Market Exclusivity Rights definition

Market Exclusivity Rights means (a) a marketing exclusivity right conferred upon the sponsor of a drug for a rare disease or condition under 21 United States Code Section 360cc, any analogous provision of law applicable in any other country in the Territory, or any provision of law that is a successor to them; and (b) “market exclusivity” that is additive or complementary to that specified in the preceding clause “a” that is earned and granted as a result of the conduct of specified paediatric studies, under 21 United States Code Section 355a, any analogous provision of law applicable in any other country in the Territory, or any provision of law that is a successor to them.
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Market Exclusivity Rights means (a) a marketing exclusivity right conferred upon the sponsor of a drug for a rare disease or condition under 00 Xxxxxx Xxxxxx Code *** Confidential Treatment Requested *** Section 360cc, any analogous provision of law applicable in any other country in the Territory, or any provision of law that is a successor to them; and (b) “market exclusivity” that is additive or complementary to that specified in the preceding clause “a” that is earned and granted as a result of the conduct of specified paediatric studies, under 00 Xxxxxx Xxxxxx Code Section 355a, any analogous provision of law applicable in any other country in the Territory, or any provision of law that is a successor to them.
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Market Exclusivity Rights means, on a country-by-country basis, unexpired rights provided by law or statute that provide a Product with exclusive marketing rights in such country, including rights conferred as a result of: (a) a designation as a drug for rare diseases or conditions under Sections 526 et seq. of the FDC Act, as amended (or the equivalent rights in any other country); (b) an exclusive right to sell under a New Drug Application (“NDA”) pursuant to Section 505(b)(1) of the FDC Act, as amended (or the equivalent rights in any other country); or (c) the completion of pediatric studies requested by the FDA under Section 505A(a) of the FDC Act (or the equivalent rights in any other country).
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Examples of Market Exclusivity Rights in a sentence

  • As an inducement for PPD to enter into this Agreement, Accentia agrees to use its best efforts to maintain exclusive license rights under the Mayo License Agreement and prosecute, perfect and maintain the Market Exclusivity Rights (as defined in the Mayo License Agreement) for a Product.

  • If Net Sales are US$[**] in the first quarter and $[**] in the second quarter; of the US$[**], US[**] is from the US, US$[**]from the Major EU Countries, and US$[**] from the Rest of World Territory; and Market Exclusivity Rights are lost or not obtained in France where there were US$[**] Net Sales for that quarter.

Related to Market Exclusivity Rights

  • Regulatory Exclusivity means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to a pharmaceutical product other than Patents, including orphan drug exclusivity, new chemical entity exclusivity, data exclusivity, or pediatric exclusivity.

  • Licensed IP Rights means, collectively, the Licensed Patent Rights and the Licensed Know-How Rights.

  • Technology Rights means BOARD's rights in any technical information, know-how, processes, procedures, compositions, devices, methods, formulae, protocols, techniques, software, designs, drawings or data created by the inventor(s) listed in Exhibit I at UTMDACC before the EFFECTIVE DATE, which are not claimed in PATENT RIGHTS but that are necessary for practicing PATENT RIGHTS.

  • 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.

  • Licensed Intellectual Property Rights means any Intellectual Property Rights owned by a third party that a Person has a right to use, exploit or practice by virtue of a license grant, immunity from Legal Action or otherwise.

  • Licensor Technology means the Licensor Patents and the Licensor Know-How.

  • Licensed Fields of Use means the fields of use identified in Appendix B.

  • Exclusivity means the specificity of the test method for validating microbial testing methods. It evaluates the ability of the method to distinguish the target organisms from similar but genetically distinct non-target organisms.

  • Product Technology means the Product Know-How and Product Patents.

  • Licensee Technology means the Licensee Know-How and Licensee Patents.

  • Company IP Rights means (a) any and all Intellectual Property used in the conduct of the business of the Company or any of its Subsidiaries as currently conducted, and (b) any and all other Intellectual Property owned by the Company or any of its Subsidiaries.

  • Intellectual Property Rights or IPR means copyright, rights related to or affording protection similar to copyright, rights in databases, patents and rights in inventions, semi-conductor topography rights, trade marks, rights in internet domain names and website addresses and other rights in trade or business names, designs, Know-How, trade secrets and other rights in Confidential Information; applications for registration, and the right to apply for registration, for any of the rights listed at (a) that are capable of being registered in any country or jurisdiction; and all other rights having equivalent or similar effect in any country or jurisdiction;

  • Licensed IP means the Licensed Patents and the Licensed Know-How.

  • Competing Products means any product or service in existence or under development that competes with any product or service of the Company Group about which the Participant obtained Confidential Information or for which the Participant provided advisory services or had sales, origination, marketing, production, distribution, research or development responsibilities in the last twenty-four (24) months of employment with the Company Group.

  • Joint Intellectual Property Rights means any work under the Subcontract, which:

  • Intellectual Property Right means, including but not limited to, any patent, registered design, copyright, trademark, trade secrets and any other intellectual or industrial property right as well as the right to apply to register any of the mentioned rights.

  • Patent Rights means all patents and patent applications, including all divisionals, continuations, substitutions, continuations-in-part, re-examinations, reissues, additions, renewals, extensions, registrations, and supplemental protection certificates and the like of any of the foregoing.

  • Licensed Technology means the Licensed Patents and the Licensed Know-How.

  • Licensed Field of Use means all fields.

  • Intellectual Property Rights (IPR) (11/18) means any patent rights, copyrights, trade secrets, trade names, service marks, trademarks, trade dress, moral rights, know-how and any other similar rights or intangible assets to which rights of ownership accrue, and all registrations, applications, disclosures, renewals, extensions, continuations, or reissues of the foregoing now or hereafter in force. “Key Personnel” (11/18) means the specific individuals identified in Section 3.11 to fill Key Positions.

  • Third Party Technology means all Intellectual Property and products owned by third parties and licensed pursuant to Third Party Licenses.

  • IP Ancillary Rights means, with respect to any other Intellectual Property, as applicable, all foreign counterparts to, and all divisionals, reversions, continuations, continuations-in-part, reissues, reexaminations, renewals and extensions of, such Intellectual Property and all income, royalties, proceeds and Liabilities at any time due or payable or asserted under or with respect to any of the foregoing or otherwise with respect to such Intellectual Property, including all rights to xxx or recover at law or in equity for any past, present or future infringement, misappropriation, dilution, violation or other impairment thereof, and, in each case, all rights to obtain any other IP Ancillary Right.

  • Licensed Know-How means any and all unpatented and/or non-patentable technical data, documents, materials, samples and other information and know‐how that is Controlled by LICENSOR or any of its Affiliates as of the Effective Date or thereafter during the Term that relates to, or is otherwise reasonably necessary or reasonably useful for, the use, Development, manufacture, or Commercialization of the Product. Licensed Know-How shall not include Licensed Patents.

  • Licensed Trademarks means the trademarks, service marks, trade dress, logos and other icons or indicia designated by SCEA in the SourceBook 2 or other Guidelines for use on or in connection with Licensed Products. Nothing contained in this Agreement shall in any way grant Publisher the right to use the trademark "Sony" in any manner. SCEA may amend such Licensed Trademarks from time to time in the SourceBook 2 or other Guidelines or upon written notice to Publisher.

  • Competing Product means [***].

  • Licensed Marks means the Localized Game Marks and such other trademarks expressly authorized in writing by Shengqu to be used by the Licensees.