Regulatory Inspections Audits Sample Clauses

Regulatory Inspections Audits. 16.1 Nova Factor shall provide to Centocor all documents and information requested by the FDA or by Centocor in support of its regulatory filings. Copies of all documents to be provided to the FDA shall be provided to Centocor in advance, if practicable, or otherwise within two (2) business days of delivery to the FDA. Nova Factor shall notify Centocor immediately upon receipt of notice of any inspection by the FDA directed specifically toward Product, and Centocor shall have the right to have an employee present at any such inspection, if allowed by law. In addition, Nova Factor shall notify Centocor of any FDA correspondence or inspections that concern Nova Factor generally and which are not related to a non-Centocor product. Nova Factor shall notify Centocor immediately of any notices, requests for information or other communications related to Product from the U.S. Department of Health and Human Services or any other government agency or any state healthcare program or other state agency and to the extent permitted under the applicable law, shall give Centocor copies of such communication.
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Regulatory Inspections Audits. 16.1 AHG shall at all times keep and maintain accurate records relating to the services provided pursuant to this Agreement. During the Term and for a period of one year thereafter, AHG shall submit to inquiries, audits and inspections by CTI or its designated agents during normal business hours or at any other time as may be reasonably requested by CTI. CTI shall give AHG at least two (2) business days prior notice of any audit or inspection and shall bear the costs of such audit or inspection. Upon receipt of such notice, AHG shall make its records and other information relevant to this Agreement available for audit and inspection in a manner reasonably satisfactory to CTI. 16.2 AHG shall provide to CTI all documents and information requested by the FDA or by CTI in support of its regulatory filings. Copies of all documents to be provided to the FDA shall be provided to CTI in advance, if practicable, or otherwise within two (2) business days of delivery to the FDA. AHG shall notify CTI immediately upon receipt of notice of any inspection by the FDA directed specifically toward the Product, and CTI shall have the right to have an employee present at any such inspection, if allowed by law. 16.3 AHG shall notify CTI within twenty-four (24) hours of receipt, and provide a copy thereof, of any notice of any FDA or other Governmental Authority inspection, investigation or other inquiry, or other material governmental notice or communication related to the Product or this Agreement (collectively, an “Inquiry”) including but not limited to an Inquiry (a) relating to the manufacture, sale, marketing, promotion, distribution, or use of the Product; or (b) that may be deemed to have regulatory implications that could reasonably be expected to have a material affect on AHG’s ability to distribute Products. The parties shall cooperate with each other during any such inspection, investigation or other inquiry. If allowed by law, AHG shall discuss with CTI any response to observations or notifications received in connection with any such inspection, investigation or other inquiry and shall provide CTI an opportunity to comment upon any proposed response before it is made, provided that CTI’s comments shall not be unreasonably withheld, delayed or conditioned. If allowed by law, AHG shall provide CTI with copies of all correspondence received by it from, or filed by it with, any Governmental Authority to the extent pertaining to the Product or the labeling, packaging, ...
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Regulatory Inspections Audits. 14.1 During the term of this Agreement and for a period of one (1) year thereafter, each party may perform an audit relating to the other party’s compliance with the requirements of this Agreement. The foregoing notwithstanding, neither party shall be required to disclose any PHI or any information it is barred from disclosing by a confidentiality agreement to a third party. Each party shall be limited to a single audit per year, whether conducted during the term of this Agreement or the one year period thereafter, provided that a party’s limit of a single audit per year shall not apply to any audit initiated for cause by such party. Any audit initiated under this Section 14.1 shall be conducted during normal business hours and upon at least thirty (30) days prior written notice (which notice shall specify the purpose of the audit and the time period to be audited). No audit may review data pertaining to time periods more than twelve (12) months prior to the notice of audit. Audits will be performed by either a party’s personnel or by a third party auditor approved by both parties (“Third Party Auditor”). The Third Party Auditor must sign a confidentiality agreement with each party before performing an audit. Each party will be responsible for all costs incurred in the performance of any audit it requests, and will reimburse the audited party for photocopying and computer processing costs (including reasonable charges for any requested computer programming and/or retrieval of archived records) incurred in connection with such audit. Each party will provide to the audited party a complete copy of any audit report generated pursuant to this Section 14.1. In addition to the above requirements and limitations, any audit desired by a party shall be conducted as follows: (i) Within fifteen (15) days of receipt of an audit notice, the party being audited shall deliver a confidentiality agreement to the requesting party or the Third Party Auditor, as applicable, and (ii) within forty-five (45) days of the execution of an audit confidentiality agreement between the parties, the party being audited shall schedule an on-site review and audit of the relevant data.
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Regulatory Inspections Audits. (a) Sarepta shall have the right, [**] from time to time during the Term of this Agreement but not more than [**] (unless otherwise agreed between the Parties and subject to and after giving effect to the provisions of Section 11.8(b)), and pursuant to the procedures set forth in the Quality Agreement (e.g., advance notice and duration of inspection), to enter and inspect the Catalent Facility and any related utilities and/or services used in the Manufacture of Bulk Drug Substance and/or Drug Product in order to: (i) carry out a cGMPs, quality and compliance audit of those parts of the Catalent Facility involved in or which could have any impact on the Manufacture of Bulk Drug Substance and/or Drug Product (including those used for storing, warehousing and/or testing and utilities); and (ii) examine any Bulk Drug Substance and any Drug Product in inventory or otherwise stored at the Catalent Facility, to ensure compliance with the terms of this Agreement. (b) Notwithstanding Section 11.8(a), Sarepta shall have the right to enter the Catalent Facility, subject to its compliance with the Catalent Facility’s applicable health and safety requirements, at any time during normal business hours, in accordance with its rights set forth in the Quality Agreement or as otherwise necessary in Sarepta’s discretion to comply with an obligation to a Regulatory Authority. In addition to the rights set out in Section 11.8(a), where any audit carried out in accordance with this Section 11.8(b) has identified any observations or negative findings then Sarepta shall have the right to carry out, upon reasonable prior notice and during normal business hours, follow up compliance audit(s). (c) Catalent shall be solely responsible for ensuring the compliance status of any approved subcontractors used in relation to the performance of its obligations pursuant to this Agreement and the Quality Agreement. Catalent shall use commercially reasonable efforts to procure the right for Sarepta to have the same inspection rights described in this Section 11.8 at the premises of any such subcontractor. If Catalent is unable to procure such rights, it shall carry out such inspections itself on Sarepta’s behalf and shall report the findings within [**] of completing the same. (d) For the avoidance of doubt, any audits or inspections, checking or tests conducted by Sarepta or any of its servants or agents in relation to Bulk Drug Substance, Drug Product or the matters covered under this Agreem...
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Regulatory Inspections Audits 
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Related to Regulatory Inspections Audits

