Inspection by Competent Authority Sample Clauses

Inspection by Competent Authority. If a Competent Authority (national or foreign) wishes to inspect the Institution or the Investigator in connection with their participation in the Trial, then the Institution, the Investigator and Staff shall, to the extent reasonably practicable, (i) immediately notify Biogen thereof and use their best efforts to obtain approval for Biogen or its agents to be present at the inspection and (ii) cooperate with the relevant Competent Authorities and comply with the legitimate requirements of an inspection. This also includes the making available (for examination and duplication) of documentation, data and information relating to the Trial. Subject medical records shall be made available where required for source document verification procedures as part of the inspection. The Institution also shall make the Investigator and other Staff available to the relevant Competent Authority to explain and discuss such documentation, data and information.
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Inspection by Competent Authority. If a Competent Authority (national or foreign) wishes to inspect the Institution or the Investigator in connection with their participation in the Trial, then the Institution, the Investigator and Staff shall, to the extent reasonably practicable, (i) immediately notify Biogen Idec thereof and use their best
Sample 1
Inspection by Competent Authority. If a Competent Authority (national or foreign) wishes to inspect the Institution or the Investigator in connection with their participation in the Trial, then the Institution, the Investigator and Staff shall, to the extent reasonably practicable, (i) immediately notify Biogen thereof and use their best efforts to obtain approval for Biogen or its agents to be present at the inspection and (ii) cooperate with the relevant Competent Authorities and comply with the legitimate requirements of an inspection in accordance with Act No. 372/2011 Coll., as amended. This also includes the making available (for examination and duplication) of documentation, data and information relating to the Trial. Subject medical records shall be made available where required for source document verification procedures as part of the inspection. The Institution also shall make the Investigator and other Staff available to the relevant Competent Authority to explain and discuss such documentation, data and information.
Sample 1
Inspection by Competent Authority. If a Competent Authority (national or foreign) wishes to inspect the Institution or the Investigator in connection with their participation in the Trial, then the Institution, the Investigator and Staff shall, to the extent (d) Kontrola prováděná příslušným orgánem. Pokud si Příslušný orgán (národní nebo zahraniční) přeje provést kontrolu ve Zdravotnickém zařízení nebo ve vztahu ke Zkoušejícímu v souvislosti s jejich účastí v Klinickém hodnocení, jsou Zdravotnické (i) immediately notify Biogen thereof and use their best efforts to obtain approval for Biogen or its agents to be present at the inspection and (ii) cooperate with the relevant Competent Authorities and comply with the legitimate requirements of an inspection. This also includes the making available (for examination and duplication) of documentation, data and information relating to the Trial. Subject medical records shall be made available where required for source document verification procedures as part of the inspection. The Institution also shall make the Investigator and other Staff available to the relevant Competent Authority to explain and discuss such documentation, data and information. zařízení, Zkoušející a Personál v důvodně požadovaném rozsahu povinni (i) okamžitě o tom vyrozumět společnost Biogen a vynaložit veškeré úsilí, aby zajistili, že společnost Biogen nebo její zástupci mohou být při kontrole přítomni, a (ii) poskytnout Příslušným orgánům součinnost a splnit oprávněné požadavky kontroly. To zahrnuje zpřístupnění (pro účely prostudování a okopírování) dokumentace, údajů a informací týkajících se Klinického hodnocení. V případech, kdy to bude nutné k ověření zdrojového dokumentu v rámci kontroly, budou dány k dispozici také zdravotní záznamy subjektu. Zdravotnické zařízení zajistí, že Zkoušející a další členové Personálu budou Příslušnému orgánu k dispozici pro účely vysvětlení a projednání takové dokumentace, údajů a informací.
Sample 1
Inspection by Competent Authority. If a Competent Authority wishes to inspect the InstitutionFoundation or the Investigator in connection with their participation in the Trial, then the InstitutionFoundation, the Investigator and Staff shall, to the extent reasonably practicable, (i) immediately notify Biogen thereof and use their best efforts to obtain approval for Biogen or its agents to be present at the inspection and (ii) cooperate with the relevant Competent Authorities and comply with the legitimate requirements of an inspection. This also includes the making available (for examination and duplication) of documentation, data and information relating to the Trial. Subject medical records shall be made available where required for source document verification procedures as part of the inspection. The (d) Inspección de la Autoridad competente. Si una Autoridad competente desea inspeccionar la InstituciónFundación o al Investigador en relación con su participación en el Ensayo, la InstituciónFundación, el Investigador y el Personal, en la medida en que sea razonablemente factible, (i) notificarán de inmediato a Biogen sobre ello y emplearán sus mejores esfuerzos para obtener la aprobación a fin de que Biogen o sus agentes estén presentes en la inspección y (ii) colaborarán con la Autoridad competente y cumplirán los requisitos legítimos de una inspección. Esto también incluye poner a disposición (para su examen y copia) la documentación, los datos y la información relacionada con el Ensayo. Los registros médicos de los Sujetos se pondrán a disposición cuando se los InstitutionFoundation also shall make the Investigator and other Staff available to the relevant Competent Authority to explain and discuss such documentation, data and information. solicite, con el fin de realizar la verificación de los documentos fuente como parte de la inspección. La InstituciónFundación también pondrá al Investigador y al Personal a disposición de la Autoridad competente relevante para explicar y analizar dicha documentación, datos e información.
