Compliance with Regulatory Authorities. (i) Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, the pre-clinical trials and other tests conducted by or (x) on behalf of or sponsored by the Company or any of its subsidiaries, or (y) in which the Company or any of its subsidiaries has participated, that are described in the Prospectus, or the results of which are referred to in the Prospectus, as applicable, were, and if still pending, are being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and its subsidiaries and all applicable statutes and all applicable rules, regulations and guidance documents of the U.S. Food and Drug Administration (“FDA”) and comparable regulatory agencies outside of the United States to which they are subject, including the European Commission and the European Medicines Agency (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Prospectus of the results of such studies and tests are materially accurate and complete descriptions and fairly present the material data derived therefrom; (iii) the Company has no knowledge of any other trials or tests conducted by or (x) on behalf of or sponsored by the Company or any of its subsidiaries, or (y) in which the Company or any of its subsidiaries has participated that are not described in the Prospectus, the results of which are materially inconsistent with or raise questions concerning the validity of the results described or referred to in the Prospectus; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and (v) except as described in the Prospectus, the Company and its subsidiaries have not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, modification or suspension of any clinical or pre-clinical trials or other clinical or pre-clinical tests that are described in the Prospectus or the results of which are referred to in the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of ...
Compliance with Regulatory Authorities. The Company and each of its Subsidiaries is in compliance in all material respects with all applicable laws, rules and regulations (including, without limitation, all applicable regulations and orders) of, or agreements with, the Board of Governors of the Federal Reserve System, the Office of the Comptroller of the Currency (the “OCC”), the Federal Deposit Insurance Corporation, the Pennsylvania Department of Banking and Securities, the Pennsylvania Department of Insurance, the Financial Industry Regulatory Authority, Inc. (“FINRA”), the SEC and the Securities Investor Protection Corporation, as applicable (collectively, the “Regulatory Authorities”), the Equal Credit Opportunity Act, the Fair Housing Act, the Truth in Lending Act, the Community Reinvestment Act (the “CRA”), the Home Mortgage Disclosure Act, the Bank Secrecy Act and Title III of the USA Patriot Act, to the extent such laws or regulations apply to the Company or the Bank, as applicable. The Company and the Bank have no knowledge of any facts and circumstances, and has no reason to believe that any facts or circumstances exist, that could cause the Bank (A) to be deemed not to be in satisfactory compliance with the CRA and the regulations promulgated thereunder or to be assigned a CRA rating by federal or state banking regulators of lower than “satisfactory,” or (B) to be deemed to be operating in violation, in any material respect, of the Bank Secrecy Act of 1970 (or otherwise known as the “Currency and Foreign Transactions Reporting Act”), the USA Patriot Act (or otherwise known as “Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001”) or any order issued with respect to the Anti-Money Laundering Laws (as defined below). As of September 30, 2017, the Bank met or exceeded the standards necessary to be considered “well capitalized” under the FDIC’s regulatory framework for prompt corrective action. The Bank has been duly chartered, is validly existing under the laws of the Commonwealth of Pennsylvania and holds the requisite authority to do business as a state-chartered bank and trust company with banking powers under the laws of the Commonwealth of Pennsylvania. The Bank is the only depository institution subsidiary of the Company, and the Bank is a member in good standing of the Federal Home Loan Bank System. The activities of the Bank are permitted under the laws and regulations of the Commonwealth of Pennsylvania. Sinc...
Compliance with Regulatory Authorities. The parties mutually agree to cooperate fully in any regulatory examination or investigation by, or proceeding of any governmental or judicial authority arising in connection with this Agreement or the offering sale, and/or servicing of insurance thereunder, and to cooperate fully in any regulatory examination or investigation by, or proceeding of any governmental or judicial authority with respect to AGENCY or BISYS, and their respective affiliates, agents, representatives or employees to the extent that such investigation or proceeding is in connection to this Agreement or any conduct relating thereto.
Compliance with Regulatory Authorities. Additional payments or price increases may also be required to comply with regulatory requirements, fees, and other expenses incurred by DSM for importation of Product into additional foreign countries outside the Territory, in accordance with Section 7.5, or for expenses incurred by DSM to comply with material changes in regulatory requirements within the Territory (to the extent not previously contemplated). Any such price increases shall be limited to reflect the actual costs incurred by DSM as a result of compliance with said requirements, and shall be based on provision of reasonable documentation to Discovery Labs supporting such increase.
