Product Non-Compliance and Remedies. If a Batch of Product fails to conform to the Specifications due to the fault of Manufacturer or was not Manufactured in compliance with cGMP (if applicable) and the Manufacturing Process, then Manufacturer will, at RADIUS’ sole option: (a) refund in full the fees and expenses paid by RADIUS for such Batch, including the costs of RADIUS Materials used in the Manufacture of such Batch; or (b) at Manufacturer’s cost and expense, including the costs of RADIUS 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, 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, or to terminate such Work Order.
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Samples: Development and Manufacturing Services Agreement (Radius Health, Inc.), Development and Manufacturing Services Agreement (Radius Health, Inc.), Development and Manufacturing Services Agreement (Radius Health, Inc.)