Patheon’s Responsibility. To the extent that a Recall or return results from, or arises out of, a failure by Patheon to provide the Manufacturing Services in accordance with the Patheon Manufacturing Responsibilities, Patheon shall be responsible for the documented out-of- pocket expenses of such Recall or return and shall use its commercially reasonable efforts to replace the Recalled or returned Drug Product with new Drug Product, contingent upon the receipt from the Client of all Granulations (which shall be paid for by Patheon, subject to the limitations set out in herein) required for the manufacture of such replacement Drug Product. In the event that Patheon is unable to replace the Recalled or returned Drug Product (except where such inability results from a failure to receive the required Granulations), then the Client may request Patheon to reimburse the Client for: (i) the price that the Client paid to Patheon for manufacturing the affected Drug Product; and (ii) the cost of the Granulations. In all other circumstances, Recalls, returns or other corrective actions shall be made at the Client’s cost and expense. Patheon’s maximum liability associated with any Recall or return of a Drug Product shall be $5,000,000 per Recall or return event.
Appears in 3 contracts
Samples: Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.), Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.), Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.)
Patheon’s Responsibility. To the extent that a Recall or return results from, or arises out of, a failure by Patheon to provide the Manufacturing Services in accordance with the Patheon Manufacturing Responsibilities, Patheon shall be responsible for the documented out-of- pocket expenses of such Recall or return and shall use its commercially reasonable efforts to replace the Recalled or returned Drug Product with new Drug Product, contingent upon the receipt from the Client of all Granulations (which shall be paid for by Patheon, subject to the limitations set out in herein) required for the manufacture of such replacement Drug Product. In the event that Patheon is unable to replace the Recalled or returned Drug Product (except where such inability results from a failure to receive the required Granulations), then the Client may request Patheon to reimburse the Client for: (i) the price that the Client paid to Patheon for manufacturing the affected Drug Product; and (ii) the cost of the Granulations. In all other circumstances, Recalls, returns or other corrective actions shall be made at the Client’s cost and expense. Patheon’s maximum liability associated with any Recall or return of a Drug Product shall be $5,000,000 [***] per Recall or return event.
Appears in 2 contracts
Samples: Manufacturing Services Agreement, Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.)