FDA Documents Clause Samples

The FDA Documents clause outlines the responsibilities and procedures related to the handling, submission, and maintenance of documents required by the U.S. Food and Drug Administration (FDA). It typically specifies which party is responsible for preparing regulatory filings, maintaining records, and ensuring compliance with FDA requirements during the development, manufacturing, or marketing of a product. This clause ensures that all necessary documentation is properly managed and submitted to the FDA, thereby facilitating regulatory approval and ongoing compliance, and reducing the risk of regulatory delays or penalties.
POPULAR SAMPLE Copied 1 times
FDA Documents. If this Agreement involves a product developed pursuant to an Invention Made under this CRADA regulated by the U.S. Food and Drug Administration (FDA), then the APOLLON or the U.S. Army Medical Research and Material Command, as appropriate, may file any required documentation with the FDA. In addition, the parties authorize and consent to allow each other or its contractor or agent limited access supervised by APOLLON designed to permit the Army to cross-reference any documents filed with the FDA related to the product.
View Source
FDA Documents. If this Agreement involves a product regulated by the U.S. Food and Drug Administration (FDA), then the Cooperator or the U.S. Army Medical Research and Materiel Command, as appropriate, may file any required documentation with the FDA. In addition, the parties authorize and consent to allow each other or their contractors or agents access to, or to cross-reference, any documents filed with the FDA related to the product.
View SourceView Similar (2)
FDA Documents. Subject Data
View SourceView Similar (2)
FDA Documents. If this Agreement involves a product regulated by the FDA, then [NON-NAVY COLLABORATOR] or [NAVY COLLABORATOR], as appropriate, may file any required documentation with the FDA. In addition, the Collaborators authorize and consent to allow each other or its contractor or agent access to, or to cross-reference, any documents filed with the FDA related to the product.
View SourceView Similar (2)
FDA Documents and Reports GTC shall cooperate fully with Merrimack in promptly filing all documents and reports required or requested by the FDA or other regulatory agency or requested by Merrimack, and shall provide Merrimack with such information as Merrimack may require or request with regard to those filings, including all reports, authorizations, certificates, methodologies, specifications and other documentation in the possession of or under the control of GTC. The costs associated with all such activities will be borne by Merrimack. GTC will provide Merrimack with an estimate for these costs within ten (10) business days after receiving a definition of the scope and deliverables required by Merrimack in support of such activities. The costs for all such activities will be calculated on a time and materials basis. GTC will not initiate any work for Merrimack until a written agreement defining the scope and costs for such work has been executed by the parties.
View Source
FDA Documents. If this Agreement involves a product regulated by the FDA, then the Collaborating Party, LWI, or the Federal Laboratory, as appropriate, may file any required documentation with the FDA. In addition, the Parties authorize and consent to allow each other or its contractor or agent access to, or to cross-reference, any documents filed with the FDA related to the product.
View Source
FDA Documents. This Agreement involves a product regulated by the U.S. Food and Drug Administration (FDA), the Parties authorize and consent to allow each other or their contractors or agents access to any documents filed with the FDA related to the product. Parties agree to include representatives from both Parties at all FDA regulatory meetings related to the Product.
View Source
FDA Documents. If this Agreement involves a product regulated by the FDA, then [Non-Navy Collaborator] or [Navy Collaborator], as appropriate, may file any required documentation with the FDA. In addition, the Collaborators authorize and consent to allow each other or its contractor or agent access to, or to cross-reference, any documents filed with the FDA related to the product.
View Source
FDA Documents. If this Agreement involves a product regulated by the U.S. Food and Drug Administration (FDA), then the JENNER or the U.S. Army Medical Research and Development Command, as appropriate, may file Subject Data or any required documentation relating to the SOW with the FDA; provided, however, each party shall request that any such filings be treated confidential to the maximum extent allowed by law. In addition, the parties authorize and consent to allow each other or its contractor or agent access to, or to cross-reference, any documents filed with the FDA related to the product.
View Source

Related to FDA Documents

  • Bid Documents The terms and conditions of the Invitation to Bid attached hereto and made a part hereof as Exhibit "B" shall be incorporated herein as a part of this Agreement.