Sample 1
Inspection by Competent Authority. If a Competent Authority wishes to inspect the Institution or the Principal Investigator in connection with their participation in the Trial, then the Institution and the Staff shall, to the extent reasonably practicable, (i) immediately notify Hexal thereof and use their best efforts to obtain approval for Hexal or its agents to be present at the inspection and (ii) cooperate with the relevant Competent Authorities and comply with the legitimate requirements of an inspection. This also includes the making available (for examination and duplication) of documentation, data and information relating to the Trial. Subject medical records shall be made available where required for source document verification procedures as part of the inspection. The Institution also shall make the Staff available to the relevant Competent Authority to explain and discuss such documentation, data and information. The Institution will promptly forward to Hexal copies of any inspection findings that the Institution receives from a Competent Authority or Ethics Committee, as applicable, in relation to the Trial. The Institution will provide Hexal with an opportunity to prospectively review any Institution responses to Competent Authority inspections in regard to the Trial.
Sample 1
Inspection by Competent Authority. If a Competent Authority (national or foreign) wishes to inspect the Institution or the Investigator in connection with their participation in the Trial, then the Institution, the Investigator and Staff shall, to the extent reasonably practicable, (i) immediately notify Biogen thereof and use their best efforts to obtain approval for Biogen or its agents to be present at the inspection and (ii) cooperate with the relevant Competent Authorities and comply přítomni, a (ii) poskytnout Příslušným orgánům součinnost a splnit oprávněné požadavky kontroly. To zahrnuje zpřístupnění (pro účely prostudování a okopírování) dokumentace, údajů a informací týkajících se Klinického hodnocení. V případech, kdy to bude nutné k ověření zdrojového dokumentu v rámci kontroly, budou dány k dispozici také zdravotní záznamy subjektu. Zdravotnické zařízení zajistí, že Zkoušející a další členové Personálu budou Příslušnému orgánu k dispozici pro účely vysvětlení a projednání takové dokumentace, údajů a informací. with the legitimate requirements of an inspection. This also includes the making available (for examination and duplication) of documentation, data and information relating to the Trial. Subject medical records shall be made available where required for source document verification procedures as part of the inspection. The Institution also shall make the Investigator and other Staff available to the relevant Competent Authority to explain and discuss such documentation, data and information.
Sample 1
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Inspection by Competent Authority. If a Competent Authority (national or foreign) wishes to inspect the Institution or the Investigator in connection with their participation in the Trial, then the Institution, the Investigator and Staff shall, to the extent reasonably practicable, (i) immediately notify Biogen thereof and use their best efforts to obtain approval for Biogen or its agents to be present at the inspection and (ii) cooperate with the relevant Competent Authorities and comply with the legitimate requirements of an inspection. This also includes the making available (for examination and duplication) of documentation, data and information relating to the Trial. Subject medical records shall be made available where required for source document verification procedures as part of the inspectionin accordance with Act No. 372/2011 Coll., as amended. The Institution also shall znění. Zdravotnické zařízení zajistí, že Zkoušející a další členové Personálu budou Příslušnému orgánu k dispozici pro účely vysvětlení a projednání takové dokumentace, údajů a informací. make the Investigator and other Staff available to the relevant Competent Authority to explain and discuss such documentation, data and information.
Sample 1
Inspection by Competent Authority. The Institution and the Principal Investigator acknowledge that the Trial is (c) Spolupráce na auditu prováděném Hexalem. Zdravotnické zařízení bude spolupracovat a rovněž zajistí, že hlavní zkoušející a pracovníci podílející se na klinickém hodnocení budou spolupracovat s Hexalem a jeho dodavateli a zástupci v případě interních auditů, na základě odpovídajícího oznámení a v průběhu normální pracovní doby. Zdravotnické zařízení dále zpřístupní Hexalu a jeho dodavatelům a zástupcům (pro kontrolu a duplikaci) veškerou dokumentaci, data a informace týkající se klinického hodnocení. Zdravotní dokumentace subjektů bude podle potřeby zpřístupněna tam, kde je to nezbytné pro účely ověřování zdrojové dokumentace jako součásti auditu. Zdravotnické zařízení zajistí, aby hlavní zkoušející a pracovníci podílející se na klinickém hodnocení byli k dispozici Hexalu a jeho dodavatelům a zástupcům k případným konzultacím v souvislosti s dokumentací, daty a záznamy. Pro odstranění případných pochybností, součinnost při auditech bude poskytována hlavním
Sample 1

