Roivant FDA Letter definition

Roivant FDA Letter means the letter from Roivant to the FDA, duly executed by Roivant, to be filed with the FDA no later than three (3) Business Days following the Closing Date with regard to the IND(s), excluding foreign equivalents of U.S. INDs, included in the Assets, the form of which is attached hereto in Section 1.58 of the Disclosure Schedule.
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Examples of Roivant FDA Letter in a sentence

  • Roivant and GSK shall file the Roivant FDA Letter and the GSK FDA Letter with the FDA within three (3) Business Days after the Closing Date.

Related to Roivant FDA Letter

  • Quality Agreement has the meaning set forth in Section 9.6.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • LOCKHEED XXXXXX Procurement Representative means a person authorized by LOCKHEED XXXXXX'x cognizant procurement organization to administer and/or execute this Contract.

  • Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.

  • SWDocID [[6027980]]" "" [[6027980]] elect or decline, in its sole discretion, to provide a New Commitment. Such New Commitments shall become effective as of such Increased Amount Date, and in the case of Incremental Term Loans, shall be made on such Increased Amount Date; provided that (i) the conditions set forth in paragraphs of (b) and (c) of Section 4.02 shall be satisfied or waived by the Required Lenders on such Increased Amount Date before or after giving effect to such New Commitments and Loans; (ii) such increase in the Revolving Facility Commitments and/or the Incremental Term Loans shall be evidenced by one or more joinder agreements executed and delivered to Administrative Agent by each New Lender, as applicable, and each shall be recorded in the register, each of which shall be reasonably satisfactory to the Administrative Agent and subject to the requirements set forth in Section 2.17(f); and (iii) the Borrower shall make any payments required pursuant to Section 2.16 in connection with the provisions of the New Commitments; provided that, with respect to any Incremental Term Loans incurred for the primary purpose of financing a Limited Conditionality Acquisition (“Acquisition-Related Incremental Term Loans”), clause (i) of this sentence shall be deemed to have been satisfied so long as (A) as of the date of execution of the related Limited Conditionality Acquisition Agreement by the parties thereto, no Default shall have occurred and be continuing or would result from entry into such Limited Conditionality Acquisition Agreement, (B) as of the date of the borrowing of such Acquisition-Related Incremental Term Loans, no Event of Default under Section 7.01(a), 7.01(b), 7.01(h) or 7.01(i) is in existence immediately before or after giving effect (including on a Pro Forma Basis) to such borrowing and to any concurrent transactions and any substantially concurrent use of proceeds thereof, (C) the representations and warranties of the Loan Parties set forth in this Agreement and the other Loan Documents shall be true and correct in all material respects as of the date of execution of the applicable Limited Conditionality Acquisition Agreement by the parties thereto, except to the extent any such representations or warranties are expressly limited to an earlier date, in which case such representations and warranties shall be true and correct in all material respects as of such specified earlier date (provided that no materiality qualifier set forth in this subclause (C) shall be applicable to any representations and warranties that already are qualified or modified by materiality in the text thereof) and (D) as of the date of the borrowing of such Acquisition-Related Incremental Term Loans, customary “Sungard” representations and warranties (with such representations and warranties to be reasonably determined by the Lenders providing such Acquisition-Related Incremental Term Loans) shall be true and correct in all material respects immediately before and after giving effect to the incurrence of such Acquisition-Related Incremental Term Loans, except to the extent any such representations or warranties are expressly limited to an earlier date, in which case such representations and warranties shall be true and correct in all material respects as of such specified earlier date (provided that no materiality qualifier set forth in this subclause (D) shall be applicable to any representations and warranties that already are qualified or modified by materiality in the text thereof).

  • Clinical Supply Agreement has the meaning set forth in Section 4.2.

  • Technology Transfer Agreement has the meaning given in Section 2.2(e).

  • Manufacturing Agreement has the meaning set forth in Section 4.3.

  • Commercial Supply Agreement has the meaning set forth in Section 6.1.

  • Technology License Agreement means the agreement in the form of Exhibit H hereto.

  • 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

  • API means the American Petroleum Institute.

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • CMC means Comprehensive maintenance Contract (labour, spare and preventive maintenance)

  • 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.

  • Technology Transfer has the meaning set forth in Section 5.2.

  • ONYX means Onyx Acceptance Corporation, and its successors.

  • End User License Agreement means a license grant or end user license agreement governing software as further described in this Agreement or any applicable Appendix.

  • National Medical Support Notice or “NMSN” shall mean a notice that contains the following information:

  • Xxxxxx Agreement means that certain Contingent Stock Agreement, effective as of January 1, 1996, by The Xxxxx Company in favor of and for the benefit of the Holders (named in Schedule I thereto) and the Representatives (therein defined), as amended.

  • SPMCIL means Security Printing and Minting Corporation Limited"SPMCIL" means Security Printing and Minting Corporation Limited

  • 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.

  • License Agreement means the agreement between SAP (or an SAP SE Affiliate, or an authorized reseller) under which Customer procured the rights to use SAP Software or a Cloud Service.

  • Quality Assurance means a systematic procedure for assessing the effectiveness, efficiency, and appropriateness of services.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;

  • Soil scientist means an individual duly qualified in accordance with standards set by the Federal Office of Personnel Management.