Paragraph IV Certification Notice definition

Paragraph IV Certification Notice means the notice of certification required by 21 U.S.C. § 355(b)(3) or 21 U.S.C. § 355(j)(2)(B).
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Paragraph IV Certification Notice means the notice of certification required by 21 U.S.C. § 355(b)(3) or 21 U.S.C. § 355(j)(2)(B). “Paragraph IV Proceeding” means an infringement Proceeding filed pursuant to 35 U.S.C. § 271(e)(2) with respect to a product controlled by the Borrower or any of the Subsidiaries. “Parent Entity” means any direct or indirect parent of the Borrower. “Participant” has the meaning assigned to such term in Section 10.04(4)(a). “Participant Register” has the meaning assigned to such term in Section 10.04(4). “Payment Conditions” means, and will be deemed to be satisfied with respect to any particular action as to which the satisfaction of the Payment Conditions is being determined if, after giving effect to the taking of such action, (1) no Designated Event of Default has occurred and is continuing immediately prior or after giving effect thereto, (2) Specified Excess Availability for each day in the 30-day period prior to such action and on the date of such proposed action would exceed the greater of (a) 12.5% of the Line Cap then in effect and (b) $31.25 million, in any such case, on a Pro Forma Basis, and (3) the Fixed Charge Coverage Ratio as of the end of the most recent Test Period would be at least 1.0 to 1.0 on a Pro Forma Basis giving effect to the subject action; provided that compliance with the Fixed Charge Coverage Ratio will not be required if after giving effect to the taking of such action, Specified Excess Availability would exceed the greater of (i) 17.5% of the Line Cap then in effect and (ii) $43.75 million, on a Pro Forma Basis. “Payment in Full” means the payment in full of the Obligations (other than Obligations in respect of Specified Hedge Agreements, Cash Management Obligations and contingent indemnification and reimbursement obligations that are not yet due and payable and for which no claim has been asserted), the expiration, termination or cash collateralization (on terms reasonably
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Examples of Paragraph IV Certification Notice in a sentence

  • The Seller has not received or been notified of and has no knowledge of any Paragraph IV Certification Notice in accordance with 21 U.S.C. § 355(j)(2)(B)(ii) advising either the Seller or the owner or assignee of the Seller Licensed Patents of the filing by an Abbreviated New Drug Application with respect to the Product (“ANDA”).

  • In September 2013, Ranbaxy received a Paragraph IV Certification Notice of filing from Wxxxxx Laboratories, Inc.

  • No Seller Party has received or been notified of and has knowledge of any Paragraph IV Certification Notice in accordance with 21U.S.C. § 355(j)(2)(B)(ii) advising such Seller Party of the filing by an Abbreviated New Drug Application with respect to the Product (“ANDA”).

  • We are involved in several patent infringement actions filed in response to Paragraph IV Certification Notice Letters that we received in March, April and October 2010, and February and October 2011, regarding ANDAs submitted to the FDA requesting approval to market and sell generic versions of Intuniv, a product that is manufactured and sold by Shire plc.

  • We are involved in a patent infringement matter filed in response to three Paragraph IV Certification Notice Letters that we received in June 2009, November 2009 and April 2010 regarding an ANDA submitted to the FDA by each of Watson Laboratories, Inc., Sandoz Inc.

  • Except as set forth in Section 3.22 of the Disclosure Schedule, Seller has not received or been notified in writing or, to Seller’s Knowledge, orally of any Paragraph IV Certification Notice in accordance with 21 U.S.C. § 355(j)(2)(B) advising Seller of the filing of an Abbreviated New Drug Application with respect to the Product (“ANDA”).

  • In connection with an ANDA, a Paragraph IV Certification Notice Letter notifies the FDA that one or more patents listed in the FDA's Approved Drug Product List (Orange Book) is alleged invalid, unenforceable or will not be infringed by the ANDA product.

  • For example, we are involved in the following matters related to Paragraph IV Certification Notice Letters that we have received in connection with our collaborators' products.

