Modafinil Paragraph IV ANDA Filing Entity definition

Modafinil Paragraph IV ANDA Filing Entity means any entity, other than Carlsbad or Xxxxxx, that has notified or subsequently notifies Cephalon that it has filed an ANDA with a Paragraph IV certification concerning a product containing modafinil as an API and for which PROVIGIL® is the reference listed drug.
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Modafinil Paragraph IV ANDA Filing Entity means any entity that has notified or subsequently notifies Cephalon that it has filed an ANDA with a Paragraph IV certification concerning a product containing modafinil as an active ingredient for which PROVIGIL® is the reference listed drug. **Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.
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Examples of Modafinil Paragraph IV ANDA Filing Entity in a sentence

  • Inc., Civil Action No. 05-CV-1089 (JCL), pending in the United States District Court for the District of New Jersey; and (c) any action filed under Title 35, United States Code, 35 U.S.C. §§ 271 and 281 against any Modafinil Paragraph IV ANDA Filing Entity.

  • For purposes of clarity, nothing in this Agreement or in the Provigil Settlement Agreement shall obligate Cephalon to seek injunctive or other relief to stop any Other Modafinil Paragraph IV ANDA Filing Entity from offering to sell or selling Subject Modafinil Products in the United States.

Related to Modafinil Paragraph IV ANDA Filing Entity

  • Patent License Agreement means the Patent License Agreement substantially in the form of Exhibit C.

  • Intellectual Property Security Agreement Supplement means, collectively, any intellectual property security agreement supplement entered into in connection with, and pursuant to the terms of, any Intellectual Property Security Agreement.

  • Company Licensed Intellectual Property means Intellectual Property Rights owned by any Person (other than a Group Company) that is licensed to any Group Company.

  • Acquired Intellectual Property has the meaning given in Section 2.1(b).

  • After-Acquired Intellectual Property has the meaning assigned to such term in Section 4.02(d).

  • WTO GPA country end product means an article that—

  • Company License Agreements means any license agreements granting any right to use or practice any rights under any Intellectual Property (except for such agreements for off-the-shelf products that are generally available for less than $25,000), and any written settlements relating to any Intellectual Property, to which the Company is a party or otherwise bound; and the term “Software” means any and all computer programs, including any and all software implementations of algorithms, models and methodologies, whether in source code or object code.

  • Company Licensed IP means all Intellectual Property rights owned or purported to be owned by a third party and licensed to the Company or any Company Subsidiary or to which the Company or any Company Subsidiary otherwise has a right to use.

  • IP License Agreement shall have the meaning set forth in Section 1.2.

  • Intellectual Property License Agreement means the intellectual property license agreement substantially in the form attached as Exhibit B to the Contribution and Distribution Agreement.

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • Trademark License Agreement means that certain Trademark License Agreement in substantially the form attached hereto as Exhibit F.

  • Intercompany License Agreement means any cost sharing agreement, commission or royalty agreement, license or sublicense agreement, distribution agreement, services agreement, intellectual property rights transfer agreement, any related agreements or similar agreements, in each case where all parties to such agreement are one or more of the Company or a Restricted Subsidiary.

  • Technology License Agreement means the agreement in the form of Exhibit H hereto.

  • Free Trade Agreement country end product means an article that—

  • ANDA means Abbreviated New Drug Application.

  • non-IOM country means a country that is not the Isle of Man;

  • Sublicense Agreement means any agreement or arrangement pursuant to which Licensee (or an Affiliate or Sublicensee) grants to any third party any of the license rights granted to the Licensee under the Agreement.

  • Collaboration Technology means all Collaboration Patents and Collaboration Know-How.

  • Additional Xxxx of Sale means each document, in the form of Attachment D hereto, executed by an authorized officer of VL Funding, the VL Funding Eligible Lender Trustee on behalf of VL Funding, Funding and the Interim Eligible Lender Trustee on behalf of Funding which shall: (i) set forth the list and certain terms of (a) Additional Loans offered by VL Funding and the VL Funding Eligible Lender Trustee on behalf of VL Funding and accepted for purchase by the Interim Eligible Lender Trustee for the benefit of Funding, including the Additional Loans Purchase Price for the Additional Loans being sold thereunder or (b) Substituted Loans substituted by VL Funding and (ii) sell, assign and convey to Funding and the Interim Eligible Lender Trustee, for the benefit of Funding, and their assignees, all right, title and interest of VL Funding and of the VL Funding Eligible Lender Trustee on behalf of VL Funding in the Additional Loans or Substituted Loans, as applicable, listed on the related Additional Xxxx of Sale and (iii) certify that the representations and warranties made by VL Funding and the VL Funding Eligible Lender Trustee on behalf of VL Funding pursuant to Sections 5(A) and (B) of these Master Terms, by the Servicer as set forth in Section 5(C) and by the Interim Eligible Lender Trustee as set forth in Section 5(D) are true and correct.

  • Company Intellectual Property Agreements means any Contract governing any Company Intellectual Property to which the Company or any Subsidiary is a party or bound by, except for Contracts for Third-Party Intellectual Property that is generally, commercially available software and (A) is not material to the Company or any Subsidiary, (B) has not been modified or customized for the Company or any Subsidiary and (C) is licensed for an annual fee under $5,000.

  • Excluded Intellectual Property shall have the meaning set forth in Section 1.2(i).

  • Least developed country end product means an article that—

  • Collaboration Know-How means all Know-How conceived, discovered, developed or otherwise made by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing (solely or jointly by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing) in the course of [***].

  • Initial Xxxx of Sale means the document, in the form of Attachment B hereto, executed by an authorized officer of SLM ECFC which shall (i) set forth the applicable Initial Loans offered by SLM ECFC and accepted for purchase by the Interim Eligible Lender Trustee for the benefit of Funding, (ii) sell, assign and convey to the Interim Eligible Lender Trustee for the benefit of Funding and its assignees all rights, title and interest of SLM ECFC in the Initial Loans listed on that Xxxx of Sale and (iii) certify that the representations and warranties made by SLM ECFC as set forth in Sections 5 (A) and (B) of these Master Terms are true and correct.

  • Sub-Licensee means all person/ agency with whom Licensee has executed sub license agreement as per terms and conditions of license agreement executed between DMRC and the Licensee, for commercial utilization of the Bare Spaces.