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 has the meaning set forth in Section 12.8.
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.
Examples of Purple Book in a sentence
The Parties shall discuss and agree to the approach for the listing of any Licensed Patent in the then-current edition of the Purple Book in connection with the Marketing Approval of any Licensed Product, or in equivalent patent listings in any other country within the Licensed Territory.
More Definitions of Purple Book
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 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 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 has the meaning set forth in Section 6.5 (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 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.