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

• Each Party expressly acknowledges that it is their intention that royalties and other consideration be paid in accordance with the terms of this Agreement, and during the periods set forth in this Agreement, notwithstanding that a Licensed Product may be royalty-bearing at a reduced rate pursuant to Section 4.8(b) in the absence of coverage by (i) Patent Rights, or after the expiration of such Patent Rights, or (ii) Data Exclusivity, or (iii) Orphan Drug Exclusivity.

• Such granted rights include use of valuable Know-How Rights, and the right to participate in the JSC and the conduct of the Development Plan so as to discover or develop Licensed Products that may not be, or may cease to be, covered by (a) Patent Rights, (b) Data Exclusivity, or (c) Orphan Drug Exclusivity.

• Data Exclusivity for New Biological Entities,” Duke University Department of Economics Working Paper.

• The obligation shall expire, on a country-by-country basis, with respect to each separate Licensed Product on the later to occur of (a) the twelfth (12th) anniversary of the First Commercial Sale of such Licensed Product in such country, and (b) such time as there is no longer (i) any Valid Claim of a Licensed Patent that claims or covers the Exploitation of such Licensed Product in such country, and (ii) any Data Exclusivity with respect to such Licensed Product in such country.

• The royalties payable pursuant to Sections 6.2.1(a) and 6.2.1(b) shall be reduced by *** (***%) on a country-by-country basis during any period in which there (i) are no Valid Claims of any INS Patent that would be infringed by the Exploitation of such Licensed Product in such country in the absence of the license grants hereunder, or (ii) is no Data Exclusivity with respect to such Licensed Product in such country.

More Definitions of Data Exclusivity

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 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 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 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 any data or market exclusivity granted to a Licensed 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 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.