Product Regulatory Approval definition

Product Regulatory Approval means any Regulatory Documentation filed in the Territory which is related to a Product in the Licensed Field, whether in existence as of the Effective Date or filed with the applicable Regulatory Authority during the Term, including any supplements or amendments thereto.
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Product Regulatory Approval means, with respect to any product for an indication, the granting or approval of a Drug Approval Application by the applicable Regulatory Authority to market and sell such product for use in such indication in a country or region. For purposes of clarity, a Product Regulatory Approval shall not include pricing or reimbursement authority or approval.
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Product Regulatory Approval means the Regulatory Approval to Commercialize the Product in the United States.
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Examples of Product Regulatory Approval in a sentence

  • Company shall, at its sole expense, store, handle, transport, and package, distribute and use Bulk Drug Product delivered to Company in compliance with the requirements set out in the Quality Agreement, the Product Regulatory Approval and all Applicable Law.

  • AstraZeneca shall use reasonable efforts to provide Targacept with at least [********] advance notice of any meeting with the FDA regarding a Drug Approval Application relating to, or Product Regulatory Approval for, any Candidate Drug or Product and Targacept may elect to send one person reasonably acceptable to AstraZeneca to attend such meeting as an observer (at Targacept’s sole expense) unless [********].

  • Following Transfer Date, Journey shall, directly and/or by or with an Affiliate and/or a Sublicensee, use Commercially Reasonable Efforts to Develop and Commercialize the Product in the Field in the Territory; provided that Journey shall (x) launch the Product in the United States within six (6) months from the receipt of Product Regulatory Approval, and (y) initiate Development of the Product in the Field in the European Union within twenty-four (24) months from the receipt of Product Regulatory Approval.

  • Subject to the terms and conditions of this Agreement, Journey hereby grants to DRL and its Affiliates an irrevocable, royalty-free, sublicensable, transferrable (subject to Section 14.6), exclusive license and right of reference under all Regulatory Approvals and any other Regulatory Materials that Journey or its Affiliates Control with respect to the Product (including the Product Regulatory Approval) to enable DRL to Exploit the Products in the Field in the DRL Territory.

  • Jubilant shall (i) conduct all correspondence with the FDA and otherwise manage the Product Regulatory Approval process; (ii) use Commercially Reasonable Efforts to satisfy any deficiencies identified by the FDA; and (iii) use Commercially Reasonable Efforts to maintain the Regulatory Approvals of such Product.

  • Purchaser shall promptly advise Seller of any changes made in any Royalty Bearing Product Regulatory Approval that could reasonably be expected to have an impact on such Regulatory Approvals of Seller outside the Territory.

  • Distributor shall, at its sole cost and expense, provide all cooperation reasonably requested by Alfacell in connection with its Product development and obtaining and maintaining of Product Regulatory Approval.

  • No Proceeding is pending or, to Seller’s Knowledge, threatened regarding the suspension or revocation of any Product Regulatory Approval.

  • The SC shall be in charge of setting such optimization process, including assuming decisions on strategic protocol design, with the objective to speed up Product Regulatory Approval.

  • The Steering Committee shall be a forum for strategic communications and planning on topics including the ongoing commercial development of the Product, Regulatory Approval of the Product in additional jurisdictions, Raw Material strategies, cost reduction initiatives and similar high-level matters.


More Definitions of Product Regulatory Approval

Product Regulatory Approval means each approval, license, registration or authorization included in Marketing Approval.
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Related to Product Regulatory Approval

  • Regulatory Approval means any and all approvals, licenses, registrations or authorizations of any Regulatory Authority that are necessary for the marketing and sale of a product in a country or group of countries.

  • 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;

  • 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).

  • 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.

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

  • 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 Approvals with respect to the Warrantholder, means, to the extent applicable and required to permit the Warrantholder to exercise this Warrant for shares of Common Stock and to own such Common Stock without the Warrantholder being in violation of applicable law, rule or regulation, the receipt of any necessary approvals and authorizations of, filings and registrations with, notifications to, or expiration or termination of any applicable waiting period under, the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended, and the rules and regulations thereunder.

  • FDA Approval means with respect to the Product, a Regulatory Approval by the FDA for the commercial use of the Product in the United States.

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

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • NDA means a New Drug Application, as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding foreign application, registration or certification.

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

  • 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 Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

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

  • ANDA means Abbreviated New Drug Application.

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

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Product Approvals 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.

  • 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.

  • 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.

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.

  • Regulatory Filing means any documentation comprising or relating to or supporting any filing or application with any Regulatory Authority with respect to the Licensed Product, including any documents submitted to any Regulatory Authority, including INDs, Regulatory Approval Applications, and all correspondence with any Regulatory Authority with respect to any Licensed Product (including minutes of any meetings, telephone conferences, or discussions with any Regulatory Authority).

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.