Notification of Communications with Federal Agencies Sample Clauses

Notification of Communications with Federal Agencies. The A Relying Institution will also promptly notify the Reviewing IRB/Reviewing IRB Institution of communications regarding unanticipated problems, suspension or termination of IRB approval, serious and/or continuing noncompliance, and/or other regulatory compliance concerns regarding Research conducted under the authority of the Relying Institution under Ceded Review that are received by the Relying Institution from, or betweenmade by the Relying Institution andto, federal human subjects research regulatory agencies FDA, OHRP, and/or other regulatory agencies, or funding agenciesregarding unanticipated problems, noncompliance, or other compliance concerns regarding the Research,. andA Relying Institution will require theits Overall PI (if any), and Site Investigator(s), and other Personnel to do the same with respect to such communications between the Overall PI/ or Site Investigator(s)/other Personnel from, or made by the Overall PI/Site Investigator(s)/other Personnel to, and such agencies.
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Notification of Communications with Federal Agencies. A Reviewing IRB/Reviewing IRB Institution will promptly notify a Relying Institution of communications regarding unanticipated problems, suspension or termination of IRB approval, serious and/or continuing noncompliance, and/or other regulatory compliance concerns regarding Research conducted under the authority of the Relying Institution under Ceded Review that are received by the Reviewing IRB/Reviewing IRB Institution from, or made by the Reviewing IRB/Reviewing IRB Institution to, federal human subjects research regulatory agencies or funding agencies.
Notification of Communications with Federal Agencies. A Relying Institution will promptly notify the Reviewing IRB/Reviewing IRB Institution of communications regarding unanticipated problems, suspension or termination of IRB approval, serious and/or continuing noncompliance, and/or other regulatory compliance concerns regarding Research conducted under the authority of the Relying Institution under Ceded Review that are received by the Relying Institution from, or made by the Relying Institution to, federal human subjects research regulatory agencies or funding agencies. A Relying Institution will require its Overall PI (if any), Site Investigator(s), and other Personnel to do the same with respect to such communications between the Overall PI/Site Investigator(s)/other Personnel from, or made by the Overall PI/Site Investigator(s)/other Personnel to, such agencies.

Related to Notification of Communications with Federal Agencies

  • Preservation Of Information; Communications With Securityholders (a) The Trustee shall preserve, in as current a form as is reasonably practicable, all information as to the names and addresses of the holders of Securities contained in the most recent list furnished to it as provided in Section 5.01 and as to the names and addresses of holders of Securities received by the Trustee in its capacity as Security Registrar (if acting in such capacity). (b) The Trustee may destroy any list furnished to it as provided in Section 5.01 upon receipt of a new list so furnished. (c) Securityholders may communicate as provided in Section 312(b) of the Trust Indenture Act with other Securityholders with respect to their rights under this Indenture or under the Securities, and, in connection with any such communications, the Trustee shall satisfy its obligations under Section 312(b) of the Trust Indenture Act in accordance with the provisions of Section 312(b) of the Trust Indenture Act.

  • Communications with Rating Agencies The parties hereto (other than the Seller and its Affiliates but excluding the Issuing Entity) agree that any notices or requests to, or any other written communications with, any of the Rating Agencies, or any of their respective officers, directors or employees, to be given or provided to such Rating Agencies pursuant to, in connection with or related, directly or indirectly, to the Basic Documents, the Collateral or the Notes, shall be in each case either (i) furnished to the Seller who shall forward such communication to the Rating Agencies pursuant to Section 10.18 of the Sale and Servicing Agreement; or (ii) furnished directly to the Rating Agencies with a prior copy to the Seller. In either case, the parties hereto (other than the Seller and its Affiliates but excluding the Issuing Entity) further agree to provide such notices, requests and communications or copies thereof, as applicable, to the Seller at least one Business Day prior to the date when such notices, requests and communications are required to be delivered (or are in fact delivered, whichever is earlier) to the Rating Agencies pursuant to the Basic Documents. So long as any Notes are Outstanding, each party hereto (other than the Seller and its Affiliates but excluding the Issuing Entity) agrees that neither it nor any party on its behalf shall engage in any oral communications with respect to the transactions contemplated hereby, under the Basic Documents or in any way relating to the Notes with any Rating Agency or any of their respective officers, directors or employees, without the participation of the Seller.

  • Communications with Accountants Each of the Borrowers authorizes the Administrative Agent and, if accompanied by the Administrative Agent, the Lenders to communicate directly with the Accountants and authorizes the Accountants to disclose to the Administrative Agent and the Lenders any and all financial statements and other supporting financial documents and schedules including copies of any management letter with respect to the business, financial condition and other affairs of such Borrower or any of its Subsidiaries. At the request of the Administrative Agent, such Borrower shall deliver a letter addressed to the Accountants instructing them to comply with the provisions of this §8.9.2.

