FDA Regulatory and Healthcare Compliance Matters Sample Clauses

FDA Regulatory and Healthcare Compliance Matters. (a) To the Knowledge of Seller, Seller is in material compliance with all Healthcare Laws applicable to the Seller and the Business. The Seller has not received any written communication or notification of any pending or threatened hearing, enforcement, audit or other action from any Governmental Authority, alleging potential or actual noncompliance by, or liability of, the Seller, with respect to the Business, under any Healthcare Law. To the Knowledge of the Seller, there are no facts or circumstances related to the Business which would reasonably be expected to result in any civil, criminal, administrative, or other legal proceeding alleging any material violation by the Seller of any applicable Healthcare Laws. (b) There are no pending or, to the Knowledge of the Seller, threatened proceedings or actions concerning the Natroba Products by the FDA or any other Governmental Authority in connection with the Natroba Products, under any applicable Law, including any Healthcare Law. There are no pending, and since January 1, 2022, there have been no, fines, injunctions, civil or criminal penalties, recalls, seizures, detentions or suspensions, or withdrawals of any authorizations, product clearances, or approvals involving the Natroba Products. There are no pending or outstanding (i) warning letters or other enforcement actions, (ii) inspectional observations or establishment inspection reports, (iii) field notifications or alerts, (iv) import or export alerts, holds, or detentions, or (v) other documents that, in the case of each of the foregoing clauses (i)-(iv), have been received by, or on behalf of, the Seller from the FDA or any other Governmental Authority relating to the Natroba Products or arising out of the development, testing, manufacturing, sale or distribution of the Natroba Products, and that assert ongoing lack of compliance with applicable Laws, including any Healthcare Law, by the Seller. (c) The Seller has not received any notice that the FDA or any other Governmental Authority has commenced and, to the Knowledge of the Seller, no Governmental Authority has threatened to initiate, any action to withdraw its authorization, approval or clearance for, or to request a recall, seizure, or detention of, any Natroba Product, or commenced or threatened in writing to initiate any action to enjoin the production of any Natroba Product at any facility of the Seller or at any facility on behalf of the Seller. To the Knowledge of the Seller, there are ...
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Related to FDA Regulatory and Healthcare Compliance Matters

  • Statutory and Regulatory Compliance Contractor shall comply with all laws and regulations applicable to the Community Development Block Grant-Disaster Recovery funds appropriated by the Disaster Relief Appropriations Act, 2013 (Pub. L. 113-2), including but not limited to the applicable Office of Management and Budget Circulars, which may impact the administration of funds and/or set forth certain cost principles, including the allowability of certain expenses.

  • Health Care Compliance Neither the Company nor any Affiliate has, prior to the Effective Time and in any material respect, violated any of the health care continuation requirements of COBRA, the requirements of FMLA, the requirements of the Health Insurance Portability and Accountability Act of 1996, the requirements of the Women's Health and Cancer Rights Act of 1998, the requirements of the Newborns' and Mothers' Health Protection Act of 1996, or any amendment to each such act, or any similar provisions of state law applicable to its Employees.

