Common use of Recalls and Voluntary Withdrawals Clause in Contracts

Recalls and Voluntary Withdrawals. (a) The Parties shall exchange their internal standard operating procedures (“SOPs”) as to product recalls and the treatment of product complaints and inquiries as to safety, quality or efficacy reasonably in advance of the date of Commercial Launch of any Licensed Product in the Territory. If either Party becomes aware of information about any Licensed Product indicating that it may not conform to the specifications for Licensed Product then in effect pursuant to the Supply Agreement, or that there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, it shall promptly so notify the other Party. The JCT shall meet to discuss such circumstances and to consider appropriate courses of action, which courses of action with respect to each recall shall be consistent with the internal SOP of the Party having the right to control such recall pursuant to this Section 5.7. Except to the extent otherwise provided in Section 5.7(b) below, Chiron shall control, at its sole expense, all recalls of Licensed Product within the Territory. Cubist shall control, at its sole expense, all recalls of Licensed Product outside the Territory. Chiron shall maintain complete and accurate records of any recall for such periods as may be required by legal requirements, but in any event for no less than three (3) years.

Recalls and Voluntary Withdrawals. (a) The Parties shall exchange their internal standard operating procedures (“SOPs”"SOPS") as to product recalls and the treatment of product complaints and inquiries as to safety, quality or efficacy reasonably in advance of the date of Commercial Launch of any Licensed Product in the Territory. If either Party becomes aware of information about any Licensed Product indicating that it may not conform to the specifications for Licensed Product then in effect pursuant to the Supply Agreement, or that there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, it shall promptly so notify the other Party. The JCT shall meet to discuss such circumstances and to consider appropriate courses of action, which courses of action with respect to each recall shall be consistent with the internal SOP of the Party having the right to control such recall pursuant to this Section 5.7. Except to the extent otherwise provided in Section 5.7(b) below, Chiron shall control, at its sole expense, all recalls of Licensed Product within the Territory. Cubist shall control, at its sole expense, all recalls of Licensed Product outside the Territory. Chiron shall maintain complete and accurate records of any recall for such periods as may be required by legal requirements, but in any event for no less than three (3) years.

Recalls and Voluntary Withdrawals. (a) The Parties shall exchange their internal standard operating procedures (“SOPs”"SOPS") as to product recalls and the treatment of product complaints and inquiries as to safety, quality or efficacy reasonably in advance of the date of Commercial Launch of any Licensed Product in the Territory. If either Party becomes aware of information about any Licensed Product indicating that it may not conform to the specifications Specifications for Licensed Product then in effect pursuant to the Supply Agreementeffect, or that there are potential adulteration, misbranding and/or other issues regarding safety or effectiveness, it shall promptly so notify the other Party. The JCT shall meet to discuss such circumstances and to consider appropriate courses of action, which * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION courses of action with respect to each recall shall be consistent with the internal SOP of the Party having the right to control such recall pursuant to this Section 5.76.6. Except to the extent otherwise provided in Section 5.7(b6.6(b) below, Chiron shall control, at its sole expense, all recalls of Licensed Product within the Territory. Cubist shall control, at its sole expense, all recalls of Licensed Product outside the Territory. Chiron shall maintain complete and accurate records of any recall for such periods as may be required by legal requirements, but in any event for no less than three (3) years.