FDA Approvals. The Company possesses all permits, licenses, registrations, certificates, authorizations, orders and approvals from the appropriate federal, state or foreign regulatory authorities necessary to conduct its business as now conducted, including all such permits, licenses, registrations, certificates, authorizations, orders and approvals required by the FDA or any other federal, state or foreign agencies or bodies engaged in the regulation of drugs, pharmaceuticals, medical devices or biohazardous materials. The Company has not received any notice of proceedings relating to the suspension, modification, revocation or cancellation of any such permit, license, registration, certificate, authorization, order or approval. Neither the Company nor, to the Company’s knowledge, any officer, employee or agent of the Company 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 entities, (B) debarment, suspension, or exclusion under any federal healthcare programs or by the General Services Administration, or (C) exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any governmental entities. Neither the Company nor any of its officers, employees, or, to the Company’s knowledge, any of its contractors or agents is the subject of any pending or threatened investigation by FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Application Integrity Policy”) and any amendments thereto, or by any other similar governmental entity pursuant to any similar policy. Neither the Company nor any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy. Neither the Company nor any of its officers, employees, or to the Company’s knowledge, any of its contractors or agents has made any materially false statements on, or material omissions from, any notifications, applications, approvals, reports and other submissions to FDA or any similar governmental entity.
FDA Approvals. Company shall use its commercially reasonable efforts to obtain promptly all Product Approvals, including, but not limited to, approvals from the FDA necessary for the commercial import, export, distribution and sale of the Product in the Territory.
FDA Approvals. Within seven days after the Closing Date, both Purchaser and Seller will inform FDA of the ownership transfer of the Assets if required by Law.
FDA Approvals. Datascope shall be solely responsible for identifying and obtaining, at its sole cost and expense, all FDA approvals in the United States as well as all other governmental approvals or certifications for the manufacture or distribution of the Licensed Devices in those countries throughout the world where the Licensed Devices are to be manufactured, distributed or sold. Masimo has received 510k clearance on its pulse oximetry system and Accessories, access and reference to which will be made available to Datascope.
FDA Approvals. Set out on Schedule 4.32 hereto is a detailed description of the United States Food and Drug Administration ("FDA") approvals that the Company is required to obtain for each of the Company's pharmaceutical products, the dates on which "Investigational New Drug Applications" and "New Drug Applications" were (or are expected to be) filed by the Company with the FDA for each such product, the dates on which clinical tests and trials were (or are expected to be) completed by the Company for each such product, and the dates on which FDA approvals were (or are expected to be) obtained by the Company for each such product.
FDA Approvals. The Company and its Subsidiaries possess all material permits, licenses, registrations, certificates, authorizations, orders and approvals required by the U.S. Food and Drug Administration (“FDA”) or, to the Company’s Knowledge, any other federal, state or foreign agencies or bodies engaged in the regulation of drugs or pharmaceuticals, in each case, necessary to conduct its and its Subsidiaries’ businesses as currently conducted as described in the Company Reporting Documents. The Company and its Subsidiaries have not received any written notice since January 1, 2017 of proceedings relating to the suspension, modification, revocation or cancellation of any such material permit, license, registration, certificate, authorization, order or approval, nor are there any still pending.
FDA Approvals. Entropin represents and warrants that it has or will obtain the necessary protocol approvals and/or amendments relative to the Study.
FDA Approvals. Ovation Platform (including Alto Abdominal Stent Graft System ) AFX Delivery System; Powerlink System: Nellix Endovascular Aneurysm Sealing System:
FDA Approvals. 27 9.03 Adverse Drug Experience; Recalls.........................27 9.04
FDA Approvals. (a) Within seven (7) days after the Closing Date, both Buyer and Seller will inform FDA of the ownership transfer of the Product Line as provided for in 21 CFR 314.72.
(b) The Buyer shall use its best efforts to apply, as soon as possible and, in any event, within one (1) year after the Closing Date, with the FDA for quality assurance test and release site, and stability test site change approvals for the Product Line required in connection with the Products and any other Product Registrations and Permits required by any Governmental Body with respect to the operation of the Product Line or the ownership or operation of the Assets.
(c) Within thirty (30) days of the approval by the FDA of the site transfers referenced in clause (b) of this Section, Buyer will assume full responsibility for the batch testing/release and stability testing of the Product Line.