  • Compliance Matters (a) The Sub-Adviser understands and agrees that it is a “service provider” to the Trust as contemplated by Rule 38a-1 under the 1940 Act. As such, the Sub-Adviser agrees to cooperate fully with the Adviser and the Trust and its Trustees and officers, including the Fund’s CCO, with respect to (i) any and all compliance-related matters, and (ii) the Trust’s efforts to assure that each of its service providers adopts and maintains policies and procedures that are reasonably designed to prevent violation of the “federal securities laws” (as that term is defined by Rule 38a-1) by the Trust, the Adviser and the Sub-Adviser. In this regard, the Sub-Adviser shall: (1) submit to the Board for its consideration and approval, prior to the effective date of this Agreement, the Sub-Adviser’s compliance program, it being understood that the Sub-Adviser’s obligation under Section 2(e) of this Agreement to vote all proxies solicited by or with respect to the issuers of securities in which the assets of the Portfolio may be invested shall be subject to the fulfillment of the condition that the Board approve the Sub-Adviser’s proxy voting policies and procedures; (2) submit annually (and at such other times as the Trust may reasonably request) to the Fund’s CCO and the Adviser for consideration by the Board, a report discussing the adequacy and effectiveness of the Sub-Adviser’s compliance program, and fully describing any material amendments to such compliance program since the most recent such report; (3) provide periodic reports, certifications and information concerning the Sub-Adviser’s compliance program including, but not limited to, the following; (i) Quarterly Compliance Certifications, including any required attachments, no later than the tenth (10th) business day after each calendar quarter; and (ii) Annual Report on Code of Ethics Matters, including any required attachments, no later than the fifteenth (15th) business day of October each year. (4) provide the Adviser and the Trust and its Trustees and officers with reasonable access to information regarding the Sub-Adviser’s compliance program, which access shall include on-site visits with the Sub-Adviser as may be reasonably requested from time to time; (5) permit the Adviser and the Trust and its Trustees and officers to maintain an active working relationship with the Sub-Adviser’s compliance personnel by, among other things, providing the Adviser and the Fund’s CCO and other officers with a specified individual within the Sub-Adviser’s organization to discuss and address compliance-related matters; (6) provide the Adviser and its chief compliance officer and the Trust and its Trustees and officers, including the Fund’s CCO, with such certifications as may be reasonably requested; and (7) reasonably cooperate with any independent registered public accounting firm engaged by the Trust, ensure that all reasonably necessary information and the appropriate personnel are made available to such independent registered public accounting firm, to support the expression of the independent registered public accounting firm’s opinion, and each year provide the Adviser and such independent registered public accounting firm with a copy of the most recent SSAE 16 Report prepared by the Sub-Adviser’s independent auditors regarding the Sub-Adviser’s internal controls. (b) The Sub-Adviser represents, warrants and covenants that it has implemented and shall maintain a compliance program in accordance with the requirements of Rule 206(4)-7 under the Advisers Act.

  • OSHA Compliance To the extent applicable to the services to be performed under this Agreement, Contractor represents and warrants, that all articles and services furnished under this Agreement meet or exceed the safety standards established and promulgated under the Federal Occupational Safety and Health Law (Public Law 91-596) and its regulations in effect or proposed as of the date of this Agreement.

  • Compliance with Healthcare Laws The tests, studies, and trials conducted by or on behalf of or sponsored by the Company or any of its subsidiaries were and, if still pending, are being conducted in all material respects in accordance with all applicable Health Care Laws (as defined below) and standard medical and scientific research protocols, procedures, and controls; none of the Company or any of its subsidiaries has received any written notice, correspondence, or other written communication from any regulatory agency or any institutional review board or comparable body requiring or threatening the termination, suspension, or material modification of any tests, studies, or trials, or commercial distribution, and to the knowledge of the Company and its subsidiaries, there are no reasonable grounds for the same. Each of the Company and its Subsidiaries has obtained (or caused to be obtained) the informed consent of each human subject who participated in a test, study, or trial. None of the tests, studies, or trials involved any investigator who has been disqualified as a clinical investigator. The Company and its directors, officers, employees, and agents are, and at all times prior hereto have been, in material compliance with, all health care laws and regulations applicable to the Company or any of its product candidates or activities, including development and testing of pharmaceutical products, kickbacks, recordkeeping, documentation requirements, the hiring of employees (to the extent governed by Health Care Laws), quality, safety, privacy, security, licensure, accreditation or any other aspect of developing and testing health care or pharmaceutical products (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the United States Food and Drug Administration, the Drug Enforcement Agency, the Centers for Medicare & Medicaid Services, and the U.S. Department of Health and Human Services Office of Inspector General, of potential or actual non-compliance by, or liability of, the Company under any Health Care Laws. To the Company’s knowledge, there are no facts or circumstances that would reasonably be expected to give rise to liability of the Company under any Health Care Laws, except that would not individually or in the aggregate have a Material Adverse Effect.

