Market Exclusivity Period definition

Market Exclusivity Period means, with respect to each Product in each country, that period of time during which (a) [a] Party[ies] has [have] the exclusive legal right, whether by means of [a] Valid Claim[s] in [a] Patent Right[s] or through other rights granted by a governmental authority in such country (each Patent Right containing such claim or each such other right, a "Market Exclusivity Right"), to market, price and sell such Product in such country, and (b) no generic equivalent of such Product is marketed in such country.
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Market Exclusivity Period means that period of time with respect to a particular country in the MN Territory during which MN has the exclusive legal right to market Licensed Products pursuant to regulations of such country’s governing health authority and during which no Generic Competition exists.
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Market Exclusivity Period refers to any exclusive marketing rights granted by the FDA or other U.S. government agency for a specified period upon Regulatory Clearance or Regulatory Approval.
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Examples of Market Exclusivity Period in a sentence

  • Each Party shall use Commercially Reasonable Efforts to maintain and, to the extent available, legally extend the Market Exclusivity Period (other than with respect to Patent Rights, for which the provisions of Article XII shall apply), granted to a Party(ies) with respect to a Product in any country in the applicable Territory.

  • Evaluating The Impact of The Orphan Drug Act’s Seven-Year Market Exclusivity Period.

  • The term of this Agreement shall conclude (a) at the end of twenty (20) years from the Effective Date of this Agreement, (b) on the expiration date of the last-to-expire Valid Claim of any Patent, or (c) at the end of the last-to-expire Market Exclusivity Period for any Licensed Product, whichever comes later, unless otherwise terminated pursuant to another provision of this Agreement.


More Definitions of Market Exclusivity Period

Market Exclusivity Period means in respect of a Product in a particular country of the Territory, the shortest period provided for in the relevant Applicable Law of such country after which a Regulatory Authority may grant a marketing authorization to a Third Party by reference to data filed with or available to such Regulatory Authority by ARS, Recordati or any of their Affiliates or Third Party Local Distributor in respect of that Product pursuant to the Applicable Law; Marketing Authorizations means collectively the EU Marketing Authorization, the Ex-EU Marketing Authorization and UK Marketing Authorization;
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Market Exclusivity Period means, with respect to each IL-1 Product in each Co-Commercialization Country, that period of time during which (a) a Party(ies) has the exclusive legal right, whether by means of a Patent Right or through other rights granted by a Governmental Authority in such country, to market, price and sell such IL-1 Product in such country, and (b) no generic equivalent of such IL-1 Product is marketed in such country.
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Market Exclusivity Period means, with respect to each IL-1 Product in each Co-Commercialization Country, that period of time during which (a) a Party(ies) has the -11- <PAGE> exclusive legal right, whether by means of a Patent Right or through other rights granted by a Governmental Authority in such country, to market, price and sell such IL-1 Product in such country, and (b) no generic equivalent of such IL-1 Product is marketed in such country. "NAFTA" shall mean the United States, Canada and Mexico. "Net Sales" shall mean, with respect to an IL-1 Product, the gross invoiced sales price of such IL-1 Product billed by or on behalf of Novartis or its Affiliates to Third Parties on sales of an IL-1 Product in bona fide arm's length transactions in the Co-Commercialization Countries, less the following deductions, determined in accordance with Novartis' standard accounting methods as generally and consistently applied by Novartis, to the extent included in the gross invoiced sales price for such IL-1 Product or otherwise directly paid or incurred by such Novartis, its Affiliates or Distributors with respect to the sale of such IL-1 Product: (a) normal and customary trade and quantity discounts actually allowed and properly taken directly with respect to sales of such IL-1 Product;
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Market Exclusivity Period means, with respect to each IL-1 Product in each Co-Commercialization Country, that period of time during which
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Related to Market Exclusivity Period

  • 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.

  • 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 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.

  • 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 the sale of Product (as indicated by shipment of Product) to an unaffiliated third-party of the Licensee, or of its sublicensee or distribution partner, such as a wholesaler, managed care organization, hospital or pharmacy and shall exclude (i) any transfer of Product by Licensee to its sublicensee, distribution partner or Affiliate and (ii) any distribution of Product for use in research, development, pre-clinical and clinical trials.

  • 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 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 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;

  • 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.

  • 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.

  • Replacement Product means electric generating capacity, capacity-related benefits, environmental attributes, Energy or other electric products from a generation resource other than the Facility that are provided or delivered to replace or substitute for Contract Capacity or Storage Capacity (or any Capacity-Related Benefit, Environmental Attribute, Other Electric Product, Contract Energy, or Storage Energy associated therewith), in each case, in whole or in part, pursuant to Section 4.6.

  • 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.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • Marketing Period means fifteen (15) consecutive Business Days after the date on which both the Required Marigold Vote and Required Montage Vote have been received (a) commencing on the date Montage shall have received the Required Financial Information, all of which is Compliant, provided, that, if Marigold shall in good faith reasonably believe it has provided the Required Financial Information, it may deliver to Montage a written notice to that effect (stating when it believes it has completed such delivery), in which case Marigold shall be deemed to have complied with its obligation to provide the Required Financial Information on the date of delivery of such notice, unless Montage in good faith reasonably believes Marigold has not completed the delivery of the Required Financial Information and within three (3) Business Days after the delivery of such notice by Marigold, delivers a written notice to Marigold to that effect (stating with specificity which Required Financial Information Marigold has not delivered), and (b) throughout which nothing has occurred and no condition exists that would cause any of the conditions set forth in Section 7.1 and Section 7.2 to fail to be satisfied, assuming the Closing were to be scheduled for any time during such fifteen (15) Business Day period; provided, however, that (i) the Marketing Period shall end on any earlier date on which the Transaction Financing is consummated and Montage shall have obtained all of the proceeds contemplated thereby, (ii) the Marketing Period shall not be deemed to have commenced if, prior to the completion of such fifteen (15) Business Day period, (A) Deloitte & Touche LLP shall have withdrawn its audit opinion with respect to any year end audited financial statements set forth in the Required Financial Information, in which case the Marketing Period shall be deemed not to commence unless and until a new unqualified audit opinion is issued with respect to such year end audited financial statements by Deloitte & Touche LLP or another independent registered accounting firm reasonably acceptable to Montage, (B) Marigold shall have publicly announced, or the Marigold Board shall have determined, that a restatement of any material financial information included in the Required Financial Information is required, in which case the Marketing Period shall be deemed not to commence unless and until such restatement has been completed and the applicable Required Financial Information has been amended to reflect such restatement or Marigold has determined that no restatement shall be required or (C) the Required Financial Information is not Compliant (it being understood, for the avoidance of doubt, that if at any time during the Marketing Period the Required Financial Information provided on the first day of the Marketing Period ceases to be Compliant, then the Marketing Period shall be deemed not to have commenced) and (iii) (x) November 25, 2016 shall not be deemed to be a Business Day for purposes of calculating such fifteen (15) consecutive Business Days period and (y) such period (1) shall commence no earlier than January 4, 2016, (2) shall either have been completed prior to August 19, 2016 or shall not commence until September 7, 2016 and (3) shall either have been completed prior to December 21, 2016 or shall not commence until January 2, 2017.

  • 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.

  • FDA Approval means the approval, license, clearance or authorization of the FDA necessary for the marketing and sale of a product for human use in the United States.