FDA Regulations. The Company and its subsidiaries: (A) are and at all times have been in compliance with all statutes, rules, or regulations, including but not limited to those administered by the United States Food and Drug Administration (“FDA”), the European Medicines Agency (“EMA”) and similar governmental authorities applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any products being developed, manufactured or distributed by the Company or its subsidiaries (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change; (B) have not received any warning letter or other correspondence or notice from the FDA, EMA or any other governmental authority alleging or asserting noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”);(C) possess all material Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations; (D) have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such governmental authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) have not received notice that any governmental authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and have no knowledge that any such governmental authority is considering such action; (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (G) have not, either voluntarily or involuntarily,...
FDA Regulations. The Company has operated and currently is in compliance with the United States Federal Food, Drug, and Cosmetic Act, as amended, and all applicable rules and regulations of the FDA and other federal, state, local and foreign governmental bodies exercising comparable authority, except where the failure to so operate or be in compliance would not reasonably be expected to have a Material Adverse Effect. The clinical studies conducted by or, to the Company’s knowledge, on behalf of the Company that are described in the Registration Statement and the Prospectus were, and, if still pending, are being, conducted in all material respects in accordance with the protocols submitted to the FDA and all applicable laws and regulations; preclinical studies conducted by or, to the Company’s knowledge, on behalf of the Company or any of its subsidiaries that are described in the Registration Statement and the Prospectus were, and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or, to the Company’s knowledge, on behalf of the Company contained in the Registration Statement and the Prospectus are accurate and complete in all material respects; and the Company is not aware of any other trials or studies, the results of which reasonably call into question the results described or referred to in the Registration Statement and the Prospectus; and the Company has not received any written notice or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension, or clinical hold of any preclinical or clinical studies, or such written notice or correspondence from any Institutional Review Board or comparable authority requiring the termination or suspension of a clinical study, conducted by or on behalf of the Company, which termination, suspension, or clinical hold would reasonably be expected to have a Material Adverse Effect. None of the Company, its subsidiaries, or their respective business operations, except as would not reasonably be expected to result in a Material Adverse Effect, is in violation of the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191) and the Health Information Technology for Economic and Clinical Health Act of 2009, and the regulations promulgated thereunde...
FDA Regulations. Except to the extent disclosed in the Prospectus (or any amendment or supplement thereto), to the Company’s knowledge after reasonable inquiry, the clinical, pre-clinical and other studies, tests and research conducted by or on behalf of or sponsored by the Company and intended to be submitted to U.S. regulatory authorities and to serve as a basis for approval are, and at all times have been, conducted in accordance with the FD&C Act and the regulations promulgated thereunder, including Title 21 of the Code of Federal Regulations, and other U.S. Food and Drug Administration (“FDA”) regulations governing clinical studies, current Good Laboratory Practices and Good Clinical Practices, the protection of human subjects and applicable institutional review board and independent ethics committee requirements, as well as other applicable federal, state, local and foreign Laws and consistent with current clinical and scientific research standards and procedures. The published descriptions of the results of such studies, tests and research are accurate and complete in all material respects and fairly present the data derived from such studies, tests and research, and the Company has no knowledge of any other studies, tests or research the results of which are inconsistent with or otherwise call into question the results described or referred to in the Prospectus. Except to the extent disclosed in the Prospectus (or any amendment or supplement thereto), the Company has not notified the FDA of any adverse reactions with respect to any clinical or pre-clinical studies, tests or research that are described in the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, and the Company has not received any notices or other correspondence from the FDA or any other governmental agency with respect to any clinical or pre-clinical studies, tests or research that are described in the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, in either case that would reasonably be expected to result in any action to place a clinical hold order on or otherwise result in the termination or suspension of such studies, tests or research, otherwise require the Company to engage in any remedial activities with respect to such studies, test or research, or threaten to impose or actually impose any fines or other disciplinary actions.
FDA Regulations. The FDA issued a Warning Letter to Xxxxxxx’x in June 2017 in response to which Xxxxxxx’x have taken certain corrective actions to address issues that the FDA identified in Xxxxxxx’x manufacturing of Pet Foods. These actions include: The defendants in the Action that engage in manufacturing have improved their current good manufacturing practices for pet food (“CGMP”), improved their employee training, and have enhanced their supplier verification and tracing of ingredients. These defendants have also created a HACCP plan and worked to ensure compliance with it through operation protocols, separation protocols (to prevent contamination and commingling), clean out protocols, and testing protocols. In addition, Xxxxxxx’x staff have: received certified training through the Food Safety Preventive Controls Alliance in food safety preventive controls; participated in training from the International Food Protection Training Institute, which is recognized by AAFCO. Xxxxxxx’x staff also completed an FDA food safety awareness module for sanitary transportation of human and animal food. In addition, Xxxxxxx’x forgoing actions also served to comply with the sections, rules, and regulations of the Food Safety Modernization Act (“FSMA”) applicable to a “Small Entity” that produces “low-acid canned food.” xxxxx://xxx.xxx.xxx/Food/GuidanceRegulation/FSMA/ucm366510.htm. Any of the defendants in the Action that engage in pet food manufacturing will continue to operate in compliance with applicable laws, rules, and regulations, including the FSMA.
