Additional Indication means any indication other than the Initial Indication.
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.
Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.
First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.
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.
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.
Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.
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.
geographical indication , in relation to goods, means an indication which identifies such goods as agricultural goods, natural goods or manufactured goods as originating, or manufactured in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of such goods is essentially attributable to its geographical origin and in case where such goods are manufactured goods one of the activities of either the production or of processing or preparation of the goods concerned takes place in such territory, region or locality, as the case may be.
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.
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.
Initial Indication means the use of a Product for the treatment of opioid addiction.
Roll-on product means any antiperspirant or deodorant that dispenses active ingredients by rolling a wetted ball or wetted cylinder on the affected area.
Hemp product means the same as that term is defined in § 3.2-4112.
Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]
Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;
Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.
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.
complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.
Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.
Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.
Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.
Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.
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)).
Therapeutically equivalent drug products means drug products that contain the same active
Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.