FDA Notification Package definition

FDA Notification Package means, collectively, executed versions of the joint FDA notification cover letter, Seller transfer acknowledgement letter and Buyer transfer acknowledgment letter in the forms set forth in Exhibits C-1, C-2, and C-3, respectively, and, with respect to such joint FDA notification cover letter as set forth in Exhibit C-1, any other documentation referred to therein as being attached thereto, in each case, with respect to the purchase and sale of the Priority Review Voucher pursuant to this Agreement to be submitted to the FDA jointly by Buyer and Seller pursuant to Section 3.2(c).
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FDA Notification Package means, collectively, executed versions of the joint FDA acknowledgement letter, Seller transfer acknowledgement letter and Buyer transfer acknowledgment letter in the forms set forth in Exhibits C, D, and E, respectively, in each case, with respect to the purchase and sale of the Priority Review Voucher pursuant to this Agreement to be submitted to the FDA in accordance with Section 3.04.
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FDA Notification Package means, collectively, executed versions of the joint FDA acknowledgement letter, Seller transfer acknowledgement letter and Buyer transfer acknowledgment letter in the forms set forth in Exhibits B, C, and D, respectively, in each case, with respect to the purchase and sale of the Priority Review Voucher pursuant to this Agreement to be submitted to the FDA in accordance with Section 3.04.
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Examples of FDA Notification Package in a sentence

  • Except for the submission to the FDA of the FDA Notification Package referenced in Section 3.2(c) and the filing of a premerger notification and report form under the HSR Act, no filing, authorization, consent, approval, permit, order, registration or declaration, governmental or otherwise, is necessary to enable or authorize Seller to enter into, and to perform its obligations under, this Agreement.

  • Except for the submission to the FDA of the FDA Notification Package referenced in Section 3.2(c) and the filing of a premerger notification and report form under the HSR Act, no filing, authorization, consent, approval, permit, order, registration or declaration, governmental or otherwise, is necessary to enable or authorize Buyer to enter into, and to perform its obligations under, this Agreement.

  • Except for the FDA Notification Package and the filing of a Premerger Notification and Report Form under the HSR Act, no filing, authorization, consent, approval, permit, order, registration or declaration, governmental or otherwise, is necessary to enable or authorize Buyer to enter into, and to perform its obligations under, this Agreement.

  • Seller shall submit the FDA Notification Package to the Subject BLA promptly following Buyer’s notification to Seller of its submission, and Seller’s receipt from Buyer, of a copy of the Buyer Notice of Transfer Submission, but in no event later than 30 days following the Closing (provided that Buyer timely complies with its obligations under this Section 3.04).

  • Considering these limits, it cannot be considered as a complete solution for adapting UIs at runtime to user’s emotions.

  • Seller shall submit the FDA Notification Package to the Subject BLA through the FDA’s Electronic Submission Gateway within 14 days following the Closing and within two (2) days thereafter provide Buyer with a copy of Seller’s submission (the “Seller Notice of Transfer Submission”).

  • A copy of the joint FDA notification cover letter and the Lumos transfer acknowledgement letter for inclusion in the FDA Notification Package, which FDA cover letter and Lumos transfer acknowledgement letter shall be in the form of Exhibit C-1 and Exhibit C-2, respectively, or such other form as the FDA may require as of the Closing Date.

  • Except for the FDA Notification Package and, if applicable, the filing of a Premerger Notification and Report Form under the HSR Act, no filing, authorization, consent, approval, permit, order, registration or declaration, governmental or otherwise, is necessary to enable or authorize Merck to enter into, and to perform its obligations under, this Agreement.

  • Except for the FDA Notification Package, and, if applicable, the filing of a Premerger Notification and Report Form under the HSR Act, no filing, authorization, consent, approval, permit, order, registration or declaration, governmental or otherwise, is necessary to enable or authorize Lumos to enter into, and to perform its obligations under, this Agreement.

  • Except for the submission to the FDA of the FDA Notification Package referenced in S ection 3.2(c) and the filing of apremerger notification and report form under the HSR Act, no filing, authorization, consent, approval, permit, order, registration or declaration, governmental or otherwise, is necessary to enable or authorize Seller to enter into, and to perform its obligations under, this Agreement.


