PR Product Registration definition

PR Product Registration means the approvals or registrations for the PR Product which have been received by Santarus from Governmental Authorities for the Territory, as the same may be amended or modified from time to time, including any applicable drug master file and NDA for the PR Product.
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Examples of PR Product Registration in a sentence

  • GSK will, on a timely basis and in response to requests made by Santarus from time to time, provide to Santarus all information that GSK has from time to time during the Term for the PR Product that is reasonably necessary and relevant to Santarus’ obligations hereunder to fulfill such PR Product Registration maintenance requirements (including providing sales distribution information concerning the PR Product and all information reasonably required for inclusion in Santarus’ Annual Reports).

  • Tenant shall conduct its business and the use of the demised premises in accordance with any and all applicable laws, regulations, and ordinances.

  • Santarus will manufacture PR Product in the Initial Supply, or cause PR Product in the Initial Supply to be manufactured, in accordance with Good Manufacturing Practices, Applicable Law, the Specifications, the Quality Agreement and the applicable PR Product Registration, as each may be amended from time to time.

  • GSK shall permit, and shall ensure that each Authorized Manufacturer permits, Santarus to review and inspect upon reasonable notice, to the extent relevant to the manufacture and distribution of PR Products, the premises, facilities, inventories of PR Products and materials used in the manufacture thereof, records and documentation maintained by such Authorized Manufacturer for the purpose of determining compliance with the PR Product Registration and Applicable Law.

  • Santarus will keep GSK informed on a timely basis as to any developments that would reasonably be anticipated to have a material adverse effect on a PR Product Registration.

  • Upon the effective date of termination of this Agreement for any reason, all licenses and rights granted to GSK by Santarus under this Agreement, including under the Intellectual Property and Trademarks, and GSK’s right to promote, distribute and sell Products under the PR Product Registration, will terminate, and all rights therein will revert to Santarus.

  • GSK will not at any time do, and neither will GSK permit its agents or representatives to do, any act in violation of the PR Product Registration.

  • GSK will ensure that all Promotional Activities comply with, and GSK will be solely responsible and liable for any failure of the Promotional Activities to comply with, the applicable labeling and PR Product Registration for the PR Product and Applicable Law.

  • Santarus will have sole responsibility for maintaining and will use Commercially Reasonable Efforts to maintain the PR Product Registration with respect to the Territory at its expense, including filing annual reports in connection with the PR Product NDA (“Annual Reports”), with copies to GSK, and paying all user fees, product fees and establishment fees associated with the PR Product Registrations with respect to the Territory.