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.

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.

Examples of Label Expansion in a sentence

• 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 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.

• Upon Label Expansion of the Product, Company shall pay Institution a royalty of [REDACTED: Amount] on the portion of Net Sales of the Product that exceeds [REDACTED: Amount] during Company’s Fiscal Year that was Sold by Company, its Affiliates, or Sublicensees (the “Royalty Payments”).

• 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.

• Company shall promptly notify Institution in writing upon the occurrence of any Clinical Milestone and any Regulatory Milestone, as well as any Label Expansion within [REDACTED: Time Period] after occurrence thereof.

• Company shall have the sole obligation for compliance with, and shall ensure that any Affiliates and Sublicensees comply with, all Laws that relate to Products and Processes, including, but not limited to, those of the FDA, and any applicable Laws and regulations of any other country in the License Territory where the Product benefitting from the Label Expansion is Sold.

• 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.

• It is understood that Net Sales of Licensed Products in the Shire Territory resulting from such Label Expansion or New Formulation shall be included in Net Sales calculations for purposes of Sections 7.2.2 and 7.3 below.

• Company shall seek Label Expansion of the Product by submitting a supplemental new drug application (or the equivalent thereof) to the FDA or EMA in accordance with Section 7.7. Label Expansion of the Product will be deemed to have occurred upon the first approval of such supplemental new drug application (or the equivalent thereof) by either the FDA or EMA, as applicable.

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 ▇▇▇▇ and NAFLD, in any patient.

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

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.

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.