Post-Registration Studies definition

Post-Registration Studies means Clinical Studies which are conducted in a particular country after the attainment of Regulatory Approval from the appropriate Regulatory Agency in that country, which studies are conducted for a variety of purposes including, but not limited to, post-marketing surveillance and/or other studies intended to confirm or enhance the commercial profile of the particular Licensed Product.
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Post-Registration Studies means clinical studies which are conducted in a particular country after the obtainment of REGULATORY APPROVAL from the appropriate regulatory agency in that country, which studies are conducted for the purpose of enhancing commercial acceptability of a PRODUCT.
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Post-Registration Studies means such studies as may be required to be conducted by any Regulatory Authority to maintain the Registration and any other studies as may be desired by Kos in respect of the Product.
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Examples of Post-Registration Studies in a sentence

  • Alpharma shall bear the Costs of all Alpharma Post-Registration Studies.

  • For the avoidance of doubt, Alpharma Post-Registration Studies shall include any Clinical Trials required as a condition to, or for the maintenance of, Regulatory Approval of the Product in Subterritory A and the Major Market Jurisdictions.

  • Alpharma shall also promptly provide to Durect a copy of final protocols and reports from such Alpharma Post-Registration Studies.

  • MINERALYS may, in its sole discretion, conduct Post-Registration Studies of Product at its own expense in the MINERALYS Territory.

  • For the avoidance of doubt, Braeburn Post-Registration Studies shall include any Clinical Trials required as a condition to, or for the maintenance of, Regulatory Approval of the Product in the Licensed Territory.

  • Braeburn shall bear the cost of all Braeburn Post-Registration Studies.

  • All clinical Data generated during the course of such Post-Registration Studies of any Product under Section 6.4 shall be owned by MINERALYS and shall be included in MINERALYS Know-How.

  • Durect shall consider in good faith all comments provided by Endo in writing within the [***] day period following Endo’s receipt of such protocols; provided, that Durect shall have the sole discretion and authority to make all decisions with respect to the final protocols and all other matters relating to Durect Post-Registration Studies.

  • For the avoidance of doubt, Post-Registration Studies shall include any Phase IV or other clinical studies required as a condition to, or for the maintenance of, Regulatory Approval of the Product in the Territory.

  • For the avoidance of doubt, Durect Post-Registration Studies shall include any Clinical Trials required as a condition to, or for the maintenance of, Regulatory Approval of the Product in the Durect Territory.