IDENTIFICATION AND DISPOSITION OF DATA. Regeneron shall keep copies of all Data relevant to this Project Agreement as required by the Food and Drug Administration (FDA) for the time specified by the FDA. The Government reserves the right to review any other data determined by the Government to be relevant to this Agreement. The Government further acknowledges that Regeneron holds the commercialization rights for all products developed under this Agreement in the U.S. and will be responsible for their registration with the FDA. This provision is subject to any applicable limitations on the Government’s rights under Article VIII.B.a-b of the BARDA OTA.
Appears in 9 contracts
Samples: Project Agreement (Regeneron Pharmaceuticals, Inc.), Project Agreement (Regeneron Pharmaceuticals, Inc.), Project Agreement (Regeneron Pharmaceuticals, Inc.)
