Permits and Regulatory Matters. (a) Merger Partner and each of its Subsidiaries have submitted all applications and obtained all permits, licenses, registrations, authorizations, certificates, orders, approvals, franchises, variances and other similar rights issued by or obtained from any Governmental Entities (collectively, “Permits”) that are material to the conduct of its business as currently conducted, including all such Permits required by the U.S. Food and Drug Administration (the “FDA”), and any other federal, state or foreign agencies or bodies (together with the FDA, the “Regulating Authority”) engaged in the regulation of pharmaceuticals or biohazardous materials.
(b) All Permits that are necessary for the conduct of the business of Merger Partner and each of its Subsidiaries as currently conducted (“Merger Partner Authorizations”) are in full force and effect, and to the knowledge of Merger Partner, Merger Partner has not received notice of any violations or notices of failure to comply in respect of any such Merger Partner Authorization. No such Merger Partner Authorization shall cease to be effective as a result of the consummation of the transactions contemplated by this Agreement. Merger Partner and each of its Subsidiaries is in compliance in all material respects under any of such Merger Partner Authorizations. All applications, reports, notices and other documents required to be filed by Merger Partner and its Subsidiaries with all Governmental Entities have been timely filed and are complete and correct in all material respects as filed or as amended prior to the date of this Agreement. None of Merger Partner, any Subsidiary of Merger Partner, and to Merger Partner’s knowledge, any officer, employee or agent of Merger Partner or any of its Subsidiaries has been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (A) disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a) or (b), or any similar law, rule or regulation of any other Governmental Entity, or (B) exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any Governmental Entity.
(c) Merger Partner and each of its Subsidiaries: (i) is and at all times has been in material compliance, to the extent applicable, with all statutes, rules, regulations (including all requirements relating to Good Manufacturing Practices, Good Clinical Practices and Good Laboratory Practices), and with all orders and admin...
Permits and Regulatory Matters. (a) Public Company and each of its Subsidiaries have all material Permits required to conduct their businesses as currently conducted, including all such Permits required by any Regulatory Authority, or any other Governmental Entity exercising comparable authority (the “Public Company Authorizations”).
(b) Public Company and its Subsidiaries are in compliance in all material respects with the terms of the Public Company Authorizations. No Public Company Authorization shall cease to be effective as a result of the consummation of the transactions contemplated by this Agreement.
(c) All manufacturing, processing, distribution, labeling, storage, testing, specifications, sampling, sale or marketing of products or other business operations performed by or on behalf of Public Company or any of its Subsidiaries are in compliance in all material respects with all applicable laws, rules, regulations or orders issued by the any Governmental Entity having jurisdiction, regulatory or other authority over Public Company or any of its Subsidiaries, as applicable. As of the date of this Agreement, except as set forth in Section 4.16(c) of the Public Company Disclosure Schedule, neither Public Company nor any of its Subsidiaries has received any written notices or other correspondence from any Governmental Entity and to the knowledge of Public Company, there is no action or proceeding pending or threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that Public Company or any of its Subsidiaries is in material noncompliance with any and all applicable laws, regulations or orders implemented by any Governmental Entity.
Permits and Regulatory Matters. (a) Public Company and each of its Subsidiaries have all permits, licenses, registrations, authorizations and franchises from Governmental Entities required to conduct their businesses as currently conducted or as currently proposed to be conducted, including without limitation all such permits, licenses, registrations, authorizations and franchises required by the FDA or any other Governmental Entity exercising comparable authority (the “Public Company Authorizations”), except for such permits, licenses, registrations, authorizations and franchises the lack of which, individually or in the aggregate, has not had, and is not reasonably likely to have, a Public Company Material Adverse Effect. Public Company and its Subsidiaries are in compliance with the terms of the Public Company Authorizations, except where the failure to so comply, individually or in the aggregate, has not had, and is not reasonably likely to have, a Public Company Material Adverse Effect. No Public Company Authorization shall cease to be effective as a result of the consummation of the transactions contemplated by this Agreement.
(b) All manufacturing, processing, distribution, labeling, storage, testing, specifications, sampling, sale or marketing of products performed by or on behalf of Public Company or any of its Subsidiaries are in compliance with all applicable laws, rules, regulations or orders administered or issued by the FDA or any other Governmental Entity exercising comparable authority, except where the failure to so comply, individually or in the aggregate, has not had, and is not reasonably likely to have, a Public Company Material Adverse Effect. Neither Public Company nor any of its Subsidiaries has received any notices or correspondence from the FDA or any other Governmental Entity exercising comparable authority, and to the knowledge of Public Company there is no action or proceeding pending or threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that Public Company or any of its Subsidiaries is not currently in compliance with any and all applicable laws, regulations or orders implemented by the FDA or any other Governmental Entity exercising comparable authority, except where the failure to so comply, individually or in the aggregate, has not had, and is not reasonably likely to have, a Public Company Material Adverse Effect.
(c) There are no seizures, recalls, market withdrawals, field notifications ...
Permits and Regulatory Matters. (a) Section 3.19 of the Company Disclosure Schedule sets forth a list of all Permits issued to or held by the Company or any Subsidiary. Each such Permit is in full force and effect; the Company or the applicable Subsidiary, as the case may be, is in compliance in all material respects with the terms of each such Permit; and, to the Knowledge of the Company, no suspension or cancellation of such Permit is threatened and there is no basis for believing that such Permit will not be renewable upon expiration. Each such Permit will continue in full force and effect immediately following the Closing.
