Safety and Effectiveness requirements Sample Clauses

Safety and Effectiveness requirements. Safety and effectiveness requirements closely correspond to the essential requirements of the Medical Device Directive. A list of Health Canada recognized standards has been issued as of April 11, 2002 in Policy on Recognition and Use of Standards under Medical Device Regulations.
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Safety and Effectiveness requirements. The Device will meet electrical safety requirements (ANSI/AAMI HF-18:2001).

Related to Safety and Effectiveness requirements

  • Term and Effectiveness This Agreement shall become effective as of the first date written above. Once effective, this Agreement shall remain in effect for two years, and thereafter shall continue automatically for successive one-year periods; provided that such continuance is specifically approved at least annually by: (i) the vote of the Board of Directors, or by the vote of a majority of the outstanding voting securities of the Company and (ii) the vote of a majority of the Independent Directors, in accordance with the requirements of the 1940 Act.

  • Effectiveness Conditions This Amendment shall be effective upon the completion of the following conditions precedent (all agreements, documents and instruments to be in form and substance satisfactory to Agent and Agent’s counsel): (a) Execution and delivery by Borrower, Guarantors and Lenders of this Amendment to Agent; (b) Execution and/or delivery by the parties of all other agreements, instruments and documents requested by Agent to effectuate and implement the terms hereof and the Existing Loan Documents.

  • Separateness Requirements Notwithstanding any other provision of this Agreement and any provision of law that otherwise so empowers the Trust, so long as any Certificates are outstanding, the Trust shall perform the following: (i) except as expressly permitted by this Agreement or the Custodial Agreement, maintain its books, records, bank accounts and files separate from those of any other Person; (ii) except as expressly permitted by this Agreement, maintain its assets in its own separate name and in such a manner that it is not costly or difficult to segregate, identify, or ascertain such assets; (iii) consider the interests of the Trust's creditors in connection with its actions; (iv) hold itself out to creditors and the public as a legal entity separate and distinct from any other Person and correct any known misunderstanding regarding its separate identity and refrain from engaging in any activity that compromises the separate legal identity of the Trust; (v) prepare and maintain separate records, accounts and financial statements in accordance with generally accepted accounting principles, consistently applied, and susceptible to audit. To the extent it is included in consolidated financial statements or consolidated tax returns, such financial statements and tax returns will reflect the separateness of the respective entities and indicate that the assets of the Trust will not be available to satisfy the debts of any other Person; (vi) allocate and charge fairly and reasonably any overhead shared with any other Person; (vii) transact all business with affiliates on an arm's-length basis and pursuant to written, enforceable agreements; (viii) conduct business solely in the name of the Trust. In that regard all written and oral communications of the Trust, including, without limitation, letters, invoices, purchase orders and contracts, shall be made solely in the name of the Trust; (ix) maintain a separate office through which its business shall be conducted, provided that such office may be an office of the Trustee, which office shall not be shared with the Company or any affiliates of the Company; (x) in the event that services have been or are in the future performed or paid by any Person on behalf of the Trust (other than the Trustee, the Delaware Trustee, the Servicer or the Tax Matters Person as permitted herein), reimburse such Person, as applicable, for the commercially reasonable value of such services or expenses provided or incurred by such Person. Accordingly, (i) the Trust shall reimburse such Person, as applicable, for the commercially reasonable value of such services or expenses provided or incurred by such Person; (ii) to the extent invoices for such services are not allocated and separately billed to the Trust, the amount thereof that was or is to be allocated and separately billed to the Trust was or will be reasonably related to the services provided to the Trust; and (iii) any other allocation of direct, indirect or overhead expenses for items shared between the Trust and any other Person, was or will be, to the extent practicable, allocated on the basis of actual use or value of services rendered or otherwise on a basis reasonably related to actual use or the value of services rendered; (xi) except as expressly permitted by this Agreement, not commingle its assets or funds with those of any other Person; (xii) except as expressly permitted by this Agreement, not assume, guarantee, or pay the debts or obligations of any other Person; (xiii) except as expressly permitted by this Agreement, not pledge its assets for the benefit of any other Person; (xiv) not hold out its credit or assets as being available to satisfy the obligations of others; (xv) pay its liabilities only out of its funds; (xvi) pay the salaries of its own employees, if any; and (xvii) cause the agents and other representatives of the Trust, if any, to act at all times with respect to the Trust consistently and in furtherance of the foregoing. None of the Trustee, the Delaware Trustee, the Company or the Servicer shall take any action that is inconsistent with the purposes of the Trust or Section 2.02 or Section 2.03. Neither the Company nor the Servicer shall direct the Trustee or the Delaware Trustee to take any action that is inconsistent with the purposes of the Trust or Section 2.02 or Section 2.03.

