Common use of Facility Inspection Clause in Contracts

Facility Inspection. If based on a facility inspection or audit by RELIANT as provided herein, or based on a specific observation made by any Regulatory Authority following an audit or inspection, RELIANT determines and notifies PRONOVA that a shipment or portion of a shipment was manufactured under conditions that materially deviated from the Act, cGMPs or Regulatory Requirements, the Parties shall agree upon the appropriate action to be taken in conformance with the FDA483 or the action letter received from FDA by PRONOVA relating to the API, the Product or any Additional Product. If rejection of API is warranted, PRONOVA shall replace, at no cost to RELIANT, that portion of the API shipment that was manufactured under conditions materially deviating from the Act, cGMPs or Regulatory Requirements. Any non-conforming portion of any shipment shall be disposed of as directed by PRONOVA, at PRONOVA’s expense. Except in instances of gross negligence or intentional misconduct by or on behalf of PRONOVA, RELIANT agrees that, in the event that PRONOVA replaces all of the non-conforming portion of such shipment within sixty (60) days of the determination and notification to PRONOVA that such shipment was manufactured under conditions materially deviating from the Act, cGMPs or Regulatory Requirements, and otherwise bears the expenses contemplated by this Section 5.10, the remedies provided for in this Section 5.10 shall be RELIANT’s sole remedies for the fact such shipment was manufactured under conditions materially deviating from the Act, cGMPs or Regulatory

Facility Inspection. If based on a facility inspection or audit by RELIANT as provided herein, or based on a specific observation made by any Regulatory Authority following an audit or inspection, RELIANT determines and notifies PRONOVA that a shipment or portion of a shipment was manufactured under conditions that materially deviated from the Act, cGMPs or Regulatory Requirements, the Parties shall agree upon the appropriate action to be taken in conformance with the FDA483 or the action letter received from FDA by PRONOVA relating to the API, the Product or any Additional Product. If rejection of API is warranted, PRONOVA shall replace, at no cost to RELIANT, that portion of the API shipment that was manufactured under conditions materially deviating from the Act, cGMPs or Regulatory Requirements. Any non-conforming portion of any shipment shall be disposed of as directed by PRONOVA, at PRONOVA’s expense. Except in instances of gross negligence or intentional misconduct by or on behalf of PRONOVA, RELIANT agrees that, in the event that PRONOVA replaces all of the non-conforming portion of such shipment within sixty (60) days of the determination and notification to PRONOVA that such shipment was manufactured under conditions materially deviating from the Act, cGMPs or Regulatory Requirements, and otherwise bears the expenses contemplated by this Section 5.10, the remedies provided for in this Section 5.10 shall be RELIANT’s sole remedies for the fact such shipment was manufactured under conditions materially deviating from the Act, cGMPs or RegulatoryRegulatory Requirements. In the event that PRONOVA fails to replace all of the so deviating portion of such shipment within sixty (60) days of the determination and notification to PRONOVA contemplated by this Section 5.10, such failure shall constitute a Failure to Supply and shall give rise to the rights and obligations of the Parties under Section 5.12.