  • Litigation and Compliance ‌ (a) Except as disclosed in the Disclosure Letter, to the best of GLC’s knowledge, there are no actions, suits, claims or proceedings, whether in equity or at law or, any Governmental investigations pending or threatened: (i) against or affecting GLC or the GLC Subsidiaries or with respect to or affecting any asset or property owned, leased or used by GLC or the GLC Subsidiaries; or (ii) which question or challenge the validity of this Agreement, or the Amalgamation or any action taken or to be taken pursuant to this Agreement, or the Amalgamation; nor is GLC aware of any basis for any such action, suit, claim, proceeding or investigation. (b) There is not outstanding against GLC or the GLC Subsidiaries, any judgment, decree, injunction, rule, order or award of any court, Governmental entity, commission, board, bureau, agency, or arbitrator. (c) Each of GLC and the GLC Subsidiaries has conducted and is conducting its business in compliance with, and is not in default or violation under, and has not received notice asserting the existence of any default or violation under, any Law applicable to its business or operations, except for non-compliance, defaults and violations which would not, in the aggregate, have a Material Adverse Effect on GLC. (d) Neither GLC nor any of its assets, including the GLC Subsidiaries, is subject to any judgment, order or decree entered in any lawsuit or proceeding which has had, or which is reasonably likely to have, a Material Adverse Effect on GLC or which is reasonably likely to prevent GLC from performing its obligations under this Agreement. (e) To the best knowledge of GLC, each of GLC and the GLC Subsidiaries has duly filed or made all reports and returns required to be filed by it with any Government and has obtained all permits, licenses, consents, approvals, certificates, registrations and authorizations (whether Governmental, regulatory or otherwise) which are required in connection with its business and operations, except where the failure to do so has not had and will not have a Material Adverse Effect on GLC.

  • Reports; Regulatory Matters (a) Each of the Companies and their Subsidiaries have timely filed or furnished, as applicable, all reports, registrations, statements and certifications, together with any amendments required to be made with respect thereto, that they were required to file or furnish, as applicable, since January 1, 2006 with (i) any state regulatory authority, (ii) the SEC, (iii) any foreign regulatory authority, and (iv) any self-regulatory authority, (collectively, “Regulatory Agencies”) and with each other applicable Governmental Entity, and all other reports and statements required to be filed or furnished by them since January 1, 2006, including any report or statement required to be filed pursuant to the laws, rules or regulations of the United States, any state, any foreign entity, or any Regulatory Agency or other Governmental Entity, and have paid all fees and assessments due and payable in connection therewith. Except as set forth in Section 3.5 of the Company Disclosure Schedule, no Regulatory Agency or other Governmental Entity has initiated since January 1, 2006 or has pending any proceeding, enforcement action or, to the knowledge of Seller, investigation into the business, disclosures or operations of any of the Companies or any of its Subsidiaries. Since January 1, 2006, no Regulatory Agency or other Governmental Entity has resolved any proceeding, enforcement action or, to the knowledge of Seller, investigation into the business, disclosures or operations of any of the Companies or any of its Subsidiaries. There is no unresolved, or, to Seller’s knowledge, threatened criticism, comment, exception or stop order by any Regulatory Agency or other Governmental Entity with respect to any report or statement relating to any examinations or inspections of any of the Companies or any of its Subsidiaries. Since January 1, 2006, there have been no formal or informal inquiries by, or disagreements or disputes with, any Regulatory Agency or other Governmental Entity with respect to the business, operations, policies or procedures of any of the Companies or any of its Subsidiaries (other than normal inquiries made by a Regulatory Agency or other Governmental Entity in the Companies’ ordinary course of business). (b) No Company nor any of its Subsidiaries is subject to any cease-and-desist or other order or enforcement action issued by, or is a party to any written agreement, consent agreement or memorandum of understanding with, or is a party to any commitment letter or similar undertaking to, or is subject to any order or directive by, or has been ordered to pay any civil money penalty by, or has been since January 1, 2006 a recipient of any supervisory letter from, or since January 1, 2006 has adopted any policies, procedures or board resolutions at the request or suggestion of, any Regulatory Agency or other Governmental Entity that currently restricts or affects in any material respect the conduct of its business (or to Seller’s knowledge that, upon consummation of the transactions contemplated hereby, would restrict in any material respect the conduct of the business of either Buyer or any of its Subsidiaries), or that in any material manner relates to its capital adequacy, its ability to pay dividends, its credit, risk management or compliance policies, its internal controls, its management or its business, other than those of general application that apply to similarly situated companies or their Subsidiaries (each item in this sentence, a “Company Regulatory Agreement”), nor has any of the Companies or any of their Subsidiaries been advised since January 1, 2006 by any Regulatory Agency or other Governmental Entity that it is considering issuing, initiating, ordering, or requesting any such Company Regulatory Agreement. (c) Seller has previously made available to Buyers an accurate and complete copy of each (i) final registration statement, prospectus, report, schedule and definitive proxy statement filed with the SEC by Seller pursuant to the Securities Act or the Securities Exchange Act of 1934, as amended (the “Exchange Act”) since January 1, 2006 (the “Seller SEC Reports”) and prior to the date of this Agreement and (ii) communication mailed by Seller to its shareholders since January 1, 2006 and prior to the date of this Agreement. No such Seller SEC Report or communication, at the time filed or communicated (or, if amended prior to the date hereof, as of the date of such amendment), with respect to the Companies and their Subsidiaries only, contained any untrue statement of a material fact or omitted to state any material fact required to be stated therein or necessary in order to make the statements made therein, in light of the circumstances in which they were made, not misleading. To the knowledge of Seller, other than as set forth in Section 3.5 of the Company Disclosure Schedule, none of the Seller SEC Reports is the subject of any ongoing review or investigation by the SEC or any other Governmental Entity and there are no unresolved SEC comments with respect to any of such documents.

