Notice of Non-Conformance. (a) Auxilium will supply to Pfizer the applicable batch number for the Bulk Product delivered as well as such other information as the Parties may set forth in the Quality Agreement with respect to the Manufacture of the Product (a “Manufacturing Certificate of Analysis”) for all Product shipped to Pfizer hereunder. Pfizer shall promptly on receipt of each shipment of Bulk Product hereunder inspect, or cause to have inspected, each shipment of the Product for any damage, defect or shortage and within a reasonable period of time give Auxilium written notice of any such damaged, defective or short shipment (a “Notice of Non-Conformance”). (b) Latent Defects shall be communicated to Auxilium, together with appropriate detail, via a Notice of Non-Conformance, without undue delay after such Latent Defect is first discovered by Pfizer (or Pfizer otherwise is notified of such Latent Defect), but in all cases within two (2) business days of the date on which such Latent Defect was first discovered by Pfizer or was notified to Pfizer by the relevant Party discovering the defect, and thereafter such Latent Defect shall be handled as set forth in the remainder of this Section 7.9 and/or the Quality Agreement, as applicable. For purposes of this Section 7.9.1(b), “Latent Defects” shall mean those defects that could not be discovered by inspection by Pfizer or its designee as described in Section 7.9.1(a).
Appears in 2 contracts
Samples: Development, Commercialization and Supply Agreement (Auxilium Pharmaceuticals Inc), Development, Commercialization and Supply Agreement (Auxilium Pharmaceuticals Inc)
Notice of Non-Conformance. (a) Auxilium will shall supply to Pfizer Asahi the applicable batch number for the Bulk Product delivered as well as such other information as the Parties may set forth in the Quality Agreement Agreements with respect to the Manufacture of the Product (a “Manufacturing Certificate of Analysis”) for all Product shipped to Pfizer Asahi hereunder. Pfizer Asahi shall promptly on receipt of each shipment of Bulk Product hereunder inspect, or cause to have inspected, each shipment of the Product for any damage, defect or shortage and within a reasonable period of time give Auxilium written notice of any such damaged, defective or short shipment (a “Notice of Non-Conformance”).
(b) Latent Defects shall be communicated to Auxilium, together with appropriate detail, via a Notice of Non-Conformance, without undue delay after such Latent Defect is first discovered by Pfizer Asahi (or Pfizer Asahi otherwise is notified of such Latent Defect), but in all cases within two five (25) business days of the date on which such Latent Defect was first discovered by Pfizer Asahi or was notified to Pfizer Asahi by the relevant Party Person discovering the defect, and thereafter such Latent Defect shall be handled as set forth in the remainder of this Section 7.9 and/or the Quality AgreementAgreements, as applicable. For purposes of this Section 7.9.1(b7.9.2(b), “Latent Defects” shall mean those defects that could not be discovered by inspection by Pfizer Asahi or its designee as described in Section 7.9.1(a7.9.2(a).
Appears in 1 contract
Samples: Development, Commercialization and Supply Agreement (Auxilium Pharmaceuticals Inc)
Notice of Non-Conformance. (a) Auxilium will supply to Pfizer Sobi the applicable batch number for the Bulk Product delivered and the Finished Product as well as such other information as the Parties may set forth in the Quality Agreement with respect to the Manufacture of the Bulk Product and the Finished Product (a “Manufacturing Certificate of Analysis”) for all Units of Product shipped manufactured by Auxilium pursuant to Pfizer orders placed by Sobi hereunder. Pfizer Sobi shall promptly on receipt of each shipment of Bulk Units of Product hereunder inspect, or cause to have inspected, each shipment of the Units of Product for any damage, defect or shortage and within a reasonable period of time give Auxilium written notice of any such damaged, defective or short shipment (a “Notice of Non-Conformance”).
(b) Latent Defects shall be communicated to Auxilium, together with appropriate detail, via a Notice of Non-Conformance, without undue delay after such Latent Defect is first discovered by Pfizer Sobi (or Pfizer Sobi otherwise is notified of such Latent Defect), but in all cases within two (2) business days of the date on which such Latent Defect was first discovered by Pfizer Sobi or was notified to Pfizer Sobi by the relevant Party Person discovering the defect, and thereafter such Latent Defect shall be handled as set forth in the remainder of this Section 7.9 and/or the Quality Agreement, as applicable. For purposes of this Section 7.9.1(b7.9.2(b), “Latent Defects” shall mean those defects that could not be discovered by inspection by Pfizer Sobi or its designee as described in Section 7.9.1(a7.9.2(a).
Appears in 1 contract
Samples: Collaboration Agreement (Auxilium Pharmaceuticals Inc)