DMF. To the extent required CMC information is not contained in any IND submitted to the FDA, Ignyta shall establish with the FDA a drug master file for the Product (“DMF”) and, if requested by Ignyta, and to the extent that Nerviano has contributed to relevant parts of the CMC section, Nerviano shall assist Ignyta in obtaining the DMF.
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Sources: License Agreement (Ignyta, Inc.), License Agreement (Ignyta, Inc.)
DMF. To the extent required CMC information is not contained in any IND the IND’s submitted to the FDA, Ignyta shall establish with the FDA a drug master file for the Product (“DMF”) and, if requested by Ignyta, and to the extent that Nerviano has contributed to relevant parts of the CMC section, Nerviano shall assist Ignyta in obtaining the DMF.
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