FDA and Other Regulatory Matters Sample Clauses

FDA and Other Regulatory Matters. (i) The Seller has all authorizations, approvals, licenses and orders of and from all governmental and regulatory offices, agencies, officers and bodies necessary to carry on the Business as it is currently being conducted, to own or hold under lease the properties and assets relating to the Business it owns or holds under lease and to perform all of its obligations under all agreements relating to the Business to which it is a party (collectively, the "Licenses"), and the Seller has been and is in compliance with all applicable laws, regulations and administrative orders of any country, state or municipality or of any subdivision thereof to which the Business and its employment of labor or its use or occupancy of properties or any part thereof are subject. Schedule 4.7(E)(i) sets forth a true and complete list of all material Licenses. (ii) With respect to the Business and the Assets: (a) The Seller has been and is in compliance with all current and otherwise applicable statutes, rules, regulations, standards, guides, or orders pertaining to the Assets (each a "Law" and collectively the "Laws") administered or issued by the federal Food and Drug Administration ("FDA") and all other federal, state, local, foreign or international governmental departments, regulatory agencies, authorities, commissions, boards or courts or other law, rule or regulation-making entities having regulatory authority over the Seller or the Business (the "Authorities"); and (b) The Seller has not received any notice from any applicable Authority of adverse findings, warning letters, Section 305 notices, subpoenas or other similar communications by any Authorities. (iii) There have been no recalls, field notifications, alerts or seizures requested or threatened relating to the Business. (iv) The Seller has made available to the Buyer a copy of all currently active investigational device exemptions ("IDE") filed with or -28- 29 approved by the FDA by or on behalf of the Seller or their predecessors-in-interest in connection with the Business and all premarket approval ("PMA") and premarket notification ("501(k)") clearance or concurrence letters received by the Seller from the FDA in connection with the Business and comparable communications received by the Seller from any other applicable Authorities and provided the Buyer with access to all related documents and information, including device master files and post-market studies. The Seller has made available to the Buyer all Europ...
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FDA and Other Regulatory Matters. (a) Each Loan Party and its Subsidiaries has, and it and its Products are in conformance with, all Registrations applicable to its respective business except where the failure to have such Registrations or be in conformance would not reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect. No Loan Party nor any of its Subsidiaries has received written notice that the FDA or any other Governmental Authority intends to suspend or revoke such Registrations or changing the marketing classification affecting the Products of the Loan Parties or any of their respective Subsidiaries. To the knowledge of each Loan Party and its Subsidiaries, there is no material false or misleading information or material omission in any product application or other submission to the FDA or other Governmental Authority administering Public Health Laws. To the knowledge of each Loan Party and its Subsidiaries, no event has occurred or condition or state of facts exists which would cause revocation or termination of any such Registration. To the knowledge of each Loan Party and its Subsidiaries, any third party that is a manufacturer or contractor for the Loan Parties or any of their respective Subsidiaries is in compliance in all material respects with all Registrations required by the FDA or comparable Governmental Authority and all Public Health Laws insofar as they reasonably pertain to the Products of the Loan Parties and their respective Subsidiaries. (b) Except as set forth on Schedule 3.18 to the Disclosure Letter: (i) each Loan Party and its Subsidiaries and, to their knowledge, their respective contract manufacturers are, and have been for the past five calendar years, in compliance in all material respects with, and each Product in current commercial distribution has been designed, developed, investigated, manufactured, prepared, assembled, packaged, tested, labeled, distributed, marketed, installed, and serviced in compliance in all material respects with the Public Health Laws or any other applicable Requirement of Law, including those regarding clinical and non-clinical testing, product approval or clearance, Quality System requirements, labeling, advertising and promotion, record-keeping, establishment registration and listing, reporting of recalls and adverse event reporting; (ii) each Loan Party and its Subsidiaries is in compliance in all material respects with the record-keeping and reporting requirements required by the F...
FDA and Other Regulatory Matters. (a) Except as set forth in Schedule 3.11(a), if applicable, none of the BioD Companies has received any notice or other communication from any Government Entity (i) contesting the uses of or the labeling and promotion of any of the products sold by the BioD Companies (“BioD Company Products”) or (ii) otherwise alleging any violation of any Law by any of the BioD Companies with respect to any BioD Company Products, excluding all observations communicated in FDA Form 483s resolved prior to 2013. (b) There have been no seizures conducted or threatened by the FDA or any other Government Entity, and no recalls, market withdrawals, field notifications, notifications of misbranding or adulteration, safety alerts conducted or adverse regulatory actions, requested, or threatened by the FDA or by any other Government Entity, in each case relating to any of the BioD Companies or the Business, any of their assets, or the BioD Company Products. (c) Certain Filings and Lists. (i) The BioD Companies have filed and maintained their respective Tissue Establishment Registrations in accordance with 21 CFR Part 1271 with FDA as processors and distributors of human cells, tissues and cellular- and tissue-based products (HCT/Ps). No filing or submission to FDA or any other Government Entity contains any material omission or material false information. (ii) Schedule 3.11(c)(ii): (1) lists all BioD Company Products (by SKU); (2) describes them by product category, general description, and type of product that each is “regulated as” (e.g., Section 361); (3) shows the applicable BioD Company’s status with respect to each BioD Company Product (e.g., “manufacturer”); and (4) indicates: (A) which BioD Company Products are commercialized, marketed, sold or placed in interstate commerce in the United States under an approved or cleared FDA authority (e.g., traditional, abbreviated or special **** This material has been omitted pursuant to a request for confidential treatment and filed separately with the Securities and Exchange Commission. 510(k), IDE, or IND); (B) which BioD Company Products are commercialized, marketed, or sold solely pursuant to a Tissue Establishment Registration, (C) which BioD Company Products are commercialized, marketed or sold outside the United States under an approved or cleared authority from another Government Entity; and (D) which BioD Company Products are not so commercialized, marketed, sold, or placed in interstate commerce under an approved or cleared ...
FDA and Other Regulatory Matters. (a) Except as set forth on Schedule 4.19(a) hereto, there are no unfulfilled outstanding agreements with or commitments to the FDA or any other regulatory body of any kind or character with respect to any Product; there are no adverse regulatory actions by the FDA or any other regulatory body (domestic or foreign) pending with respect to any Product; and Seller does not have any knowledge or information with respect to the initiation, pendency or threat by the FDA or other such regulatory body of any adverse regulatory action affecting any of the Products. Any Products manufactured or sold in the United States (i) are not misbranded or adulterated and (ii) have been produced in accordance with Good Manufacturing Practices, in each case within the meaning of the Act and any applicable FDA, state and local regulations. (b) The submissions made by Seller to obtain any NDA or any other regulatory filing to be made with any foreign, federal, state or other regulatory agency with respect to the Products were made in good faith and contained accurate and complete data and information regarding the Products as required by applicable laws, rules and, regulations.

