Commercialization Approval definition

Commercialization Approval means, with respect to a Licensed Product and any country or regulatory jurisdiction, receipt of [***].
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Commercialization Approval means, [**]: [**].
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Commercialization Approval means, with respect to a Licensed Product and any country or regulatory jurisdiction, receipt of both: (i) approval of a Marketing Approval Application for such Licensed Product by the applicable Regulatory Authority in such country or regulatory jurisdiction; and [***]
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Examples of Commercialization Approval in a sentence

  • In the event that Xxxxxxx conducts an Independent Development Activity that requires a regulatory filing to conduct such activity in Greater China, or completes a Registration Study as an Independent Development Activity and desires to file a Drug Approval Application related to such study in Greater China, Legend shall make such filing on Xxxxxxx’x behalf at Xxxxxxx’x request and, with respect to any such Drug Approval Application, shall use Diligent Efforts to obtain Commercialization Approval.

  • Following receipt of Commercialization Approval of [***], Xxxxxxx will use Commercially Reasonable Efforts to [***].

  • Following receipt of Commercialization Approval of [***], Xxxxxxx will use Commercially Reasonable Efforts to Commercialize [***].

  • Following receipt of Commercialization Approval of a Licensed Product in the U.S., a Major European Country or Japan, Xxxxxxx would use Commercially Reasonable Efforts to Commercialize the Licensed Product in such country.

  • Xxxxxxx shall use Commercially Reasonable Efforts to Commercialize each Licensed Product in [...***...] (each, a “Major Country”) following receipt of Commercialization Approval of such Licensed Product in the applicable country.

  • For each Target, Xxxxxxx shall use Commercially Reasonable Efforts to (a) Develop and seek to obtain Commercialization Approval for at least [**] Directed to such Target for [**], and (b) following receipt of Commercialization Approval in [**], Commercialize such Licensed Product in such country.


More Definitions of Commercialization Approval

Commercialization Approval means, with respect to a Product and any country or regulatory jurisdiction, receipt of [***] Marketing Approval for such Product from the applicable Regulatory Authority in such country or regulatory jurisdiction[***]. For illustrative purposes, as of the Execution Date the following are [***] [***] and [***]:
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Commercialization Approval means any and all Regulatory Licenses that are necessary to market and/or sell a drug, biological product, cell therapy or gene therapy in a country or jurisdiction for one or more uses, including any pricing and reimbursement approvals that are necessary to conduct a launch of such drug, biological product, cell therapy or gene therapy in such country or jurisdiction (even if such pricing and reimbursement approvals are not legally required to launch such drug, biological product, cell therapy or gene therapy in such country or jurisdiction). For purposes of illustration with respect to the Major European Countries, the following pricing and reimbursement approvals are examples of those that are necessary to conduct a launch of a drug, biological product, cell therapy or gene therapy: in France, publication of the reimbursed price level in the official journal and registration on a reimbursement list by or on behalf of Comité Economique des Produits de Santé or Haute Autorité de Santé (or a successor agency); in Italy, publication of reimbursement in the Government’s Official Gazette (by Agenzia Italiana del Farmaco or a successor agency); in Germany, execution of contract with the head association of sick funds (GKV-Spitzenverband, Gesetzlichen Krankenversicherung, or a successor agency); in Spain, authorization by La Comisión Interministerial de Precios de los Medicamentos or La Comisión Nacional para el Uso Racional de los Medicamentos (or a successor agency) for national patient access to reimbursement by or on behalf of a Governmental Authority; and in the United Kingdom, a recommendation by the National Institute for Health and Care Excellence (or a successor agency) to obtain mandatory funding to enable broad market access. For clarity, as of the Effective Date, no pricing or reimbursement approval as described above is required to launch a drug, biological product, cell therapy or gene therapy in the United States.
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Commercialization Approval means [***].
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Commercialization Approval means, with respect to a Licensed Product and any country or regulatory jurisdiction: (a) approval of a Drug Approval Application for such Licensed Product by the applicable Regulatory Authority in such country or regulatory jurisdiction if the application for such Drug Approval Application included efficacy data from a Clinical Study referred to in the GDP; and (b) any pricing and reimbursement approvals that are necessary to conduct a launch of such Licensed Product in such country or regulatory jurisdiction (even if such approvals are not legally required to launch such Licensed Product in such country or regulatory jurisdiction). For purposes of illustration with respect to the Major European Countries, the following pricing and reimbursement approvals are examples of those that are currently necessary to conduct a launch of a drug or biological product: in France, publication of the reimbursed price level in the official journal and registration on a reimbursement list by or on behalf of Comité Economique des Produits de Santé or Haute Autorité de Santé (or a successor agency); in Italy, publication of reimbursement in the Government’s Official Gazette (by Agenzia Italiana del Farmaco or a successor agency); in Germany, execution of contract with the head association of sick funds (GKV-Spitzenverband, Gesetzlichen Krankenversicherung, or a successor agency); in Spain, authorization by La Comisión Interministerial de Precios de los Medicamentos or La Comisión Nacional para el Uso Racional de los Medicamentos (or a successor agency) for national patient access to reimbursement by or on behalf of a Governmental Authority; and in the United Kingdom, a recommendation by the National Institute for Health and Care Excellence (or a successor agency) to obtain mandatory funding to enable broad market access.
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Related to Commercialization Approval

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • Regulatory Approval means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.

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

  • Drug Approval Application means, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.