Permits; Regulatory Compliance. The Company and its subsidiaries have all authorizations, approvals, clearances, licenses, permits, certificates or exemptions (including manufacturing approvals and authorizations, pricing and reimbursement approvals, labeling approvals, registration notifications or their foreign equivalent) issued by any regulatory authority or governmental agency (collectively, “Permits”) required to conduct their respective businesses as currently conducted except to the extent that the failure to have such Permits would not have a Material Adverse Effect. The conduct of business by the Company complies, and at all times has substantially complied, in all material respects, with the Food, Drug, and Cosmetic Act of 7 1938, as amended, and other federal, state and foreign laws applicable to the evaluation, testing, manufacturing, distribution, advertising and marketing of each of the Company’s products, in whatever stage of development or commercialization, except to the extent that the failure to so comply would not have a Material Adverse Effect. To the knowledge of the Company, as of the date hereof, neither the U.S. Food and Drug Administration (the “FDA”) nor any comparable regulatory authority or governmental agency is considering limiting, suspending or revoking any such Permit or changing the marketing classification or labeling of the products of the Company or any of its subsidiaries. To the knowledge of the Company, there is no false or misleading information or material omission in any product application or other submission by the Company or any of its subsidiaries to the FDA or any comparable regulatory authority or governmental agency. The Company or its subsidiaries have fulfilled and performed in all material respects their obligations under each Permit, and, as of the date hereof, to the knowledge of the Company, no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Permit except to the extent that such breach, default, revocation or termination would not have a Material Adverse Effect. To the knowledge of the Company, any third party that is a manufacturer or contractor for the Company or any of its subsidiaries is in compliance in all material respects with all Permits insofar as they pertain to the manufacture of product components or products for the Company. The Company and its subsidiaries have not received any notice of adverse finding, warning ...
Permits; Regulatory Compliance. Except as disclosed in the Company’s Form 20-F for the fiscal year ended December 31, 2018 or except as disclosed in Schedule 4n, the Company does not own any equity interest and has not made any loans or advances to or guarantees of indebtedness to any person, corporation, partnership or other entity and is not a party to any joint venture, other than travel advances and expenses made in the ordinary course of business. Except as disclosed in Schedule 4n of the Disclosure Schedule or as disclosed in the Company’s Form 20-F for the fiscal year ended December 31, 2018 and any 6-K filed thereafter, to the knowledge of the Company, the conduct of business by the Company as presently and proposed to be conducted is not subject to continuing oversight, supervision, regulation or examination by any governmental official or body of the United States, or any other jurisdiction wherein the Company conducts or proposes to conduct such business, except (i) for the applicable laws, rules and regulations governing the drug and medical industry, including the Food and Drug Administration (the “FDA” or “USFDA”), and other similar laws, rules and regulations or other agencies, and governmental authorities around the world applicable to the Company or to its products, (ii) as described in the Subscription Documents and except as such regulation is applicable to commercial enterprises generally, applicable to the industry of the Company or to all companies in Israel or biomed companies in general. The Company has obtained all material licenses, permits and other governmental authorizations necessary to conduct its business as presently conducted, except where the failure to do so would not be reasonably expected to cause a Material Adverse Effect. The Company has not received any notice of any violation of, or noncompliance with, any material federal, state, local or foreign laws, ordinances, regulations and orders (including, without limitation, those relating to environmental protection, occupational safety and health, securities laws, equal employment opportunity) applicable to its business, the violation of, or noncompliance with, would have a Material Adverse Effect, and the Company knows of no facts or set of circumstances which could give rise to such a notice.
Permits; Regulatory Compliance. (a) Each of Company, its Subsidiaries other than Flotation and to the Company’s knowledge Flotation, possesses all certificates, authorizations and permits issued by the appropriate federal, state, local or foreign regulatory authorities necessary to conduct their respective businesses as such businesses are described in the SEC Filings (as defined in Section 4.15) and the Private Placement Memorandum, except where the failure to possess such permits would not reasonably be expected to result in a Material Adverse Effect, and neither the Company, any Subsidiary other than Flotation, nor to the Company’s knowledge Flotation, has received any notice of proceedings relating to the revocation or modification of any material permit.
Permits; Regulatory Compliance. (a) Each of the Acquired Companies is, and has at all times been, acting or operated in compliance with any Law or Order applicable to the Acquired Companies and their assets and properties. None of the Acquired Companies or any Person acting on their behalf has (i) received any notice, notification or communication from any Governmental Authority or other Person regarding any actual or possible violation of, or failure to comply with any provision of, any Law or Order applicable to the Acquired Companies or their assets or properties, or (ii) filed or otherwise provided any notice, notification or communication to any Governmental Authority or other Person regarding any actual or possible material violation of, or failure to comply with any material provision of any Law or Order applicable to the Acquired Companies or their assets or properties.
