Compendia Listing definition

Compendia Listing means a listing for a tumor type indication in the USA for a Licensed Product or Improvement that is supported by a citation in at least one of the following authoritative drug reference books: (i) the American Society of Health System Pharmacists’ American Hospital Formulary Service (AHFS), or (ii) the U.S. Pharmacopeia Drug Information.
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Compendia Listing means a listing of a Licensed Product for use in an indication in the United States that is supported by a citation in at least one of the following authoritative drug reference books (or in another similar authoritative drug reference book), in each case that is relied on by Third Party payors in authorizing reimbursement for such Licensed Product for such indication: (a) the American Society of Health-System Pharmacists’ American Hospital Formulary Service; (b) the U.S. Pharmacopoeia Drug Information; or (c) the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology.
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Compendia Listing means a listing for an indication in the United States for a Product that is supported by a citation in at least one of the following authoritative drug reference books: (a) the American Society of Health-System Pharmacists’ American Hospital Formulary Service (AHFS), or (b) the U.S. Pharmacopoeia Drug Information, or in another similar authoritative drug reference book that is relied on by Third Party payors in authorizing reimbursement for such Product for such indication.
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Examples of Compendia Listing in a sentence

  • NOVACEA shall be solely responsible for determining whether the data package from the Clinical Trials conducted for a given indication supports an Approval for such indication or a Compendia Listing in a given country in the NOVACEA Territory.

  • NOVACEA shall use Diligent Efforts to make regulatory submissions in the NOVACEA Territory for the purpose of securing Approval of the Licensed Product based on data from the registrational Clinical Trials to be performed in support of those indications for which a registration strategy (as opposed to a Compendia Listing strategy) is set forth in the Development Plan.

  • The costs of any such recall or withdrawal relating to: (i) the Development of a Co-Developed Product for an indication prior to the approval of the Drug Approval Application (or Compendia Listing, as the case may be) for such indication (other than with respect to a recall related to a [*]); or (ii) the Commercialization of a Co-Promotion Product shall each be included in Regulatory Expenses.


More Definitions of Compendia Listing

Compendia Listing means a listing for an indication in the United States for a Product that is supported by a citation in at least one of the following authoritative drug reference books: (a) the American Society of Health-System Pharmacists’ American Hospital Formulary Service (AHFS), or (b) the U.S. Pharmacopoeia Drug Information, or in another similar authoritative drug reference book that is relied on by Third Party payors in authorizing reimbursement for such Product for such indication. Competing Product [***] [Confidential Treatment Required] Confidential Information means all Information and all Materials provided by a Party or its Affiliates to the other Party or its Affiliates either in connection with the discussions or negotiations pertaining to, or in the course of performing, this Agreement, including all Information and Materials developed during the course of Development, Commercialisation or Manufacture of Antibody Products under this Agreement and all Information of a Party disclosed at any meeting of any Committee or disclosed through a report to or from any such Committee. The terms of this Agreement and the Joint Know-How shall be considered Confidential Information of each Party.
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Related to Compendia Listing

  • De-listing means, in respect of any relevant Fund Share, the Exchange announces that pursuant to the rules of such Exchange, such Fund Share ceases (or will cease) to be listed, traded or publicly quoted on such Exchange for any reason (other than a Merger Event or Tender Offer) and are not immediately re-listed, re-traded or re-quoted on (i) where the Exchange is located in the United States, any of the New York Stock Exchange, the American Stock Exchange or the NASDAQ Global Market or Global Select Market (or their respective successors) or (ii) an exchange or quotation system located in the same country as the Exchange (or, where the Exchange is within the European Union, in any member state of the European Union).

  • SEBI Listing Regulations means SEBI (Listing Obligation and Disclosure Requirements) Regulations, 2015, as amended

  • Blacklisting means barring a bidder, contractor, consultant or supplier from participating in any future procurement proceedings.

  • UK Listing Authority means the Financial Services Authority in its capacity as competent authority under the Financial Services and Markets Xxx 0000.

  • After Listing means the period which commences on the Listing Date and continues until the relevant Sub-Fund is terminated.

  • Direct Listing means the Company’s initial listing of its Common Stock (other than shares of Common Stock not eligible for resale under Rule 144 under the Securities Act) on a national securities exchange by means of an effective registration statement on Form S-1 filed by the Company with the SEC that registers shares of existing capital stock of the Company for resale, as approved by the Company’s board of directors. For the avoidance of doubt, a Direct Listing shall not be deemed to be an underwritten offering and shall not involve any underwriting services.

  • Primary Listing means the single directory listing provided to Customers by Publisher under the terms of this Agreement. Each telephone configuration that allows a terminating call to xxxx for an available time among a series of lines shall be considered a single Customer entitled to a single primary listing. “Proprietary Information” is as defined in Article 20, Section 20.1.1.

  • Transparency Reports means a report in accordance with Schedule 7 Part 1 (Transparency Reports) containing the contract information as set out in the table for that Part for publication by the Authority in the interests of transparency.

  • Listing means the listing of the shares of Common Stock on a national securities exchange.

  • Listing Regulations means the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015.

  • Listing Market means the national securities exchange on which any securities of the Company are listed for trading, and if not listed for trading, by the rules of the Nasdaq Stock Market.

  • JSE Listings Requirements means the Listings Requirements of the JSE applicable from time to time;

  • AMEX means the American Stock Exchange.

  • GEM Listing Rules the Rules Governing the Listing of Securities on GEM

  • online marketplace means a service using software, including a website, part of a website or an application, operated by or on behalf of a trader which allows consumers to conclude distance contracts with other traders or consumers;

  • Insider Trading Regulations means the Securities and Exchange Board of India (Prohibition of Insider Trading) Regulations, 2015, as amended from time to time.

  • Farmers market means a marketplace which operates seasonally, principally as a common market for Iowa-produced farm products on a retail basis for consumption elsewhere.

  • Securities Regulatory Authorities means the securities commission or similar regulatory authority in each province and territory of Canada that is responsible for administering the Canadian securities legislation in force in such jurisdictions;

  • ASX Listing Rules means the official listing rules of the ASX.

  • Conduct Regulations means the Conduct of Employment Agencies and Employment Businesses Regulations 2003;

  • Securities Trading Act means the Securities Trading Act of 2007 no.75 of the Relevant Jurisdiction.

  • EEA Regulated Market means a market as defined by Article 4.1(21) of Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments, as amended;

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • securities regulatory authority or “SRA” means a body created by statute in any Canadian or foreign jurisdiction to administer securities law, regulation and policy (e.g. securities commission), but does not include an exchange or other self regulatory entity;

  • Listings means information identifying the listed names of subscribers of carriers and subscribers’ telephone numbers, addresses or primary advertising classification or any combination, and that carrier or affiliate has published, caused to be published or accepted for publication in any directory format.

  • National Road Traffic Act means the National Road Traffic Act, 1996 (Act 93 of 1996);