  • Financing Documents The CAC Credit Facility Documents, the ▇▇▇▇▇ Fargo Warehouse Documents, the Fifth Third Warehouse Documents, the Flagstar Warehouse Documents, the BMO Warehouse Documents, the Credit Suisse Warehouse Documents, the 2018-3 Securitization Documents, the 2018-2 Securitization Documents, the 2018-1 Securitization Documents, the 2017-3 Securitization Documents, the 2017-2 Securitization Documents, the 2017-1 Securitization Documents, the 2016-3 Securitization Documents, the 2016-2 Securitization Documents, the 2016-1 Securitization Documents and the 2015-2 Securitization Documents.

  • Bidding Documents The Construction Documents, the Invitation to Bid, the Instructions to Bidders, the Bid Form, and all Addenda, upon which the Bidder submits a Bid.

  • Referenced Documents 2.3.1 Unless the context shall otherwise specifically require, and subject to Section 21, whenever any provision of this Agreement refers to a technical reference, technical publication, CLEC Practice, SBC-13STATE Practice, any publication of telecommunications industry administrative or technical standards, or any other document specifically incorporated into this Agreement (collectively, a “Referenced Instrument”), it will be deemed to be a reference to the then-current version or edition (including any amendments, supplements, addenda, or successors) of each Referenced Instrument that is in effect, and will include the then-current version or edition (including any amendments, supplements, addenda, or successors) of any other Referenced Instrument incorporated by reference therein.

  • Public Documents The Common Stock of the Borrower is registered pursuant to Section 12 of the Exchange Act and the Borrower is subject to the reporting requirements of Section 13 or 15(d) of the Exchange Act. The Borrower has timely filed all reports, schedules, forms, statements and other documents required to be filed by it with the SEC, the Principal Trading Market, or any other Governmental Authority, as applicable (all of the foregoing filed within the two (2) years preceding the date hereof or amended after the date hereof and all exhibits included therein and financial statements and schedules thereto and documents incorporated by reference therein, being hereinafter referred to as the “Public Documents”). The Borrower is current with its filing obligations with the SEC, the Principal Trading Market, or any other Governmental Authority, as applicable, and all Public Documents have been filed on a timely basis by the Borrower. The Borrower represents and warrants that true and complete copies of the Public Documents are available on the SEC website or the Principal Trading Market website, as applicable (▇▇▇.▇▇▇.▇▇▇, or ▇▇▇.▇▇▇▇▇▇▇▇▇▇.▇▇▇) at no charge to Lender, and Lender acknowledges that it may retrieve all Public Documents from such websites and Lender’s access to such Public Documents through such website shall constitute delivery of the Public Documents to Lender; provided, however, that if Lender is unable to obtain any of such Public Documents from such websites at no charge, as result of such websites not being available or any other reason beyond Lender’s control, then upon request from Lender, the Borrower shall deliver to Lender true and complete copies of such Public Documents. The Borrower shall also deliver to Lender true and complete copies of all draft filings, reports, schedules, statements and other documents required to be filed with the requirements of the Principal Trading Market that have been prepared but not filed with the Principal Trading Market as of the date hereof. None of the Public Documents, at the time they were filed with the SEC, the Principal Trading Market, or other Governmental Authority, as applicable, contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. None of the statements made in any such Public Documents is, or has been, required to be amended or updated under applicable law (except for such statements as have been amended or updated in subsequent filings prior the date hereof, which amendments or updates are also part of the Public Documents). As of their respective dates, the consolidated financial statements of the Borrower and its Subsidiaries included in the Public Documents complied in all material respects with applicable accounting requirements and any published rules and regulations of the SEC and Principal Trading Market with respect thereto.