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

  • 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.

  • 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.

  • 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.

  • 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.

  • If the Product Marketing Authorization has been transferred to Menarini pursuant to Section 4.2, such assistance shall include, without limitation, filing the Label Expansion Filing on VIVUS’s behalf.

  • 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.

  • If the JSC determines to include such Label Expansion or New Formulation in an applicable Development Plan or where applicable a new Development Plan, then such Development Plan shall include the work plan, budget and timeline proposed by the Developing Party, or as the JSC may otherwise determine.

  • In the event that Institution, through its Principal Investigator, fails to provide the Technological Information that is necessary for Company to conduct the Pivotal Clinical Trial seeking Label Expansion, Company may, upon giving [REDACTED: Time Period] written notice, terminate this A&R Agreement for such breach by Institution, provided Institution shall not have cured such breach within the aforementioned [REDACTED: Time Period] period.

  • If a Label Expansion or New Formulation is included in the Development Plan in accordance with Section 6.1.1(a) above, or if the [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED.

  • 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.


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 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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Label Expansion. (Certain Definitions; Section 1) is hereby deleted in its entirety and replaced with the following:
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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 WTL, 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 Finalised 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 WTL. 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.

  • Non-Microsoft Product means any third-party-branded software, data, service, website or product, unless incorporated by Microsoft in a Product.

  • 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 2.2.

  • Development Work means any work carried out in relation to the physical construction of a mine;

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

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

  • 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:

  • 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.

  • 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.

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

  • Design Criteria Package means concise, performance-oriented drawings or specifications for a public construction project. The purpose of the Design Criteria Package is to furnish sufficient information to permit Design-Build Firms to prepare a bid or a response to the District’s Request for Proposals, or to permit the District to enter into a negotiated Design- Build Contract. The Design Criteria Package must specify performance- based criteria for the public construction project, including the legal description of the site, survey information concerning the site, interior space requirements, material quality standards, schematic layouts and conceptual design criteria of the project, cost or budget estimates, design and construction schedules, site development requirements, provisions for utilities, stormwater retention and disposal, and parking requirements applicable to the project. Design Criteria Packages shall require firms to submit information regarding the qualifications, availability, and past work of the firms, including the partners and members thereof.