Technical Document definition
Examples of Technical Document in a sentence
Upon Jazz’s request, Pfenex shall provide reasonable support with respect to CMC (including writing applicable M3 modules of the International Conference on Harmonisation Common Technical Document specifically related to the production strains with respect to the applicable Product), pharmacovigilance, and other matters for the HemOnc Products in connection with Jazz’s regulatory activities.
Licensee agrees to promptly notify Orion of any Recro Clinical Data and/or Recro Know-How generated and Recro Grant-Back Patents issued, and shall, or shall cause one or more of its Affiliates to, make available to Orion the Recro Clinical Data and/or Recro Know-How and upon Orion’s request, provide a copy of the Common Technical Document, updates thereto and other unique studies and data that supplement the Common Technical Document.
Licensee agrees to utilize the Common Technical Document format for its marketing applications in order to facilitate any subsequent submissions filed by NovaDel or its Extraterritorial Licensee’s outside of the Territory.
During the Term, Catalent will assist Client with all regulatory matters relating to Processing and review the Common Technical Document pertaining to the Product and make such corrections as are necessary to accurately reflect the Product, in each case at Client’s request and reasonable expense; provided, however, Catalent shall review and correct such documents as they relate to Catalent activities at no charge to Client.
The chart uses figures taken from the Lorain MZ10F50 Technical Document and assumes a 730 hour month.
This application is written in a standardized format: The Common Technical Document (CTD) format.
Astellas shall be responsible for assembling the various sections of the Common Technical Document.
In the Collaboration Territory, the Regulatory Lead shall be responsible for preparing and submitting the Common Technical Document (CTD) to the Regulatory Authority as agreed in the filing plan.
Ipsen will use reasonable commercial efforts to submit the non-EU Marketing Authorization Applications at its cost as promptly as reasonable after receiving such Common Technical Document and other documents from Auxilium, provided, however, that Auxilium acknowledges that Product potential may vary from country to country or change from time to time based upon availability of competing product as well as scientific, business, marketing and return on investment considerations.
City of Vancouver will consider an update to the Park Impact Fee Technical Document to establish the Park Service Area Overlays, as shown in Figure 1.