Regulatory Responsible Party definition

Regulatory Responsible Party means [***].
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Regulatory Responsible Party has the meaning set forth in Section 3.5.1.
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Regulatory Responsible Party means (a) BioCryst until the Regulatory Responsibility Transfer Date and (b) Torii from and after the Regulatory Responsibility Transfer Date; provided that, as between the Parties, BioCryst will remain the Regulatory Responsible Party after the Regulatory Responsibility Transfer Date to the extent that BioCryst is required by Applicable Law or any Regulatory Authority in the Territory with respect to (i) BioCryst’s Manufacture and supply of the Licensed Product for the Territory, and (ii) BioCryst’s conduct of Development activities for the Licensed Product in the Field in the Territory, including the submissions of any CTA.
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Examples of Regulatory Responsible Party in a sentence

  • If the Parties’ Executive Officers are unable to reach agreement on the content of such Jointly-Agreed Regulatory Submission within a period of [***], then the Regulatory Responsible Party will have final decision-making authority with respect to the content of such Jointly-Agreed Regulatory Submission.

  • If the Parties cannot come to a mutual agreement through the Regulatory Sub-Committee on an issue related to regulatory matters, then the Regulatory Responsible Party for the applicable Product at such time will have the final decision-making authority over such matter, except as otherwise set forth in Section 3.5.6 with respect to decisions regarding the label for a Product and class generic claims included in any regulatory filings for a Product.

  • If Partner is the Regulatory Responsible Party, uniQure is still Manufacturing the applicable Licensed Product, and such written or electronic correspondence relates to the Manufacture or safety of the Licensed Product, then Partner will notify uniQure, and provide uniQure with copies of such written or electronic correspondence as soon as reasonably practicable, but not later than [*] after receipt of such correspondence.

  • The Regulatory Responsible Party will not be required to delay any submission, correspondence, or communication with any Regulatory Authorities in a manner that affects such Regulatory Responsible Party’s ability to comply with any Regulatory Authority requirement or deadline or Applicable Law in such jurisdiction.

  • Subject to [***] and on a Region-by-Region basis, the Regulatory Responsible Party shall lead all regulatory matters relating to the DT Co-Co Products in accordance with the Development Plan.

  • The Regulatory Responsible Party will not be required to delay any submission, correspondence, or communication with any Regulatory Authorities in its jurisdiction in a manner that affects such Regulatory Responsible Party’s ability to comply with any Regulatory Authority requirement or deadline or Applicable Law in such jurisdiction.

  • If Partner is the Regulatory Responsible Party, then Partner may also reasonably request that uniQure attend such meetings, conferences, or discussions.

  • The non-Regulatory Responsible Party shall strictly follow the applicable Regulatory Responsible Party’s instructions with respect to any such meeting that it attends, and shall not discuss the contents of any such meeting with any Third Party or Regulatory Authority except as required by Applicable Laws or authorized by the Regulatory Responsible Party in writing.

  • All such documents or reports described in subclause (b) above will be provided to the non-Regulatory Responsible Party at least [***] prior to their submission to the applicable Regulatory Authority (or such later date as the Parties may reasonably agree), and the Regulatory Responsible Party will reasonably consider any comments provided by the non-Regulatory Responsible Party with respect to such documents or reports in good faith.

  • The Regulatory Responsible Party will use Commercially Reasonable Efforts to obtain and maintain all Regulatory Approvals and Reimbursement Approvals required to Commercialize the Licensed Product in the Field in the Territory.


More Definitions of Regulatory Responsible Party

Regulatory Responsible Party means the Party designated under Section 5.1 (Regulatory Responsible Party).
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Regulatory Responsible Party means, with respect to a DT Co-Co Product, on a country-by-country basis in the Territory, (i) the Lead Party prior to any Opt-Out and the Opt-Out Date or (ii) the Primary Party after the Opt-Out Date.
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Regulatory Responsible Party means Partner; provided that, as between the Parties, uniQure will remain the Regulatory Responsible Party to the extent that uniQure is required by Applicable Law or any Regulatory Authority in the Territory [*].
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Regulatory Responsible Party has the meaning set forth in Section 6.2.1 (Regulatory Responsibilities).
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Regulatory Responsible Party means (a) with respect to the E.U., (i) [***] (or its Affiliates), [***] of Regulatory Approval from the EMA for the Licensed Product for each of the DD-CKD Indication and the NDD-CKD Indication, and (ii) [***] (or its Affiliates [***]), [***] Regulatory Approval from the EMA for the Licensed Product for each of the DD-CKD Indication and the NDD-CKD Indication, and (b) [***] (or its Affiliates [***]), with respect to all other countries within the Territory, in each case ((a) and (b)), subject to Akebia’s ongoing Development obligations in the Territory related to the Licensed Products.
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Related to Regulatory Responsible Party

  • Responsible Party means a public or private body or any other person which, alone or in conjunction with others, determines the purpose of and means for processing personal information, as defined in POPI.

  • Responsible Parties means all Retailers and Customers, including Transmission Load Customers, Distribution Load Customers, DG Customers, MG Customers or agents of the foregoing;

  • Responsible administrative authority means, with respect to a structured settlement, any government authority vested by law with exclusive jurisdiction over the settled claim resolved by the structured settlement.

  • regulatory action level RBC means the product of 1.5 and its authorized control level RBC;

  • Regulatory Action means an administrative, regulatory, or judicial enforcement action, proceeding, investigation or inspection, FDA Form 483 notice of inspectional observation, warning letter, untitled letter, other notice of violation letter, recall, seizure, Section 305 notice or other similar written communication, injunction or consent decree, issued by the FDA or a federal or state court.

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

  • Regulatory Agencies The Office of the Comptroller of the Currency; the Board of Governors of the Federal Reserve System; the Federal Deposit Insurance Corporation; the Federal Housing Finance Agency; the Securities and Exchange Commission; and the Department of Housing and Urban Development.

  • 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.

  • Regulatory Agreement means the regulatory agreement between HPD and the Owner establishing certain controls upon the operation of the Exemption Area during the term of the Exemption.

  • Regulatory Agency means any federal or state agency charged with the supervision or regulation of depository institutions or holding companies of depository institutions, or engaged in the insurance of depository institution deposits, or any court, administrative agency or commission or other authority, body or agency having supervisory or regulatory authority with respect to the Company, the Bank or any of their Subsidiaries.