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).

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.

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.

Examples of PH20 Drug in a sentence

• If any material regulatory communication will be oral or in-person, and the PH20 Drug component of a Product is scheduled to be discussed, then Company, to the extent practicable and allowed by the Regulatory Authority, will give Halozyme a reasonable opportunity to attend such oral or in-person meeting, but Halozyme will only participate with respect to the PH20 Drug component of the Product.

• Company shall 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”).

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

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

• If during any such material oral or in-person meeting that Halozyme is not attending and has not declined to attend, the PH20 Drug component of a Product arises, Company will reasonably request, as practicable, a postponement of such discussion until a Halozyme person can participate; provided that in no event will Company be required to postpone any discussions that would have a material effect on Company’s interactions with such Regulatory Authority or Regulatory Approval of a Product.

• 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 PH20 Drug as necessary with respect to obtaining Regulatory Approval for any Product.

• Company shall promptly, within [***], inform Halozyme in writing, in reasonably specific detail, of any material data, results or other information from a pre- clinical study or human clinical trial used (e.g., registrational trial) for (a) a first registration of a Product, (b) label submission of new formulations of such Product in which either the concentration of Company Molecule or PH20 Drug is changed and (c) label extension of such Product outside the therapeutic area of such first registration.

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

• 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.

• Halozyme shall have the right to make reasonable use of Company’s logo and Product logos on its website and ENHANZE marketing materials solely to indicate that the Product incorporates the PH20 Drug.