Relevant NDA definition

Relevant NDA means a New Drug Application in the U.S. in relation to a Licensed Product submitted to the FDA by the Licensee under section 505(b)(2) of the U.S Food, Drugs and Cosmetics Act during the NCE Exclusivity Period which is a First U.S. Application for that Licensed Product.
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Examples of Relevant NDA in a sentence

  • The Licensor shall, following receipt of such written request, request pursuant to Clause 5 of the Head Licence that ViiV submits to the FDA a Selective Waiver Letter in respect of the Licensee’s Relevant ANDA or Relevant NDA (as applicable).

  • The Licensee shall provide to the Licensor such information in respect of its Relevant ANDA or Relevant NDA as the Licensor or ViiV may reasonably require in connection with the preparation of such a Selective Waiver Letter and/or in order to assess the Licensee’s compliance with the requirements of this Clause 6.

  • If, in the absence of a protective order or other remedy or the receipt of a waiver by the Relevant NDA Party, the party (or the party whose Affiliate or Associate is) requested or required to make the disclosure is nonetheless, under the advice of counsel, required to make such disclosure, such party may, without liability hereunder, make only that portion of the disclosure that such counsel advises is required to be disclosed.

Related to Relevant NDA

  • Relevant Number means the number specified as such in the applicable Final Terms (or, if no such number is specified, five);

  • Relevant Ship means the Ships and any other vessel from time to time (whether before or after the date of this Agreement) owned, managed or crewed by, or chartered to, any Relevant Party;

  • Relevant Authorities means any governmental or statutory authority with the

  • relevant contract means the contract relied on by an applicant under this section to satisfy the requirements of subsection (1)(a)(ii);

  • Safety Authorisation and “deemed Safety Authorisation” have the meanings given to “safety authorisation” and “deemed safety authorisation” by the Railways and Other Guided Transport Systems (Safety) Regulations 2006;

  • relevant Minister means the Secretary of State or the Minister for the Cabinet Office;

  • relevant week means the reduction week or part-week in which the capital in question of which the applicant has deprived himself within the meaning of paragraph 67(1)—

  • Marketing Authorisation means, with respect to a country, region or other jurisdiction in the Territory, any and all approvals (including Drug Approval Applications), licenses, registrations, or authorisations of any Regulatory Authority necessary to commercially distribute, sell, or market Product in such country or other jurisdiction, including, where applicable, (a) pre- and post-approval regulatory approvals (including any prerequisite manufacturing approval or authorisation related thereto), and (b) approval of Product labelling.

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.

  • Relevant Tax Authority means HMRC, or, if applicable, the tax authority in the jurisdiction in which the Supplier is established;

  • relevant system means a relevant system for the holding and transfer of shares in uncertificated form;

  • Relevant UK Resolution Authority means any authority with the ability to exercise a UK Bail-in Power.

  • relevant scheme means any other scheme approved or seeking approval under Chapter 1 Part XIV of the Act and in respect of a Class A Member who is a Controlling Director also any retirement annuity contract or trust scheme approved under Chapter III Part XIV or any personal pension scheme as approved under Chapter IV Part XIV of the Act insofar as it provides benefits secured by contributions in respect of Service.

  • relevant authority means the authority of which M is a member;

  • PMDA means Japan’s Pharmaceuticals and Medical Devices Agency and any successor agency(ies) or authority having substantially the same function.

  • Relevant Tax means any present or future taxes, duties, assessments or governmental charges of whatever nature, imposed or levied by or on behalf of any Relevant Jurisdiction or any authority therein or thereof having the power to tax.

  • MHLW means the Japanese Ministry of Health, Labour and Welfare, and any successor agency thereto.

  • Relevant Governmental Body means the Federal Reserve Board and/or the Federal Reserve Bank of New York, or a committee officially endorsed or convened by the Federal Reserve Board and/or the Federal Reserve Bank of New York or any successor thereto.

  • Aboriginal as defined in the constitution of Canada, "includes the Indian, Inuit and Métis peoples of Canada".

  • Relevant Agreement means an agreement benefiting persons who receive educational instruction at the School.

  • Relevant Institution means a person that has permission under Part 4A of the Financial Services and Markets Act 2000 (permission to carry on regulated activity).

  • EU GDPR means Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC.

  • Relevant Declaration means the declaration relevant to the Shareholder as set out in Schedule 2B of the Taxes Act.

  • Major European Country means any of France, Germany, Italy, Spain or the United Kingdom.

  • Authorisations means any consent, registration, filing, notarisation, licence, approval, permit, authority or exemption from, by or with any Governmental Authority and all corporate, creditors’, shareholders’ and third-party approvals or consents;

  • MFDA means the Mutual Fund Dealers Association of Canada;