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".
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Purple Book has the meaning set forth in Section 12.8.
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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.
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Examples of Purple Book in a sentence

  • The following paragraphs of the Purple Book and the Manual Handbook remain as part of the new national agreement until superseded by local arrangements following local reviews of grading structure.

  • General and specific considerations concerning labeling requirements are provided in Hazard communication: Labelling (Chapter 1.4) of the UN Purple Book.

  • This SDS is prepared by Product Regulatory Services and Hazard Communications Groups from information supplied by internal references within our company.Classification was done in accordance with UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Purple Book and complies with the Regulations for Hazardous Chemical Agents, 2021.

  • A licensed biosimilar product determined by the FDA to be therapeutically equivalent to the reference biological product and published in the Purple Book.

  • Guidance for Controlling ACM in Buildings (Purple Book) EPA 560/5-85- 024 C.

  • With respect to filings in the FDA’s Orange Book or Purple Book or other similar filings or listings as may be applicable to a biologic or drug (and foreign equivalents) for issued patents for a Licensed Product, upon request by Gilead, Hookipa shall provide reasonable cooperation to Gilead in filing and maintaining any such listing and filings.

  • General and specific considerations concerning labeling requirements are provided in Hazard communication: Labeling (Chapter 1.4) of the UN Purple Book.

  • With respect to data exclusivity periods (such as those periods listed in the FDA’s Orange or Purple Book (including, without limitation, any available pediatric extensions) or periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or orphan exclusivity periods, and all equivalents in any country), Apollo shall have the sole and exclusive right to seek and maintain all such data exclusivity periods available for the Licensed Products.

  • As between the Parties, Licensee shall have the sole right to make decisions regarding and Licensee shall have the right to make all filings with Regulatory Authorities in the Territory with respect to the Exclusive Licensed Patents including as required or allowed (i) in the United States, in the FDA’s Purple Book and (ii) in the European Union, under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents.

  • Besides, effects on benefits and costs both have compounding strengths over time.


More Definitions of Purple Book

Purple Book means the FDA’s Purple Book Database of FDA-licensed biological products or any replacement thereof established or approved by the FDA.
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Purple Book means FDA’s List of Licensed Biological Products with Reference Product Exclusivity and
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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.”
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Purple Book has the meaning set forth in Section 6.5 (Patent Listing).
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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.
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Related to Purple Book

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  • DAILY LOG BOOK means the format as may be certified by the Company's Engineer on a day-to-day basis during the tenure of this Agreement.

  • Master Account Approval List means the list of Attendee reservations and Dates which the Judicial Council has authorized the Contractor to xxxx associated sleeping room charges and tax against the Judicial Council’s Master Account.

  • Open Item List means a list of work activities, Punchlist items, changes or other issues that are not expected by Owner and Contractor to be complete prior to Substantial Completion.

  • City Ledger Report means a list submitted by the Contractor indicating on a daily basis its total number of sleeping room nights rented as well as the total number for sleeping rooms removed from its available inventory or rentals, for purposes of repair.

  • Open Book Data means complete and accurate financial and non-financial information which is sufficient to enable the Customer to verify the Call Off Contract Charges already paid or payable and Call Off Contract Charges forecast to be paid during the remainder of this Call Off Contract, including details and all assumptions relating to: the Supplier’s Costs broken down against each Good and/or Service and/or Deliverable, including actual capital expenditure (including capital replacement costs); operating expenditure relating to the provision of the Goods and/or Services including an analysis showing: the unit costs and quantity of Goods and any other consumables and bought-in services; manpower resources broken down into the number and grade/role of all Supplier Personnel (free of any contingency) together with a list of agreed rates against each manpower grade; a list of Costs underpinning those rates for each manpower grade, being the agreed rate less the Supplier’s Profit Margin; and Overheads; all interest, expenses and any other third party financing costs incurred in relation to the provision of the Services; the Supplier Profit achieved over the Call Off Contract Period and on an annual basis; confirmation that all methods of Cost apportionment and Overhead allocation are consistent with and not more onerous than such methods applied generally by the Supplier; an explanation of the type and value of risk and contingencies associated with the provision of the Goods and/or Services, including the amount of money attributed to each risk and/or contingency; and the actual Costs profile for each Service Period.

  • Approved List means Securities followed by the Global Fundamental Research Group and tracked on the Approved List. Securities may be added, removed, or undergo periodic ratings changes.

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  • 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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