Regulatory Authorisations definition
Regulatory Authorisations means all authorisations, approvals, clearances, and licences of a Competent Authority (including an NDA) that may be required in any country of the Territory prior to commercial sale of the relevant Licensed Product in the Field, including any necessary variations thereto, but excluding any Price Approvals.
Regulatory Authorisations means all marketing authorisations, approvals, clearances and authorisations that may be required by a Regulatory Authority in any country or region within the Territory prior to Phase II Clinical Trial Commencement and/or Phase III Clinical Trial Commencement and/or commercial sale of the Licensed Product, including any necessary variations thereto, but excluding always any Price Approvals.
Regulatory Authorisations means those authorisations, licences, permits and consents issued by a Regulatory Authority that must be obtained by any Party in order for it to be able to perform its obligations under this Agreement.
Examples of Regulatory Authorisations in a sentence
The Charity will be the sole sponsor of clinical aspects of the Clinical Trial, and it will be the Charity’s responsibility to apply for Regulatory Authorisations relating to performance of the Clinical Trial.
The Licensee shall, at its own cost, obtain and maintain all Regulatory Authorisations necessary to Exploit the Licensed Rights and Licensed Products, and perform its obligations, in accordance with this Agreement.
More Definitions of Regulatory Authorisations
Regulatory Authorisations means all marketing authorisations, approvals, clearances and authorisations that may be
Regulatory Authorisations means all authorisations, approvals and clearances that may be required by a Regulatory Authority in any country or region in the Territory before (as the context may require) Phase II Clinical Trial Commencement or Phase III Clinical Trial Commencement or commercial sale of the Agent Product or the Collaboration Product. Price Approvals are not Regulatory Authorisations;
Regulatory Authorisations has the meaning given in Warranty 13.2;
Regulatory Authorisations means any and all Marketing Authorisations, licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any Health Care Laws;
Regulatory Authorisations means any authorisations required pursuant to the Regulatory Requirements;