  • Regulatory Inspections Manufacturer will permit Rhythm or its agents to be present and participate in any visit or inspection by any Authority of the Facility (to the extent it relates in any way to any Product) or the Manufacturing Process. Manufacturer will give as much advance notice as reasonably possible to Rhythm of any such visit or inspection. Manufacturer will provide Rhythm with a copy of any report or other written communication * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. received from such Authority in connection with such visit or inspection, and any written communication received from any Authority relating to any Product, the Facility (if it relates to or affects the Development and/or Manufacture of Product) or the Manufacturing Process, within two (2) business days after receipt, and will consult with, and require approval from, Rhythm before responding to each such communication. Manufacturer will provide Rhythm with a copy of its final responses within five (5) business days after submission.

  • OIG INSPECTION, AUDIT, AND REVIEW RIGHTS ‌ In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine or request copies of Xxxxxx’x books, records, and other documents and supporting materials and/or conduct on-site reviews of any of Xxxxxx’x locations for the purpose of verifying and evaluating: (a) Xxxxxx’x compliance with the terms of this IA and (b) Xxxxxx’x compliance with the requirements of the Federal health care programs. The documentation described above shall be made available by Xxxxxx to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview Xxxxxx and any of Xxxxxx’x employees or contractors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Xxxxxx shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. Xxxxxx’x employees and contractors may elect to be interviewed with or without a representative of Xxxxxx present.

  • Regulatory Investigations TCI and TLIC agree to cooperate fully in any insurance or judicial regulatory investigation or proceeding arising in connection with Contracts distributed under this Agreement. TCI and TLIC further agree to cooperate fully in any securities regulatory inspection, inquiry, investigation or proceeding or any judicial proceeding with respect to TLIC, TCI, their affiliates and their representatives to the extent that such inspection, inquiry, investigation or proceeding or judicial proceeding is in connection with Contracts distributed under this Agreement. Without limiting the foregoing: (a) TCI will be notified promptly of any customer complaint or notice of any regulatory inspection, inquiry investigation or proceeding or judicial proceeding received by TLIC with respect to TCI or any representative or which may affect TLIC’s issuance of any Contracts marketed under this Agreement; and (b) TCI will promptly notify TLIC of any customer complaint or notice of any regulatory inspection, inquiry, investigation or judicial proceeding received by TCI or any representative with respect to TLIC or its affiliates in connection with any Contracts distributed under this Agreement. In the case of a customer complaint, TCI and TLIC will cooperate in investigating such complaint and shall arrive at a mutually satisfactory response.

