Food and Drug Administration Matters. (a) For purposes of this Agreement, "
Food and Drug Administration Matters. (a) For purposes of this Agreement: (i) "FDA" means the United States Food and Drug Administration and corresponding regulatory agencies in other counties and states of the United States, (ii) "FDA clearance and approval" means any pre-market notification or pre-market approval application, consent, certificate, registration, permit, license or other authorization, and the filing of any notification, application, report or information, required by the FDA or any other government entity pursuant to any FDA Law, (iii) "FDA Company Contractor" means any person with which the Company or any of its Subsidiaries formerly or presently had or has any agreement or arrangement (whether oral or written) under which that person has or had physical possession of, or was or is obligated to develop, test, process, investigate, manufacture or produce, any FDA Regulated Product on behalf of the Company or any of its Subsidiaries, (iv) "FDA Law" means any statute, regulation, judicial or administrative interpretation, guideline, point-to-consider, recommendation or standard international guidance relating to any FDA Regulated Product, including, without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. sec. 301 et seq., the FDA Modernization Act of 1997, Stand Alone Provisions, Pub. L. No. 105-115, 111 Stat. 2295 (1997), and equivalent statutes, regulations and guidances adopted by countries, international bodies and other jurisdictions, in addition to the United States, where the Company or any of its Subsidiaries has facilities, does business, or directly or through others sells or offers for sale any FDA Regulated Product, and (v) "FDA Regulated Product" means any product or component including, without limitation, any medical device, that is studied, used, held or offered for sale for human research or investigation or clinical use.
Food and Drug Administration Matters. (a) PharmAthene and its Subsidiaries are not in violation of the FDCA, the PHSA, or the Drug Laws applicable to their activities, including those relating to GLP, good clinical practices, adverse event reporting, good manufacturing practices, recordkeeping, user fees, clinical trial registries, and filing of reports, except for such violations that would not, individually or in the aggregate, reasonably be expected to have a PharmAthene Material Adverse Effect. PharmAthene and its Subsidiaries have not received any written notice or other written communication from the FDA or any other Governmental Entity alleging any violation of any Drug Law, including any failure to maintain systems and programs adequate to ensure compliance with any applicable Law related to product quality, including “Good Manufacturing Practice,” “Good Laboratory Practice,” and “Good Clinical Practice” as those terms are defined by the FDA and in all applicable Drug Laws, by PharmAthene or any of its Subsidiaries relating to any activity that is subject to Drug Laws. Neither PharmAthene nor any of its Subsidiaries, nor, to the knowledge of PharmAthene, any third party acting on behalf of PharmAthene, has received any (i) notices of inspectional observations (including those recorded on form FDA 483), warning letters, untitled letters from the FDA or any other Governmental Entity, (ii) notice of any intention to conduct an investigation or review from the FDA or any other Governmental Entity, or (iii) other written documents issued by the FDA or any other Governmental Entity that indicate lack of compliance with any Drug Law by PharmAthene or its Subsidiaries or by persons who are otherwise performing services for the benefit of PharmAthene or its Subsidiaries. To PharmAthene’s knowledge, no third party acting on behalf of PharmAthene is subject to any regulatory restriction that would affect the development of PharmAthene products.
Food and Drug Administration Matters. (a) Except as set forth on SCHEDULE 5.29, KCAS has not received any communication (including, any warning letter) or is otherwise aware of any action or proceeding pending or, to the best of their knowledge, threatened, including, without limitation, warning
Food and Drug Administration Matters. (a) Except as set forth on Schedule 5.29, KCAS has not received any communication (including, any warning letter) or is otherwise aware of any action or proceeding pending or, to the best of their knowledge, threatened, including, without limitation, warning letter, prosecution, injunction, seizure, civil fine or recall, alleging that such Person is not in compliance with any and all applicable laws, regulations or orders implemented by the Food and Drug Administration, or implemented by the relevant state, local or international agency responsible for regulating the pharmaceutical industry, including but not limited to, allegations related to (i) drug development establishments operated by KCAS or (ii) drug or product license applications submitted directly by such Person or by a customer of such Person that includes data generated by KCAS other than non-material correspondence received from the Food and Drug Administration in connection with the filing and review of applications. To KCAS's knowledge, no employee of KCAS is or has been the subject of any similar pending or threatened action or proceeding.
Food and Drug Administration Matters. (i) SINO possesses all FDA clearances and approvals required under all applicable FDA Laws to conduct its current businesses, to manufacture, hold, and sell FDA Regulated Products. Any and all FDA clearances and approvals are in full force and effect.
Food and Drug Administration Matters. (a) Except as set forth SCHEDULE 5.28, neither MTRA nor any of its Subsidiaries has received any communication (including, any warning letter) or is otherwise aware of any action or proceeding pending or, to the best of their knowledge, threatened, including, without limitation, warning letter, prosecution, injunction, seizure, civil fine or recall, alleging that such Person is not in compliance with any and all applicable laws, regulations or orders implemented by the Food and Drug Administration, or implemented by the relevant state, local or international agency responsible for regulating the pharmaceutical industry, including but not limited to, allegations related to (i) drug development and/or clinical research establishments operated by MTRA or any of its Subsidiaries or (ii) drug or product license applications submitted directly by such Person, or by a customer of such Person that includes
Food and Drug Administration Matters. (a) SIGA has not obtained any clearances or approvals from the FDA to conduct its current businesses, to manufacture, hold or sell FDA Regulated Products, and to use and occupy the SIGA Real Properties.
Food and Drug Administration Matters. (a) Since January 31, 2017, (i) all Assets stored, distributed, or used by or on behalf of the Company in connection with the Company Services that are subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) are being or have been stored, distributed, or used in compliance in all material respects with all applicable Laws administered or issued by the FDA or any other Governmental Authorities with oversight of such Assets and (ii) the Company and each Subsidiary is in compliance in all material respects with the Federal Food, Drug, and Cosmetic Act and implementing regulations, as applicable, governing reporting and recordkeeping for such Assets, including complaint records adverse event reporting, inventory management and expiration dates. The Company and its Subsidiaries have commercially reasonable policies and procedures in place to ensure that any required product recalls, withdrawals, suspensions, seizures or discontinuations initiated by a product manufacturer or Governmental Authority are conducted in material compliance with the requirement of the entity that initiated such recall, withdrawal, suspension, seizure or discontinuation.
Food and Drug Administration Matters. (a) All products stored, tracked, developed, formulated, tested, manufactured, compounded, labeled, distributed, or marketed by or on behalf of the Group Companies that are subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) are being or have been stored, tracked, developed, formulated, tested, manufactured, compounded, labeled, distributed, or marketed in compliance in all material respects with all applicable Laws administered or issued by the FDA or any other Governmental Entities with oversight of the products by the Group Companies and, to the Knowledge of the Company, all other Persons acting on behalf of the Group Companies.
