Patents or Patent Rights mean any patents and patent applications and all substitutions, divisionals, continuations, continuation-in-parts, any patent issued with respect to any such patent applications, any reissue, reexamination, utility models or design patents, renewal or extension (including any supplementary protection certificate) of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent, and all counterparts thereof in any country.
Phase I Clinical Trial means a clinical trial in humans, the principal purpose of which is to make a preliminary determination of metabolism, pharmacokinetics, dose findings or preliminary safety in healthy individuals or patients.
Phase II Clinical Trial means a clinical trial in humans, the principal purpose of which is to make a preliminary determination that a given product is safe for its intended use and to obtain information about such products efficacy sufficient to permit the design of further clinical trials, or if no further trials are necessary, to enable an MAA filing.
Phase III Clinical Trial means a study in humans designed to confirm the effectiveness of a given product, monitor side effects, compare the product to commonly used treatments, and collect information that will allow the product to be used safely.
Phase IV Clinical Trials means post-marketing studies to delineate additional information about a products risks, benefits, and optimal use, commenced after receipt of Regulatory Approval for a product in the indication for which such trial is being conducted.
Pricing Approval means the approval, agreement, determination or decision from a governmental authority establishing the price and/or reimbursement for Product in the Territory, as required by Applicable Laws prior to the sale of Product in the Territory.
Product means a product supplied by Histogen (or its Affiliate or related party, or a Third Party on behalf of Histogen, its Affiliate or related party) to Pineworld (or its Affiliate, sublicensee or related party) containing the Hair Stimulating Complex (HSC), which (1) is a soluble formulation developed by Histogen as an injectable for hair regrowth, (2) comprises growth factors involved in hair viability such as keratinocyte growth factor (KGF), vascular endothelial growth factor (VEGF), and follistatin, and (3) is produced by neonatal cells grown under simulated embryonic conditions of hypoxia (3-5% oxygen).
Product IP means (a) the Patents as set forth in Exhibit 1 hereto (b) the Histogen Trademarks, and (c) any other Intellectual Property necessary or reasonably useful for the manufacture, use or sale of the Products that are Controlled by Histogen or its Affiliates as of the Effective Date or at any time during the Term of the Agreement.
Product Approval means the approval of a governmental authority necessary for the marketing and sale of Product in the Territory, which may include the approval of an MAA (but shall not include any Pricing Approvals).
Regulatory Approval means all necessary approvals (including INDs, NDAs, Product Approvals, Pricing Approvals, import permits, IDLs and, in each case any supplements and amendments thereto), licenses, registrations or authorizations of any governmental authority, necessary for the distribution, use, promotion and sale of Product in the Territory.