Regulatory Applications definition

Regulatory Applications means any and all applications that are necessary and appropriate to obtain a Regulatory Approval with respect to a Licensed Product or Lilly Product, including, without limitation, all required documents, data and information concerning a Licensed Product or Lilly Product, filed or required to be filed with or, otherwise submitted to, a Regulatory Authority.

Regulatory Applications means any and all applications and submissions by the Company for Product Approvals, and all supplements, amendments and revisions thereto, whether approved or not.

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.

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.

• The Company shall be responsible for filing all Regulatory Applications (whether prepared by the Company or ERS) and, thereafter, to conduct all communications with the Regulatory Authorities during the registration process (provided that, if ERS is the responsible Party for the preparation of such Regulatory Application, it will work with the Company with respect to all such regulatory activities).

• The other such Party shall provide all technical data and support necessary to assist the responsible Party to prepare such Regulatory Applications.

• 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.

More Definitions of Regulatory Applications

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.

Regulatory Applications means the applications submitted by P&GP or its Related Parties to Regulatory Authorities seeking authorization or approval for the development, manufacture, testing, storage, transport, marketing, advertisement, promotion, sale, use, distribution or other disposal of the Products in all or any portion of the Territory, including the INDs and the NDAs for the Products.

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 is defined in Section 5.1. "Regulatory Approval" means the approvals of the FRB, FDIC, PDB and OTS described in Sections 2.5 and 3.5. "SEC" shall mean the United States Securities and Exchange Commission. "Securities Act" shall mean the Securities Act of 1933, as amended. "Special Meeting" is defined in Section 5.3. "Stock Election Shares" shall have meaning given to such term in Section 1.10(b). "Subsequent Determination" is defined in Section 5.4(c). "Superior Proposal" means an unsolicited bona fide Acquisition Proposal that the Board of Directors of Company determines in good faith, after consultation with its financial advisors, to be reasonably likely to result in a transaction that is more favorable to the Company Stockholders from a financial point of view than the transactions contemplated by this Agreement taking into account, among other factors, the payments that would be due under Section 7.3(a) and any delay and uncertainty in receipt of the consideration in the transaction. "Surviving Corporation" is defined in the Recitals. "Termination Fee" is defined in Section 7.3(a). A-6

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.