Initial Regulatory Approval definition

Initial Regulatory Approval of the Licensed Product for an indication means (a) with respect to the United States, the approval by FDA (whether through means of an NDA, subpart E, or subpart H filing or otherwise); or (b) with respect to a country in a regulatory jurisdiction in the Licensee Territory, the approval by the applicable Regulatory Authorities, of the Drug Approval Application with respect to the Licensed Product for such indication in the applicable regulatory jurisdiction (including, in the European Union, the approval by the EMEA of an MAA filed pursuant to the centralized approval procedure, if applicable, or otherwise with respect to the mutual recognition approval procedure on a country-by-country basis with the applicable Regulatory Authority of a country in Europe).
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Initial Regulatory Approval means the first approvals, licenses, registrations, CE Marking or authorizations of any national, supra-national (e.g., the FDA, the EMEA or Koseisho), state or local regulatory agency, department, bureau, commission, council or other governmental entity, sufficient for the manufacture, distribution, use and sale of Licensed Product in a regulatory jurisdiction in accordance with applicable laws, excluding receipt of pricing and reimbursement approvals.
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Initial Regulatory Approval of a Licensed Product for an Indication means (a) with respect to the United States, the approval by FDA (whether through means of an NDA, subpart E, or subpart H filing or otherwise); or (b) with respect to a country in a regulatory jurisdiction in the Licensee Territory outside the United States, the approval by the applicable Regulatory Authorities, of the Drug Approval Application with respect to a Licensed Product for an Indication in the applicable regulatory jurisdiction (including, in Europe, the approval by the European Commission of an MAA filed pursuant to the centralized approval procedure.
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Examples of Initial Regulatory Approval in a sentence

  • Subject to Section 6.5(c), during the period commencing on the Amendment Effective Date and ending on the earlier of (a) the Termination Date, and (b) the [***] ([***]) anniversary of the Initial Regulatory Approval Date, neither Q-Med nor NSH, nor any of their Affiliates, shall, directly or indirectly, Commercialize in the Licensed Field in the Territory any Competitive Product.

  • Thereafter, Yakult shall, on or before January 31 of each Calendar Year, provide to the SC for its review and comment proposed amendments to the Commercialization Plan, which, after the first anniversary of April 1 of the Calendar Year in which the Initial Regulatory Approval for the Licensed Product is achieved in Japan, shall include the Commercialization Plan for the Calendar Year commencing on the third anniversary of January 1 of the then-current Calendar Year.

  • No later than twelve (12) months prior to the expected date of the Initial Regulatory Approval of the Licensed Product in Japan, Yakult shall prepare for review and comment by the SC a proposed Commercialization Plan for the Licensed Product from the date of launch through the third anniversary of April 1 of the Calendar Year in which the Initial Regulatory Approval is expected to be achieved.

  • Stage 1 of the Collaborative Activities shall consist of (i) toxicology and pharmacology studies and stability and compatibility studies necessary to generate such data and information as is reasonably necessary to seek and obtain, if practicable, Initial Regulatory Approval, and (ii) modification of the Drug formulation and/or System design as may be necessary to receive such Initial Regulatory Approval.

  • Stage I will be considered complete upon receipt of Initial Regulatory Approval of the IND.

  • Each party will be responsible for ensuring that its respective responsibilities concerning studies performed under the Collaborative Activities are performed in compliance with applicable GMP, GLP and GCP requirements and all regulatory requirements for the filing and prosecution of the Initial Regulatory Approval and subsequent approvals.

  • When you open your account you will receive a passbook.Additional InformationKey Features• Tax free savings• Penalty free access to your savings• Variable interest rate*Providing you can give 45 days’ notice, otherwise you will lose45 days interest on the amount withdrawn or the closing balance.


More Definitions of Initial Regulatory Approval

Initial Regulatory Approval of the Licensed Product for an indication shall mean (a) with respect to the United States, the first approval by FDA or (b) with respect to Japan, the first marketing approval by MHLW, of the Drug Approval Application with respect to the Licensed Product for such indication.
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Initial Regulatory Approval means activation by the FDA of Orphan's IND submission covering the Drug-System Combination.
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Initial Regulatory Approval means the first authorization or approval of Drug Approval Applications for marketing or commercial sale of Product for Crohn’s disease in Europe and in the United States by the European Commission and the FDA, respectively.
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Initial Regulatory Approval of a Licensed Product for an indication means (a) with respect to the United States, the approval by the FDA and, (b) with respect to a country or jurisdiction other than the United States, the approval by the applicable Regulatory Authorities of the Drug Approval Application with respect to such Licensed Product for such indication in the applicable regulatory jurisdiction (including, in the European Union, the approval by the EMEA of an MAA filed pursuant to the centralized Approval procedure, if applicable, or otherwise with respect to the mutual recognition Approval procedure on a country-by-country basis with the applicable Regulatory Authority of a country in Europe).
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Initial Regulatory Approval of a Product means (a) with respect to the United States, the approval by FDA (whether through means of a BLA, subpart E, or subpart H filing or otherwise); and (b) with respect to a country in a regulatory jurisdiction in the Royalty Territory, the approval by the applicable Regulatory Authorities of the Drug Approval Application with respect to such Product in the applicable regulatory jurisdiction (including, in the European Union, the approval by the EMEA of an MAA filed pursuant to the centralized Approval procedure, if applicable, or otherwise with respect to the mutual recognition Approval procedure on a country-by-country basis with the applicable Regulatory Authority of a country in Europe). If “Initial Regulatory Approval” is used with respect to a particular Product (i) without reference to a particular Indication, then it shall mean the first Initial Regulatory Approval of a Product containing the particular Antibody, either as the sole active ingredient, or for use in combination with one or more Agents, irrespective of the Indication and (ii) with respect to a particular Indication, then it shall mean the first Initial Regulatory Approval of a Product containing the particular Antibody for such Indication, either as the sole active ingredient or for use in combination with one or more Agents. Unless an Initial Regulatory Approval for a Product is expressly stated to be for an Indication, it shall be deemed to relate to the applicable Product generally, as reflected by the example set forth in clause (i) above, and not to a specific Indication.
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Initial Regulatory Approval is used with respect to a particular Product (i) without reference to a particular Indication, then it shall mean the first Initial Regulatory Approval of a Product containing the particular Antibody, either as the sole active ingredient, or for use in combination with one or more Agents, irrespective of the Indication and (ii) with respect to a particular Indication, then it shall mean the first Initial Regulatory Approval of a Product containing the particular Antibody for such Indication, either as the sole active ingredient or for use in combination with one or more Agents. Unless an Initial Regulatory Approval for a Product is expressly stated to be for an Indication, it shall be deemed to relate to the applicable Product generally, as reflected by the example set forth in clause (i) above, and not to a specific Indication.
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Related to Initial Regulatory Approval

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.

  • 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.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • FDA Approval means the approval by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Pricing Approval means any approval, agreement, determination, or decision establishing prices that can be charged to consumers for a pharmaceutical or biological product or that will be reimbursed by Governmental Authorities for a pharmaceutical or biological product, in each case, in a country where Governmental Authorities approve or determine pricing for pharmaceutical or biological products for reimbursement or otherwise.

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • 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.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • ANDA means an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.