Regulatory Information definition

Regulatory Information means information, whether or not presented as a document, related to transport of cargo in the territory of the Union, including by way of transit, which is to be made available by an economic operator concerned in accordance with the provisions referred to in Article 1(2) in order to prove compliance with the relevant requirements of the acts concerned;

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Regulatory Information means (a) all correspondence and submissions between Seller or any of the Divesting Entities and any United States Governmental Authority, including the FDA and the DEA, with respect to the Transferred Governmental Authorizations, including any reports, filings, or notices submitted to any Governmental Authority to support, maintain or obtain such Transferred Governmental Authorizations; and (b) records and data from all clinical and pre-clinical studies and trials conducted or being conducted by or on behalf of Seller or any of the Divesting Entities, which concern the Products and are (i) described in the Governmental Authorizations, (ii) the subject of a post-marketing requirement as imposed by the FDA or the subject of a post-marketing commitment to the FDA, or (iii) listed on Section 1.01(e) of the Disclosure Schedules; in each case of (a) and (b) to the extent not already in the possession or control of Purchaser. For the avoidance of doubt, Regulatory Information shall include a complete copy of the Product NDAs.

Regulatory Information means know-how, trade secrets, procedures, information, technology, experimental data, pre-clinical, non-clinical and clinical data, clinical safety, post-market safety, efficacy or comparative data, including without limitation raw or patient data, and any and all material information or reports relating to the development, registration, manufacture and commercialization of a Product that is reasonably necessary or required for Regulatory Approval of a Product. For illustration, Regulatory Information includes, but is not limited to draft and final copies of all NDAs and INDs that are to be submitted or have been submitted by JT and Gilead or their respective Affiliates to the regulatory authorities, including, without limitation, the FDA or EMA, and that are included in other NDAs and INDs for a Product filed by either Party or its Affiliates, together with all material subsequent correspondence and data submissions relating to the foregoing, and all improvements or inventions made or obtained by either Party or its Affiliates, which are reasonably necessary or required to the formulation of a Product or the manufacture, development and registration of a Product.

Examples of Regulatory Information in a sentence

• Immediately following the Asset Transfer Closing, all Transferred IP and Regulatory Information will be available for use by the Company on the same terms as they were available for use by Hemispherian immediately prior to the Asset Transfer Closing.

• Regulatory Information and Business Information as defined and specified in this Agreement constitute all and the complete regulatory and business information that is material to the Transferred IP at Asset Transfer Closing.

• Neither the execution, delivery, or performance of this Agreement, nor the consummation of the transactions contemplated hereunder, will result in the loss or impairment of or payment of any additional amounts with respect to, or require the consent of any other Person in respect of, the Company’s right to own or use any Transferred IP and Regulatory Information in its conduct of business.

• Upon transfer of the Transferred IP and Regulatory Information pursuant to this Agreement, the Company will own all right, title and interest to such Transferred IP and Regulatory Information on the same terms as they were owned by Hemispherian immediately prior to the transfer of such Transferred IP and Regulatory Information.

• There are no Actions by Hemispherian or, to Hemispherian’s best knowledge, by any other Person alleging any infringement, misappropriation, or other violation by any Person of any Transferred IP or Regulatory Information.

More Definitions of Regulatory Information

Regulatory Information means information held by NHS England in connection with—

Regulatory Information. We have the following authorisations and registrations: 1.2.1 authorised by the Financial Conduct Authority as an Authorised Payment Institution under the Payment Services Regulations with FCA registration number 507958; 1.2.2 a registered money services business with HM Revenue and Customs No. 12206957.

Regulatory Information has the meaning specified in Section 2.14(a).

Regulatory Information means information, whether or not presented in the form of a document, that is related to the transport of goods in the territory of the Union, including of goods in transit, which is to be made available by an economic operator

Regulatory Information means copies of the Product Registrations, together with copies of related correspondence between any Seller Group Company or Group Company and the applicable Governmental Authority, current approved packaging and any other existing files and dossiers, in each case relating to the Product Registrations and/or to the underlying data or information used to support, maintain or obtain marketing authorization of the underlying Product;

Regulatory Information has the meaning specified in Section 4.01(e).

Regulatory Information means pre-clinical, clinical, manufacturing and testing data, protocols, and chemical, pharmacological, toxicological, pharmaceutical, physical, analytical, safety, efficacy, bioequivalency, quality assurance, quality control and other information and data relating to any investigations, trials and/or the preparation, submission and prosecution of one or more applications filed in connection with obtaining regulatory approval for any product, including but not limited to, with respect to GLAUKOS, information relating to preliminary investigations and the preparation, submission and prosecution of one or more applications filed in connection with obtaining regulatory approval for the iStent® (a/k/a G1 device), iStent Inject™ (a/k/a G2 device), and iStent Supra™ (a/k/a G3 device) including but not limited to FDA application materials, safety and efficacy data, clinical trial protocols and reports, statistical analyses, communications with the FDA, etc.