Autolus Product definition

Autolus Product means medicinal product(s) that are manufactured using one or more Miltenyi Products and that are researched, developed and/or commercialized by or on behalf of Autolus in the Field, as such products are identified in Exhibit A to this Agreement, including related development candidate(s) and investigational medicinal products used under the sponsorship of Autolus or pursuant to investigator-initiated clinical trials, as Exhibit A may be amended from time to time by written notification of Autolus to Miltenyi to add or remove product(s) in the Field.
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Autolus Product means an AUTO1/22 Product, AUTO6NG Product, and Obe-cel Product, in each case in the form in which such product exists as of the Effective Date.
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Autolus Product means an AUTO1/22 Product, AUTO6NG Product, and Obe-cel Product, in each case in the form in which such product exists as of the Effective Date. 1.25 “Autolus’s Knowledge” means the [***] knowledge [***], of any of: [***]. 1.26 “AUTO1/22 Next Gen Product” means any AUTO1/22 Product Developed by Autolus or its Affiliates to [***]. 1.27 “AUTO1/22 Product” means Autolus’s proprietary autologous CAR-T Cell Therapy targeting CD19 and CD22 in the form under Development as of the Effective Date, as more particularly set forth on Schedule 1.27, together with any new dosage forms, strengths, methods of manufacture, or methods of administration thereof and any improvements or modifications of such products, but excluding any AUTO1/22 Next Gen Product. 1.28 “AUTO6NG Next Gen Product” means any AUTO6NG Product Developed by Autolus or its Affiliates to [***]. 1.29 “AUTO6NG Product” means Autolus’s proprietary autologous CAR-T Cell Therapy targeting GD2 in the form under Development as of the Effective Date, as more particularly set forth on Schedule 1.29, together with any new dosage forms, strengths, methods of manufacture, or methods of administration thereof and any improvements or modifications of such products, but excluding any AUTO6NG Next Gen Product. 1.30 “[***]” means [***]. 1.31 “[***]” has the meaning [***]. 1.32 “[***]” has the meaning [***]. 1.33 “Available” has the meaning set out in Section 6.4(b). 1.34 “Availability Notice” has the meaning set out in Section 6.4(b). 1.35 “Background IP” has the meaning set out in Section 11.1. 1.36 “Baseball Arbitration” means the baseball arbitration procedure set out in Schedule 1.36. 1.37 “[***]” means [***]. 1.38 “[***] Licensed Binder” means (a) that certain Binder of [***], and (b) [***], provided that clause (b) shall not include any Binder that (i) [***], or (ii) [***].
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Examples of Autolus Product in a sentence

  • Miltenyi shall in no way be held responsible for any refusal by any Regulatory Authority or ethics committee to grant permission to conduct a clinical trial(s) and/or for any refusal by any Regulatory Authority to grant approval under an Investigational New Drug Application (IND) or under a Biological License Application (BLA) or for compassionate use for a Autolus Product.

  • Subject to responsibilities pertaining to Miltenyi Products that are solely reserved by Miltenyi under this Agreement, and subject to the provisions in this Article 4 (including Section 4.7), Autolus shall be solely responsible for all regulatory activities with respect to any Autolus Product, including the manufacture and quality control thereof.

  • With respect to any Autolus Product, Autolus may request that Miltenyi provide additional regulatory assistance beyond the scope of the Regulatory Work, and/or may request that Miltenyi perform additional services (i.e., the generation of additional supportive data for inclusion in a Master File for Miltenyi Product) that alter, amend, add to and/or supplement the Regulatory Work.

  • Employees have no contractual rights to the benefits provided by the Company from time to time and the Company reserves the right to change, modify, discontinue or terminate, at its sole discretion, its policies and employee benefits program.

  • For purposes of clarification, the obligations imposed on Autolus pursuant to this Section 4.7(c) shall not apply with respect to Communications with Regulatory Authorities that are focused primarily on a non-Miltenyi Product portions or on an Autolus Product.

  • Autolus shall have sole responsibility that the any Autolus Product is safe for human use, and Autolus hereby assumes sole risk and liability arising out of or in connection with the use of Autolus Products in clinical trials by or on behalf of Autolus or commercialization of Autolus Products (including product liability with respect thereto).

  • In connection with any Change pursuant to this Section 3.2, the Parties shall cooperate, share information, and otherwise act in good faith to prepare the appropriate documentation as may be necessary to secure and maintain appropriate regulatory approvals or manufacturing permits for Miltenyi Product and Autolus Product, respectively.

  • In connection with any [***] pursuant to this Section 3.2, the Parties shall cooperate, share information, and otherwise act in good faith to prepare the appropriate documentation as may be necessary to secure and maintain appropriate regulatory approvals or manufacturing permits for Miltenyi Product and Autolus Product, respectively.

Related to Autolus Product

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

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • 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.

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • Hemp products means all products made from industrial hemp,

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

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

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

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • Cannabis products 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.

  • 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.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • 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.

  • 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;

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.