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.

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

  • 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.

  • 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.

  • Label Expansion We believe that a significant opportunity exists in the U.S. for Feraheme beyond the treatment of IDA in adult patients with CKD.

  • We first address the important distinction between public and private players, and then consider the analysis of synergies specific to certain industry segments.

  • Label Expansion On the Fly Classification Leveraging Unlabeled Data Domain Adaptation To reduce the error being made in approximating the oracle document, we need to make sure the label names are representative of the category.

  • Repeat every 21-28 days.NOTE TO USER: READ THE FOLLOWING BEFORE USING THIS PRODUCT FOR THE INDICATED SPECIAL USEAPPLICATIONS (BELOW): The DIRECTIONS FOR USE for this product for the uses described below were developed by persons other than Bayer CropScience and accepted for registration by Health Canada under the User Requested Minor Use Label Expansion program.

  • This use is registered under the UserRequested Minor Use Label Expansion (URMULE) program.

  • The DIRECTIONS FOR USE for the uses described in this section of the label were developed by persons other than BASF Canada under the User Requested Minor Use Label Expansion program.


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 HIV-infected patients.
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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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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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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.

  • Research Budget has the meaning set forth in Section 3.2.

  • Development Work means the conduct of preclinical and clinical trials, the compilation of the regulatory dossier concerning Licensed Products and the conduct of other work necessary or useful for obtaining Regulatory Approval of Licensed Products.

  • 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” 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.

  • 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.

  • 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 a location where a manufacturing

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

  • 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;

  • The Works/Project means the works to be executed or done under this contract.