Government Inspections; Correspondence Sample Clauses

Government Inspections; Correspondence. Notwithstanding the provisions of ARTICLE 11, in the event the Facility is inspected by representatives of the FDA or other U.S. Government agency, and such inspection relates to HOVIONE’s processes for the Manufacture of the Product or any portion of the Facility directly related to the [***] 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. Confidential Treatment Requested by Achaogen, Inc. Manufacture of the Product, HOVIONE shall notify ACHAOGEN as soon as reasonably practicable, but in no event later than [***] (by telephone, and if possible, in writing) upon learning of such inspection. HOVIONE shall provide ACHAOGEN (which ACHAOGEN will provide to BARDA) with electronic copies of all written materials and correspondence received from or sent to the FDA or other U.S. Government agency relating to any such inspection; provided however, that the documentation contains information relating to any of HOVIONE’s manufacturing process(es) used in the Manufacture of the Product or which may have an effect on HOVIONE’s ability to supply the Product to ACHAOGEN (“Relevant Information”) and provided further, that HOVIONE may redact any information that does not qualify as Relevant Information. To the extent reasonably practicable, HOVIONE shall share with ACHAOGEN drafts of any written materials in advance of submitting such materials to the FDA or other U.S. Government agency so as to allow for review and comment by ACHAOGEN and/or BARDA. The Parties shall consult regarding the nature, extent, duration, and possible impact of such inspection on the development and manufacture of the Product so as to determine whether ACHAOGEN and/or BARDA may have an interest to send representatives to the Facility and be present for any part of such inspection.
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Related to Government Inspections; Correspondence

  • Correspondence Any notice or payment required to be given to either party under this Agreement shall be deemed to have been properly given and effective:

  • 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.

  • Correspondence, Statements and Confirmations The Financial Institution will promptly send copies of all statements, confirmations and other correspondence concerning any Collateral Account and, if applicable, any financial assets credited thereto, simultaneously to the Grantor and the Secured Party.

  • Payment of Checks, Drafts and Orders Subject to Section 9.5, the Assuming Institution agrees to pay all properly drawn checks, drafts and withdrawal orders of depositors of the Failed Bank presented for payment, whether drawn on the check or draft forms provided by the Failed Bank or by the Assuming Institution, to the extent that the Deposit balances to the credit of the respective makers or drawers assumed by the Assuming Institution under this Agreement are sufficient to permit the payment thereof, and in all other respects to discharge, in the usual course of conducting a banking business, the duties and obligations of the Failed Bank with respect to the Deposit balances due and owing to the depositors of the Failed Bank assumed by the Assuming Institution under this Agreement.

  • Delivery of SEC Correspondence To supply the Underwriters with copies of all correspondence to and from, and all documents issued to and by, the Commission in connection with the registration of the Stock under the Securities Act or any of the Registration Statement, any Preliminary Prospectus or the Prospectus, or any amendment or supplement thereto or document incorporated by reference therein.

  • Complaints and Investigations Pacific Mutual, PEN, Selling Broker-Dealer and General Agent agree to cooperate fully in any insurance regulatory investigation or proceeding or judicial proceeding arising in connection with the Contracts distributed under this Agreement. Pacific Mutual, PEN, Selling Broker-Dealer and General Agent further agree to cooperate fully in any securities regulatory investigation or proceeding with respect to Pacific Mutual, PEN, Selling Broker-Dealer and General Agent, their affiliates and their agents or representatives to the extent that such investigation or proceeding is in connection with the Contracts distributed under this Agreement. Without limiting the foregoing:

  • Regulatory Investigations It shall be the Administrator’s duty and responsibility, and not the Owner Trustee’s duty and responsibility, to cause the Trust to respond to, defend, participate in or otherwise act in connection with any regulatory, administrative, governmental, investigative or other proceeding or inquiry relating in any way to the Trust, its assets or the conduct of its business.

  • NOTICES AND CORRESPONDENCE Notices regarding the subject matter of this Agreement or breach or termination thereof shall be in writing and shall be addressed in duplicate to the last known address of each other party, marked respectively to the attention of its President and, if any, its General Counsel.

  • Communications Regulatory Matters (A) Schedule 5.13(A) sets forth a true and complete list of the following information for each License issued to each Loan Party or its Subsidiaries: the name of the licensee, the type of service, the expiration date and the geographic area covered by such License.

  • Notice to Taxing Authorities and Insurance Companies The Seller shall transmit to the applicable taxing authorities and insurance companies (including primary mortgage insurance policy insurers, if applicable) and/or agents, notification of the transfer of the servicing to the Purchaser, or its designee, and instructions to deliver all notices, tax bills and insurance statements, as the case may be, to the Purchaser from and after the Transfer Date. The Seller shall provide the Purchaser with copies of all such notices within five (5) Business Days following the Transfer Date;

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