Disclosure of Regulatory Notices and Communications Sample Clauses

Disclosure of Regulatory Notices and Communications. Apellis hereby represents and warrants that, as of [**] prior to the Effective Date, the regulatory communications and, if any, notices of inspection, inspection reports, warning letters and deficiency letters related to the Product made available by Apellis in the Data Room were true and complete copies of such documents. To the knowledge of Apellis, such documents comprise all material written regulatory communications related to Trial design or the chemistry, manufacturing or controls of the Product from the FDA or the EMA in the possession of Apellis as of [**] prior to the Effective Date.
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Disclosure of Regulatory Notices and Communications. CymaBay hereby represents and warrants that, as of the Effective Date, the regulatory communications and, if any, notices of inspection, inspection reports, warning letters and deficiency letters related to the Product made available by CymaBay in the Data Room were true and complete copies of such documents. CymaBay hereby represents and warrants that such documents comprise all material written regulatory communications related to the Product from all Regulatory Authorities in the possession of CymaBay as of the Effective Date.
Sample 1
Disclosure of Regulatory Notices and Communications. PB hereby represents and warrants that, as of [***] prior to the Effective Date, the regulatory communications and, if any, notices of inspection, inspection reports, warning letters and deficiency letters related to the Product made available by PB in the Data Room were true and complete copies of such documents. To the knowledge of PB, such documents comprise all material written regulatory communications related to Clinical Trials design or the chemistry, manufacturing or controls of the Product from all Regulatory Authorities in the possession of PB as of [***] prior to the Effective Date.
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Disclosure of Regulatory Notices and Communications. Alnylam hereby represents and warrants that, as of the Effective Date, all material regulatory communications and, if any, notices of inspection, inspection reports, warning letters and deficiency letters related to the Products made available by Alnylam in the Data Room were true and complete copies of such documents. Alnylam hereby represents and warrants that such documents comprise all material written regulatory communications related to the Products from all Regulatory Authorities in the possession of Alnylam as of the Effective Date.
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Disclosure of Regulatory Notices and Communications. Reata hereby represents and warrants that, as of the Effective Date, all material regulatory communications and, if any, notices of inspection, inspection reports, warning letters and deficiency letters related to the Product made available by Reata in the Data Room, and to Reata’s knowledge, all such materials were true and complete copies of such documents. To the knowledge of Reata, such documents comprise all material written regulatory communications related to Product Trials design or the chemistry, manufacturing or controls of the Product from the FDA or the EMA in the possession of Reata as of the Effective Date.
Sample 1

Related to Disclosure of Regulatory Notices and Communications

  • Notices and Communications Any legal notice under this Agreement shall be in writing to the other party at such address as the other party may designate from time to time for the receipt of such legal notice and shall be deemed to be received on the earlier of the date actually received or on the fourth day after the postmark if such legal notice is mailed first class postage prepaid. In relation to communications other than legal notices under this Agreement, each party may communicate with and provide information to the other party in whatever medium deemed appropriate. This may include the use of e-mail, the internet or other electronic means, in the place of paper communications.

  • Regulatory Communications Each Party agrees to notify the other immediately by telephone (with prompt written follow-up) of any inquiry, contact or communication received from any governmental regulatory agency or other official body that materially and adversely relates to or impacts upon the Product(s) or any component or ingredient thereof, and will promptly furnish the other Party with copies of all written communications relating thereto sent to or received from said regulatory agency.

