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.
Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.
Data Subject Request means a request from a Data Subject to exercise its rights under the Data Protection Laws in respect of that Data Subject's Personal Data;
Data Source Annual Fiscal Audit Report, Terms of Debt, Other Formal Notifications Received by School. Exceeds Standard The school has met standard for at least 3 consecutive years. Approaches Standard The school experienced one or more instances of minor default during the fiscal year (such as making late payments); however, the school is not currently in default of any financial obligations. Does Not Meet Standard School is currently in default of financial obligations.
Planning Submission or “CAPS” or “Community Accountability Planning Submission” means the HSP Board approved planning document submitted by the HSP to the Funder. The form, content and scheduling of the Planning Submission will be identified by the Funder;
data user means a natural or legal person who has lawful access to certain personal or non-personal data and is authorised to use that data for commercial or non-commercial purposes;
Electronic Submission means a successful submittal of Offeror’s proposal.
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.
Data Site means an electronic password protected data site maintained by the Borrower (or by the Collateral Manager on behalf of Borrower) at Xxxxxxx Corporation, Intralinks, SyndTrak Online or any other similar electronic distribution system reasonably acceptable to the Administrative Agent.
Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.
Regulatory Materials means regulatory applications, submissions, notifications, registrations, Marketing Authorizations or other written materials, correspondence, submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize the Licensed Products in the Field in a particular country.
Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.
Data Subject Access Request means a request made by a Data Subject in accordance with rights granted pursuant to the DPA to access his or her Personal Data;
Regulatory Filings means all applications, filings, dossiers and the like submitted to a Regulatory Authority in a particular jurisdiction for the purpose of obtaining Regulatory Approval of a Licensed Product from that regulatory authority with respect to such jurisdiction. Regulatory Filings shall include, but not be limited to, all INDs and Drug Approval Applications for Licensed Product.
Selected submission means and refers to the submission sent to the City of Waco by the Selected Firm.
Data Log means a complete record of all Data Interchanged representing the Messages and their Associated Data between the parties;
Data Set means specific CancerMPact or Epi Database data provided by Oracle to Client pursuant to the Agreement and Order. This includes the data, analysis, models and any other information contained in the database or report to be accessed by multiple subscribers, and any other non-custom engagement performed by Oracle.
Third-party filer means an entity that submits a Product filing to the Commission on behalf of an Insurer.
the data subject s consent' shall mean any freely given specific and informed indication of his wishes by which the data subject signifies his agreement to personal data relating to him being processed.
Third Party Applications means online, Web-based applications and offline software products that are provided by third parties and are identified as third-party applications, including but not limited to those listed on the AppExchange and the Reseller Application.
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).
Regulatory Information Service means a regulatory information service as defined in the Takeover Rules.
Data Subject means the identified or identifiable person to whom Personal Data relates.
Study Data shall have the meaning set forth in Section 8.1.
Data Subjects means all individuals whose Personal Information we receive in the course of our banking relationship with you, including your direct and indirect beneficial owners, directors, officers and authorized persons.
Application Review Start Date means the later date of either the date on which the District issues its written notice that the Applicant has submitted a completed Application or the date on which the Comptroller issues its written notice that the Applicant has submitted a completed Application and as further identified in Section 2.3.A of this Agreement.