Paragraph IV Notice Letter definition

Examples of Paragraph IV Notice Letter in a sentence

• We understand the cases arise from a May 16, 2013 Paragraph IV Notice Letter providing notice of the filing of an ANDA with the FDA seeking regulatory approval to market a generic version of VIMOVO before the expiration of the patents-in-suit.
• We understand the cases arise from a March 29, 2013 Paragraph IV Notice Letter providing notice of the filing of an ANDA with the FDA seeking regulatory approval to market a generic version of VIMOVO before the expiration of the patents-in-suit.
• OTHER FIRST QUARTER DEVELOPMENTS Paragraph IV Notice Letter for ADDERALL XR· In February 2011, Shire was notified by Watson Laboratories, Inc.
• Shire is currently reviewing the details of Teva’s Paragraph IV Notice Letter which was only directed to the ‘599 and ‘794 patents.
• Shire Receives INTUNIV™ Paragraph IV Notice Letter from Teva Pharmaceuticals Dublin, Ireland – 16 March 2010 – Shire plc (LSE: SHP, NASDAQ; SHPGY), announces that it has received a Paragraph IV Notice Letter from Teva Pharmaceuticals USA, Inc.

Related to Paragraph IV Notice Letter

• 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.
• Third Party Agreement has the meaning set forth in Section 6(a) hereof.
• License Agreement means the agreement between SAP (or an SAP SE Affiliate, or an authorized reseller) under which Customer procured the rights to use SAP Software or a Cloud Service.
• Notice of Extension has the meaning specified in Section 2.20.
• infringement notice has the meaning set forth in Section 7.4.1;
• End User License Agreement means a license grant or end user license agreement governing software as further described in this Agreement or any applicable Appendix.
• Notice of Sale means the Notice of Sale of the Trust relating to the sale of the Series 2014A Bonds to be dated on or about April 28, 2014, substantially in the form attached hereto as Exhibit D.
• Technology License Agreement means the agreement in the form of Exhibit H hereto.
• Estoppel Letter A document executed by the Cooperative Corporation certifying, with respect to a Cooperative Unit, (i) the appurtenant Proprietary Lease will be in full force and effect as of the date of issuance thereof, (ii) the related stock certificate was registered in the Mortgagor's name and the Cooperative Corporation has not been notified of any lien upon, pledge of, levy of execution on or disposition of such stock certificate, and (iii) the Mortgagor is not in default under the appurtenant Proprietary Lease and all charges due the Cooperative Corporation have been paid.
• Licensing Agreement means a commercial agreement between a design approval holder and a production approval holder (or applicant) formalizing the rights and duties of both parties to use the design data for the purpose of manufacturing the product or article.
• Renewal Application means a document used to collect pertinent data for renewal of permits
• Cross License Agreement means that certain Cross License Agreement between and among Medarex, Cell Genesys, Inc., Abgenix, Inc., Xenotech, L.P. and Japan Tobacco Inc., dated March 26, 1997.
• Patent Assignment Agreement means the patent assignment agreement substantially in the form of Exhibit A.
• Collaboration Agreement has the meaning set forth in the Recitals.
• Software License Agreement means the Motorola Software License Agreement (Exhibit A).
• Notice of Appeal means a notice given pursuant to Condition 6.2.
• Patent License Agreement means the Patent License Agreement substantially in the form of Exhibit C.
• statutory notice means a notice served by the company under the Companies Acts requiring particulars of interests in shares or of the identity of persons interested in shares.
• CAFA Notice refers to the notice requirements imposed by 28 U.S.C. § 1715(b).
• Mediation Notice is defined in Section 6.2(b).
• Collaboration Know-How means all Know-How and Materials discovered, created, conceived, developed or reduced to practice in the course of performing activities under the Collaboration Program (whether solely by one Party or jointly by the Parties, in each case with their Affiliates or any Third Parties or any employees, consultants or agents of any of the foregoing which perform activities under the Collaboration Program).
• Denial notice means a board notification denying an application for the issuance or renewal of a license as required by the Act.
• 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.
• IP License Agreement means the Intellectual Property License agreement set forth as Exhibit E hereto.