  • Addresses for communications A notice shall be sent:

  • Notices; Communications (a) Except in the case of notices and other communications expressly permitted to be given by telephone (and except as provided in Section 9.01(b) below), all notices and other communications provided for herein shall be in writing and shall be delivered by hand or overnight courier service, mailed by certified or registered mail or sent by telecopier or other electronic means as follows, and all notices and other communications expressly permitted hereunder to be given by telephone shall be made to the applicable telephone number, as follows:

  • Communications and Notices All notices, requests and other communications made or given in connection with the Loan Documents shall be in writing and, unless receipt is stated herein to be required, shall be deemed to have been validly given if delivered personally to the individual or division or department to whose attention notices to a party are to be addressed, or by private carrier, or registered or certified mail, return receipt requested, or by telecopy with the original forwarded by first-class mail, in all cases, with charges prepaid, addressed as follows, until some other address (or individual or division or department for attention) shall have been designated by notice given by one party to the other: To Borrower: Consolidated Stainless, Inc. 0000 Xxxx Xxxxxx Xxxxxx Orlando, FL 32803 Attention: Xxxxxx X. Xxxxx, President Telecopier No.: (000) 000-0000 with a copy to: Saul, Ewing, Xxxxxx & Xxxx LLP Centre Square West 0000 Xxxxxx Xxxxxx, 00xx Xxxxx Xxxxxxxxxxxx, XX 00000 Attention: Xxxx X. Xxxxxx, Esquire Telecopier No.: (000) 000-0000 with a copy to: Greenberg, Traurig, Hoffman, Lipoff, Xxxxx & Quentel Citicorp Center 000 X. 00xx Xxxxxx Xxx Xxxx, XX 00000 Attention: Xxxxxxx Xxxxxx, Esquire Telecopier No.: (000) 000-0000 To Bank: Mellon Bank, N.A. 0000 Xxxxxx Xxxxxx, 0xx Xxxxx Xxxxxxxxxxxx, XX 00000 Attention: Xxxxxx Xxxxxx, Vice President Telecopier No.: (000) 000-0000 with a copy to: Klehr, Harrison, Xxxxxx, Branzburg & Xxxxxx LLP 0000 Xxxxxx Xxxxxx Xxxxxxxxxxxx, XX 00000 Attention: Xxxxxxx X. Xxxxxxx, Esquire Telecopier No.: (000) 000-0000 with a copy to: Wolf, Block, Xxxxxx & Xxxxx-Xxxxx LLP 000 Xxxxx 00xx Xxxxxx Xxxxxxxxxxxx, XX 00000 Attention: Xxxxxx Xxxxxx, Esquire Telecopier No.: (000)000-0000

  • Addresses and Notices; Written Communications (a) Any notice, demand, request, report or proxy materials required or permitted to be given or made to a Partner under this Agreement shall be in writing and shall be deemed given or made when delivered in person or when sent by first class United States mail or by other means of written communication to the Partner at the address described below. Any notice, payment or report to be given or made to a Partner hereunder shall be deemed conclusively to have been given or made, and the obligation to give such notice or report or to make such payment shall be deemed conclusively to have been fully satisfied, upon sending of such notice, payment or report to the Record Holder of such Partnership Interests at his address as shown on the records of the Transfer Agent or as otherwise shown on the records of the Partnership, regardless of any claim of any Person who may have an interest in such Partnership Interests by reason of any assignment or otherwise. Notwithstanding the foregoing, if (i) a Partner shall consent to receiving notices, demands, requests, reports or proxy materials via electronic mail or by the Internet or (ii) the rules of the Commission shall permit any report or proxy materials to be delivered electronically or made available via the Internet, any such notice, demand, request, report or proxy materials shall be deemed given or made when delivered or made available via such mode of delivery. An affidavit or certificate of making of any notice, payment or report in accordance with the provisions of this Section 16.1 executed by the General Partner, the Transfer Agent or the mailing organization shall be prima facie evidence of the giving or making of such notice, payment or report. If any notice, payment or report given or made in accordance with the provisions of this Section 16.1 is returned marked to indicate that such notice, payment or report was unable to be delivered, such notice, payment or report and, in the case of notices, payments or reports returned by the United States Postal Service (or other physical mail delivery mail service outside the United States of America), any subsequent notices, payments and reports shall be deemed to have been duly given or made without further mailing (until such time as such Record Holder or another Person notifies the Transfer Agent or the Partnership of a change in his address) or other delivery if they are available for the Partner at the principal office of the Partnership for a period of one year from the date of the giving or making of such notice, payment or report to the other Partners. Any notice to the Partnership shall be deemed given if received by the General Partner at the principal office of the Partnership designated pursuant to Section 2.3. The General Partner may rely and shall be protected in relying on any notice or other document from a Partner or other Person if believed by it to be genuine.