Related to FDA and Other Regulatory Matters

  • Regulatory and Other Approvals (a) Subject to the terms and conditions of this Agreement and without limiting the provisions of Annex C, the Company will proceed diligently and in good faith to, as promptly as practicable, (i) obtain all consents, approvals or actions of, make all filings with and give all notices to Governmental or Regulatory Authorities (including state securities commissions) or any other public or private third parties required of the Company or any of its Subsidiaries to consummate the Offer and the other matters contemplated hereby, and (ii) provide such other information and communications to such Governmental or Regulatory Authorities or other public or private third parties as the other party or such Governmental or Regulatory Authorities or other public or private third parties may reasonably request in connection therewith. The Holders shall cooperate with the Company as it may reasonably request in connection with the Company's satisfaction of its obligations under this paragraph (a). (b) Subject to the terms and conditions of this Agreement and without limiting the provisions of Annex C, each Holder will proceed diligently and in good faith to, as promptly as practicable, (i) obtain all consents, approvals or actions of, make all filings with and give all notices to Governmental or Regulatory Authorities (including state securities commissions) or any other public or private third parties required of such Holder or any of its Subsidiaries to consummate the Offer and the other matters contemplated hereby, and (ii) provide such other information and communications to such Governmental or Regulatory Authorities or other public or private third parties as the other party or such Governmental or Regulatory Authorities or other public or private third parties may reasonably request in connection therewith. The Company shall cooperate with each Holder as it may reasonably request in connection with such Holder's satisfaction of its obligations under this paragraph (b).

