Assigned Regulatory Submissions definition

Assigned Regulatory Submissions has the definition set forth in Section 7.6.1 (U.S. BLA for U.S. [***] Products).
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Assigned Regulatory Submissions means all INDs, XXXx, and other Regulatory Approvals or Regulatory Submissions assigned by Takeda to Neurocrine pursuant to Section 5.2 (Assignment of Regulatory Submissions).
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Assigned Regulatory Submissions means all INDs, MAAs, and other Regulatory Approvals or Regulatory Submissions assigned by Arrowhead to Takeda pursuant to Section 4.2 (Assignment of Regulatory Submissions).
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Examples of Assigned Regulatory Submissions in a sentence

  • HMI will bear all Third Party expenses in connection with the transfer and assignment of all Assigned Regulatory Submissions, and any other copies of Regulatory Submissions provided to HMI pursuant to this Article 7 (Regulatory Affairs).

  • No later than [***] after the completion of all transition activities set forth in this Section 4.2.1(b) (Other Assigned Regulatory Submissions), Arrowhead will send a letter to each applicable Regulatory Authority to record and notify such Regulatory Authority of the transfer to Takeda of all Regulatory Approvals and Regulatory Submissions for all Products.

  • Any such Regulatory Submission provided by Takeda (following agreement by each Party) will be included in the Assigned Regulatory Submissions.

  • Subject to the terms and conditions of this Agreement, within a reasonable time following Takeda’s request, Arrowhead will execute and deliver, or will cause to be executed and delivered, to Takeda such endorsements, assignments, and other documents as may be reasonably necessary to assign, convey, transfer, and deliver to Takeda all of Arrowhead’s rights, title, and interests in and to the Assigned Regulatory Submissions.

  • Subject to the terms and conditions of this Agreement, within a reasonable time following Neurocrine’s request, Takeda will execute and deliver, or will cause to be executed and delivered, to Neurocrine such endorsements, assignments, and other documents as may be reasonably necessary to assign, convey, transfer, and deliver to Neurocrine all of Takeda’s rights, title, and interests in and to the Assigned Regulatory Submissions.

  • No later than [***] after the completion of all transition activities set forth in this Section 5.2.1(b) (Other Assigned Regulatory Submissions), Takeda will send a letter to each applicable Regulatory Authority to record and notify such Regulatory Authority of the transfer to Neurocrine of all Regulatory Approvals and Regulatory Submissions for the Phase II Asset.

  • Day One will bear all Third Party expenses in connection with the transfer and assignment of all Assigned Regulatory Submissions.


More Definitions of Assigned Regulatory Submissions

Assigned Regulatory Submissions has the definition set forth in Section 7.6.1 (U.S. BLA for U.S. SCD Products).
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Assigned Regulatory Submissions means the Regulatory Submissions set forth on Schedule 1.11, which lists the Regulatory Submissions that are Controlled by Takeda or its Affiliates and relate solely to one or more Products or the Compound and not to any other product Controlled by Takeda or any of its Affiliates.
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Assigned Regulatory Submissions has the meaning set forth in Section 5.1.5(a) (Transfer of Other Assigned Regulatory Submissions).
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Related to Assigned Regulatory Submissions

  • 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 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.

  • Regulatory Filing means any approvals, licenses, registrations, submissions and authorizations, and applications therefor, including IND, NDA, BLA, drug dossier or drug master file filed, or Marketing Approval obtained, with respect to an Option Product, Licensed Product or Companion Diagnostic, as applicable, in the Field, including all amendments, supplements, annual reports and the like thereof or therefor filed with or otherwise provided to the applicable Regulatory Authority.

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, or other filings made to or with a Regulatory Authority that are necessary or reasonably desirable in order to develop, manufacture, market, sell or otherwise commercialize a product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, XXXx and NDAs (as applications, but not the approvals with respect thereto).

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

  • Regulatory Filings means any submission to a Regulatory Authority of any appropriate regulatory application together with any related correspondence and documentation, and will include any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

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

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Regulatory Documents means the prospectus, annual report, semi-annual report and any other document required under applicable federal securities law to be delivered by the Trust to Fund shareholders.

  • 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 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.

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • Third-Party Filer means an entity that submits a Product filing to the Commission on behalf of an Insurer.

  • 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.

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

  • Regulatory Documentation means all applications, registrations, licenses, authorizations and approvals (including all Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority), all supporting documents and all Clinical Trials and tests, including the manufacturing batch records, relating to a Product, and all data contained in any of the foregoing, including all regulatory drug lists, advertising and promotion documents, adverse event files and complaint files.

  • FDA means the United States Food and Drug Administration.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • 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.

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • Regulatory Authorities means the Commissions and the Exchange;

  • IND means (i) an investigational new drug application filed with the FDA for authorization to commence clinical studies and its equivalent in other countries or regulatory jurisdictions and (ii) all supplements and amendments that may be filed with respect to the foregoing.

  • DMF means any drug master file filed with the FDA, and any equivalent filing in other countries or regulatory jurisdictions.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • 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.