FOOD AND DRUG ADMINISTRATION MATTERS. (a) For purposes of this Agreement:
FOOD AND DRUG ADMINISTRATION MATTERS. (a) For purposes of this Agreement, "FDA Thoratec Contractor" means any Person with which Thoratec or any Thoratec Subsidiary 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, manufacture or produce, any FDA Regulated Product on behalf of Thoratec or any Thoratec Subsidiary.
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.
(b) PharmAthene and its Subsidiaries have all Authorizations from Governmental Entities that are material to the conduct of the business of PharmAthene and its Subsidiaries, taken as a whole, as currently conducted, and such Authorizations are in full force and effect in all material respects. PharmAthene and its Subsidiaries have filed all material reports, notifications and filings with, and have paid all material regulatory fees to, the applicable Governmental Entity necessary to maintain all of such Authorizations in full force and effect. PharmAthene ...
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.
(b) To the best knowledge of KCAS after appropriate inquiry, all consultants utilized by KCAS to generate information to be submitted to the Food and Drug Administration, or any equivalent state, local or international agency, including, but not limited to, contract research organizations, pre-clinical testing laboratories, clinical investigators and institutional review boards, are in compliance with all applicable Food and Drug Administration requirements, as well as the applicable requirements of relevant state, local and international agencies with regard to the development of data to be utilized by KCAS as part of the relevant drug or product approval process.
(c) Neither KCAS, nor any employee of KCAS, has received any correspondence from the Food and Drug Administration or is aware of any action or proceeding, pending or, to the best of KCAS's knowledge, threatened, against KCAS or any such employee regarding any debarment action or investigation undertaken pursuant to the Generic Drug Enforcement Act of 1992, 21 U.S.C. ss. 335, or any other similar regulation of the Food and Drug Administration.
(d) Neither KCAS, nor any employee of KCAS, has been the subject, officially or otherwise, of any investigation by the Food and Drug Administration pursuant to its Fraud, Untrue, Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy.
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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) For purposes of this Agreement: (i)”FDA” means the United States Food and Drug Administration and corresponding regulatory agencies in other countries and in 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 Pharmathene or SIGA, as the case may be, 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 Pharmathene, (iv)”FDA Law” means any statute, regulation, judicial or administrative interpretation,
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.
(b) SIGA has no obligations to submit reports and filings to the FDA.
(c) There is no civil, criminal or administrative action, suit, demand, claim, complaint, hearing, notice of violation, investigation, notice, demand letter, proceeding or request for information pending or any liability (whether actual or contingent) to comply with any FDA Laws. There is no act, omission, event or circumstance of which SIGA has knowledge that may give rise to any such action, suit, demand, claim, complaint, hearing, notice of violation, investigations, notice, demand letter, proceeding or request, or any such liability:
(i) against, involving or of SIGA, or
(ii) against, involving or of any other person (including, without limitation, any FDA Company Contractor) that could be imputed or attributed to SIGA.
(d) There has not been any violation of any FDA Laws by SIGA in their prior product developmental efforts, or any other government entity (or any failure to make any such submission or report) that could reasonably be expected to require investigation, corrective action or enforcement action.
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.
(b) The Group Companies and, to the Knowledge of the Company, all Persons that formulate, manufacture, distribute or dispense products on behalf of the Group Companies, hold and are in compliance in all material respects with all registrations, approvals, clearances, permits, licenses, certifications, National Drug Codes, or other authorizations that, under applicable Laws administered or issued by the FDA or by any other Governmental Entities with oversight of the products, are required to carry on the Group Companies’ business as it is now being conducted.
(c) The Group Companies have not engaged in the non-clinical or clinical development, manufacture or compounding (sterile or non-sterile) of drugs that are subject to the jurisdiction of the FDA or state authorities, including state controlled substances acts.
(d) The Group Companies are in material compliance with all applicable import and export requirements, including FDA import-for-export requirements, export notifications or authorizations and record keeping requirements.
(e) To the Knowledge of the Company, each product distributed, marketed or sold by or on behalf of the Group Companies is in material compliance with all applicable product safety standards of each applicable product safety agency, commission, board or other Governmental Entity. Each of the Group Companies 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 the products, including complaint records adverse event reporting, inventory management and expiration dates. Any required product recalls, withdrawals, suspensions, seizures or discontinuations initiated by a product manufacturer or Governmental Entity have been conducted in material compliance with the...
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.
(ii) There are no facts or circumstances known to SINO that could lead to any FDA clearances or approvals possessed by SINO being revoked, suspended, canceled, or not renewed. SINO has submitted all necessary reports and filings to the FDA.
(iii) The execution and delivery of the Agreement, the consummation of the transactions contemplated by this Agreement, and the exercise by SINO of the rights to own and operate the businesses of SINO, as presently owned and operated, will not affect the validity, or require the transfer, of any FDA clearances or approvals held by SINO or any of its Subsidiaries.
(iv) There is no civil, criminal, or administrative action, suit, demand, claim, complaint, hearing, notice of violation, investigation, notice, demand letter, proceeding, or request for information pending or any liability (whether actual or contingent) to comply with any FDA Laws that requires any change in any manufacturing procedures by SINO. There is no act, omission, event, or circumstance of which SINO has knowledge that may give rise to any such action, suit, demand, claim, complaint, hearing, notice of violation, investigations, notice, demand letter, proceeding, or request, or any such liability: (A) against, involving, or of SINO or (B) against, involving, or of any other Person (including, without limitation, any FDA SINO Contractor) that could be imputed or attributed to SINO.
