Exclusivity Extension definition

Exclusivity Extension means any applicable exclusivity extensions for a pharmaceutical product, including without limitation pediatric, biologic product, or data exclusivity, in a country with respect to a product (such as those periods listed in the FDA’s Orange Book or periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83, and equivalents in other countries in the Territory).
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Examples of Exclusivity Extension in a sentence

  • If ALL has timely provided a Conversion Notice and GenMark has not, within the Extended Exclusivity Option Period, provided ALL with an Exclusivity Extension Exercise notice and paid the Exclusivity Extension Fee, the licenses granted to GenMark in Sections 5.1.1. 5.1.2 and 5.2 shall become non-exclusive.

  • Labeling Changes and Costs for Clinical Trials Performed Under the US Food and Drug Administration Pediatric Exclusivity Extension, 2007 to 2012.

  • Operating and non-operating revenues and expenses Operating revenues are those revenues that are generated directly by the School’s primary mission.

  • Adesto agrees that it shall pay Fees to Axon as required by Section 6.1 (Fees) of the Agreement and pursuant to Section 2.2 (Stand-alone Memory Blocks) of Exhibit A to the Agreement for any number of additional [*] inch diameter equivalent Production Wafers containing Authorized Products consisting primarily of Memory Blocks manufactured by an Authorized Manufacturer that exceeds the Minimum Wafer Requirement in any year during the Exclusivity Extension Period.

  • For the purposes hereof, “Valid Patent Claim” shall include any patent term extension such as but not limited to supplementary protection certificates pursuant to Council Regulation (EEC) No. 1768/92, any Pediatric Exclusivity Extension, and foreign equivalents of any of the foregoing relating to such patents.

  • Financial Risk Management (cont’d)(c) Liquidity risk (cont’d)The maturity analysis of the Group’s financial liabilities is as follows:5.

  • Rather than file either proposed plan, the Debtors elected to file a motion seeking further extension of the Exclusive Filing Period through July 31, 2018 and the Exclusive Solicitation Period through October 1, 2018 (the “July Exclusivity Extension Motion”).

  • Development Collaboration and License Agreement Page 13 th th th th Execution Version breach of this Agreement or the Supply Agreement by ALL, then ALL shall have the right to terminate this Agreement pursuant to Section 10.2.1. If paid, the Exclusivity Extension Fee shall be fully creditable against any future payment due to ALL pursuant to Section 6.4.

  • If ALL has timely provided a Conversion Notice and GenMark has timely provided ALL with an Exclusivity Extension Exercise notice and paid the Exclusivity Extension Fee, the licenses granted to GenMark in Sections 5.1.1. 5.1.2 and 5.2 shall remain exclusive, provided that the First Commercial Sale of a Licensed Product occurs by the seventh (7th) anniversary of the Effective Date.

  • Upon the delivery by X4 of the Financing Exclusivity Extension Notice, the Financing Exclusivity Period shall automatically be extended [***].

Related to Exclusivity Extension

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

  • Patent Term Extension means any term extensions, supplementary protection certificates, regulatory exclusivity 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:

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

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

  • 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.

  • 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.

  • Exclusivity Agreement , in relation to land, means an agreement, by the owner or a lessee of the land, not to permit any person (other than the persons identified in the agreement) to construct a solar pv station on the land;”;

  • Service Extension shall have the meaning set forth in Section 7.1(c).

  • Second Extension Period means the period commencing on the day following the First Extended Scheduled Maturity Date and ending on the Second Extended Scheduled Maturity Date.

  • Extension Term means the time period defined in §2.C.

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

  • Renewal Application means a document used to collect pertinent data for renewal of permits

  • First Extension Period means a period of twelve (12) consecutive months following the Initial Maturity Date.

  • Non-Extension Notice has the meaning specified in Section 2.10.

  • Development Term means the period commencing on the Closing Date and ending on the earlier of (a) the Option Closing Date or (b) the date the Option terminates or expires other than by exercise.

  • Line Extension means the provision of facilities (including, but not limited to, poles, fixtures, wires, and appurtenances) necessary for delivering electrical energy from the point of origin to one or more of the customer's points of delivery. Facilities provided by the Company to maintain, protect, upgrade, or improve its overall distribution system (even if necessary due to a customer's load addition) are not considered part of a line extension.

  • REO Extension As defined in Section 3.16(a).

  • Extension Effective Date has the meaning assigned to such term in Section 2.22(a).

  • Research Term has the meaning set forth in Section 3.2.

  • Repudiation/Moratorium Extension Notice means a notice from the Calculation Agent to the Issuer (which the Calculation Agent has the right but not the obligation to deliver) that describes a Potential Repudiation/Moratorium that occurred on or prior to the Scheduled Maturity Date. A Repudiation/Moratorium Extension Notice must contain a description in reasonable detail of the facts relevant to the determination that a Potential Repudiation/Moratorium has occurred and indicate the date of the occurrence. The Potential Repudiation/Moratorium that is the subject of the Repudiation/Moratorium Extension Notice need not be continuing on the date the Repudiation/Moratorium Extension Notice is effective.

  • Research License means a nontransferable, nonexclusive license to make and to use the Licensed Products or the Licensed Processes as defined by the Licensed Patent Rights for purposes of research and not for purposes of commercial manufacture or distribution or in lieu of purchase.

  • Resolution Extension Period As defined in Section 2.03(b).

  • Extension has the meaning specified in Section 2.18(a).

  • Non-Extension Notice Date has the meaning specified in Section 2.03(b)(iii).

  • Initial Term Loan shall have the meaning provided in Section 2.1(a).