Additional Legal Compliance Sample Clauses

Additional Legal Compliance. (i) to AcelRx’s Best Knowledge, AcelRx and its Affiliates and any outsourcing company and contract research organization to which AcelRx or its Affiliates have subcontracted activities in connection with Device and the Licensed Product (the “Contractors”) have complied with all Applicable Laws, permits, governmental licenses, registrations, approvals, concessions, franchises, authorizations, orders, injunctions and decrees in the research, development, Manufacture and use of the Licensed Product and Device, and neither AcelRx nor any of its Affiliates or its Contractors has received any written notice from any governmental authority claiming that any such activities as conducted by them are not in such compliance. (ii) no governmental authority (including the FDA) has commenced or, to AcelRx’s Best Knowledge, threatened to initiate any action to enjoin production of the Device or the Licensed Product at any facility, nor has AcelRx or any of its Affiliates or, to the Best Knowledge of AcelRx, any of its Contractors, received any notice to such effect. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (iii) all development activities conducted by AcelRx and its Affiliates and Contractors relating to the Licensed Product and/or Device have been conducted in compliance with all Applicable Laws, including all GCPs, GLPs and GMPs when applicable. (iv) to AcelRx’s Best Knowledge, no employee or agent of AcelRx or any of its Affiliates or Contractors has made an untrue statement of a material fact to any governmental authority with respect to the Licensed Product and/or Device (whether in any Regulatory Filings or otherwise), or failed to disclose a material fact to any governmental authority required to be disclosed with respect to the Licensed Product and/or Device. (v) To AcelRx’s Best Knowledge, AcelRx has disclosed or otherwise provided Grünenthal with all information that would have, or would be reasonably likely to have, a material effect on the ability of Grünenthal to develop or commercialize the Licensed Product in the Field in the Territory under the terms and conditions of this Agreement and that relates to (A) the AcelRx Technology, (B) any Third Party intellectual property rights or claims that relate to the commercialization or development of the Licensed ...
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Additional Legal Compliance. (i) [***] Nanobiotix and its Affiliates have complied [***] with all Applicable Laws in conducting Development and Manufacturing of the Licensed Product prior to the Effective Date, and neither Nanobiotix nor any of its Affiliates has received any written notice from any Governmental Authority in the Territory claiming that any such activities as conducted by them are not in such compliance. (ii) No Governmental Authority in the Territory has commenced or [***] threatened to initiate any action to enjoin production of the Licensed Product at any facility, nor has Nanobiotix or any of its Affiliates or [***] any of its contractor manufacturers, received any notice to such effect, nor has Nanobiotix received any order not to import the Licensed Product into the Territory.
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Additional Legal Compliance. (i) No governmental authority (including the FDA) has commenced or, to the Knowledge of Arena, threatened to initiate any action to enjoin production of the Initial Product at any facility, nor has Arena or any of its Affiliates or, to the Knowledge of Arena, any of its contractors, received any written notice thereof. (ii) Arena or one of its Affiliates has prepared, maintained and retained all Regulatory Filings that are required to be maintained or retained as of the 2nd Amendment Effective Date pursuant to and in accordance with GLP, GCP and other Applicable Laws. (iii) Neither Arena nor any of its Affiliates received any written notice or to the Knowledge of Arena, any oral notice, that indicates that any of the INDs for the Initial Product are not currently in good standing with the FDA. (iv) Arena or one of its Affiliates has filed with the FDA all required notices, supplemental applications and annual or other reports or documents, including adverse experience reports, with respect to each IND that are material to the continued development of the Initial Product. (v) Neither Arena nor any of its Affiliates, nor any of its or their respective officers, employees, or agents has made an untrue statement of material fact or fraudulent statement to the FDA or any other Regulatory Authority with respect to the development of the Initial Product, failed to disclose a material fact required to be disclosed to the FDA with respect to the development of the Initial Product, or committed an act, made a statement, or failed to make a statement with respect to the development of the Initial Product that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto.
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Additional Legal Compliance. Provider shall comply at its sole expense with all applicable laws in performance of the Agreement. Provider agrees that, if it receives information or records concerning any student in provision of the Services, it shall not disclose the same except as permitted by the Family Educational Rights and Privacy Act a/k/a FERPA. Provider shall furthermore comply at its sole expense with the requirements of Section 22.0834 of the Texas Education Code, Section 153.1117 of Title 19 of the Texas Administrative Code, and any YISD board policy relating to or arising from such statute or regulation, shall ensure that no covered employee of Provider or of any subcontractor [if authorized] with a disqualifying criminal history performs services under the Agreement at or for YISD, and shall timely provide to written certifications thereunder in such form and substance as requested by YISD.
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Additional Legal Compliance. Based on the District’s review and the School’s assurances of compliance, and except as noted below or elsewhere in this evaluation, The District believes that the School complies with the following requirements/laws, as applicable:
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Additional Legal Compliance to AcelRx’s Best Knowledge, AcelRx and its Affiliates and any outsourcing company and contract research organization to which AcelRx or its Affiliates have subcontracted activities in connection with Device and the Licensed Product (the “Contractors”) have complied with all Applicable Laws, permits, governmental licenses, registrations, approvals, concessions, franchises, authorizations, orders, injunctions and decrees in the research, development, Manufacture and use of the Licensed Product and Device, and neither AcelRx nor any of its Affiliates or its Contractors has received any written notice from any governmental authority claiming that any such activities as conducted by them are not in such compliance.
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Additional Legal Compliance. (i) As of the Effective Date, ACADIA and its Affiliates and, to the Best Knowledge of ACADIA, any outsourcing company and contract research organization to which ACADIA or its Affiliates have subcontracted activities in connection with Pimavanserin (the “Contractors”) have complied in all material respects with all Applicable Laws, including all GCPs, GLPs and GMPs, permits, governmental licenses, registrations, approvals, concessions, franchises, authorizations, orders, injunctions and decrees, in the research, development, manufacture and use of Pimavanserin, and neither ACADIA nor any of its Affiliates nor, to the Best Knowledge of ACADIA, its Contractors, has received any written notice from any governmental authority claiming that any such activities as conducted by them are not in such compliance.
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Additional Legal Compliance. No governmental authority has commenced or, to the Knowledge of Arena, threatened to initiate any action to enjoin production of a Compound at any Facility, nor has Arena or any of its Affiliates or, to the Knowledge of Arena, any of its contractors, received any written notice thereof.
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Related to Additional Legal Compliance