Related to Inspection by Competent Authority

  • Investigation by Buyer Buyer has undertaken an independent review and analysis of the business, operations, assets, liabilities, results of operations, financial condition and prospects of the Business and has performed all due diligence that it has deemed necessary to perform concerning the Business, the Purchased Assets, and the Assumed Obligations in connection with its decision to enter into this Agreement and the Ancillary Agreements and to consummate the transactions contemplated hereby and thereby and acknowledges that Buyer and Buyer’s Representatives have been provided access to the personnel, properties, premises and records of Seller for such purpose. In entering into this Agreement, Buyer has relied solely upon its own investigation and analysis, and Buyer: (a) acknowledges that none of Seller or any of its Affiliates or any of Seller’s Representatives makes or has made any representation or warranty, of any kind or nature whatsoever, oral or written, express or implied (including, but not limited to, any relating to (a) projections, estimates or budgets delivered or made available to Buyer (or any of its Affiliates, officers, directors, employees or representatives) of, except as set forth in Section 5.4, the future results of operations (or any component thereof), cash flows or financial condition (or any component thereof), of the Business; (b) future business, operations, revenues or profits of the Business; (c) maintenance, repair, condition, design, performance, value, merchantability or fitness for any particular purpose of the Purchased Assets; or (d) as to the accuracy or completeness of any of the information provided or made available to Buyer or Buyer’s Representatives), except for those representations and warranties expressly set forth in Article V of ‎this Agreement (as qualified by the Seller Disclosure Schedules), and Seller hereby disclaims any such other representations or warranties; (b) agrees, to the fullest extent permitted by applicable Law, that none of Seller or any of its Affiliates or any of Seller’s Representatives shall have any liability or responsibility whatsoever to Buyer on any basis based upon any information provided or made available, or statements made, to Buyer or Buyer’s Representatives (including any forecasts or projected information), except that the foregoing limitations shall not apply with respect to Seller to the extent Seller has liability for indemnification pursuant to ‎Article IX for the breach of the specific representations and warranties set forth in ‎Article V of this Agreement (as qualified by the Seller Disclosure Schedules), but always subject to the limitations and restrictions contained herein; (c) acknowledges that, except as expressly set forth in this Agreement, there are no representations or warranties of any kind, express or implied, with respect to the Business, the Purchased Assets or the Assumed Obligations; and (d) none of Seller, its Affiliates or Seller’s Representatives shall have any liability or responsibility based upon any information provided or made available or statements made or omissions therefrom to Buyer, its Affiliates or their respective Representatives, except as and only to the extent expressly set forth in ‎Article V of this Agreement (as qualified by the Seller Disclosure Schedules).

  • Inspection by Lessor Upon reasonable advance notice, Lessee, during reasonable business hours and subject to Lessee's security requirements, will make the Equipment and its related log and maintenance records available to Lessor for inspection.

