Orange Book Listed Patents definition

Orange Book Listed Patents means any patent that is listed for the Product in the Food and Drug Administration’s Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations as found in the printed Orange Book publication or at xxxx://xxx.xxxxxxxxxx.xxx.xxx/scripts/cder/ob/default.cfm (or equivalent FDA website).
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Orange Book Listed Patents means the Licensed Patents set forth on Exhibit F hereto.
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Orange Book Listed Patents means any patent that is listed for the Product in the Food and Drug Administration’s Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations as found in the printed Orange Book publication or at http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm (or equivalent FDA website).
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Examples of Orange Book Listed Patents in a sentence

  • Orange Book Listed Patents and Use Codes can Delay Generic (and 505(b)(2)) Drug Market EntryFDA’s Proposed Rules to Address Inaccurate Orange Book Use CodesOrange Book patent listing(s) can and have delayed the market entry of generic (and 505(b)(2)) drugs.

  • Correcting Inaccurate Orange Book Listed Patents and Use Codes via Counterclaiming in LitigationCongress took a first step in addressing correction of inaccurate Orange Book listings and use codes in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (the Act).

  • ERLEADABeginning in May 2022, Aragon Pharmaceuticals, Inc., Janssen Biotech, Inc., Sloan Kettering Institute for Cancer Research and The Regents of the University of California filed patent infringement lawsuits in United States district courts against generic manufacturers who have filed ANDAs seeking approval to market generic versions of ERLEADA before expiration of certain Orange Book Listed Patents.

  • In each of these lawsuits, the Company’s subsidiaries are seeking an order enjoining the defendant from marketing a generic version of a product before the expiration of the relevant patents (Orange Book Listed Patents).

  • Anaphylactic reactions in children--a questionnaire-based survey in Germany.

Related to Orange Book Listed Patents

  • Orange Book means the FDA publication entitled “Approved Drug Products with Therapeutic Equivalence Evaluations” or any replacement thereof established or approved by the FDA.

  • Program Patents has the meaning set forth in Section 7.1.2.

  • Patent Applications means all published and unpublished nonprovisional and provisional patent applications, reexamination proceedings, invention disclosures and records of invention, applications for certificates of invention and priority rights, in any country and regardless of formal name, including without limitation, substitutions, continuations, continuations-in-part, divisions, renewals, revivals, reissues, re-examinations and extensions thereof.

  • Product Patents means any and all United States patents and patent applications, all divisionals, continuations, continuations-in-part, re-issues, extensions or foreign counterparts thereof, now or hereafter owned or controlled ("controlled" being used in the sense of having the right to grant licenses thereunder) by PERIMMUNE, covering the manufacture, use, sale, offer for sale and/or importation of the Product, including but not limited to, the U.S. Patent No. 5,407,912 attached hereto as Exhibit B.

  • Existing Patents has the meaning set forth in Section 10.2.1.

  • Collaboration Patents means any and all Patents that claim or cover any of the Collaboration Know-How.

  • Program Patent Rights means any Patent Rights that contain one or more claims that cover Program Inventions.

  • Collaboration Patent Rights means Patent Rights claiming Collaboration Know-How.

  • Licensee Patents means any Patents within the Control of Licensee as of the Effective Date and at any time during the Term relating to the Product.

  • Patent Application means an application for patent protection for a CRADA Subject Invention with the United States Patent and Trademark Office (“U.S.P.T.O.”) or the corresponding patent-issuing authority of another nation.

  • Joint Patents means all Patents claiming any Joint Invention.

  • Patent Rights means all patents and patent applications, including all divisionals, continuations, substitutions, continuations-in-part, re-examinations, reissues, additions, renewals, extensions, registrations, and supplemental protection certificates and the like of any of the foregoing.

  • Joint Patent Rights means Patent Rights that contain one or more claims that cover Joint Technology.

  • Company Patents means Patents owned by the Company or used or held for use by the Company in the Business.

