Specification Dispute Resolution Sample Clauses

Specification Dispute Resolution. In case of any disagreement between the Parties as to whether a Drug Product conformed with applicable Draft Specifications or Final Specifications, a representative sample of the disputed Drug Product shall be submitted for tests and final determination of whether the Drug Product conformed with such applicable specifications to an independent testing organization mutually agreed upon by the Parties (the “Laboratory”). The Laboratory must meet current Good Laboratory Practices as defined by the FDA from time to time, and the appointment of such Laboratory shall not be unreasonably withheld or delayed by either Party. Such Laboratory shall use the test methods contained in the applicable specifications. The determination of such Laboratory with respect to all or part of the Drug Product shall be final and binding on the Parties. The fees and expenses of the Laboratory incurred in making such determination shall be paid by the Party against whom the determination is made.