Common use of Product Non-Compliance and Remedies Clause in Contracts

Product Non-Compliance and Remedies. If a Batch of Product fails to conform to the Specifications due to the actions or omissions of Manufacturer, or was not Manufactured in compliance with cGMP (if applicable) or the Manufacturing Process, then Manufacturer will, at Anterios’ sole option: (a) refund in full the fees and expenses paid by Anterios for such Batch, including the costs of Anterios Materials used in the Manufacture of such Batch; or (b) at Manufacturer’s cost and expense, including the costs of Anterios Materials used in the Manufacture of such Batch, produce a new Batch of Product as soon as reasonably possible; or (c) Rework or Reprocess the Product, at Manufacturer’s cost and expense, so that the Batch can be deemed to have been Manufactured in compliance with cGMP (if applicable) and the Manufacturing Process, and to conform to Specifications. Moreover, Manufacturer will promptly undertake an investigation and the parties will meet to discuss, evaluate and analyze the reasons for and implications of the failure to comply with cGMP (if applicable) and/or the Manufacturing Process and will decide whether to proceed with or to amend the applicable Work Order via a Change Order, or to terminate such Work Order.

Product Non-Compliance and Remedies. If a Batch of Product fails to conform to the Specifications due to the actions or omissions of Manufacturer, or was not Manufactured in compliance with cGMP (if applicable) or and the Manufacturing Process, then Manufacturer will, at Anterios’ Rhythm’s sole option: (a) refund in full the fees and expenses paid by Anterios Rhythm for such Batch, including including, but not limited to, the costs cost of Anterios Rhythm Materials used in the Manufacture of such Batch; or (b) at Manufacturer’s cost and expense, including including, but not limited to, the costs cost of Anterios Rhythm Materials used in the Manufacture of such Batch, produce Manufacture a new Batch of Product as soon as reasonably possible; or (c) where deemed possible by Manufacturer Rework or Reprocess the Product, at Manufacturer’s cost and expense, so that the Batch can be deemed to have been Manufactured in compliance with cGMP (if applicable) and the Manufacturing Process, and to conform to Specifications. The parties agree that the table in Schedule 1 is indicative of the responsibility for such a failure, Moreover, Manufacturer will promptly undertake an investigation and the parties will meet to discuss, evaluate and analyze the reasons for and implications of the failure to comply with cGMP (if applicable) and/or the Manufacturing Process and will decide whether to proceed with or to amend the applicable Work Order via a Change Order, or to terminate such Work Order.

Product Non-Compliance and Remedies. If following the receipt of a notice of rejection from Portola pursuant to Section 6.3, it is determined by agreement of the Parties (or in the absence of such agreement, by the laboratory) that a Batch of Product fails to conform to the Specifications due to the actions or omissions of Manufacturer, or was not Manufactured in compliance with cGMP (if applicable) or the Quality Agreement and the Manufacturing Process, then Manufacturer will, at Anterios’ sole option[*]: (a) refund in full the fees and expenses paid by Anterios Portola for such Batch, including the costs of Anterios Portola Materials used in the Manufacture of such Batch; or (b) at Manufacturer’s cost and expense, including the costs of Anterios Portola Materials used in the Manufacture of such Batch, produce a new Batch of Product as soon as reasonably possible; or (c) Rework or Reprocess the Productnon-confirming Batch, at Manufacturer’s cost and expense, so that the Batch can be deemed to have been Manufactured in compliance with cGMP (if applicable) the Quality Agreement and the Manufacturing Process, and to conform to Specifications. Moreover, Manufacturer will promptly undertake an investigation and the parties will meet to discuss, evaluate and analyze the reasons for and implications of the failure to comply with cGMP (if applicable) the Quality Agreement and/or the Manufacturing Process and will decide whether to proceed with or to amend the applicable Work Order via a Change Order, or to terminate such Work Order.