Label Expansion definition

Label Expansion means any expansion of the label beyond the Initial Label.
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Label Expansion means, with respect to each Product for which Regulatory Approval for a Primary Indication or Schizophrenia is obtained in a particular country or region in the Territory, Regulatory Approval for a change or supplement to such Product’s approved labeling in such country or region (a) to reflect [********] of, or [********] for, such Product or to reflect that such Product is [********] or for [********] and (b) that does not result in such approved labeling, as changed or supplemented, constituting (i) a separate Primary Indication or Small Market Indication or (ii) if the Regulatory Approval was for an indication other than Schizophrenia, Schizophrenia.
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Label Expansion means, following first receipt of Regulatory Approval for a pharmaceutical or diagnostic product in an Oncology Indication (the “First Approval in an Oncology Indication” for such Product), any subsequent receipt of Regulatory Approval for such Product in the same Oncology Indication as such First Approval in an Oncology Indication, for a different subpatient population, line of therapy or new use as a monotherapy or in combination with another treatment or drug for such Oncology Indication.
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Examples of Label Expansion in a sentence

  • Where some or all of the expenditure is expected to be reimbursed by insurance or some other party, and it is virtually certain, the reimbursement is recognized as a separate asset on the balance sheets, and the net amount is recorded in the statements of operations.

  • Teva shall have exclusive and sole decision-making authority regarding conducting and funding all development and regulatory activities (including making Regulatory Filings and paying fees for Regulatory Filings) associated with the Product in the U.S., including any FDA Mandated Studies and Label Expansion Studies.

  • VIVUS shall have [****] from approval of the MAA by the European Commission to seek modification of the SmPC in one or more Label Expansion Filings; provided, however, that such deadline shall automatically be extended to [****] after approval of the MAA by the European Commission if modification of the SmPC is delayed as a result of the action or inaction of Menarini.

  • NOTE TO USER: READ THE FOLLOWING BEFORE USING THIS PRODUCT FOR SPECIAL USE APPLICATIONS: The DIRECTIONS FOR USE for this product for the use described below were developed by persons other than AgraCity and accepted for registration by Health Canada under the User Requested Minor Use Label Expansion program.

  • A JPT (the “Development JPT”) shall review and discuss reports, results and data from the Parties that result from their respective development activities to the extent such reports, results and data are generated by the Parties internally in the ordinary course of business, in advance of each JSC meeting as referenced in Section 3.1(c) above, including reports, results and data relating to the FDA Mandated Studies, Teva’s Development Plans, and Label Expansion Studies.

  • Teva shall retain the rights, powers and discretion granted to it under this Agreement to have exclusive and sole decision-making authority regarding commercialization of the Product, including any Development Plans, Commercialization Strategies, Commercialization Plans, and Label Expansion Studies, and no such rights, powers, or discretion shall be delegated to or vested in the JSC.

  • CropMites Controlled Red MiteNOTE TO USER: READ THE FOLLOWING BEFORE USING THIS PRODUCT FOR THE INDICATED SPECIAL USE APPLICATIONS: The DIRECTIONS FOR USE for this product for the uses described below were developed by persons other than 0DFGHUPLG $JULFXOWXUDO 6ROXWLRQV &DQDGD &RPSDQ\ and accepted for registration by Health Canada under the User Requested Minor Use Label Expansion Program.

  • Further, in the event that transfer of de facto control, or of a material part, of Supplier's business to a third party is contemplated, Supplier must give timely notice to Buyer, but no less than [***] prior to any such transfer or, in the event Supplier does not have knowledge of such transfer prior to its occurrence, Supplier agrees to give notice to Buyer [***] after said occurrence.

  • Note to user: Read the following before using this product for the indicated special use applications: The Directions for use for this product for the use(s) described on this below were developed by persons other than Woodstream Canada Corporation and accepted for registration by Health Canada under the User Requested Minor Use Label Expansion program.

  • Date: April 27, 2009 By: /s/ Jan SmilekName: Jan SmilekTitle: Chief Financial OfficerExhibit 99.1 Sucampo Acquires Rights to Rescula for U.S. and Canada Strengthens Sucampo’s Prostone Product Portfolio Potential for Label Expansion in Dry AMD BETHESDA, Md. & TOKYO--(BUSINESS WIRE)--April 23, 2009--Sucampo Pharmaceuticals, Inc., (NASDAQ:SCMP) and R- Tech Ueno, Ltd.


More Definitions of Label Expansion

Label Expansion means the first date of regulatory approval, including conditional approval, of the Product by the FDA and/or the EMA, as applicable, for the treatment of any fatty liver disease, including XXXX and NAFLD, in any patient.
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Label Expansion. (Certain Definitions; Section 1) is hereby deleted in its entirety and replaced with the following:
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Label Expansion means, with respect to the Approved NDA for a Licensed Product, any receipt of Regulatory Approval for such Licensed Product for (a) a different patient subpopulation, (b) a new line of therapy, or (c) new use in combination with another or different treatment, or drug, in each case as compared to the Approved NDA.
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Label Expansion means, following first receipt of Regulatory Approval for a Licensed Product in an Indication, any subsequent receipt of Regulatory Approval for a New Indication.
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Related to Label Expansion

  • Lateral expansion means a horizontal expansion of the waste boundaries of an existing MSW landfill. A lateral expansion is not a modification unless it results in an increase in the design capacity of the landfill.

  • Expansion means the addition of buildings, structures, machinery or equipment for purposes of increasing production capacity.

