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 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.