Response Letter definition

Response Letter shall have the meaning set forth in Section 3.5.
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Response Letter has the meaning set forth in Section 2.8(b).
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Response Letter shall have the meaning assigned thereto in Section 11.23.
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Examples of Response Letter in a sentence

  • On July 7, 2016, the Company announced it received a Complete Response Letter stating the sNDA cannot be approved in its present form and requested additional information.

  • On July 7, 2016, the Company received a Complete Response Letter stating the sNDA cannot be approved in its present form and requested additional information.

  • Reference is made to paragraph 6 of the Response Letter (as defined in the First Amendment), wherein Seller recognizes the Item 8 Exception (as defined in the First Amendment).

  • Agency Response Letter GRAS Notice No. GRN 000044, 22 November 2000.

  • DMPED will send a Response Letter to eligible applicants, informing them of their status in the review process and requesting the following supplemental documentation.

  • A Complete Response Letter indicates that the review cycle of the application is complete and the application is not ready for approval.

  • In order to remain eligible for this grant, all supplemental documentation must be submitted to DMPED within 7 business days of the Response Letter.

  • The efficacy and safety of the HDB regimen in STEMI has been evaluated in more than 20 clinical studies involving over 11,000 patients and is currently recommended by the ACCF/AHA Guideline for the Management of STEMI.On July 7, 2016, the Company received a Complete Response Letter (“CRL”) from the FDA for its sNDA requesting an expanded indication for patients presenting with STEMI.

  • Thereafter, the BRLMs by way of a letter dated January 9, 2020 (“Request Letter”), requested SSWPL to intimate them of any further concerns either with respect to the Company or Naresh Vijaykumar Goyal, pursuant to the receipt of the Response Letter.

  • A Complete Response Letter indicates that the review cycle of the application is complete and the application will not be approved in its present form.


More Definitions of Response Letter

Response Letter formally notifies the initiator and other named parties that a party is willing to participate in the RDRP and, at a minimum, attend at least one settlement meeting.
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Response Letter shall have the meaning set forth in Section 7.9.
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Response Letter means a properly completed response letter to an investor questionnaire to be submitted by Eligible MariaDB Shareholders to the Exchange Agent in connection with an election for the Unlisted Unit Alternative;
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Response Letter means a written response to an Applicant addressing the Application, including whether all, none, or any part of the Application has been approved for inspection or production. Samples are attached to this Manual in Sections 8.3 through 8.5.
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Related to Response Letter

  • Response Notice is defined in Section 14.3(b)(ii).

  • Response Deadline means 60 days after the Administrator mails Notice to Class Members and Aggrieved Employees, and shall be the last date on which Class Members may: (a) fax, email, or mail Requests for Exclusion from the Settlement, or (b) fax, email, or mail his or her Objection to the Settlement. Class Members to whom Notice Packets are resent after having been returned undeliverable to the Administrator shall have an additional 14 calendar days beyond the Response Deadline has expired.

  • Estoppel Letter A document executed by the Cooperative Corporation certifying, with respect to a Cooperative Unit, (i) the appurtenant Proprietary Lease will be in full force and effect as of the date of issuance thereof, (ii) the related stock certificate was registered in the Mortgagor's name and the Cooperative Corporation has not been notified of any lien upon, pledge of, levy of execution on or disposition of such stock certificate, and (iii) the Mortgagor is not in default under the appurtenant Proprietary Lease and all charges due the Cooperative Corporation have been paid.

  • Acceptance Letter means the letter from Adviser to BD pursuant to which the Adviser appoints BD as a Broker Dealer for each series of MuniPreferred issued by any Fund that has executed a Request Letter.

  • Responsive and Responsible Bidder means an entity or individual that has submitted a bid that conforms in all material respects to the Invitation to Bid and has the capability in all respects to fully perform the contract requirements and the integrity and reliability that will assure good faith performance. “Responsive and Responsible Vendor” means an entity or individual that has submitted a proposal, reply, or response that conforms in all material respects to the Request for Proposals, Invitation to Negotiate, or Competitive Solicitation and has the capability in all respects to fully perform the contract requirements and the integrity and reliability that will assure good faith performance. In determining whether an entity or individual is a Responsive and Responsible Bidder (or Vendor), the District may consider, in addition to factors described in the Invitation to Bid, Request for Proposals, Invitation to Negotiate, or Competitive Solicitation, the following:

  • Rejection Notice has the meaning specified in Section 2.05(b)(v).

  • Response Date has the meaning assigned to such term in Section 2.22(a).

  • Response Period has the meaning set forth in Section 9.6(a).

  • Response Costs means all costs, including, but not limited to, direct and indirect costs, that the United States incurs in monitoring and supervising Respondents’ performance of the Work to determine whether such performance is consistent with the requirements of this Order, including costs incurred in reviewing deliverables submitted pursuant to this Order, as well as costs incurred in overseeing implementation of this Order, including, but not limited to, payroll costs, contractor costs, travel costs, and laboratory costs.]

  • Response Action means the investigation, cleanup, removal, remediation, containment, control, abatement, monitoring of or any other response action to the presence of Regulated Substances or Contamination in, on, at, under or emanating from the Stadium Site, including the correction or abatement of any violation required pursuant to Environmental Laws or by a Governmental Authority.

  • Consent Notice has the meaning set forth in Section 4.6(a).

  • Approval Letter means the letter from WRAS to the Applicant confirming the grant of WRAS Approval in respect of a Product;

  • Due Diligence Request means the due diligence request letter from Xxxxxxx and Xxxxxx LLP, counsel to the Purchaser, dated March 6, 2024.

  • Environmental Notice means any written directive, notice of violation or infraction, or notice respecting any Environmental Claim relating to actual or alleged non-compliance with any Environmental Law or any term or condition of any Environmental Permit.

  • Instruction Letter means written instructions in a form acceptable to NCPS and executed by Issuer Party with Issuer Party directing NCPS to promptly disburse the Escrow Funds to Issuer pursuant to Section 4(a).

  • CAFA Notice refers to the notice requirements imposed by 28 U.S.C. § 1715(b).

  • Closing Notice Has the meaning specified in the NPA. Company: Has the meaning specified in the first paragraph of this Trust Supplement.

  • Contract Letter means the letter identifying those documents which form the Contract.

  • Indemnity Notice shall have the meaning specified in Section 9.3(b).

  • Response means the material submitted by the respondent in answering the solicitation.

  • Lowest and Best Responsible Bidder means the Bidder submitting the lowest Bid received that is within the range of acceptable bids, that also has the ability to timely perform the Contract bid upon considering such factors as financial resources, skills, quality of materials, past work record, and ability to comply with state, federal, and local requirements, including those set forth in the SBE Regulations.

  • Objection Notice has the meaning set forth in Section 2.3(a) of this Agreement.

  • Acquisition Notice has the meaning set forth in Section 2.5(a).

  • PAGA Notice means Plaintiff’s October 27, 2022, letter to Ansible and the LWDA providing notice pursuant to Labor Code section 2699.3, subd.(a).

  • Notice of Dissatisfaction means the notice given by either Party to the other indicating its dissatisfaction and intention to commence arbitration.

  • Repurchase Response Notice means a notice delivered by the Indenture Trustee at the direction of the Administrator to a Noteholder or Note Owner indicating that a Repurchase Request is unresolved.