Resolution of Conflict. If Manufacturer does not agree with Customer’s determination that Products fails to conform to the Specifications, then Manufacturer shall so notify Customer within [***] ([***]) days of receipt of Customer’s Notice of non-conformity with respect to such Products and (if requested) Products sample. In the event of: (i) a conflict between the Parties with respect to the conclusions to be drawn from any test results or, (ii) a difference of opinion between the Parties regarding the rejection of any Batch by Customer with respect to any shipment of Products in such Batch, a sample of such Products Batch shall be submitted by Manufacturer to an independent testing organization, or to a consultant of recognized repute within the US pharmaceutical industry, in either case mutually agreed upon in writing by the Parties (such organization or consultant, the “Laboratory”), the appointment of which shall not be unreasonably withheld or delayed by either Party, for testing against the Specifications utilizing the methods set out in the Specifications. The determination of the Laboratory with respect to all or part of any shipment of Products shall be final and binding on the Parties. The fees and expenses of the Laboratory testing shall be borne entirely by: (i) Manufacturer, if the Laboratory determines that Manufacturer is attributable for the nonconformity, (ii) shared equally by the Parties if the Laboratory is unable to make a final determination as to the cause of the nonconformity, and (iii) Customer, in all other circumstances.
Appears in 1 contract
Sources: Manufacturing Supply Agreement (Arcutis Biotherapeutics, Inc.)
Resolution of Conflict. If Manufacturer DPT does not agree with CustomerCOMPANY’s determination that Products the Product fails to conform to the Specifications, then Manufacturer DPT shall so notify Customer COMPANY within [***] ([***]) days of receipt of CustomerCOMPANY’s Notice notice of non-conformity with respect to such Products Product and (if requested) Products Product sample. In the event of: (i) a conflict between the Parties with respect to the conclusions to be drawn from any test results or, (ii) a difference of opinion between the Parties regarding the rejection of any Batch batch by Customer DPT with respect to any shipment of Products Product in such Batchbatch, a sample of such Products Batch Product batch shall be submitted by Manufacturer DPT to an independent testing organization, or to a consultant of recognized repute within the US United States pharmaceutical industry, in either case mutually agreed upon in writing by the Parties (such organization or consultant, the “Laboratory”), the appointment of which shall not be unreasonably withheld or delayed by either Party, for testing against the Specifications utilizing the methods set out in the Specifications. The determination of the Laboratory with respect to all or part of any shipment of Products Product shall be final and binding on the Parties. The fees and expenses of the Laboratory testing shall be borne entirely by: (i) Manufacturer, if by the Party against whom such Laboratory’s findings are made. If results from the Laboratory determines that Manufacturer is attributable for the nonconformityare inconclusive, (ii) shared equally by the Parties if the Laboratory is unable to make a final determination as to the cause of the nonconformity, and (iii) Customer, resolution will be settled in all other circumstancesaccordance with Article 13 below.
Appears in 1 contract
Sources: Supply and Manufacturing Agreement (Arcutis Biotherapeutics, Inc.)
Resolution of Conflict. If Manufacturer DPT does not agree with CustomerCOMPANY’s determination that Products the Product fails to conform to the Specifications, then Manufacturer DPT shall so notify Customer COMPANY within [***] thirty ([***]30) days of receipt of CustomerCOMPANY’s Notice notice of non-conformity with respect to such Products Product and (if requested) Products Product sample. In the event of: (i) a conflict between the Parties with respect to the conclusions to be drawn from any test results or, (ii) a difference of opinion between the Parties regarding the rejection of any Batch batch by Customer DPT with respect to any shipment of Products Product in such Batchbatch, a sample of such Products Batch Product batch shall be submitted by Manufacturer DPT to an independent testing organization, or to a consultant of recognized repute within the US United States pharmaceutical industry, in either case mutually agreed upon in writing by the Parties (such organization or consultant, the “Laboratory”), the appointment of which shall not be unreasonably withheld or delayed by either Party, for testing against the Specifications utilizing the methods set out in the Specifications. The determination of the Laboratory with respect to all or part of any shipment of Products Product shall be final and binding on the Parties. The fees and expenses of the Laboratory testing shall be borne entirely by: (i) Manufacturer, if by the Party against whom such Laboratory’s findings are made. If results from the Laboratory determines that Manufacturer is attributable for the nonconformityare inconclusive, (ii) shared equally by the Parties if the Laboratory is unable to make a final determination as to the cause of the nonconformity, and (iii) Customer, resolution will be settled in all other circumstancesaccordance with Article 13 below.
Appears in 1 contract
Sources: Supply and Manufacturing Agreement (Evofem Biosciences, Inc.)