  • Pollution and Other Regulations (a) Each of Holdings, the Borrower and its Subsidiaries is in compliance with all Environmental Laws governing its business for which failure to comply is reasonably likely to have a Material Adverse Effect, and neither Holdings, the Borrower nor any of its Subsidiaries is liable for any material penalties, fines or forfeitures for failure to comply with any of the foregoing in the manner set forth above. All licenses, permits, registrations or approvals required for the business of the Borrower and each of its Subsidiaries, as conducted as of the Restatement Effective Date, under any Environmental Law have been secured and the Borrower and each of its Subsidiaries is in substantial compliance therewith, except such licenses, permits, registrations or approvals the failure to secure or to comply therewith is not likely to have a Material Adverse Effect. Neither Holdings, the Borrower nor any of its Subsidiaries is in noncompliance with, breach of or default under any applicable writ, order, judgment, injunction, or decree to which Holdings, the Borrower or such Subsidiary is a party or which would affect the ability of the Borrower or such Subsidiary to operate any real property and no event has occurred and is continuing which, with the passage of time or the giving of notice or both, would constitute noncompliance, breach of or default thereunder, except in each such case, such noncompliance, breaches or defaults as are not likely to, in the aggregate, have a Material Adverse Effect. There are as of the Restatement Effective Date no Environmental Claims pending or, to the best knowledge of the Borrower, threatened, which (a) challenge the validity, term or entitlement of the Borrower or any of its Subsidiaries for any permit, license, order or registration required for the operation of any facility under the Environmental Laws which the Borrower or any of its Subsidiaries operates and (b) wherein an unfavorable decision, ruling or finding would be reasonably likely to have a Material Adverse Effect. There are no facts, circumstances, conditions or occurrences concerning Holdings, the Borrower or any of its Subsidiaries, any of their operations or on any Real Property or, to the knowledge of the Borrower, on any property adjacent to any such Real Property that could reasonably be expected (i) to form the basis of an Environmental Claim against the Borrower, any of its Subsidiaries or any Real Property of the Borrower or any of its Subsidiaries, or (ii) to cause such Real Property to be subject to any restrictions on the ownership, occupancy, use or transferability of such Real Property under any Environmental Law, except in each such case, such Environmental Claims or restrictions that individually or in the aggregate are not reasonably likely to have a Material Adverse Effect. (b) Hazardous Materials have not at any time been (i) generated, used, treated or stored on, or transported to or from, any Real Property of the Borrower or any of its Subsidiaries or (ii) released on any Real Property, in each case where such occurrence or event individually or in the aggregate is reasonably likely to have a Material Adverse Effect.

