FDA Inspections Sample Clauses

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FDA Inspections. Except as otherwise provided herein, Seller shall be responsible, at Seller’s sole expense, for handling and responding to any FDA or other Regulatory Authority inspections with respect to Seller’s Manufacture of the Products during the Term of this Agreement. Seller shall provide to Buyer any information reasonably requested by Buyer and all information requested by any Regulatory Authority concerning any inspection by any Governmental Authority related to the Products. To the extent Seller requires the assistance of Buyer in order to fulfill its obligations pursuant to this Section 5.3, Buyer agrees to fully cooperate and assist Seller, at Buyer’s sole expense. In the event Seller is provided notice by any Regulatory Authority that it will be inspected by such Regulatory Authority in connection with the Products, Seller shall promptly notify Buyer of any observations made during such inspection. Notwithstanding any provision herein to the contrary, Seller shall provide Buyer with the opportunity to comment on any filings, notices or other correspondence with any Regulatory Authority that relates to or could affect the Manufacture or supply of Products hereunder.
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FDA Inspections. Except as otherwise provided herein, PRONOVA shall be responsible, at PRONOVA’s sole expense, for handling and responding to any FDA or other Regulatory Authority inspections with respect to PRONOVA’s manufacture of the API during the term of this Agreement. PRONOVA shall provide to RELIANT any information reasonably requested by RELIANT and all information requested by any Regulatory Authority concerning any inspection by any Governmental Authority related to the Products. In the event PRONOVA is provided notice by any Regulatory Authority that it will be inspected by such Regulatory Authority in connection with the API, PRONOVA shall promptly notify RELIANT of any observations made during such inspection. Notwithstanding any provision herein to the contrary, PRONOVA shall provide RELIANT with the opportunity to comment on any filings, notices or other correspondence with any Regulatory Authority that relates to or could affect the manufacture or supply of API hereunder.
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FDA Inspections. During the Term of the Agreement, Licensee shall be responsible for all activities relating to quarterly inspections by the FDA, including, without limitation, all costs, fees, expenses and other charges arising therefrom.
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FDA Inspections. In the event Blu's or Blu's Contract Manufacturer's manufacturing, packaging, testing or storage facility (or facilities) producing Journey Product is/are inspected by representatives of any federal agency in connection with Blu's or Blu's Contract Manufacturer's manufacture of the Journey Product, Blu will notify Journey within twenty four hours upon learning of such inspection, and will supply Journey with complete copies of any correspondence or communications or portions thereof which relate to the Journey Product. INFORMATION HAS BEEN MARKED WITH “[***].
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FDA Inspections. UT will agree to notify the sponsor of any anticipated FDA or similar inspection and to allow them to be present, if reasonable, and in accordance with applicable law. UT will NOT agree to let sponsors edit UT's responses to the audit, or to delay UT's response.
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FDA Inspections. Supplier acknowledges that Goods and Services purchased hereunder may be incorporated into products which will be purchased by an agency or branch of the federal government. In the event the federal government requests an inspection by the FDA of the manufacturing facilities and records relative to the Good purchased hereunder, Supplier hereby agrees that said inspection shall be permitted. Supplier shall immediately notify Purchaser when it learns such an inspection is scheduled or is occurring, shall notify Purchaser of the results of any such inspection and, if any deficiency is noted, shall provide Purchaser with its corrective action plan.
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FDA Inspections. ICU shall advise Abbott immediately of the findings of FDA inspections and shall take all steps necessary to correct deficiencies found by the FDA relating to manufacturing of Product. ICU shall advise Abbott of any FDA compliance issues, including but not limited to, the receipt of FDA form 483 or any quality assurance problems with ICU's production facilities used in the manufacture of Product. ICU shall provide Abbott with copies of all such reports issued by the FDA as such relate to Products, shall provide Abbott with all responses to the FDA, and shall consider all ▇▇▇▇▇▇'▇ comments relating to any response.
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Related to FDA Inspections

  • IN INSPECTION Before, at the time of the Tenant accepting possession, or shortly thereafter, the Landlord and Tenant: (check one)

  • Goods Inspection The Commissioner of DAS, in consultation with the Client Agency, shall determine the manner and prescribe the inspection of all Goods and the tests of all samples submitted to determine whether they comply with all of the specifications in the Contract. If any Goods fail in any way to meet the specifications in the Contract, the Client Agency or the Commissioner of DAS may, in its sole discretion, either reject it and owe nothing or accept it and pay for it on an adjusted price basis, depending on the degree to which the Goods meet the specifications. Any decision pertaining to any such failure or rejection shall be final and binding.

  • 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.

  • Site Inspections Grantees must ensure by site inspections that facilities on the Project site are being operated and maintained for outdoor recreation for a minimum period of twenty-five (25) years from the Project Completion Date set forth in the Project Completion Certificate. The Project site must be open at reasonable times and must be managed in a safe and attractive manner.

  • Records; Inspection Reneo shall, and shall cause its Affiliates and Sublicensees to, keep complete, true and accurate books of account and records for the purpose of determining the payments to be made under this Agreement. Such books and records shall be kept for [***] years following the end of the calendar year to which they pertain. Such records shall be open for inspection during such period by independent accountants, solely for the purpose of verifying payment statements hereunder for a period covering not more than the [***] prior to the date of request; provided that no period shall be subject to inspection under this section more than once. Such inspections shall be made no more than once each calendar year, on reasonable notice during normal business hours. The auditor will execute a reasonable written confidentiality agreement with Reneo and will disclose to vTv only such information as is reasonably necessary to provide vTv with information regarding any actual or potential discrepancies between amounts reported and actually paid and amounts payable under this Agreement. The auditor will send a copy of the report to Reneo at the same time it is sent to vTv. The report sent to both Parties will include the methodology and calculations used to determine the results. Any unpaid amounts (plus interest as set forth in Section 3.8) that are discovered shall be paid promptly by Reneo. Inspections conducted under this Section 3.9 shall be at the expense of vTv, unless the inspection discloses an underpayment by Reneo of [***] or more of the amount due for any period covered by the inspection, whereupon all costs relating to the inspection for such period shall be paid promptly by Reneo. If an inspection conducted pursuant to this Section 3.9 discloses an overpayment by Reneo, then Reneo will deduct the amount of such overpayment from amounts otherwise owed to vTv under this Agreement, unless no further payments are due hereunder, in which case the amount of such overpayment shall be refunded by vTv to Reneo.