Purple Book definition
Purple Book means "Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations", an FDA publication that is commonly referred to as the "Purple Book".
Purple Book means the United States Food and Drug Administration's "Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations" publication and its cumulative supplements, which include lists of licensed biological products with biosimilarity and interchangeability evaluations.
Purple Book has the meaning set forth in Section 12.8.
Examples of Purple Book in a sentence
Eureka will have the full and exclusive right, in its sole discretion, to determine and control the listing of any Eureka Controlled Patent Right in the then-current patent listing that is equivalent to the Orange Book or the Purple Book in any country of the Eureka Territory in connection with the Regulatory Approval of any Licensed Product for the Eureka Territory.
More Definitions of Purple Book
Purple Book means FDA’s List of Licensed Biological Products with Reference Product Exclusivity and
Purple Book means the FDA’s Purple Book Database of FDA-licensed biological products or any replacement thereof established or approved by the FDA.
Purple Book means the electronic or hard copy version of the FDA’s publication, Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations, and any successor publication thereto or equivalent publication thereof.
Purple Book has the meaning set forth in Section 7.5 (Patent Listing).
Purple Book means the United States Food and Drug Administration’s “List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations” publication and its cumulative supplements, which include a list of licensed biological products with biosimilarity and interchangeability evaluations.”
Purple Book means the FDA’s Purple Book Database of FDA- licensed biological products or any replacement thereof established or approved by the FDA.
Purple Book or any equivalent thereto in any country in the Territory with respect to the Licensed Products. Anaptys shall reasonably cooperate with Licensee in making or withdrawing any such listing for an Anaptys Patent, including executing all necessary documents to implement such patent listing, at Licensee’s cost and expense.