Regulatory Data Exclusivity definition

Regulatory Data Exclusivity means an exclusive right, other than through the issuance of a patent, lawfully granted by a Governmental Authority, to market, or to rely on certain data in supporting the marketing of, a Collaboration Product or Reversion Product, as applicable, in that country in respect of which that Governmental Authority has jurisdiction conferred on it by Applicable Law, which exclusive right effectively prohibits reliance on the regulatory submissions made with respect to such product, directly or indirectly and in whole or in part, in that country for the relevant time period.
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Regulatory Data Exclusivity means any exclusive marketing rights, data exclusivity rights or other benefits conferred by any Governmental Authority with respect to the Product other than a patent right in the Licensed Territory, including, where applicable, pediatric exclusivity and/or orphan drug exclusivity and/or any other regulatory data protection or exclusivity.
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Regulatory Data Exclusivity means data, market or other regulatory exclusivity (as distinct from and excluding any exclusivity arising under Patent Rights) for a Licensed Product in a country or region in the Territory under applicable laws, rules and regulations in such country or region, including, without limitation, (a) any such exclusivity provided in countries in the EU under national laws and regulations implementing Section 10.1(a)(iii) of the Directive 2001/EC/83, (b) U.S. exclusivity periods such as U.S. biosimilars exclusivity, pediatric exclusivity, orphan drug exclusivity, and the Hatch-Waxman data exclusivity or (c) any analogous laws or regulations in other countries in the Territory.
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Examples of Regulatory Data Exclusivity in a sentence

  • Company’s obligation to pay royalties to UCB on sales of Licensed Product shall continue on a product-by-product and country-by-country basis until the latest of: (i) the expiration of the last Valid Claim to expire in such country; (ii) the expiration of all periods of Regulatory Data Exclusivity that apply to such Licensed Product in such country; or (iii) ten (10) years after the First Commercial Sale of the relevant Licensed Product in such country.

  • The term of this Agreement (the “Term”) shall commence on the Effective Date and continue until the later of (a) ten (10) years after the date of First Commercial Sale in the Licensed Territory, (b) the expiration of the last Valid Claim of any Lung Tx Patents, if any, that Covers the Product in the Licensed Territory, and (c) the expiration of the Regulatory Data Exclusivity in the Licensed Territory, unless earlier terminated pursuant to Section 13.4.

  • With respect to Net Sales of a given Licensed Product in a country where neither a Valid Claim nor Regulatory Data Exclusivity exists ***.


More Definitions of Regulatory Data Exclusivity

Regulatory Data Exclusivity means data, market or other regulatory exclusivity (as distinct from and excluding any exclusivity arising under Patent Rights) for a Licensed Product in a country or region in the Territory under applicable laws, rules and regulations in such country or region, including, without limitation, (a) any such exclusivity provided in countries in the EU under national laws and regulations implementing Section 10.1(a)(iii) of the Directive 2001/EC/83, (b) U.S. exclusivity periods such as U.S. biosimilars exclusivity, pediatric exclusivity, orphan drug exclusivity, and the ▇▇▇▇▇-▇▇▇▇▇▇ data exclusivity or (c) any analogous laws or regulations in other countries in the Territory.
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Regulatory Data Exclusivity means with respect to a Licensed Product in a Region, the period of time during which (a) a Party or its Affiliate or Sublicensee has been granted the exclusive legal right by a Regulatory Authority in such Region to market and sell the Licensed Product; and (b) the data and information submitted by a Party or its Affiliate or Sublicensee to the relevant Regulatory Authority in such Region for purposes of obtaining Regulatory Approval may not be disclosed, referenced, or relied upon in any way by a Third Party or such Regulatory Authority (including by relying upon the Regulatory Authority’s previous findings regarding the safety or effectiveness of the Licensed Product) to support the Regulatory Approval of any product by a Third Party in such Region.
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Related to Regulatory Data Exclusivity

  • Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing and control data, preclinical data, clinical data and all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product (including any applicable Drug Master Files (“DMFs”), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).

  • Regulatory Exclusivity means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to a pharmaceutical product other than Patents, including orphan drug exclusivity, new chemical entity exclusivity, data exclusivity, or pediatric exclusivity.

  • Regulatory Materials means regulatory applications, submissions, notifications, communications, correspondence, registrations, Regulatory Approvals or other filings made to, received from or otherwise conducted with a Regulatory Authority in order to Develop, Manufacture, or Commercialize a Licensed Product in a particular country or jurisdiction.

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.