Product Exclusivity definition

Product Exclusivity means (a) any period during which the FDA, Health Canada or other Regulatory Authority in a region of the Territory grants any exclusive marketing rights or data exclusivity rights with respect to the Product (other than patents), including orphan drug exclusivity, new chemical entity exclusivity, or pediatric exclusivity, in each case to the extent the grant conveys to the beneficiary thereof the right to exclude others from marketing or selling such Product for the relevant indication or (b) the period from the Effective Date to the Patent Expiration Date, whichever of (a) and (b) is longer. The determination of the existence of Product Exclusivity shall be made on a country-by-country, product-by-product and indication-by-indication basis.
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Product Exclusivity. “Product” means the Reader and accessories listed on and further defined by the Specifications referenced in Schedule 1 hereto. During the Subcontract Term, (a) 3M and its affiliates shall purchase exclusively from RBC all of their commercial sale requirements for the 3MTM Rapid Detect Reader Products listed on Schedule 1 and shall purchase non-exclusively from RBC the Accessory Products listed on Schedule 1; and (b) RBC will supply all Products listed on Schedule 1 non-exclusively to 3M and its affiliates.
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Product Exclusivity means the exclusivity of the licenses granted to Ventana in Article 2.
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Examples of Product Exclusivity in a sentence

  • Under 42 U.S.C. 351(k), patents that may be infringed by a sponsor of a biosimilar or interchangeable product must be in the “List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability” (referred to as the “Purple Book”).

  • Neither Party shall be obligated to commercialize such VP Product Exclusivity Unit itself, to the extent such Party does not have OTC commercialization abilities; and the JSC shall agree on any Third Party that shall perform the commercialization activities for such VP Product Exclusivity Unit on behalf of either or both Parties.

  • FOOD & DRUG ADMIN., Purple Book: Lists of Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations, https://www.fda.gov/drugs/developmentapprovalprocess/howdrugs- aredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm411418.htm (last updated Jul.

  • FOOD & DRUG ADMIN., Purple Book: Lists of Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (page last updated Jul.

  • During the Developed Product Exclusivity Period for a Developed Product, and subject to Section 10.4, SPWR shall have the exclusive right to sell and offer to sell, and MSSG shall have the exclusive right to supply to SPWR, within the Collaboration Market Segment, such Developed Product.

  • If at any time after expiration of the Developed Product Exclusivity Period for a Developed Product, but during the Agreement Term (“ROFO/ROFR Term”), MSSG desires to negotiate, execute, agree to or otherwise become bound by one or more contractual or other obligations to supply Developed Products manufactured by MSSG to a third party for sale in the Collaboration Market Segment, MSSG shall first offer to enter into such supply agreement with SPWR.

  • See Background Information: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (Purple Book), U.S. FOOD & DRUG ADMIN.

  • The FDA “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations” (more familiarly called the “Purple Book”) will be a compendium for the biologic agents similar to the generic reference, the “Orange Book” for SMD.

  • Subsequent Event.” Products, Intellectual Property and Product Exclusivity Our pharmaceutical products include chemically-synthesized or small molecule drugs and products produced from biological processes, called “biologics.” Small molecule drugs are typically administered orally, e.g., in the form of a pill or tablet, although other drug delivery mechanisms are used as well.

  • For a period of one (1) year following the expiration of the Developed Product Exclusivity Period for a Developed Product, neither MSSG nor SPWR shall, within the Collaboration Market Segment, enter into an exclusive supply relationship with a third party for such Developed Product.


More Definitions of Product Exclusivity

Product Exclusivity means Handspring will not provide London to any other party to market, promote or sell directly or indirectly in the Territory, but Handspring will be allowed to market any other CDMA-based Handspring product in the Territory through any means so long as such other CDMA product is commercially distinguishable or distinct (e.g., without limitation, in industrial design, embedded applications, or network functionality, etc.) from the then current design of the London product. As long as Sprint satisfies the Minimum Product Purchase Levels detailed in Section 4.2 below, Sprint will receive Product Exclusivity during the first [*] of the MPPL Term. Market Exclusivity and Product Exclusivity are collectively referred to herein as the "Exclusive Rights".
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Product Exclusivity means (a) any period during which Health Canada grants data protection pursuant to section C.08.004.1 of the Food and Drug Regulations, including pediatric extension, in respect of the Product or (b) the period from the Effective Date to the Patent Expiration Date, whichever of (a) and (b) is longer.
Sample 1

Related to Product Exclusivity

  • 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.

  • 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 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.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • 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.

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Licensed Compound means [***].

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • Existing Product means any formulation of the same product category and form sold, supplied, manufactured, or offered for sale in California prior to the following dates, or any subsequently introduced identical formulation:

  • Product Labeling means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority‑approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) all labels and other written, printed, or graphic matter upon a container, wrapper, or any package insert utilized with or for such Licensed Product in such country or other jurisdiction.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Royalty Product means, either (a) an Alnylam Royalty Product, or (b) an Inex Royalty Product.

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • 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.

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Licensed producer means an agent, broker, or reinsurance intermediary licensed pursuant to the applicable provision of the insurance law of any jurisdiction.

  • Licensed Field means [***].

  • Licensed Fields of Use means the fields of use identified in Appendix B.

  • Non-Microsoft Product means any third-party-branded software, data, service, website or product, unless incorporated by Microsoft in a Product.

  • Licensed Territory means worldwide.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Competing Product means [***].