Common use of Test Result Dispute Clause in Contracts

Test Result Dispute. In the event that a dispute arises between TransMedics and Fresenius in the testing performed by Fresenius for the PRODUCTS, the resolution will proceed in stages. The first stage requires direct communication between analysts from both parties to determine that the methods of analysis are the same and are being executed in the same manner at both sites. Second, carefully controlled and split samples should be sent from one site to another in an attempt to reach agreement. Should there be a failure to achieve resolution, analysts from both parties will be required to meet to work through the analysis of a mutually agreeable sample. If these actions fail to achieve resolution, and only after these avenues have been exhausted, a qualified referee laboratory will be used to achieve resolution. This laboratory must be agreeable to both parties prior to use. The results from this referee laboratory will be used as final authority to determine responsibilities, but whatever the outcome, TransMedics retains the right to determine product release status. Financial liability will be determined according to the DEVELOPMENT AND SUPPLY AGREEMENT. In the event that an independent third party laboratory must be retained to settle dispute between the Parties with respect to the conformity or non-conformity of a Product, Fresenius will be responsible for the technology transfer to such laboratory, and will confirm that the technology transfer had been successful and that the laboratory was capable of reproducing Fresenius laboratory results. Fresenius and TransMedics must agree that the laboratory was in compliance with cGMP.

Appears in 3 contracts

Samples: Development and Supply Agreement (TransMedics Group, Inc.), Development and Supply Agreement (TransMedics Group, Inc.), Development and Supply Agreement (TransMedics Group, Inc.)

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Test Result Dispute. In the event that a dispute arises between TransMedics SkyePharma and Fresenius Enzon in the testing performed by Fresenius SkyePharma for the PRODUCTS, the resolution will proceed in stages. The first stage requires direct communication between analysts from both parties to determine that the methods of analysis are the same and are being executed in the same manner at both sites. Second, carefully controlled and split samples should be sent from one site to another in an attempt to reach agreement. Should there be a failure to achieve resolution, analysts from both parties will be required to meet to work through the analysis of a mutually agreeable sample. If these actions fail to achieve resolution, and only after these avenues have been exhausted, a qualified referee laboratory will be used to achieve resolution. This laboratory must be agreeable to both parties prior to use. The results from this referee laboratory will be used as final authority to determine responsibilities, but whatever the outcome, TransMedics SkyePharma retains the right to determine product release status. Financial liability will be determined according to the DEVELOPMENT AND SUPPLY AGREEMENT. In the event that an independent third party laboratory must be retained to settle dispute between the Parties with respect to the conformity or non-conformity nonconformity of a Product, Fresenius SkyePharma will be responsible for the technology transfer to such laboratory, and will confirm that the technology transfer had been successful and that successful, the laboratory was capable of reproducing Fresenius SkyePharma laboratory results. Fresenius results and TransMedics must agree that the laboratory was in compliance with cGMP.

Appears in 1 contract

Samples: Supply and Distribution Agreement (Pacira Pharmaceuticals, Inc.)

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