Regulatory Responsible Party definition

Regulatory Responsible Party means [***].
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Regulatory Responsible Party means the Party designated under Section 5.1 (Regulatory Responsible Party).
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Regulatory Responsible Party means the Party designated under Section 5.7.1 (Regulatory Responsible Party).
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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.

  • 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.

  • 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.

  • Subject to the obligations in this Article 5 (Regulatory Affairs), the Regulatory Responsible Party will be responsible for, and [***] all Regulatory Submissions, communications, and other dealings with the Regulatory Authorities relating to the Licensed Products in the applicable Territory, and for seeking and maintaining all Regulatory Approvals with respect to the Licensed Product in the applicable Territory.

  • Ionis will be the Regulatory Responsible Party for the Licensed Products in the Ionis Territory.

  • At the Regulatory Responsible Party’s request, the other Party shall diligently cooperate with the Regulatory Responsible Party in connection with any Regulatory Filings and other regulatory compliance related activities with respect to the DT Co-Co Products, including harmonization of any Regulatory Documentation and Regulatory Filings.

  • Subject to each Party’s right of reference as described in Section 4.5 (Right of Reference), the Regulatory Responsible Party shall file for in its name, and will own, all Regulatory Filings in the countries in which it is responsible for Development and will own all Regulatory Approvals for all Licensed Products in the Territory until such Regulatory Filings are assigned to GSK pursuant to Section 4.2 (Assignment of Regulatory Filings).

  • As reasonably requested by the Regulatory Responsible Party from time to time during the Term, the other Party shall promptly provide reasonable assistance to the Regulatory Responsible Party with respect to filings and other interactions with Regulatory Authorities regarding the Licensed Compound and Licensed Products for which such Regulatory Responsible Party is responsible.

  • Subject to the terms of this Agreement, the applicable Regulatory Responsible Party will be responsible for the preparation and submission of all Regulatory Submissions for the Licensed Product in the Field in the Territory.

  • Without limiting the foregoing, the Regulatory Responsible Party shall: (i) be responsible to draft and file, in its own name or name of its designee, and shall own, the Regulatory Filings required to seek and maintain Marketing Authorization for such Licensed COVID-19 Mono Product in such country, jurisdiction, or region, and (ii) be responsible for, and the right to prepare and conduct, all communications with the applicable Regulatory Authorities in connection with (ii).


More Definitions of Regulatory Responsible Party

Regulatory Responsible Party has the meaning set forth in Section 3.5.1.
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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 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 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 (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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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 Minister , in relation to a scheme, means the Minister to whom the administration of the relevant scheme Act is for the time being committed by the Governor;

  • Responsible Vendor means a vendor with adequate financial resources (or the ability to obtain such resources), who can comply with the delivery requirements, and who is a qualified and established firm regularly engaged in the type of business that provides the goods and/or services herein.

  • Regulatory Flood Protection Elevation means the “Base Flood Elevation” plus the “Freeboard”. In “Special Flood Hazard Areas” where Base Flood Elevations (BFEs) have been determined, this elevation shall be the BFE plus two (2) feet of freeboard. In “Special Flood Hazard Areas” where no BFE has been established, this elevation shall be at least two (2) feet above the highest adjacent grade.

  • Responsible adult means a parent, guardian or other adult specifically authorized by law or authorized by a parent or guardian to have custody or control of a minor.

  • 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;

  • Responsible public entity means a public entity that has the power to develop or operate the applicable qualifying project.

  • Regulatory Action means an administrative or regulatory 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, or consent decree, issued by the FDA.

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

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

  • Regulatory Floodway means the channel of a river or other watercourse and the adjacent land areas that must be reserved in order to discharge the base flood without cumulatively increasing the water surface elevation more than a designated height.

  • Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Corporate Social Responsibility means Corporate Social Responsibility (CSR) as defined in Section 135 of the Companies Act, 2013 and Companies Corporate Social Responsibility Policy) Rules, 2014;

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • 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.

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

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • Person responsible for the child s care” means (1) an individual functioning within the family unit and having responsibilities for the care of the child such as a parent, guardian, or other person having similar care responsibilities, or (2) an individual functioning outside the family unit and having responsibilities for the care of the child such as a teacher, school administrator, other school employees or agents, or other lawful custodian of a child having either full-time or short-term care responsibilities including, but not limited to, day care, babysitting whether paid or unpaid, counseling, teaching, and coaching.

  • 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.

  • Designated crisis responder means a mental health

  • 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.

  • Responsible Authority means any of the following: -

  • Responsible Respondent means a Respondent that has the capability in all material respects to perform the scope of work and specifications of the Contract. In determining whether a Respondent is a Responsible Respondent, the Agency may consider various factors including, but not limited to, the Respondent’s competence and qualifications to provide the goods or services requested, the Respondent’s integrity and reliability, the past performance of the Respondent and the best interest of the Agency and the State.