  • Effectiveness of Covenants (a) After the Issue Date, following the first day: (i) the Notes have an Investment Grade Rating from both of the Ratings Agencies; and (ii) no Default has occurred and is continuing under this Indenture; the Company and its Restricted Subsidiaries will not be subject to Sections 4.10, 4.11, 4.13, 4.14, 4.16 and 5.01(a)(ii) of this Indenture (collectively, the “Suspended Covenants”). (b) If at any time the Notes’ credit rating is downgraded from an Investment Grade Rating by any Rating Agency, then the Suspended Covenants will thereafter be reinstated as if such covenants had never been suspended (the “Reinstatement Date”) and be applicable pursuant to the terms of this Indenture (including in connection with performing any calculation or assessment to determine compliance with the terms of this Indenture), unless and until the Notes subsequently attain an Investment Grade Rating and no Default or Event of Default is in existence (in which event the Suspended Covenants shall no longer be in effect for such time that the Notes maintain an Investment Grade Rating); provided, however, that no Default, Event of Default or breach of any kind shall be deemed to exist or have occurred under this Indenture, the Notes or the Guarantees with respect to the Suspended Covenants based on, and none of the Company or any of its Subsidiaries shall bear any liability for, any actions taken or events occurring during the Suspension Period or any actions taken at any time pursuant to any contractual obligation arising prior to the Reinstatement Date, regardless of whether such actions or events would have been permitted if the applicable Suspended Covenants remained in effect during such period. The period of time between the date of suspension of the covenants and the Reinstatement Date is referred to as the “Suspension Period.” (c) On the Reinstatement Date, all Indebtedness Incurred during the Suspension Period will be deemed to have been outstanding on the Issue Date, so that it is classified as permitted under clause (iii) of the definition of “Permitted Indebtedness”. Calculations made after the Reinstatement Date of the amount available to be made as Restricted Payments under Section 4.11 will be made as though Section 4.11 had been in effect since the Issue Date and throughout the Suspension Period. Accordingly, Restricted Payments made during the Suspension Period will reduce the amount available to be made as Restricted Payments under the first paragraph of Section 4.11 to the extent such Restricted Payments were not otherwise permitted to be made pursuant to clauses (i) through (ix) of the third paragraph of Section 4.11, provided that the amount available to be made as Restricted Payments on the Reinstatement Date pursuant to the first paragraph of Section 4.11 shall not be reduced below zero solely as a result of such Restricted Payments under Section 4.11. Additionally, upon any Reinstatement Date, the amount of Available Asset Sale Proceeds will be reset to zero. (d) During any period when the Suspended Covenants are suspended, the Board of Directors of the Company may not designate any of the Company’s Subsidiaries as Unrestricted Subsidiaries pursuant to this Indenture. The Company shall give the Trustee prompt written notification of the beginning of any Suspension Period or any Reinstatement Date.

