Examples of Regulatory Applications in a sentence
Aspen will cooperate with Gilead to enable Gilead to cross reference Aspen’s Regulatory Approvals and Regulatory Applications in any Regulatory Application submitted or filed by Gilead with respect to the Products.
Aspen will promptly notify Gilead of and provide copies of (or summaries of oral communications) (including validated English translations if applicable) of any communications from Regulatory Authorities relating to Products or Regulatory Applications or Regulatory Approvals.
For those jurisdictions in the Distribution Territory in which the applicable laws prohibit the Gilead name and trademark to be included in the labeling and packaging of the Products without holding the Regulatory Approval, Gilead authorizes Aspen to file in Gilead’s name any Regulatory Applications using regulatory dossiers and information provided or approved in advance in writing by Gilead, to accept and receive correspondence and communications regarding these applications.
Gilead authorizes Aspen to file in Aspen’s name any Regulatory Applications required in the Distribution Territory, using regulatory dossiers and information provided or approved in advance in writing by Gilead, and to accept and receive correspondence and communications regarding such Regulatory Applications; provided that such applications be limited to Regulatory Approvals in jurisdictions which permit the Gilead Marks to be included in the labeling and packaging of the Products.
Aspen will obtain Gilead’s approval prior to filing any Regulatory Applications or making material communications with or commitments to Regulatory Authorities with respect to Regulatory Applications or Regulatory Approvals.