Orange Book Patents definition

Orange Book Patents means those patents held (whether by ownership or license) by Credit Parties or their Subsidiaries listed in the FDA’s publication of Approved Drug Products with Therapeutic Equivalence Evaluations (commonly referred to as the Orange Book), including U.S. patent Nos. 8,748,382, 8,148,333 and 7,803,770.

Orange Book Patents means, on a country-by-country basis, the Licensed Patents that are listed with, and/or are required to be listed with, applicable Regulatory Authorities Covering any Product being Developed by Novartis, its Affiliates or Sublicensees hereunder that Novartis, its Affiliate or Sublicensee intends to, or has begun to, Commercialize, and that have become the subject of an NDA, MAA or other marketing application submitted to any applicable Regulatory Authority, such listings to include, without limitation, all so-called “Orange Book” listings required under the Xxxxx-Xxxxxx Act and all so-called “Patent Register” listings as required in Canada. For purposes of determining royalties payable under Section 7.8, Orange Book Patents will include any and all foreign equivalent and counterpart Patent Rights to the Patent Rights described above. For the avoidance of doubt, on a country-by-country basis, where there is:

Orange Book Patents means the Patents listed in the Orange Book by the Company and relating to Tebi.

Examples of Orange Book Patents in a sentence

• Novartis will promptly, accurately and completely list, with the applicable Regulatory Authorities during the Agreement Term, all applicable Orange Book Patents.

• 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.

• Co., Ltd.’s ANDA filing, including its Paragraph IV certifications regarding the Orange Book Patents at issue here, is suit-related and has a substantial connection with this District because it reliably, non-speculatively predicts activities in this District by Hisun.

• Teva shall have the sole right to reference any Teva Patents and Teva [ * ] Patents with respect to the Product in the U.S., including listing Teva Patents as Orange Book Patents.

• Teva shall have the sole right to list any Alexza Patents issued or filed after the Effective Date with respect to the Product in the U.S. as additional Orange Book Patents.

More Definitions of Orange Book Patents

Orange Book Patents means any and all patents that are listed, now or in the future, in the Orange Book in relation to NDA No. 21-777 (Anesta’s AMRIX® product).

Orange Book Patents means collectively the Orange Book Patents I and Orange Book Patents II.

Orange Book Patents means the Patents listed in the Orange Book by Seller, its Affiliates or Licensees in connection with Pacritinib.

Orange Book Patents means the Patent Rights that are listed with, and/or are required to be listed with, applicable Regulatory Authorities Covering any Product being Developed by Bayer, its Affiliates or Sublicensees hereunder that Bayer, its Affiliate or Sublicensee intends to, or has begun to, Commercialize, and that have become the subject of an NDA submitted to any applicable Regulatory Authority, such listings to include, without limitation, all so-called “Orange Book” listings required under the Xxxxx-Xxxxxx Act and all so-called “Patent Register” listings as required in Canada. For purposes of determining royalties payable under Section 7.9, Orange Book Patents will include any and all foreign equivalent and counterpart Patent Rights to the Patent Rights described above.

Orange Book Patents means those patents listed in the FDA Orange Book as protecting Veltassa and its use under its approved label, including U.S. Patent Nos.7,556,799, 8,147,873, 8,216,560, 8,282,913, 8,287,847, 8,337,824, 8,475,780, 8,778,324 and 8,889,115.

Orange Book Patents is defined in Section 5.4(b).

Orange Book Patents means any Exicure Patents or Joint Collaboration Patents, in each case, that are or can be, in accordance with applicable Laws, listed in the Orange Book with respect to a Licensed Product. For the avoidance of doubt, Orange Book Patents may include Product-Specific Patents.