FDA Inspections Sample Clauses

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. 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. CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT BOTH (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. SUCH EXCLUDED INFORMATION HAS BEEN MARKED WITH “[***].
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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. 3)
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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 Xxxxxx'x comments relating to any response.
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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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Related to FDA Inspections

  • 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.

  • Records; Inspection Payor shall keep, and shall require its Permitted Sellers to keep, complete, true and accurate books of accounts and records for the purpose of determining the basis and accuracy of payments to be made under this Agreement. Such records shall be kept in accordance with GAAP, showing Net Sales on country-by-country and Licensed Product-by-Licensed Product basis, and Payor’s or its Permitted Sellers’ usual internal practices and procedures (which shall be commercially reasonable), consistently applied. Such books and records shall be kept for at least [*] ([*]) years following the end of the Calendar Quarter to which they pertain. Such records will be open for inspection by Payee during such five (5) year period by independent accountants reasonably acceptable to Payor, solely for the purpose of verifying the basis and accuracy of amounts in the payment statements hereunder. Such inspections shall be made no more than [*] each Calendar Year, at reasonable time and on reasonable notice and shall be limited to information related to Licensed Products. Results of any such inspection shall be deemed to be Confidential Information of Payor. If any errors in favor of Payor are discovered in the course of such inspection, then within thirty (30) days of written request by Payee, Payor shall pay Payee those amounts that Payee would have received in the absence of such errors, plus interest pursuant to and in accordance with Section 6.1(c). Inspections conducted under this Section 6.5 shall be at the expense of Payee, unless a variation or error in favor of Payor exceeding [*] percent ([*] %) of the amount due for the period covered by the inspection is established in the course of such inspection, whereupon all reasonable, documented costs relating to the inspection for such period will be paid promptly by Payor. In the event of overpayment to Payee, any amount of such overpayment shall be fully creditable against amounts payable for the immediately succeeding Calendar Quarter.

  • Environmental Inspections In the event Landlord has a reasonable basis to believe that Tenant is in breach of its obligations under this Article XXXII, Landlord shall have the right, from time to time, during normal business hours, subject to the rights of subtenants and hotel guests at the Leased Property and upon not less than five (5) days written notice to Tenant, except in the case of an emergency in which event no notice shall be required, to conduct an inspection of the Leased Property to determine the existence or presence of Hazardous Substances on or about the Leased Property. Landlord shall have the right to enter and inspect the Leased Property, (upon not less than ten (10) days written notice to Tenant for invasive testing except in the case of emergency when no advance notice shall be required; provided, that Landlord shall provide notice to Tenant within a reasonable period thereafter) conduct any testing, sampling and analyses it deems necessary and shall have the right to inspect Hazardous Substances brought into the Leased Property; provided that, except in the case of emergency or during the occurrence and continuance of an Event of Default, Landlord shall use commercially reasonable efforts to cause any such testing, sampling and analyses to be performed in such a manner so as to reasonably minimize any interference with the operations and occupancy of the Leased Property and to reasonably minimize any disturbance to guests of Tenant. Landlord may, in its discretion, retain such experts to conduct the inspection, perform the tests referred to herein, and to prepare a written report in connection therewith. All reasonable costs and expenses incurred by Landlord under this Section 32.5 shall be paid on demand as Additional Charges by Tenant to Landlord. Failure to conduct an environmental inspection or to detect unfavorable conditions if such inspection is conducted shall in no fashion be intended as a release of any liability for environmental conditions subsequently determined to be associated with or to have occurred during Xxxxxx’s tenancy. To the extent Tenant may be liable pursuant to this Article XXXII, Tenant shall remain liable for any environmental condition related to or having occurred during its tenancy regardless of when such conditions are discovered and regardless of whether or not Landlord conducts an environmental inspection at the termination of this Master Lease.

  • 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.