  • FDA Compliance The Company: (A) is and at all times has been in material compliance with all statutes, rules or regulations of the FDA and other comparable governmental entities 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 product under development, manufactured or distributed by the Company (“Applicable Laws”); (B) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any governmental entity alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such Authorizations; (D) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA or any governmental entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) has not received notice that the FDA or any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity is considering such action; and (F) has 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 materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).

  • Cooperation on forestry matters and environmental protection 1. The aims of cooperation on forestry matters and environmental protection will be, but not limited to, as follows: (a) establishing bilateral cooperation relations in the forestry sector; (b) developing a training program and studies for sustainable management of forests; (c) improving the rehabilitation and sustainable management of forest with the aim of increasing carbon sinks and reduce the impact of climate change in the Asia-Pacific region; (d) cooperating on the execution of national projects, aimed at: improving the management of forest plantations for its transformation for industrial purposes and environmental protection; (e) elaborating studies on sustainable use of timber; (f) developing new technologies for the transformation and processing of timber and non-timber species; and (g) improving cooperation in agro-forestry technologies. 2. To achieve the objectives of the Article 149 (Objectives), the Parties may focus, as a means of cooperation and negotiations on concluding a bilateral agreement on forestry cooperation between the two Parties. Such collaboration will be as follows: (a) exchanges on science and technology as well as policies and laws relating the sustainable use of forest resources; (b) cooperation in training programs, internships, exchange of experts and projects advisory; (c) advice and technical assistance to public institutions and organizations of the Parties on sustainable use of forest resources and environmental protection; (d) facilitating forest policy dialogue and technical cooperation under the Network of Sustainable Forest Management and Forest Rehabilitation in Asia- Pacific Region, initiated at the 15th Asia Pacific Economic Cooperation (APEC) Meeting; (e) encouraging joint studies, working visits, exchange of experiences, among others; and (f) others activities mutually agreed.

  • Reporting of Compliance Matters (a) The Sub-Adviser shall promptly provide to the Trust’s Chief Compliance Officer (“CCO”) the following documents: (i) copies of all SEC examination correspondences, including correspondences regarding books and records examinations and “sweep” examinations, issued during the term of this Agreement, in which the SEC identified any concerns, issues or matters (such correspondences are commonly referred to as “deficiency letters”) relating to any aspect of the Sub-Adviser’s investment advisory business and the Sub-Adviser’s responses thereto; (ii) a report of any material violations of the Sub-Adviser’s Compliance Program or any “material compliance matters” (as such term is defined in Rule 38a-1 under the 0000 Xxx) that have occurred with respect to the Sub-Adviser’s Compliance Program; (iii) a report of any material changes to the policies and procedures that compose the Sub-Adviser’s Compliance Program; (iv) a copy of the Sub-Adviser’s chief compliance officer’s report (or similar document(s) which serve the same purpose) regarding his or her annual review of the Sub-Adviser’s Compliance Program, as required by Rule 206(4)-7 under the Advisers Act; and (v) an annual (or more frequently as the Trust’s CCO may reasonably request) representation regarding the Sub-Adviser’s compliance with Paragraphs 7 and 8 of this Agreement. (b) The Sub-Adviser shall also provide the Trust’s CCO with: (i) reasonable access to the testing, analyses, reports and other documentation, or summaries thereof, that the Sub-Adviser’s chief compliance officer relies upon to monitor the effectiveness of the implementation of the Sub-Adviser’s Compliance Program; and (ii) reasonable access, during normal business hours, to the Sub-Adviser’s facilities for the purpose of conducting pre-arranged on-site compliance related due diligence meetings with personnel of the Sub-Adviser.

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