Regulatory Clearance definition

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Regulatory Clearance means, with respect to any Person, requirements pursuant to Insurance Laws or the HSR Act to make a filing, await expiration or termination of a regulatory clearance waiting period, or obtain a clearance, approval or waiver, under Insurance Laws or the HSR Act, before such Person may lawfully acquire shares of Parent Common Stock or other securities of Parent that are entitled to vote in the election of directors of Parent generally.

Regulatory Clearance means, with respect to any Person, requirements pursuant to Insurance Laws or Competition Laws to make a filing, await expiration or termination of a regulatory clearance waiting period, or obtain a clearance, approval or waiver, under Insurance Laws or Competition Laws, before such Person may lawfully acquire shares of Common Stock or other securities of the Corporation that are entitled to vote in the election of directors of the Corporation generally.

Examples of Regulatory Clearance in a sentence

Any such substitution shall be subject to the Issuer having complied with the Regulatory Clearance Condition.
ASSIGNOR is the holder of certain diagnostic tests, and test systems that have received U.S. Food and Drug Administration (the “FDA”) Regulatory Clearance and include a Desktop Immunoassay Multi-light Spectrum Analyzer and Target System Diagnostic Test Cartridge Platform.
Prior to the anticipated date of Regulatory Clearance and/or Approval of the first of CCT’s extracellular matrix derived from the human placenta (“ECM”) products, the Parties shall enter into a supply agreement with respect to such ECM product that is on substantially the same terms as this Agreement, except that the purchase price shall be as set forth in Schedule 2.5 to this Agreement.
In addition, Alliqua shall submit an initial Commercialization Plan for ECMs to the JSC no later than ninety (90) days prior to anticipated 510(k) or other Regulatory Clearance and/or Approval in each relevant jurisdiction within the Territory.
Subject to the terms of this Agreement and the License Agreement, all matters in the Territory regarding obtaining and supporting Regulatory Clearance and/or Approval of the Manufactured Products, and manufacturing and testing of the Manufactured Products in compliance with the applicable Specifications for the Manufactured Product and applicable Law (including cGTPs), shall be the responsibility of, and shall remain under the control of CCT.

More Definitions of Regulatory Clearance

Regulatory Clearance means, with respect to any phase of the Clinical Trials Program, the issuance by a Territorial Regulator of authorization to commence or proceed to the next phase of the Clinical Trials Program or, if no such authorization is legally required, the passage of any required or customary waiting period following submission of the results of such phase and any other required data without imposition by a Territorial Regulator of a clinical hold or other similar action suspending or terminating the Clinical Trials Program in the jurisdiction in question.

Regulatory Clearance means all clearances or registrations necessary, if any, for the commercial sale of a Licensed Product in the Field in the Territory, which shall include satisfaction of all applicable regulatory and notification requirements, but which shall exclude any pricing and reimbursement approvals.

Regulatory Clearance means, with respect to any country or jurisdiction, all acts of the applicable Regulatory Authority that are necessary under Applicable Laws for the manufacture, marketing, distribution and sale of the Product in that country or jurisdiction, and satisfaction of all applicable regulatory and notification requirements, including NDA# 209128, received from the FDA in respect of the Product.

Regulatory Clearance means (a) (i) in the case of a product, a clearance by the FDA and (ii) in the case of product clearance by the FDA for the sale or other disposition of the patent target system for its specific and intended use; or (b) in the event of any change in the regulatory process, a clearance similar to the foregoing for the sale and distribution of said product. "Third Party Claim" means, in respect of the obligations of an Indemnifying Party hereunder, a claim asserted against, imposed upon or incurred by the Indemnified Party by any third party.

Regulatory Clearance means the 510(k) clearance for the Device, and any other clearance or approval that is necessary to allow the Device to be marketed and sold in the Territory.

Regulatory Clearance means, with respect to any country or jurisdiction, all acts of the applicable Regulatory Authority that are necessary under applicable Regulatory Laws for the manufacture, marketing, distribution and sale of the Product in that country or jurisdiction, and satisfaction of all applicable regulatory and notification requirements and, to the extent applicable, the grant of Pricing Approval.

Regulatory Clearance means obtaining the approval of the relevant product for the general sale and/or distribution to professional users in the relevant territory by the relevant authority (i.e. [**Redacted**]) within in the Target Period. The relevant Targets (of Category 1) are set out in the following Target Table 1: Target Territory Cash Payment Timeline (as from Completion) Regulatory clearance of following developed test in the required territory Up to $28M (cap) [**Redacted**] [**Redacted**] $6M 36 Months [**Redacted**] [**Redacted**] $8M 36 Months [**Redacted**] [**Redacted**] $1M 36 Months [**Redacted**] [**Redacted**] $3M 36 Months [**Redacted**] [**Redacted**] $3M 36 Months [**Redacted**] [**Redacted**] $2M 36 Months [**Redacted**] [**Redacted**] $3M 36 Months [**Redacted**] [**Redacted**] $1M 36 Months [**Redacted**] [**Redacted**] $1M 36 Months

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