Notice of Audit or Inquiry Sample Clauses

Notice of Audit or Inquiry. Each party agrees to promptly notify the other of any FDA audit, or any audit by any other regulatory body, of its facilities used for the manufacture, storage or distribution of Products, or any request for information from the FDA, or other regulatory body, related to the manufacture of Products, as soon as practicable after it received notice of such audit or request.
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Notice of Audit or Inquiry. Juneau agrees to provide Predictive on a prompt basis with copies of all correspondence to and from the FDA and other Regulatory Authorities relating to the Licensed Assay including, without limitation, correspondence relating to the Regulatory Approvals and the results of inspections or audits. In addition, Juneau agrees to notify Predictive (i) of any audit or inspection (such as an FDA audit or CLIA inspection) by a Regulatory Authority of facilities used for the manufacture of or to process the Licensed Assay and (ii) of any request for information from the FDA (or other Regulatory Authority) related to the sale, processing or manufacture of the Licensed Assay, as soon as practicable after Juneau receives notice of such audit, inspection or request.

Related to Notice of Audit or Inquiry

  • Audit Request Each Party shall, at its sole cost and expense (except as provided below), have the right one (1) time each Calendar Year to audit, during regular business hours and upon not less than fifteen (15) days prior written notice to the other Party, the books and records maintained by such other Party to determine with respect to any Calendar Year, the accuracy of any report or payment made or expense charged by one Party to the other under this Agreement in the [***] Calendar Years. If a Party desires to audit such records, it shall engage an independent, certified public accountant reasonably acceptable to the other Party, to examine such records under conditions of confidentiality. Such accountant shall be instructed to provide to the auditing Party a report verifying any report made or payment submitted or expense charged by the other Party during such period, but shall not disclose to the auditing Party any Confidential Information of the other Party not necessary to be disclosed. The expense of such audit shall be borne by the auditing Party; provided, however, that, if an error of more than five percent (5%) is discovered, then such expenses shall be paid by the other Party. If such accountant concludes that additional payment amounts were owed or additional expenses were charged to the auditing Party during any period, the other Party shall pay such payment amount (including interest thereon pursuant to Section 7.9 (Interest) from the date such amounts were payable) within thirty (30) days after the date the auditing Party delivers to the other Party such accountant’s written report so concluding, unless such other Party notifies the auditing Party of any dispute regarding the audit and commences proceedings under Article 14 (DISPUTE RESOLUTION) within thirty (30) days after delivery of the accountant’s report (in which case the payment shall be delayed until conclusion of the proceeding). Such auditors shall not be paid on a contingency basis.

  • Notice of Auction Results (a) On each Auction Date, the Auction Agent shall notify BD by telephone as set forth in paragraph (a) of the Settlement Procedures. On the Business Day next succeeding such Auction Date, the Auction Agent shall notify BD in writing of the disposition of all Orders submitted by BD in the Auction held on such Auction Date.

  • Legal Action Notice A prompt report of any legal actions pending or threatened in writing against Borrower or any of its Subsidiaries that could result in damages or costs to Borrower or any of its Subsidiaries of, individually or in the aggregate, One Hundred Thousand Dollars ($100,000) or more; and

  • Notification of Threatened Action Each Party will immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by any Regulatory Authority, which may affect the safety or efficacy claims of any Licensed Product or the continued marketing of any Licensed Product. Upon receipt of such information, the Parties will consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

  • Annual Statement as to Compliance; Notice of Servicer Default (a) The Servicer shall deliver to the Indenture Trustee and the Owner Trustee, on or before March 15 of each year, beginning March 15, 2018 (or, if such day is not a Business Day, the next succeeding Business Day), an officer’s certificate signed by an Authorized Officer of the Servicer, dated as of December 31 of the immediately preceding year, in each instance stating that (i) a review of the activities of the Servicer during the preceding twelve (12) month period (or, with respect to the first such certificate, such period as shall have elapsed from the Closing Date to the date of such certificate) and of its performance under this Agreement has been made under such officer’s supervision and (ii) to the best of such officer’s knowledge, based on such review, the Servicer has fulfilled all its obligations under this Agreement in all material respects throughout such period, or, if there has been a default in the fulfillment of any such obligation, in any material respect specifying each such default known to such officer and the nature and status thereof.

  • Notice of Complaints Each Purchaser shall promptly notify the applicable Seller upon becoming aware of any complaint concerning any Serviced Appointment made by any party to the Serviced Corporate Trust Contract, any Securityholder, any Credit Enhancement Provider or any rating agency.

  • Annual Statement as to Compliance; Notice of Default (a) The Servicer shall deliver to the Issuing Entity and the Indenture Trustee, on or before March 30 of each year, an Officer’s Certificate of the Servicer providing such information as is required under Item 1123 of Regulation AB with respect to the prior calendar year.

  • Agent Counsel Legal Opinion Agent shall have received from Xxxxxx LLP, counsel for Agent, such opinion or opinions, on or before the date on which the delivery of the Company counsel legal opinion is required pursuant to Section 4(p), with respect to such matters as Agent may reasonably require, and the Company shall have furnished to such counsel such documents as they request for enabling them to pass upon such matters.

  • Selection of Independent Counsel If the determination of entitlement to indemnification pursuant to Section 6.2 will be made by an Independent Counsel, the Independent Counsel will be selected as provided in this Section 6.3. The Independent Counsel will be selected by the Company (unless the Company requests that such selection be made by the Indemnitee, in which event the immediately following sentence will apply), and the Company will give written notice to Indemnitee advising Indemnitee of the identity of the Independent Counsel so selected. If the Independent Counsel is selected by the Indemnitee, Indemnitee will give written notice to the Company advising of the identity of the Independent Counsel so selected. In either event, Indemnitee or the Company, as the case may be, may, within ten days after such written notice of selection is given, deliver to the Company or to Indemnitee, as the case may be, a written objection to such selection; provided, however, that such objection may be asserted only on the ground that the Independent Counsel so selected does not meet the requirements of “Independent Counsel” as defined in this Agreement, and the objection will set forth with particularity the factual basis of such assertion. Absent a proper and timely objection, the person so selected will act as Independent Counsel. If a written objection is made and substantiated, the Independent Counsel selected may not serve as Independent Counsel unless and until such objection is withdrawn or a court has determined that such objection is without merit. If, within 30 days after submission by Indemnitee of a written request for indemnification pursuant to Section 6.1, no Independent Counsel is selected, or an Independent Counsel for which an objection thereto has been properly made remains unresolved, either the Company or Indemnitee may petition a court of competent jurisdiction for resolution of any objection which has been made by the Company or Indemnitee to the other’s selection of Independent Counsel and/or for the appointment as Independent Counsel of a person selected by the court or by such other person as the court may designate, and the person with respect to whom all objections are so resolved or the person so appointed will act as Independent Counsel under Section 6.2. The Company will pay any and all reasonable and necessary fees and expenses incurred by such Independent Counsel in connection with acting pursuant to Section 6.2 hereof, and the Company will pay all fees and expenses incident to the procedures of this Section 6.3, regardless of the manner in which such Independent Counsel was selected or appointed.

  • Notice of Material Events and Change of Address Borrower will promptly notify each Lender in writing, stating that such notice is being given pursuant to this Agreement, of:

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