  • Legal Compliance Contractor represents and warrants that it shall secure all notices and comply with all applicable laws, ordinances, rules and regulations of any governmental entity in conjunction with the performance of obligations under the Contract. Prior to award and during the Contract term and any renewals thereof, Contractor must establish to the satisfaction of the Commissioner that it meets or exceeds all requirements of the Bid and Contract and any applicable laws, including but not limited to, permits, licensing, and shall provide such proof as required by the Commissioner. Failure to comply or failure to provide proof may constitute grounds for the Commissioner to terminate or suspend the Contract, in whole or in part, or to take any other action deemed necessary by the Commissioner. Contractor also agrees to disclose information and provide affirmations and certifications to comply with Sections 139-j and 139-k of the State Finance Law.

  • Representations Relating to Documents and Legal Compliance Borrower represents and warrants to Silicon as follows: All statements made and all unpaid balances appearing in all invoices, instruments and other documents evidencing the Receivables are and shall be true and correct and all such invoices, instruments and other documents and all of Borrower's books and records are and shall be genuine and in all respects what they purport to be, and all signatories and endorsers have the capacity to contract. All sales and other transactions underlying or giving rise to each Receivable shall fully comply with all applicable laws and governmental rules and regulations. All signatures and endorsements on all documents, instruments, and agreements relating to all Receivables are and shall be genuine, and all such documents, instruments and agreements are and shall be legally enforceable in accordance with their terms.

