PH20 Drug definition

PH20 Drug means the active compound, recombinant human PH20 hyaluronidase (i.e. a truncated form of native human PH20 hyaluronidase consisting of residues 36-482, inclusive, of the native human PH20 hyaluronidase).
View Source
PH20 Drug means the active compound, recombinant human PH20 hyaluronidase (i.e. a truncated form of native human PH20 hyaluronidase consisting of residues 36-482, inclusive, of the native human PH20 hyaluronidase or its successor molecule based on this technology), supplied by Halozyme to Roche pursuant to this Agreement.
View Source
PH20 Drug means 150 USP units per container of the active compound, recombinant human PH20 hyaluronidase (i.e. a truncated form of native human PH20 hyaluronidase consisting of residues 36-482, inclusive, of the native human PH20 hyaluronidase), in any liquid injectable or subcutaneously infusible formulation, supplied by Halozyme to Baxter hereunder.
View Source

Examples of PH20 Drug in a sentence

  • Company shall not itself manufacture or purchase from any Third Party the PH20 Drug or any derivative, part or polymorphism (including a splice variant) of the PH20 Drug.

  • Company may use certain bioanalytical, clinical immunogenicity and/or pharmacokinetics assays provided by Halozyme for the PH20 Drug on a stand-alone basis (each, a “Halozyme Assay”) as well as certain formulation and manufacturing assays (“Other Halozyme Assays”).

  • Such dossier will include information within Halozyme’s Control and regarding the PH20 Drug, including chemistry, manufacturing and controls sections and pre-clinical pharmacology and toxicology sections.

  • Halozyme shall own any DMF for the PH20 Drug substance of each Product.

  • Notwithstanding the foregoing, Company shall not conduct any study utilizing the PH20 Drug (a) as the sole active ingredient, (b) in a placebo arm (including with saline or in any other formulation), or (c) in an arm with blood derived products, in each case, without the prior written consent of Halozyme.

  • In addition to Section 5.2.4, Company may request Halozyme to provide authorization to regulatory agencies for Company to cross-reference appropriate regulatory filings previously made by Halozyme or its Affiliates regarding the PH20 Drug as necessary with respect to obtaining Regulatory Approval for any Product.

  • Company shall promptly notify Halozyme of any changes mandated or requested by any Regulatory Authority prior to making any such changes to the dossier or (if applicable) DMF for the PH20 Drug in order to enable the Parties to agree on the appropriate changes to be made.

  • Halozyme shall promptly notify Company of any changes to the dossier or (if applicable) DMF or regulatory registration for the PH20 Drug substance.

  • If Halozyme files, holds, or controls a DMF or other regulatory registration for the PH20 Drug substance: (a) Company shall have the right to cross-reference such DMF or regulatory registration; or (b) in countries where this is not feasible, Halozyme shall provide Company, at Company’s cost, with such information in Halozyme’s Control regarding the PH20 Drug substance of each Product as is reasonably necessary for Company to include in the applicable Regulatory Approval filings for such Product.

  • Except as expressly set forth in this Agreement, Company shall not otherwise have any rights to use or license (or sublicense) the Licensed IP Rights or the PH20 Drug.


More Definitions of PH20 Drug

PH20 Drug means [***].
View Source
PH20 Drug means [***]. 1.78 “Phase I Clinical Trial” means a human clinical trial in any country that is intended to initially evaluate the safety and/or pharmacological effect of a product in subjects or that would otherwise satisfy requirements of 21 CFR 312.21(a), or its foreign equivalent. 1.79 “Phase II Clinical Trial” means a human clinical trial in any country that is intended to initially evaluate the effectiveness of a product for a particular indication or indications in patients with the disease or indication under study or that would otherwise satisfy requirements of 21 CFR 312.21(b), or its foreign equivalent. 1.80 “Phase III Clinical Trial” means a pivotal human clinical trial in any country the results of which could be used to establish safety and efficacy of a product as a basis for an NDA/BLA/MAA or foreign equivalent, or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.
View Source