records of any recall of in the Licensed Product according to its then current SOPs Territory for such periods as may be required by applicable Laws, but in no event for less than [***]three (3) years.