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 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.

  • 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.

  • 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 Securities, that the Exchange announces that pursuant to the rules of such Exchange, the Securities cease (or will cease) to be listed, traded or publicly quoted on the Exchange for any reason (other than a Merger Event or Tender Offer) and are not immediately re-listed, re- traded or re-quoted on 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 Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015, as amended from time to time.

  • 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 ▇▇▇ ▇▇▇▇.

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