(b) The Company and the Subsidiaries have all material Permits required to conduct their businesses as currently conducted, including all such Permits required by the FDA, Health Canada, the European Medicines Agency (the “EMA”) or any other Governmental Entity exercising comparable authority.
(c) All manufacturing, processing, distribution, labeling, storage, and testing of product candidates performed by or on behalf of Company are in compliance in all material respects with all applicable Laws administered or issued by the FDA, Health Canada, the EMA or any other Governmental Entity exercising comparable authority. Neither the Company nor any Subsidiary has received any written notices or correspondence from the FDA, the Health Canada, the EMA or any other Governmental Entity exercising comparable authority, and to the Knowledge of the Company, there is no action or proceeding pending or threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that the Company or any Subsidiary is not currently in compliance with any and all applicable Laws implemented by the FDA, Health Canada, the EMA or any other Governmental Entity exercising comparable authority.
(d) The studies, tests and preclinical and clinical trials of product candidates conducted by or on behalf of the Company and the Subsidiaries were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards. Neither the Company nor any Subsidiary has received any written notices or correspondence from the FDA, Health Canada, the EMA or any other Governmental Entity exercising comparable authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinica...
Permits and Regulatory Matters. (i) The Subject Company has or is in the process of obtaining all permits, licenses, registrations, authorizations, certificates, orders, approvals, franchises, variances and other similar rights issued by or obtained from any Governmental Entities (collectively, “Permits”) that are material to the conduct of its business as currently conducted.
(ii) All Permits that are necessary for the conduct of the business of the Subject Company as currently conducted are in full force and effect, and to the Knowledge of AAI, no violations or notices of failure to comply have been issued or recorded by any Governmental Entity in respect of any such Permit. No such Permit shall cease to be effective as a result of the consummation of the transactions contemplated by this Agreement. The Subject Company is in compliance in all material respects under any of such Permits.
Permits and Regulatory Matters. (a) Merger Partner has all permits, licenses, registrations, authorizations, certificates, orders, approvals, franchises, variances and other similar rights issued by or obtained from any Governmental Entities (collectively, “Permits”) that are material to the conduct of its business as currently conducted.
(b) All Permits that are necessary for the conduct of the business of Xxxxxx Partner as currently conducted (“Merger Partner Authorizations”) are in full force and effect, and to the knowledge of Merger Partner, no violations or notices of failure to comply have been issued or recorded by any Governmental Entities in respect of any such Merger Partner Authorization. No such Merger Partner Authorization shall cease to be effective as a result of the consummation of the transactions contemplated by this Agreement. Merger Partner is in compliance in all material respects under any of such Merger Partner Authorizations.
Permits and Regulatory Matters. (a) Public Company and each of its Subsidiaries have all Permits that are material to the conduct of its business as currently conducted.
(b) All Permits that are necessary for the conduct of the business of Public Company and each of its Subsidiaries as currently conducted (the "Public Company Authorizations") are in full force and effect, and to the knowledge of Public Company, no violations or notices of failure to comply have been issued or recorded by any Governmental Entity in respect of any such Public Company Authorization. No such Public Company Authorization shall cease to be effective as a result of the consummation of the transactions contemplated by this Agreement. Public Company and each of its Subsidiaries are in compliance in all material respects under any of such Public Company Authorizations.
Permits and Regulatory Matters. (a) Section 4.18(a) of the Seller Disclosure Schedule sets forth a true and complete list of all material Permits (including Environmental Permits) owned or held by Seller, any of its Affiliates and the Company as of the date of this Agreement that are required for the ownership, maintenance, occupancy, management and operation of the Project and the Business (collectively, with respect to the Project, the “Material Permits”), which of Seller, Seller’s Affiliates or the Company is the owner or holder thereof, the date of issuance thereof and the date of expiration thereof. Except for Exempt Wholesale Generator status, all material Permits for the ownership, maintenance, occupancy, management and operation of the Project and the Business have been obtained by Seller, its Affiliates and the Company. True and complete copies of all Material Permits have been made available to Purchaser prior to the date of this Agreement. Except as set forth on Section 4.18(a) of the Seller Disclosure Schedule or as would not, individually or in the aggregate, reasonably be expected to be material to the condition (financial or otherwise), assets, liabilities, businesses or result of operations of the Company:
(i) each Material Permit is valid and in full force and effect;
(ii) the Company is in material compliance with all Material Permits held by it; and
(iii) to the Knowledge of Seller, no event has occurred that, with or without notice or lapse of time or both, would reasonably be expected to result in the revocation, suspension, lapse or limitation of each Material Permit.
(b) Prior to the Closing, the Company has filed a notice of self-certification as an Exempt Wholesale Generator, which notice is effective and the Company will be an Exempt Wholesale Generator from the Pre-Closing Restructuring, and will continue through the Closing, to be an Exempt Wholesale Generator.
(c) The Company has received MBR Authority, which MBR Authority is in full force and effect as of the Closing.
(d) The Company is not a “holding company” as defined in PUHCA.
Permits and Regulatory Matters. 30 3.18 Insurance .....................................................................................................................31 3.19
Permits and Regulatory Matters. (a) Public Company and each of its Subsidiaries have all material permits, licenses, registrations, authorizations, certificates, orders, approvals, franchises, variances and other similar rights issued by or obtained from any Governmental Entities (collectively, “Permits”) required to conduct their businesses as currently conducted (the “Public Company Authorizations”).
(b) To the knowledge of Public Company, Public Company and its Subsidiaries are in compliance in all material respects with the terms of Public Company
