Selected Drug definition

Selected Drug has the meaning given such term in section 1192(c) of the Act and any‌‌ applicable regulations and guidance. Except where such terms are expressly defined in this Agreement, all other terms shall have the meanings given to them under the provisions of sections 1860D-1 through 1860D-43 of the Act and any applicable regulations and guidance implementing those provisions.
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Selected Drug means a drug selected under the Drug Price Negotiation Program, as described in Section 1192 of the Social Security
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Selected Drug means [***].
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Examples of Selected Drug in a sentence

  • How to Investigate Drug Use in Health Facilities: Selected Drug Use Indicators.

  • Because cultivated pasture, greenhouse land, gardens, and so on are included in cultivated land from GlobeLand30, whereas onlyarable land and permanent crops comprise cropland in this study, among all grids with cultivated land > 0, 79.44% of grids from GlobeLand30 have more cultivated land than this study.

  • Novartis and Idenix shall have equal responsibility for any royalties, fees or other amounts payable to Third Parties to obtain rights under any Blocking Third Party Intellectual Property Rights with respect to any other Selected Drug Candidates or corresponding Products, or under any other Third Party intellectual property rights that may be reasonably necessary for the Development, Commercialization or Manufacture of any Selected Drug Candidate or Product.

  • Notwithstanding anything to the contrary contained herein, Idenix shall not file any submissions with respect to any Early Selection Compound or Selected Drug Candidate (including any corresponding Products) without the prior written consent of Novartis.

  • Novartis may, in its sole discretion, amend or modify any proposed or previously-approved Development Budget for a Selected Drug Candidate.

  • The Parties acknowledge and agree that the HBV Drug Candidates are Selected Drug Candidates.

  • Promptly after the Effective Date with respect to the Initial HCV Drug Candidate, and promptly following the applicable Selection Date for any Product, the Parties shall undertake development of the Manufacturing capability, including Technical Development, for such Initial HCV Drug Candidate (and related Products) and Products (and related Selected Drug Candidates) in accordance with the respective Manufacturing Plan.

  • With respect to any Drug Candidate that is neither an Early Selection Compound nor a Selected Drug Candidate, Idenix alone may, in its sole discretion, determine whether and how to Develop such Drug Candidate and corresponding products, and shall be responsible for all related Development expenses; provided that Idenix shall provide Novartis with quarterly written reports regarding the status of such Development activities.

  • Except to the extent specified to the contrary in the relevant approved Development Plan, Idenix shall be responsible for administering and executing the Development of the Early Selection Compounds and the Selected Drug Candidates, and the Products derived therefrom, in accordance with, respectively, the Development Plans developed in consultation with Novartis and the approved Development Plans.

  • Either Party may, at any time and from time to time, in good faith provide written notice to the Joint Steering Committee requesting that a Drug Candidate which is neither an Early Selection Compound nor a Selected Drug Candidate be considered as an Early Selection Compound.


More Definitions of Selected Drug

Selected Drug means a drug that was selected for Medicare price negotiation and published by the Secretary of the U.S. Department of Health and Human Services, in each case, under the Inflation Reduction Act.
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Selected Drug means a drug selected under the Drug Price Negotiation Program, as described in Section 1192 of the Social Security Act.
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Selected Drug shall have the meaning assigned in Section 3.5(b).
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Selected Drug has the meaning set forth in Section 1192(c)(1) of the Social Security Act.
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Selected Drug has the meaning set forth in Section 7.3.2(e).
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Selected Drug means a drug selected under the IRA’s drug price negotiation program, as described in 42 U.S.C. § 1320f-1.
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Related to Selected Drug

  • Generic Drug means a Prescription Drug that is medically equivalent to a Brand Name Drug as determined by the FDA. It meets the same standards as a Brand Name Drug for purity, safety, strength and effectiveness and is manufactured and sold under its chemical, common, or official name.

  • New drug means: (i) any drug, except a new animal drug or an animal feed bearing or containing

  • Covered drug means any prescription drug that:

  • Automated drug dispensing system means a mechanical or electronic system that performs

  • FFDCA means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).

  • cosmetic product means any substance or mixture intended to be placed in contact with the external parts of the human body (epi­ dermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;

  • New Drug Application means a new drug application in the United States for authorization to market a product, as defined in the applicable laws and regulations and submitted to the FDA.

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • low protein modified food product means a food product that is specially formulated to have less than one gram of protein per serving and is intended to be used under the direction of a Practitioner for the dietary treatment of an inherited metabolic disease, but does not include a natural food that is naturally low in protein; and

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).

  • Wholesale drug distributor means anyone engaged in the

  • Prescription drug order means an original or new order from a practitioner for drugs, drug-related devices or treatment for a human or animal, including orders issued through collaborative care agreements. Lawful prescriptions result from a valid practitioner-patient relationship, are intended to address a legitimate medical need, and fall within the prescribing practitioner's scope of professional practice;

  • FDCA shall have the meaning ascribed to such term in Section 3.1(hh).

  • Legend drug or "prescription drug" means any drug or device that has been determined to be unsafe for self- medication or any drug or device that bears or is required to bear the legend:

  • Legend drugs means any drugs which are required by state

  • MHLW means the Japanese Ministry of Health, Labour and Welfare, and any successor agency thereto.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Invalid Drug Test means the result of a drug test for an oral fluid specimen that contains an unidentified adulterant, or an unidentified substance, that has abnormal physical characteristics, or that has an endogenous substance at an abnormal concentration preventing the laboratory from completing or obtaining a valid drug test result.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • Prescription drug means any drug required by federal law or regulation to be dispensed only