Investigational Authorization definition

Investigational Authorization means, with respect to a Country, the ----------------------------- regulatory authorization required to investigate a Collaboration Product in such Country as granted by the relevant Governmental Authority.
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Examples of Investigational Authorization in a sentence

  • Upon receipt of the initial Investigational Authorization and Marketing Authorization for the GI Products in the United States, GSK shall have exclusive authority and responsibility to and will use Commercially Reasonable Efforts to maintain and seek appropriate revisions of the conditions of each such Investigational Authorization and Marketing Authorization for the GI Products, provided any such revisions are not inconsistent with the provisions of this Agreement or the U.S. Marketing Plan.

  • Subject to the provisions of the Pharmacovigilance ------ Agreement, GSK shall not, without the consent of Adolor, correspond or communicate with any Governmental Authority in the United States concerning the Adolor Products, or otherwise take any action with any Governmental Authority in the United States concerning any Investigational Authorization or Marketing Authorization or permission under which the Adolor Products are sold or any application for the same, except as may be required by Law.

  • Upon receipt of the initial Investigational Authorizations and Marketing Authorization for the Adolor Products in the United States, Adolor shall have exclusive authority and responsibility to and will use Commercially Reasonable Efforts to maintain and seek appropriate revisions of the conditions of each such Investigational Authorization and Marketing Authorization for the Adolor Products, provided any such revisions are not inconsistent with the provisions of this Agreement or the U.S. Marketing Plan.

  • Adolor shall permit GSK access to and grant GSK the right to reference and use, in association with the Collaboration Products, all data, regulatory filings and regulatory communications associated with any submissions for Investigational Authorization or Marketing Authorization or other issues associated with any Collaboration Product or, subject to any Third Party Rights, Combination Products, that is or would be relevant to GSK's Development or Commercialization of a Collaboration Product.