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.
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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;
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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 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.

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

  • 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 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.

  • Minimum Term means the minimum initial period of service for each Service as shown on the Service Agreement and Order Schedule, such 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 the minimum term will be 12 months from your contract commencement date or other such date 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, on a country-by-country basis, the period commencing on the First Commercial Sale of a Licensed Product in a country and ending on the latest of (a) ** thereafter, (b) expiration of the last-to-expire Valid Claim of a Licensed Patent that Covers the composition of matter of the Licensed Product in the country in which it is sold, or (c) the expiration of all Regulatory Exclusivity Rights with respect to such Licensed Product in the country in which it is sold.

  • 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 2.14 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 2.14.

  • 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.

  • 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 7a.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 begins on the Effective Date and ends after three (3) full months. At all times during the Ramp period, Customer will receive the rates, discounts, charges and credits in the agreement and will not be subject to an AVC. Annual Volume Commitment (“AVC”): Customer agrees to pay Company no less than $2,836,000 in Total Service Charges in each twelve-month period during the Initial Term (“Contract Year”), which is the Annual Volume Commitment (“AVC”).

  • 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.