Regulatory Inspections Audits Sample Clauses

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.
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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. 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:
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Regulatory Inspections Audits. If any governmental or regulatory authority (a) contacts the Principal Investigator with respect to the Study, (b) conducts, or gives notice of its intent to conduct, an inspection that could reasonably be expected to impact any data or clinical activity under the Study or (c) takes, or gives notice of its intent to take, any other regulatory action with respect to any activity of the Principal Investigator that could reasonably be expected to impact any data or clinical activity under the Study, then the Principal Investigator shall promptly notify Sponsor of such contact or notice. Except as limited by such authorities rules and regulations, Sponsor shall be given the right to be present at and to participate in any such inspection or regulatory action with respect to the Study. The Principal Investigator shall provide Sponsor with copies of all pertinent information and documentation issued by any governmental or regulatory authority directly related to the Study and any proposed response. Sponsor shall be given the opportunity to review in advance any responses which pertain to the Study, and to provide comment which Principal Investigator will consider in good faith. However, Xxxxxxx acknowledges that Sponsor may not direct the manner in which the Principal Investigator fulfills his/her obligations to permit inspection by governmental entities. It shall not be a breach of this Agreement for Principal Investigator to comply with the demands and requests of any governmental entity, however, the Principal Investigator shall have an obligation to contact Sponsor first, if permitted by law, before complying with any such demand or request. No such response shall contain any false or misleading information with respect to the Study, the Study Drug or Sponsor.
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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.

  • Regulatory Investigations It shall be the Administrator’s duty and responsibility, and not the Owner Trustee’s duty and responsibility, to cause the Trust to respond to, defend, participate in or otherwise act in connection with any regulatory, administrative, governmental, investigative or other proceeding or inquiry relating in any way to the Trust, its assets or the conduct of its business.

  • Site Visits and Inspections; Regulatory Examinations During the term of this Agreement, authorized representatives of the Fund may conduct periodic site visits of the Transfer Agent’s facilities and inspect the Transfer Agent’s records and procedures solely as they pertain to the Transfer Agent’s services for the Fund under or pursuant to this Agreement. Such inspections shall be conducted at the Fund’s expense (which shall include costs related to providing materials, copying, faxing, retrieving stored materials, and similar expenses) and shall occur during the Transfer Agent’s regular business hours and, except as otherwise agreed to by the parties, no more frequently than twice a year. In connection with such site visit and/or inspection, the Fund shall not attempt to access, nor will it review, the records of any other clients of the Transfer Agent and the Fund shall conduct the visit/inspection in a manner that will not interfere with the Transfer Agent’s normal and customary conduct of its business activities, including the provision of services to the Fund and to other clients. The Transfer Agent shall have the right to immediately require the removal of any Fund representatives from its premises in the event that their actions, in the reasonable opinion of the Transfer Agent, jeopardize the information security of its systems and/or other client data or otherwise are disruptive to the business of the Transfer Agent. The Transfer Agent may require any persons seeking access to its facilities to provide reasonable evidence of their authority. The Transfer Agent may also reasonably require any of the Fund’s representatives to execute a confidentiality agreement before granting such individuals access to its facilities. The Transfer Agent will also provide reasonable access to the Fund’s governmental regulators, at the Fund’s expense, solely to (i) the Fund’s records held by the Transfer Agent and (ii) the procedures of the Transfer Agent directly related to its provision of services to the Fund under the Agreement.

  • 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 Audits BNY Mellon shall, upon reasonable prior notice when possible, make all books and records available to the applicable Voya or Voya Fund regulators and state government representatives or their designees to audit, evaluate and inspect BNY Mellon’s books and records for Voya and such Voya Fund. BNY Mellon agrees to reasonably cooperate with and assist Voya in meeting any regulatory requirements related to audits or inspections imposed upon Voya to the extent that Voya notifies BNY Mellon of such requirements.

  • 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.

  • 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.

  • 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.

  • Records; Audits Merck will keep, and will cause each of the other Selling Parties, as applicable, to keep, and Moderna will keep, adequate books and records of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] following the end of the Calendar Year to which each will pertain, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party to have access during normal business hours to such of the records as may be reasonably necessary to verify the accuracy of the payments [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder for any Calendar Year ending not more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreement.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

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