  • Evidence of Compliance with Conditions Precedent The Guarantor shall provide to the Guarantee Trustee such evidence of compliance with such conditions precedent, if any, provided for in this Guarantee Agreement that relate to any of the matters set forth in Section 314(c) of the Trust Indenture Act. Any certificate or opinion required to be given by an officer pursuant to Section 314(c)(1) may be given in the form of an Officers' Certificate.

  • Existence; Compliance with Legal Requirements Borrower shall, and shall cause Mortgage Borrower, Senior Mezzanine Borrower and Operating Company to, do or cause to be done all things necessary to preserve, renew and keep in full force and effect their existence, rights, licenses, permits and franchises and comply with all Legal Requirements applicable to Borrower, Senior Mezzanine Borrower, Mortgage Borrower, the Collateral, the Senior Mezzanine Collateral, Operating Company and the Properties, including, without limitation, Prescribed Laws. There shall never be committed by Borrower and Borrower shall not permit Mortgage Borrower or Senior Mezzanine Borrower to permit any other Person in occupancy of or involved with the operation or use of the Properties, including Operating Company, to commit any act or omission affording the federal government or any state or local government the right of forfeiture against the Collateral, the Senior Mezzanine Collateral, any Individual Property or any part thereof or any monies paid in performance of Borrower’s obligations under any of the Loan Documents. Borrower hereby covenants and agrees not to commit, permit or suffer to exist any act or omission affording such right of forfeiture. Borrower shall, and shall cause Mortgage Borrower to, at all times maintain, preserve and protect all franchises and trade names and preserve all the remainder of its property used or useful in the conduct of its business and shall keep the Properties in good working order and repair. Borrower shall cause Mortgage Borrower to keep the Properties insured at all times as (and in the amounts) provided elsewhere in this Agreement. Borrower shall cause Mortgage Borrower to operate any Individual Property that is the subject of the O&M Agreement in accordance with the terms and provisions thereof in all material respects. After prior notice to Lender, Borrower, at its own expense, may contest (or cause Mortgage Borrower to contest) by appropriate legal proceeding promptly initiated and conducted in good faith and with due diligence, the validity of any Legal Requirement, the applicability of any Legal Requirement to Borrower, Senior Mezzanine Borrower, Mortgage Borrower, the Collateral, the Senior Mezzanine Collateral or any Individual Property or any alleged violation of any Legal Requirement, provided that (i) no Event of Default has occurred and remains uncured; (ii) such proceeding shall be permitted under and be conducted in accordance with the provisions of any applicable material instrument to which Borrower, Senior Mezzanine Borrower or Mortgage Borrower is subject and shall not constitute a default thereunder and such proceeding shall be conducted in accordance with all Legal Requirements; (iii) none of the Collateral, the Senior Mezzanine Collateral or any Individual Property nor any material part thereof or interest therein will be in imminent danger of being sold, forfeited, terminated, cancelled or lost; (iv) Borrower shall promptly upon receipt of a final, non-appealable determination thereof comply with any such Legal Requirement determined to be valid or applicable or cure any violation of any such Legal Requirement; (v) such proceeding shall suspend the enforcement of the contested Legal Requirement against Borrower, Senior Mezzanine Borrower, Mortgage Borrower, the Collateral, the Senior Mezzanine Collateral and any Individual Property; and (vi) Borrower shall furnish such security as may be required in the proceeding, or as may be reasonably requested by Lender, to insure compliance with such Legal Requirement, together with all interest and penalties payable in connection therewith. Lender may apply any such security, as necessary to cause compliance with such Legal Requirement at any time when, in the reasonable judgment of Lender, the validity, applicability or violation of such Legal Requirement is finally established or the Collateral, the Senior Mezzanine Collateral or any Individual Property (or any part thereof or interest therein) shall be in imminent danger of being sold, forfeited, terminated, cancelled or lost.

