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 Period shall have the meaning set forth in Section 6.11.
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.
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.
Royalty Term has the meaning set forth in Section 8.3(b).
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.
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.
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.
Competitive Product means a product or service, made or provided by a Competitor, which is the same as or is directly competitive with one with respect to which the Employee acquired confidential information relating to the Company, or its business, products or services by reason of the Employee's work with the Company.
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.
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.
Exclusive Period means the period of time set forth in Section 2.2.
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;
Opt-Out Period means the period that begins the day after the earliest date on which the Notice is first mailed, and that ends no later than 30 days before the Final Approval Hearing. The deadline for the Opt-Out Period will be specified in the Notice.
Launch Date has the meaning specified therefor in Section 2.02(b) of this Agreement.
Competitive negotiation means a procedure for contracting for supplies, materials, equipment or contractual services, in which proposals are solicited from qualified suppliers by a request for proposals, and changes may be negotiated in proposals and prices after being submitted.
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).
End of Term Extension means the time period defined in §2.D.
Competing Product means […***…].
Penalty Period has the meaning set forth in Section 6.3.
Permanent exclusion means the student is banned forever from attending a public school in the State of Ohio. (See Policy 5610.01)
NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.
Marketing Period means the first period of twenty (20) consecutive days after the date of this Agreement throughout and on the last day of which (a) Buyers shall have received all of the Required Information and such Required Information is Compliant (provided, that if the Company shall in good faith reasonably believe it has provided the Required Information and that the Marketing Period has commenced, it may deliver to Buyers a written notice to that effect (stating when it believes it completed such delivery), in which case the Marketing Period will be deemed to have commenced on the date of such notice unless Buyers in good faith reasonably believes the Marketing Period has not commenced and within two Business Days after the delivery of such notice by the Company, delivers a written notice to the Company to that effect (setting forth with specificity why they believe the Marketing Period has not commenced)), and (b) the conditions set forth in Article VII shall be satisfied or waived (other than the condition set forth in Sections 7.01(e) and 7.01(j) and other those that by their nature need not be satisfied until the Closing or are to be performed at Closing, but subject to the satisfaction or waiver of those conditions at such time); provided, that the Marketing Period shall not be deemed to have commenced if at any time during such twenty (20) consecutive day period (i) the applicable independent auditors of the Company shall have withdrawn any audit opinion contained in the Required Information, (ii) any Required Information ceases to be Compliant or (iii) the Company or its independent auditors determines that the Company must restate any historical financial statements or material financial information included in the Required Information (each of the conditions set forth in clauses (i) through (iii) above being referred to as a “Marketing Period Delay Condition”), then, in each case, the Marketing Period shall not be deemed to have commenced until the date on which such Marketing Period Delay Condition is cured, subject, in each case, to the conditions set forth in clauses (a) and (b) and clauses (i) through (iii) above (which may result in a subsequent Marketing Period Delay Condition). Notwithstanding anything to the contrary in this definition, (A) the Marketing Period shall not include any date from and including November 27, 2014 through and including November 28, 2014, and if such Marketing Period has not ended prior to December 19, 2014, such Marketing Period will not begin until January 5, 2015, (B) if the Required Information is Compliant and any of the Company’s applicable current or former independent accountants declines to issue customary comfort letters (including as to customary negative assurance comfort and change period) with respect to any Required Information, the Marketing Period shall end no earlier than five (5) days after all applicable independent accountants have issued such comfort letters, and (C) the Marketing Period shall terminate on the date on which the Debt Financing or the related financings described in the Debt Commitment Letters required to consummate the transactions contemplated hereby is consummated if such date is earlier than the last day of the twenty (20) consecutive day period described above (including any required extensions, as provided above).
FDA Approval means the approval by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.
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: