Conflict Resolution of Analytical Issues. In the event that a dispute arises between Bachem and Xeris in the analysis of the Product, the resolution shall conform with GMP rules on OOS results and shall proceed in stages. The first stage requires direct communication between analytical experts from the Parties to determine that the methods of analysis are the same and are being executed in the same manner at both sites. In a second stage, carefully controlled and split samples shall be exchanged to attempt to reach agreement. Should there be a failure to achieve a common set of results, analytical experts from the Parties shall be required to meet to work through the analysis of a mutually agreed sample, if these actions fail to achieve a common set of results a qualified, independent, third party referee laboratory shall be used to achieve resolution. This laboratory shall be selected mutually by the Parties. The results from this referee laboratory shall be binding on both Parties. Whatever the outcome, Xeris retains the right to decide whether the Product will be used to manufacture Xeris’s Pharmaceutical Product. Nothing in this Section 6.14 shall be construed to limit Bachem’s or Xeris’ rights.
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Samples: Quality Assurance Agreement, Quality Assurance Agreement (Xeris Pharmaceuticals Inc), Quality Assurance Agreement (Xeris Pharmaceuticals Inc)
Conflict Resolution of Analytical Issues. In the event that a dispute arises between Bachem and Xeris Biodel in the analysis of the Product, the resolution shall conform with GMP rules on OOS results and shall proceed in stages. The first stage requires direct communication between analytical experts from the Parties to determine that the methods of analysis are the same and are being executed in the same manner at both sites. In a second stage, carefully controlled and split samples shall be exchanged to attempt to reach agreement. Should there be a failure to achieve a common set of results, analytical experts from the Parties shall be required to meet to work through the analysis of a mutually agreed sample, if . If these actions fail to achieve a common set of results results, a qualified, independent, third party referee laboratory shall be used to achieve resolution. This laboratory shall be selected mutually by the Parties. The results from this referee laboratory shall be binding on both Parties. Whatever the outcome, Xeris Biodel retains the right to decide whether the Product will be used to manufacture XerisBiodel’s Pharmaceutical Product. Nothing in this Section 6.14 shall be construed to limit BachemBiodel’s or Xeris’ rightsrights under Article 7 of the Commercial Agreement.
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