  • Project Plan means the document to be developed by the Contractor and approved by Webel Technology Ltd., based on the requirements of the Contract and the Preliminary Project Plan included in the Contractor’s bid. For the sake of clarity, the Agreed and Finalized Project Plan” refers to the version of the Project Plan submitted by the contractor after receiving the letter of Award and the same approved by Webel Technology Ltd. The project plan may be changed/ modified during the course of the project. Should the Project Plan conflict with the provisions of the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

  • Development Phase means the period before a vehicle type is type approved.

  • Development Schedule shall have the meaning set forth in Section 1.1.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Development Work means the work of development to be performed on or with respect to the Land (including, without limitation, the installation of utilities, roads and all related on-site and off-site improvements) in connection with the development of the Land for the subsequent construction thereon of Homes, all of which work and construction shall be completed by or on behalf of the Borrower in accordance with the Plans and Specifications, but shall not include the Construction Improvements.

  • Development Plan has the meaning set forth in Section 3.2.

  • Development Project means a project for the development of land within a

  • Development Tool Kit means a DS Offering specifically designed for application or content development. A Development Tool Kit is either identified (i) with “CAA” or “ENOVIA Studio” or “Toolkit” or “Development Toolkit” in the DS Offering name, or (ii) in the Transaction Document and/or the Product Portfolio. Extended Enterprise User means an employee of Customer’s affiliate(s), supplier(s) and/or customer(s) authorized to use Customer’s DS Offering for the sole and exclusive purpose of enabling the Extended Enterprise User(s) to conduct business with Customer. The use of the DS Offering by any such Extended Enterprise User(s) (1) shall be solely limited to use (a) as configured and deployed by Customer and (b) in connection with the Extended Enterprise User’s performance of services for and on behalf of Customer, and (2) shall exclude any use by Extended Enterprise User (a) for its own account or a third party’s account, or (b) for the purpose of modifying, otherwise using, maintaining or hosting the DS Offering. Extended Enterprise Users are authorized if so specified in the Product Portfolio. Machine means a device on which a DS Offering is executed and which is either (1) (i) (a) belonging to Customer or under its sole control or supervision and (b) located on Customer’s premises or according to Teleworking conditions, or (ii) authorized by Customer according to its own information technology charter or equivalent whereby third party devices (such as Users own devices) are specifically authorized, or (2) operated by a third party service provider as specifically authorized in the Agreement solely for and on behalf of Customer. Product Portfolio means a set of information related to the DS Offerings available at xxxxx://xxx.0xx.xxx/terms/product-portfolio/licensed-programs. Remote Access means, if so specified in the Product Portfolio, that Users and/or Extended Enterprise Users may access and use the DS Offering remotely via the Internet from any country (subject inter alia to the export and re-export laws and regulations provisions of the Agreement). Teleworking means any program authorized by and for the benefit of Customer to enable its employees to work outside its own premises, using information and communication technology (or equivalent program established by a Customer entitled to Academic Use of the DS Offerings for its Users). Any use of DS Offerings while Teleworking is authorized if all of the following conditions are at all times met: (a) Customer’s employees do so on Machine(s) connected to Customer's network (e.g. via Virtual Private Network), (b) Customer is able to provide access to such Machine(s) during a compliance verification according to the Agreement, and (c) Customer’s employees use the DS Offerings for Customer’s exclusive internal needs. Same use is authorized for Users of a Customer entitled to Academic Use of the DS Offerings. User means any (a) Customer’s employee, or (b) employee of Customer’s consultant(s) or subcontractor(s) (i) who accesses a DS Offering,

  • Manufacturing Cost means ***

  • Improvement Plan means the plan required by the Authority from the Supplier which shall detail how the Supplier will improve the provision of the Goods and/or Services pursuant to Clause 29.1.1 (Authority Remedies);

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • Nuclear fuel cycle-related research and development activities means those activities which are specifically related to any process or system development aspect of any of the following: - conversion of nuclear material, - enrichment of nuclear material, - nuclear fuel fabrication, - reactors, - critical facilities, - reprocessing of nuclear fuel, - processing (not including repackaging or conditioning not involving the separation of elements, for storage or disposal) of intermediate or high-level waste containing plutonium, high enriched uranium or uranium-233, but do not include activities related to theoretical or basic scientific research or to research and development on industrial radioisotope applications, medical, hydrological and agricultural applications, health and environmental effects and improved maintenance.

  • Expansion Project has the meaning set forth in Section IV.3.a of this Agreement.

  • Structural components means liners, leachate collection systems, final covers, run-on/run-off systems, and any other component used in the construction and operation of the MSWLF that is necessary for protection of human health and the environment.

  • The Project Plan means the document to be developed by the Supplier and approved by the Purchaser, pursuant to GCC Clause 19, based on the requirements of the Contract and the Preliminary Project Plan included in the Supplier’s bid. The “Agreed and Finalized Project Plan” is the version of the Project Plan approved by the Purchaser, in accordance with GCC Clause 19.2. Should the Project Plan conflict with the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

  • Project Implementation means all steps which the Grantee undertakes in order to deliver the Project which is being supported by funding provided under this Grant Contract. Any reference to UK primary legislation (Acts) or secondary legislation (Statutory Instruments) in this Grant Contract includes reference to any changes to or replacement of those Acts or Statutory Instruments.

  • Manufacturing site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Project Scope means the description or activity of work to be accomplished on the project.

  • Detailed Specifications means the specifications for materials and works as specified in PWD BSR/ issued under the authority of PWD/ or as implied/added to or superseded by the special conditions.

  • Work Plan means a plan that describes each individual activity to be conducted to complete eligible activities and the associated costs of each individual activity.

  • Development Works means the external development works and internal development works on immovable property;