  • Inspections The Servicer shall inspect the Mortgaged Property as often as deemed necessary by the Servicer in accordance with Accepted Servicing Practices to assure itself that the value of the Mortgaged Property is being preserved. In addition, if any Mortgage Loan is more than 45 days delinquent, the Servicer promptly shall inspect the Mortgaged Property and shall conduct subsequent inspections in accordance with Accepted Servicing Practices or as may be required by the primary mortgage guaranty insurer. Upon request, the Servicer shall produce an electronic report of each such inspection.

  • Final Inspection Contractor shall complete the list of items identified on the pre-final Punchlist prior to requesting a final inspection. Unless otherwise specified, or otherwise agreed in writing by the parties as documented on the Certificate of Substantial Completion, Contractor shall complete and/or correct all Work within thirty (30) days of the Substantial Completion date. Upon completion of the pre-final Punchlist work, Contractor shall give written notice to ODR and A/E that the Work will be ready for final inspection on a specific date. Contractor shall accompany this notice with a copy of the updated pre-final Punchlist indicating resolution of all items. On the date specified or as soon thereafter as is practicable, ODR, A/E and Contractor will inspect the Work. A/E will submit to Contractor a final Punchlist of open items that the inspection team requires corrected or completed before final acceptance of the Work.

  • 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.

  • Books and Records; Inspections Each Credit Party will, and will cause each of its Subsidiaries to, keep proper books of record and accounts in which full, true and correct entries in conformity in all material respects with GAAP shall be made of all dealings and transactions in relation to its business and activities. Each Credit Party will, and will cause each of its Subsidiaries to, permit any authorized representatives designated by the Administrative Agent at the request of the Requisite Lenders (including the right to appoint third party agents), at the Borrower’s expense (subject to the proviso below), to visit and inspect any of the properties of any Credit Party and any of its respective Subsidiaries, to inspect, copy and take extracts from its and their financial and accounting records, and to discuss its and their affairs, finances and accounts with its and their officers and independent public accountants (and an authorized representative of the Borrower shall be allowed to be present during such discussions), all upon reasonable notice and at such reasonable times during normal business hours and as often as may reasonably be requested, in each case, in a manner that does not unduly interfere with the business and operations of the Credit Parties and their Subsidiaries; provided that (i) the Borrower shall only be obligated to reimburse the Administrative Agent and the Requisite Lenders for the expenses of one such inspection per calendar year prior to the occurrence of an Event of Default; and (ii) any authorized representatives designated by any Lender (including the right to appoint third party agents) may accompany the Administrative Agent or its representative in connection with any inspection, in each case at such Lender’s sole expense; provided, further, that, notwithstanding anything to the contrary in this Section 5.6, none of Holdings or any of its Subsidiaries will be required to disclose, permit the inspection, examination or making copies or abstracts of, or discussion of, any document, information or other matter (a) in respect of which disclosure to the Administrative Agent or any Lender (or their respective representatives or contractors) is prohibited by law or any binding confidentiality obligation pursuant to any Contractual Obligation with any Third Party in effect prior to (and not entered into in contemplation of) such Credit Party’s or Subsidiary’s obligations under this Section 5.6 (it being understood and agreed that the Credit Parties shall use their commercially reasonable efforts to provide such information in a manner which would comply with such confidentiality obligation) or (b) that is subject to attorney-client or similar privilege or constitutes attorney work product.

  • Environmental Inspection 13 ARTICLE XI....................................................................14 11.1 Modifications...................................................14 ARTICLE XII...................................................................15 12.1

  • Site Inspection Where a site inspection is required by the Bid Specifications or Project Definition, Bidder shall be required to inspect the site, including environmental or other conditions for pre-existing deficiencies that may affect the installed Product, equipment, or environment or services to be provided and, which may affect Bidder’s ability to properly deliver, install or otherwise provide the required Product. All inquiries regarding such conditions shall be made in writing. Bidder shall be deemed to have knowledge of any deficiencies or conditions which such inspection or inquiry might have disclosed. Bidder must provide a detailed explanation with its Bid if additional work is required under this clause in order to properly complete the delivery and installation of the required Product or provide the requested service.

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