Compliance with Laws; Regulatory Compliance. (a) The Exploitation by Seller and its Affiliates of any Product and the ownership by Seller and its Affiliates of the Purchased Assets have been, at all times, in material compliance with all applicable Law, including applicable Regulatory Laws. Except as set forth in Seller’s Disclosure Schedule, neither Seller nor any Affiliate has received any written communication from a Governmental Entity that alleges that Seller or any Affiliate is not in compliance in any material respect with any Law or Order with respect to its Exploitation of any Product or with respect to ownership of the Purchased Assets, respectively and as applicable. Seller and its Affiliates have, and have had, all Product Registrations necessary for its lawful Exploitation of any Product prior to the Closing Date, and each of such Product Registrations, if any, is valid and in full force and effect.
(b) Except as set forth in the Seller Disclosure Schedule, there has not been any claim of which Seller or any Affiliate has received notice of any Action pending or threatened against Seller or an Affiliate relating to any Product or the Purchased Assets. To the Knowledge of Seller, there is no fact or circumstance that would reasonably be expected to serve as a basis for any Action against Seller or any Affiliate relating to any Product or any Purchased Assets or that, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement. There is no Action pending by Seller or any Affiliate, or which Seller intends to initiate against any Third Party relating to any Product or any Purchased Asset. There is no outstanding Order of any Governmental Entity against Seller (i) that relates to the Business, a Product or any Purchased Asset, (ii) that could reasonably be expected to be materially adverse to the Business, any Product or any Purchased Asset, or (iii) that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement.
(c) There is no Action pending or, to the Knowledge of Seller, threatened against Seller by any Governmental Entity, and there is no claim, investigation or administrative action of any Governmental Entity pending or, to the Knowledge of Seller, threatened, that affects or, if successful, could reasonably be expected to be materially adverse to Seller, the Bus...
Compliance with Laws; Regulatory Compliance. There are no existing violations by Seller of any applicable federal, canton or local law or regulation that could materially adversely affect the Assets, the Real Estate or the Business. Seller has complied in all material respects with all applicable laws, regulations and licensing requirements, and has filed with the proper authorities, all necessary statements and reports relating to the Business. Seller possesses all necessary licenses, franchises, permits and governmental authorizations to own the Assets and conduct the Business as now conducted.
Compliance with Laws; Regulatory Compliance. In the exercise of their respective rights and in the performance of their respective obligations under this Agreement, Licensee and Licensor shall, at all times, comply with all applicable laws, regulations and orders. Licensee specifically acknowledges that Licensor is subject to the gaming and licensing requirements of various jurisdictions and is obliged to take reasonable efforts to determine the suitability of its business associates. Licensee agrees to cooperate fully with Licensor in providing it with any reasonable information, of whatever nature, that Licensor deems necessary or appropriate in assuring itself that Licensee possesses the good character, honesty, integrity, and reputation applicable to those engaged in the gaming industry and Licensee specifically represents that there is nothing in Licensee’s background, history, or reputation that would be deemed unsuitable under the standards applicable to the gaming industry. If, during the term of the Agreement, Licensor is notified in writing by any regulatory agency that the conduct of business with Licensee will jeopardize Licensor’s, or its Affiliates’, license or ability to be licensed or if Licensor concludes that Licensee fails to meet the above criteria, the Agreement shall terminate upon written notice by Licensor and Licensor shall owe no further affirmative duty to Licensee.
Compliance with Laws; Regulatory Compliance. (a) Enlivex is in compliance in all material respects with all Laws, and Enlivex has no material liability for failure to comply with any Law. No investigation or review by any Governmental Entity with respect to Enlivex is pending or threatened, nor has any Governmental Entity indicated an intention to conduct the same.
(b) Enlivex has not, nor has any director, officer, employee, agent or Representative thereof, committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any amendments thereto, or for any other Governmental Entity that is concerned with the quality, identity, strength, purity, safety, efficacy, or manufacturing of Enlivex products (any such Governmental Entity, a “Enlivex Regulatory Agency”) to invoke any similar policy. No director, officer, employee, agent or Representative thereof, has engaged in any activity prohibited under any Health Care Law. There is no civil, criminal, administrative or other proceeding, notice or demand pending or threatened against Enlivex that relates to an alleged violation of any Health Care Law. No director, officer, employee, agent or Representative thereof, has been convicted of any crime or engaged in any conduct for which debarment or exclusion is mandated by 21 U.S.C. sec. 335a(a), 42 U.S.C. sec. 1320a-7(a) or any similar Law or authorized by 21 U.S.C. sec. 335a(b), 42 U.S.C. sec. 1320a-7(b) or any similar Law. There are no consent decrees (including plea agreements) or similar actions to which any director, officer, employee, agent or Representative thereof, are bound or which relate to Enlivex products or services.
(c) Enlivex has complied in all material respects with all applicable statutes, rules, regulations, decrees, writs and orders of the FDA and any other Enlivex Regulatory Agency with respect to the labeling, advertising, storing, testing, development, manufacture, packaging and distribution of Enlivex products. All pre-clinical studies conducted by Enlivex have been and are being conducted in compliance in all material respects with applicable licenses and Laws, including, without limitation, the applicable requirements of the FDA’s current Good Manufacturing Practices, Good Laboratory Practices and Good Clinical Practices. Each clinical trial con...