More Definitions of FDA Notification Package

FDA Notification Package means, collectively, executed versions of the joint FDA notification cover letter, Lumos and BioProtection Systems Corporation transfer acknowledgement letter and Merck transfer acknowledgement letter in the forms set forth in Exhibits C-1, C-2, and C3, respectively, and, with respect to such joint FDA notification cover letter as set forth in Exhibit C-1, any other documentation referred to therein as being attached thereto, in each case, with respect to the purchase and sale of the Priority Review Voucher pursuant to this Agreement to be submitted to the FDA jointly by Merck and Lumos or BioProtection Systems Corporation pursuant to Section 3.2(c).
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FDA Notification Package means, collectively, executed versions of the joint FDA notification cover letter, Lumos and BioProtection Systems Corporation transfer acknowledgement letter and Merck transfer acknowledgement letter in the forms set forth in E xhibits C-1, C -2, and C 3, respectively, and, with respect to such joint FDA notification cover letter as set forth in E xhibit C-1, any other documentation referred to therein as being attached thereto, in each case, with respect to the purchase and sale of the Priority Review Voucher pursuant to this Agreement to be submitted to the FDA jointly by Merck and Lumos or BioProtection Systems Corporation pursuant to S ection 3.2(c).
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Related to FDA Notification Package

  • DDA Notification has the meaning provided therefor in Section 6.13(a)(i).

  • Application Package means the forms, schedules, checklists, exhibits, computer disks and instructions thereto obtained from the Agency, which shall be completed and submitted to the Agency in accordance with all regulations in order to apply for the HTC Program.

  • Information Package means the most recent compilation of financial and other data with respect to the Failed Bank, including any amendments or supplements thereto, provided to the Assuming Institution by the Corporation on the web site used by the Corporation to market the Failed Bank to potential acquirers.

  • Defects Notification Period means the period for notifying defects in the Works or a Section (as the case may be) under Sub-Clause 11.1 [Completion of Outstanding Work and Remedying Defects], which extends over 365 days except if otherwise stated in the SCC (with any extension under Sub-Clause 11.3 [Extension of Defects Notification Period]), calculated from the date on which the Works or Section is completed as certified under Sub-Clause 10.1[Taking Over of the Works and Sections].

  • Additional Disclosure Notification The form of notification to be included with any Additional Form 10-D Disclosure, Additional Form 10-K Disclosure or Form 8-K Disclosure Information which is attached to this Agreement as Exhibit W.

  • major non-compliance outcome notification means a notification received by a council under section 19N(3) or (4) of the Food Act 1984, or advice given to council by an authorized officer under that Act, of a deficiency that does not pose an immediate serious threat to public health but may do so if no remedial action is taken

  • Review Package A package of documents consisting of a memorandum outlining the analysis and recommendation (in accordance with the Servicing Standard) of the Master Servicer or the Special Servicer, as the case may be, with respect to the matters that are the subject thereof, and copies of all relevant documentation.

  • Application packet means the information, documents, and fees required by the Department for the:

  • 1940 Act Notification means a notification of registration of the Fund as an investment company under the 1940 Act on Form N-8A, as the 1940 Act Notification may be amended from time to time.

  • Tax Certification Forms means any forms or other documentation as may be issued or required by a Tax Authority or by us from time to time to confirm your tax status [or the tax status of a Connected Person].

  • Pick Up Report means the report detailing the number of sleeping rooms per day actually used out of the Program’s room block.

  • Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • UCC Filing Authorization Letter means a letter duly executed by each Loan Party authorizing the Collateral Agent to file appropriate financing statements on Form UCC-1 without the signature of such Loan Party in such office or offices as may be necessary or, in the opinion of the Collateral Agent, desirable to perfect the security interests purported to be created by each Security Agreement and each Mortgage.

  • Case Report Form means a printed, optical or electronic document or database designed to record all of the information, which is required by the Protocol to be reported to the Sponsor on each Study Participant.

  • Release Certificate means a Release Certificate in the form attached to this Appendix "C" as Schedule 2 executed by a duly authorized officer of the Custodian and delivered by the Custodian to the applicable Fund by facsimile transmission or in such other manner as such Fund and the Custodian may agree in writing.

  • License Certificate means evidence of a license provided by Licensor to Licensee in electronic or printed form.

  • date of notification means the date on which a notice is served as contemplated in section 35 or published in the media or Provincial Gazette;

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Database application form means the application form required by the Hibiscus Coast Municipality to be filled in by the successful tenderer, following the award of the contract, for inclusion on the HCM database before payment is made.

  • Progress Report Form means UN Women’s standard form for progress reports attached to this Agreement.

  • Non-Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • CMSA Operating Statement Analysis Report means a report substantially in the form of, and containing the information called for in, the downloadable form of the "Operating Statement Analysis Report" available as of the Closing Date on the CMSA Website or in such other form for the presentation of such information and containing such additional information as may from time to time be approved by the CMSA for commercial mortgage-backed securities transactions generally.

  • Post-Closing Statement has the meaning set forth in Section 3.3(c).

  • Bid Application Form means the form as specified in Annexure II of this E-Auction Process Information Document;

  • Rollover Notification Date shall be defined as set forth in the Prospectus under "Summary of Essential Information."

  • Data File means a single record or collection of data records that are logically related to each other, and are handled as a unit;