Data Exclusivity definition

Data Exclusivity means any data or market exclusivity periods established by Applicable Law, including any such periods listed in the FDA’s Orange Book or periods under national implementations of Article 10.l(a)(iii) of Directive 2001/83/EC (as amended), and all international equivalents.

Data Exclusivity has the meaning set forth in Section 1.73.

Data Exclusivity means, with respect to a Licensed Product in a country, that period during which a Party or any of its Affiliates or Sublicensees has been granted the exclusive legal right by a Regulatory Authority (or is otherwise entitled to the exclusive legal right by operation of applicable Law) in such country to market and sell such Licensed Product in such country in the approved indication in the Field.

Examples of Data Exclusivity in a sentence

• Baker, Ending Drug Registration Apartheid: Taming Data Exclusivity and Patent/Registration Linkage, 34 AM.

• Carlos Christopher Smith Díaz, Delving into the Fog of Ambiguity: An Analysis of the Trans- Pacific Partnership’s Data Exclusivity Provisions and Their Implications for Access to Medicines in New Zealand, 48 VICTORIA U.

• Different Scenarios for Data Exclusivity and Patent Protection Source: CRS reproduction of figure from Government Accountability Office (GAO), Intellectual Property: U.S. Trade Policy Guidance on WTO Declaration on Access to Medicines May Need Clarification, GAO-07-1198, September 2007.

• Baker, Ending Drug Registration Apartheid: Taming Data Exclusivity And Patent/Registration Linkage, 34 AM.

• See e.g., Rosario Cartagena & Amir Attaran, A Study of Pharmaceutical Data Exclusivity Laws in Latin America: Is Access to Affordable Medicine Threatened, 17 health l.

More Definitions of Data Exclusivity

Data Exclusivity means any data or market exclusivity granted to the Product in the Field in the Territory by any Regulatory Authority as of the Effective Date or at any time during the Term.

Data Exclusivity means a marketing or data exclusivity right conferred as a result of (a) designation as a drug for rare diseases or conditions under Sections 525 et seq. of the FDC Act, (b) an exclusive right to sell under an NDA pursuant to Section 505(j)(5)(F)(ii), (iii) and (iv) or 505(c)(3)(E)(ii), (iii) and (iv) of the FDC Act or any relevant subsequent legislation, rules or regulations, (c) the exclusive right granted by the FDA upon completion of pediatric studies requested by the FDA under Section 505A of the FDC Act, (d) Article 10 of EU Directive 2001/83/EC and/or Article 3(3) of EU Regulation 726/2004/EC or (e) EU Regulations 141/2000/EC and/or 847/2000/EC, as applicable, or any equivalent or similar rights in the Territory, successor legislations of any of the foregoing or subsequent legislation that has the effect of extending marketing or data exclusivity right to a pharmaceutical product.

Data Exclusivity means a period of exclusivity granted by a regulatory authority during which no Third Party may sell a generic product that competes with a Product.

Data Exclusivity means the one‐year period of exclusive use of the Data specified by the Data Producer to analyze the data and prepare for publication. This one‐year period may be extended upon agreement between the Data Producers and OBI.

Data Exclusivity means any data or market exclusivity granted to a Drug Substance or Drug Product in the SPA Territory by any Regulatory Authority as of the Effective Date or at any time during the Term.

Data Exclusivity means the one-year period of exclusive use of the Data specified by the Data Producer to analyze the data and prepare for publication. This one-year period may be extended upon agreement between the Data Producers and OBI.

Data Exclusivity means proprietary data that is part of the Acquired Assets and is held by Buyer (or that the Buyer licenses or sublicenses) that can be used to prevent other parties from marketing the Product.