Regulatory Clearance definition

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.

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

• The Issuer shall not be entitled to amend or otherwise vary the terms of the Notes or substitute the Notes unless it has notified the PRA in writing of its intention to do so not less than one month (or such other period as may be required by the PRA or the Relevant Rules at the relevant time) prior to the date on which such amendment, variation or substitution is to become effective and the Regulatory Clearance Condition has been satisfied in respect of such proposed amendment, variation or substitution.

• No modification to these Conditions or any other provisions of the Trust Deed shall become effective unless the Issuer shall have first satisfied the Regulatory Clearance Condition.

• Wherever in these Conditions and/or the Trust Deed there is a requirement for the Regulatory Clearance Condition to be satisfied, the Trustee shall be entitled to assume without enquiry that such condition has been satisfied unless notified in writing to the contrary by the Issuer.

• Except as provided herein, any modification to, or waiver in respect of, these Conditions or any provisions of the Trust Deed will be subject to satisfaction of the Regulatory Clearance Condition.

• In addition, prior to the publication of any notice of redemption before the Maturity Date or any substitution, variation or purchase of the Notes, the Issuer or, as the case may be, the Guarantor will be required to have complied with the Regulatory Clearance Condition and be in continued compliance with Regulatory Capital Requirements.

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 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

Regulatory Clearance means, with respect to a particular Breast Implant Product listed on Exhibit A-1 ( i.e. , for all shapes, sizes and SKUs on such Exhibit A-1 ), that such Product has been determined to be a Class III medical device and has received pre-market approval from the FDA and all other applicable Government Regulatory Authorities in the United States, where such approvals are necessary to market such Product in the United States.