  • Communications with Regulatory Authorities During the Collaboration Term, Xencor shall provide MorphoSys with reasonable advance notice of any meeting or substantive telephone conference with any Regulatory Authority relating to any Licensed Antibody and/or Licensed Product. MorphoSys shall have the right to attend and observe (but not participate actively in) any material meeting or material conference call with any Regulatory Authority regarding any of MorphoSys (or its Affiliate’s or Sublicensee’s) Licensed Antibody and/or Licensed Products. In addition, Xencor shall promptly furnish to MorphoSys copies of all correspondence that Xencor (or its Affiliate) receives from, or submits to, any Regulatory Authority (including contact reports concerning conversations or substantive meetings) relating to any Licensed Antibody and/or Licensed Product. Xencor shall also provide to MorphoSys any meeting minutes that reflect material communications with any Regulatory Authority regarding a Licensed Antibody and/or Licensed Product. Subject to the provisions of Section 2.2(c)(ii), MorphoSys shall provide in its MorphoSys Annual Development Reports to Xencor, and through JDC discussion, information regarding its (or its Affiliate’s or, to the extent permitted by the Sublicense, Sublicensee’s) interactions with Regulatory Authorities with respect to all Licensed Antibodies and/or Licensed Products in its respective Territory. In addition, to the extent permitted by law and subject to Section 3.6, Xencor may participate in communications and meetings with any Regulatory Authority to the extent the name and/or then-current Xencor logo is used on the drug product label and such labeling is being discussed in such communication or meeting. Notwithstanding MorphoSys’ obligations under this Article 3, MorphoSys shall not be required to share with Xencor any information which MorphoSys is not permitted to share with Xencor under the applicable laws or regulations of the Securities & Exchange Commission or other regulatory body of the US or elsewhere.

  • Compliance with Federal Law, Regulations, and Executive Orders This is an acknowledgement that FEMA financial assistance will be used to fund all or a portion of the contract. The contractor will comply with all applicable Federal law, regulations, executive orders, FEMA policies, procedures, and directives.

  • NOTIFICATION TO STATE AND FEDERAL AGENCIES Copies of this document will be provided to other state and federal agencies as a means of notifying them of this approval.

  • APPROVAL OF GENERAL COMMUNICATIONS Competitive Supplier shall cooperate with and assist the Town in the drafting and sending of messages and information to Eligible Consumers concerning the Program or any matter arising under or related to this Agreement or the Program. Competitive Supplier shall, prior to sending any direct mail, advertising, solicitation, bill insert, electronic mail, or other similar written or electronic communication (collectively, “General Communications”) to Participating Consumers (but excluding individually drafted or tailored communications responding to a specific complaint or communication of an individual consumer), provide a copy of such General Communication to the Town for its review (for consistency with the Town’s purposes and goals) and approval. The Town shall have the right to disapprove such General Communications and suggest revisions if it finds the communication inconsistent with the purposes and goals of the Town, factually inaccurate, or likely to mislead provided, however, that: (i) the communication shall be deemed approved if the Town fails to respond within ten (10) Business Days, and (ii) no approval shall be necessary for any communication (a) regarding any emergency situation involving any risk to the public health, safety or welfare; (b) that has been approved by the Department, the DOER; or (c) in the nature of routine monthly or periodic bills, or collection notices, except that any bill insert or message included at the bottom of such bill not within the scope of (a) or (b) above shall require advanced review and approval by the Town; and (iii) no approval or lack of approval shall relieve the Competitive Supplier of its obligations and responsibility for its actions and omissions under this Agreement, or other than as set forth in sub-clause ‘i’ of this Section 7.6, result in a waiver of any rights, remedies or defenses of the Town. The Town may reject or exclude any proposed General Communication that, in its reasonable judgment, is contrary to the interests and objectives of the Program or the Town.

  • Relations with Governments 26 5.29 Disclosure......................................................26 5.30

  • Agreement Administration and Communications A. Under this Agreement, either of the representatives of the Judicial Council identified below will monitor the Work and act as the Judicial Council’s liaisons with the Contractor: i. The Meeting Planner will be MPname. B. The Judicial Council may reallocate funds between the estimated amounts set forth in Exhibit G, without an Amendment to this Agreement, as long as the total amount to be paid under this Agreement does not exceed the Contract Amount. C. All requests and communications about the Work to be performed under this Agreement, including signing of any BEO’s, shall be made through the Meeting Planner or his or her designee or successor. D. Any Notice from the Contractor to the Judicial Council shall be delivered to the following address: MP name, Meeting Planner Judicial Council of California 000 Xxxxxx Xxxx Xxxxxx Xxx Xxxxxxxxx, XX 00000-0000 E. Notice to the Contractor shall be directed to the Contractor’s liaison, Attn, or his or her designee or successor, at the following address: Attn: Ktr DifferentAddress1 DifferentAddress2

  • Access to Records; Discussions With Officers and Accountants On an annual basis, or upon the occurrence of a Material Adverse Change, the Sub-Servicer shall, upon the reasonable request of the Insurer, permit the Insurer or its authorized agents: (i) to inspect the books and records of the Sub-Servicer as they may relate to the Obligations, the obligations of the Sub-Servicer under the Transaction Documents, and the Transaction; (ii) to discuss the affairs, finances and accounts of the Sub-Servicer with the chief operating officer and the chief financial officer of the Sub-Servicer; and (iii) with the Sub-Servicer's consent, which consent shall not be unreasonably withheld, to discuss the affairs, finances and accounts of the Sub-Servicer with the Sub-Servicer's independent accountants, provided that an officer of the Sub-Servicer shall have the right to be present during such discussions. Such inspections and discussions shall be conducted upon reasonable notice and during normal business hours and shall not unreasonably disrupt the business of the Sub-Servicer. The books and records of the Sub-Servicer shall be maintained at the address of the Sub-Servicer designated herein for receipt of notices, unless the Sub-Servicer shall otherwise advise the parties hereto in writing. The Insurer agrees that it and its shareholders, directors, agents, accountants and attorneys shall keep confidential any matter of which it becomes aware through such inspections or discussions (unless readily available from public sources), except as may be otherwise required by regulation, law or court order or requested by appropriate governmental authorities or as necessary to preserve its rights or security under or to enforce the Transaction Documents, provided that the foregoing shall not limit the right of the Insurer to make such information available to its regulators, securities rating agencies, reinsurers, credit and liquidity providers, counsel and accountants.

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