Additional Ingredient definition

Additional Ingredient means any compound or substance which (i) is contained in a product and (ii) when administered to a patient has a therapeutic or prophylactic clinical effect independent of a Product, either directly or by acting synergistically with or otherwise enhancing the effect of other compounds or substances (including the Product) contained in such product.
Additional Ingredient means any compound or substance which is not any of (x) a Licensed Product, (y) a New Development or (z) developed in the Contemplated Clinical Trials or otherwise results from the development of the Drug hereunder, and (i) which is contained in a product and (ii) when administered to a patient has a therapeutic or prophylactic clinical effect independent of a Licensed Product, either directly or by acting synergistically with or otherwise enhancing the effect of other compounds or substances contained in such product.
Additional Ingredient means any active ingredient, in addition to any Licensed Compound, which is contained in a Licensed Product. Drug delivery vehicles, adjuvants, and excipients shall not be deemed to be “active ingredients”, except in the case where such delivery vehicle, adjuvant, or excipient is recognized as an active ingredient in accordance with 21 C.F.R. § 210.3(b)(7) (as amended).

Examples of Additional Ingredient in a sentence

  • Notwithstanding the foregoing, no adjustment of Net Sales shall be made pursuant to this subsection where the Company obtained a license to such Additional Ingredient under a cross-license and where the sole consideration paid by Company for the license to use the Additional Ingredient was a sublicense of rights in Licensed Technology.


More Definitions of Additional Ingredient

Additional Ingredient means any (i) active pharmaceutical ingredient (API) which is contained in a Combination Product, which, when administered to a patient, has a therapeutic or prophylactic effect independent of the Product contained in such Combination Product, [***] or (ii) [***].
Additional Ingredient means any compound or substance owned by BioLine or to which it has rights which (i) is contained in a product and (ii) when administered to a patient has a therapeutic or prophylactic clinical effect independent of a Licensed Product, either directly or by acting synergistically with or otherwise enhancing the effect of other compounds or substances contained in such product.
Additional Ingredient means any compound or substance owned by BioLine or to which it has rights which (i) is contained in a product and
Additional Ingredient means a therapeutically active ingredient other than one developed using Ramot Technology. Unless recognized as active ingredients by the FDA (or equivalent body), drug delivery vehicles, non-therapeutic adjuvants, and excipients are hereby deemed not to be “therapeutically active ingredients”, and their presence alone shall not be deemed to create a Combined Product for purposes of this Agreement.

Related to Additional Ingredient

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).

  • Feed ingredient means each of the constituent materials making up a commercial feed.

  • Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.

  • Active Ingredient means the clinically active material(s) that provide pharmacological activity in a pharmaceutical product (excluding formulation components such as coatings, stabilizers, excipients or solvents, adjuvants or controlled release technologies).

  • Additional Products means products, services and applications that are not part of the Services but that may be accessible, via the Admin Console or otherwise, for use with the Services.

  • Inert ingredient means an ingredient which is not an active ingredient.

  • Back Ordered Products If product is not expected to ship within the time provided to the TIPS Member by the Vendor, the Member is to be notified within 3 business days and appropriate action taken based on customer request. TIPS Vendor Agreement Signature Form RFP 200401 Food Service Equipment, Chemicals, Supplies and Services Parts Town, LLC dba Heritage Food Service Group, LLC Company Name Address 0000 Xxxxxxxxx Xxxx City Fort Xxxxx State IN Zip 46808 Phone 000-000-0000 Fax 000-000-0000 Email of Authorized Representative XxxxxxxxXxxxxxxx@xxxx.xxx Name of Authorized Representative Xxxx Xxxxxx Title Customer Service Manager Signature of Authorized Representative 5/1/2020 TIPS Authorized Representative Name TIPS Authorized Representative Signature Approved by ESC Region 8 Date пͿлмͿлйлй TIPS VENDORS RESPOND TO ATTRIBUTE QUESTIONS AS PART OF TIPS COMPETITIVE SOLICITATION PROCESS. THE VENDOR’S RESPONSES TO ATTRIBUTE QUESTIONS ARE INCLUDED HEREIN AS “SUPPLIER RESPONSE.” PLEASE BE ADVISED THAT DEVIATIONS, IF ANY, IN VENDOR’S RESPONSE TO ATTRIBUTE QUESTIONS MAY NOT REFLECT VENDOR’S FINAL ATTRIBUTE RESPONSE, WHICH IS SUBJECT TO NEGOTIATIONS PRIOR TO AWARD. PLEASE CONTACT THE TIPS OFFICE AT 866-839- 8477 WITH QUESTIONS OR CONCERNS REGARDING VENDOR ATTRIBUTE RESPONSE DEVIATIONS. PLEASE KEEP IN MIND THAT TIPS DOES NOT PROVIDE LEGAL COUNSEL TO MEMBERS. TIPS RECOMMENDS THAT YOU CONSULT YOUR LEGAL COUNSEL WHEN EXECUTING CONTRACTS WITH OR MAKING PURCHASES FROM TIPS VENDORS. Number: 200401 Addendum 1 Title: Food Service Equipment, Chemicals, Supplies and Services Type: Request for Proposal Issue Date: 4/2/2020 Deadline: 5/15/2020 03:00 PM (CT) Address: Region 8 Education Service Center 0000 XX Xxxxxxx 000 Xxxxx Xxxxxxxxx, XX 00000 Phone: +0 (000) 000-0000 Email: xxxx@xxxx-xxx.xxx Address: 0000 Xxxxxxxxx Xxxx Xxxx Xxxxx, IN 46808 Phone: (000) 000-0000 Fax: (000) 000-0000 Toll Free: (000) 000-0000 By submitting your response, you certify that you are authorized to represent and bind your company.

  • Training Materials means any and all materials, documentation, notebooks, forms, diagrams, manuals and other written materials and tangible objects, describing how to maintain the Facilities, including any corrections, improvements and enhancements thereto to the Bloom Systems which are delivered by Operator to Owner, but excluding any data and reports delivered to Owner.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Additional Indication means any indication other than the Initial Indication.

  • ingredient means any substance, including a food additive used in the manufacture or preparation of food and present in the final product, possibly in a modified form;

  • Product Specifications means the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;

  • Alternative nicotine product means any noncombustible product containing nicotine that is intended for human consumption, whether chewed, absorbed, dissolved, or ingested by any other means. "Alternative nicotine product" does not include any nicotine vapor product, tobacco product, or product regulated as a drug or device by the U.S. Food and Drug Administration (FDA) under Chapter V (21

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Technical Specifications A specification in a document defining the characteristics of a product or a service, such as the quality levels, the environmental and climate performance levels, the design for all needs, including accessibility for people with disabilities, and the evaluation of conformity, of product performance, of the use of the product, safety or dimensions, as well as requirements applicable to the product as regards the name by which it is sold, terminology, symbols, testing and test methods, packaging, marking or labelling, instructions for use, the production processes and methods at every stage in the life cycle of the supply or service, as well as the evaluation and conformity procedures;

  • Aerosol Product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • UNICEF Supply Website means UNICEF's public access webpage available at http://www.unicef.org/supply/index_procurement_policies.html, as may be updated from time to time.

  • labelling means any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a food and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such food;

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • Contract Specifications means the principal trading terms in CFD (for example Spread, Swaps, Lot Size, Initial Margin, Necessary Margin, Hedged Margin, the minimum level for placing Stop Loss, Take Profit and Limit Orders, financing charges, charges etc) for each type of CFD as determined by the Company from time to time. The Contract Specifications appear on the Website.