  • Existence; Compliance with Legal Requirements; Insurance Each Borrower and Operating Lessee shall do or cause to be done all things necessary to preserve, renew and keep in full force and effect its Entity existence, rights, licenses, Permits and franchises necessary for the conduct of its business and to comply or to initiate compliance in all material respects with all applicable Legal Requirements and Insurance Requirements applicable to it and each Individual Property. Each Borrower and Operating Lessee shall notify Lender promptly of any written notice or order that such Borrower or Operating Lessee receives from any Governmental Authority relating to such Borrower’s or Operating Lessee’s failure to comply with such applicable Legal Requirements relating to such Borrower’s or Operating Lessee’s applicable Individual Property and promptly take any and all actions necessary to bring its operations at such Individual Property into compliance with such applicable Legal Requirements (and shall fully comply with the requirements of such Legal Requirements that at any time are applicable to its operations at any Individual Property) provided, that such Borrower or Operating Lessee at its expense may, after prior notice to the Lender, contest by appropriate legal, administrative or other proceedings conducted in good faith and with due diligence, the validity or application, in whole or in part, of any such applicable Legal Requirements as long as (i) neither the applicable Collateral nor any part thereof or any interest therein, will be sold, forfeited or lost or subject to a continuing Lien if such Borrower or Operating Lessee pays the amount or satisfies the condition being contested, and such Borrower or Operating Lessee would have the opportunity to do so, in the event of such Borrower’s or Operating Lessee’s failure to prevail in the contest, (ii) Lender would not, by virtue of such permitted contest, be exposed to any risk of any civil liability or criminal liability, and (iii) such Borrower or Operating Lessee shall have furnished to the Lender additional security in respect of the claim being contested or the loss or damage that may result from such Borrower’s or Operating Lessee’s failure to prevail in such contest in such amount as may be reasonably requested by Lender but in no event less than one hundred twenty-five percent (125%) of the amount of such claim. Each Borrower and Operating Lessee shall at all times maintain, preserve and protect, or cause the maintenance, preservation and protection of, all franchises and trade names and preserve or cause the preservation of all the remainder of its property necessary for the continued conduct of its business and keep the applicable Individual Properties, or cause the same to be kept, in good repair, working order and condition, except for reasonable wear and use, and from time to time make, or cause to be made, all necessary repairs, renewals, replacements, betterments and improvements thereto, all as more fully provided in the Mortgages. Borrowers and Operating Lessee shall keep their Individual Properties insured at all times, as provided in the Mortgages.

  • Certification of Compliance San Diego Municipal Code section 22.4225 requires each Bidder to fill out and file a living wage certification with the Living Wage Program Manager within thirty (30) days of Award of the Contract.

  • CEQA Compliance The District has complied with all assessment requirements imposed upon it by the California Environmental Quality Act (Public Resource Code Section 21000 et seq. (“CEQA”) in connection with the Project, and no further environmental review of the Project is necessary pursuant to CEQA before the construction of the Project may commence.

  • CERTIFICATION REGARDING DRUG-FREE WORKPLACE REQUIREMENTS 1. The Contractor certifies that it will provide a drug-free workplace by: a. Publishing a statement notifying employees that the unlawful manufacture, distribution, dispensing, possession or use of a controlled substance is prohibited in the Contractor’s workplace and specifying the actions that will be taken against employees for violation of such prohibition;

  • Deemed Compliance with Proposition 65 The Parties agree that compliance by Xxxxxxxx with this Settlement Agreement constitutes compliance with Proposition 65 with respect to exposure to DEHP from use of the Products.

  • COMPLIANCE OF LAWS, NOTIFICATIONS ETC. BY PARTIES The Parties are entering into this Agreement for the allotment of a Apartment with the full knowledge of all laws, rules, regulations, notifications applicable to the project.

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