FDA Inspection Reports Sample Clauses

FDA Inspection Reports. Contractor shall provide the Buyer with copies of any FDA Form 483 observations, follow-up warning letters and/or close-out reports for those portions of FDA CGMP / QSR compliance inspection reports relating specifically to the manufacture of the Product(s) for any facility where the Product(s) is manufactured.
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FDA Inspection Reports. Marquette will provide OSI with copies of any ---------------------- FDA Form 483 observations, follow-up earning letters and/or close-out reports for those portions of GMP compliance inspection reports resulting specifically to the manufacture of ABG Modules for any facility where ABG Modules are manufactured.
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FDA Inspection Reports. Supplier shall provide Aastrom with copies of any FDA Form 483 observations, follow-up warning letters and/or close-out reports for those portions of FDA CGMP/QSR compliance inspection reports relating specifically to the Instruments or the System's regulatory submission for any facility where the Instruments are manufactured and will work closely with Aastrom when responding to Form 483 observations that impact the Instruments or System. Additionally, Supplier shall advise Aastrom of any Form 483 observations not directly related to the System, but affecting the Quality Systems that are used in manufacture of the Instruments. Supplier shall immediately report to Aastrom in writing any adverse events, circumstances, or potential problems relating to Suppliers registrations or inspections that could adversely effect the Instrument or System approval. Supplier shall furnish to Aastrom a copy of the facility registrations and inspection reports specifically related to the System applicable as of the date of this Agreement and throughout the term of this Agreement. Supplier shall allow Aastrom and its agent to review and inspect Suppliers facilities, and regulatory compliance files, and correspondence to and from the FDA regarding inspections, registrations, and audits that pertain directly to the Instruments or any regulatory submission with regard to the System.
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FDA Inspection Reports. Contractor shall, within five working days of receipt, provide the Buyer with copies of any FDA Form 483 observations, follow-up warning letters or close-out reports for those portions of FDA cGMP compliance inspection reports relating specifically to the manufacture of the Product(s) for any facility where the Product(s) is manufactured.
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Related to FDA Inspection Reports

  • Inspection; Reports (a) The Shipowner will at all reasonable times afford the Mortgagee or its authorized representatives full and complete access to the Vessel for the purpose of inspecting the Vessel and her cargo and papers, including without limitation all records pertaining to the Vessel’s maintenance and repair, and, at the request of the Mortgagee, the Shipowner will deliver for inspection copies of any and all contracts and documents relating to the Vessel, whether on board or not.

  • Inspection of Reports The Depositary shall make available for inspection by holders of Receipts at the Corporate Office and at such other places as it may from time to time deem advisable during normal business hours any reports and communications received from the Company that are both received by the Depositary as the holder of deposited Preferred Stock and made generally available to the holders of the Preferred Stock. In addition, the Depositary shall transmit certain notices and reports to the holders of Receipts as provided in Section 5.05.

  • Inspection; Compliance Lessor and Lessor's Lender(s) (as defined in Paragraph 8.3(a)) shall have the right to enter the Premises at any time, in the case of an emergency, and otherwise at reasonable times, for the purpose of inspecting the condition of the Premises and for verifying compliance by Lessee with this Lease and all Applicable Laws (as defined in Paragraph 6.3), and to employ experts and/or consultants in connection therewith and/or to advise Lessor with respect to Lessee's activities, including but not limited to the installation, operation, use, monitoring, maintenance, or removal of any Hazardous Substance or storage tank on or from the Premises. The costs and expenses of any such inspections shall be paid by the party requesting same, unless a Default or Breach of this Lease, violation of Applicable Law, or a contamination, caused or materially contributed to by Lessee is found to exist or be imminent, or unless the inspection is requested or ordered by a governmental authority as the result of any such existing or imminent violation or contamination. In any such case, Lessee shall upon request reimburse Lessor or Lessor's Lender, as the case may be, for the costs and expenses of such inspections.

  • Records; Inspection Toshiba and SanDisk shall keep complete, true and accurate books of account and records on its own behalf and on behalf of the Toshiba and SanDisk Affiliates for the purpose of determining the CDP Product Fee amounts, Non-CDP Product Fee amounts, and any amounts payable by Toshiba or SanDisk as applicable pursuant to Section 5.10, under this Agreement. Such books and records shall be kept at Toshiba and SanDisk for at least [*] years following the end of the calendar quarter to which they pertain. Such records will be open for inspection during such [*] year period by an independent auditor who is reasonably acceptable to the parties and agrees to be bound to confidentiality protections of similar scope to those set out in Section 8 hereof, solely for the purpose of verifying statements related to amounts payable hereunder. Such auditor shall be instructed to report only as to whether there is a discrepancy, and if so, the amount of such discrepancy. With reasonable prior notice in writing, such inspections may be made no more than once each calendar year Intermolecular Confidential [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. during regular business hours (other than during quarter-end or year-end financial closing periods), to the extent not unreasonably hindering any operations of Toshiba and SanDisk. Inspections conducted under this Section shall be at the expense of Intermolecular, unless a variation or error producing an increase exceeding [*] percent ([*]%) of the royalties payable for any period covered by the inspection is established and confirmed in the course of any such inspection, whereupon all reasonable and documented costs relating to the inspection for such period and any unpaid amounts that are discovered will be paid promptly by Toshiba and/or SanDisk, as applicable. Further, if the foregoing inspection indicates a need for a follow-up inspection, Intermolecular will have the right thereafter to conduct additional inspections from time to time within one year (in such case, the scope of the inspection shall be limited to those issues which Intermolecular needs to confirm the implementation of any corrective action therefor). Each party agrees to hold in confidence pursuant to Section 8 all information concerning payments and associated reports, and all information learned in the course of any audit or inspection, except to the extent necessary for that party to reveal such information in order to enforce its rights under this Agreement or if disclosure is required by law.

