Regulatory Exclusivity Period means with respect to a Licensed Product in a country, the period of time during which (a) Celgene 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 Law) in such country to market and sell the Licensed Product, or (b) the data and information submitted by Celgene or any of its Affiliates or Sublicensees to the relevant Regulatory Authority in such country for purposes of obtaining Regulatory Approval may not be disclosed, referenced or relied upon in any way by 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 or marketing of any product by a Third Party in such country.

Regulatory Exclusivity Period means any period of data, market or other regulatory exclusivity, including any such periods listed in the FDA’s Orange Book.

Examples of Regulatory Exclusivity Period in a sentence

If, in a given country during a Calendar Quarter for which royalties are being calculated hereunder for Net Sales, any Product is not covered by a Valid Claim included in the Assigned Patents or by any Regulatory Exclusivity Period AND Generic Competition exists for the particular Product(s) in such country, then the royalty rate otherwise applicable to the Net Sales will be reduced by [*].
If such exclusivity is not available with respect to a Licensed Product in a country, the Regulatory Exclusivity Period for such Licensed Product in such country shall be deemed to expire upon the First Commercial Sale of such Licensed Product in such country.
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More Definitions of Regulatory Exclusivity Period

Regulatory Exclusivity Period means, with respect to a given Licensed Product and given country, a period of exclusivity (other than patent exclusivity), granted or afforded by Applicable Laws or by a Regulatory Authority in such country, that confers exclusive marketing rights with respect to such Licensed Product in such country and prevents the initial market entry of a generic product with respect to such Licensed Product. In the event that such exclusivity is not available with respect to a Licensed Product in a country, the Regulatory Exclusivity Period for such Licensed Product in such country shall be deemed to expire upon the First Commercial Sale of such Licensed Product in such country

Regulatory Exclusivity Period means any period of data., market or other regulatory exclusivity (other than supplementary protection certificates, which will be treated as part of the Acquired Patents hereunder) which prevents a Third Party from referencing data submitted by Buyer or Buyer Licensee in connection with obtaining Regulatory Approval of a Product, including any such. periods under national implementations in the European Union of Section 10.1(a)(iii) of Directive 2001/EC/83 and all foreign equivalents.

Regulatory Exclusivity Period means with respect to a Product in a country, the period of time during which Merck or any of its Sublicensees has been granted the exclusive legal right, other than Patent protection, by a Regulatory Authority (or is otherwise entitled to the exclusive legal right by operation of Law) in such country to market and sell the Product (e.g., pediatric exclusivity, or any applicable data exclusivity).

Regulatory Exclusivity Period means, with respect to each Product in any country, any period of data, market or other regulatory exclusivity (other than Patent exclusivity) granted or afforded by law or by a Regulatory Authority in such country that confers exclusive marketing rights with respect to such Product in such country or prevents another party from using or otherwise relying on any data supporting the Marketing Approval for such Product.

Regulatory Exclusivity Period means, with respect to each Licensed Product in any country in the Territory, a period of exclusivity (other than Patent exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such country that confers exclusive marketing rights with respect to such Licensed Product in such country or prevents another Person from using, referencing or otherwise relying on data supporting the Marketing Approval for such Licensed Product without the prior written consent of the Marketing Approval holder, including regulatory data exclusivity, new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, pediatric exclusivity and orphan drug designations.

Regulatory Exclusivity Period means, with respect to each Licensed Product in any country in the Territory, a period of exclusivity (other than Patent exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such country that confers exclusive marketing rights with respect to such Licensed Product in such country or prevents another Person from using or otherwise relying on any data supporting the approval of the Drug Approval Application for such Licensed Product to support an application for regulatory approval of another product for any indication without the prior written consent of the Drug Approval Application holder.