Regulatory Exclusivity Period definition

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.

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

• Constant Comparative Method was used to analyze the gathered data.

• During the Royalty Term and on a country-by-country basis, the Royalty Rate which would otherwise be due in respect of the Net Sales of a Product pursuant to Article 6.3 shall be reduced by [***]upon expiry of the Regulatory Exclusivity Period for such Product in such country, provided that such expiration is not due directly to any breach of this Agreement by or on behalf of Partner or its Affiliates.

• Royalties on Net Sales under this Section 1.3(c) will be payable on a Product-by-Product and country-by-country basis, commencing on the first commercial sale of a Finished Product in a country until the later of (i) the invalidation, revocation, lapse or expiration of the last to expire Valid Claim of any Patent that would be infringed by the sale of such Finished Product in such country or (ii) the expiration of any Regulatory Exclusivity Period for such Product in such country (the “Royalty Term”).

• 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 [*].

• In the event that, upon the expiration of any Regulatory Exclusivity Period or the expiration of the last-to-expire of the Licensed Patents containing a Valid Claim, generic products capture more than thirty percent (30%) of the market for the Product in the Territory, the Parties will, in good faith, discuss an adjustment to the royalty rate set forth in Section 9.3.1 if such adjustment would enable KDP to maximize Net Sales in the Territory.

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 will mean any period of data, market or other regulatory exclusivity (other than supplementary protection certificates, which will be treated as Patents hereunder), including any such periods under national implementations in the EU of Section 10.1(a)(iii) of Directive 2001/EC/83 and all international equivalents.

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 a Collaboration Product in any country in the Territory, a period of exclusivity (other than exclusivity with respect to a Patent Right) granted or afforded by Applicable Laws or by a Regulatory Authority in such country that confers exclusive marketing rights with respect to such Collaboration Product in such country. Where such exclusive marketing rights only relate to a specific indication, the applicable Regulatory Exclusivity Period shall only be deemed to apply to such Collaboration Product in such indication.

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 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 which confers an exclusive Commercialization period during which AbbVie or its Affiliates or Sublicensees have the exclusive right to market and sell a Licensed Compound or Licensed Product in such country through a regulatory exclusivity right.

Regulatory Exclusivity Period means, with respect to each Licensed Product in any country in the Territory, any period of data, market or other regulatory 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 party from using or otherwise relying on any data supporting the approval of the NDA or supporting the MAA for such Licensed Product without the prior written consent of the NDA-holder or MAA-holder, as applicable, such as new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, non-patent related paediatric exclusivity or any other applicable marketing or data exclusivity, including any such periods listed in the FDA’s Orange Book or any such periods under national implementations in the EU of Article 10 of Directive 2001/83/ED, Article 14(11) of Parliament and Council Regulation (EC) No. 726/2004, Parliament and Council Regulation (ED) No. 141/2000 on orphan medicines, Parliament and Council Regulation (ED) No. 1901/2006 on medicinal products for paediatric use and all international equivalents of any of the foregoing.