  • Audits/Inspections Upon reasonable notice and during normal business hours, the Borrower will, and will cause each of its Subsidiaries to, permit representatives appointed by the Administrative Agent, including, without limitation, independent accountants, agents, attorneys, and appraisers to visit and inspect its property, including its books and records, its accounts receivable and inventory, its facilities and its other business assets, and to make photocopies or photographs thereof and to write down and record any information such representative obtains and shall permit the Administrative Agent or its representatives to investigate and verify the accuracy of information provided to the Lenders and to discuss all such matters with the officers, employees and representatives of such Person.

  • Physical Conditions Reports Lender shall have received Physical Conditions Reports with respect to the Property, which reports shall be reasonably satisfactory in form and substance to Lender.

  • 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.

  • Due Diligence Review; Information The Company shall make available, during normal business hours, for inspection and review by the Investors, advisors to and representatives of the Investors (who may or may not be affiliated with the Investors and who are reasonably acceptable to the Company), all financial and other records, all SEC Filings (as defined in the Purchase Agreement) and other filings with the SEC, and all other corporate documents and properties of the Company as may be reasonably necessary for the purpose of such review, and cause the Company’s officers, directors and employees, within a reasonable time period, to supply all such information reasonably requested by the Investors or any such representative, advisor or underwriter in connection with such Registration Statement (including, without limitation, in response to all questions and other inquiries reasonably made or submitted by any of them), prior to and from time to time after the filing and effectiveness of the Registration Statement for the sole purpose of enabling the Investors and such representatives, advisors and underwriters and their respective accountants and attorneys to conduct initial and ongoing due diligence with respect to the Company and the accuracy of such Registration Statement. The Company shall not disclose material nonpublic information to the Investors, or to advisors to or representatives of the Investors, unless prior to disclosure of such information the Company identifies such information as being material nonpublic information and provides the Investors, such advisors and representatives with the opportunity to accept or refuse to accept such material nonpublic information for review and any Investor wishing to obtain such information enters into an appropriate confidentiality agreement with the Company with respect thereto.

  • Environmental Inspections In the event Landlord has a reasonable basis to believe that Tenant is in breach of its obligations under Sections 32.1 through 32.4, Landlord shall have the right, from time to time, during normal business hours and upon not less than five (5) Business Days written notice to Tenant (except in the case of an emergency that constitutes an imminent threat to human health or safety or damage to property, in which event Landlord shall undertake reasonable efforts to notify a representative of Tenant as soon as practicable under the circumstances), to conduct an inspection of the Leased Property or any portion thereof (and Tenant shall be permitted to have Landlord or its representatives accompanied by a representative of Tenant) to determine the existence or presence of Hazardous Substances on or about the Leased Property or any portion thereof. In the event Landlord has a reasonable basis to believe that Tenant is in breach of its obligations under Sections 32.1 through 32.4, Landlord shall have the right to enter and inspect the Leased Property or any portion thereof, conduct any testing, sampling and analyses it reasonably deems necessary and shall have the right to inspect materials brought into the Leased Property or any portion thereof. 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 if Landlord has a reasonable basis to believe that Tenant is in breach of its obligations under Sections 32.1 through 32.4. All costs and expenses incurred by Landlord under this Section 32.6 shall be the responsibility of Landlord, except solely to the extent Tenant has breached its obligations under Sections 32.1 through 32.5, in which event such reasonable costs and expenses shall be paid by Tenant to Landlord as provided in Section 32.4. Failure to conduct an environmental inspection or to detect unfavorable conditions if such inspection is conducted shall in no fashion constitute a release of any liability for environmental conditions subsequently determined to be associated with or to have occurred during Tenant’s tenancy. 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 Lease. The obligations set forth in this Article XXXII shall survive the expiration or earlier termination of this Lease but in no event shall Article XXXII apply to matters first occurring after the later of (x) the end of the Term and (y) the date upon which Tenant shall have vacated the Leased Property and surrendered the same to Landlord, in each case to the extent such matters are not or were not caused by the acts or omissions of Tenant in breach of this Lease.

  • Agreements Regarding Collateral and Field Examination Reports (ll) Lien Releases;

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