  • Regulatory and Other Authorizations; Consents (a) Subject to the other provisions of this Agreement, each party hereto shall each use its reasonable best efforts to perform its obligations under this Agreement and to take, or cause to be taken, and do, or cause to be done, all things necessary, proper or advisable under applicable Law to obtain all consents required under this Agreement and all regulatory approvals and to satisfy all conditions to its obligations under this Agreement and to cause the transactions contemplated hereby to be effected as soon as practicable, but in any event on or prior to the End Date, in accordance with the terms of this Agreement and shall cooperate fully with each other party hereto and their Representatives in connection with any step required to be taken as a part of its obligations under this Agreement. (b) Each party to this Agreement agrees to cooperate in obtaining any consents and approvals that may be required in connection with the transactions contemplated by this Agreement and the Companion Agreements; provided, however, that neither the Buyer nor the Sellers shall be required to compensate any Person, commence or participate in litigation or offer or grant any accommodation (financial or otherwise) to any Person to obtain any such consent or approval. Neither the Sellers nor the Buyer shall take any action that they should be reasonably aware would have the effect of delaying, impairing or impeding the receipt of any required consents or approvals. (c) Each party hereto promptly shall make all filings and submissions required of such party and shall take all actions necessary, proper or advisable under applicable Laws to obtain any required approval of any Governmental Authority with jurisdiction over the transactions contemplated hereby. Each party hereto shall use its reasonable best efforts to furnish to the appropriate Governmental Authority all information required for any application or other filing to be made pursuant to any applicable Law in connection with the transactions contemplated hereby. The Buyer and the Sellers shall make their respective HSR Act filings at such time as mutually agreed, if applicable. Each of the parties hereto shall cooperate with the other parties hereto in promptly filing any other necessary applications, reports or other documents with any Governmental Authority having jurisdiction with respect to this Agreement and the transactions contemplated hereby, and in seeking necessary consultation with and prompt favorable action by such Governmental Authority, including the resolution of any objections, if any, as may be asserted with respect to the transactions contemplated by this Agreement and the Companion Agreements under any applicable Law regarding antitrust matters. (d) Notwithstanding anything in this Agreement to the contrary, the Buyer acknowledges on behalf of itself and its Affiliates and its and their directors, officers, employees, Affiliates, agents, representatives, successors and assigns that the operation of the Business shall remain in the dominion and control of the Sellers until the Closing and that none of the foregoing Persons will provide, directly or indirectly, any directions, orders, advice, aid, assistance or information to any director, officer or employee of any of the Sellers with respect to the operation of the Business, except as specifically contemplated or permitted by this Article V or as otherwise consented to in advance by an executive officer of a Seller. (e) Notwithstanding anything in this Section 5.05 to the contrary, neither the Buyer nor any of its Subsidiaries shall be required to take any action, including responding to and/or defending any court or administrative proceeding, proposing or making any divestiture or other undertaking, or proposing or entering into any consent decree or taking any action which the Buyer reasonably determines could be material to the benefits expected to be derived by the Buyer as a result of the transactions contemplated hereby or be material to the business of the Buyer and its Subsidiaries or the Business as currently conducted or as contemplated to be conducted following the transactions contemplated hereby.

  • Compliance with Laws and Other Requirements (A) Tenant shall cause the Premises to comply in all material respects with all laws, ordinances, regulations and directives of any governmental authority having jurisdiction including, without limitation, any certificate of occupancy and any law, ordinance, regulation, covenant, condition or restriction affecting the Building or the Premises which in the future may become applicable to the Premises (collectively "Applicable Laws"). (B) Tenant shall not use the Premises, or permit the Premises to be used, in any manner which: (a) violates any Applicable Law; (b) causes or is reasonably likely to cause damage to the Building or the Premises; (c) violates a requirement or condition of any fire and extended insurance policy covering the Building and/or the Premises, or increases the cost of such policy; (d) constitutes or is reasonably likely to constitute a nuisance, annoyance or inconvenience to other tenants or occupants of the Building or its equipment, facilities or systems; (e) interferes with, or is reasonably likely to interfere with, the transmission or reception of microwave, television, radio, telephone or other communication signals by antennae or other facilities located in the Building; or (f) violates the Rules and Regulations described in Article XIX.

  • Regulatory and Other Authorizations; Notices and Consents (a) Subject to clause (c) of this Section 6.5, each of the parties shall use all reasonable efforts to (i) obtain all permits, authorizations, consents, orders and approvals of all Government Authorities that may be or become necessary for its execution and delivery of, and the performance of its obligations pursuant to, this Agreement, including those consents set forth in the Company Disclosure Schedule; (ii) lift or rescind any injunction or restraining order or other order adversely affecting the ability of the parties to this Agreement to consummate the transactions contemplated by this Agreement; and (iii) fulfill all conditions to the such party’s obligations under this Agreement. Each party to this Agreement shall cooperate fully with the other party in promptly seeking to obtain all such permits, authorizations, consents, orders and approvals, giving such notice and making such filings. (b) Each party agrees to make an appropriate filing pursuant to the HSR Act with respect to the transactions contemplated by this Agreement within five (5) Business Days of the date of this Agreement (including a request for early termination of the applicable waiting period under the HSR Act), shall supply promptly any additional information and documentary material that may be requested by any Governmental Authority and to supply as promptly as practicable to the appropriate Governmental Authorities any additional information and documentary material that may be requested pursuant thereto. Buyer shall have no obligations to divest any of its businesses or assets or to engage in litigation in order to secure approval under the HSR Act. (c) Each party hereto shall be responsible for the payment of its expenses, including legal fees and expenses, in substantially complying with any formal request for additional information or documentary material from any Governmental Authority. Buyer shall pay all filing fees required under the HSR Act. (d) Each of Buyer and the Merger Sub, on the one hand, and the Company on the other hand, shall, in connection with the efforts referenced in Section 6.5(a) to obtain all requisite permits, authorizations, consents, orders and approvals for the transactions contemplated by this Agreement, use its reasonable best efforts to (i) cooperate in all respects with each other in connection with any filing or submission and in connection with any investigation or other inquiry, (ii) keep the other party reasonably informed of the status of matters related to the transactions contemplated by this Agreement, including furnishing the other with any written notices or other communications received by such party from, or given by such party to, any Governmental Authority and (iii) permit the other party to review any communications given by it to, and consult with each other in advance of any meeting or conference with, any Governmental Authority; provided that nothing will prevent a party from responding to or complying with a subpoena or other legal process required by Law or submitting factual information in response to a request therefor.

