Orange Book Patent definition

Orange Book Patent means any Product Patents listed in the FDA’s Orange Book pursuant to 21 U.S.C. Section 355(b)(1), as such patent listing may be amended from time to time, together with all foreign counterpart patents.
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Orange Book Patent has the meaning set forth in Section 5.3(f).
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Orange Book Patent means the Patents listed in the Orange Book by Seller, its Affiliates or Licensees in connection with any Product. “Other Component” is defined in the definition of “Combination Products”.
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Examples of Orange Book Patent in a sentence

  • Until the [ * ] ([ * ]) anniversary of the Effective Date, Teva shall notify Alexza that it requests the right to bring and control any action or proceeding with respect to infringement of any Orange Book Patent I in the U.S., at its own expense and by counsel of its own choice, and the Parties shall discuss in good faith the reasons for Teva’s request within [ * ] Business Days of Alexza receiving such notice.

  • Subject to this Section 10.3(b), Teva shall have the first right, as between Alexza and Teva, to bring and control any action or proceeding with respect to infringement of any Orange Book Patent II or Product-Specific Alexza Patent in the U.S., at its own expense and by counsel of its own choice; provided that Teva shall not enter into any settlement agreement with respect to such infringement without the prior written consent of Alexza.

  • The Senior Executives shall meet promptly to discuss such matter and determine a resolution, provided, however, that if the Senior Executives are unable to determine a resolution in a timely manner, which shall in no event be more than [ * ] Business Days after such matter was referred to them, then Teva shall have the right to bring and control any action or proceeding with respect to infringement of any Orange Book Patent I.

  • In addition, Alexza agrees that it will not allow any Orange Book Patent references for any Product not licensed hereunder to Teva, including any Alternative Product, in the U.S., but Alexza retains the right to list and reference any Orange Book Patents (other than Teva Patents listed pursuant to Section 10.2(b)(ii)) for itself, its Affiliates and its licensees with respect to any other product in the U.S., except an Alternative Product.

  • At any time after the period set forth in Section 10.3(d), Teva may request the right to bring and control any action or proceeding with respect to infringement of any Alexza Patent that is an Orange Book Patent I or that is not a Product-Specific Alexza Patent in the U.S., wherein such infringement is related to the Product, provided that for any Orange Book Patent I.

  • Notwithstanding any other obligation of Seller under this Section 6.5(b), Seller shall (i) timely bring and prosecute infringement actions in response to certifications made under paragraph IV of 21 U.S.C. §355(j)(2)(A)(vii) or §355(b)(2)(A) with respect to any Orange Book Patent, (ii) defend the Orange Book Patents against any claim of invalidity or unenforceability, and (iii) not disclaim or abandon any Orange Book Patent.

  • Notwithstanding any other obligation of Seller under this ‎Section 6.5(a), Seller shall (i) timely bring and prosecute infringement actions in response to certifications made under paragraph IV of 21 U.S.C. §355(j)(2)(A)(vii) or §355(b)(2)(A) with respect to any Orange Book Patent, (ii) defend the Orange Book Patents against any claim of invalidity or unenforceability, and (iii) not disclaim or abandon any Orange Book Patent.

  • Notwithstanding the preceding sentence, GSK will retain final decision-making authority as to the listing of all applicable GSK Orange Book Patents for such Licensed Product (excluding Isis Core Technology Patents), regardless of which Party owns such GSK Orange Book Patent.

  • This Agreement shall become effective on the Effective Date and shall remain in force until the last date on which the sale of the Product in the Territory would infringe a Valid Claim of an Orange Book Patent in the Territory but for the grant of the rights under this Agreement (“Initial Term”).

  • Each Party shall provide to the other Party prompt written notice of any actual or threatened infringement of any Orange Book Patent, Product-Specific Patent, Joint Collaboration Patent or Allergan Collaboration Patent in the Territory of which such Party becomes aware.


More Definitions of Orange Book Patent

Orange Book Patent means, with respect to Symproic, any patent listed in the Orange Book pursuant to 21 U.S.C. § 355(b)(1) for the Assigned NDA.
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Orange Book Patent means the Patents listed in the Orange Book by Seller, its Affiliates or Licensees in connection with any Product.
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Related to Orange Book Patent

  • Patent Rights means the rights and interests in and to issued patents and pending patent applications (which, for purposes of this Agreement, include certificates of invention, applications for certificates of invention and priority rights) in any country or region, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, all letters patent granted thereon, and all reissues, re-examinations and extensions thereof, and all foreign counterparts of any of the foregoing.

  • Licensed Patent Rights means:

  • 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.

  • 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.

  • 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.

  • Valid Claim means a claim within the Patent Rights (including any re-issued and unexpired patents) which has not been held unenforceable or invalid by the decision of a court or other governmental agency of competent jurisdiction unappealable or unappealed within the time allowed for appeal and which has not been admitted to be invalid or unenforceable through re-issue or disclaimer or otherwise.

  • 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.