  • Investigation by Purchaser (a) Each Buyer Party acknowledges that it and its representatives have been permitted reasonable access to the Books and Records, facilities, equipment, Tax Returns, Contracts, insurance policies (or summaries thereof) and other Properties of the Acquired Companies, and that it and its representatives have had a reasonable opportunity to meet with the officers and employees of the Acquired Companies to discuss the Business. Each of the Buyer Parties further acknowledges that, except as set forth in this Agreement or any of the Ancillary Agreements, the Schedules and the certificates to be delivered at the Closing, (i) none of Seller, the Acquired Companies or any other Person has made any representation or warranty, expressed or implied, as to the Acquired Companies or the accuracy or completeness of any information regarding the Acquired Companies furnished or made available to the Buyer Parties and their respective representatives, (ii) neither Buyer Party has relied on any representation or warranty from Seller, the Acquired Companies or any other Person in determining to enter into this Agreement, and (iii) neither Seller nor any other Person shall have or be subject to any liability to the Buyer Parties or any other Person resulting from the distribution to the Buyer Parties or any other Person, or the Buyer Parties’ or any other Person’s use of, any information, documents or material made available to the Buyers Parties’ or any other Person in any “data rooms,” management presentations or in any other form in expectation of the Transactions. (b) As of the date of this Agreement, the Buyer Parties and their respective Affiliates do not have any actual knowledge that the representations and warranties of Seller made in this Agreement qualified as to materiality are not true and correct, or that those not so qualified are not true and correct in any material respect. The Buyer Parties do not have any actual knowledge of any material errors in, or omissions from, any Schedule.

  • Inspection of Agreement A copy of this Agreement shall be available at all reasonable times at the principal corporate trust office of the Warrant Agent for inspection by the holder of any Warrant Certificate. The Warrant Agent may require such holder to submit his Warrant Certificate for inspection by it.

  • Search, Enquiry, Investigation, Examination And Verification a. The Property is sold on an “as is where is basis” subject to all the necessary inspection, search (including but not limited to the status of title), enquiry (including but not limited to the terms of consent to transfer and/or assignment and outstanding charges), investigation, examination and verification of which the Purchaser is already advised to conduct prior to the auction and which the Purchaser warrants to the Assignee has been conducted by the Purchaser’s independent legal advisors at the time of execution of the Memorandum. b. The intending bidder or the Purchaser is responsible at own costs and expenses to make and shall be deemed to have carried out own search, enquiry, investigation, examination and verification on all liabilities and encumbrances affecting the Property, the title particulars as well as the accuracy and correctness of the particulars and information provided. c. The Purchaser shall be deemed to purchase the Property in all respects subject thereto and shall also be deemed to have full knowledge of the state and condition of the Property regardless of whether or not the said search, enquiry, investigation, examination and verification have been conducted. d. The Purchaser shall be deemed to have read, understood and accepted these Conditions of Sale prior to the auction and to have knowledge of all matters which would have been disclosed thereby and the Purchaser expressly warrants to the Assignee that the Purchaser has sought independent legal advice on all matters pertaining to this sale and has been advised by his/her/its independent legal advisor of the effect of all the Conditions of Sale. e. Neither the Assignee nor the Auctioneer shall be required or bound to inform the Purchaser of any such matters whether known to them or not and the Purchaser shall raise no enquiry, requisition or objection thereon or thereto.

  • Notification of Breach / Compliance Reports The Adviser shall notify the Trust immediately upon detection of (i) any material failure to manage any Fund in accordance with its investment objectives and policies or any applicable law; or (ii) any material breach of any of the Funds’ or the Adviser’s policies, guidelines or procedures. In addition, the Adviser shall provide a quarterly report regarding each Fund’s compliance with its investment objectives and policies, applicable law, including, but not limited to the 1940 Act and Subchapter M of the Code, as applicable, and the Fund’s policies, guidelines or procedures as applicable to the Adviser’s obligations under this Agreement. The Adviser agrees to correct any such failure promptly and to take any action that the Board may reasonably request in connection with any such breach. Upon request, the Adviser shall also provide the officers of the Trust with supporting certifications in connection with such certifications of Fund financial statements and disclosure controls pursuant to the Xxxxxxxx-Xxxxx Act. The Adviser will promptly notify the Trust in the event (i) the Adviser is served or otherwise receives notice of any action, suit, proceeding, inquiry or investigation, at law or in equity, before or by any court, public board, or body, involving the affairs of the Trust (excluding class action suits in which a Fund is a member of the plaintiff class by reason of the Fund’s ownership of shares in the defendant) or the compliance by the Adviser with the federal or state securities laws or (ii) an actual change in control of the Adviser resulting in an “assignment” (as defined in the 0000 Xxx) has occurred or is otherwise proposed to occur.