  • Regulatory Notices Manager will, within 2 Business Days after its receipt, give Sprint PCS written notice of all oral and written communications it receives from regulatory authorities (including but not limited to the FCC, the FAA, state public service commissions, environmental authorities, and historic preservation authorities) and complaints respecting Manager's construction, operation, and management of the Service Area Network that could result in actions affecting the License as well as written notice of the details respecting such communications and complaints, including a copy of any written material received in connection with such communications and complaints. Manager will cooperate with Sprint PCS in responding to such communications and complaints received by Manager. Sprint PCS has the right to respond to all such communications and complaints, with counsel and consultants of its own choice. If Sprint PCS chooses to respond to such communications and complaints, Manager will not respond to them without the consent of Sprint PCS, and Manager will pay the costs of Sprint PCS' responding to such communications and complaints, including reasonable attorneys' and consultants' fees, investigation costs, and all other reasonable costs and expenses incurred by Sprint PCS.

  • Provision of copies of communications The Borrower shall procure that each Owner shall provide the Security Trustee, at the time of each such communication, copies of all written communications between that Owner and:

  • Preservation of Information; Communications to Securityholders (a) The Trustee shall preserve, in as current a form as is reasonably practicable, the names and addresses of Holders of Securities contained in the most recent list furnished to the Trustee as provided in Section 7.01 and the names and addresses of Holders of Securities received by the Trustee in its capacity as Security Registrar, if so acting. The Trustee may destroy any list furnished to it as provided in Section 7.01 upon receipt of a new list so furnished.

  • Offering Communications Other than the Preliminary Prospectus and the Prospectus, each Underwriter severally represents, warrants and agrees with VW Credit and the Seller that it has not made, used, prepared, authorized, approved or referred to and will not prepare, make, use, authorize, approve or refer to any “written communication” (as defined in Rule 405 under the Securities Act) that constitutes an offer to sell or solicitation of an offer to buy the Notes, including, but not limited to any “ABS informational and computational materials” as defined in Item 1101(a) of Regulation AB under the Securities Act unless such Underwriter has obtained the prior written approval of VW Credit and the Seller; provided, however, each Underwriter may prepare and convey to one or more of its potential investors without the consent of VW Credit, the Seller or any of their respective affiliates one or more “written communications” (as defined in Rule 405 under the Securities Act) in the form of (i) an Intex CDI file that does not contain any Issuer Information (as defined below) other than Issuer Information included in the Preliminary Prospectus previously filed with the Commission or (ii) other written communication containing no more than the following: (a) information contemplated by Rule 134 under the Securities Act, (b) information included or to be included in the Preliminary Prospectus or the Prospectus, and (c) a column or other entry showing the status of the subscriptions for the Notes and/or expected pricing parameters of the Notes (each such written communication, an “Underwriter Free Writing Prospectus”). VW Credit and the Seller each authorize each Underwriter to disseminate any “road show” (as defined under Rule 433(h) under the Securities Act) in which representatives of VW Credit or the Seller participate. As used herein, the term “Issuer Information” means any information of the type specified in clauses (1) – (5) of footnote 271 of Commission Release No. 33-8591 (Securities Offering Reform), other than Underwriter Derived Information. As used herein, the term “Underwriter Derived Information” shall refer to information of the type described in clause (5) of footnote 271 of Commission Release No. 33-8591 (Securities Offering Reform) when prepared by any Underwriter, including traditional computational and analytical materials prepared by the Underwriter.

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