REPORTING; RESPONSE TO INQUIRIES Sample Clauses

REPORTING; RESPONSE TO INQUIRIES. SECTION 5.3.1. During the Term, each Party shall notify the other Party within two (2) business days of receipt of any inquiry, complaint, claim or adverse reaction report regarding the Product (any of the foregoing, a "Report"), including, without limitation, any inquiry or notice from the FDA or any other Regulatory Authority regarding any alleged regulatory non-compliance of the Product, which notice shall describe in reasonable detail all information contained in the Report or otherwise known to the applicable Party regarding the subject matter thereof and shall include copies of any documentation comprising such Report. SECTION 5.3.2. With respect to any inquiry of the FDA or another applicable Regulatory Authority in respect of Product manufactured by Xxxxxxx, Xxxxxxx shall use its commercially reasonable efforts to (a) notify NitroMed of any such inquiry directed to Xxxxxxx, (b) respond fully and accurately to all such inquiries directed to Xxxxxxx, (c) assist NitroMed in responding to inquiries directed to NitroMed, (d) provide the FDA or such other Regulatory Authority with such information or data in Xxxxxxx'x possession as the FDA or such other Regulatory Authority requests in connection with such inquiry or the Product, and (e) consult with NitroMed regarding Xxxxxxx'x response to any such inquiry. ARTICLE VI
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Related to REPORTING; RESPONSE TO INQUIRIES

  • Reporting Responsibility a) Vendor shall be responsible for reporting all services purchased under the Contract. Vendor shall file the monthly reports, subcontract reports, and pay the administrative fees in accordance with the due dates specified in this section. b) DIR shall have the right to verify required reports and to take any actions necessary to enforce its rights under this section, including but not limited to compliance checks of Vendor’s applicable Contract. Vendor will provide all required documentation at no cost.

  • Reporting of Compliance Matters (a) The Sub-Adviser shall promptly provide to the Trust’s Chief Compliance Officer (“CCO”) the following documents: (i) copies of all SEC examination correspondences, including correspondences regarding books and records examinations and “sweep” examinations, issued during the term of this Agreement, in which the SEC identified any concerns, issues or matters (such correspondences are commonly referred to as “deficiency letters”) relating to any aspect of the Sub-Adviser’s investment advisory business and the Sub-Adviser’s responses thereto; (ii) a report of any material violations of the Sub-Adviser’s Compliance Program or any “material compliance matters” (as such term is defined in Rule 38a-1 under the 0000 Xxx) that have occurred with respect to the Sub-Adviser’s Compliance Program; (iii) a report of any material changes to the policies and procedures that compose the Sub-Adviser’s Compliance Program; (iv) a copy of the Sub-Adviser’s chief compliance officer’s report (or similar document(s) which serve the same purpose) regarding his or her annual review of the Sub-Adviser’s Compliance Program, as required by Rule 206(4)-7 under the Advisers Act; and (v) an annual (or more frequently as the Trust’s CCO may reasonably request) representation regarding the Sub-Adviser’s compliance with Paragraphs 7 and 8 of this Agreement. (b) The Sub-Adviser shall also provide the Trust’s CCO with: (i) reasonable access to the testing, analyses, reports and other documentation, or summaries thereof, that the Sub-Adviser’s chief compliance officer relies upon to monitor the effectiveness of the implementation of the Sub-Adviser’s Compliance Program; and (ii) reasonable access, during normal business hours, to the Sub-Adviser’s facilities for the purpose of conducting pre-arranged on-site compliance related due diligence meetings with personnel of the Sub-Adviser.

  • Information for Regulatory Compliance Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities.

  • Response to Objections Each Party retains the right to respond to any objection raised by a Participating Class Member, including the right to file responsive documents in Court no later than five court days prior to the Final Approval Hearing, or as otherwise ordered or accepted by the Court.

  • NOTIFICATIONS AND SUBMISSION OF REPORTS Unless otherwise stated in writing after the Effective Date, all notifications and reports required under this IA shall be submitted to the following entities: Administrative and Civil Remedies Branch Office of Counsel to the Inspector General Office of Inspector General U.S. Department of Health and Human Services Xxxxx Building, Room 5527 000 Xxxxxxxxxxxx Xxxxxx, XX Xxxxxxxxxx, XX 00000 Telephone: (000) 000-0000 Facsimile: (000) 000-0000 LFAC: Xxxxxxx X. Xxxxx, DPM 0000 Xxxxxxxxxxx Xx. X-000 Xxxxxxxxx, XX 00000 Telephone: (000) 000-0000 Email: xx.xxxxx@xxxxx.xxx Unless otherwise specified, all notifications and reports required by this IA may be made by electronic mail, overnight mail, hand delivery, or other means, provided that there is proof that such notification was received. Upon request by OIG, LFAC may be required to provide OIG with an additional copy of each notification or report required by this IA in OIG’s requested format (electronic or paper).

  • Response to Notice Within ten business days of receiving the Claim Notice, the Respondent must notify the Claimant of its representative to negotiate the dispute.

  • Reporting Responsibilities The IRA Owner agrees to provide the Custodian with information necessary for the Custodian to prepare any reports required under Code Sections 408(i), 408A(d)(3)(D), and Regulations Sections 1.408-5 and 1.408-6. The Custodian agrees to submit reports to the IRS and the IRA Owner (or Beneficiary(ies) upon the IRA Owner’s death) as prescribed by the IRS and such additional reports as the Custodian may choose to deliver. The Custodian shall furnish annual calendar-year reports concerning the status of the IRA and such information concerning required minimum distributions as is prescribed by the Commissioner of the IRS.

  • Lobbying Activities - Standard Form - LLL No response Do not upload this form unless Vendor has reportable lobbying activities. There are Attributes entitled, “2 CFR Part 200 or Federal Provision - Xxxx Anti-Lobbying Amendment – Continued.” Properly respond to those Attributes and only upload this form if applicable/instructed. If upload is required based on your response to those Attributes, the Disclosure of Lobbying Activities – Standard Form - LLL must be downloaded from the “Attachments” section of the IonWave eBid System, reviewed, properly completed, and uploaded to this location.

  • Child Abuse Reporting Requirement Grantee will: a. comply with child abuse and neglect reporting requirements in Texas Family Code Chapter 261. This section is in addition to and does not supersede any other legal obligation of the Grantee to report child abuse. b. develop, implement and enforce a written policy that includes at a minimum the System Agency’s Child Abuse Screening, Documenting, and Reporting Policy for Grantees/Providers and train all staff on reporting requirements. c. use the System Agency Child Abuse Reporting Form located at xxxxx://xxx.xxxx.xxxxx.xx.xx/Contact Us/report abuse.asp as required by the System Agency. d. retain reporting documentation on site and make it available for inspection by the System Agency.

  • Child Abuse Reporting Requirements A. Grantees shall comply with child abuse and neglect reporting requirements in Texas Family Code Chapter 261. This section is in addition to and does not supersede any other legal obligation of the Grantee to report child abuse. B. Grantee shall use the Texas Abuse Hotline Website located at xxxxx://xxx.xxxxxxxxxxxxxx.xxx/Login/Default.aspx as required by the System Agency. Grantee shall retain reporting documentation on site and make it available for inspection by the System Agency.

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