Theravance Assistance. To the extent reasonably required by Clinigen for the exercise of their rights hereunder, Theravance shall provide free of charge to Clinigen the existing US, Canadian and European Union regulatory dossier and, within reason, other related documents such as variations, amendments and supporting information for the Licensed Product (in CTD format), as well as stability data according to ICH guidelines. Upon Clinigen’s request, and at Theravance’s sole discretion and cost, Theravance will endeavor to provide Clinigen such other reasonable assistance as may be reasonably required by Clinigen to achieve its Marketing Authorization Approval objectives and Diligent Efforts obligations related to the Licensed Product, which such assistance may be provided directly or through Theravance’s vendors or contractors.
Appears in 4 contracts
Samples: Commercialization Agreement, Commercialization Agreement (Theravance Biopharma, Inc.), Commercialization Agreement (Theravance Biopharma, Inc.)