  • Governmental and Other Approvals Apply for, obtain and/or maintain in effect, as applicable, all authorizations, consents, approvals, licenses, qualifications, exemptions, filings, declarations and registrations (whether with any court, governmental agency, regulatory authority, securities exchange or otherwise) which are necessary or reasonably requested by Agent in connection with the execution, delivery and performance by any Credit Party of, as applicable, this Agreement, the other Loan Documents, the Subordinated Debt Documents, or any other documents or instruments to be executed and/or delivered by any Credit Party, as applicable in connection therewith or herewith, except where the failure to so apply for, obtain or maintain could not reasonably be expected to have a Material Adverse Effect.

  • VERIFICATION OF LICENSES, CREDENTIALS AND OTHER DOCUMENTS CONTRACTOR shall submit to LEA a staff list, and copies of all current licenses, credentials, certifications, permits and/or other documents which entitle the holder to provide special education and/or related services by individuals employed, contracted, and/or otherwise hired or sub-contracted by CONTRACTOR. CONTRACTOR shall ensure that all licenses, credentials, permits or other documents are on file at the office of the County Superintendent of Schools. CONTRACTOR shall provide the LEA with the verified dates of fingerprint clearance, Department of Justice clearance and Tuberculosis Test clearance for all employees, approved subcontractors and/or volunteers prior to such individuals starting to work with any student. CONTRACTOR shall monitor the status of licenses, credentials, certifications, permits and/or other documents for all individuals employed, contracted, and/or otherwise hired by CONTRACTOR. CONTRACTOR shall notify LEA and CDE in writing within forty-five (45) days when personnel changes occur which may affect the provision of special education and/or related services to LEA students. CONTRACTOR shall notify LEA within forty-five (45) days if any such licenses, certifications or waivers are expired, suspended, revoked, rescinded, challenged pursuant to an administrative or legal complaint or lawsuit, or otherwise nullified during the effective period of this Master Contract. The LEA shall not be obligated to pay for any services provided by a person whose such licenses, certifications or waivers are expired, suspended, revoked, rescinded, or otherwise nullified during the period which such person is providing services under this Master Contract. Failure to notify the LEA and CDE of any changes in credentialing/licensed staff may result in suspension or revocation of CDE certification and/or suspension or termination of this Master Contract by the LEA.

