FDA Documents Sample Clauses

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.

FDA Documents. Subject Data

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.

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.

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.

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.

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.

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.

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.