Proposed Biosimilar Product definition

Proposed Biosimilar Product is defined in Section 5.5.1 hereof.
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Proposed Biosimilar Product has the meaning set forth in Section 8.4.1 (Notice).
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Proposed Biosimilar Product has the meaning set forth in Section 11.9.1 (Response to Biosimilar Applicants; Notice).
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Examples of Proposed Biosimilar Product in a sentence

  • As soon as practicable following the date of receipt by CytomX of any such patent, ImmunoGen and CytomX shall discuss in good faith whether such patent would be infringed by the manufacture and/or sale of the Proposed Biosimilar Product.

  • Without limiting the foregoing, Novartis agrees to take such actions with respect to Licensed Patent Rights as may required under the BPCIA and regulations thereunder, and any other Applicable Laws pertaining to the approval or sale of biosimilars or follow-on biologic products, as are permitted to persons having rights to a reference product in order to object to or prevent the sale of a Proposed Biosimilar Product.

  • As soon as practicable following the date of receipt by ImmunoGen of any such patent, CytomX and ImmunoGen shall discuss in good faith whether such patent would be infringed by the manufacture and/or sale of the Proposed Biosimilar Product.

  • As soon as practicable following the date of receipt by Lilly of any such patent, ImmunoGen and Lilly shall discuss in good faith whether such patent would be infringed by the manufacture and/or sale of the Proposed Biosimilar Product.

  • As soon as practicable following the issuance of such U.S. patent, ImmunoGen shall provide Millennium with a copy of the issued patent and both Parties shall discuss in good faith whether such patent would be infringed by the manufacture or sale of the Proposed Biosimilar Product and whether such patent should be included in the Initial Patent List.

  • As soon as practicable following the date of receipt by Vertex of any such patent, ImmunoGen and Vertex will discuss in good faith whether such patent could reasonably be asserted with respect to the making, using, offering to sell, selling, or importing of the Proposed Biosimilar Product.

  • Upon written request from ImmunoGen and to the extent permitted by applicable Law, Vertex will provide ImmunoGen with confidential access to the Biosimilar Application and such other information that describes the process used to manufacture the Proposed Biosimilar Product, in each case, to the extent provided to Vertex by the Third Party that submitted the Biosimilar Application (the “Applicant”); provided, however, [***].

  • As soon as practicable following the issuance of any such patent, ImmunoGen and Jazz shall discuss in good faith whether such patent would be infringed by the manufacture and/or sale of the Proposed Biosimilar Product.

  • As soon as practicable after the date of receipt by Jazz of a copy of a Biosimilar Application and related manufacturing information and ImmunoGen’s receipt of notice contemplated by Section 9.5.1, Jazz shall prepare and provide ImmunoGen with a list of those patents within the Licensed Patent Rights that Jazz reasonably believes would be infringed by the manufacture or sale of the Proposed Biosimilar Product (the “Proposed Initial Patent List”).

  • Rights on the Proposed Patent List would be infringed by the commercial marketing of the Proposed Biosimilar Product, and (ii) responds to Applicant’s claims, if any, that the patents within the Licensed Patent Rights on the Proposed Patent List are invalid or unenforceable.

Related to Proposed Biosimilar Product

  • Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.

  • 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.

  • Vapor product means any:

  • Alternative nicotine product means any vaping product, whether or not it includes nicotine, including electronic smoking devices, that can be ingested into the body by chewing, smoking, absorbing, dissolving, inhaling, or by any other means. ‘Alternative nicotine product’ does not include:

  • Licensed Compound means [***].

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • Generic Product means any pharmaceutical product that (i) is sold by a Third Party that is not an Affiliate or licensee of Buyer and (ii) (a) contains the same active pharmaceutical ingredient as the Product or (b) is categorized by the applicable Governmental Entity in a country to be therapeutically equivalent to, or interchangeable with, the Product, such that the pharmaceutical product may be substituted for the Product at the point of dispensing without any intervention by the prescribing physician in such country.

  • 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.

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

  • Biosimilar means a biological product that is highly similar to a specific reference biological

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

  • Spray buff product means a product designed to restore a worn floor finish in conjunction with a floor buffing machine and special pad.

  • Competing Product means […***…].

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

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • Combination Product means any product that comprises a Licensed Compound or Licensed Product sold in conjunction with another active component so as to be a combination product (whether packaged together or in the same therapeutic formulation).

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

  • Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.

  • 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.

  • Third Party Product means a product (whether hardware, software or services) supplied to you by a third party;

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

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