Compliance with Laws; Regulatory Compliance. (a) The Exploitation by the Sellers of the Products and the ownership by the Sellers of the Purchased Assets have been, since November 1, 2019, in compliance with all applicable Laws, including Regulatory Laws. Since November 1, 2019, neither of the Sellers has received any written communication from a Governmental Entity that alleges that either Seller or a Seller Affiliate is not in compliance in any material respect with any Law or Order with respect to their respective Exploitation of the Products or ownership of the Purchased Assets.
(b) To the extent the Sellers or their Affiliates have Exploited the Products, the Sellers and their Affiliates, as applicable, have, and have had, all Product Registrations necessary for such Exploitation of the Products, and each of such Product Registrations, if any, is valid and in full force and effect. Since November 1, 2019, there has occurred no violation by either Seller or any Seller Affiliate of, default (with or without notice or lapse of time or both) by either Seller or any Seller Affiliate under, or event giving to others any right of termination, suspension, revocation, material modification or cancellation of, with or without notice or lapse of time or both, any Product Registrations. Seller and its Affiliates are, and have been, in compliance with the terms of all Product Registrations and the consummation of this Agreement, in and of itself, will not cause the revocation or cancellation of any Product Registrations pursuant to the terms of any such Product Registrations.
(c) Since November 1, 2019, all Products that are subject to the jurisdiction of the FDA, DEA, or any other Regulatory Authority are being manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, advertised, promoted, and distributed by Seller and any Seller Affiliate in compliance with all applicable requirements under any Product Registrations or Laws administered or enforced by the FDA, DEA or any other applicable Regulatory Authority.
(d) There has not been any claim of which either Seller or a Seller Affiliate has received notice, suit, action, subpoena, demand, investigation, indictment, administrative proceedings, hearing, arbitration, alternative dispute resolution or other legal proceeding (whether sounding in contract, tort or otherwise, whether civil or criminal and whether brought at law or in equity) (“Litigation”) pending or threatened against either Seller or an Affiliate relating to the ...
Compliance with Laws; Regulatory Compliance. (a) Each of the Company and its Subsidiaries is in compliance with all Laws or Orders, except where any such failure to be in compliance has not had, or would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. No investigation or review by any Governmental Authority with respect to the Company or any of its Subsidiaries is pending or, to the Knowledge of the Company, threatened, nor has any Governmental Authority indicated an intention to conduct the same which, in each case, would reasonably be expected to have a material and adverse impact on the Company or any of its Subsidiaries.
(b) Except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, each of the Company and its Subsidiaries and their respective employees and agents hold all permits, licenses, variances, registrations, exemptions, Orders, consents and approvals from the U.S. Food and Drug Administration (the “FDA”) and any other Governmental Authority that is concerned with the quality, identity, strength, purity, safety, efficacy or manufacturing of Company Products (any such Governmental Authority, a “Company Regulatory Agency”) necessary for the lawful operating of the businesses of the Company and each of its Subsidiaries as currently conducted (the “Company Permits”), including all authorizations required under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), and the regulations of the FDA promulgated thereunder, and the Public Health Service Act of 1944, as amended (the “PHSA”). Notwithstanding the foregoing, it is acknowledged that no Company Product is a marketed product or has received marketing approval and, therefore, that further permits, licenses, variances, registrations, exemptions, Orders, consents and/or approvals will be required before any Company Product may be marketed. Except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, all such Company Permits are valid, and in full force and effect. Since January 1, 2013, there has not occurred any violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Company Permit except as has not had, and would not reasonably be expected to have, individu...
Compliance with Laws; Regulatory Compliance. (a) Each of Phoenix and each of its Subsidiaries is in compliance with all Laws or Orders, except where any such failure to be in compliance has not had, or would not reasonably be expected to have, individually or in the aggregate, a Phoenix Material Adverse Effect. No investigation or review by any Governmental Authority with respect to Phoenix or any of its Subsidiaries is pending or, to the Knowledge of the Phoenix, threatened, nor has any Governmental Authority indicated an intention to conduct the same which, in each case, would reasonably be expected to have a material and adverse impact on Phoenix or any of its Subsidiaries.
(b) Except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Phoenix Material Adverse Effect, each of Phoenix and its Subsidiaries and their respective employees and agents hold all permits, licenses, variances, registrations, exemptions, Orders, consents and approvals from the FDA and any other Governmental Authority that is concerned with the quality, identity, strength, purity, safety, efficacy or manufacturing of Phoenix Products (any such Governmental Authority, a “Phoenix Regulatory Agency”) necessary for the lawful operating of the businesses of Phoenix and each of its Subsidiaries as currently conducted (the “Phoenix Permits”), including all authorizations required under the FDCA and the regulations of the FDA promulgated thereunder, and the PHSA. Notwithstanding the foregoing, it is acknowledged that no Phoenix Product is a marketed product or has received marketing approval and, therefore, that further permits, licenses, variances, registrations, exemptions, Orders, consents and/or approvals will be required before any Phoenix Product may be marketed. Except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Phoenix Material Adverse Effect, all such Phoenix Permits are valid, and in full force and effect. Since January 1, 2013, there has not occurred any violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Phoenix Permit except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Phoenix Material Adverse Effect. Each of Phoenix and each of its Subsidiaries is in compliance in all material respects with the terms of all Pho...
