Human Biological Samples definition

Human Biological Samples means human biological material (including any derivative or progeny thereof), including any portion of an organ, any tissue, skin, bone, muscle, connective tissue, blood, cerebrospinal fluid, cells, gametes, or sub-cellular structures such as DNA, or any derivative of such biological material such as stem cells or cell lines; and any human biological product, including, but not limited to, hair, nail clippings, teeth, urine, faeces, breast milk, and sweat.
Human Biological Samples means human biological samples (including any derivatives or progeny thereof) and information regarding the origin, pathology or integrity of such samples obtained by a Party from the provider of such samples.
Human Biological Samples or “HBS” means any human biological material, including human bodily parts and organs in whole or sub-samples, any tissue, skin, bone, muscle, connective tissue, blood, cerebrospinal fluid, cells, gametes or sub-cellular structures, such as DNA, or any derivative or product of such human biological materials including stem cells, cell lines, bodily fluids, blood derivatives and urine.

Examples of Human Biological Samples in a sentence

  • GSK and CureVac undertake that the Human Biological Samples used or collected in connection with the Development have been obtained and will be stored, transferred, used and disposed of in accordance with all Applicable Laws and any generally accepted ethical guidelines regarding the collection, use, transport and disposal of human tissue, including with regard to consents from patients, volunteers and other donors.

  • The study will be performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with ICH/Good Clinical Practice, applicable regulatory requirements and the AstraZeneca policy on Bioethics and Human Biological Samples.

  • If the Parties wish to source Human Biologicals Samples on each other’s behalf or exchange Human Biological Samples between them, such exchange shall be recorded in separate addendums to this Agreement setting forth further terms and conditions for the specific purpose.

  • The Human Biological Samples transferred to GSK by Surface in the course of the Technical Transition Services have been obtained and will be stored, transferred, used and disposed of in accordance with all applicable Laws and any generally accepted ethical guidelines regarding the collection, use, transport and disposal of human tissue.

  • If the Parties wish to source Human Biologicals Samples on each other's behalf or exchange Human Biological Samples between them, such exchange shall be recorded in separate addendums to this Agreement setting forth further terms and conditions for the specific purpose.

  • Clinical Trial Results All Results arising from a clinical trial that is supported directly or indirectly by a Grant, other than Human Biological Samples.

  • All the relevant ethics committee approvals and informed consents have been obtained to enable the use of the Human Biological Samples obtained from patients or human subject volunteers or other donors in the Development or Manufacture of Licensed Antibodies.

  • In the event of a discrepancy between the terms set forth in this Exhibit and any other parts of the Agreement, the terms of this Exhibit shall govern all matters relating to Human Biological Samples and all other matters shall be governed by the relevant terms set forth in any other parts of this Agreement.

  • Further details on Handling of Human Biological Samples are provided in Appendix C.

  • The study will be performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with ICH/GCP, applicable regulatory requirements, and the AstraZeneca policy on Bioethics and Human Biological Samples.


More Definitions of Human Biological Samples

Human Biological Samples means any human biological material (including any derivative or progeny thereof), including any portion of an organ, any tissue, skin, bone, muscle, connective tissue, blood, cerebrospinal fluid, cells, gametes, or sub-cellular structures such as DNA, or any derivative of such biological material such as stem cells or cell lines; and any human biological product, including hair, nail clippings, teeth, urine, feces, breast milk, and sweat. For clarity, any microbe collected from a human subject shall not be considered a Human Biological Sample.
Human Biological Samples or “HBS” means biological materials acquired or derived from living or deceased human beings, which consist of or include human cells, subject to the following inclusions and exclusions: 1.10.1 Human Biological Samples or HBS include, but are not limited to:
Human Biological Samples or “HBS” means any human biological material (including any derivative or progeny thereof), including [***], which shall be used by Tempus to carry out the applicable Activities under any Task Order.
Human Biological Samples means any human biological material [***]; and any human biological product [***], which shall be used by 23andMe to carry out its Research and Development activities under the Agreement (“Activities”).
Human Biological Samples means any human biological material (including any derivative or progeny thereof), including any portion of an organ, any tissue, skin, bone, muscle, connective tissue, blood, cerebrospinal fluid, cells, gametes, or sub-cellular structures such as DNA, or any derivative of such biological material such as stem cells or cell lines; and any human biological product, including, but not limited to, hair, nail clippings, teeth, urine, faeces, breast milk, and sweat. 1.110 “ICH” means the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. 1.111 “IFRS” means International Financial Reporting Standards applied on a consistent basis. 1.112 “In-Licensed Arrowhead Patent Rights” has the meaning set forth in Section 10.2.3. 1.113 “IND” means an Investigational New Drug Application filed with the FDA, or a similar application filed with a Regulatory Authority outside of the United States for authorization to commence a Clinical Trial, such as a clinical trial application or a clinical trial exemption, or any related regulatory submission, license or authorization. 1.114 “Indemnified Party” has the meaning set forth in Section 11.1.
Human Biological Samples means any human biological materials including, without limitation, blood, tissue, cells or sub-cellular structures such as DNA or any derivative of such human biological materials including cell lines, bodily fluids, urine and blood derivatives; “LGC” means LGC Limited; “Personal Data” has the meaning set out in the Regulation; “Personnel” means any officers, employees, agents or subcontractors; “Price” means the price agreed for the Services; “Processing” has the meaning set out in the Regulation; “Regulation” means Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 (General Data Protection Regulation); “Report” means the report, if any, to be supplied by LGC to the Customer on completion of the Services; “Services” means the services to be provided by LGC to the Customer.

Related to Human Biological Samples

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

  • 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”).

  • 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.

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

  • 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.

  • 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;

  • Biological Material means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system;

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

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • Therapeutic school means a residential group living facility:

  • Active Ingredient means the clinically active material(s) that provide pharmacological activity in a pharmaceutical product (excluding formulation components such as coatings, stabilizers, excipients or solvents, adjuvants or controlled release technologies).

  • 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.

  • Biological Materials means certain tangible biological materials that are necessary for the effective exercise of the Patent Rights, which materials are described on Exhibit A, as well as tangible materials that are routinely produced through use of the original materials, including, for example, any progeny derived from a cell line, monoclonal antibodies produced by hybridoma cells, DNA or RNA replicated from isolated DNA or RNA, recombinant proteins produced through use of isolated DNA or RNA, and substances routinely purified from a source material included in the original materials (such as recombinant proteins isolated from a cell extract or supernatant by non-proprietary affinity purification methods). These Biological Materials shall be listed on Exhibit A, which will be periodically amended to include any additional Biological Materials that Medical School may furnish to Company.

  • Interchangeable biological product means a biological product that the federal Food and Drug Administration has:

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

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

  • Biological diversity means the variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems.

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

  • animals means animals as defined in the Terrestrial Animal Health Code or the Aquatic Animal Health Code of the World Organisation for Animal Health (OIE), respectively;

  • 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;

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • 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”).

  • 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.

  • 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.

  • Antipsychotic medications means that class of drugs

  • Cannabinoid edible means food or potable liquid into which a cannabinoid concentrate, cannabinoid extract or dried marijuana leaves or flowers have been incorporated.