  • Response/Compliance with Audit or Inspection Findings A. Grantee must act to ensure its and its Subcontractors’ compliance with all corrections necessary to address any finding of noncompliance with any law, regulation, audit requirement, or generally accepted accounting principle, or any other deficiency identified in any audit, review, inspection or investigation of the Grant Agreement and the services and Deliverables provided. Any such correction will be at Grantee’s or its Subcontractor's sole expense. Whether Xxxxxxx's action corrects the noncompliance shall be solely the decision of the System Agency. B. As part of the services, Grantee must provide to HHS upon request a copy of those portions of Grantee's and its Subcontractors' internal audit reports relating to the services and Deliverables provided to the State under the Grant Agreement. C. Grantee shall include the requirement to provide to System Agency (and any of its duly authorized federal, state, or local authorities) internal audit reports related to this Grant Agreement in any Subcontract it awards. Upon request by System Agency, Grantee shall enforce this requirement against its Subcontractor. Further, Grantee shall include in any Subcontract it awards a requirement that all Subcontractor Subcontracts must also include these provisions.

  • Inspection by Landlord Landlord shall have the right to inspect the Tenant Improvements at all times, provided however, that Landlord’s failure to inspect the Tenant Improvements shall in no event constitute a waiver of any of Landlord’s rights hereunder nor shall Landlord’s inspection of the Tenant Improvements constitute Landlord’s approval of the same. Should Landlord disapprove any portion of the Tenant Improvements, Landlord shall notify Tenant in writing of such disapproval and shall specify the items disapproved. Any defects or deviations in, and/or disapproval by Landlord of, the Tenant Improvements shall be rectified by Tenant at no expense to Landlord, provided however, that in the event Landlord determines that a defect or deviation exists or disapproves of any matter in connection with any portion of the Tenant Improvements and such defect, deviation or matter might adversely affect the mechanical, electrical, plumbing, heating, ventilating and air conditioning or life-safety systems of the Building, the structure or exterior appearance of the Building or any other tenant’s use of such other tenant’s leased premises, Landlord may, take such action as Landlord deems necessary, at Tenant’s expense and without incurring any liability on Landlord’s part, to correct any such defect, deviation and/or matter, including, without limitation, causing the cessation of performance of the construction of the Tenant Improvements until such time as the defect, deviation and/or matter is corrected to Landlord’s satisfaction.

  • Evidence of Action by Holders (a) Whenever in this Indenture it is provided that the holders of a majority or specified percentage in aggregate principal amount of the Debentures may take any action (including the making of any demand or request, the giving of any notice, consent or waiver or the taking of any other action), the fact that at the time of taking any such action the holders of such majority or specified percentage have joined therein may be evidenced by any instrument or any number of instruments of similar tenor executed by such holders of Debentures in Person or by agent or proxy appointed in writing. (b) If the Company shall solicit from the Debentureholders any request, demand, authorization, direction, notice, consent, waiver or other action, the Company may, at its option, as evidenced by an Officers' Certificate, fix in advance a record date for the determination of Debentureholders entitled to give such request, demand, authorization, direction, notice, consent, waiver or other action, but the Company shall have no obligation to do so. If such a record date is fixed, such request, demand, authorization, direction, notice, consent, waiver or other action may be given before or after the record date, but only the Debentureholders of record at the close of business on the record date shall be deemed to be Debentureholders for the purposes of determining whether Debentureholders of the requisite proportion of Outstanding Debentures have authorized or agreed or consented to such request, demand, authorization, direction, notice, consent, waiver or other action, and for that purpose the Outstanding Debentures shall be computed as of the record date; provided, however, that no such authorization, agreement or consent by such Debentureholders on the record date shall be deemed effective unless it shall become effective pursuant to the provisions of this Indenture not later than six months after the record date.

  • No Physical Presence of Quorum and Participation by Audio or Video; Disaster Declaration The ability of the Board to meet in person with a quorum physically present at its meeting location may be affected by the Governor or the Director of the Ill. Dept. of Public Health issuing a disaster declaration related to a public health emergency. The Board President or, if the office is vacant or the President is absent or unable to perform the office’s duties, the Vice President determines that an in- person meeting or a meeting conducted under the Quorum and Participation by Audio or Video Means subhead above, is not practical or prudent because of the disaster declaration; if neither the President nor Vice President are present or able to perform this determination, the Superintendent shall serve as the duly authorized designee for purposes of making this determination. The individual who makes this determination for the Board shall put it in writing, include it on the Board’s published notice and agenda for the audio or video meeting and in the meeting minutes, and ensure that the Board meets every OMA requirement for the Board to meet by video or audio conference without the physical presence of a quorum.

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