Quality Control Testing. Any Party responsible for the manufacture of Tositumomab or Iodine I 131 Tositumomab shall maintain a quality control and testing program consistent with GMP, as required by the FDA and/or any other governmental entity whether in the United States or part of another applicable foreign jurisdiction, with respect to the manufacture by or on behalf of either Party hereunder; provided that regarding such requirements in the Territory, Corixa shall be obligated to comply only with requirements of the EU itself and not of individual countries or territories within the Territory to the extent such requirements may differ from those of the EU. Corixa shall be entitled to audit the quality control program for the manufacture of Tositumomab and Iodine I 131 Tositumomab that is manufactured by Amersham. Each Party shall bear its own expenses for such audits.
Appears in 2 contracts
Sources: Manufacturing and Supply Agreement (Corixa Corp), Manufacturing and Supply Agreement (Corixa Corp)