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.

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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 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

• 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.

• 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.

• 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.

• ETHYPHARM shall, at its own cost, cooperate with and assist RELIANT in the preparation, filing and prosecution of the Regulatory Applications, and shall prepare and deliver such other documents, and take such other actions, as may be necessary or appropriate to apply for, prosecute or obtain any Applicable Permits.

More Definitions of Regulatory Applications

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

Regulatory Applications shall have the meaning specified in Section 2.4.

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 ▇▇ ▇▇▇▇▇ 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.

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 applications seeking consent or approval of, or filings, notices, declarations or registrations with, any Government Entity required under or by the Communications Laws, LFAs, or State Regulatory Authorities necessary for the consummation of the transactions contemplated hereby, including in connection with the assignment or transfer of control of Cabot Governmental Authorizations but excluding filings with Government Antitrust Entities under the Antitrust Laws.