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 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.

Examples of Regulatory Applications in a sentence

• Aspen will cooperate with Gilead to enable Gilead to cross reference Aspen’s Regulatory Approvals and Regulatory Applications in any Regulatory Application submitted or filed by Gilead with respect to the Products.

• Aspen will promptly notify Gilead of and provide copies of (or summaries of oral communications) (including validated English translations if applicable) of any communications from Regulatory Authorities relating to Products or Regulatory Applications or Regulatory Approvals.

• For those jurisdictions in the Distribution Territory in which the applicable laws prohibit the Gilead name and trademark to be included in the labeling and packaging of the Products without holding the Regulatory Approval, Gilead authorizes Aspen to file in Gilead’s name any Regulatory Applications using regulatory dossiers and information provided or approved in advance in writing by Gilead, to accept and receive correspondence and communications regarding these applications.

• Gilead authorizes Aspen to file in Aspen’s name any Regulatory Applications required in the Distribution Territory, using regulatory dossiers and information provided or approved in advance in writing by Gilead, and to accept and receive correspondence and communications regarding such Regulatory Applications; provided that such applications be limited to Regulatory Approvals in jurisdictions which permit the Gilead Marks to be included in the labeling and packaging of the Products.

• Aspen will obtain Gilead’s approval prior to filing any Regulatory Applications or making material communications with or commitments to Regulatory Authorities with respect to Regulatory Applications or Regulatory Approvals.

More Definitions of Regulatory Applications

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 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 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 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 shall have the meaning ascribed to it in Section 5.6.

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 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