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.
Orange Book Patent has the meaning set forth in Section 5.3(f).
Orange Book Patent means any Product Patents issued in the U.S. and listed in 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. “Organizational Documents” means (a) with respect to any corporation or company, its certificate, articles or memorandum of incorporation, organization or association, and its by-laws, (b) with respect to any limited partnership, its certificate of limited partnership, and its partnership agreement, (c) with respect to any general partnership, its partnership agreement, and (d) with respect to any limited liability company, its articles of organization, and its operating agreement (or, in each case of (a) through (d), the equivalent or comparable constitutive documents with respect to any non-U.S. jurisdiction). In the event any term or condition of this Agreement or any other Loan Document requires any Organizational Document to be certified by a secretary of state or similar governmental official, the reference to any such “Organizational Document” shall only be to a document of a type customarily certified by such governmental official. “Other Connection Taxes” has the meaning specified in Section 2.15(a). “Other Taxes” has the meaning specified in Section 2.15(a). “Outbound License Agreement” means, individually or collectively as the context requires, the agreements listed in Items 1 through and including 5 of Schedule 4.23(b)(ii). “Participant Register” has the meaning specified in Section 10.6(h)(ii). “Partnered Assets” means (a) [**], (b) [**], and (c) any Products that are the subject of any Specified Transaction after such Specified Transaction is entered into. “Patent” means any patent or patent application, including any continuation, continuation-in-part, division, provisional or any substitute applications, any patent issued with respect to any of the foregoing patent applications, any certificate, reissue, reexamination, renewal or patent term extension or adjustment (including any supplementary protection certificate) of any such patent or other governmental actions which extend the duration or any of the subject matter of a patent, and any substitution patent, confirmation patent or registration patent or patent of addition based on any such patent, and all foreign counterparts of any of the foregoing. “PATRIOT Act” has the meaning specified in Section 4.29. “Payment Office” means Administrative Agent’s office located at 0000 X...

Examples of Orange Book Patent in a sentence

  • The Seller shall keep the Purchaser informed of all such actions taken at the Purchaser’s request with respect to such Orange Book Patent in such Major Market Country and the Purchaser shall have the opportunity to participate and meaningfully consult with the Seller with respect to the direction thereof and the Seller shall consider the Purchaser’s comments in good faith.

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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Neither Borrower nor any of its Subsidiaries has received any written notice or communication from the FTC, any other Governmental Authority, or any other person alleging that any Orange Book Patent for EMPAVELI and SYFOVRE may constitute an unfair or anticompetitive business practice.

  • If, after expiration of the ‘537 Patent, a patent within the Patent Rights (other than the ‘537 Patent) is listed in the Orange Book for the Vivus Product (an “Orange Book Patent”), then VIVUS would pay royalties hereunder on Net Sales in the United States on such Orange Book Patent until its expiration.

  • 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 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 ofCombination Products”.

Related to Orange Book Patent

  • Product Patents means any Patent Controlled or owned by Quoin in the Territory that, absent the license in Section 2.1, would be infringed by the importation, sale, or use of the Product in the Territory by a third party.

  • 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.

  • 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.