Compliance with Regulatory Authorities. In the event Company desires to file a marketing authorization application, or the equivalent thereof, with any regulatory authority which filing requires Company to submit Study Data, results or information pertaining to the Study, then Principal Investigator and Institution hereby agree to assist Company in complying with such request and shall give Company access to such data, information and results as reasonably necessary to enable Company to comply with such request. In addition, if reasonably required by Company or required by any regulatory authority, Institution and Principal Investigator shall forward the requested data, results or information directly to such regulatory authority.
Compliance with Regulatory Authorities. The Company has operated at all times and is currently in material compliance, with all applicable statutes, rules, regulations and policies of the U.S. Food and Drug Administration (the “FDA”), the U.S. Department of Health and Human Services (“HHS”) and applicable foreign regulatory authorities, including the European Medicines Agency (collectively, the “Regulatory Authorities”), including, without limitation:
(i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder;
(ii) all applicable federal, state, local and foreign health care laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), all applicable federal, state, local and foreign criminal laws relating to health care fraud and abuse, including but not limited to the U.S. False Statements Law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws, the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes;
(iii) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any applicable state or non-U.S. counterpart thereof or any other applicable law or regulation the purpose of which is to protect the privacy of individuals or prescribers;
(iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, and the regulations promulgated thereunder;
(v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and
(vi) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company and the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, ...
Compliance with Regulatory Authorities. The Merger and the issuance of securities in connection with the Merger shall be in compliance with all state and federal regulatory authorities.
Compliance with Regulatory Authorities. The clinical and pre-clinical tests conducted by or on behalf of or sponsored by the Company or the Subsidiary that are described in the documents incorporated by reference in the Final Offering Memorandum were and, if still pending, are being conducted in accordance, in all material respects, with standard medical and scientific research procedures; the descriptions in the Final Offering Memorandum of the results of such studies and tests are accurate and complete in all material respects and fairly present the data derived from such studies and tests; the Company and the Subsidiary have no knowledge of any other published studies conducted by third parties the results of which contest or contradict, and have no knowledge of any other published studies conducted by third parties that unsuccessfully attempted to replicate, the results described or referred to in the Final Offering Memorandum. Since January 1, 2003, the Company and the Subsidiary have operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the U.S. Food and Drug Administration (the “FDA”) and comparable drug regulatory agencies outside of the United States (collectively, the “Regulatory Authorities”); the Company has not received any notices or other correspondence from the Regulatory Authorities or any other governmental agency requiring the termination or suspension of any clinical or pre-clinical study or test sponsored by the Company or the Subsidiary and that is described in the Final Offering Memorandum or the results of which are referred to in the Final Offering Memorandum .
Compliance with Regulatory Authorities. The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiary that are described in the Prospectus or the results of which are referred to in the Prospectus were and, if still pending, are being conducted in accordance, in all material respects, with standard medical and scientific research procedures; the descriptions in the Prospectus of the results of such studies and tests are accurate and complete in all material respects and fairly present the data derived from such studies and tests; the Company and its subsidiary have no knowledge of any other studies or tests conducted by third parties the results of which contest or contradict, and have no knowledge of any other studies or tests conducted by third parties that unsuccessfully attempted to replicate, the results described or referred to in the Prospectus; except to the extent disclosed in the Registration Statement and the Prospectus, the Company and its subsidiary have operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the U.S. Food and Drug Administration (the “FDA”) and comparable drug regulatory agencies outside of the United States (collectively, the “Regulatory Authorities”); and except for the partial clinical hold placed on the Company’s D9902B trial in May 2002, which hold was lifted in October 2002, or otherwise to the extent disclosed in the Registration Statement and the Prospectus, the Company has not received any notices or other correspondence from the Regulatory Authorities or any other governmental agency requiring the termination or suspension of any clinical or pre-clinical study or test sponsored by the Company or its subsidiary and that is described in the Prospectus or the results of which are referred to in the Prospectus. Any certificate signed by an officer of the Company and delivered to the Representative or to counsel for the Underwriters shall be deemed to be a representation and warranty by the Company to each Underwriter as to the matters set forth therein.
Compliance with Regulatory Authorities
