Marketing Exclusivity definition

Marketing Exclusivity means, with respect to the Licensed Territory, the period of data exclusivity as provided under local Laws during which Third Parties do not have the right, in connection with seeking or obtaining Marketing Approval of a pharmaceutical product that contains the same or substantially similar active ingredient(s) or the same active moiety(ies) as a Licensed Product, (i) to reference the Licensed Product’s clinical dossier without an express right of reference from the dossier holder, or (ii) to rely on previous Regulatory Authority determinations of safety and effectiveness with respect to the Licensed Product to support the submission, review or approval of a Drug Approval Application or similar regulatory submission filed with the applicable Regulatory Authority for such pharmaceutical product, as well as any other exclusivity periods available under local Laws (e.g. with respect to orphan drugs, new chemical entity exclusivity and pediatric exclusivity) during which Third Parties are prevented from filing or having accepted by Regulatory Authorities a Drug Approval Application for, or obtaining Marketing Approval of, a pharmaceutical product that contains the same or substantially similar active ingredient(s) or the same active moiety(ies) as a Licensed Product in the Licensed Field in the Licensed Territory.

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Marketing Exclusivity means the exclusivity from the purview of common carrier or contract carrier as specified in regulation 6 of the Petroleum and Natural Gas Regulatory Board (Exclusivity for City or Local Natural Gas Distribution Network) Regulations, 2008;

Marketing Exclusivity. Marketing Exclusivity means, with respect to a Licensed Product, the marketing exclusivity afforded approved drug products pursuant to (a) Sections 505(c), 505(j), and 505A of the FD&C Act, and the regulations promulgated thereunder, as amended from time to time, or its equivalent in a country other than the United States, or (b) the orphan drug exclusivity afforded approved drugs designated for rare diseases or conditions under Sections 526 and 527 of the FD&C Act, and the regulations promulgated thereunder, or its equivalent in a country other than the United States.

Examples of Marketing Exclusivity in a sentence

Such reduction shall be first applied with respect to such country starting with sales in the Calendar Quarter following the Calendar Quarter in which Loss of Marketing Exclusivity occurs for such Product in such country.
If, on a product-by-product basis, during the Term (i) no Valid Claim exists in the Licensed Territory Covering the Licensed Product or its manufacture, use or sale, or (ii) the Marketing Exclusivity with respect to such Licensed Product in the Licensed Territory has expired, then the royalty rate shall be reduced to [***] of annual Net Sales for the remainder of the Term in the Licensed Territory for such Licensed Product.
Such royalty obligation shall expire on a country-by-country basis on the later of: (A) the expiration of the last Valid Claim within the Translational Research Patent Rights Covering an AVEO Label Claim Product, (B) the expiration of any Marketing Exclusivity for such AVEO Label Claim Product in such country, and (C) the 10th anniversary of the date of the First Commercial Sale by AVEO or any of its Affiliates or Sublicensees to an unaffiliated Third Party of such AVEO Label Claim Product in such country.
With respect to Marketing Exclusivity Rights or other data exclusivity periods (such as those periods listed in the FDA’s Orange Book (including without limitation any available pediatric extensions) and all foreign equivalents in the Territory), Endo shall use Commercially Reasonable Efforts consistent with its obligations under applicable law to seek, maintain and enforce all of the foregoing available for the Products in all countries in the Territory where Regulatory Approval is obtained.
Each Party shall use Commercially Reasonable Efforts to secure any available forms of Marketing Exclusivity and extensions of patent term as may be available in a particular country or region for any Licensed Product that is being Commercialized by it or its Affiliates or Sublicensees.

More Definitions of Marketing Exclusivity

Marketing Exclusivity means, with respect to a pharmaceutical product in a country: (a) the exclusivity afforded to the pharmaceutical product for being the first drug product containing the active ingredient to receive regulatory approval in that country, (b) pediatric exclusivity, or (c) orphan drug exclusivity, but only when the pharmaceutical product does not also have a non-orphan drug indication that is not protected by an unexpired exclusivity.

