IDENTIFICATION AND DISPOSITION OF DATA. The Contractor will be required to provide certain data generated under this contract to the Department of Health and Human Services (DHHS). DHHS reserves the right to review any other data determined by DHHS to be relevant to this contract. The contractor shall keep copies of all data required by the Food and Drug Administration (FDA) relevant to this contract for the time specified by the FDA.
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.
IDENTIFICATION AND DISPOSITION OF DATA. The Contractor will be required to provide certain data generated under this contract to the Department of Health and Human Services (HHS). HHS reserves the right to review any other data determined by HHS to be relevant to this contract. The Contractor shall keep copies of all data required by the Food and Drug Administration (FDA) relevant to this contract for the time specified by the FDA.
IDENTIFICATION AND DISPOSITION OF DATA. SUBCONTRACTOR shall keep copies of all data required by the Food and Drug Administration (FDA) relevant to this Agreement for the time specified by the FDA. SPONSOR will be required to provide certain data generated under this Agreement to the SPONSOR and Department of Health and Human Services (DHHS). SPONSOR reserves the right to review any other data determined by SPONSOR or DHHS to be relevant to work under this Agreement.
IDENTIFICATION AND DISPOSITION OF DATA. The Project Awardee shall keep copies of all Data required by the FDA relevant to the Project Award for the time specified by the FDA. In addition, the Project Awardee shall provide regulatory data to the OTTR and OTAS (through the CMF) in accordance with the deliverable schedules in the Project Award’s Statement of Work. 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 Project Awardee holds the commercialization rights for all products developed under the Project Award and will be responsible for their registration with the FDA.
IDENTIFICATION AND DISPOSITION OF DATA. The Subcontractor shall keep copies of all Data required by the Food and Drug Administration (FDA) relevant to this Agreement for the time specified by the FDA. In addition, the Subcontractor shall provide regulatory data to AstraZeneca in accordance to pre-determined Reporting Requirements. AstraZeneca and the Government reserve the right to review any other data determined by AstraZeneca or HHS to be relevant to this Agreement
IDENTIFICATION AND DISPOSITION OF DATA. The Contractor will be required to provide certain data generated with USG funding under this contract to the Department of Health and Human Services (DHHS). DHHS reserves the right, subject to the provisions of FAR 52.227-14, FAR 52.227-14 Alt II and HHSAR 352.224-71, to review any other data determined by DHHS to have been generated with USG funding. The Contractor shall keep copies of all data required by the Food and Drug Administration (FDA) relevant to this contract for the time specified by the FDA.
IDENTIFICATION AND DISPOSITION OF DATA. The Recipient shall keep copies of all Data required by the Food and Drug Administration (FDA) relevant to this Agreement for the time specified by the FDA. In addition, the Recipient shall provide regulatory data to the OTTR and OTAO in accordance with Attachment 2: Reporting Requirements. DHHS reserves the right to review any other data determined by DHHS to be relevant to this Agreement. DHHS further acknowledges that, MDCO holds the commercialization rights in the US for all products developed under this Agreement and will be responsible for their registration with the FDA.
IDENTIFICATION AND DISPOSITION OF DATA. Subcontractor shall keep copies of all data relevant to the Subcontract as required by the Food and Drug Administration (“FDA”) for the time specified by the FDA. In addition, Subcontractor shall provide regulatory data to Regeneron. Subcontractor shall permit the U.S. Government to review any other data determined by the U.S. Government to be relevant to the Subcontract.
IDENTIFICATION AND DISPOSITION OF DATA. HHS reserves the right to review any other data determined by HHS to be relevant to this contract.
