Oligonucleotide Drug definition

Oligonucleotide Drug means any single stranded, [...***...] oligonucleotide including those [...***...] used as a human therapeutic and/or prophylactic compound containing between [...***...] nucleotides and/or nucleosides including oligonucleotide analogs which may include [...***...
Oligonucleotide Drug means any single stranded, [***] at physiological pH oligonucleotide including those [***] used as a human therapeutic and/or prophylactic compound containing between [***] nucleotides and/or nucleosides including oligonucleotide analogs which may include [***]. For purposes of this agreement, Oligonucleotide Drug shall specifically exclude oligonucleotides used in [***], oligonucleotides used as [***] an oligonucleotide, oligonucleotides used [***] or oligonucleotides used as [***];
Oligonucleotide Drug means any single stranded, [...***...] oligonucleotide including those [...***...] used as a human therapeutic and/or prophylactic compound containing between [...***...] nucleotides and/or nucleosides including oligonucleotide analogs which may include [...***...]. For purposes of this Agreement, Oligonucleotide Drug shall specifically exclude oligonucleotides used in gene therapy except [...***...] an oligonucleotide, oligonucleotides used as [...***...] or oligonucleotides used as adjuvants. Oligonucleotide Drug shall also specifically exclude polymers in which the linkages are amide based, such as peptides and proteins but shall not exclude [...***...]. Should Isis develop [...***...] oligonucleotides or should Elan independently discover drug delivery technology it believes to be potentially applicable to [...***...] oligonucleotides, then the Participants shall discuss in good faith whether such oligonucleotides can be formulated for Oral delivery using the Oral Platform, and whether such formulation appears feasible without requiring a significant further investment in developing or enhancing the Oral Platform; if such formulation appears feasible, the Participants shall discuss in good faith the inclusion of such oligonucleotides as Oligonucleotide Drugs.

Examples of Oligonucleotide Drug in a sentence

  • Isis will notify Elan in writing of Isis' good faith intention to manufacture or have manufactured an Oligonucleotide Drug incorporating any Elan Intellectual Property.

  • If Elan fails to respond to Isis' notice within the [***] or if Elan declines in writing to exercise its right of first negotiation, then, Isis will be free to manufacture and supply (either on its own or with a third party) the Oligonucleotide Drug.

  • The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations.’’ It does not establish any rights for any person and is not binding on FDA or the public.You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

  • If Elan wishes to manufacture the Oligonucleotide Drug incorporating any Elan Intellectual Property, the parties will negotiate in good faith the terms of a manufacturing agreement.

  • If despite good faith negotiations, Elan and Isis do not reach agreement within [***] from Elan's exercise of its right of first negotiation, then Isis will be free to manufacture and supply (either on its own or with a third party) the Oligonucleotide Drug.

  • The draft guidance, when finalized, will represent the current thinking of FDA on “IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations.” It does not establish any rights for any person and is not binding on FDA or the public.

  • Elan will have [***] from the receipt of such notice to notify Isis in writing whether or not Elan wishes to negotiate with Isis regarding the manufacture of the Oligonucleotide Drug.

  • The draft guidance, when finalized, will represent the current thinking of FDA on “IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations.” It does not establish any rights for any person and is not binding on FDA or the public.

  • The effects of different modifications and scale on the manufacturing process as well as techniques for developing scaled-down process models will be discussed.9:00 Introduction to the TutorialLubomir Nechev, Ph.D., Senior Director, Process Chemistry,Alnylam Pharmaceuticals, Inc., USA9:10 A History of DNA/RNA SynthesizersJeffrey Christopher Strauss, Vice President, BioAutomation Corp., USA9:50 Challenges in the Preparation and Analysis of Conjugated Oligonucleotide Drug CandidatesKenneth W.

Related to Oligonucleotide Drug

  • Antibody means a molecule comprising or containing one or more immunoglobulin variable domains or any fragments, derivatives, variants or modifications thereof that bind to the same antigen.

  • Antigen means a substance recognized by the body as being foreign; it results in the production of specific antibodies directed against it.

  • Biomarker means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • Compounds means any or all of the following chemicals, as the context requires:

  • Licensed Compound means [***].

  • Reagent means any product other than fuel that is stored on-board the vehicle and is provided to the exhaust after-treatment system upon request of the emission control system.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Vaccine means a specially prepared antigen which, upon administration to a person, will result in immunity and, specifically for the purposes of this rule, shall mean influenza and pneumococcal vaccines.

  • 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”).

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

  • Preceptor means an individual who provides, directs, or verifies training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, or a radiation safety officer.

  • Biological agent shall mean any pathogenic (disease producing) micro-organism(s) and/or biologically produced toxin(s) (including genetically modified organisms and chemically synthesized toxins) which cause illness and/or death in humans, animals or plants.

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

  • Compound means the taking of two or more ingredients and fabricating them into a single

  • 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;

  • Corrosion inhibitor means a substance capable of reducing the corrosivity of water toward metal plumbing materials, especially lead and copper, by forming a protective film on the interior surface of those materials.

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

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

  • 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)).

  • Receptor means enclosed spaces, conduits, protected groundwater sources, drinking and non-drinking water wells, surface water bodies, and public water systems which when impacted by chemicals of concern may result in exposure to humans and aquatic life, explosive conditions or other adverse effects on health, safety and the environment as specified in these rules.

  • Microorganisms (1 2) means bacteria, viruses, mycoplasms, rickettsiae, chlamydiae or fungi, whether natural, enhanced or modified, either in the form of "isolated live cultures" or as material including living material which has been deliberately inoculated or contaminated with such cultures.

  • 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.

  • Formulation means the combination of various ingredients designed to render the product useful and effective for the purpose claimed, or the form of pesticide as purchased by users;

  • Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."

  • Assay means a laboratory analysis of Crude Petroleum to include the following: A.P.I. Gravity, Reid vapor pressure, composition, pour point, water and sediment content, sulfur content, viscosity, distillation, hydrogen sulfide, flash/boiling point and other characteristics as may be required by Carrier.