Premarket Clearance Sample Clauses

Premarket Clearance. Each FDA Product in current commercial distribution as an FDA regulated medical device is either a Class I or Class II medical device as defined under 21 U.S.C. §360c(a)(1)(A), (B) and applicable rules and regulations thereunder and was first marketed under, and is covered by, a premarket notification owned and held exclusively by the Company (or the manufacturer for whom the Company distributes the FDA Product) and in compliance in all material respects with 21 U.S.C. §360(k) and the applicable rules and regulations thereunder, or is exempt from such premarket notification in accordance with 21 U.S.C. §360(l) or (m) and applicable rules and regulations thereunder. All FDA Products in current commercial distribution as an FDA regulated HCT/P meet the definition of an HCT/P in 21 C.F.R. § 1271.3 and, on that basis, do not currently require premarket clearance or approval under the FDCA or PHSA.
Sample 1
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Related to Premarket Clearance

  • FINRA Clearance On or before the date of this Agreement, the Representative shall have received clearance from FINRA as to the amount of compensation allowable or payable to the Underwriters as described in the Registration Statement.

  • NASD Clearance By the Effective Date, the Representative shall have received clearance from the NASD as to the amount of compensation allowable or payable to the Underwriters as described in the Registration Statement.

  • HSR Clearance All applicable waiting periods under the HSR Act shall have expired or been terminated.

  • Customs Clearance 1. The Parties shall apply their respective customsprocedures in a predictable, consistent, and transparentmanner. 2. For prompt customs clearance of goods traded between theParties, each Party shall: (a) endeavor to make use of information and communications technology; (b) simplify its customs procedures; (c) harmonize its customs procedures, as far as possible,with relevant international standards and recommended practices such as those made under the auspices of theCustoms Co-operation Council; and (d) promote cooperation, wherever appropriate, betweenits customs authority and: (i) other national authorities of the Party; (ii) the trading communities of the Party; and (iii) the customs authorities of non- Parties. 3. Each Party shall provide affected parties with easilyaccessible processes of administrative and judicial review ofits administrative actions relating to customs matters.

  • Exchange Stock Market Clearance On the Closing Date, the Company’s shares of Common Stock, including the Firm Shares, shall have been approved for listing on the Exchange, subject only to official notice of issuance. On the first Option Closing Date (if any), the Company’s shares of Common Stock, including the Option Shares, shall have been approved for listing on the Exchange, subject only to official notice of issuance.

  • Security Clearance 6.7.1 Where specified by the Authority or the Contract user, the Supplier shall be responsible for ensuring that all Staff are security cleared to the level required by the Security Requirements not less than 5 Working Days before such person begins to perform the Services. If the Authority is responsible for applying for security clearance for Staff pursuant to this Clause 6.7.1, the Supplier shall provide a completed security clearance application form for such members of Staff to the Authority not less than 30 days before such members of Staff begin to perform the Services. 6.7.2 The Authority shall issue a pass for all Staff who are security cleared to an appropriate level for the Premises in accordance with Clause 6.7.1 on or before the date when such member of Staff is required to enter onto the Premises in Order to perform the Services. Passes shall remain the property of the Authority and shall be surrendered on demand or on termination or expiry of this Contract. 6.7.3 A member of Staff not in possession of a pass who is required by the Supplier or any Sub-contractor to provide the services urgently shall be allowed temporary access to the Premises on condition that the Supplier ensures, or procures that any Sub- contractor shall ensure, that such individual is accompanied at all times while on the Premises by a member of Staff who has been issued with a pass in accordance with Clause 6.7.1. 6.7.4 Without prejudice to the provisions of Clauses 6.7.1 to 6.7.3 inclusive, the Authority may refuse any member of Staff Admission to the Premises or require the removal of any member of Staff from the Premises in accordance with Clause 3.3 if such member of Staff is not in possession of a pass pursuant to Clause 6.7.2 or accompanied in accordance with Clause 6.7.3.

  • Exchange Clearance On the Closing Date, the Firm Shares shall have been approved for listing on the Exchange, subject only to official notice of issuance. On the first Option Closing Date (if any), the Option Shares shall have been approved for listing on the Exchange, subject only to official notice of issuance.

  • Contractor Security Clearance Customers may designate certain duties and/or positions as positions of “special trust” because they involve special trust responsibilities, are located in sensitive locations, or have key capabilities with access to sensitive or confidential information. The designation of a special trust position or duties is at the sole discretion of the Customer. Contractor or Contractor’s employees and Staff who, in the performance of this Contract, will be assigned to work in positions determined by the Customer to be positions of special trust, may be required to submit to background screening and be approved by the Customer to work on this Contract.

  • Security Clearances A. The General Contractor is to supply the Court with names, dates of birth, and social security numbers of all employees who will be on site. This information must be submitted one (1) week prior to access to the site. The Court has final word on who will or who will not be allowed on the project premises.

  • Antitrust Notification If the Holder determines, in its sole judgment upon the advice of counsel, that the issuance of any Warrant Shares pursuant to the terms hereof would be subject to the provisions of the Hxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended (the “HSR Act”), the Company shall file as soon as practicable after the date on which the Company receives notice from the Holder of the applicability of the HSR Act and a request to so file with the United States Federal Trade Commission and the United States Department of Justice the notification and report form required to be filed by it pursuant to the HSR Act in connection with such issuance.

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