FDA Regulations. UCSF understands and acknowledges that, as of the Third Amendment Effective Date, pending 510(k) marketing clearance from the U.S. Food and Drug Administration (“FDA”), the In-Kind Contributions are not available for sale in the United States. Accordingly, notwithstanding any provision herein to the contrary, pending 510(k) marketing clearance from the FDA, UCSF and the Principal Investigators shall use the In-Kind Contributions only to the extent such use is permitted under FDA regulations. Furthermore, pending 510(k) marketing clearance from the FDA, UCSF agrees that it will negotiate in good faith an amendment hereto if required by, and to the extent required by, FDA regulations in order to assure that this Amendment is consistent therewith.
FDA Regulations. Attached hereto as SCHEDULE 2.16 is a complete list of any and all warning letters, Form FDA 483s or other correspondence received by Seller which pertain to the Product Line copies of which have been previously provided to Buyer. To Seller's knowledge, the Seller is currently in full compliance with all U.S. Food and Drug Administration ("FDA") regulations pertaining to the operation of the Product Line, including, without limitation, the Medical Device Reporting Regulations as specified in 21 C.F.R. ss. 803, and any FDA registrations or reports are current.
FDA Regulations. AIR, Principal Investigator and Sponsor will comply with all applicable federal, state, and local laws, regulations and guidelines including, but not limited to, the FDCA, as amended, and regulations promulgated thereunder ("the Act") and the United States Food and Drug Administration ("FDA") regulations governing the protection of human subjects and regulations governing clinical investigators. XXXXX SCIENTIFIC SYSTEMS HOMATROPINE PROTOCOL PI/SPO#
FDA Regulations. CLIENT shall use the Services only for the purposes described within this agreement. If applicable, the Practice Intelligence portion of the Pearl Platform is NOT to be used as a Medical Device for the purpose of clinical review or diagnosis of patient radiographs as such term is defined in the Medical Device Regulation Act or Medical Device Amendments of 1976 published in the Code of Federal Regulations (“C.F.R.”) at Title 21, Sections 804 and 820 (The “FDA Regulations”). CLIENT hereby agrees not to use the Practice Intelligence portion of the Pearl Platform clinically without the execution of a separate Licensing Agreement for use of Second Opinion® as a Computer Aided Detection Device.
FDA Regulations. Except to the extent disclosed in the General Disclosure Package and the Final Prospectus (or any amendment or supplement thereto), to the Company’s knowledge after reasonable inquiry, the clinical, pre-clinical and other studies, tests and research conducted by or on behalf of or sponsored by the Company and intended to be submitted to U.S. regulatory authorities and to serve as a basis for approval are, and at all times have been, conducted in accordance with the FD&C Act and the regulations promulgated thereunder, including Title 21 of the Code of Federal Regulations, and other U.S. Food and Drug Administration (“FDA”) regulations governing clinical studies, current Good Laboratory Practices and Good Clinical Practices, the protection of human subjects and applicable institutional review board and independent ethics committee requirements, as well as other applicable federal, state, local and foreign Laws and consistent with current clinical and scientific research standards and procedures. The published descriptions of the results of such studies, tests and research are accurate and complete in all material respects and fairly present the data derived from such studies, tests and research, and the Company has no knowledge of any other studies, tests or research the results of which are inconsistent with or otherwise call into question the results described or referred to in the Prospectus. Except to the extent disclosed in the General Disclosure Package and the Final Prospectus (or any amendment or supplement thereto), the Company has not notified the FDA of any adverse reactions with respect to any clinical or pre-clinical studies, tests or research that are described in the General Disclosure Package or the Final Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure Package or the Final Prospectus, and the Company has not received any notices or other correspondence from the FDA or any other governmental agency with respect to any clinical or pre-clinical studies, tests or research that are described in the General Disclosure Package or the Final Prospectus or the results of which are referred to in the Registration Statement, General Disclosure Package or the Final Prospectus, in either case that would reasonably be expected to result in any action to place a clinical hold order on or otherwise result in the termination or suspension of such studies, tests or research, otherwise require the Company ...
FDA Regulations. Except to the extent disclosed in the Prospectus (or any amendment or supplement thereto), to the Company’s knowledge after reasonable inquiry, the clinical, pre-clinical and other studies, tests and research conducted by or on behalf of or sponsored by the Company and intended to be submitted to U.S. regulatory authorities and to serve as a basis for approval are, and at all times have been, conducted, to the extent so required, in material compliance with the FD&C Act and the regulations promulgated thereunder, including Title 21 of the Code of Federal Regulations, and other U.S. Food and Drug Administration (“FDA”) regulations governing clinical studies, current Good Laboratory Practices and Good Clinical Practices, the protection of human subjects and applicable institutional review board and independent ethics committee requirements, as well as other applicable federal, state, local and foreign Laws and consistent with current clinical and scientific research standards and procedures. The published descriptions of the results of such studies, tests and research are accurate and complete in all material respects and fairly present the data derived from such studies, tests and research, and the Company has no knowledge of any other studies, tests or research the results of which are inconsistent with or otherwise call into question the results described or referred to in the Prospectus. Except to the extent disclosed in the Prospectus (or any amendment or supplement thereto), the Company has not received any notices or other correspondence from the FDA or any other governmental agency with respect to any clinical or pre-clinical studies, tests or research that are described in the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, in either case that would reasonably be expected to result in any action to place a clinical hold order on or otherwise result in the termination or suspension of such studies, tests or research, otherwise require the Company to engage in any remedial activities with respect to such studies, test or research, or threaten to impose or actually impose any fines or other disciplinary actions.
