CV Indication definition

CV Indication means the [*] For clarity, a CV Indication [*] including [*] and [*], or [*] or [*] or [*]
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CV Indication means the first cardiovascular indication to be determined by the JSC and approved by the JEC.
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CV Indication means the [*] For clarity, a CV Indication [*] including [*] and [*], or [*] or [*] or [*] “Dollars” or “$”means the legal tender of the U.S.
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Examples of CV Indication in a sentence

  • Effective as of the Canakinumab Exclusive License Effective Date, (x) each of the Canakinumab Non-CV Indication Non-Exclusive License and the Canakinumab CV Indication Non-Exclusive License are hereby converted into the Canakinumab Exclusive License; and (y) the provisions set forth in EXHIBIT B shall apply with respect to the Canakinumab Exclusive License.

  • On December 13, 2019, FDA approved VASCEPA® for the CV Indication, based on the results of the REDUCE-IT clinical trial.

  • Deputy Assistant, Assistant, Senior Assistant, and Supervisory Assistant State’s Attorneys are subject to discipline and removal in accordance with the collective bargaining agreement between the State of Connecticut Division of Criminal Justice and the Connecticut Association of Prosecutors.

  • The $1.1 billion in Vascepa® sales referenced in Hikma’s September 2020 Press Release includes sales for all uses of Vascepa®, including the CV Indication (which Hikma knew made up more than 75% of sales).

  • The report therefore classifies the Netherlands as a tier 1 country.85 Wetenschappelijk Onderzoek- en Documentatiecentrum (WODC), Prostitution in the Netherlands since the lifting of the brothel ban, 2007.

  • On information and belief, following VASCEPA®’s approval for the CV Indication and the concurrent removal of the CV Limitation of Use from the VASCEPA® label, healthcare providers rapidly associated administration of icosapent ethyl together with a statin as a method for reducing risk of cardiovascular events in patients with baseline triglycerides ≥ 150 mg/dL.

  • Hikma’s March 2020 Press Release communicates to and instructs healthcare providers and patients that Hikma’s “generic version” of VASCEPA® should be used for all the same indications as VASCEPA®, including to reduce the risk of CV events per the CV Indication awarded to VASCEPA®, and thus promotes and encourages that use.

  • Note that the markings and quotations give a good but approximate idea of his interests in the texts.

  • With provincial and federal approvals obtained or pending, Manitoba Hydro plans to begin construction in fall 2019.

  • The $919 million in Vascepa® sales referenced in Hikma’s March 2020 Press Release includes sales for all uses of Vascepa®, including the CV Indication (which Hikma knew made up more than 75% of VASCEPA®’s sales).

Related to CV Indication

  • Second Indication means [***].

  • First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.

  • Initial Indication means the use of a Product for the treatment of opioid addiction.

  • 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.

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Additional Indication means any indication other than the Initial Indication.

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • geographical indication , in relation to goods, means an indication which identifies such goods as agricultural goods, natural goods or manufactured goods as originating, or manufactured in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of such goods is essentially attributable to its geographical origin and in case where such goods are manufactured goods one of the activities of either the production or of processing or preparation of the goods concerned takes place in such territory, region or locality, as the case may be.

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

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • 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.

  • Generic Product means any pharmaceutical product that (i) is sold by a Third Party that is not an Affiliate or licensee of Buyer and (ii) (a) contains the same active pharmaceutical ingredient as the Product or (b) is categorized by the applicable Governmental Entity in a country to be therapeutically equivalent to, or interchangeable with, the Product, such that the pharmaceutical product may be substituted for the Product at the point of dispensing without any intervention by the prescribing physician in such country.

  • 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.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Licensed Compound means [***].

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

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