Biosimilar Biologic Product definition

Biosimilar Biologic Product is defined in Section 5.5.2(a).
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Biosimilar Biologic Product with respect to a Licensed Product if such product (1) has been licensed as a biosimilar or interchangeable product by FDA pursuant to Section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)), as may be amended, or any subsequent or superseding law, statute or regulation, (2) has been licensed as a similar biological medicinal product by EMA pursuant to Directive 2001/83/EC, as may be amended, or any subsequent or superseding law, statute or regulation, or (3) has otherwise achieved analogous Regulatory Marketing Approval from another applicable Regulatory Authority. In no event will the royalty payable to CytomX for such Licensed Product be reduced below three percent (3%) by operation of this Section 5.5.2(a).
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Examples of Biosimilar Biologic Product in a sentence

  • The paper proceeds to identify ICT- based strategies that are adopted in the SPECA subregion, particularly among SMEs, and the way forward in order to manage and reduce the impact of disasters on businesses and governments.

  • Royalties payable following establishment of Generic Competition with respect to the sale by a Third Party of a product that is a Biosimilar Biologic Product to such Licensed Product in such country shall be payable at [***] of the otherwise applicable rate prior to application of this Section 5.5.2(a).

  • Additional interactions related to the comparative clinical study were held via a Biosimilar Biologic Product Development (BPD) Type 2 meeting on January 28, 2014.

  • Royalties payable following establishment of Generic Competition with respect to the sale by a Third Party of a product that is a Biosimilar Biologic Product to such Pfizer Licensed Product in such country will be payable at [***] of the otherwise applicable rate prior to application of this Section 5.4.2(a).

  • Royalties payable following establishment of Generic Competition with respect to the sale by a Third Party of a product that is a Biosimilar Biologic Product to such Licensed Product in such country shall be payable at fifty percent (50%) of the otherwise applicable rate prior to application of this Section 5.5.2(a).

  • Pre-IND/IND DevelopmentThe design and statistical analysis of the comparative clinical study (Study 301) was discussed with the applicant at a Type 2 Biosimilar Biologic Product Development (BPD) meeting held on 1/14/2013.

  • Review of Biosimilar Biologic Product Applications, s.l.: s.n. Food & Drug Administration, US, 2012.

Related to Biosimilar Biologic 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.

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

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

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

  • Licensed Compound means [***].

  • 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.

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

  • 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.

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

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

  • 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.

  • Combination Product means a product (a) containing a Licensed Product together with one or more other active ingredients, or (b) with one or more products, devices, pieces of equipment or components, but sold for an integrated price (e.g., with the purchase of one product the customer gets a coupon for the other) or for a single price.

  • 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.

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

  • Product Candidate means each of MYO-101, MYO-102, MYO-103, MYO-201 and MYO-301, as defined on Exhibit B, in each case in any form or formulation.

  • 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)).

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

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

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