Common use of Recalls and Voluntary Withdrawals Clause in Contracts

Recalls and Voluntary Withdrawals. If either Party becomes aware of information about distributed Product containing Bulk Product indicating that it may be Non-Conforming with respect to the Bulk Product or that there is potential adulteration, misbranding and/or any potential issues regarding safety or effectiveness with respect to the Bulk Product, it shall promptly serve Notice to that effect on the other Party. Savient will initiate an investigation and assessment of such circumstances and shall promptly notify BTG of its findings and any proposed course of action. The Parties shall meet to discuss such circumstances and to consider appropriate courses of action. Savient shall bear all costs associated with a recall of the Product unless such recall is caused by a Hidden Defect with respect to the Bulk Product, in which case BTG shall pay all costs associated with the recall, up to the maximum value of the Product Price paid by Savient to BTG for the Bulk Product containing such Hidden Defect.

Appears in 4 contracts

Samples: Commercial Supply Agreement (Horizon Therapeutics Public LTD Co), Commercial Supply Agreement (Horizon Pharma PLC), Commercial Supply Agreement (Horizon Pharma PLC)

AutoNDA by SimpleDocs

Recalls and Voluntary Withdrawals. If either Party becomes aware of information about distributed Product containing Bulk Product indicating that it may be Non-Conforming NonConforming with respect to the Bulk Product or that there is potential adulteration, misbranding and/or any potential issues regarding safety or effectiveness with respect to the Bulk Product, it shall promptly serve Notice to that effect on the other Party. Savient will initiate an investigation and assessment of such circumstances and shall promptly notify BTG of its findings and any proposed course of action. The Parties shall meet to discuss such circumstances and to consider appropriate courses of action. Savient shall bear all costs associated with a recall of the Product unless such recall is caused by a Hidden Defect with respect to the Bulk Product, in which case BTG shall pay all costs associated with the recall, up to the maximum value of the Product Price paid by Savient to BTG for the Bulk Product containing such Hidden Defect.

Appears in 1 contract

Samples: Commercial Supply Agreement (Savient Pharmaceuticals Inc)

AutoNDA by SimpleDocs
Time is Money Join Law Insider Premium to draft better contracts faster.