180-Day Exclusivity definition

180-Day Exclusivity means the period defined in 21 U.S.C. 355(j)(5)(B)(iv) alone or shared with others. 1.2 "Affiliates" shall mean, with respect to any Person, any Person directly or indirectly controlling, controlled by, or under common control with, that party. For purposes of this Agreement, the term "controlled" (including the terms "controlled by" and "under common control with"), as used with respect to any Person, shall mean the direct or indirect ability or power to direct or cause the direction of management policies of such Person or otherwise direct the affairs of such Person, whether through ownership of voting securities or otherwise.
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180-Day Exclusivity means the Xxxxx-Xxxxxx exclusivity as described in 21 U.S.C. § 355(j)(5)(B)(iv)(II)(aa) (as amended or replaced).
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Examples of 180-Day Exclusivity in a sentence

  • See also draft guidance for industry on 180-Day Exclusivity: Questions and Answers, Q.

  • Karst, FDA Rules Against Patent Expiration 180-Day Exclusivity Forfeiture for Generic COZAAR/HYZAAR, But in Doing So FDA Repudiates Its Own Decision and Asks to be Sued, FDA LAW BLOG (Mar.

  • Nielsen Hobbs, 180-Day Exclusivity Ruling on Cosopt Signals Need for Strong Patent Challenges, THE PINK SHEET (Nov.

  • The Effect of Patent Expiration on 180-Day Exclusivity Related to the issue of whether voluntary patent delisting by the NDA holder constitutes a forfeiture event is the issue of whether patent expiration (other than natural expiration) constitutes a forfeiture event under 21 U.S.C. § 355(j)(5)(D)(i)(VI).

  • FDA, Guidance for Industry: 180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day, http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidanc es/UCM072851.pdf.Consistent with Congress's policy objective, in recent years there has been an overall increase in pharmaceutical patent challenges, as well as a sharper increase in challenges soon after initial approval of the brand-name drug.

  • Scott, A New History and Discussion of 180-Day Exclusivity, 64 Food & Drug L.

  • Shashank Upadhye, Triggering the 180-Day Exclusivity Clock Under the Post- MMA Rules, GENERIC PHARMACEUTICAL PATENT AND FDA LAW, Feb.

  • Center for Drug Evaluation and Research, Guidance for Industry, 180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day (July 2003) available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm072851.pdf.

  • Erika King Lietzan, A Brief History of 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act, 59 FOOD & DRUG L.J. 287, 309–313 (2004).

  • Guidance for Industry: 180-Day Exclusivity: Questions and Answers (Draft Guidance).

Related to 180-Day 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 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.

  • 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.

  • Exclusivity Period means the period beginning on the date hereof and ending on the first to occur of (a) the date six (6) months after the date hereof and (b) the mutually agreed termination of this Agreement pursuant to Section 6.01(b).

  • Royalty Term has the meaning set forth in Section 8.4(b).

  • License expiration date means June 30 of even-numbered years.

  • License Term means the duration of a License as specified in the Order.

  • Opt-Out Period means the period that begins the day after the earliest date on which the Notice is first distributed, and that ends no later than 30 days before the Final Approval Hearing. The deadline for the Opt-Out Period shall be specified in the Notice.

  • Patent Term Extension means any term extensions, supplementary protection certificates and equivalents thereof offering Patent protection beyond the initial term with respect to any issued Patents.

  • PEA Period means the period commencing at 9:30 a.m., Eastern time, on the fifth (5th) Business Day immediately prior to the filing of any post-effective amendment to the Registration Statement (as defined herein) or New Registration Statement (as such term is defined in the Registration Rights Agreement), and ending at 9:30 a.m., Eastern time, on the Business Day immediately following, the effective date of any post-effective amendment to the Registration Statement (as defined herein) or New Registration Statement (as such term is defined in the Registration Rights Agreement).

  • Risk Period means the period for which the Landlord decides to insure against loss of Rent, being a minimum of [three] years and a maximum of [five]14 years, starting on the date of the relevant damage or destruction;

  • Commercial Sale means for a given product and country the sale for value of that product by a Party (or, as the case may be, by an Affiliate or permitted sublicensee of a Party), to a Third Party after regulatory approval (if necessary) has been obtained for such product in such country.

  • Term Expiration Date means the earlier of (i) the date that is thirty (30) years after the Term Commencement Date; provided that if such date occurs within an NFL Season or within thirty (30) days following an NFL Season, such date shall be automatically extended to the date that is thirty (30) days following the end of such NFL Season, as applicable, or (ii) the date on which the Stadium Lease is terminated pursuant to the express rights and terms of the Stadium Lease.

  • License Period means the period beginning from the Commencement Date and ending on the Termination Date.

  • Exclusion period means a period during which specified treatments or services are ex-

  • License Effective Date means, with respect to each Component System of the Licensed System that Company is given the right to access and use, the date as of which the Company is first given such right to access and use.

  • Period shall have the meaning ascribed to it in Schedule 8;

  • Valid Claim means a claim of an issued and unexpired Patent that (i) has not been revoked or held unenforceable or invalid by a decision of a court or other Governmental Entity of competent jurisdiction from which no appeal can be taken or has been taken within the time allowed for appeal and (ii) has not been abandoned, disclaimed, denied, or admitted to be invalid or unenforceable through reissue or disclaimer or otherwise in such country.

  • End of Term Extension means the time period defined in §2.D.

  • Application Period means the months beginning with the month in which the application is considered to be filed, through and including the month in which an eligibility determination is made.

  • Tail Period has the meaning set forth in Section 4.2.

  • Exclusive Field means the diagnosis, treatment or prevention of any cancer in humans through the use of Engineered T-Cells, which shall exclude the diagnosis, treatment or prevention of medullary cystic kidney disease 1 regardless of whether such disease is characterized as a cancer.

  • Applicable Anniversary of the Commencement Date means the fifth (5th) anniversary of the Commencement Date.

  • Limitation Period means any period while any amount remains owing on the Note and interest on such amount, calculated at the applicable interest rate, plus any fees or other sums payable under any Loan Document and deemed to be interest under applicable law, would exceed the amount of interest which would accrue at the Highest Lawful Rate.

  • Lookback Period means the three completed fiscal years immediately preceding the Accounting Restatement Date, as well as any transition period (resulting from a change in the Company’s fiscal year) within or immediately following those three completed fiscal years (except that a transition period of at least nine months shall count as a completed fiscal year). Notwithstanding the foregoing, the Lookback Period shall not include fiscal years completed prior to the Effective Date.

  • Exclusive Period means the period of time set forth in Section 2.2.