  • We are involved in a patent infringement matter filed in response to four Paragraph IV Certification Notice Letters that we received in November 2010, January 2011, April 2011 and September 2011 regarding an ANDA, submitted to the FDA by each of Lupin Limited, Sandoz Inc., Impax Laboratories, Inc.

  • In April 2020, we received a Paragraph IV Certification Notice Letter (Notice Letter) from Liquidia, stating that it intends to market LIQ861 before the expiration of all patents currently listed in the Orange Book for Tyvaso.

Related to Paragraph IV Certification Notice

  • Xxxxx Notice means the Notice of Grant of Stock Option accompanying the Agreement, pursuant to which Optionee has been informed of the basic terms of the option evidenced hereby.

  • Confirmation Notice means a notice provided by the Issuer to an Investor in accordance with clause 1.3(c) of the Terms;

  • Rectification Notice means a notice in writing that identifies a defect in a work and requires rectification of the defect within a specified period of time.

  • Termination Notice means the communication issued in accordance with this Agreement by one Party to the other Party terminating this Agreement;

  • Back-Up Certification As defined in Section 13.06.

  • Addition Notice With respect to the transfer of Subsequent Mortgage Loans to the Trust Fund pursuant to Section 2.08, a notice of the Depositor's designation of the Subsequent Mortgage Loans to be sold to the Trust Fund and the aggregate principal balance of such Subsequent Mortgage Loans as of the Subsequent Cut-off Date. The Addition Notice shall be given not later than three Business Days prior to the related Subsequent Transfer Date and shall be substantially in the form attached hereto as Exhibit P.

  • FOIA Notice means a decision notice, enforcement notice and/or an information notice;

  • Certification period means the period for which an individual is certified eligible for a program.

  • Valuation Notice means the notice given by the Partnership pursuant to Section 8.5(b) or Section 8.6(a) and stating the Initial Value at which a Purchase Right is to be exercised or at which a Repurchase Obligation is to be effected.

  • Nomination Notice means all information and documents that a Nominating Stockholder is required to submit to the Secretary of the Corporation pursuant to Section 2.6(f).

  • Escalation Notice has the meaning set forth in Section 8.02.

  • CAFA Notice refers to the notice requirements imposed by 28 U.S.C. § 1715(b).

  • Election Notice has the meaning set forth in Section 11.01(b).

  • Defects Notification Period means the period for notifying defects in the Works or a Section (as the case may be) under Sub-Clause 11.1 [Completion of Outstanding Work and Remedying Defects], which extends over 365 days except if otherwise stated in the SCC (with any extension under Sub-Clause 11.3 [Extension of Defects Notification Period]), calculated from the date on which the Works or Section is completed as certified under Sub-Clause 10.1[Taking Over of the Works and Sections].

  • Indemnity Notice shall have the meaning specified in Section 9.3(b).

  • Indemnification Notice has the meaning set forth in Section 11.3(a).

  • Rejection Notice has the meaning specified in Section 2.05(b)(v).

  • Selection Notice means a notice substantially in the form set out in Part II of Schedule 3 (Requests) given in accordance with Clause 9 (Interest Periods).

  • Designation Notice means a notice from any Lender or an Affiliate of a Lender substantially in the form of Exhibit I.

  • Mediation Notice is defined in Section 6.2(b).

  • Penalty Notice means a written no- tification from the Director informing a respondent that the Director has made a finding of violation and, absent a request for a hearing, will impose a civil monetary penalty.

  • Determination Notice is defined in Section 6.1(b)(i) of the Agreement.

  • Auction Notice has the meaning assigned to such term in the definition of “Dutch Auction”.

  • Denial notice means a board notification denying an application for the issuance or renewal of a license as required by the Act.

  • Publication Notice means the summary notice of proposed Settlement and hearing for publication substantially in the form attached as Exhibit 3 to Exhibit A.

  • Notice of Extension has the meaning specified in Section 2.20.