Regulatory Applications definition

Regulatory Applications means any and all applications that are necessary and appropriate to obtain a Regulatory Approval, including, without limitation, all required documents, data and information concerning, filed or required to be filed or, otherwise submitted by Lilly or any of its Affiliates or licensees to a Regulatory Authority.

Regulatory Applications shall have the meaning specified in Section 2.4.

Regulatory Applications means copies of any and all applications filed with any Governmental Entity by or on behalf of the Sellers or their Affiliates with respect to any of the Products for approval to develop, test, manufacture, process, distribute, import, market, store, label, package, promote, sell, or offer to sell the Products, and all supplements, amendments and revisions thereto, whether approved or pending.

Examples of Regulatory Applications in a sentence

• If the Company suspends the issuance of Option Shares pursuant to the exercise of options issued under the Option Award Notice, the Company shall give prompt written notice thereof to the Optionee (but the failure of the Company to give such notice shall not prevent the Company from suspending the issuance of Option Shares as permitted hereby) and, at such time as such period of suspension ends, shall give prompt written notice thereof to Optionee.

• The information supplied, or to be supplied, by Purchaser for inclusion in the Regulatory Applications will, at the time such documents are filed with any Governmental Entity and up to and including the date of the attainment of any required regulatory approvals, be accurate in all material respects.

• VOC exempt listhttp://www.cdpr.ca.gov/docs/emon/vocs/vocproj/2voc_exempt_list.pdf Criteria for VOC-exempt solventshttp://www.epa.gov/sites/production/files/2014-02/documents/dfe_criteria_voc_exempt_solvents.pdf Updated Maximum Incremental Reactivity Scale and Hydrocarbon Bin Reactivities for Regulatory Applications.

• In order to expedite the receipt of Regulatory Approvals for the Licensed Products throughout the Territory, and to ensure that all pertinent information regarding the safety and efficacy of the Licensed Products are timely communicated between the Operating Parties, each Operating Party shall, at least sixty (60) days in advance of such filings or submissions, inform the other Operating Parties of its intent to file Regulatory Applications to market and sell Licensed Products.

• Legal and Regulatory Applications: Acting in accordance with relevant laws, rules, and policies; recognizing governmental influences on education; working within local rules, procedures, and directives; administering contracts.

More Definitions of Regulatory Applications

Regulatory Applications means any and all applications for approval to develop, test (including conducting clinical trials), manufacture, process, distribute, import, market, store, label, package, promote, sell, or offer to sell the Product in any jurisdiction in the Territory, and all supplements, amendments and revisions thereto, whether approved or not.

Regulatory Applications means all applications for Regulatory Approval submitted to or filed with a Regulatory Authority with respect to a Product,

Regulatory Applications means copies of any and all applications (including pending NDAs) filed with any Governmental Entity by or on behalf of Seller or its Affiliates with respect to any of the Products for approval to develop, test, manufacture, process, distribute, import, market, store, label, package, promote, sell, or offer to sell the Products, and all supplements, amendments and revisions thereto, whether approved or pending.

Regulatory Applications shall have the meaning ascribed to it in Section 5.6.

Regulatory Applications means any and all applications submitted or caused to be submitted by the Companies for approval to develop, test (including conducting clinical trials), manufacture, process, distribute, import, market, store, label, package, relabel, repackage, promote, sell, or offer to sell the Products, and all supplements, amendments and revisions thereto, whether approved or not.

Regulatory Applications shall have the meaning set forth in Section 6.03 hereof.

Regulatory Applications means all investigational device applications, 510(k) pre-market notifications, pre-market approval applications, supplemental pre-market approval applications, Notified Body dossiers, master files, and any other permits, approvals, registrations, licenses, grants, authorizations, exemptions, orders, certifications, conformity assessments, declarations or consents relevant to any Regulated Product or required under the FDCA and any other applicable Law (including all XX xxxxx and any applications or assessments to obtain marking authorization outside of the United States), whether pending or approved or cleared by a relevant Governmental Body, including all supplements or amendments thereto and all information submitted with or incorporated by reference therein.