BL or B/L means Bill of Lading"BL or B/L" means Bill of Lading "CD" means Custom Duty"CD" means Custom Duty
BL or B/L means Bill of Lading"BL or B/L" means Bill of Lading "CD" means Custom Duty"CD" means Custom Duty
A or B means "A or B or both," not "either A or B but not both").
ANDA means Abbreviated New Drug Application.
Active Trade or Business means the active conduct (determined in accordance with Section 355(b) of the Code) of the business conducted by the WRECO Group members. For these purposes, members shall include only those members that are part of WRECO’s “separate affiliated group” within the meaning of Section 355(b)(3)(B) of the Code.
Combination Product means any combination of the Product with one (1) or more other active ingredients, products or services that is not the Product, where such products are sold either as a fixed dose/unit or as separate doses/units in a single package for a single price.
NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.
Sub-Licensee means all person/ agency with whom Licensee has executed sub license agreement as per terms and conditions of license agreement executed between DMRC and the Licensee, for commercial utilization of the Bare Spaces.
Victim or target of Nazi persecution means any individual persecuted or targeted for persecution by
Acquired Entity or Business has the meaning specified in the definition of the term “Consolidated EBITDA.”
Total organ dose equivalent (TODE) means the sum of the deep dose equivalent and the committed dose equivalent to the organ receiving the highest dose as described in 641—40.86(1)“f.”
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.
Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."
Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.
Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.
inherited metabolic disease means a disease caused by an inherited abnormality of body chemistry for which testing is mandated by law;
Major Market Country means each of the United States, Japan, France, Germany, Italy, Spain and the United Kingdom.
Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;
Exempt compound means the same as defined in Rule 2.
Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.
Generic Version means, with respect to a Licensed Product, a product (including a “biogeneric,” “follow-on biologic,” “follow-on biological medicine or product,” “follow-on protein product,” “similar biological medicine or product,” or “biosimilar product”) that: (a) within the U.S., is “biosimilar” or “interchangeable,” with respect to such Licensed Product as evaluated by the FDA or otherwise determined by Applicable Law; or (b) in the ROW, is determined by the applicable Regulatory Authority or by Applicable Law to be “similar,” “comparable,” “interchangeable,” “bioequivalent,” or “biosimilar” to such Licensed Product. For clarity, a Biosimilar of a Licensed Product shall constitute a Generic Version of such Licensed Product.
Serialization within the part, lot, or batch number means each item of a particular part, lot, or batch number is assigned a unique serial number within that part, lot, or batch number assignment. The enterprise is responsible for ensuring unique serialization within the part, lot, or batch number within the enterprise identifier.
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.
Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.
Generic Equivalent or "generically equivalent" means a drug that has an identical amount of the same active chemical ingredients in the same dosage form, that meets applicable standards of strength, quality and purity according to the United States pharmacopeia or other nationally recognized compendium and that, if administered in the same amounts, will provide comparable therapeutic effects. Generic equivalent or generically equivalent does not include a drug that is listed by the federal food and drug administration as having unresolved bioequivalence concerns according to the administration's most recent publication of approved drug products with therapeutic equivalence evaluations.
Co-licensed partner means a person who, with at least one other person, has the right to engage in