Major Market Countries means the United States, Japan, England, Germany, France, Italy and Spain.
Major Market Country means one or more of the following: Canada, France, Germany, Italy, Japan, Spain, Switzerland, United Kingdom, and United States of America.
Major Market means any of the United States, the United Kingdom, Japan, and any two of the following: France, Spain, Germany and Italy.
Major Markets means [***].
Major EU Country means France, Germany, Italy, Spain and the United Kingdom.
U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.
Major European Countries means France, Germany, Italy, Spain and the United Kingdom.
Licensed Territory means worldwide.
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.
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.
Major Countries means Canada, France, Germany, Italy, Japan, Spain, United Kingdom and the United States.
Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.
Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.
Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.
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. [***]
Initial Indication means the use of a Product for the treatment of opioid addiction.
Major European Country means any of France, Germany, Italy, Spain or the United Kingdom.
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.
Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.
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.
Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).
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.
Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.
NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.
Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.
Selected Countries the jurisdictions listed on Appendix C as such may be amended from time to time in accordance with Article II.