Full Regulatory Approval definition

Full Regulatory Approval. The Original Agreement shall be amended by adding the following new definition as Section 1.13A:
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Full Regulatory Approval means, with respect to the Product, the approval or authorization granted by a Regulatory Authority (FDA) for NDA # 21-853 in the Territory for the initial and ongoing commercialization of the Product for patients with triglyceride levels between 200 mg/dL and 499 mg/dL (inclusive).”
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Full Regulatory Approval means (i) FDA Regulatory Approval, and (ii) DEA Regulatory Approval.
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Examples of Full Regulatory Approval in a sentence

  • Suburb Town/City Postal code Contact detailsContact name Phone number Mobile number Email address Additional Production Sites or Contract Manufacturers For Full Regulatory Approval, suppliers must hold an acceptable food certification (see details below).

  • Subject to Section 5.12, PRONOVA shall, after FDA approval of the Product for the indication HTG under NDA # 21-654 or Full Regulatory Approval for NDA # 21-853, manufacture and supply to RELIANT the total of RELIANT’s requirements of the API for the Product for sale and distribution in the Territory.

  • PRONOVA agrees to use commercially reasonable efforts to qualify an additional manufacturing site prior to one (1) year following the Full Regulatory Approval.

  • Provided that PRONOVA is not in breach of its supply obligations under Section 5, this Agreement will be subject to RELIANT making at least the following purchases of API for Trade Product during the first twelve month period following the First Commercial Sale and every 12-month period thereafter (each a “Commercialization Year”) prior to Full Regulatory Approval (the “Reduced Base Minimum Purchase Levels”): • 1st Commercialization Year: USD 3,000,000.

  • This has been very special and wonderful journey of my life and has given me precious memories to cherish all my life.

  • Commencing at the Closing, Otsuka shall have the exclusive right, and shall use Commercially Reasonable Efforts, to commercialize one or more Licensed Products in the Territory, which have been the subject of Full Regulatory Approval in relation to each Licensed Product for each indication, *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

  • Following the Closing, GW Pharma shall diligently perform its obligations regarding development and Full Regulatory Approval of the Licensed Products as set forth in this Agreement and the First Indication Development Plan and the Second Indication Development Plan and any other Development Plan agreed upon by the Parties.

  • RELIANT shall have a sales force of at least [***] representatives detailing the Product for the first three years from the date of Full Regulatory Approval.

  • A sample calculation of Full Base Minimum Purchase Levels is set forth on Schedule 6.1 attached hereto.” In the event that Full Regulatory Approval includes one or more conditions which, when taken as a whole, would reasonably be expected to materially and adversely impact the commercial potential of the Product for those patients with triglyceride levels between 200 mg/dL and 499 mg/dL, the parties shall meet in good faith to discuss appropriate adjustments to the Full Base Minimum Purchase Levels.

  • Of the Original Agreement shall be deleted in its entirety and replaced with the following: “Notwithstanding anything to the contrary contained in this Section 8.2, until Full Regulatory Approval has been received with respect to the Product, the number [***]: Certain information on this page has been omitted and filed separately with the Commission.


More Definitions of Full Regulatory Approval

Full Regulatory Approval means the final approval by the FDA of the new drug application or supplemental new drug application filed with the FDA pursuant to 21 U.S.C § 355(b) that is necessary for the commercial marketing and sale of the Product in the United States of America for the Indication, regardless of any obligation to conduct any post-marketing study.
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Full Regulatory Approval means, with respect to the Product, the approval or authorization granted by a Regulatory Authority (FDA) for NDA # 21-853 in the Territory for the initial and ongoing commercialization of the Product for [***].”
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Related to Full Regulatory Approval

  • Regulatory Approval means, with respect to the Licensed Product in any country or jurisdiction, all approvals (including, where required, pricing and reimbursement approvals), registrations, licenses or authorizations from the relevant regulatory authority in a country or jurisdiction that is specific to the Licensed Product and necessary to market and sell such Licensed Product in such country or jurisdiction.

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

  • 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.

  • 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.

  • FDA Approval means the approval of the United States Food and Drug Administration necessary for the marketing, distribution in interstate commerce and sale of the Initial Product (as defined in the Collaboration and License Agreement) in the United States.

  • 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).

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

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

  • 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.

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

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

  • Pricing Approval means such governmental approval, agreement, determination or decision establishing prices for a Licensed Product that can be charged and/or reimbursed in regulatory jurisdictions where the applicable Governmental Authorities approve or determine the price and/or reimbursement of pharmaceutical products.

  • 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.

  • 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.

  • 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.

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation, all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • Biologics License Application or “BLA” means, with respect to a country or extra-national territory, a request for permission to introduce, distribute, sell or market a biologic product in such country or some or all of such extra-national territory, including pursuant to 21 CFR 601.2 in the U.S.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • national regulatory authority means the body or bodies charged by a Member State with any of the regulatory tasks assigned in this Directive and the Specific Directives;

  • Product Approval(s) means any approvals, registrations, permits, licenses, consents, authorizations, and other approvals, and pending applications and requests therefor, required by applicable Agencies related to the research, Development, manufacture, distribution, finishing, packaging, marketing, sale, storage or transport of a Product within the United States of America, and includes, without limitation, all approvals, registrations, licenses or authorizations granted in connection with any Application related to that Product.

  • CFIUS Approval means that any of the following shall have occurred: (a) the review period under the DPA commencing on the date that a CFIUS Notice is accepted by CFIUS shall have expired and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS to the effect that such review has been concluded and that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, (b) an investigation under the DPA shall have been commenced after such review period and CFIUS shall have determined to conclude all action under the DPA without sending a report to the President of the United States, and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, or (c) CFIUS shall have sent a report to the President of the United States requesting the President’s decision and either (i) the President shall have announced a decision not to take any action to suspend or prohibit the Contemplated Transactions or, (ii) the period under the DPA during which the President may announce his decision to take action to suspend, prohibit or place any limitations on the Contemplated Transactions shall have expired without any such action being threatened, announced or taken.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Foreign Financial Regulatory Authority shall have the meaning given by Section 2(a)(50) of the 0000 Xxx.

  • Development approval means any written authorization from a

  • ANDA means an abbreviated new drug application filed with the FDA, pursuant to its rules and regulations (or any equivalent or replacement mechanism).