Cystic Fibrosis Drug Franchise Assets definition

Cystic Fibrosis Drug Franchise Assets means (a) all approved products manufactured, sold and/or distributed by the Company or any of its Subsidiaries in any country related to the treatment of patients with cystic fibrosis, including, ivacaftor (tradename KALYDECO), lumacaftor in combination with ivacaftor (tradename ORKAMBI), tezacaftor in combination with ivacaftor (tradenames SYMDEKO (US) and SYMKEVI (EU)), elexacaftor in combination with tezacaftor and ivacaftor (tradenames TRIKAFTA(US) and KAFTRIO (EU)) and any drug candidates related to the treatment of cystic fibrosis for which the Company has submitted an application for regulatory approval in any country, including the triple-combination of elexacaftor in combination with ivacaftor and tezacaftor and (b) all proceeds, Intellectual Property, permits and other assets of the Company or any of its Subsidiaries related thereto.
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Cystic Fibrosis Drug Franchise Assets means (1) ivacaftor (tradename KALYDECO), for use in treating patients with cystic fibrosis six years of age and older who carry the G551D mutation in the CFTR gene; (2) lumacaftor in combination with ivacaftor which is being developed for potential use in treating patients twelve years and older who are homozygous for the F508del mutation in their CFTR gene; (3) VX-661 in combination with ivacaftor which is being developed for use in treating patients twelve years and older who carry certain mutations in the CFTR gene and (4) all proceeds, IP Rights, Permits and other assets related thereto and all Products, IP Rights or other assets developed or acquired in connection with cystic fibrosis.
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Cystic Fibrosis Drug Franchise Assets means (a) all products in development, developed, acquired, manufactured, sold and/or distributed by the Borrower or any of its Subsidiaries related to the treatment of patients with cystic fibrosis, including, ivacaftor (tradename KALYDECO), lumacaftor in combination with ivacaftor (tradename ORKAMBI) and VX-661 in combination with ivacaftor, and (b) all proceeds, Intellectual Property, Permits and other assets of the Borrower or any of its Subsidiaries related thereto.
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Examples of Cystic Fibrosis Drug Franchise Assets in a sentence

  • Permit any Unrestricted Subsidiary to (i) own, or possess the right to use, any Intellectual Property, or (ii) own any of the material economic rights derived from any Intellectual Property, in each case with respect to clause (i) or (ii), covering the Cystic Fibrosis Drug Franchise Assets.

  • Each group of price line item(s) in a category shall be awarded as a group.

  • Permit any Unrestricted Subsidiary to (a) own, or possess the right to use, any Intellectual Property, or (b) own any of the material economic rights derived from any Intellectual Property, in each case with respect to clause (a) or (b), covering the Cystic Fibrosis Drug Franchise Assets.

  • Permit any Unrestricted Subsidiary to (ia) own, or possess the right to use, any Intellectual Property, or (iib) own any of the material economic rights derived from any Intellectual Property, in each case with respect to clause (ia) or (iib), covering the Cystic Fibrosis Drug Franchise Assets.


More Definitions of Cystic Fibrosis Drug Franchise Assets

Cystic Fibrosis Drug Franchise Assets means (a) all approved products manufactured, sold and/or distributed by the Company or any of its Subsidiaries in any country related to the treatment of patients with cystic fibrosis, including, ivacaftor (tradename KALYDECO), lumacaftor in combination with ivacaftor (tradename ORKAMBI) and tezacaftor in combination with ivacaftor (tradenames SYMDEKO (US) and SYMKEVI (EU)) and any drug candidates related to the treatment of cystic fibrosis for which the Company has submitted an application for regulatory approval in any country, including the triple-combination of elexacaftor in combination with ivacaftor and tezacaftor and (b) all proceeds, Intellectual Property, permits and other assets of the Company or any of its Subsidiaries related thereto.
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Cystic Fibrosis Drug Franchise Assets means (a) all approved products manufactured, sold and/or distributed by the Company or any of its Subsidiaries in any country related to the treatment of patients with cystic fibrosis, including, ivacaftor (tradename KALYDECO), lumacaftor in combination with ivacaftor (tradename ORKAMBI), tezacaftor in combination with ivacaftor (tradenames SYMDEKO (US) and SYMKEVI (EU)), elexacaftor in combination with tezacaftor and ivacaftor (tradenames TRIKAFTA(US) and KAFTRIO (EU)) and any drug candidates related to the treatment of cystic fibrosis for which the Company has submitted an application for regulatory approval in any country and (b) all proceeds, Intellectual Property, permits and other assets of the Company or any of its Subsidiaries related thereto.
Sample 1
Cystic Fibrosis Drug Franchise Assets means (a) all approved products manufactured, sold and/or distributed by the Company or any of its Subsidiaries in any country related to the treatment of patients with cystic fibrosis, including, ivacaftor (tradename KALYDECO), lumacaftor in combination with ivacaftor (tradename ORKAMBI) and, tezacaftor in combination with ivacaftor (tradenames SYMDEKO (US) and SYMKEVI (EU)), elexacaftor in combination with tezacaftor and ivacaftor (tradenames TRIKAFTA(US) and KAFTRIO (EU)) and any drug candidates related to the treatment of cystic fibrosis for which the Company has submitted an application for regulatory approval in any country, including the triple-combination of elexacaftor in combination with ivacaftor and tezacaftor and (b) all proceeds, Intellectual Property, permits and other assets of the Company or any of its Subsidiaries related thereto.
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Related to Cystic Fibrosis Drug Franchise Assets

  • Diagnostic x-ray system means an x-ray system designed for irradiation of any part of the human or animal body for the purpose of diagnosis or visualization.

  • Anti-Static Product means a product that is labeled to eliminate, prevent, or inhibit the accumulation of static electricity. “Anti-Static Product” does not include “Electronic Cleaner,” “Floor Polish or Wax,” “Floor Coating,” and products that meet the definition of “Aerosol Coating Product” or “Architectural Coating.”

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by BMS and that otherwise fit the foregoing definition.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Opioid antidote means any drug, regardless of dosage amount or method of administration, which has been approved by the United States Food and Drug Administration (FDA) for the treatment of an opioid overdose. “Opioid antidote” includes, but is not limited to, naloxone hydrochloride, in any dosage amount, which is administered through nasal spray or any other FDA-approved means or methods.

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • 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:

  • 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.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • 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.

  • Biological safety cabinet means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Analytical x-ray system means a group of components utilizing x-rays to determine the elemental composition or to examine the microstructure of materials.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Licensed clinical social worker means an individual who meets the licensed clinical social worker requirements established in KRS 335.100.

  • Drug addiction means a disease characterized by a

  • Clean coal technology demonstration project means a project using funds appropriated under the heading “Department of Energy—Clean Coal Technology,” up to a total amount of $2,500,000,000 for commercial demonstration of clean coal technology, or similar projects funded through appropriations for the Environmental Protection Agency. The federal contribution for a qualifying project shall be at least 20 percent of the total cost of the demonstration project.

  • 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

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • CREFC® Intellectual Property Royalty License Fee Rate With respect to each Mortgage Loan, a rate equal to 0.0005% per annum.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.