  • Tax and Other Returns and Reports 4.7.1 The Seller Parties have timely filed or have caused to be filed or will file or will cause to be filed all Tax Returns required to be filed and have paid all Taxes required to be paid by the Seller Parties for all periods ending on or before the Closing Date. Adequate provision has been made in the books and records of each of the Sellers, and to the extent required by GAAP in the Financial Statements, for all Taxes whether or not due and payable and whether or not disputed. The Seller Parties have prepared all required Tax Returns, including amendments to date, in good faith without gross negligence or willful misrepresentation, and such Tax Returns are complete and accurate in all material respects. Section 4.7.1 of the Sellers Disclosure Schedule lists the date or dates through which the IRS and any other Governmental Entity have examined the United States federal income tax returns and any other Tax Returns of the Seller Parties. Except as set forth in Section 4.7.1 of the Sellers Disclosure Schedule, no Governmental Entity has during the past three years, examined or is in the process of examining any Tax Returns of the Seller Parties or proposed (tentatively or definitively), asserted or assessed or, to the best knowledge of each of the Seller Parties, threatened to propose or assert, any deficiency, assessment or claim for Taxes and there would be no basis for any such delinquency assessment or claim. 4.7.2 Each of the Sellers withheld and paid all Taxes required to have been withheld and paid in connection with amounts paid or owing to any employee, independent contractor, creditor, shareholder or other third party. 4.7.3 None of the Seller Parties nor any director or officer (or employee responsible for Tax matters) of the Sellers reasonably expects any authority to assess any additional Taxes for any period for which Tax Returns have been filed. There is no dispute or claim concerning any Tax Liability of any of the Sellers either (a) claimed or raised by any authority in writing or (b) as to which any of the Seller Parties and the directors and officers (and employees responsible for Tax matters) of the Sellers has knowledge based upon personal contact with any agent of such authority. Section 4.7.3 of the Sellers Disclosure Schedule lists all federal, state, local, and foreign income Tax Returns that have been audited and/or that currently are the subject of audit. Sellers have delivered to PEI or its designee correct and complete copies of all federal income Tax Returns, examination reports, and statements of deficiencies assessed against or agreed to by any of the Sellers since their date of incorporation. 4.7.4 None of the Seller Parties has waived any statute of limitations in respect of Taxes or agreed to any extension of time with respect to a Tax assessment or deficiency. 4.7.5 To the knowledge of each of the Seller Parties, the unpaid Taxes of Sellers (a) did not, as of the Most Recent Fiscal Month End, exceed the reserve for Tax Liability (rather than any reserve for deferred Taxes established to reflect timing differences between book and Tax income) set forth on the face of the Most Recent Balance Sheet (rather than in any notes thereto) and (b) do not exceed that reserve as adjusted for the passage of time through the Closing Date in accordance with the past custom and practice of Sellers in filing their Tax Returns. 4.7.6 None of the Seller Parties is a party to any Tax allocation or sharing agreement. None of the Sellers (a) has been a member of an Affiliated Group filing a consolidated federal income Tax Return (other than a group the common parent of which were one or the other of the Sellers) or (b) has any Liability for the Taxes of any Person (other than any of the Sellers) under Reg. ss.1.1502-6 (or any similar provision of state, local, or foreign law), as a transferee or successor, by contract, or otherwise.

  • Compliance with Laws and Other Instruments The execution, delivery and performance by Parent and/or Acquisition Corp. of the Merger Documents and the other agreements to be made by Parent or Acquisition Corp. pursuant to or in connection with the Merger Documents and the consummation by Parent and/or Acquisition Corp. of the transactions contemplated by the Merger Documents will not cause Parent and/or Acquisition Corp. to violate or contravene (a) any provision of law, (b) any rule or regulation of any agency or government, (c) any order, judgment or decree of any court or (d) any provision of their respective charters or By-laws as amended and in effect on and as of the Closing Date and will not violate or be in conflict with, result in a breach of or constitute (with or without notice or lapse of time, or both) a default under any material indenture, loan or credit agreement, deed of trust, mortgage, security agreement or other agreement or contract to which Parent or Acquisition Corp. is a party or by which Parent and/or Acquisition Corp. or any of their respective properties is bound.

  • Tax Returns and Other Reports The Administrative Trustees shall prepare (or cause to be prepared) at the principal office of the Trust in the United States, as defined for purposes of Treasury regulations section 301.7701-7, at the Depositor’s expense, and file, all United States federal, state and local tax and information returns and reports required to be filed by or in respect of the Trust. The Administrative Trustees shall prepare at the principal office of the Trust in the United States, as defined for purposes of Treasury regulations section 301.7701-7, and furnish (or cause to be prepared and furnished), by January 31 in each taxable year of the Trust to each Holder all Internal Revenue Service forms and returns required to be provided by the Trust. The Administrative Trustees shall provide the Depositor, Taberna Capital Management, LLC and the Property Trustee with a copy of all such returns and reports promptly after such filing or furnishing.

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