FDA Submissions & Correspondence i. The Contractor shall provide BARDA the opportunity to review and comment upon all documents submitted to the FDA. In addition, an electronic copy of the final FDA submissions
FDA Submissions & Correspondence Sample Clauses
Related to FDA Submissions & Correspondence
SUBMISSIONS You acknowledge and agree that any questions, comments, suggestions, ideas, feedback, or other information regarding the Site ("Submissions") provided by you to us are non-confidential and shall become our sole property. We shall own exclusive rights, including all intellectual property rights, and shall be entitled to the unrestricted use and dissemination of these Submissions for any lawful purpose, commercial or otherwise, without acknowledgment or compensation to you. You hereby waive all moral rights to any such Submissions, and you hereby warrant that any such Submissions are original with you or that you have the right to submit such Submissions. You agree there shall be no recourse against us for any alleged or actual infringement or misappropriation of any proprietary right in your Submissions.
Correspondence (a) The Employer agrees that all correspondence between the Employer and the Union related to matters covered by this Agreement shall be sent to the President of the Union or his/her designate.
SUBMISSIONS, APPROVALS, AND NOTICES Department and Concessionaire agree that all submissions, approvals, and notices which may be required under the Agreement shall be forwarded by email or fax, regular and certified mail return receipt requested and addressed as follows: To Department: Department of Environmental Protection Natural and Historic Resources Office of Leases & Concessions PO Box 420, Mail Code: 501-04C Trenton, New Jersey 00000-0000 Fax: (000) 000-0000 Email: XxxxxxxxXxxxxx@xxx.xx.xxx Copy to Area Superintendent: Atsion Recreation Area 744 Route 206 Shamong, New Jersey 08088 Fax: (000) 000-0000 Email: Xxxxxx.Xxxxxxxxxx@xxx.xx.xxx To Concessionaire: Name Title and/or Entity Designation Street Address Town, NJ Zip Code Email: Either Department or Concessionaire may, at any time, change such address(es) by mailing, to the address(es) of the other, above, a notice of the change at least ten (10) calendar days prior to the effective date of such change.
APPROVAL OF GENERAL COMMUNICATIONS Competitive Supplier may only communicate with Program participants and/or use the lists of Eligible Consumers/Program participants to send Department-approved education materials, opt- out notices, or other communications essential to the operation of the Program. Such lists may not be used by Competitive Supplier to market any additional products or services to Eligible Consumers or Program Participants. 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, not essential to the operation of the program, 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.
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.
Manufacturer's Recommendations All work or materials shall be installed in accordance with the manufacturer's recommendations and requirements. The Contractor shall obtain the manufacturer’s recommendations and requirements, for its use at the Site in executing the Work, copies of bulletins, circulars, catalogues, or other publications bearing the manufacturer’s titles, numbers, editions, dates, etc. If the manufacturer’s recommendations and requirements are not available, the Contractor shall request installation instructions from the Design Professional.
Regulatory Filings NYISO and Connecting Transmission Owner shall file this Agreement (and any amendment hereto) with the appropriate Governmental Authority, if required. Any information related to studies for interconnection asserted by Developer to contain Confidential Information shall be treated in accordance with Article 22 of this Agreement and Attachment F to the ISO OATT. If the Developer has executed this Agreement, or any amendment thereto, the Developer shall reasonably cooperate with NYISO and Connecting Transmission Owner with respect to such filing and to provide any information reasonably requested by NYISO and Connecting Transmission Owner needed to comply with Applicable Laws and Regulations.
Submittals Submittals required by the Contract Documents shall be prepared specifically for the Work by the Contractor to illustrate some portion of the Work. Submittals are not Contract Documents.
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: OIG: 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).