Compliance with Laws; Regulatory Compliance. (a) The ownership of the Interests and, to the best of Antrim's knowledge, the ownership of the Joint Assets, the use of the Permits and the conduct of the Joint Operations have been and currently are in compliance with the provisions and requirements of any applicable law, licensing requirement or regulation. Antrim has filed with the proper authorities all necessary statements and reports required to be filed by it with respect to, and has at all times maintained all necessary licenses, permits, governmental authority or any other such authority to own, the Interests, and no existing violations exist in respect to such. There are no existing violations by Antrim of any applicable law or regulation that could materially adversely affect the Interests, nor, to the best of Antrim's knowledge, the Permits, the Joint Operations or the Joint Assets.
(b) Antrim is not aware of any facts, conditions or circumstances that could reasonably be expected to give rise to any claim or assertion that the Interests, the Permits, the Joint Operations or the Joint Assets are not in compliance with an applicable law or regulation or with any term or condition of any applicable license, permit, governmental authority, or any other such authority.
Compliance with Laws; Regulatory Compliance. (a) The Group Companies are, and for the past four years have been, in compliance in all material respects with all Laws or Orders. No investigation, inquiry, proceeding or similar action by any Governmental Authority with respect to any of the Group Companies is pending or, to the Knowledge of the Company, threatened in writing, nor has any Governmental Authority indicated in writing an intention to conduct the same which, in each case, would reasonably be expected to have a Company Material Adverse Effect.
(b) Each of the Group Companies holds all material Permits from the Ministry of Health and Welfare of Taiwan (the “MHW”) and any other Governmental Authority necessary for the operating of the Company Business in material compliance with applicable Laws (the “Company Permits”), including all Company Permits required under any Health Care Laws of other applicable jurisdictions. All such Company Permits are valid, and in full force and effect. There has not occurred any violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Company Permit. Each of the Group Companies is in compliance in all material respects with the terms of all Company Permits, and no event has occurred that, to the Knowledge of the Company, would reasonably be expected to result in the revocation, cancellation, non-renewal or adverse modification of any Company Permit.
(c) The Group Companies and the facilities owned or, to the Knowledge of the Company, used by each of the Group Companies have conducted, and, if still pending, are conducting, all clinical trials in compliance, in all material respects, with (i) all protocols as approved by the MHW or applicable Governmental Authorities, (ii) procedures and controls pursuant to the protocols, relevant industry standards, accepted professional and scientific standards, and (iii) all Laws implemented and/or administered by the MHW or other Governmental Authority in Taiwan or any other applicable jurisdiction relating to clinical investigations, and pre- and post-marketing adverse drug experience reporting, and all other pre- and post-marketing reporting requirements, as applicable (the “Rules”).
(d) None of the Group Companies has made any materially false statements on, or material omissions from, any representations, reports or other submissions, whether oral, written, or electro...
Compliance with Laws; Regulatory Compliance. (a) Each of Bioblast and its Subsidiaries is in compliance in all material respects, with all Laws. No investigation or review by any Governmental Entity with respect to Bioblast or any of its Subsidiaries is pending or threatened, nor has any Governmental Entity indicated an intention to conduct the same.
(b) Each of Bioblast and its Subsidiaries and their respective employees and agents hold all permits, certificates, licenses, variances, registrations, exemptions, orders, consents and approvals from the U.S. Food and Drug Administration (the “FDA”) and any other Governmental Entity that is concerned with the quality, identity, strength, purity, safety, efficacy or manufacturing of Bioblast products (any such Governmental Entity, a “Bioblast Regulatory Agency”) necessary for the lawful operation of the businesses of Bioblast and each of its Subsidiaries as currently conducted (the “Bioblast Permits”), including all authorizations required under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”) and the regulations of the FDA promulgated thereunder, and the Public Health Service Act of 1944, as amended (the “PHSA”). Section 3.21(b) of the Bioblast Disclosure Letter sets forth a list of all material Bioblast Permits as of the date of this Agreement. All such Bioblast Permits are valid, and in full force and effect. There has not occurred any material violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, under any Bioblast Permit. Each of Bioblast and each of its Subsidiaries is in compliance in all material respects with the terms of all Bioblast Permits, and no event has occurred that, would reasonably be expected to result in the revocation, cancellation, non-renewal or adverse modification of any Bioblast Permit.
(c) None of Bioblast or its Subsidiaries nor any director, officer, employee, agent or Representative thereof, has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any amendments thereto, or for any other Bioblast Regulatory Agency to invoke a similar policy. None of Bioblast or its Subsidiaries nor any director, off...
