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the NDA definition

the NDA s first accounting year” means—
the NDA s first accounting year” means— 20

Examples of the NDA in a sentence

  • If, for example, the combination contains one never-before-approved active moiety and one previously approved active moiety, answer "yes." (An active moiety that is marketed under an OTC monograph, but that was never approved under an NDA, is considered not previously approved.)YES NO If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA #(s).

  • YES NO If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA #(s).

  • If the applicant has a licensing agreement with the NDA holder/patent owner, proceed to question #15.

  • Notwithstanding and further to anything stated elsewhere in the NDA, IHiS reserves the right and the Company agrees that IHiS may conduct (or appoint a qualified, independent third party to conduct) an audit and/or assessment of the standard of compliance or non-compliance by the Company with its obligations under this Clause 4.

  • Every year thereafter, for so long as the NDA is in effect and in which you make a written request, we will provide that same information.

  • To the extent the use of subcontractors is permitted under this Contract, the requirements of this entire section shall be incorporated into any subcontractor agreement entered into by the Contractor and any data sharing shall be compliant with these security and protection requirements and the NDA.

  • Please describe how funds will be managed by the NDA and/or the Readiness Delivery Partner.

  • Please describe how implementation arrangements will be made and how funds will be managed by the NDA and/or the Delivery Partner.

  • All prior negotiations, representations, agreements and understandings are merged into, extinguished by and completely expressed by this Agreement and the NDA.

  • Together with the NDA, this Agreement constitutes the entire agreement between the parties relating to the subject matter hereof.

Related to the NDA

  • Addendum/Addenda means formally issued written or graphic modifications and/or interpretations of the Construction Documents that may add to, delete from, clarify or correct the description and/or scope of the Work. Addenda are issued during the bidding phase of the project.

  • Research Agreement means a new written contract, grant or cooperative agreement entered into between a person and a college or research corporation for the performance of qualified research; however, all qualified research costs generating a rebate must be spent by the college or research corporation on qualified research undertaken according to a research agreement.

  • EEA Agreement means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992 as adjusted by the Protocol signed at Brussels on 17th March 1993;

  • Original license means a motor vehicle dealer license issued to an applicant who has never been

  • Confidentiality Agreements means the confidentiality agreements between the Company and each Sponsor (or an affiliate thereof), as amended and restated from time to time.

  • State of principal license means a member state where a physician holds a license to practice medicine and which has been designated as such by the physician for purposes of registration and participation in the Compact.

  • Technical Agreement means any technical or quality agreements signed by You (or Your Affiliate) and RB (or RB’s Affiliates) specifying technical and quality responsibilities in respect of the Output entered into prior to the date of the Order.

  • Confidentiality Agreement has the meaning set forth in Section 6.3.

  • Standard Terms and Conditions or “Standard Terms” means these terms and conditions for the grant of the Loan to the Borrower by ABFL.

  • Commonwealth Standard Grant Conditions means this document.

  • GTCs means these AVEVA General Terms and Conditions, which includes those terms and conditions set forth in the main body of the GTCs, and all of the various exhibits, addenda, and other documents incorporated into the GTCs.

  • Primary Terms and Conditions means the terms and conditions applicable to the ICICI Bank’s internet banking facility/service.

  • Commercial Agreement means an agreement, other than an agency agreement, made between carriers and relating to the provision of their joint services for carriage of passengers by air;

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

  • Same terms and conditions means that the medical service corporation cannot apply more restrictive non-quantitative limitations, such as utilization review and other criteria or more quantitative limitations such as copayments, deductibles, aggregate or annual limits or benefit limits to mental health condition and substance use disorder benefits than those applied to substantially all other medical or surgical benefits.

  • Entire Agreement This Agreement, including the Enrollment form and/or Welcome letter and your Contract Summary, constitute the entire Agreement and understanding between you and XOOM with respect to its subject matter and superseding all prior written and oral Agreements and representations made with respect to the subject matter.

  • CDA has the meaning set forth in Section 8.4.

  • DMF means a drug master file, as provided for in 21 CFR § 314.420 or similar submission to or file maintained with the FDA or other Governmental Authority or Regulatory Authority that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

  • Commercial Agreements means all or any Agreement or Agreements with any third party including but not limited to broadcasting, media, sponsorship, marketing, merchandising, licensing and advertising, for the general promotion of each or any of the Clubs in the Competition and the Company, and which have the object of promoting the welfare and general commercial interest and increasing the financial resources of each of the Clubs, the Company and the Competition.

  • Relevant Terms and Conditions means terms and conditions relating to:

  • Hire Agreement means every agreement between Access and the Hirer for the hire of Equipment (whether signed or not) including a Hire Docket, all of which will be deemed to include:

  • the Statutes means the Companies Act and every other act (as may from time to time be amended) for the time being in force in Bermuda applying to or affecting the Company, the Memorandum of Association and/or these presents;

  • General Agreement means the Government Officers Salaries, Allowances and Conditions General Agreement PSA AG 25 of 2002 or its replacement or the Public Service General Agreement PSA AG 24 of 2002 or its replacement whichever is applicable.

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

  • Prior CDA has the meaning set forth in Section 9.4.

  • The terms affiliated person," "assignment," "interested person" and "vote of a majority of the outstanding voting securities", when used in this Agreement, shall have the respective meanings specified in the Investment Company Act.