Dosage Strength definition

Dosage Strength meanss the amount of Peanut Flour expressed as mg peanut protein in a capsule or sachet of Product.
Sample 1
Dosage Strength means the 5mg, 7.5mg, 10mg, 12.5 mg, 15mg, 17.5mg, and 20mg dosage strengths of the Product. 1.4 “Field” means the treatment of (i) prolonged or acute, convulsive seizures in all ages, or such other definition that is consistent with the foregoing and agreed upon in good faith by the Parties in writing, and (ii) the medical indications set forth in Pharmanovia’s present approved label for Valium™(diazepam) in all territories, including those where there is currently not a Valium approved product. 1.5 “Product” means diazepam buccal film. 1.6 “Manufacturing Facility” means, as of the Effective Date, Aquestive’s manufacturing site located at 0000 Xxxxxxxxx Xxxxx, Xxxxxxx, Xxxxxxx (XX) 00000, Xxxxxx Xxxxxx (XXX), FDA Establishment Number 3004395604. 1.7 “Territory” means all of: 1.7.1 the countries of the European Union (as of the Effective Date), Sweden, Switzerland and Norway; (ii) the United Kingdom (England, Scotland, Wales and Northern Ireland); and (iii) the Middle East and North Africa (Algeria, Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Qatar, Saudi Arabia, Syria, Tunisia, United Arab Emirates and Yemen) (the “Original Territories”); and 1.7.2 all of the countries in the world excluding the Original Territories, USA, Canada, and China (the “Extension Territories”). 2.
Sample 1
Dosage Strength means a [* *].
Sample 1

Examples of Dosage Strength in a sentence

  • AND PATHEON DATED <EFFECTIVE DATE HERE>: PRODUCT(S) Product (s) Dosage Form Dosage (Strength) Master Manufacturing Services Agreement Appendix B TO THE QUALITY AGREEMENT BETWEEN TETRAPHASE PHARMACEUTICALS, INC.

  • MSRx shall have the right to access, use and reference the NDA, including any and all data and other information directly relating thereto solely for the purpose of developing and obtaining Regulatory Approvals to market and sell products outside of the Territory, the Indication and/or the Dosage Strength.

  • The first such forecast for each Product by Dosage Strength shall be delivered by Galena to MSRx no later than thirty (30) days after the Effective Date of the Agreement and thereafter on the first Business Day of each February, May, August and November of each calendar year during the Term for the immediately succeeding calendar quarter.

  • Confidential treatment requested with respect to certain portions hereof denoted with “***” EXHIBIT A INITIAL BDSI TPMCXA Dosage Strength of Licensed Product Initial BDSI TPMCXA *** mcg US$*** *** mcg US$*** *** mcg US$*** *** mcg US$*** *** mcg US$*** *** mcg US$*** *** mcg US$*** EXHIBIT B LICENSED XXXXX Xxxx Application No./Date Registration No./Date Renewal Date Goods BELBUCA 1,694,096 09/16/2014 TMA932,689 03/29/2016 03/29/2031 Pharmaceutical preparations, namely analgesics.

  • Dosage Strength Cost Per Bottle 10 mg $*** 15 mg $*** 20 mg $*** 30 mg $*** 40 mg $*** 60 mg $*** 80 mg $*** *** Certain confidential information contained in this document, marked with three asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

  • Levulan® Kerastick®: DUSA Trademarks: Levulan® Kerastick® DUSA® DUSA Pharmaceuticals, Inc.® Dosage Strength / Administration: 20% topical solution Packaging: Standard US packaging; box containing six Kerastick® units.

  • Seller has not voluntarily or involuntarily surrendered, terminated or permitted to lapse or expire any Regulatory Approval used or maintained by Seller in the conduct of the Product Business or the development of the 2.5 mg Dosage Strength or [***] Product in the Buyer Territory, except where any such Regulatory Approval has been not renewed in the ordinary course of business.

  • Neither Seller nor its Affiliates is in violation of the terms of any Regulatory Approval related to the Product, the 2.5 mg Dosage Strength or [***] Product.

  • For clarity, Buyer shall pay to Seller (x) the Floor Price for validation batches of 2.5 mg Dosage Strength Manufactured in connection with the activities described in this Section 2.7, and (y) the Supply Price for 2.5 mg Dosage Strength validation batch product supply that is sold commercially in the Buyer Territory.

  • Dosage Strength Dosage Form Lot Size Bottle Count Price/ Bottle 6-mg Tablet [**] 100 $[**] 18-mg Tablet [**] 30 $[**] 30-mg Tablet [**] 30 $[**] 36-mg Tablet [**] 30 $[**] ActiveUS 164239593v.1 Exhibit B Specifications [Attached] ActiveUS 164239593v.1 Bulk Product Specification Confidential Materials omitted and filed separately with the Securities and Exchange Commission.


