NCE Exclusivity Period definition

NCE Exclusivity Period means in relation to each of the VOCABRIA NDA and the APRETUDE NDA, the applicable periods described in section 505(c)(3)(E)(ii) and 505(j)(5)(F)(ii) including any applicable extensions of paediatric exclusivity described in section 505A(c)(1)(A)(i)(I) of the U.S Food, Drugs and Cosmetics Act.
NCE Exclusivity Period means the period described in section 505(c)(3)(E)(ii) and 505(j)(5)(F)(ii) applicable to and dating from the first approval of NDA 204790 for TIVICAY (dolutegravir) tablets 50 mg on August 12, 2013, including any applicable extension of paediatric exclusivity described in section 505A(c)(1)(A)(i)(I) of the U.S. Food, Drugs and Cosmetics Act;

Examples of NCE Exclusivity Period in a sentence

  • Also, the poor living conditions in the home – an issue also addressed in several reports, including that of the Committee for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment (CPT) – was deemed to breach Articles 3 and 13 of the CRPD in conjunction with the Article 3 of the ECHR.

Related to NCE Exclusivity Period

  • Exclusivity Period shall have the meaning set forth in Section 6.11.

  • 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 prevents the approval or marketing of any Biosimilar Product of such Licensed Product in such country.

  • Minimum Hire Period means the Minimum Hire Period as described on the invoices, quotation, authority to hire, or any other forms as provided by the Supplier to the Client.

  • Royalty Period means the partial calendar quarter commencing on the date on which the first Licensed Product is sold or used and every complete or partial calendar quarter thereafter during which either (a) this Agreement remains in effect or (b) Company has the right to complete and sell work-in-progress and inventory of Licensed Products pursuant to Section 8.5.

  • License Term means in respect of each Site, the period for its license to be used by the Access Seeker commencing on the Commencement Date and as stipulated in the respective SLO.

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

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

  • Extended Period As defined in Section 9.04(b).

  • 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).

  • Regulatory Exclusivity means any exclusive marketing rights or data exclusivity rights granted by a Regulatory Authority (other than Patents) with respect to a Licensed Product sold in a given country, including orphan drug exclusivity, new chemical entity exclusivity, data exclusivity or pediatric exclusivity.

  • Minimum Term means each minimum initial and subsequent period of service for each Service as shown on the Service Agreement and Order Schedule, the initial period to start on the date on which the relevant Service is first made available to you for use. For the avoidance of doubt, unless otherwise agreed or if not stated on the Service Agreement or order schedules, the Minimum Term will be 12 months or such other period as may be notified to you in accordance with paragraph 19.2.

  • 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.

  • Penalty Period has the meaning set forth in Section 6.3.

  • Risk Period means the period that the Landlord [in its absolute discretion]21 decides, being a minimum of [three] years and a maximum of [five]22 years, starting on the date of the relevant damage or destruction;

  • Royalty Term means, with respect to each Licensed Product, the period of time beginning on the first sale of a Licensed Product in a country following receipt of regulatory approval for the marketing and sale of such Licensed Product in such country and continuing on a country-by-country and product-by-product basis until the later of (1) the expiration of the Patent Term, or (ii) ten (10) years from the date of such sale of such Licensed Product in such country (other than any sale or transfer between Licensee and its Affiliates or Sublicensees).

  • Benchmark Unavailability Period means, the period (if any) (a) beginning at the time that a Benchmark Replacement Date has occurred if, at such time, no Benchmark Replacement has replaced the then-current Benchmark for all purposes hereunder and under any Loan Document in accordance with Section 2.23 and (b) ending at the time that a Benchmark Replacement has replaced the then-current Benchmark for all purposes hereunder and under any Loan Document in accordance with Section 2.23.

  • 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.

  • Contract Term Extension means an extension of the term of this contract, at the request of Purchaser, under this Subsection. This Subsection does not obligate Contracting Officer to grant Contract Term Extension. When such extension is made, Forest Service shall make an appraisal using standard Forest Service methods and appraisal data in effect 45 days prior to the original Termination Date. Bid Premium Rates shall be added to such appraised rates to establish Flat Rates or Tentative Rates for the extension period. In event rates so established would develop Current Contract Value immediately prior to such an extension that is less than Current Contract Value at that time, Flat Rates and Tentative Rates in effect immediately prior to extension shall be retained for the extension period. In consideration for granting an extension, Purchaser shall pay the Government for Purchaser’s failure to cut and remove timber meeting Utilization Standards prior to Contract Term Extension, an amount that shall be the total of the costs to the Government resulting from the delay in harvest of Included Timber. Such costs will be determined by Forest Service and shall include, but not be limited to, the following:

  • Ramp-Up Period means the period from and including the Effective Date to, but excluding, September 23, 2016.

  • duty period means a period which starts when a crew member is required by an operator to report for or to commence a duty and ends when that person is free of all duties, including post-flight duty;

  • Hire Period means the period commencing when the Customer holds the Hire Goods on hire (including Saturdays Sundays and Bank Holidays) and ending upon the happening of any of the following events:

  • Peak Period means the time between 6 a.m. and 10 p.m. (April through September) or between 7 a.m. and 11 p.m. (October through March) on all days except Saturdays and Sundays, which daily time period will be subject to change from time to time at the Company's option. This change would occur after no less than ten (10) days notice has been given to all Customers who would be affected, and to the Commission.

  • Lock-up Period means the period beginning on the date hereof and continuing through the close of trading on the date that is 90 days after the date of the Prospectus (as defined in the Underwriting Agreement).

  • Ramp Period The Ramp Period shall begin on the Effective Date and continue for a period of 3 months following the Effective Date. Commencing with the Effective Date and at all times during the Ramp Period thereafter, Customer will receive the rates, discounts, charges and credits set forth herein and will not be subject to the AVC. Annual Volume Commitment (“AVC”): $360,000 in Total Service Charges (“AVC”) during each contract year of the Term (following the expiration of the Ramp Period).

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

  • Run-Out Period means a period after the close of a Plan Year or other period during which Participants in a flexible spending arrangement (FSA) may request reimbursement for expenses incurred during the Period of Coverage.