Major Regulatory Filings definition

Major Regulatory Filings has the meaning provided in Section 4.03.
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Major Regulatory Filings has the meaning set forth in Section 3.8.2(c). *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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Major Regulatory Filings has the meaning set forth in Section 3.10.1(e).
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Examples of Major Regulatory Filings in a sentence

  • PII shall use Diligent Efforts in preparing the Major Regulatory Filings for Regulatory Approval of the Licensed Product(s) and in causing such agency applications to progress through the Regulatory Approval process.

  • AbbVie shall provide access to interim drafts of such Major Regulatory Filings to Galapagos via the access methods (such as secure databases) established by the JDC, and Galapagos shall provide its comments on the final drafts of such Major Regulatory Filings or of proposed material actions within […***…] ([…***…]) Business Days ([…***…] ([…***…]) Business Days for Drug Approval Applications), or such other longer period of time mutually agreed to by the Parties.

  • AbbVie shall provide access to interim drafts of such Major Regulatory Filings to Licensor via the access methods (such as secure databases) established by the JDC, and Licensor shall provide its comments on the final drafts of such Major Regulatory Filings or of proposed material actions within [***] ([***] for Drug Approval Applications), or such other longer period of time mutually agreed to by the Parties.

  • Prior to the Option Exercise Date for a particular Designated Target, Denali shall provide Takeda with a reasonable opportunity to review and comment on any material communications with the applicable Regulatory Authorities with respect to Research Biologics included in the Research Program for such Designated Target, including to the extent existing prior to the Option Exercise Date, any INDs and other Major Regulatory Filings.

  • The Regulatory Lead shall provide access to interim drafts of such Major Regulatory Filings to the Non-Regulatory Lead via the access methods (such as secure databases) established by the JPT, and the Non-Regulatory Lead shall provide its comments on the final drafts of such Major Regulatory Filings or of proposed material actions within [***] Business Days (or [***] Business Days in the case of Drug Approval Applications), or such other period of time mutually agreed to by the Parties.

  • Xxxxxx shall provide access to interim drafts of such Major Regulatory Filings to Galapagos via the access methods (such as secure databases) established by the JDC, and Galapagos shall provide its comments on the final drafts of such Major Regulatory Filings or of proposed material actions within […***…] ([…***…]) Business days ([…***…] ([…***…]) Business days for Drug Approval Applications), or such other longer period of time mutually agreed to by the Parties.

  • Each Party shall provide access to interim drafts of the Major Regulatory Filings to the other Party via the access methods (such as secure databases) established by the JDC, and the other Party shall provide its comments on the then-current drafts of Major Regulatory Filings or of proposed material actions within [***] ([***]) ([***] ([***]) days for Drug Approval Applications), or such other longer period of time mutually agreed to by the Parties.

  • AbbVie shall provide access to interim drafts of such Major Regulatory Filings to Galapagos via the access methods (such as secure databases) established by the JDC, and Galapagos shall provide its comments on the final drafts of such Major Regulatory Filings or of proposed material actions within [...***...] Business Days ([...***...] Business Days for Drug Approval Applications), or such other longer period of time mutually agreed to by the Parties.

  • Each Party shall provide access to interim drafts of the Major Regulatory Filings to the other Party via the access methods (such as secure databases) established by the JDC, and the other Party shall provide its comments on the then-current drafts of Major Regulatory Filings or of proposed material actions within [***] days ([***] days for Drug Approval Applications), or such other longer period of time mutually agreed to by the Parties.

  • In respect of the Regulatory Activities for which the Regulatory Party is responsible in the Pfizer Territory, the Regulatory Party shall promptly provide to the other Party copies of all Major Regulatory Filings filed with any Regulatory Authority in the Pfizer Territory, in each case, relating to any Product in the Field.

Related to Major Regulatory Filings

  • Regulatory Filings means any and all regulatory applications, filings, approvals and associated correspondence required to Develop, manufacture, market, sell and import Products in, or into, each country or jurisdiction in the Territory.

  • 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).

  • Regulatory Authorities means the Commissions and the Exchange;

  • Regulatory Authorizations means all approvals, clearances, notifications, authorizations, orders, exemptions, registrations, listings, certifications, licenses and permits granted by, submitted to or filed with any Regulatory Agencies necessary for the testing, manufacture, development, distribution, use, storage, import, export, transport, promotion, marketing, sale or other commercialization of any Product in any country or jurisdiction, including any Investigational Application.

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

  • Regulatory Submissions means any filing, application or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals and any pricing or reimbursement approvals, as applicable, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

  • 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.

  • 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;

  • 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.

  • Regulatory Materials means regulatory applications, submissions, notifications, communications, correspondence, registrations, Regulatory Approvals or other filings made to, received from or otherwise conducted with a Regulatory Authority in order to Develop, Manufacture, or Commercialize a Licensed Product in a particular country or jurisdiction.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • 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 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).

  • 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.

  • 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.

  • 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.

  • Regulatory Authority means, with respect to a particular country, extra-national territory, province, state, or other regulatory jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval and/or, to the extent required for such country, extra-national territory, province, state, or other or regulatory jurisdiction, pricing or reimbursement approval of a Product in such country or regulatory jurisdiction, including the FDA, the EMA, the European Commission and MHLW, and in each case including any successor thereto.

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

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

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

  • 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.

  • Insurance Regulatory Authority means, with respect to any Insurance Subsidiary, the insurance department or similar Governmental Authority charged with regulating insurance companies or insurance holding companies, in its jurisdiction of domicile and, to the extent that it has regulatory authority over such Insurance Subsidiary, in each other jurisdiction in which such Insurance Subsidiary conducts business or is licensed to conduct business.

  • Securities Regulatory Authorities means the securities commission or similar regulatory authority in each province and territory of Canada that is responsible for administering the Canadian securities legislation in force in such jurisdictions;

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing and control data, preclinical data, clinical data and all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product (including any applicable Drug Master Files (“DMFs”), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).