  • Audits/Inspections Contractor agrees to permit the County’s Auditor-Controller or the Auditor- Controller’s authorized representative (including auditors from a private auditing firm hired by the County) access during normal working hours to all books, accounts, records, reports, files, financial records, supporting documentation, including payroll and accounts payable/receivable records, and other papers or property of Contractor for the purpose of auditing or inspecting any aspect of performance under this Contract. The inspection and/or audit will be confined to those matters connected with the performance of the Contract including, but not limited to, the costs of administering the Contract. The County will provide reasonable notice of such an audit or inspection. The County reserves the right to audit and verify the Contractor’s records before final payment is made. Contractor agrees to maintain such records for possible audit for a minimum of three years after final payment, unless a longer period of records retention is stipulated under this Contract or by law. Contractor agrees to allow interviews of any employees or others who might reasonably have information related to such records. Further, Contractor agrees to include a similar right to the County to audit records and interview staff of any subcontractor related to performance of this Contract. Should the Contractor cease to exist as a legal entity, the Contractor’s records pertaining to this Contract shall be forwarded to the County’s project manager.

  • Regulatory Information (a) All the notaries at De Pinna LLP are regulated through the Faculty Office of the Archbishop of Canterbury. Its address is The Faculty Office, 0 Xxx Xxxxxxxxx, Xxxxxxxxxxx, Xxxxxx XX0X 0XX, its telephone: 000 0000 0000, and it can be reached by email at xxxxxxx.xxxxxx@0xxxxxxxxxxxx.xxx. It also has a website at xxx.xxxxxxxxxxxxx.xxx.xx. (b) We are required to comply with the rules of professional conduct and other regulatory arrangements of the Master of the Faculties, the sole regulator of notarial activities under the Legal Services Act 2007. Information about those rules and regulations may be found at xxxx://xxx.xxxxxxxxxxxxx.xxx.xx/notary/i-am-a-notary/notaries-rules-regulations/. (c) We comply with the Code of Practice published by the Master of the Faculties: xxxx://xxx.xxxxxxxxxxxxx.xxx.xx/notary/code-of-practice.

  • Inspection & Audit Contractor agrees that the relevant books, records (written, electronic, computer related or otherwise), including, without limitation, relevant accounting procedures and practices of Contractor or its subcontractors, financial statements and supporting documentation, and documentation related to the work product shall be subject, at any reasonable time, to inspection, examination, review, audit, and copying at any office or location of Contractor where such records may be found, with or without notice by the City, and with regard to any federal funding, the relevant federal agency, the Comptroller General, the General Accounting Office, the Office of the Inspector General, or any of their authorized representatives. All subcontracts shall reflect the requirements of this paragraph.

  • 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.

  • Periodic Review of Costs of Environmental Compliance In the ordinary course of its business, the Company conducts a periodic review of the effect of Environmental Laws on the business, operations and properties of the Company and its subsidiaries, in the course of which it identifies and evaluates associated costs and liabilities (including, without limitation, any capital or operating expenditures required for clean-up, closure of properties or compliance with Environmental Laws or any permit, license or approval, any related constraints on operating activities and any potential liabilities to third parties). On the basis of such review and the amount of its established reserves, the Company has reasonably concluded that such associated costs and liabilities would not, individually or in the aggregate, result in a Material Adverse Change.

  • 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.

  • Audits No more than once a year, or following unauthorized access, upon receipt of a written request from the LEA with at least ten (10) business days’ notice and upon the execution of an appropriate confidentiality agreement, the Provider will allow the LEA to audit the security and privacy measures that are in place to ensure protection of Student Data or any portion thereof as it pertains to the delivery of services to the LEA . The Provider will cooperate reasonably with the LEA and any local, state, or federal agency with oversight authority or jurisdiction in connection with any audit or investigation of the Provider and/or delivery of Services to students and/or LEA, and shall provide reasonable access to the Provider’s facilities, staff, agents and XXX’s Student Data and all records pertaining to the Provider, LEA and delivery of Services to the LEA. Failure to reasonably cooperate shall be deemed a material breach of the DPA.

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