Permits; Regulatory Compliance. (a) Neither the Company nor, to the knowledge of the Company, any person acting on behalf of the Company, is in default or violation of any Law or any order, judgment, decision, determination, ruling, subpoena, verdict, writ, stipulation, award, injunction, decree, settlement agreement or similar agreement, arbitration award or finding entered by or with any Governmental Authority (including those of the Food and Drug Administration (the “FDA”) or any nongovernmental self-regulatory agency). The Company has timely filed or otherwise provided, or holds, all registrations, reports, data, documents, and other information and applications with respect to all products that are subject to federal, state or local regulatory requirements (the “Regulated Products”), if any, required to be filed with or otherwise provided to the FDA or any Governmental Authority with jurisdiction over the manufacture, distribution, labeling, advertising, promotion, use or sale of the Regulated Products, and all regulatory licenses or approvals in respect thereof are in full force and effect. The Regulated Products are not misbranded or adulterated or otherwise in violation of the Federal Food, Drug, and Cosmetic Act or other applicable federal, state or local Laws.
Permits; Regulatory Compliance. (a) Section 6.9(a) of the Seller Disclosure Schedule contains a complete and accurate list of each Regulatory Filing made or held by Seller for the Current Compounds and Current Products resulting from the Programs as currently conducted by Seller and material license, registration, franchise, application, permit or other similar authorization obtained by Seller to conduct the Programs as currently conducted by or on behalf of Seller, together with the name of the Governmental or Regulatory Authority issuing such license or permit (the “Permits”) made or held by Seller. Each such Permit is valid and in full force and effect, except as could not be expected to have an Adverse Effect on the ability to conduct the Programs. Seller has fulfilled and performed all of its material obligations with respect to the Permits, and no event has occurred, and Seller has not received any notice in writing from any Governmental or Regulatory Authority or otherwise of the occurrence of any event, that will constitute a violation of or a failure to comply with any term or requirement of any such Permit, or that would allow, or after notice or lapse of time would allow, the revocation, withdrawal, suspension, cancellation, or termination of any such Permit, except as could not be expected to have an Adverse Effect on the ability to conduct the Programs.
Permits; Regulatory Compliance. (a) The Company as a whole owns, holds or possesses all material Permits that are necessary to entitle the Company to own or lease, operate and use their assets, and to carry on and conduct the business of the Company in all material respects as conducted immediately prior to the date hereof, and a list of all such Permits as of the date hereof is set forth on Schedule 3.19(a). The Company has complied in all material respects with the terms and conditions of such Permits.
Permits; Regulatory Compliance. (a) The Company and its Subsidiaries are and since January 1, 2010, have been in possession and operating in material compliance with all required franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority material to the Company or any of its Subsidiaries in connection with the ownership, lease or operation of its properties and the operation of its business consistent with its past practice (the “Company Permits”). As of the date of this Agreement, no suspension or cancellation of any of the Company Permits is pending or, to the knowledge of the Company, threatened. Neither the Company nor any of its Subsidiaries is in violation of (i) any Company Permit or (ii) any applicable Law, including any consumer protection, equal opportunity, patient confidentiality, health, health care industry regulation and third-party reimbursement laws including under any Federal Health Care Program (as defined in Section 1128B(f) of the U.S. Federal Social Security Act), except in the case of clauses (i) or (ii) as would not have a Company Material Adverse Effect.
Permits; Regulatory Compliance. (a) The Company is, and has at all times been, acting or operated in material compliance with any Law or Order applicable to the Company and its assets and properties. The Company, or any Person acting on its behalf, has not (i) received any written notice, notification or communication from any Governmental Authority or other Person regarding any actual or possible violation of, or failure to comply with any provision of, any Law or Order applicable to the Company or its assets or properties, or (ii) filed or otherwise provided any written notice, notification or communication to any Governmental Authority or other Person regarding any actual or possible violation of, or failure to comply with any provision of any Law or Order applicable to the Company or its assets or properties. For the avoidance of doubt, this Section 4.07 does not include any representations related to Intellectual Property.
Permits; Regulatory Compliance. Supplier will be responsible for obtaining and maintaining at its expense, any licenses or permits, and any regulatory or governmental approvals necessary for Supplier’s manufacture of API at its manufacturing site. Customer will be responsible for maintaining full compliance with regulatory requirements as it relates to the API or its testing after Delivery. Each Party agrees to provide the other with reasonable assistance and take all reasonable actions requested by the other that are necessary or desirable to enable the other Party to comply with any law or regulation applicable to the API, or any ingredient of the API, or to the testing of the API.