More Definitions of Dosage Strength

Dosage Strength means the 50mg dosage strength of the Product. 1.39 “Drug Product” means a chemical drug product as defined in Applicable Law for administration to human subjects. 1.40 “Excluded Claim” has the meaning set forth in Section 15.12.8. 1.41 “Effective Date” has the meaning set forth in the Preamble of this Agreement. 1.42 “Events” means the events set forth in Section 8.1. 1.43 “Executive Officer” has the meaning set forth in Section 15.12.2. 1.44 “Field” means administration of the Product for Amyotrophic Lateral Sclerosis. 1.45 “First Commercial Sale” means the first sale of the Product to a Third Party by Haisco or its Affiliates or agents within the Territory after receipt of Regulatory Approval; provided, that, the following shall not constitute a First Commercial Sale: (a) any sale to an Affiliate or sublicensee (unless the Affiliate or sublicensee is the last entity in the distribution chain of the Product); (b) any use of the Product in clinical trials or other research or Development activities; or (c) the disposal or transfer of the Product for a bona fide charitable purpose, without consideration, including for any compassionate use and/or as “named patient sales”. 1.46 “Force Majeure” has the meaning set forth in Section 15.7. 1.47 “Generic Product” means, with respect to the Product in the Field in the Territory, any Drug Product (other than the Product) that: (a) contains the API as the active pharmaceutical ingredient; and (b) is approved by the NMPA pursuant to an abbreviated application filed with the NMPA pursuant to the Applicable Law of the People’s Republic of China for which the Product is the Reference Listed Drug and which is not held in the name of Aquestive, Haisco or an Affiliate thereof, or sublicensee or subcontractor thereof.
Sample 1
Dosage Strength means a formulation of MT 400 containing [***] mg sumatriptan base or [***] mg sumatriptan (1:1) succinate combined with [***] mg naproxen sodium.
Sample 1
Dosage Strength means the dosage strength with respect to the Product as set forth in the Product Schedule. 1.35 “Dossier” means a copy of the documents submitted to the FDA in support of the NDA for the Product including scientific and technical data relating to the Product and other related information that may be required for Pharmanovia’s submissions for Regulatory Approvals in the Territory; for the avoidance of doubt this includes but not limited to any raw technical data supporting the NDA during pre-assessment and assessment phases. 1.36 “Excluded Claim” has the meaning set forth in Section 14.12.8. 1.37 “Effective Date” has the meaning set forth in the Preamble of this Agreement. 1.38 “Exchange Rate” has the meaning set forth in Section 7.2. 1.39 “Executive Officer” has the meaning set forth in Section 14.12.2. 1.40 “FCPA” means the U.S. Foreign Corrupt Practices Act (15 U.S.C. Section 78dd-1, et. seq.), as amended and as may be further amended after the Effective Date, and any equivalent non-U.S. regulations or standards, if and as applicable during the Term. 1.41 “FDA” means the United States Food and Drug Administration, and any of its successor agencies or departments. 1.42 “Field” means the field with respect to the Product as set forth in the Product Schedule. 1.43 “First Commercial Sale” means with respect to a country in the Territory, the first sale of the Product to a Third Party by Pharmanovia (or any Affiliate or subcontractor of Pharmanovia authorized by Pharmanovia pursuant to this Agreement) within such country in the Territory after Regulatory Approval (and where applicable, (i) pricing or reimbursement approval in such country and (ii) labeling approval) for the Product has been obtained in such country. 1.44 “Force Majeure” has the meaning set forth in Section 14.7. 1.45 “GAAP” means generally accepted accounting principles set forth from time to time in the opinions and pronouncements of the Accounting Principles Board and the American
Sample 1
Dosage Strength means the 0xx, 0.0xx, 10mg, 12.5 mg, 15mg, 17.5mg, and 20mg dosage strengths of the Product. 1.4 “Field” means the treatment of prolonged or acute, convulsive seizures in all ages, or such other definition that is consistent with the foregoing and agreed upon in good faith by the Parties in writing). 1.5 “Product” means diazepam buccal film. 1.6 “Manufacturing Facility” means, as of the Effective Date, Aquestive’s manufacturing site located at 0000 Xxxxxxxxx Xxxxx, Xxxxxxx, Xxxxxxx (XX) 00000, Xxxxxx Xxxxxx (XXX), FDA Establishment Number 0000000000. 1.7 “Territory” means: (i) the countries of the European Union (as of the Effective Date), Sweden, Switzerland and Norway; (ii) the United Kingdom (England, Scotland, Wales and Northern Ireland); and (iii) the Middle East and North Africa (Algeria, Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Qatar, Saudi Arabia, Syria, Tunisia, United Arab Emirates and Yemen). 2.
Sample 1

Related to Dosage Strength

  • Pharmaceutical means any compound or mixture, other than food, used in the prevention, diagnosis, alleviation, treatment, or cure of disease in human and animal.

  • Radiopharmaceutical means any drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any non-radioactive reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance, but does not include drugs such as carbon-containing compounds or potassium-containing salts that include trace quantities of naturally occurring radionuclides. The term also includes any biological product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide.

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • Investment product means a financial instrument (within the meaning of Article 4(1)(15) of MiFID II) or a structured deposit (within the meaning of Article 4(1)(43) of MiFID II).

  • Satellite Manufacturer means, with respect to any Satellite, the prime contractor and manufacturer of such Satellite.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Stable means that a rating is not likely to change

  • Scale means the height, width and length of each building proposed within the development in relation to its surroundings;

  • Cannabis products 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.

  • 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.

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Generic means that no specific brand or name shall be included as part of the specifications unless such a brand or name is required to identify the intent of a purchase, order or proposal.

  • Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate) meets 1 or more of the following:

  • Commercial Product means any such product as defined in FAR 2.101.

  • Manufacturer means the person or body responsible to the approval authority for all aspects of the type approval process and for ensuring conformity of production. It is not essential that the person or body is directly involved in all stages of the construction of the vehicle which is the subject of the approval process.

  • MANUFACTURERS means M/s and shall include their legal representatives, successors, and assigns.

  • Engine Manufacturer means CFM International, Inc.

  • Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.

  • Viable means a disposal system or a public water supply system which is self-sufficient and has the financial, managerial, and technical capability to reliably meet standards of performance on a long-term basis, as required by state and federal law, including the federal Water Pollution Control Act and the federal Safe Drinking Water Act.