Product Regulatory Materials definition

Product Regulatory Materials means all written notices, submissions, reports, documentation, medical letters, the Product safety database, and correspondence between Sellers, on the one hand, and Governmental Entities in the United States, including the FDA, on the other hand, in each case only to the extent the material and (i) is necessary for the development, manufacture, distribution, marketing or sale of the Product in the United States as such activities are conducted by Sellers as of immediately prior to the Closing, (ii) relates solely to the MA or the Product, and (iii) is maintained by or otherwise in the possession of Sellers as of the Closing Date or which are received by Sellers subsequent to the Closing Date.

Product Regulatory Materials means (a) all adverse event reports and other data, information and materials relating to adverse experiences with respect to each Product; (b) all written notices, filings, communications or other correspondence between any Seller, on the one hand, and any Governmental Authority, on the other hand, relating to each Product, including any safety reports or updates, complaint files and product quality reviews, and clinical or pre-clinical data derived from clinical studies conducted or sponsored by a Seller, which data relates to each Product; and (c) all other information regarding activities pertaining to each Product's compliance with any law or regulation of any jurisdiction, including audit reports, corrective and preventive action documentation and reports, and relevant data and correspondence, maintained by or otherwise in the possession of any Seller as of the Closing Date.

Product Regulatory Materials means all written notices, submissions, reports, documentation, medical letters, the Product safety database, and correspondence between KKUS, on the one hand, and Governmental Authorities in the Territory, including the FDA, on the other hand, in each case only to the extent the material (i) is necessary for the development, manufacture, distribution, marketing or sale of the Product in the Territory as such activities are conducted by KKUS as of sixty (60) days prior to the Effective Date, (ii) relates solely to the NDA or the Product, and (iii) is maintained by or otherwise in the possession of KKUS as of the Closing Date or which are received by KKUS subsequent to the Closing Date.

Examples of Product Regulatory Materials in a sentence

• KKUS shall be entitled to retain copies of the NDA, the IND, Product Records, Product Regulatory Materials and Marketing and Promotional Material in order to comply with its legal obligations.

• For the avoidance of doubt, the Assets shall not include the NDA until the NDA Transfer Date, as set forth in Section 2.2 below, the Excluded Assets as defined in Section 2.8, and copies of Product Records, Product Regulatory Materials and Marketing and Promotional Material retained by KKUS to comply with its legal obligations.

• Seller has made available to Purchaser true and complete copies of all material correspondence with any Governmental Entity in Seller’s possession or control with respect to the Transferred Product Regulatory Materials.

• As soon as practical after the Closing Date and in no event more than sixty (60) days following the Closing Date, Seller shall deliver to Buyer or to an Affiliate of Buyer as directed by Buyer, in physical and electronic form, the Product Regulatory Materials and Books and Records.

• On September 14, 2022, CW-2 sent the dispatcher a text message containing a photo of a dollar bill, which would serve as the pick-up token (as described in the October 7, 2022 Complaint), and the location for the meet.

More Definitions of Product Regulatory Materials

Product Regulatory Materials means all Regulatory Materials developed by DRL or any of its Affiliates, solely, or jointly with Journey, in the execution of the Development Plan, and any Regulatory Materials developed by DRL and submitted to FDA in connection with Regulatory Authority approval for Products (which, for the avoidance of doubt, includes the 20 mg and 40 mg products described in the IND), including all Regulatory Materials that reference the IND and that were developed prior to the Transfer Date.

Product Regulatory Materials means (a) all adverse event reports and other data, information and materials relating to adverse experiences with respect to each Product in the Territory; (b) all written notices, filings, communications or other correspondence between Seller, on the one hand, and any Governmental Entity, on the other hand, relating to each Product in the Territory, including any safety reports or updates, complaint files and product quality reviews, and clinical or pre-clinical data derived from clinical studies conducted or sponsored by Seller, which data relates to each Product in the Territory; and (c) all other information regarding activities pertaining to each Product’s compliance with any law or regulation of any jurisdiction in the Territory, including audit reports, corrective and preventive action documentation and reports, and relevant data and correspondence, maintained by or otherwise in the possession of Seller as of the Closing Date.

Product Regulatory Materials means (a) all adverse event reports and other data, information and materials relating to adverse experiences with respect to the Product in the Territory; and (b) all written notices, communications or other correspondence between Seller, on the one hand, and any Governmental Entity, on the other hand, relating to the Product in the Territory, including any safety reports or updates, complaint files and product quality reviews, all clinical or pre-clinical data derived from clinical studies conducted or sponsored by Seller, which data relates to the Product in the Territory and is maintained by or otherwise in the possession of Seller as of the Closing Date.