Academic Board means the Academic Board of the University College established under paragraph 13;
Academic and professional matters means the following policy development and implementation matters:
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.
Academic year means the period of twelve months beginning on 1st January, 1st April, 1st July or 1st September according to whether the course in question begins in the winter, the spring, the summer or the autumn respectively but if students are required to begin attending the course during August or September and to continue attending through the autumn, the academic year of the course is to be considered to begin in the autumn rather than the summer;
Academic Council means the Academic Council of the University;
Collaboration Technology means all Collaboration Patents and Collaboration Know-How.
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).
Academic Unit means an Academic Department, research unit, School, non-departmentalized Faculty, Faculty of Medicine Division, the Fisheries and Marine Institute, the School of Arctic and Subarctic Studies, the Student Wellness and Counselling Centre, or the University Library, to which one (1) or more ASMs have their primary or sole appointment. For Counselling Faculty Members at Xxxxxxxx Campus who are not members of a School, the Academic Unit shall be Xxxxxxxx Campus. For Faculty Members in the Faculty of Medicine who are not members of a Division, the Academic Unit shall be the Faculty.
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).
Complaint Investigation means an investigation of any complaint that has been made to a proper authority that is not covered by an abuse investigation.
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.
Third Party IPR means any Intellectual Property Rights not belonging to either party to this Agreement but used by the Supplier in the creation of the Deliverables and/or in the course of or in connection with the Project.
Development Works means the external development works and internal development works on immovable property;
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 Oversight Committee means the committee of the Board constituted in accordance with Rule 204.
Collaboration has the meaning set forth in Section 2.1.
Quebec Action means the Quebec Action as defined in Schedule A.
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.
Collaboration IP means Collaboration Know-How and Collaboration Patents.
Adjudicatory hearing means a hearing to determine:
Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.
Third Party Action means any suit or proceeding by a person or entity other than a Party for which indemnification may be sought by a Party under Article VII.
Internal Collaboration means collaborative arrangements within a group of companies or within various strategic business. units/subsidiaries/operating divisions in order to gain a strategic position whilst sharing resources, profits and losses as well as risks
Investigating Committee means any Officer/Committee appointed by Competent Authority to conduct investigation.
Professional Conduct Committee means the professional conduct committee established by the Council in terms of section 12(2)(b);
Infringement Action has the meaning set forth in Section 9.6(b).