Marketing Exclusivity means the marketing exclusivity afforded approved drug products pursuant to (a) the exclusivity provisions of the United States "Drug Price Competition and Patent Term Restoration Act of 1984", or its equivalent in a country other than the United States, or (b) the exclusivity provisions of the United States "Orphan Drug Act", or its equivalent in a country other than the United States.

Marketing Exclusivity means any exclusive marketing, data protection or other exclusivity rights conferred by FDA, EMA or any other Regulatory Authority with respect to the Licensed Product, including orphan drug exclusivity, pediatric exclusivity and rights conferred under the Drug Price Competition and Patent Term Restoration Act of 1984, as amended from time to time.

Marketing Exclusivity means, with respect to the Licensed Tenito1y, the period of data exclusivity as provided under local Law during which Third Patties do not have the right, in connection with seeking or obtaining Marketing Approval of a pharmaceutical product that contains the s▇▇▇▇ or substantially similar active ingredient(s) or the s▇▇▇▇ active moiety(ies) as a Licensed Product, (i) to reference the Licensed Product’s clinical dossier without an express right of reference from the dossier holder, or (ii) to rely on previous Regulato1y Authority dete1IDinations of safety and effectiveness with respect to the Licensed Product to support the submission, review or approval of a Marketing Approval Application or similar· regulato1y submission filed with the applicable Regulato1y Authority for such pharmaceutical product, as well as any other exclusivity periods available under local Law (e.g. with respect to orphan drugs, new chemical entity exclusivity and pediatric exclusivity) during which Third Patties ai·e prevented from filing or having accepted by Regulato1y Authorities a Marketing Approval Application for, or obtaining Marketing Approval of, a pharmaceutical product that contains the s▇▇▇▇ or substantially similai· active ingredient(s) or the same active moiety(ies) as a Licensed Product in the Licensed Field in the Licensed Tenito1y. [***]

Marketing Exclusivity means, with respect to a Licensed Product that the Licensed Product has been granted marketing exclusivity afforded approved drug products pursuant to (a) Sections 505(c), 505(j), and 505A of the FD&C Act or its equivalent in a country other than the United States, or (b) the orphan drug exclusivity afforded approved drugs designated for rare diseases or conditions under Sections 526 and 527 of the FD&C Act or its equivalent in a country other than the United States, or (c) applicable law covering the Licensed Product which precludes the Regulatory Authority in a country from granting Marketing Approval for another product that contains the same active ingredient as that which is contained in the applicable Licensed Product.

Marketing Exclusivity means, with respect to a Product in a country: (a) the exclusivity afforded to the Product for being the first drug product containing the active ingredient to receive Regulatory Approval in that country, (b) pediatric exclusivity, (c) orphan drug exclusivity, but only when all other indications of the applicable Product that have been approved by the applicable Regulatory Authority and appear in the labeling for such Product are also protected by an unexpired orphan exclusivity or other exclusivity pursuant to clause (a), (b) or (d) of this Section 1.48, or (d) other statutory and/or regulatory exclusivity.

Marketing Exclusivity. Marketing Exclusivity means, with respect to a Royalty-Bearing Product, that such Royalty-Bearing Product has been granted marketing exclusivity afforded approved drug products pursuant to (a) Sections 505(c), 505(j), and 505A of the Act, and the regulations promulgated thereunder, as amended from time to time, or its equivalent in a country other than the United States, or (b) the orphan drug exclusivity afforded approved drugs designated for rare diseases or conditions under Sections 526 and 527 of the Act, and the regulations promulgated thereunder, as amended from time to time, or its equivalent in a country other than the United States, or (c) applicable Law covering the Royalty-Bearing Product which precludes the Regulatory Authority in a country from granting Regulatory Approval for another product that contains the same active ingredient as that which is contained in the applicable Royalty-Bearing Product.