The FDA Clause Samples

The FDA clause defines the role and authority of the U.S. Food and Drug Administration (FDA) as it relates to the agreement or subject matter at hand. Typically, this clause outlines the requirement for compliance with FDA regulations, such as obtaining necessary approvals or adhering to specific standards for products or services regulated by the FDA. For example, it may require that all medical devices or pharmaceuticals involved in the contract be approved or cleared by the FDA before distribution. The core function of this clause is to ensure legal and regulatory compliance, thereby reducing the risk of enforcement actions or penalties due to non-compliance with federal health and safety laws.
POPULAR SAMPLE Copied 2 times
The FDA. The "FDA" shall mean the United States Food and Drug Administration. * PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED SEPARATELY PURSUANT TO AN APPLICATION FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
View Source

Related to The FDA

  • The FTPS Unit Servicing Agent shall distribute to redeeming FTPS Unit holders of record on its books redemption proceeds it receives pursuant to Section 5.02 of the Standard Terms and Conditions of Trust from the Trustee as the sole record owner of FTPS Units on the Trustee's books.

  • The Front end Fee payable by the Borrower shall be equal to one quarter of one percent (0.25%) of the Loan amount.

  • Marking of Licensed Products To the extent commercially feasible and consistent with prevailing business practices, Company shall ▇▇▇▇, and shall cause its Affiliates and Sublicensees to ▇▇▇▇, all Licensed Products that are manufactured or sold under this Agreement with the number of each issued patent under the Patent Rights that applies to such Licensed Product.

  • The Supplier must during and after the Term keep the Buyer fully indemnified against all Losses, damages, costs or expenses and other liabilities (including legal fees) arising from any breach of the Supplier's obligations under incorporated Framework Agreement clause

  • Research Use Reporting To assure adherence to NIH GDS Policy, the PI agrees to provide annual Progress Updates as part of the annual Project Renewal or Project Close-out processes, prior to the expiration of the one (1) year data access period. The PI who is seeking Renewal or Close-out of a project agree to complete the appropriate online forms and provide specific information such as how the data have been used, including publications or presentations that resulted from the use of the requested dataset(s), a summary of any plans for future research use (if the PI is seeking renewal), any violations of the terms of access described within this Agreement and the implemented remediation, and information on any downstream intellectual property generated from the data. The PI also may include general comments regarding suggestions for improving the data access process in general. Information provided in the progress updates helps NIH evaluate program activities and may be considered by the NIH GDS governance committees as part of NIH’s effort to provide ongoing stewardship of data sharing activities subject to the NIH GDS Policy.