  • Filing and Effectiveness The Company shall file a Registration Statement relating to any Demand Registration as promptly as practicable, but in any event no later than sixty (60) days after receipt of a Demand Notice, with the SEC and use its reasonable best efforts to cause such Registration Statement to be declared effective as soon as practicable thereafter and to remain effective for a period of time reasonably required for the disposition of the Registrable Securities covered by such Registration Statement. If any Demand Registration is requested to be effected as a shelf registration pursuant to Rule 415 under the Securities Act by the Holders demanding such Demand Registration, the Company shall keep the Registration Statement filed in respect thereof effective for a period of six (6) months from the date on which the SEC declares such Registration Statement effective or such shorter period that will terminate when all Registrable Securities covered by such Registration Statement have been sold pursuant to such Registration Statement. The Company shall promptly, and in any event within ten (10) Business Days after receipt of a Demand Notice, notify all other Holders in writing of the receipt of such Demand Notice and each such other Holder shall have the right to have all or a part of such Holder’s Registrable Securities included in such registration thereof by delivering a written notice (a “Participating Notice”) to the Company within ten (10) Business Days after receipt of the aforementioned notice from the Company (each Holder that delivers a Participating Notice to the Company pursuant to this Section 3(b), a “Participating Demand Holder”). Each Participating Demand Holder shall specify in the Participating Notice the number of Registrable Securities that such Participating Demand Holder elects to include in such registration and the Company shall include in such registration all Registrable Securities requested by the Participating Demand Holders for inclusion as specified in the Participation Notices.

  • Filing and Effectiveness of Registration Statement The Company has prepared and filed with the Commission the Registration Statement (file number 333-[●]) on Form S-1, including the related Preliminary Prospectus, for registration under the Act of the offering and sale of the Offered Securities. Such Registration Statement, including any amendments thereto filed prior to the Execution Time, has become effective. The Company has filed one or more amendments thereto, including the related Preliminary Prospectus, each of which has previously been furnished to the Representative. The Company will file with the Commission the Prospectus in accordance with Rule 424(b). As filed, such Prospectus shall contain all information required by the Act and, except to the extent the Representative shall agree in writing to a modification, shall be in all substantive respects in the form furnished to the Representative prior to the Execution Time or, to the extent not completed at the Execution Time, shall contain only such specific additional information and other changes (beyond that contained in the latest Preliminary Prospectus) as the Company has advised the Representative, prior to the Execution Time, will be included or made therein. The Company has complied to the Commission’s satisfaction with all requests of the Commission for additional or supplemental information.

  • COMPLIANCE WITH HEALTH, SAFETY, AND ENVIRONMENTAL REGULATIONS The Contractor, it’s Subcontractors, and their respective employees, shall comply fully with all applicable federal, state, and local health, safety, and environmental laws, ordinances, rules and regulations in the performance of the services, including but not limited to those promulgated by the City and by the Occupational Safety and Health Administration (OSHA). In case of conflict, the most stringent safety requirement shall govern. The Contractor shall indemnify and hold the City harmless from and against all claims, demands, suits, actions, judgments, fines, penalties and liability of every kind arising from the breach of the Contractor’s obligations under this paragraph.

  • Effectiveness of Registration Statement; Compliance with Registration Requirements; No Stop Order During the period from and after the execution of this Agreement to and including the Closing Date or the Option Closing Date, as applicable: (i) the Company shall have filed the Prospectus with the Commission (including the information required by Rule 430A under the Securities Act) in the manner and within the time period required by Rule 424(b) under the Securities Act; or the Company shall have filed a post-effective amendment to the Registration Statement containing the information required by such Rule 430A, and such post-effective amendment shall have become effective; and (ii) no stop order suspending the effectiveness of the Registration Statement, or any post-effective amendment to the Registration Statement, shall be in effect and no proceedings for such purpose shall have been instituted or threatened by the Commission.

  • Continuing Effectiveness, etc As herein amended, the Credit Agreement shall remain in full force and effect and is hereby ratified and confirmed in all respects.

  • Effectiveness of Agreement This Agreement shall become effective upon the execution and delivery hereof by the parties hereto.

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