Orange Book definition

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

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Orange Book means the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations, as may be amended from time to time.

Orange Book means the Approved Drug Products book published by the FDA most recently and for subsequent years during the term of this Agreement, including its printed, monthly supplements, and the electronic version of the Orange Book found at ▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/cder/ob/default.htm, or as the site address is amended.

Examples of Orange Book in a sentence

• With respect to filings in the FDA Orange Book (and foreign equivalents) for issued patents for a Product, upon request by BMS (and at BMS’ expense), Exelixis shall provide reasonable cooperation to BMS in filing and maintaining such Orange Book (and foreign equivalent) listings.

• With respect to patent listing filings in any FDA Orange Book (and equivalents) for issued patents for a Licensed Product, Company shall, consistent with its obligations under applicable Law, list in a timely manner and maintain all applicable BMS Patent Rights.

• When determining MAC prices, the MCO may only compare drugs listed as therapeutically equivalent in the most recent version of the Orange Book to formulate the MAC price.

• To place an outpatient drug on a MAC list, the MCO must ensure that: • the drug is listed as "A" or "B" rated in the most recent version of the United States Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book, has an "NR" or "NA" rating or similar rating by a nationally recognized reference; and • the drug is generally available for purchase by pharmacies in Texas from national or regional wholesalers and is not obsolete.

• BMS shall provide, consistent with its obligations under applicable Law, reasonable cooperation to Company in filing and maintaining such Orange Book (and foreign equivalent) listings.

More Definitions of Orange Book

Orange Book has the meaning set forth in Section 11.3 (Patent Listing).

Orange Book means "Approved Drug Products with Therapeutic Equivalence Evaluations", an FDA publication that is commonly referred to as the "Orange Book".

Orange Book means the electronic or hard copy version of the FDA’s publication, Approved Drug Products with Therapeutic Equivalence Evaluations, and any successor or equivalent publication thereto.

Orange Book has the meaning set forth in Section 7.6(b).

Orange Book means the latest edition of the “Standard Specifications Book for Public Works Construction” sponsored and distributed by the Regional Transportation Commission in conjunction with City and other governmental entities. Further, public works construction shall be completed in a diligent and workmanlike manner of good quality free from faults and defects.

Orange Book means the United States Food and Drug Administration's "Approved Drug Products with Therapeutic Equivalence Evaluations" publication and its cumulative supplements, which include a list of approved prescription drug products with therapeutic equivalence evaluations.

Orange Book means the publication Approved Drug Products with Therapeutic Equivalence Evaluations that identifies drug products approved on the basis of safety and effectiveness by the FDA under the FFDCA.