Allergan’s Responsibility Clause Samples

Allergan’s Responsibility. If the failure to meet applicable legal requirements resulting in a recall or issuance of an NDA Field Alert for a Product is not caused by the act or omission of Contractor, then Allergan shall reimburse Contractor for any costs reasonably expended by Contractor to affect the recall. Allergan shall bear the cost of (a) any API and/or Intermediate Product involved in such a recall and (b) the Production Fees for any Product that is recalled and (c) reimburse Contractor on a time and materials basis which shall not exceed the Production Fees, for any Work-in-Process, Finished but non-approved Product, or Product that cannot be shipped due to the condition requiring the recall, provided that as of the date that the Processing and/or Packaging was suspended as a result of the recall, such Work-in-Process had been otherwise Processed and/or Packaged in accordance with the Master Batch Record and/or Master Packaging Record, and the non-approved Product and/or unshipped Product conforms in all material aspects to the Specifications and was Processed and/or Packaged in accordance with the Processing and/or Packaging, quality assurance and Validation procedures set forth in the Specifications and with any applicable regulations of any Regulatory Authorities, including GMPs.