  • Licensed Patents means (a) all United States patents and patent applications listed in Exhibit A, as modified pursuant to Section 2.6.1, including patents arising from such patent applications; and (b) any re-examination certificates thereof, and their foreign counterparts and extensions, continuations, divisionals, and re-issue applications; provided that “Licensed Patents” will not include any claim of a patent or patent application covering any Manufacturing Technology.

  • Licensed Patent Rights means: (a) Patent applications (including provisional patent applications and PCT patent applications) or patents listed in Appendix A, all divisions and continuations of these applications, all patents issuing from these applications, divisions, and continuations, and any reissues, reexaminations, and extensions of these patents; (b) to the extent that the following contain one or more claims directed to the invention or inventions disclosed in 2.9(a): (i) continuations-in-part of 2.9(a); (ii) all divisions and continuations of these continuations-in-part; (iii) all patents issuing from these continuations-in-part, divisions, and continuations; (iv) priority patent application(s) of 2.9(a); and (v) any reissues, reexaminations, and extensions of these patents; (c) to the extent that the following contain one or more claims directed to the invention or inventions disclosed in 2.9(a): all counterpart foreign and U.S. patent applications and patents to 2.9(a) and 2.9(b), including those listed in Appendix A; and (d) Licensed Patent Rights shall not include 2.9(b) or 2.9(c) to the extent that they contain one or more claims directed to new matter which is not the subject matter disclosed in 2.9(a).

  • Patents means all patents, patent applications and like protections including without limitation improvements, divisions, continuations, renewals, reissues, extensions and continuations-in-part of the same.

  • Patent means (a) all patents and patent applications in any country or supranational jurisdiction in the Territory, (b) any substitutions, divisionals, continuations, continuations-in-part, provisional applications, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like of any such patents or patent applications, and (c) foreign counterparts of any of the foregoing.

  • Joint Patent means a patent that issues from a Joint Patent Application.

  • Regents' Patent Rights means REGENTS' rights in (a) the patent and patent applications expressly identified in Appendix C and their foreign counterparts;

  • Patent Right means: (a) an issued or granted patent, including any extension, supplemental protection certificate, registration, confirmation, reissue, reexamination, extension or restoration by existing or future extension or restoration mechanisms (including, without limitation, supplementary protection certificates or the equivalent thereof), or renewal thereof; (b) a pending patent application, including any continuation, divisional, continuation-in-part, substitute or provisional application thereof; and (c) all counterparts or foreign equivalents of any of the foregoing issued by or filed in any country or other jurisdiction.

  • Valid Claims means Settlement Claims in an amount approved by the Claims Administrator or found to be valid through the claims processing and/or Dispute Resolution process.

  • Product Registrations means the approvals, licenses, registrations, listings, franchises, permits, certificates, consents, clearances, or other authorizations (including, but not limited to, NDAs and NDSs) and comparable regulatory filings required by any Governmental Authority for the Products held in Sellers’ name as set forth in Schedule 1.1(d).

  • Licensed Patent means Stanford's rights in U.S. Patent Application, Serial Number , filed , any foreign patent application corresponding thereto, and any divisional, continuation, or reexamination application, extension, and each patent that issues or reissues from any of these patent applications. Any claim of an unexpired Licensed Patent is presumed to be valid unless it has been held to be invalid by a final judgment of a court of competent jurisdiction from which no appeal can be or is taken. “Licensed Patent” excludes any continuation-in-part (CIP) patent application or patent.

  • Patent Cooperation Treaty means the Patent Cooperation Treaty done at Washington on June 19, 1970;

  • Product Trademarks means the Trademark(s) to be used by Adapt or its Affiliates or its or their respective Sublicensees for the Commercialization of Products and any registrations thereof or any pending applications relating thereto (excluding, in any event, any trademarks, service marks, names or logos that include any corporate name or logo of the Parties or their Affiliates).